USD 2337

Pall Solutions
for the
BioPharmaceutical
Industry
Contents and Introduction
 Global Expertise

Pall Corporation is the leading global provider Time

of filtration, purification and separation
technologies to the diverse and rapidly
expanding Life Sciences market. Its products
are used from the earliest stages of discovery
and development of new drugs, through
production and delivery of therapies for the
prevention, diagnosis and treatment of
disease. Our total sales turnover is more than
US$ 1.7 billion.
Capabilities
Pall’s unique capability comes from a strong
blend of BioPharmaceutical expertise, leading
technologies and customer support. We
provide reliable and fully integrated solutions
for design, manufacture, sales and servicing of
our products. Comprehensive support is
available in all parts of the world.
Timely process development and the
procurement of production capacity are
crucial for our customers’ success. We know
development of new drug products is a
demanding and costly exercise. Pall has
expert teams available at every stage of the
process for fast and flexible solutions.
Quality
Drug products have to be available at a
consistently high quality with manufacturing
and equipment subject to comprehensive
validation and documentation. Pall® products
already present in more than 1000
applications, fulfill exacting demands in design
and manufacture, resulting in excellent
process reproducibility and reliability.

Experience

Pall Life Sciences handles all purification,

filtration, and separation applications from bulk
preparation and synthesis to biological and
biotech-based production of active
ingredients, to downstream processing and
formulation and final filling of products. More
than 50 years experience in providing proven
engineered solutions is a good basis to
partner with us.

ii
 Contents

Introduction Page Direct Flow Liquid Filtration Page Filter Housings Page
Introduction ii Mini Kleenpak Sterilizing-grade 77 Junior B series Filter Housings 145
Table of Contents iii Capsule Filters Sealkleen™ Filter Housings 147
Usage Instructions iv Kleenpak Capsules with 79 Pall Advanta™ Junior Filter Housings 149
Supor® EKV Membrane Assemblies
Pall Advanta Junior F Liquid 151
Supor EKV Sterilizing-grade 81 Filter Housings
Applications Filter Cartridges
Pall Advanta ALT Liquid Filter Housings 153
Biotechnology and Cell Culture 2 Supor EBV Sterilizing-grade 83
Flow Diagram Filter Cartridges Pall Advanta In-Line Liquid and Gas 155
Filter Housings
Blood Products and Fractionation 4 Kleenpak Capsules with 85
Flow Diagram Fluorodyne® II Membrane Assemblies Pall Advanta Jacketed Housings 157
API - Active Pharmaceutical Ingredients 6 Fluorodyne II Hydrophilic PVDF 87 Pall Advanta AGT Gas Filter Housings 159
Flow Diagram Filter Cartridges Pall Advanta AVL Liquid and Gas 161
Formulation and Filling 8 Kleenpak Capsules with 89 Filter Housings
Flow Diagram Ultipor N66 Membrane Assemblies Pall Advanta ALT4 Multi-round Housings 163
Water Purification 10 Sealkleen Membrane Filter Cartridges 91 Veladisc™ Depth Filter Module Housings 165
Flow Diagram
Ultipor N66 Sterilizing-grade 93 Pall Advanta Electrical Trace Heater 167
Filter Cartridges
MDS Junior Style Industrial Housings 168
Direct Flow Liquid Filtration Kleenpak Capsules with 95
IOL and IDL Single-round 169
Depth Filter Sheets, Modules, and Capsules Posidyne® Membrane Assemblies
Industrial Housings
Bio-Series Depth Filter Sheets 15 Posidyne Filter Cartridges 97
PCY Polypropylene Filter Housings 171
P-Series Depth Filter Sheets 17 Novasip™ Liquid Sterilizing-grade 99
Megaplast™ Plastic Filter Housings 173
and Modules Capsule Filters
K-Series Depth Filter Sheets 19 Kleenpak Nova Sterilizing-grade 101
and Virus Removal Capsule Filters Tangential Flow Filtration
T-Series Depth Filter Sheets 21
Novasip DV20 and DV50 103 Tangential Flow Filtration Technology 177
Z-Series Depth Filter Sheets 23
Virus Removal Filter Capsules
E-Series Depth Filter Sheets 25 Ultrafiltration and Microfiltration 179
Ultipor VF Grade DV50 105 TFF Cassette Membranes
Supradisc® Depth Filter Modules 27 Virus Removal Filter Cartridges –
SBF Junior Style Matching Membrane Cassettes to 180
Supradisc II Modules 29
Applications
Supracap™ 60 Depth Filter Capsules 31 Ultipor VF Grade DV20 Virus Removal 107
Filter Cartridges Minimate™ Tangential Flow 181
Supracap 200 Encapsulated 33 Filtration Capsules
Depth Filter Modules Ultipor VF Grade DV50 Virus Removal 109
Filter Cartridges Minimate TFF System 183
Tangential Flow Filtration 185
Direct Flow Liquid Filtration Membrane Cassettes
Membrane and Depth Filter Cartridges, Air and Gas Filtration Tangential Flow Filtration 188
Capsules and Disposable Systems Novasip Capsules with Emflon PFR 113 Membrane Cassette Holders
Disposable Systems 37 Membrane Assemblies Pilot and Process 194
Kleenpak™ Connectors 39 Kleenpak Capsules with Emflon II 115 Development Capabilities
Membrane Assemblies Tangential Flow Filtration Systems 195
Kleenpak Nova Particulate and 41
Prefilter Capsule Filters Kleenpak Capsules with Emflon PFR 117 TFF Polymeric Hollow Fiber Membranes 197
Membrane Assemblies and Ceramic Modules
PreFlow™ Capsule Filters 43
Kleenpak Capsules with HDC II 119 Microza* Membranes 198
Mini Profile® Capsule Filters 45 Gas Filter Assemblies
Kleenpak Capsules with 47 Membralox® Ceramic 203
Emflon PFR Junior-style Filter Cartridges 121 Membrane Products
HDC® II Filter Assemblies
Emflon PFR Sterilizing-grade Filter 123 Pallsep™ Vibrating Membrane 205
HDC II Junior Style Filter Cartridges 49 Cartridges Filtration Technology
Profile II Filter Cartridges 51 Emflon CPFR High-temperature 125 Sheet TFF Membranes 207
Profile II Plus Filter Cartridges 53 Sterilizing-grade Filter Cartridges
Profile Star Filter Cartridges 55 Emflon PFA Filter Cartridges 127
Chromatography
StarClear™ Filter Cartridges 57 Ultipor GF Plus Air and Gas Filters 129
Mustang® Membrane 211
Profile Filter Cartridges with 59 HDC II Gas Filter Cartridges 131
Chromatography Starter Kits
Ultipleat® Construction PallCell Air and Gas Filter Cartridges
®
133
Mustang Coin Unit 215
HDC II Filter Cartridges 61 LG Liquid and Gas Coalescing 135
Mustang Chromatography Capsules 217
Ultipor® GF Plus Filter Cartridges 63 Filter Cartridges
and Cartridges
PreFlow Filter Cartridges 65 Porous Metal Filters for
Resolute** Chromatography Columns 221
Marksman™ Elements with 67 Liquid and Gas Service
Resolute Slurry Packing Systems 223
Nexus A Series Filters Rigimesh® Sintered Metal Mesh 137
Filter Cartridges PK Chromatography Skids 225
Marksman Elements with 69
Poly-Fine® XLD Series Filters PSS Porous Metal Filter Cartridges
®
139
Marksman Elements with 71 PMM® Metal Membrane Filter Cartridges 141
Poly-Fine® II Series Filters
Palltronic® Instruments
Emflon® FM Filter Cartridges 73 Palltronic Flowstar XC 229
Filter Integrity Test Instruments
Ultipor N66 Particulate and 75 * Microza is a trademark of Asahi Kasei Corporation.
Bioreduction Filter Cartridges Palltronic Aquawit XC System 231 iii
** Resolute is a trademark of Euroflow (UK) Ltd.
 Palltronic® Instruments Page Pall Technical Services Page Appendices and Index Page
Palltronic Flow Check Device 233 Pre-Inspection Reviews 253 Filter Configurations and Dimensions 272
Palltronic Training Program 234 Filter Integrity Test Equipment 255 O-Rings and Gaskets Reference Guide 274
Drivers for Palltronic Filter Integrity 235 Validation Index 275
Test Instruments Troubleshooting and 257 Trademarks 282
Palltronic Filter Manager 237 Consultancy Services
International Offices 283

Pall Technical Services Systems

Process-Specific Filter Validation 241 Pall Process Engineered Systems 261
Kleenpak Connector Validation 243 DGM Plate and Frame Filter Systems 263
Disposable Filtration System Validation 245 ZHF Centrifugal Discharge 265
Contamination Analysis 247 Filter System
Process Development and 249 PEF Multi Purpose Processor 267
Optimization Pure Water Systems 269
Training 251

How to Use this Catalogue

Selecting the Appropriate Pall Solution
You may refer to the diagrams in the Applications section
(pp. 8 – 17) for Pall products that have been optimized for specific
unit operations.
The catalog is organized into the following sections:
– Applications
Symbols
The following symbols are used throughout the catalog to identify
product categories. Symbols that apply to a specific product appear
in full color. Symbols that do not apply to the product appear faded.
Key to Product Symbols

– Direct Flow Liquid Filtration

Depth Filter Sheets, Modules and Capsules Fluid Clarification, Cartridges
Bioburden Reduction and
– Direct Flow Liquid Filtration
Prefiltration
Membrane and Depth Filter Cartridges, Capsules Modules
and Disposable Systems
– Air and Gas Filtration (including porous Metal Filter Cartridges) Sterile Filtration –
Sanitary Housing Sheets
– Housings for direct-flow filtration Cartridges
Applications
– Tangential Flow Filtration (including holders)
UpscaleSM Progarm
– Chromatography (Mustang and Resolute technologies)
Industrial Housing
– Palltronic Instruments (for integrity testing and filterability)
Tangential Flow Filtration
– Pall Technical Services
Virus Removal
– Palltronic Services
Chromatography
– Systems.
Capsules

iv
Applications
 Biotechnology and Cell Culture
Flow Diagram

Upstream Processing Cell Harvest and

Product Separation
Innoculation

Media Filtration Kleenpak

Connector
Exhaust

Particulate Virus Sterilizing-grade HDC II J012 Emflon PFR

Removal Filter Liquid Filter Air Prefilter Sterilizing-grade
Filter Air Filter

Aeration

Liquid Gas
Coalescer

Fermenter

Emflon PFR Depth Filtration

Particulate Sterilizing-grade
Removal Air Filter
Filter

Aeration and Exhaust Media Filtration

LG Liquid and Gas Coalescing 135 Particulate Removal Liquid Filters
Filter Cartridges PreFlow™ Filters 43, 65
Particulate Removal Air Filters Virus Removal Filters
HDC® II Gas and Vent Filters 119, 131 Ultipor VF Virus Removal Filters 103 – 109
Ultipor® GF Plus Air and Gas Filters 129 Sterilizing-grade Liquid Filters
PallCell® Air and Gas Filters 133 Supor® EKV Filters 77
Sterilizing-grade Air Filters 79
Emflon® PFR Sterilizing-grade 113 81
Membrane Filters 117 101
121 Fluorodyne® DFL and DJL Filters 85
123 87
99
101
Innoculation
Kleenpak™ Connector 39
Cell Harvest and Cell Separation
Depth Filtration
Perfusion Culture
SupraDisc® Depth Filter Modules 27
Microza* Hollow Fiber Modules 198
SupraCap™ 200 Encapsulated 33
Depth Filter Modules
P-Series Depth Filter Sheets 17
* Microza is a trademark of Asahi Kasei Corporation.

2
 Biotechnology and Cell Culture
Flow Diagram

Downstream Processing and Purification

Supor EKV Supor EKV

Buffer Filter Buffer Filter

Capture Sterilizing-grade Concentration Purification

Chromatography Liquid Filtration Diafiltration Chromatography

Emflon PFR
Sterilizing-grade
Air Filter

Virus Sterilizing-grade
Tangential Flow Filtration Polishing Removal Liquid Filter
Chromatography Filtration

Formulation
and Filling

Storage Mustang Membrane

Chromatography

Cell Harvest and Cell Separation

Tangential Flow Filtration Sterilizing-grade Buffer Filters
Supor Cassettes 186 Supor EKV Filters 77
Microza* Hollow Fiber Modules 198 79
81
Membralox® Ceramic Modules 203 101
PallSep™ VMF System 205 Sterilizing-grade Vent Filters
Emflon PFR Sterilizing-grade 113
Downstream Processing and Membrane Filters 117
Purification 121
123
Prefiltration and Clarification
Concentration and Diafiltration
PreFlow Filters 43, 65
Omega™ and Regen™ Cassettes 186
Sterilizing-grade Liquid Filters for
Product Filtration Purification Chromatography
Supor EKV Filters 77 Resolute** Chromatography Columns 221
79 and Systems 225, 261
81 Contaminant Removal/Reduction
101 Mustang® Membrane Chromatography 211
Fluorodyne DFL and DJL Filters 85 215
87 217
99 Virus Removal Filters
101
Ultipor VF Virus Removal Filters 103
105
107
109
Note: The products listed are examples only and
others may be more suitable for your application.
Specific recommendations can be obtained from your
* Microza is a trademark of Asahi Kasei Corporation. 3
local Pall or distributor office.
** Resolute is a trademark of Euroflow (UK) Ltd.
 Blood Products and Fractionation
Flow Diagram

Cryo-Precipitation Fractionation
Ethanol Filtration

Fractionation
Emflon PFR - Albumin
Sterilizing-grade - Globulin
Vent Filter
Particulate Sterilizing-
Removal grade
Filter Liquid Emflon PFR
Filter Sterilizing Vent
Filter
Anion
Centrifugation Exchanger

Plasma Ethanol Filtration Precipitate

Harvest

Capsule Bag Systems

Kleenpak Connector

Particulate Sterilizing-grade
Removal Liquid Filter Storage Membraplan DG/DGM with
Cryo-Precipitation Cryo-Poor Plasma Filter
- Factor VIII, Fibrinogen - Factor VII, IX, ATIII, C1 Supradur 50P or E-Series
Filter Sheets

Supradisc Bio-Depth
Filter Modules

Supor EKV
Buffer Filter

Immunoaffinity
Chromatography
Virus Fraction I
Inactivation
Particulate Supor EKV
Removal Filter Sterilizing-grade
Liquid Filter
Fraction II + III
precipitates
Immunoglobulin

Supor EKV
Emflon PFR
Buffer Filter Fraction III
Sterilizing Vent
Filter

Purification of
Supor EKV
Storage Contaminant Sterilizing-grade Cryo-Factors Fraction IV
Removal Filter

Formulation Fraction V
and Filling Albumin

Capsule Bag Systems Mustang Diafiltration

Kleenpak Connector Membrane Centrasette
Chromatography System with
Omega Cassettes

4
 Blood Products and Fractionation
Flow Diagram

Ethanol Filtration
Particulate Removal Filter
Emflon® FM 73
Purification of Sterilizing-grade Liquid Filter
Immunoglobulin Ethanol Filtration Supor® EKV Filters 77
79
Emflon PFR 81
Sterilizing 101
Vent Filter
Fluorodyne® DFL and DJL Filters 85
87
Particulate Sterilizing-grade
Removal Liquid Filter
99
Filter 101

Separation Paste III Harvest Paste II Vent Filters

Sterilizing-grade Vent Filters
Emflon PFR Sterilizing-grade 113
Membrane Filters 117
Suspension Suspension 121
and Precipitation Depth Filtration and Precipitation Depth Filtration
123

Disposable Bag Systems

Emflon PFR Supor EKV Supor EKV Kleenpak™ Connector 39
Sterilizing Vent Buffer Filter Buffer Filter Disposable Systems 37
Filter

Virus
Chromatography
Removal Resolute* Chromatography Columns 221
and Systems 225, 261
Mustang® Membrane Chromatography 211
215
Formulation
and Filling 217

Suspension Process Centrasette

Chromatography System with Buffer Filtration
Omega Cassettes
Sterilizing-grade Buffer Filters
Supor EKV Filters 77
Depth Filtration 79
81
Clarification Color Removal
101
Supor EKV
Sterilizing Product Filtration
Liquid Filter
Tangential Flow Filtration
Omega™ Cassettes 186
Particulate Removal Filters
Supradisc EKS P Supradisc
AKS5/AKS6 PreFlow™ Filters 65
Depth Filters
SupraDisc® Depth Filter Modules 27
Emflon PFR Supor EKV
Sterilizing Vent Buffer
SupraCap™ 200 Encapsulated 33
Filter Filter Depth Filter Modules
Purification of Depth Filter Sheets 15–25
Albumin Sterilizing-grade Filters
Supor EKV Filters 77
79
81
101
Formulation Fluorodyne DFL and DJL Filters 85
Pasteurization and Filling
87
Storage Centrasette 99
System with 101
Omega Cassettes
Virus Removal Filters
Ultipor® VF Virus Removal Filters 103
105
107
109
Note: The products listed are examples only and
others may be more suitable for your application.
Specific recommendations can be obtained from your
local Pall or distributor office.

* Resolute is a trademark of Euroflow (UK) Ltd.

5
 API - (Active Pharmaceutical Ingredients)
Flow Diagram

Upstream Process Activated Carbon or

Catalyst Removal
Tank Farm Supracap and Supradisc
Depth Filters

Point-of-Use Inert Gas

Particulate
Removal Filter Gas
Reactor
Filter

Marksman Filters

Activated
Carbon or Catalyst

First
Particulate
Removal
ZHF Automated Systems
Filter
Point-of-Use
Sterilizing-grade
Filter

Activated
Carbon Modules

AKS Depth Filter

Modules

Upstream Process Crystallization

Solvent Particulate Removal Filters Solvent Particulate Removal Filters
Emflon® FM 73 Emflon FM 73
Prefiltration or 41–76 Solvent Sterilizing-grade Filters
Particulate Removal Filters Supor® EKV Filters 77
Gas and Vent Sterilizing-grade Filters 121–126 79
81
101
Activated Carbon or Catalyst Removal
Fluorodyne® DFL and DJL Filters 85
SupraCap® 200 Encapsulated 33 87
Depth Filter Modules 99
Depth Filter Sheets 17, 19 101
Depth Filter Modules 29
31
Solvent Recycling
Marksman™ Bag Filters 67–72
Liquid – Liquid Coalescer
ZHF Automated Systems 265
Note: The products listed are examples only and
others may be more suitable for your application.
Activated Carbon Filters Specific recommendations can be obtained from your
local Pall or distributor office.
AKS Depth Filters 27, 33

6
 API - (Active Pharmaceutical Ingredients)
Flow Diagram

Crystallization Solvent Recycling

Reactor
Clean
Distillation Solvent
Column
Solvent
Filter

Solvent
Filter
Particulate
Removal
Filter

Centrifugal
Discharge
System

Water
Removal
Liquid – Liquid
Coalescer

Centrifuge

Formulation
and Filling

Dryer

7
 Formulation and Filling
Flow Diagram

Bulk Product
Emflon PFR
Sterilizing Vent
Filter

Emflon PFR
Sterilizing Vent
Filter
Formulation
Tank

Particulate Sterilizing-grade
Removal Liquid Filter Intermediate
Filter Tank

Water

Liquid Filters
Particulate Removal Filters Disposable Systems
PreFlow™ Filters 43, 65 Kleenpak™ Connector 39
Sterilizing-grade Liquid Filters Disposable Systems 37
Supor® EKV Filters 77
79
Integrity Test Instruments
81
101 Palltronic® Flowstar XC instrument 229
Fluorodyne DFL and DJL Filters
®
85 Palltronic AquaWIT XC system 231
87
99 Automated Systems
101
Automated Systems 261

Gas and Vent Filters

Pharmaceutical Services
Sterilizing-grade Filters
Pharmaceutical Services 241-257
Emflon® PFR Sterilizing-grade 113
Membrane Filters 117 Note: The products listed are examples only and
121 others may be more suitable for your application.
123 Specific recommendations can be obtained from your
local Pall or distributor office.
Emflon CPFR High Temperature 125
Membrane Filters

8
 Formulation and Filling
Flow Diagram

Filling

Particulate Sterilizing-grade
Removal Liquid Filter
Filter

9
 Water Purification
Flow Diagram

Ultipleat Profile
Pure Water Storage
Ultipleat High-flow Particulate Water Tank
Particulate Removal Filter Sterilizing-grade
Removal Filter Vent Filter

Two Stage Reverse Osmosis

High Purity Water/Purified Water

Municipal
Water

Ultrafiltration Pure Water

Profile Coreless
Particulate Softening
Removal Filter Activated Ion
Carbon Exchange
Storage

Point-of-Use
Marksman Sterilizing-grade
Particulate Carbon Particulate
Removal Filter Removal Filter Liquid Filter
Removal 0.1 µm and Distillation
Bag Filter 0.2 µm
Sterilizing-grade
Water for Injection
Filters

10
 Water Purification
Flow Diagram

Liquid Filters
Metal Filters
Rigimesh® Sintered Metal Mesh Filter 137
Particulate Removal Filters
High Flow Ultipleat®
Profile® Coreless
Gas and Storage Tank/ Sterilizing-grade Marksman™ Bag Filter 67
Compressed Air Fermenter Vent Filter 69
Vent Filter 71
Profile® Star Filters 55
Carbon Removal Filters
Autoclave/
Freeze Dryer
Steam Sterilizing-grade Liquid Filters
Supor® EKV Filters 77
79
81
101
Pharmaceutical Production Formulation Fluorodyne® DFL and DJL Filters 85
Process and Filling
87
99
101

Pure Water Buffers and Gas and Vent Filters

Systems Media
Sterilizing-grade Filters
Emflon PFR Sterilizing-grade 113
Membrane Filters 117
121
123
Emflon CPFR High Temperature 125
Membrane Filters
Emflon PFR Steam Filters
Sterile Gas
Filter PSS® Porous Metal Filter Cartridges 139
Note: The products listed are examples only and
Washing of Primary Packaging others may be more suitable for your application.
Compressed Air Specific recommendations can be obtained from your
for Blowing local Pall or distributor office.
Down
Washing Machine

Prewash Final Wash

Water for
Injection
Profile Star Rigimesh Fluorodyne DLF
Particulate Stainless Steel Liquid Filter
Removal Particulate Sterilizing-grade
Filter Removal
Filter
Pure Water

11
12
Direct Flow Liquid Filtration
Depth Filter
Sheets, Modules, and Capsules
 Depth Filter Sheets, Modules and Capsules
Pall offers a complete line of cellulosic depth
filter sheets, modules and capsules for use in
the pharmaceutical industry. A broad array of
depth filter grades, from coarse filtration
through fine prefiltration, is available to ensure
maximum efficiency for every process. Pall’s
depth filter sheets are available in a wide
range of sizes for use in process development
to large-scale manufacturing.
Depth filter sheets provide an economical and
efficient means of coarse filtration, clarification,
and prefiltration for a wide variety of
pharmaceutical and biological fluids. In
addition to the mechanical depth filtration
mechanisms, Pall’s depth filter sheets possess
either a slight positive charge or a high
positive charge that further enhances their
filtration capacity. This inherent Positive Zeta
Potential helps to remove negatively-charged
contaminants from the fluid stream.
14
In addition to the full line of depth filter sheets,
Pall also offers a complete line of Supradisc
and Supradisc II (SD II) depth filter modules.
The Supradisc modules are designed around
a rigid polypropylene core to ensure the
integrity of the filter modules throughout their
use. The SD II modules offer the advantages
of an extremely rigid and durable design with
patented clip construction and reverse-flow
capabilities. The depth filter modules offer
decreased setup and operation while
increasing the safety of the process.
Supradisc modules are also available in an
encapsulated Supracap format for single-use
processing minimizing cleaning and cleaning
validation
The Supracap 60 Depth Filter Capsules offer
ease of use in a disposable device for scale-
up testing and process optimization.
 Bio-Series Depth Filter Sheets
Exceptional Purity and Low Protein Binding

Extractables Release The BIO series of depth filter sheets from 18

500 0.45

450
Pall (formerly SeitzSchenk) was specially
0.4 16
400
developed for the strict requirements of the
0.35 14
biotechnological and pharmaceutical
Al/Ni – Ions in ppb

350
Fe – Ions in ppm

Retention rates (µm)

0.3 12
300 industries. Stringent manufacturing and
0.25
250 control methods in line with requirements 10
0.2
200 of the pharmaceutical industry guarantee 8
0.15
150 constant high filtration quality as well as 6
0.1
100 highest purity of the filter medium.
0.05 4
50

0 0
BIO depth filter sheets are available with 2
Bio Depth Filter Non-Pall Non-Pall three different retention rates.
Ion Reduced Standard 0
Product Bio 10 Bio 20 Bio 40
Highly purified natural and modified
Extractables in the first rinse fraction (5 L/m2) ∆p = 1 bar (14.5 psi) with water at 20 °C (68 °F).
■ Aluminum ■ Iron Ions ■ Nickel
celluloses are used in manufacture. These
celluloses are completely free from
1200
inorganic materials like kieselguhr, perlite,
Permeability L/m2/min at 1 bar (14.5 psi) 1100
or glass fibers. The distinguishing feature of
1000
the BIO depth filters is the low release of 900
extractables. BIO depth filters release 800
essentially less extractable metal ions, such 700

as iron, aluminum, or nickel, than any other 600

filter sheet. 500

400
When filtering ion-sensitive products like 300
parenteral solutions, therapeutics, and 200

dialysis solutions, as well as protein-based 100

diagnostics, a considerably better filtrate 0

Bio 10 Bio 20 Bio 40
quality is reached with BIO depth filters.
∆p = 1 bar (14.5 psi) with water at 20 °C (68 *F).
Due to their electrokinetic adsorption
potential, positively-charged resins increase 40

retention of the smallest particles well 35

above mechanical separation alone.
30
Rel. protein loss

The use of selected cellulose fibers and 25

their arrangement result in a very low 20
protein adsorption in the filter matrix and
15
excellent rinse-out after filtration.
10
Pall BIO series depth filters are used
5
worldwide in biotechnological and
0
pharmaceutical applications to provide BIO Depth Filter Conventional
Filter Sheet
reliable and economical filtration.
Tested with bovine serum albumin (20 – 60 µg/mL).
■ Without post rinse ■ With post rinse

15
 Bio-Series Depth Filter Sheets
Technical Specifications

Characterization
The tests are carried out according to the methods of the Technical
and Analytical Work Group within the European Depth Filtration
Association or in accordance with in-house test methods.

Technical Data
Sheet Weight per Area Thickness Ash Content Extractable Ions Soluble in 0.025 µm H2 SO4
(g/m2) (mm) (%) (mg/m2)

Ca Fe Al

BIO 10 1400 3.0 <1 350 5 1

BIO 20 1400 3.2 <1 350 5 1

BIO 40 1200 3.5 <1 350 5 1

Heavy metals < 50 ppm (according to the recommendation XXXVI/1 BgVV-German Federal Institute for Health Protection of Consumers and Veterinary Medicine). The figures quoted in the
diagrams and tables should be regarded as guidelines.

Application Areas Sheet Application

Sterilization and Bacteria Reduction
BIO 10 Cell harvest, clarifying filtration of fermenter broths (cell separation), clarifying filtration of
TFF permeate, clarifying filtration of cell cultures, filtration of CHO cells, protection for
chromatography columns and membrane processes, protection of sterile filter membranes,
filtration of pharmaceuticals and BioPharmaceuticals, filtration of therapeutic proteins,
vaccines, diagnostics and blood products, therapeutic DNA, filtration of nutrients.

Sterile Prefiltration BIO 20 Cell harvest, clarifying filtration of TFF permeate, clarifying filtration of centrifugation
supernatant, filtration of biopharmaceuticals, filtration of therapeutic proteins, of
vaccines, diagnostics and blood products, plasma fractionation (fine filtration),
filtration of nutrients, protection of chromatography columns and membrane
processes, protection of sterile filter membranes.

Fine Clarifying Filtration BIO 40 Fine filtration of pharmaceuticals and biopharmaceuticals, plasma fractionation (fine
filtration, protein separation), filtration of antibiotics, filtration of
vaccines, separation of adsorbents, filter media, and extraction residues.

BIO Series Depth Filters meet the following Requirements:

• Recommendation XXXVI/1 BgVV, 21 CFR 177.260 e-k
• Biological Safety: Cytotoxicity, Haemolysis, Plastic Class V
• Drug Master File

The following Certificates and Documentation are available:

• Certificate of Compliance according to
DIN 50049 – 2.1/EN 10204-2.1
• Special Test Report according to DIN 50049 – 2.3/EN 10204-2.3
• Factory Acceptance Test (on demand)
• Pharmaceutical Documentation P Depth Filters
• Materials Safety Data Sheet

16
 P–Series Depth Filter Sheets and Modules
Optimized for Low Endotoxins and Low Extractables

Due to their electrokinetic adsorption • K 100 P up to K 250 P are depth filter

potential, positively charged resins increase sheets and modules for fine filtration in
the retention of smallest particles, such as the pharmaceutical and biotech-
P-series depth filter sheets and modules whole and crushed cells, cell lysate nological industries. The application
were developed for the strict requirements components, endotoxins, DNA and area is filtration of fermenter broth, TFF
in biotechnological and pharmaceutical viruses, which usually are negatively permeate, therapeutical proteins,
industries. For many years, manufacturing charged. Pall P-series depth filters are vaccines, diagnostics and blood
has been carried out and stringent used worldwide in biotechnological and products, filtration of nutrients,
in-process control methods in line with the pharmaceutical applications and provide separation of adsorbents, filter media
requirements of the pharmaceutical reliable and economical filtration. and extraction residues.
industry. This assures constant high • K 700 P up to K 900 P are depth filter
filtration quality as well as a very high purity Product Range and Typical sheets and modules for coarse filtration
of the filter medium, both features our Applications in the biotechnological industries. The
customers benefit from. • EKS P up to Supra 80 P are application area is filtration of fermenter
The P-series depth filter sheets and microorganism-reducing filter sheets broth, cell culture, therapeutical
modules are available in 10 different types. and modules for depth filtration in the proteins, vaccines, diagnostics and
Due to specific manufacturing methods the biotechnological and pharmaceutical blood product.
distinguishing feature of the P-series is high industries. The application area is
purity resulting in a very low release of clarification of fermenter broth, TFF Features and Benefits
extractables. The depth filter material has permeate, cell cultures, protection of
• Low unspecific protein binding
been especially optimized to provide a very chromatography columns and
low release of endotoxins (< 0.02 EU/mL membrane processes, protection of • High dirt hold capacity
after flushing with 50 L/m2 WFI). sterile filter membranes, filtration of • Good membrane protection
therapeutical proteins, vaccines,
The filter matrix especially developed for • Long life time
diagnostics and blood products,
the P-series assures retention rates down
filtration of nutrients and DNA removal. • Well graded sheets over the entire range
to 0.1 µm and thus enables an optimal
pre-filtration of biological products like no • P-grade sheets and Supradisc
other depth filter for the protection of modules are steam sterilizable at
downstream process steps. 125 °C (257 °F) for 30 minutes
• All plastic components used in
constructions meet the specifications
2500 for the biological test listed in the
2200 current version of the USP class VI
2000 121° C
• All P-grade depth filter sheets used in
Permeability (L/m2/min)

1500 constructions meet the specifications

980
for the biological test listed in the
1000 current version of the USP class V
600 121 °C
500
240 • P-grade sheets in sizes
130 159
29 41 64 93 > 400 x 400 mm (16 x 16 in.) and
0
Supradisc modules as well as all their
P

-P

-P

P
P
P
S-

50

0
M

0
80
1

10

25

70

90
20
EK

EK

components are fully traceable

EK

KS

A
K

K
K
PR
A
PR

SU
SU

∆p = 1 bar (14.5 psi), T = 20 °C (68 °F), medium H2O

17
 P–Series Depth Filter Sheets and Modules
Technical Specifications

Typical Values for Ions after Flushing with 50 L/m2 WFI(1) Technical Data
Ca Mg Fe Cu Al Ni Code Retention Ash Content Endotoxin
0.5 ppm < 0.1 ppm < 0.1 ppm < 0.1 ppm < 50 ppb < 10 ppb Rate (µm) (%) Level(3)
(1)
The tests are carried out according the methods of the Technical and Analytical Work PEKS 0.1 – 0.3 58 < 0.02 EU/mL
Group within the European Depth Filter Association or in accordance with in-house
tests methods. PEKM 0.2 – 0.4 48 < 0.02 EU/mL
PEK1 0.25 – 0.45 47 < 0.02 EU/mL
Operating Conditions(2) P050 0.5 – 0.85 46 < 0.02 EU/mL
Maximum Operating 80 °C (176 °F) P100 1.5 – 3.5 45 < 0.02 EU/mL
Temperature
P080 1.5 – 4.0 49 < 0.02 EU/mL
Maximum Operating 2.4 bard (35 psid) P200 2.8 – 6.0 43 < 0.02 EU/mL
Pressure
P250 4.0 – 9.0 44 < 0.02 EU/mL
(2)
With compatible fluids, which do not soften, swell or adversely affect the products or
their material of construction. P700 6.0 – 15.0 45 < 0.02 EU/mL
P900 10.0 – 22.0 45 < 0.02 EU/mL
Plastic Parts of Construction of Supradisc Modules (3)
After Flushing with 50 L/m2 WFI.
Supradisc Components Polypropylene
O-rings Silicone elastomer The FDA (Food and Drug Administration) in the USA has registered
Supradisc modules under DMF (Drug Master File) No. 14325.
Sterilization With regard to total extractables P-grade depth filter sheets and
Steam in place 125 °C (257 °F), for 30 minutes at 0.3 bard (4.3 psid) Supradisc modules meet the specifications according to FDA
maximum. guideline CFR part177.2260 e, f, g, h, I, j, k, l, volume 21 chapter 1,
applicable for depth filters with resins. The Quality Management
Nominal Dimensions – Supradisc Modules System of Pall has been certified according to DIN EN ISO 9001 by
Nominal Total Length Double O-ring Execution:
TÜV Cert (Certification Office TÜV Rheinland, Sicherheit und
332 mm (13.1 in.) Umweltschutz GmbH). With regard to food law conformity the
manufacture of depth filter sheets is also subject to ongoing analysis
Flat Gasket Execution:
272 mm (10.7 in.) by the German ISEGA Forschungs-und Untersuchungsgesellschaft
mbH, Aschaffenburg.
Nominal Diameter 284 mm (11.2 in.)
410 mm (16.1 in.)
Technical Service
Flat Sheets
For best possible results and maximum reliability we recommend a
Available in all common sizes test run under real-life conditions.

Part Numbering and Ordering Information

Code Filter Code Filter Code Gasket Code Filter Code Gasket Code Plastic Parts
Spacing Type Option Area Material

00 Standard PEKS EKS-P S Double 205 0.5 m2(4) (5.9 ft2) S Silicone P Polypropylene
O-ring elastomer
30 Increased PEKM EKM-P 209 1.0 m (10.7 ft )
2 2

cell PEK1 SUPRA C Flat

distance Gasket 216 1.8 m2 (19.3 ft2)
EK 1 P
409 2.1 m2 (22.6 ft2)
P050 KS 50 P
P100 K 100 P 416 3.7 m2 (39.8 ft2)

P080 SUPRA 421 5.0 m2 (53.8 ft2)

80 P (4)
Only available with double
P200 K 200 P O-ring.

P250 K 250 P
P700 K 700 P
P900 K 900 P

18
 K–Series Depth Filter Sheets
Bioburden Reduction and Fluid Clarification

With 13 different retention rates, the To obtain assurance of sterile filtrate

K series represents the standard depth through a sterilizing membrane filter
filter sheet series from Pall. cartridge, downstream of depth filter
sheets is essential.
They are classified as microorganism-
reducing depth filters. They can produce
filtrate with low organism counts or even Typical LRV Figures
zero counts for the EKS, EK 1 and EK (Log Reduction Value)
grades if the influent bioburden is low. EKS > 8.5(1)
Grades K 100 through to K 900 cover the EK 1 > 7.5(1)
entire range from fine filtration through
EK > 7.0(2)
clarifying filtration to coarse filtration.
KS 50 > 6.5(2)

High Efficiency Bioburden KS 80 > 6.0(2)

Reduction
(1)
Test organisms: Brevundimonas diminuta.
(2)
Test organisms: Serratia marcescens.

Successful bioburden reduction to achieve

very low organism counts necessitates
knowledge of the microbiological status of
the product. The filtration procedure has to
be adapted in such a way that the
organism challenge limit validated for a
particular depth filter sheet is not
exceeded. Differential pressure must be
limited to a maximum of 1.5 bar (14.5 psi)
The flow velocity should not exceed
500 L/m2 /h. These figures may be lower in
the case of difficult or demanding
products.

1800 25
1700

1600

1400 20
1275
Permeability (L/m2/min)

1200
Retention rates (µm)

15
1000 925

800 785
10
600 510

400
213 5
200 146 185
93 113
29 41 68
0
0
EKS EK1 EK KS50 KS80 K100 K150 K200 K250 K300 K700 K800 K900 EKS EK1 EK KS50 KS80 K100 K150 K200 K250 K300 K700 K800 K900

19
 K–Series Depth Filter Sheets
Technical Specifications

Technical Data
Sheet Weight per Area Thickness Ash Content Extractable Ions Soluble in 0.025 µm H2 SO4
(g/m2) (mm) (%) (mg/m2)

Ca Fe Al
EKS 1400 3.7 58 1800 15 150
EK1 1400 3.7 51 1600 15 140
EK 1350 3.7 46 1400 10 120
KS50 1350 3.7 46 1400 10 120
KS80 1350 3.7 46 1200 15 120
K100 1350 3.7 46 1400 15 120
K150 1350 3.9 46 1300 15 120
K200 1350 3.9 46 1200 15 110
K250 1300 4.0 46 1000 15 70
K300 1300 4.2 46 900 15 50
K700 1300 4.1 46 900 15 50
K800 1300 4.1 46 900 15 45
K900 1300 4.3 46 900 25 40
Heavy metals < 50 ppm (according to the Recommendation XXXVI/1 BgVV-German Federal Institute for Health Protection of Consumers and Veterinary Medicine).

Sheet
EKS Vaccines, pharmaceuticals and BioPharmaceuticals, phytopharmaceuticals (sterile filtration), plasma fractionation, serum, aqueous cosmetics
(clarifying and fine filtration)

EK 1 Aqueous cosmetics (clarifying and fine filtration), pharmaceuticals and BioPharmaceuticals, plasma fractionation

EK Pharmaceuticals and BioPharmaceuticals.

KS 50 Phytopharmaceuticals (clarifying filtration)

KS 80 Antibiotics (clarifying filtration), vaccines, infusion solutions, plant extracts (clarifying filtration), plasma fractionation
K 100 Clarifying filtration
K 150 Pharmaceuticals and BioPharmaceuticals (clarifying filtration), serum (pre-filtration)
K 200 Vaccines (prefiltration), phytopharmaceuticals (clarifying filtration)
K 250
K 300 Antibiotics (clarifying filtration), cosmetics (clarifying filtration)
K 700 Antibiotics (clarifying filtration), serum (prefiltration), cell harvest
K 800 Vaccines (prefiltration), cell harvest
K 900 Infusion solutions (prefiltration), cosmetics (particle filtration), cell harvest

The following Certificates are available:

• Certificate of Compliance according to
DIN 50049-2.1/EN 10204-2.1
• Materials Safety Data Sheet
The depth filters conform to the Recommendation XXXVI/1 BgVV
(German Federal Institute for Health Protection of Consumers and
Veterinary Medicine) and meet the requirements of the Lebensmittel-
und Bedarfsgegenständegesetz – LMBG – (Foodstuff and other
Commodities Act), in particular §§ 5, 30 and 31.

20
 T–Series Depth Filter Sheets
High Output with Long Filtration Cycles

The T series depth filter sheets from Pall

includes 10 different retention rates.
Grades T 120 to T 950 are used for
clarifying filtration. Due to their positive
ZETA potential, these depth filters possess
a high adsorption capacity.
In contrast, grades T 1000 to T 5500 are
designed for coarse filtration. They are
characterized by a more open structure
and combine very high outputs with long
in-service life due to their high dirt-holding
capacity.
Grades T 1000 to T 5500 have proved
successful in the filtration of viscous media,
for the retention of gel particles and coarse
dispersed substances at low differential
pressures. Furthermore, they can be
inserted into plate and frame kieselguhr
filters to retain the pre-coat filter material.

80 30000

70 25000
25000

60

20000
Permeability (L/m2/min)

50
Retention rates (µm)

40 15000
12750

30 10200 10200
10000

20 7285
5000 3400
10 1700
213 465 565

0 0
T 120 T500 T750 T950 T1000 T1500 T2100 T2600 T3500 T5500 T 120 T500 T750 T950 T1000 T1500 T2100 T2600 T3500 T5500

∆p = 1 bar (14.5 psi) with water at 20 °C (68 °F).

21
 T–Series Depth Filter Sheets
Technical Specifications

Characterization
The tests are carried out according to the methods of the Technical
and Analytical Work Group within the European Depth Filtration
Association or in accordance with in-house test methods.

Technical Data
Sheet Weight per Area Thickness Ash Content Extractable Ions Soluble in 0.025 µm H2 SO4
(g/m2) (mm) (%) (mg/m2)

Ca Fe Al
T 120 900 2.8 43 1250 20 75
T 500 850 2.7 38 1000 15 45
T 750 850 2.7 40 770 15 45
T 950 850 2.8 40 600 13 25
T 1000 950 3.6 35 570 15 30
T 1500 850 3.7 33 500 12 25
T 2100 700 3.3 15 350 11 20
T 2600 700 2.9 <1 300 1 5
T 3500 880 4.6 15 450 15 30
T 5500 750 4.5 <1 300 1 5
Heavy metals < 50 ppm (according to the Recommendation XXXVI/1 BgVV-German Federal Institute for Health Protection of Consumers and Veterinary Medicine). The figures quoted in the
diagrams and tables should be regarded as guidelines.

The following Certificates are available:

Sheet Typical Application • Certificate of Compliance according to
T 120 Fine clarification DIN 50049-2.1/EN 10204-2.1
T 500
T 750 • Materials Safety Data Sheet

T 950 General prefiltration The Depth Filters conform to the Recommendation XXXVI/1 BgVV
T 1000 (German Federal Institute for Health Protection of Consumers and
T 1500
Veterinary Medicine) and meet the requirements of the Lebensmittel -
T 2100
und Bedarfsgegenständegesetz – LMBG – (Foodstuff and other
T 2600 Pharmaceuticals and Commodities Act), in particular §§ 5, 30 and 31.
T 3500 BioPharmaceuticals (solid/liquid
T 5500 separation)
Serum (prefiltration), vaccines
(prefiltration)

22
 Z–Series Depth Filter Sheets
Positive Zeta Potential for Adsorptive Removal from Aqueous Suspensions

Z series depth filters have been developed

for applications demanding excellent
filtration removal efficiency with maximum
filtration throughput.
Due to the pronounced positive Zeta
potential, these grades of filter sheets are
particularly suited for adsorptive removal of
negatively-charged particles from aqueous
suspensions. As opposed to standard filter
sheets, depth filter sheets with an
adsorptive effect exhibit a considerably
improved clarifying effect without a
sacrifice in output.
The grades Z 200 and Z 400 are
characterized by a high bacteria retention
capability; provided that they are suitably
conditioned, they are capable of removing
endotoxins from aqueous solutions.
For endotoxin removal, see also special
documentation on Supra EK 1P Depth
Filter.
Z–Series adsorptive filter sheets are
compatible with most solvents as well as
acids and alkalis provided that their
concentration is low.

10 400

9 350
350

8
300
7
Permeability (L/m2/min)
Retention rates (µm)

250
6

5 200

4 150

3
100 80
2 65
50
1

0
0 Z 200 Z 400 Z 2000
Z 200 Z 400 Z 2000

∆p = 1 bar (14.5 psi) with water at 20 °C (68 °F).

23
 Z–Series Depth Filter Sheets
Technical Specifications

Characterization
The tests are performed in accordance with the methods of the
Technical and Analytical Work Group within the European Depth
Filtration Association or in accordance with in-house test methods.

Technical Data
Sheet Weight per Area Thickness Ash Content Extractable Ions Soluble in 0.025 µm H2 SO4
(g/m2) (mm) (%) (mg/m2)

Ca Fe Al
Z 200 1360 3.8 46 2450 35 125
Z 400 1320 3.8 46 2050 45 135
Z 2000 1220 3.9 45 1400 30 80
Heavy metals < 50 ppm (according to the Recommendation XXXVI/1 BgVV-German Federal Institute for Health Protection of Consumers and Veterinary Medicine). The figures quoted in the
diagrams and tables should be regarded as guidelines.

The following Certificates are available:

Sheet Typical Application
• Certificate of Compliance according to
Z 200 Enzyme solutions, fermenter broths, DIN 50049-2.1/EN 10204-2.1
water
• Materials Safety Data Sheet
Z 400 Pharmaceuticals
Z 2000 Pharmaceuticals The depth filters conform to the Recommendation XXXVI/1 BgVV
(German Federal Institute for Health Protection of Consumers and
Veterinary Medicine) and meet the requirements of the Lebensmittel-
und Bedarfsgegenständegesetz – LMBG – (Foodstuff and other
Commodities Act), in particular §§ 5, 30 and 31.

24
 E-Series Depth Filter Sheets
Filter Paper with Depth Filter Properties for Solid and Liquid Separation or Clarifying Filtration

Introduction Main Applications

E-Series is a new filter paper with depth
filter properties for use in the
pharmaceutical industry. It substitutes for
conventional filter paper in solid and liquid
separation or clarifying filtration. Compared
with conventional filter paper, the E-Series
has the following advantages:
• Better clarifying results due to depth
filter properties
• Better mechanical stability due to higher
wet strength
• Very easy discharge of proteins or
protein cake due to special surface
treatment
The high wet strength combined with the
low weight per area allows for the best
separation results, even in pre-coat
filtration for the separation of pastes.
Features and Benefits
E-Series is a filter paper with depth filter
properties, which is obtained by the
thickness of the filter medium.
In comparison with filter papers having the
same retention rates, the E-Series
provides significantly better clarification
than conventional filter papers.
• Blood plasma fractionation
• Therapeutic proteins
• Biomass separation
• Antibiotics production
• Vaccines
• Natural plant extracts and transgenics
The high wet strength of the E-Series
enables filtration at higher operating
pressures compared to conventional filter
papers, without the risk of breakthrough or
damage (tearing). The stiffness of the
E-Series sheets enables easier and safer
handling.
Due to a special manufacturing method,
the E-Series has a very smooth surface
with extremely low adhesion of proteins.
The special surface treatment ensures an
easy and complete discharge of both
protein and protein cakes. Because of the
very small loss of product on the filter
surface, high product yield is obtained in
solid and liquid separation applications.

Advantages
• Safe operation due to high wet strength
• High mechanical stability (filtration at
high operating pressure is possible)
• Easy removal of protein cakes due to
the very smooth, low adhesive surface
• Higher clarity and retention due to the
depth filter properties
• High dirt-holding capacity

25
 E-Series Depth Filter Sheets
Technical Specifications

Technical Data Components

E-Series is available in all common sheet sizes • Cellulose
Permeability ∆p 340 L/m2/min
• Resin (< 3%)
0.2 bar (2.9 psi)
Weight per Area 550 g/m2 • Resins according to the recommendations XXXVI and XXXVI/1 in
connection with the German Foodstuff and Consumer Good Act
Thickness 1.4 mm
resp. Chapter 21 of Federal regulation (CFR) § 177.2260
Ash Content <1%

Extractables Soluble in Acetic Acid (5%) Quality

(mg/m )2
(mg/Kg) • The manufacture of E-Series is carried out under stringent quality
Ca 250 450 control using specially developed equipment.

Fe 1 1 • E-Series complies with recommendations XXXVI and XXXVI/1 of

Al 5 5 the German Foodstuff and Consumer Goods Act §§5, 30 and 31
Heavy metals < 50 ppm (according to the Recommendation XXXVI/1 BgVV-German
(LMBG).
Federal Institute for Health Protection of Consumers and Veterinary Medicine).
• E-Series meets the specification of extractables 21 CFR, part
177.2260 e, f, g, h j, k, l, for depth filter with resin
Comparison of Technical Data
Wet Strength Thickness Specific Weight
per Area The following Documents are available:

E-Series 350 N/cm 2

1.4 mm 550 g/m 2 • Data Sheet

Filter Papers 20 N/cm2 0.2 – 0.8 mm 60 – 200 g/m2 • Certificate of Compliance

Technical Support
Fast and reliable technical support is essential. Our Scientific and
Laboratory Services (SLS) teams are at your disposal for technical
service on site, or if you have further questions.

26

SD Range
Standard range for numerous applications.
SDP Range
A filter material low in endotoxins for
applications in the pharmaceutical industry.
BIO Range (Kieselguhr-free)
Highly pure natural and modified grades of
cellulose – ideal for applications where
minimum ion extraction and low protein
adsorption are of major concern.
SDT Range
This series is characterized by open
construction and reduced thickness to give
a low filtration resistance and high flow
rates. Therefore it is ideally suited for
viscous media, for the removal of gel
particles and coarsely dispersed
components.
SH Range
Permits reliable filtration up to 160 °C
(320 °F) and has been specially developed
for application in APIs.
SD AKS Range (Activated Carbon)
Due to the incorporation of activated
carbon into the matrix of the filter this
range possesses an extremely high
adsorption capacity and is therefore
amongst others recommended
for decolorization, deodorization, and
dechlorination tasks and removal of lipids
from protein solutions.
Supradisc Depth Filter Modules
Benefits of Depth Filter Sheets in Module Form
The Supradisc module design concept combines the
advantages of conventional depth filter sheets with the positive
features of enclosed filters.
Module Concept
Each module consists of three major
components:
• Filter cells or lenticles
• Tubular
• Adapters
The individual filter cells comprising two
filter media layers and a drainage plate are
edge-sealed in an injection-molding
process.
Up to 21 cells are stacked on a tubular
core, compressed and joined to form a
module.
This design results in reliable sealing
between the filter cells, even if the module
is in a dry state, which eliminates the need
for retightening after wetting.
Filter Media
Depth filters, which prove highly successful
in a vast range of applications, are
incorporated as filter media. Due to their
excellent mechanical strength, they can be
readily incorporated into modules.
Almost all grades of depth filters available
in Pall sheet format are also available in
modular configuration, so that change-over
from open sheet filter systems to closed
systems is relatively easy.
The Complete Filter System
The proven adapter is fitted with two
O-rings and a bayonet lock, a successful
concept, adopted by the pharmaceutical
industry for filter cartridges. Consequently,
Supradisc modules can be mounted into
filter housings rapidly and easily.
Due to their specific design, Supradisc
modules are characterized by a very high
mechanical stability.
A range of module types with different
permeabilities, filter media, and diameters –
284 and 410 mm (11.2 and 16.1 in.) –
permits precise optimization of the filter
system to specific filtration tasks.
Modules to retrofit most commercial
housings are available.
™
Features and Benefits
• Permits filtration without product losses
due to the enclosed design
• Requires less space than classical
filtration systems due to its vertical
design
• Offers maximum reliability against
product contamination
• Affords maximum operational safety
due to the exclusion of emissions
• Very simple to handle due to rapid
module change and ease of cleaning
• Modules with double O-ring adapters
guarantee maximum reliability during
the entire process
• A depth filter system with an extremely
high retention capability for solids
• Long service life: due to the mechanical
depth filter effect and the ZETA
potential, particles are retained by both
mechanical and electrokinetic
adsorption
• Grades for the retention of yeast,
bacteria, and colloids are available
• Supplied as a ready-to use unit,
subsequent retightening after wetting is
not necessary, simplifying handling
• Highly efficient in the protection of
downstream membrane filters with
“police filter” duties, media and
media-difficult filter
• Can be sterilized by autoclaving or
steam-sterilization or disinfected with
hot water or by chemical means
• Can be disposed of with common
industrial waste and can be incinerated
Note: For used depth filters, the disposal regulations
applicable for the filtered product must be considered.
27
 Supradisc Depth Filter Modules
Technical Specifications

Operating Conditions(1) Sterilization

Maximum Operating 85 °C (185 °F) Steam in Place 125 °C (257 °F), for 30 minutes at
Temperature 0.3 bard (4.3 psid) maximum.

Maximum Operating 2.5 bard (36 psid)

Pressure Nominal Dimensions – Supradisc Modules
(1)
With compatible fluids, which do not soften, swell or adversely affect the products or Nominal Total Length Double-O-ring Execution:
its material of construction. 332 mm (13.1 in.)

Flat Gasket Execution:

Plastic Parts of Construction of Supradisc Modules 272 mm (10.7 in.)

Supradisc Components Polypropylene Nominal Diameter 284 mm (11.2 in.)

Polyamid (high temperature version) 413 mm (16.3 in.)
O-rings Silicone elastomer

Table 1
Sheet Depth Filter Weight per Ash Content Extractable Ions Soluble in 0.025 µm H2 SO4
Type Area (g/m2) (%) (mg/m2)

Ca Fe Al
B010 BIO 10 1400 <1 0.28 ppm(1) < 0.05 ppm(1) < 5 ppb(1)
B020 BIO 20 1400 <1 0.17 ppm(1) < 0.05 ppm(1) < 5 ppb(1)
B040 BIO 40 1200 <1 0.48 ppm (1)
< 0.05 ppm (1)
< 5 ppb(1)
XEK1 EK 1 1400 51 1600 15 140
XEK0 EK 1350 46 1400 10 120
X050 KS 50 1350 46 1400 10 120
X080 KS 80 1350 46 1200 15 120
X100 K 100 1350 46 1400 15 120
X150 K 150 1350 46 1300 15 120
X200 K 200 1350 46 1200 15 110
X250 K 250 1300 46 1000 15 70
X300 K 300 1300 46 900 15 50
X700 K 700 1300 46 900 15 50
X900 K 900 1300 46 900 25 40
C100 K 100 IR 1400 51 200 20 75
C250 K 250 IR 1250 46 150 15 50
C800 K 800 IR 1250 46 120 10 30
C900 K 900 IR 1200 46 120 10 30
T950 T 950 850 40 600 13 25
T100 T 1000 950 35 570 15 30
T150 T 1500 850 33 500 12 25
T210 T 2100 700 15 350 11 20
T260 T 2600 700 <1 300 1 5
T350 T 3500 880 15 450 15 30
T550 T 5500 750 <1 300 1 5
(1)
Soluble after 50 L/m2 flushing with WFI.

Part Numbering and Ordering Information

Code Filter Code Filter Code Gasket Code Filter Code Gasket Code Plastic Parts
Spacing Type Option Area Material

00 Standard See Above Table 1 S Double 203 0.3 m2 (3.2 ft2) S Silicone P Polypropylene
O-ring elastomer
01 High 205 0.5 m (5.9 ft )
2 2
A Polyamide(2)
Temperature C Flat Other Gaskets available on
Gasket 209 1.0 m2 (10.7 ft2) request
(2)
High Temperature only.
30 Increased
cell 216 1.8 m (19.3 ft )
2 2

distance 509 2.3 m2 (24.7 ft2)

516 4.0 m2 (43.0 ft2)

28 520 5.0 m2 (53.8 ft2)
 Supradisc™ II Modules
Next Generation Rigid Interlocked Depth Filter Module

Supradisc II depth filter modules have a Application Benefits

design that eliminates direct operator
• Higher flow rates
handling of the discs to prevent damage
and to ensure uniform performance. As • Eliminates contamination bypass
part of this unique design, the Supradisc II • More resistant to temperature and
modules have a clip-seal interlock that pressure shocks
holds the filter sheet in place with an
outside and inside separator. In addition, • Superior sealing in module housing
the filter sheet is fastened during • Proprietary seal eliminates
manufacture to both the polypropylene contamination bypass
core and the outer casing to provide
• Retrofits existing hardware
maximum stability without the need for
welds or resins. This ensures that the • Provides optimal filtration performance
system will not fail under changing • Exceptional chemical compatibility
pressures.
• Steam-sterilizable
The new depth filter module can be used
with either a double O-ring or flat gasket • Consistent and reproducible filtration
filter housing. By using a double O-ring results
seal, the Supradisc II depth filter module • Polypropylene parts and silicone
achieves the highest degree of safety in O-rings meet all USP, Class VI – 121 °C
preventing contaminants from entering the criteria.
filter stream. The ability to fit either type of P-grade media meets all USP,
housing maximizes utilization of investment Class V – 121 °C criteria
in existing equipment. The Supradisc II
depth filter module provides optimal See The Difference In The Design
filtration performance with a wide range of
media grades. • Highly rigid module construction
maintains structural integrity after
multiple steam-sterilization even cycles
Features and Benefits
The unique design of the Supradisc II
depth filter module provides increased
process safety, reliability, and performance.
• More effective filter area per cell
• Multiple flow channels
• Proprietary clip connection
• Highly rigid module construction
• Available with nearly all grades of depth
filter media
• All-polypropylene molded parts
• Steam-sterilizable for multiple cycles
• FDA-listed materials of construction
• Produced under an ISO 9001 quality
system
• Reverse-flow capabilities 29
 Supradisc II Modules
Technical Specifications

Materials of Construction Chemical Compatibility

Filter Media Composition Cellulose, Diatomaceous Earth, Perlite Resistant over a wide pH range of 3 – 10
and Binders
(Polyolefin fibers in certain media types)
Toxicity
Core and Molded Parts Polypropylene
Polypropylene parts and silicone O-rings meet all USP, Class VI – 121 °C
Adapter Polypropylene with Stainless Steel Insert (250 °F) criteria. P-grade media meets all USP, Class V – 121 °C (250 °F)
O-rings Standard: criteria.
Silicone Elastomer

Optional:
Nominal Dimensions and Weights
Viton* 1 A, EPDM
Diameter 284 mm (11.2 in.)
Gaskets Standard:
Buna N Height (Standard) Flat Gasket:
Approx. 272 mm (11 in.)
Optional:
Silicone, PTFE, Viton A, EPDM O-ring:
Approx. 332 mm (13 in.)
* Viton is a registered trademark of DuPont Dow (non-FDA materials).
Dry Weight 5 – 6 kg (11 – 13 lbs)
depending on filter media
Maximum Differential Pressure
Filter Area 1.8 m2 (19.4 ft2)
Forward Flow 3.5 bard (50 psid) @ 90 °C (195 °F )
Reverse Flow 0.45 bard (6 psid)

Ordering Information

Pall Part Number

Code Filter Media Code Adapter Code Sealing Materials Code Filter Area Code Molded Parts
200 S Double O-ring S Silicone 232 1.8 m2 (19.4 ft2) P Polypropylene
(White; MVQ)
C Flat gasket
V Viton A
E EPDM
P Buna N
T PTFE
F FEP Encapsulated
Silicone

Code Filter Media Code Filter Media

XEKO EK C100 K 100 IR
XEK1 EK 1 C250 K 250 IR
X050 KS 50 C800 K 800 IR
X080 KS 80 D120 Permadur
X100 K 100 PEKS EKS P
X150 K 150 PEK1 Supra EK 1 P
X200 K 200 P050 KS 50 P
X250 K 250 P080 Supra 80 P
X300 K 300 T100 T 1000
X700 K 700 T150 T 1500
X900 K 900 T210 T 2100
B010 BIO 10 T260 T 2600
B020 BIO 20 T350 T 3500
B040 BIO 40 T550 T 5500

30
 Supracap™ 60 Depth Filter Capsules
Capsules for Process Development and Scale-up Studies

The Pall Supracap™ 60 filter capsule is Applications

specifically designed for applications where
• Cell harvest
the use of a depth filter with a small
surface area and low hold-up volume is • Clarification of fermentation broth
critical. • Antibiotics
Supracap 60 capsules are especially • Serum
useful for the development and
optimization of a process during scale-up • Blood products
and scale-down studies. • Vaccines
The special manufacturing process • Plant extracts
provides a highly permeable media, with an
extremely high dirt-holding capacity. Pall’s UpscaleSM Program

Features and Benefits From drug discovery and basic research,

through process development and
The key benefits of Supracap 60 filters production, Pall Corporation is the single
include: source for all your filtration and separation
• Scale-up to Pall Supradisc® modules needs. Our UpScale program provides
and depth filter sheets you with the scalable products and the
support you need to bring new products to
• Disposable format with luer-lok* market faster.
connections for ease of use
• Upstream vent valve for easier process
control
• Available in a wide range of Pall depth
filter media for optimum grade selection
• Easy and economic process
optimization
• Broad chemical compatibility for use
with a wide range of solutions found in
the BioPharmaceutical industry
High Quality Standards
• Batch-tested in order to meet all quality
requirements
• Manufactured under a Quality
Management System certified to
ISO 9000
• Constructed from plastics which meet
USP Class VI
* Luer-Lok is a trademark of Becton-Dickenson & Co.

31
 Supracap 60 Depth Filter Capsules
Technical Specifications

Materials of Construction Typical Filtration Area

Media Cellulose base(1) 0.26 cm2 (0.040 in2)
Capsule Polycarbonate
Luer-Lok* Vent Fitting Polypropylene
Sterilization
Autoclaving at 125 °C (275 °F) 1 cycle x 30 minutes
Sealing Technology Thermal bonding
See ordering information.
(1)

* Luer-Lok is a trademark of Becton-Dickenson & Co. Dimensions

Operating Parameters
Maximum Operating
Pressure and Temperature
A Maximum:
32 mm (1.26 in)
Depends on thickness of sheet
3 bar (44 psi) at 40 °C (104 °F)
B 70 mm (2.76 in)

Maximum Differential 1.5 bar (22 psi)

Pressure

Typical Values for Ions after Flushing with 50 L/m2 WFI(2)

Ca Mg Fe Cu Al Ni
A
0.5 ppm < 0.1 ppm < 0.1 ppm < 0.1 ppm < 50 ppb < 10 ppb
(2)
The tests are carried out according the methods of the Technical and Analytical Work
Group within the European Depth Filter Association or in accordance with in-house
tests methods.

Ordering Information
Code Type of Sheet Retention Range Ash Content Endotoxin Level(4)
(SC060*) (µm) (%)

P-series: Produced under specific manufacturing and control procedure for low endotoxin content.
Well balanced composition including cellulose fibers as well as kieselguhr and perlites
PEKS EKS-P 0.1 – 0.3 58 < 0.02 EU/mL
PEKM EKM-P 0.2 – 0.4 48 < 0.02 EU/mL
PEK1 SUPRA EK 1 P 0.25 – 0.45 47 < 0.02 EU/mL
P050 KS 50 P 0.5 – 0.85 46 < 0.02 EU/mL
P100 K 100 P 1.5 – 3.5 45 < 0.02 EU/mL
P080 SUPRA 80 P 1.5 – 4.0 49 < 0.02 EU/mL
P200 K 200 P 2.8 – 6.0 43 < 0.02 EU/mL
P250 K 250 P 4–9 44 < 0.02 EU/mL
P700 K 700 P 6 – 15 45 < 0.02 EU/mL
P900 K 900 P 10 – 22 45 < 0.02 EU/mL
Supradur: Depth filter sheets with perlites up to 40 % w/w of selected polyolefin microfibers
D50P Supradur 50 P 0.6 – 3.8 23 < 0.02 EU/ml
BIO Series: Depth filter sheets with highly purified and modified cellulose with very low extractables and low protein adsorption
B010 BIO 10 0.1 – 0.3 <1 < 0.02 EU/mL
B020 BIO 20 0.5 – 1.0 <1 < 0.02 EU/mL
B040 BIO 40 6 – 18 <1 < 0.02 EU/mL
Activated Carbon containing depth filter sheet for decolourization of blood products, glucose solution and antibiotics
XAK5 AKS 5 Methylene blue adsorption <1 < 0.02 EU/mL
> 170 g/m2
(4)
After flushing with 50 L/m2 WFI.

32
Supracap ™ 200 Encapsulated Depth Filter Modules
First Encapsulated Single-use Depth Filter Module for Process-scale Applications

The Supracap 200 depth filter capsule Design Features

provides all the features and benefits of the
• No contact between operator and
Supradisc and Supradisc II modules in a
fluids, means reduced exposure risks
single-use, disposable design.
• Less product loss due to less void
The advantages of encapsulated
volume means higher yields
disposable systems are tied to highly
reduced operator exposure risks, less • Better handling of difficult and toxic
cleaning effort, increased yields, and products
optimized handling. These are the main • Lower process times due to reduced
reasons why disposable capsules are used cleaning
throughout the pharmaceutical industry.
Capsule filters can help eliminate cleaning • No cross-contamination risks
problems, especially where biological • All Pall Supracap 200 modules are
products are to be filtered. In applications 100% pressure-tested after production
where hazardous materials are being
• Pall Supracap 200 modules are
filtered, such as cytotoxic drugs, or where
sterilizable at 125 °C (257 °F) for 60
toxic materials like catalysts or
minutes
contaminated activated carbon has to be
removed, Pall Supracap 200 capsules • All plastic components used in
offer better operator protection and simplify construction meet the specifications for
process-handling. Pall Supracap 200 the biological tests listed in the current
capsules are the first encapsulated version of the USP class VI at 121 °C
single-use depth filter modules for • Pall Supracap 200 modules as well as
large-scale process filtration. all their components are fully traceable
The capsule design provides a lower by serial number
hold-up volume than Supradisc modules in
stainless steel housings, allowing greater
product recovery. The encapsulated
modules are installed in a Pall Advanta
Supracap 200 housing. The housing
functions as a means of secondary
pressure containment and does not require
cleaning. The inlet and outlet pipes are
removable and cleanable. The Supracap
200 housing can also be used wih
Supradisc modules.

Applications
• Filtration of fermenter broth
• Serum filtration
• Blood plasma filtration Supracap 200 modules in a Pall
• Removal of mammalian cells prior to Advanta Supracap 200 housing

downstream processing
• Filtration of toxic products
• Removal of filter aids
• Removal of catalysts
33
• Removal of activated carbon
 Supracap ™ 200 Encapsulated Depth Filter Modules
Technical Specifications

Material of Construction Sterilization

Pall Supracap 200 Capsule Polypropylene Steam-In-Place 125 °C (140 °F), for 60 minutes
Components
O-rings Silicone elastomer Nominal Dimensions
Total Length 324 mm (12.7 in.)
Operating Conditions(1) Total Diameter 298 mm (11.7 in.)
Maximum Operating 60 °C (140 °F)
Temperature

Maximum Operating 6 barg (87 psig) at 60 °C (140 °F)

Pressure
(1)
With compatible fluids, which do not soften, swell or adversely affect the products or
its material of construction.

Filter Media Specifications

Code Depth Filter Type Water Flow in Retention Rate Ash Content Positively-
L/m2/min @
∆p 1 bar (14.5 psi) in µm in % Charged Media
PEKS EKS-P 29 0.1 – 0.3 58 no
PEKM EKM-P 41 0.2 – 0.4 48 no
PEK1 SUPRA EK 1 P 64 0.25 – 0.45 47 yes
P050 KS 50 P 93 0.5 – 0.85 46 no
P100 K 100 P 130 1.5 – 3.5 39 no
P080 SUPRA 80 P 159 1.5 – 4.0 49 yes
P200 K 200 P 240 2.8 – 6.0 43 no
P250 K 250 P 600 4–9 44 no
P700 K 700 P 980 6 – 15 45 no
P900 K 900 P 2200 10 – 22 45 no
B010 BIO 10 30 0.1 – 0.3 <1 no
B020 BIO 20 75 0.5 – 1.0 <1 no
B040 BIO 40 1125 6 – 18 <1 no
X150 K 150 185 2.5 – 5.0 46 no
X300 K 300 785 5 – 12 46 no
T950 T 950 1700 8 – 20 40 no
T100 T 1000 3400 10 – 25 35 no
T150 T 1500 7285 11 – 30 33 no
T210 T 2100 10200 13 – 35 15 no
T260 T 2600 10200 15 – 40 <1 no
T350 T 3500 12750 19 – 50 15 no
T550 T 5500 25500 25 – 70 <1 no
XAK5 AKS 5 310 – 1 no
XAK6 AKS 6 250 – 1 no

Part Numbering and Ordering Information

C S P

Code Module Code Inter Disc Code Filter Code Filter Area Code Gasket
Type Spacing Media Material

2 Supradisc II 00 Standard See above table 209(2) 1.0 m2 (10 ft2) S Silicone elastomer
3 Supradisc I 30 Increased cell 214(3) 1.6 m2 (17.2 ft2) F FEP coated silicone
distance(1)
216(2) 1.8 m2 (19.4 ft2)
(1)
Supradisc I design only.
232(4) 1.8 m2 (19.4 ft2)
(2)
Supradisc I design only.
(3)
AKS 5/6 in Supradisc I design only.
(4)
Supradisc II design only.
34
Direct Flow Liquid Filtration
Membrane and Depth Filter Cartridges,
Capsules, and Disposable Systems
 Membrane and Depth Filter
Cartridges, Capsules, and Disposable Systems
Pall offers a wide range of filter media and
filter configurations to serve your liquid
filtration needs.
Membranes have been developed to meet
specific application requirements. Pall provides
the broadest array of membranes, including:
®
• Supor PES (polyethersulfone)
sterilizing-grade 0.2 µm filters, which are
ideal for applications that require broad
pH compatibility.
®
• Low-binding Fluorodyne II
DBL (0.45 µm)
DFL (0.2 µm sterilizing-grade)
DJL (0.1 µm sterilizing-grade), which
have a PVDF (polyvinylidenedifluoride)
membrane and provide excellent flow
rates
®
• Ultipor N66 filters, which provide
excellent wettability and are available in
bioburden reduction, prefiltration, and
sterilizing grades
• Ultipor VF Grade DV 20 and DV50 for
virus removal applications (50 and
20 nm)
Pall also offers process-optimized prefilters, to
protect sterilizing-grade filters, as well as for
clarification and bioburden reduction including;
®
• PreFlow and Ultipor GF resin-bonded
glass fiber filters
36
® ® TM
• Profile , HDC II, and Marksman
polypropylene filters
®
• Emflon FM PTFE filters for solvent
polishing
Pall filters for liquid service are available in a
variety of cartridge configurations that can be
used in filter housings. In addition, Pall liquid
filters are available in disposable capsule filter
formats of all sizes with surface areas from
0.02 m2 (31 in.2) to to 4.8 m2 (50 ft2). These
capsules can be used in disposable systems*.
One of Pall’s most convenient products, the
TM
Kleenpak connector can be used to make
aseptic connections in any process
environment. These connectors can be
incorporated in disposable filter assemblies.
Note: It is important to maintain the integrity
of 0.2 µm and 0.1 µm sterilizing grade filters
and virus filters. Pall recommends
integrity-testing of all sterilizing-grade filters
prior to steaming, after steaming, and after the
filtration process to ensure that the integrity of
the filter has been maintained.
Contact Pall for recommended procedures
and integrity test parameters.
* Capsules supplied with sanitary flanges are Tri-Clamp
compatible. Tri-Clamp is a trademark of Alfa-Laval, Inc.

Improving Choice, Flexibility, and Operational Costs for System Designs
Managing the issues of cleaning and
cleaning validation is one of the major
challenges facing the BioPharmaceutical
industry. This has resulted in the use of
disposable equipment being the preferred
option wherever possible. Using disposable
equipment offers many benefits.
Features and Benefits
• Reduced assembly costs
• Reduced cleaning costs
• Reduced cleaning validation
• Reduced costs for capital equipment –
capsule filters have a typical installation
cost that is 80% lower than a similar
sized stainless steel housing system
• Reduced risk of lost production time
due to simpler procedures
In applications where hazardous materials
are being processed, such as cytotoxic
drugs, disposable equipment can play an
important additional role in helping protect
operators. Hazardous liquids can be
contained during processing with minimal
risk of operator exposure.
Choice and Flexibility
Pall supplies a wide range of disposable
filter assemblies and disposable filtration
sets, such as capsule filters with
customized tubing systems attached. Pall
also supports the use of filters attached to
disposable bag-based processing
systems. Disposable capsule filters of all
sizes with surface areas from a few cm2 to
as much as 4.8 m2 (50 ft2) are available and
can be used in disposable systems. Filters
join together in series for protection of the
final filter or in parallel for increased area,
making it possible to have unlimited
filtration area in disposable systems.
Flexibility of system design facilitates
changes in product to process
development.
Disposable Systems
Disposable filters can be offered with a
wide range of filter media for:
• Prefiltration and clarification
• Sterilization
• Virus removal
They are made from a range of materials
such as:
• PES (polyethersulfone)
• PVDF (polyvinylidenedifluoride)
• Nylon 66
• PTFE (polytetrafluoroethylene)
• Polypropylene
• Resin-bonded glass fiber
• Cellulose-based depth media
In addition to single-use capsule filters for
direct flow clarification, sterilization and viral
clearance, Pall provides single-use
chromatography and tangential flow (TFF)
products.
Scaling Up and Scaling Down
Pall is well-equipped to support processes
as they are scaled up. Different size
capsules for each specific Pall filter grade
contain identical filter materials. This
feature ensures that scale-up and
scale-down studies yield relevant
information and minimum requalification for
various batch sizes.
The availability of a variety of capsules for
small scale operations is beneficial,
particularly for new product developments.
Capital investment can be a concern since
not all new BioPharmaceutical products
become commercialized. Single-use
capsules and systems make it possible to
produce new products during the early
development stages, without a large
capital investment. Capital deferment and
risk avoidance makes it easy to produce
tests batches for early clinical trials and
toxicity studies without capital equipment.
37
 Disposable Systems
Technical Specifications

Filter and Tubing Sets

Pall is able to supply a wide range of filtration and purification
products with flexible tubing and connectors for your specific process
requirements, preassembled and pre-sterilized.

Disposable Processing Systems

Fully integrated, single-use systems can include a filter, bag, tubing
and other components. These systems are manufactured and
sterilized as one, thereby eliminating the contamination risks
associated with aseptic connections during coupling of a
non-integrated system. Assembly and cleaning, as well as cleaning
validation are eliminated for disposable process systems.
Additionally, since the system is used only once, cross-contamination
risks for facilities that produce many different BioPharmaceutical
products are minimized.
Fully integrated single-use systems bring other benefits for
multi-product facilities by offering flexibility, and allowing the
modification of batch sizes as required.
Pall has a close working relationship with all the major disposable
polymeric container suppliers. We can work with you and the
company of your choice to provide a disposable processing system
that is supplied pre-assembled and pre-sterilized by
gamma-irradiation. These systems are typically custom-designed to
include the flexible tubing of your choice in the configuration to best
fit into your process and with the most appropriate connection
devices, including Pall’s Kleenpak connectors.
For more information please contact your local Pall representative.

38

For Simple Sterile Connections between Components
The single use, Kleenpak™ Connector allows for the simple dry
connection of two separate pre-sterilized fluid pathways, while
maintaining the sterile integrity of both. The connector consists
of a male and a female connector, each covered by a vented
peel away strip that protects the port and maintains the sterility
of the sterile fluid pathway.
Applications
• Transfer of inocula to reactors
• Sampling during fermentation or cell
culture
• Connection of small sterile equipment
to large equipment (e.g. bioreactors)
• Handling of bulk material in a
non-sterile environment
• Connection to a disposable system
(systems that contain capsule filters or
bags)
Features and Benefits
• No capital equipment required
• Connection is made in seconds
• Easy to make connection – even in a
cramped environment
• Maintains a sterile fluid pathway upon
activation of device
• Peel-away strip maintains sterility until
ready to use
• Vented to allow steam penetration and
to prevent tubing collapse after
autoclaving
• Shape coding and locking mechanism
prevents incorrect assembly
• Device makes audible snap when
engaged
Making the Connection
1. Lift and pull tab of protective caps to
remove caps from connectors.
2. Hold the barrel of the larger (male)
connector above the base. Align the
smaller (female) connector with the
larger (male) connector, so that the
white peel away strips are facing each
other as they exit the flat sides of the
connectors.
3. Once aligned correctly, press the two
connectors together firmly until both
clips snap together tightly.
Step 1. Step 2. Step 3. Step 4.
Kleenpak™ Connectors
4. With one hand, hold the barrel of the
male connector. Using the other hand,
grasp both white peel away strips and
pull them out simultaneously in a
smooth continuous motion. Do not use
if only one white peel away strip is
removed accidentally instead of two;
this will affect the sterility of the
pathway.
5. Rotate the thumb rest on the male
connector one full turn. The rotation
serves to bend the anti-actuation tabs,
which prevent inadvertant engagement
before this step. The thumb rest can be
turned one full turn back to re-align
tubing, as required.
6. Push the thumb rest of the male
connector down towards the base of
the barrel until they meet.
7. Start the fluid transfer.
High Quality Standards
• Manufactured under clean conditions in
a controlled environment
• Manufactured under a Quality
Management System certified to
ISO 9000
• Supplied with a Certificate of Test
confirming the quality standards and
quality control tests performed by Pall
• A detailed validation guide is available
The fluid path materials of construction
meet
• USP Biological Reactivity Test, in vivo,
for Class VI-121 °C Plastics
Steps 5 – 6. Step 7.
39
 Kleenpak Connectors
Technical Specifications

Materials of Construction Typical Flow Rate

Connector Body(1) Polycarbonate 4.0
250
Plunger Polycarbonate 3.5
Rubber Grommets Thermoplastic Elastomer
3.0 200

Differential Pressure (mbar)

O-ring Internally Lubricated Ethylene Propylene

Differential Pressure (psi)

(EPDM)
2.5
Protective Cap Polypropylene 150
2.0
Peel-away Strip Hydrophobic Polyethersulfone (PES)
(1)
Fluid path. 1.5 100

Sterilization Methods 1.0

50
Gamma-irradiation Maximum Dosage: 50 kGy 0.5
Autoclave (121 °C) 1 cycle, 30 minutes
0 0
Consult with Pall Corporation on sterilization methods. 0 10 20 30 40 50
Flow Rate (L/min)
Operating Conditions
Maximum Operating Pressure 3 bar (43.5 psi) at 40 °C (104 °F)
and Temperature

Operating and Storage 3 °C to 40 °C

Temperature Range (37 °F to 104 °F)
Female Part Actuated Connector
13 mm (0.5 inch)
hose barb
D
Nominal Dimensions
A Internal Diameter 12.2 mm (0.48 in.) Locking clips C
(on both sides)
B Length when Actuated 123 mm (4.8 in.)
A
C Female Connector Length 55 mm (2.17 in.) Protective Caps
with Cap

D Maximum Diameter of 37.64 mm (1.48 in.)

Female Connector Barrel Plunger

E Male Connector Length 100 mm (3.94 in.) B

O-ring E
Base
with Cap

F Maximum Diameter of 37.64 mm (1.48 in.) Thumb Rest

Male Connector Male Part
13 mm (0.5 inch)
hose barb
Connections (Male and Female Connectors) F

13 mm ( ⁄2 in.) hose barb

1

Ordering Information
Part Number Description Quantity
ACD02S6 Male plus Female Connector with 13 mm (1⁄2 in.) hose barb 1
ACD02F6 Female Connector with 13 mm (1⁄2 in.) hose barb 25 per box, double-bagged
ACD02M6 Male Connector with 13 mm (1⁄2 in.) hose barb 25 per box, double-bagged

40
 Kleenpak Nova Particulate and Prefilter Capsule Filters
TM

Improving Choice, Flexibility and Operating Costs for the Prefiltration and Clarification of Liquids

The issues of effective cleaning and Kleenpak Nova capsules are used in a
cleaning validation result in disposable wide range of critical applications including
equipment being the preferred option. the filtration of BioPharmaceuticals,
For many processes, disposable filters can biologicals, diagnostic reagents, serum,
help eliminate cleaning problems, tissue culture media, and culture media
especially where biological products are to components.
be filtered. In applications where hazardous
materials are being filtered, such as Kleenpak Nova Filters Reduce
cytotoxic drugs, capsule filters can play an Operating Costs
important role in helping protect operators.
Kleenpak Nova filters have a typical
Kleenpak Nova capsule filters are installation cost that is 80% lower than a
designed to provide choice, similar sized stainless steel housing
cost-effectiveness and flexibility, while system. Therefore, they offer an extremely
ensuring ease of use for the operator. cost-effective alternative to housing and
cartridge systems. Kleenpak Nova filters
Designed to Provide Choice and can also provide further cost savings:
Flexibility
• No housing maintenance —
Kleenpak Nova capsule filters are available Lower maintenance costs
with either in-line or T-style configurations.
• No housing cleaning or cleaning
The T-style configuration is ideal for
validation —
manipulating multiple filters in series or
Lower labor costs
parallel configuration.
• Filter is pre-assembled —
Kleenpak Nova capsule filters incorporate
Lower labor costs
either a 10 in. (254 mm), 20 in. (508 mm)
or 30 in. (762 mm) length standard Pall • Filter can be provided pre-sterilized —
cartridge filters which have traditionally Lower energy costs
been installed in stainless steel housings.
In applications where a particular filter is
already specified, the user can switch from
a stainless steel housing to a fully
disposable assembly with minimal
requalification. This means the extensive
range of cartridges currently available from
Pall for clarification, bioburden reduction
and prefiltration can easily be provided as
a capsule filter. These include:
• PreFlow™ Filters
• Ultipor® GF Plus Filters
• Profile® Filters
Kleenpak Nova capsules are especially
suited to pilot- and process-scale
applications. They can be autoclaved or
sterilized by gamma-irradiation and can be
supplied as part of pre-sterilized
processing systems such as a
filter/tubing/bag set. 41
 Kleenpak Nova Particulate and Prefilter Capsule Filters
Technical Specifications

Operating Conditions(1) Kleenpak Nova NP Capsule —

Maximum Operating 40 °C (104 °F) Typical Water Flow Rates at 20 °C (68 °F)
Temperature Flow Rate (Gal /min)
5 10 15 20 25
Maximum Operating 3 barg (43.5 psig) at 40 °C (104 °F). 600
Pressure 8
500

Differential Pressure (mbar)

(1)
With compatible fluids which do not soften, swell or adversely affect the product or its 7

Differential Pressure (psi)

P6
materials of construction.
6
400
5
Capsule Materials of Construction 300
4
Housing Bowl Polypropylene
3
200
Housing Head(2) Polypropylene P9
2
O-rings Silicone elastomer 100
1
P1
(2)
Formulated with TiO2 whitener which does not contribute to organic extractables.
0
0 20 40 60 80 100
Sterilization Flow Rate (L /min)
• P6 Capsules (13 mm ( ⁄2 in.) hose barb)
1

Autoclave (Maximum) single-cycle, 3 x 20 minutes • P9 Capsule (25 mm (1 in.) hose barb)

135 °C, for 1 hour • P1 Capsules (sanitary flange)

Gamma-irradiation Maximum Dosage: 50 kGy Kleenpak Nova NT Capsule —

Typical Water Flow Rates at 20 °C (68 °F)
Consult Pall for procedures.
Flow Rate (Gal /min)
5 10 15 20 25
2.5
Nominal Dimensions 160 P9
Differential Pressure @ 20 °C (mbar)

Differential Pressure @ 68 °F (psi)

In-line NP6 NP7 NP8 140
P19 2
Maximum Diameter 154 mm 154 mm 154 mm 120
(including Valves) (6.1 in.) (6.1 in.) (6.1 in.)
100 P1 1.5
Length with Hose Barb 397 mm 644 mm 895 mm
Inlet and Outlet (15.6 in.) (25.4 in.) (35.2 in.) 80
1
Length with Sanitary 335 mm 584 mm 834 mm 60
Inlet and Outlet (13.2 in.) (23.5 in.) (32.8 in.) 40
0.5
T-style NT6 NT7 NT8 20
Maximum Diameter 240 mm 240 mm 240 mm
0 0
(including Valves) (9.5 in.) (9.5 in.) (9.5 in.) 0 20 40 60 80 90 100
Flow Rate (L/min)
Length 349 mm 598 mm 848 mm
• P1 Capsules (sanitary flange)
(13.7 in.) (23.5 in.) (33.4 in.)
• P19 Capsules (sanitary flange inlet, 25 mm (1 in.) hose barb outlet)
• P9 Capsule (25 mm (1 in.) hose barb)
Note: Empty Kleenpak Nova Capsule Housings for water at 20 °C (68 °F), 1 cP. For other
liquids, multiply pressure times the viscosity in centipoise. For complete assembly,
including AB-Style filter cartridge, add housing, and cartridge media pressure-drop
values, contact Pall for assistance.

Ordering Information
NP – In-Line
NT – T-style

Code Filter Size Code Filter Type Code Filter Grade Code Connection Options Code Sterilization
6 AB1 10 in. Pre-filter Grades P Pharmaceutical 1 1 – 11⁄2 in. sanitary flange inlet Status
(254 mm) UUA 0.2 µm rated with Certificate and outlet G Non-sterilized
7 AB2 20 in. UUAP PreFlow filter of Test and Full 9 25 mm (1 in.) single-barb S Pre-sterilized
(508 mm) UB 0.45 µm rated Traceability hose barb inlet and outlet
8 AB3 30 in. UBP PreFlow filter Omit Pharmaceutical 19 1 – 11⁄2 in. sanitary flange inlet
(762 mm) U010Z 1.0 µm rated and 25 mm (1 in.) single-barb
U010ZP Ultipor GF Plus filter hose barb outlet
U2-20Z 2.0 µm rated Options for In-line Only
U2-20ZP Ultipor GF Plus filter 6 13 mm (1⁄2 in.) single-barb
A015P 1.5 µm rated hose barb inlet and outlet
Profile Star filter 16 1 – 11⁄2 in. sanitary flange inlet
Code Vent and Drain
A030P 3.0 µm rated and 13 mm (1⁄2 in.) single-barb
hose barb outlet – Stäubli(1) vent and
Profile Star filter
stepped hose barb
A050P 5.0 µm rated Options for T-style Only
drain
Profile Star filter 1H 1 – 11⁄2 in. sanitary flange inlet
A Stäubli(1) vent and
UY045P 4.5 µm rated and outlet, with 13 mm (1⁄2 in.)
drain
Profile filter with sanitary port on inlet
Ultipleat® construction 1H9 1 – 11⁄2 in. sanitary flange inlet (1)
Stäubli is a trademark of
and 25 mm (1 in.) single-barb Stäubli AG.
42 Note: Partial list of part numbers.
hose barb outlet, with 13 mm
Contact Pall for specific part numbers.
(1⁄2 in.) sanitary port on inlet
 PreFlow™ Capsule Filters
Scalable Prefilters with PreFlow UUA and UB Media

PreFlow capsule filters have been Applications

designed for small volume production and
scale-up evaluation.
Pall PreFlow media provide bioburden
reduction, clarification, and prefiltration for
sterilizing-grade filters when processing
biological fluids. The fixed pore structure
and proprietary resin-bonded glass fiber
composite media provide exceptional
capacity for fine contaminants and long
service life.
PreFlow filters have the following
properties:
• Fixed pore construction
• Resistant to contaminant unloading
• Meets USP Biological Reactivity Test,
in vivo, for Class VI – 121 °C Plastics
Features and Benefits
The PreFlow range of filters has been
specifically designed for the filtration of
biological fluids including:
• Serum
• Vaccines
• Cell Culture Media
• Protein Solutions
Pall’s UpScaleSM Program
From drug discovery and basic research,
through process development and
production, Pall Corporation is the single
source for all of your filtration and
separation needs. Our UpScale program
provides you with the scalable filtration
products and support you need to bring
new products to market faster.

The key benefits of DFA PreFlow capsules

for prefiltration applications include:
• Scalablity to production filters
• Capsule format for ease of use
• Effective and reliable protection of final
filters, including 0.2 µm and 0.1 µm
sterilizing-grade — providing higher
throughputs and longer filter life
• Low hold-up volumes
• High-strength design allows for multiple
autoclave cycles
• Supplied with Certificate of Test giving
batch traceability

43
 PreFlow Capsule Filters
Technical Specifications

Materials of Construction Typical Liquid Flow Rates at 20 °C (68 °F)(3)

Filter Medium Resin-bonded glass fiber 20 3

Core and End Caps Polypropylene DFA3001UBC

Support and Drainage Polypropylene

15

Differential Pressure (mbar)

Differential Pressure (psid)

Shell Polypropylene
2

Operating Conditions (1) DFA3001UUAC

10
Maximum Operating 40 °C (104 °F)
Temperature
1
Maximum Operating 3.5 barg (50 psig)
Pressure 5

(1)
In compatible fluids which do not soften, swell or adversely affect the filter or its
materials of construction.

0 0
0 2 4 6 8
Typical Extractables in Water at 20 °C (68 °F)
after 4 hours Extraction Flow Rate (L/min)

DFA3001UUAC < 10 mg (3)

Typical initial clean media ∆P; water at 20 °C (68 °F) viscosity 1cP.
For assistance in sizing, contact your local pall representative.
DFA3001UBC < 30 mg

Autoclave Sterilization(2)
3 x 1-hour cycles at 125 °C (257 °F) Nominal Filtration Area
(2)
Warning: This product must not be sterilized in situ by passing steam through under 0.1 m2 (1.0 ft2)
pressure.

Nominal Dimensions
Length 124 mm (4.9 in.)
Maximum Diameter 72 mm (2.8 in.)
Connections 10 mm (3⁄8 in.) hose barb

Ordering Information
Part Number Absolute Removal Rating
DFA3001UUAC 0.2 µm
DFA3001UBC 0.45 µm

44
 Mini Profile Capsule Filters
®

Scalable Depth Filters with Profile II and Profile Star Media

Pall Mini Profile Capsule Filters have been
designed for small volume production and
scale-up evaluation. These scalable
capsule filters are available in two media
types to complement and extend the range
of depth filters available in the Pall
UpScaleSM Program.
They can be used for a wide range of
applications including clarification of
biological products.
Pall Profile II filters are all-polypropylene
depth filter elements, featuring tapered
pores that narrow to an inner (downstream)
absolute-rated section. This thick depth
structure provides high-capacity for larger
solids and gels as well as for fine particles.
Profile Star filter cartridges feature
high-area star-shaped pleat construction.
The patented design combines the
advantages of depth filters with the high
flow rates of high-area pleated filters.
Features and Benefits
• Excellent gel removal
• Higher flows and throughputs
• Easy to use self-venting format
• Pharmaceutical P optimized grades
with Certificate of Test provides batch
traceability
• Low extractables and low
protein-binding
• Manufactured under clean conditions in
a controlled environment
• Rating range from 0.5 µm to 5 µm
Pall’s UpScaleSM Program
From drug discovery and basic research,
through process development and
production, Pall Corporation is the single
source for all of your filtration and
separation needs. Our UpScale program
provides you with the scalable filtration
products and the support you need to
bring new products to market faster.

• Can be used in scale-up evaluation

• Capsule format for ease of use
• Choice of high void-volume depth
medium or high-area pleated depth
filter
• Absolute particle-rated for reliability
• Low hold-up volumes
• Broad chemical compatibilities
• Optimized for viscous fluids

45
 Mini Profile Capsule Filters
®

Technical Specifications

Materials of Construction Typical Liquid Flow Rates(3)

Filter Medium Polypropylene 3500 5
BYY005P6 BYY010P6
Core and End Caps Polypropylene 3000
4

Differential Pressure (mbar)

Housing Polypropylene

Differential Pressure (psi)

2500
13 mm (1⁄2 in.) Single Polypropylene
Hose Barb Adapter 3
2000

Absolute Removal Ratings (Liquid) 1500 BYA015P6

2
Profile II 1 µm and 0.5 µm(1)
1000
Profile Star 5 µm, 3 µm and 1.5 µm(1) BYA030P6 1
BYA050P6
(1)
Extrapolated. 99.98% by modified OSU-F2 Beta test. For further details, contact Pall. 500

0 0
0 1 2 3 4 5
Nominal Filtration Area
Flow Rate (L/min)
Profile II 46 cm2 (7.1 in2) (3)
Typical initial clean media ∆P; water at 20 °C (68 °F) viscosity 1cP.
Profile Star 90 cm2 (14.5 in2) For assistance in sizing, contact your local Pall representative.

Connections (Inlet and Outlet)

Operating Conditions
13 mm (1⁄2 in.) hose barb
Maximum operating pressure and temperatures in compatible(4) fluids

Temperature Maximum 85 mm
Differential Pressure (3.35 in.)

Profile II 30 °C (86 °F) 4.1 bard (60 psid)

37 mm
(1.45 in.)
50 °C (122 °F) 3.4 bard (49 psid)
Profile Star 50 °C (122 °F) 5.0 bard (72 psid)
(4)
Fluids which do not adversely affect the filter or materials of construction.

76.5 mm
Maximum Accumulated Autoclave Time (3.07 in.)

Up to 125 °C 3 x 30-minute cycles 50 mm

(1.97 in.)
Warning: Mini Profile Capsule filters must not be in situ steam-sterilized by passing
steam through under pressure. The figures given are maximum allowable figures
determined by testing under controlled laboratory conditions to the length of time
indicated. Actual operating conditions may affect the filter’s long-term response to
sterilization. Filters should be qualified for each process application.
77.5 mm
(3.05 in.)

Ordering Information(2)
Part Number Medium Removal Rating
BYA015P6 Profile Star 1.5 µm
BYA030P6 Profile Star 3 µm
BYA050P6 Profile Star 5 µm
BYY005P6 Profile II 0.5 µm
BYY010P6 Profile II 1 µm
(2)
This is a guide to the part number structure only.
For availability of specific options, please contact Pall or your local Pall distributor.

46
 Kleenpak™ Capsules with HDC II Filter Assemblies
High Dirt Retention Polypropylene Liquid Filters in the most Convenient Form
Pall Kleenpak filters combine the widest
available range of filter media and specially
designed self-contained assemblies
to satisfy the very highest standards of
filtration security and user convenience.
HDC II Filter Medium
At the heart of every Kleenpak filter with
HDC II media is a high-performance
pleated cartridge with polypropylene filter
medium. The HDC II medium is produced
by a proprietary technique, varying the fiber
diameter continuously to provide a
pore-size distribution from coarse
(upstream) to fine (downstream) while
maintaining constant void-volume
throughout the depth of the filter medium.
• The varied fiber diameter means
extraordinary contaminant-holding
capacity, maximum flow rate, and low
costs per liter of filtered fluid
• The fixed pore structure means that
contaminants will not unload under
variations in flow or pressure differential,
and fibers will not migrate or become
dislodged to contaminate process fluids
Clean and Robust Design
The Kleenpak filter uses well-proven
proprietary Pall techniques for filter
construction and heat sealing.
• The highest possible security against
filter bypass is ensured, even under
conditions of pulsed flow
• High-strength design allows multiple
autoclave cycles for extended use and
maximum filter economy
• Polypropylene outer shell is designed to
provide long-term assurance of
pressure and temperature ratings
• Internal hold-up volume and dead
space is minimized for maximum
product recovery
®
• A total absence of glues, binder resins
and surfactants results in very low filter
extractables and extremely clean filtrate
• All filter materials of construction have
met the specifications for USP Class VI
biological tests for plastics at 121 °C
and meet FDA requirements for food
contact use 21 CFR parts 170-199
Quality and Bio-Safety
Biological Tests
• Meets USP Biological Reactivity,
In Vivo, for Class VI-121 °C plastics
Effluent Quality Tests*
• Meets Cleanliness per USP Particulates
in Injectables
• Non-Fiber-Releasing
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
• Meets Total Organic Carbon and Water
Conductivity per USP Purified Water,
pH per USP Sterile Purified Water
* Per lot sample soak or rinse-up flush aliquots.
Convenience to Suit All Needs
The self-contained design of each
Kleenpak filter means that operator
intervention and exposure during filter
installation and change-out are minimized.
• Integrally molded inlet and outlet
connections
◆ Maximum convenience and security
• Vent and drain connections with seal
protected threads and precision molded
valves
◆ Exceptionally simple and reliable
operation
• Available in three standard sizes.
◆ Flexibility in batch size or flow rate
requirements
47
 Kleenpak Capsules with HDC II Filter Assemblies
Technical Specifications

Materials of Construction Typical Liquid Flow Rates(2)

Medium Polypropylene Flow Rate (L/min)
0 1 2 3 4
Support, Drainage, Core, Polypropylene 1
KA1J012 KA2J012
Cage, End Caps and Shell KA1J045
60
Vent and Drain Valve O-rings Ethylene Propylene (EPDM)

Differential Pressure (mbar)

Differential Pressure (psid)
KA3J012
Nominal Dimensions KA2J045 40
Size Code KA1 KA2 KA3 KA1J100
0.5
Maximum Diameter of 94 mm 94 mm 109 mm
Bowl (including Valves) (3.7 in.) (3.7 in.) (4.2 in.)
KA3J045 20
Nominal Length (including 117 mm 158 mm 174 mm KA2J100
11⁄2 in. Sanitary Flange (4.6 in.) (6.2 in.) (6.8 in.)
KA3J100
Connection)
0 0
Nominal Length (including 158 mm 199 mm – 0 0.2 0.4 0.6 0.8 1.0
Stepped Hose Barb (6.2 in.) (7.8 in.) – Flow Rate (Gal/min)
Connection)
Flow Rate (L/min)
Nominal Length (including – – 210 mm 0 1 2 3 4
Hose Barb Connection) – – (8.2 in.) 0.5
5 0

5
02 06

02
2J 1J 25 30
3J0

1J
KA KA KA

KA

Differential Pressure (mbar)

Nominal Filter Areas
Differential Pressure (psid)

60
2J0
Effective Size Code KA
Filter Area KA1 KA2 KA3 20
0.25
J012, J025 0.06 m2 (0.6 ft2) 0.1 m2 (1.0 ft2) 0.2 m2 (2.0 ft2) J060
KA3
J045 0.06 m2 (0.6 ft2) 0.11 m2 (1.2 ft2) 0.22 m2 (2.3 ft2)
10
J060 0.03 m2 (0.3 ft2) 0.05 m2 (0.5 ft2) 0.10 m2 (1.0 ft2)

J100 0.03 m2 (0.3 ft2) 0.07 m2 (0.7 ft2) 0.13 m2 (1.4 ft2)
0 0
0 0.2 0.4 0.6 0.8 1.0
Removal Ratings (Liquids)(1) Flow Rate (Gal/min)
(2)
Typical initial clean ∆P, water at 20 °C (68 °F). Values shown are for 38 mm
J100 J060 J045 J025 J012
(11⁄2 in.) sanitary flange connections. Values with other connections are
10 µm 6 µm 4.5 µm 2.5 µm 1.2 µm available on request. For assistance in filter sizing, contact your local Pall
representative.
(1)
> 99.98% by modified OSU-F2 Beta test.
Operating Conditions(2)

Connections (Inlet and Outlet)
KA1 and KA2 Styles
KA3
Maximum Operating 5.2 barg (75 psig) at 40 °C (104 °F)
Pressure and Temperature
38 mm (11⁄2 in.) sanitary flange
6 – 13 mm (1⁄4 – 1⁄2 in.) stepped hose barb Maximum Differential 4.1 bard (60 psid) at 40 °C (104 °F)
Pressure and Temperature
38 mm (1 ⁄2 in.) sanitary flange
1
(2)
Using compatible liquids. Maximum 3.5 barg (50 psig) in air and gas service.
14 mm (9⁄16 in.) stepped hose barb

Steam Autoclaving
Cumulative Autoclave Time(3) 50 hours at 140 °C
(3)
Laboratory tests (1-hour cycles) establish multi-cycle resistance. Filters should be
qualified in actual use.

Warning: Kleenpak filters must not be steamed in situ by passing steam through under
pressure.

Ordering Information

K A P

Code Grade Removal Ratings in Liquids(4) Code Connectors

1 J012 1.2 µm 1 38 mm (11⁄2 in.)
sanitary flange
2 J025 2.5 µm
2 6 to 13 mm
3 J045 4.5 µm
(1⁄4 to 1⁄2 in.)
J060 6.0 µm stepped hose barb
J100 10 µm 6 14 mm (9⁄16 in.)
(4)
Based on modified OSU F-2 test.
48 Contact Pall for further details.
 HDC II Junior Style Filter Cartridges
®
HDC II High Dirt Capacity Polypropylene Filters
HDC II Junior Style Filter Cartridges
(including Sealkleen™ cartridges) are high
dirt capacity pleated polypropylene filters
constructed with a proprietary technique:
varying the fiber diameter instantaneously
and continuously to produce a pore-size
distribution from coarse (upstream) to fine
(downstream) while maintaining constant
void-volume throughout the depth of the
filter medium. This unique construction
means that more contaminants are
trapped in the outer and inner layers of the
medium, thereby substantially increasing its
dirt-holding capacity, and the service life of
the filter.
Sealkleen and Junior HDC II style filters
are available in absolute removal ratings
from 0.6 µm to 40 µm.
The all-polypropylene construction of these
filters make them compatible with an
extremely wide range of fluids. Cartridges
with a P option are optimized for
pharmaceutical applications.
All materials of construction are FDA-listed
materials per 21 CFR.
Features and Benefits
Varied Fiber Diameter
• Extraordinarily high dirt-holding capacity
Fixed Pore Structure
• No solids unloading under variations in
flow or pressure differential
• Fibers will not migrate or become
dislodged and contaminate process
fluid
Pure Polypropylene Construction
• Extremely good chemical compatibility
with a wide range of fluids
• No surfactants or binder resins
• Cartridges can be in situ
steam-sterilized
Quality and Bio-Safety
Biological Tests
• Meets USP Biological Reactivity,
In Vivo, for Class VI-121 °C plastics
Effluent Quality Tests*
• Meets Cleanliness per USP Particulates
in Injectables
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
• Meets Total Organic Carbon and Water
Conductivity per USP Purified Water,
pH per USP Sterile Purified Water
* Per lot sample soak or rinse-up flush aliquots.
49
 HDC II Junior Style Filter Cartridges
Technical Specifications

Operational Limits Typical Liquid Flow Rates for SLK7002 and MCY4463 Styles
500
Operating 50 °C (122 °F) 80 °C (176 °F)
J006 J012 7
Temperature (Maximum)
J025
Maximum Differential 5.5 bard (80 psid) 4.1 bard (60 psid) 400 6
Pressure

Differential Pressure (mbar)

Differential Pressure (psi)

5
Nominal Filter Area 300 J045
4
Grade SLK7001 Style MCY4463 and
J060
SLK7002 Styles
200 3
J006 0.11 m2 (1.2 ft2) 0.22 m2 (2.4 ft2) J100

J012 0.12 m2 (1.3 ft2) 0.25 m2 (2.7 ft2) 2

J200
100
J025 0.14 m (1.6 ft )
2 2
0.25 m (2.7 ft )
2 2

J400 1
J045 0.14 m2 (1.6 ft2) 0.25 m2 (2.7 ft2)
0 0
J060 0.07 m2 (0.8 ft2) 0.15 m2 (1.7 ft2) 0 10 20 30 40 50 60
J100 0.09 m (1.0 ft )
2 2
0.19 m (2.1 ft )
2 2
Flow Rate (L/min)

J200 0.09 m2 (1.0 ft2) 0.19 m2 (2.1 ft2) Sterilization

J400 0.06 m2 (0.7 ft2) 0.25 m2 (2.7 ft2) Steam-sterilizing Up to 140 °C (284 °F) in situ
Temperature or autoclave
Note: Differential pressures are for liquids with a viscosity of 1 cP. Differential pressures
for liquids at other viscosities can be conservatively estimated by multiplying the
indicated differential pressure by the viscosity in cP. To obtain the total pressure drop of a
complete filter assembly the housing pressure drop must be added. Please refer to the
relevant housing literature or contact Pall.

Ordering Information
Sealkleen Style
Single open-ended 57 mm (2.25 in.) diameter element (excluding flange). Incorporates a patented sealing arrangement that eliminates any chance of fluid bypass via
the seal, from the upstream side of the filter element to the downstream side. The housing elastomeric O-ring is placed on a special flange, which is an integral part
of the element outlet end cap.

SLK

Code Nominal Length HDC II Filter Grade Removal Rating Code Filter Grade
7001 2.5 in. (66 mm) J006 0.6 µm(1) P Pharmaceutical
7002 5.2 in. (133 mm) J012 1.2 µm Omit Other
J025 2.5 µm
J045 4.5 µm
J060 6.0 µm
J100 10.0 µm
J200 20.0 µm
J400 40.0 µm
Junior Style (MCY)
Single open-ended 57 mm (2.25 in.) diameter element with single external O-ring seal contained in the outlet end cap.
Cartridge nominal length of 133 mm (5.25 in.).

MCY

Code Nominal Length HDC II Filter Grade Removal Rating Code Filter Grade Code O-ring
Option
4463 5.2 in. (133 mm) J006 (1)
0.6 µm (1)

P Pharmaceutical* H4 Silicone
J012 1.2 µm
Other O-ring options on request.
J025 2.5 µm
Omit General Use
J045 4.5 µm
* Pall pharmaceutical-grade
J060 6.0 µm filters are designed for use in
conformance with CGMP in
J100 10.0 µm Manufacturing, Processing,
Packing or Holding of Drugs
J200 20.0 µm (21CFR210) and CGMP for
J400 40.0 µm finished Pharmaceuticals
(21CFR211.72) including
(1)
Extrapolated value. batch release certificate and
50 full traceability.
 Profile II Filter Cartridges
®

Absolute-rated Depth Filters with Excellent Chemical Compatibility

and Long Service Life

Pall Profile II filters provide: Applications

• Absolute removal ratings for reliability Profile II polypropylene filters have a wide
• Built in prefiltration for economy range of applications including filtration of
fermentation broths, lysates, biological
• Revolutionary new construction for long
fluids, blood products, ophthalmics,
service life and high flow-rates
organic solvents, pH adjusters, buffers,
purified water, parenterals and many other
Features and Benefits fluids.
Based on the widely accepted modified
F-2 Filter Performance Test(1), Profile II Other Profile II filters available
filters can be expected to yield longer
Profile II nylon filters — for applications
service life, in many cases by factors of six
where polypropylene Profile II filters are
or more, and higher flow rates when
chemically or physically incompatible, such
compared with existing products of similar
as for the filtration of hot vegetable and
physical appearance at equal efficiency.
mineral oils and aromatic solvents.
The specific features include:
Profile II Plus filters — these
• Excellent compatibility with a wide
all-polypropylene filters have a positive
range of chemicals
charge to provide enhanced removal
• Continuous operating temperatures up efficiency for small particles, bacteria and
to 82 °C (180 °F) viruses.
• Wide choice of particulate removal Profile II capsule filters — disposable
efficiencies from 0.3 µm to 120 µm assemblies for ease of use.
absolute to optimize filter ratings for
each application
• No media migration — the fibers are
continuous and fixed by intertwining
during the manufacturing process
• Very low extractables — no binders,
lubricants or surfactants are used
during manufacture
• Choice of cartridge length to match
flow rates
• Choice of three cartridge styles —
AB, RMF and RF style to suit different
housing styles and applications
(1)
For additional information on the complete range of
Profile II filters and the F-2 Filter Performance Test,
please contact Pall.

Note: These filters are also available in Kleenpak Nova

capsule format.

51
 Profile II Filter Cartridges
Technical Specifications

Operating Conditions(1) Extractables

Operating 30 °C 50 °C 70 °C 82 °C
Extractables (non-volatile residues) of less than 10 mg per 10 in.
Temperature (86 °F) (122 °F) (158 °F) (180 °F) (250 mm) cartridge were found in a standard 24 hour reciprocating
test in water at 20 °C (68 °F).
Maximum 4.0 bar 3.4 bar 2.0 bar 1.0 bar
Differential Pressure (58 psi) (49 psi) (29 psi) (15 psi)
(1)
In fully compatible liquids which do not soften, swell or attack the filter. AB Code 7
style elements can be heated to 125 °C (257 °F), for example during in situ
steam-sterilization or autoclaving and subsequent cooling to ambient temperatures
prior to use. If RF or RMF style elements are heated in situ for any reason, and the filter
is then used at a temperature lower by 20 °C (68 °F) or more, sealing of the element
within the housing may be marginal.

Retention Ratings and Flow Rates

Liquids Flow Rates for a 10 in. (254 mm)
Element with water (1 cP)
Code Absolute Retention Rates(2)
ß ≥ 5000 (> 99.98%) ß = 1000 (99.9%) ß = 100 (99%) ß = 10 (90%)
∆P = ∆P =
100 mbar (1.45 psi) 50 mbar (0.75 psi)
003 0.3 µm(3) < 0.3(3) < 0.3(3) < 0.3(3) 1.6 –
005 0.5 µm (3)
< 0.5 (3)
< 0.5 (3)
< 0.5(3) 1.8 –
010 1.0 µm 0.5(3) < 0.5(3) < 0.5(3) 2.1 –
020 2.0 µm 1.5 1.0 < 1.0(3) 2.9 –
030 3.0 µm 2.5 1.8 < 1.0(3) 3.7 –
050 5.0 µm 4.0 3.0 2.0 6.7 –
100 10.0 µm 9.0 7.5 6.5 – 8.3
150 15.0 µm 13.0 10.0 8.0 – 16.7
200 20.0 µm 18.0 14.0 10.0 – 27.7
300 30.0 µm 26.0 18.0 14.0 – 33.3
400 40.0 µm 35.0 30.0 20.0 – 50.0
700 –(4) 70.0 50.0 32.0 – 50.0
900 –(4) 90.0(3) 78.0(3) 50.0 – 50.0
1200 –(4) 120.0(3) 100.0(3) 60.0 – 50.0
(2)
Modified OSU-F2 test.
(3)
Extrapolated data.
(4)
Not measurable.

Ordering Information and Selection Guide

AB Style RMF Style RF Style
RF Style: R F
Code 7 63.5 mm 63.5 mm
70 mm (2.5 in.) (2.5 in.)
(2.75 in.) diameter diameter
RMF Style: RM F
diameter Flat gasket crush seal
Double 226 seal
O-ring seal

AB Style: AB Y

Code Nominal Length Code Removal Code Removal Code Cartridge Code Filter Code O-ring
Rating(5) Rating(5) Style Grade Option
1 10 in. (254 mm)
003 0.3 µm 150 15 µm 7 Double 226 P Pharmaceutical* H4 Silicone
2 20 in. (508 mm)
O-ring J Ethylene
005 0.5 µm 200 20 µm Omit General Use
3 30 in. (762 mm) with bayonet Propylene
010 1 µm 300 30 µm lock and * Pall pharmaceutical-grade
4 40 in. (1016 mm) fin end filters are designed for use in Other materials available on
020 2 µm 400 40 µm conformance with CGMP in request.
Manufacturing, Processing,
030 3 µm 700 – Packing or Holding of Drugs
(21CFR210) and CGMP for
050 5 µm 900 – finished Pharmaceuticals
(21CFR211.72) including
100 10 µm 1200 –
batch release certificate and
(5)
The removal rating is the value in microns at full traceability.
which the modified OSU-F2 test gives a Beta
value of ≥ 5000.
52
 Profile Star Filter Cartridges
®

Absolute-rated Pleated Depth Filters combining Long Service Life and High Flow-rates

To keep pace with advancing technologies, Features and Benefits

Pall continues its tradition of filtration
innovations with the Profile Star filter:
a state-of-the-art concept for pleated
polypropylene filters. The proven and
successful Pall technique of varying the
fiber diameter produces a pore-size
gradient from coarse (upstream) to fine
(downstream) while maintaining constant
high void-volume throughout the depth of
the filter medium. Profile Star filters offer
longer life than many competitive pleated
filters. Due to their proprietary construction,
Profile Star filters deliver the benefits of
both traditional pleated polypropylene and
depth style filters — the ideal combination.
The pressure drop and flow capability is
comparable to competitive pleated
polypropylene filters while also providing
excellent removal of soft contaminants,
such as gels, because of the depth of the
medium.
Profile Star filters are available in absolute
removal ratings from 1.0 µm to 90 µm and
in four nominal cartridge lengths:
• 10 in. (254 mm)
• 20 in. (508 mm)
• 30 in. (762 mm)
• 40 in. (1016 mm)
Their all-polypropylene construction makes
them compatible with an extremely wide
range of fluids. Cartridges are available in a
P grade which is optimized for
pharmaceutical applications.
Note: These filters are also available in Kleenpak Nova
capsule format.
Pleated High-area
• Extraordinarily high dirt-holding capacity
• Long service life
• High flow-rates
• Excellent gel removal capability
Fixed Pore Structure
• No solids unloading under variations in
flow or pressure differential
• Fibers will not migrate or become
dislodged and contaminate process
fluid
All-polypropylene Construction
• Extremely good chemical compatibility
with a wide range of fluids
• Very low extractables
• No surfactants or binder resins are
used during manufacture
• Continuous construction without side
seam
• Media melt-sealed to solid components
to ensure maximum integrity
Quality and Bio-Safety
Biological Tests
• Meets USP Biological Reactivity,
In Vivo, for Class VI-121 °C plastics
Effluent Quality Tests*
• Meets Cleanliness per
USP Particulates in Injectables
• Non-Fiber-Releasing
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
• Meets Total Organic Carbon and Water
Conductivity per USP Purified Water,
pH per USP Sterile Purified Water
* Per lot sample soak or rinse-up flush aliquots.

55
 Profile Star Filter Cartridges
Technical Specifications

Typical Liquid Flow Rates

Materials of Construction 120

Filter Medium, Cage, Core, Polypropylene

End Caps and Adapters
1.5
100
O-rings Silicone or Ethylene Propylene (EPDM)

5
A01
as standard

A01

50
30

A0
A0
Differential Pressure (mbar)
80

Differential Pressure (psi)

Operating Conditions – Maximum Operating Differential Pressures and
Temperatures in Compatible(1) Liquids
00 1
A1
Maximum Operating 50 °C (122 °F) 80 °C (176 °F)
60
Temperature
50
A1
Maximum Differential 5.0 bar (72 psi) 3.4 bar (49 psi)
Pressure
40
0
Steam-sterilizing Temperature 125 °C A20 0.5
(in situ or Autoclave) A400
Cartridge Style AB Code 3 P grade and AB Code 7 20
00
Maximum Recommended 10 hours A700/9
Cumulative Steam Life
at 125 °C 0
0
(1)
Fluids which do not soften, swell or adversely affect the filter or materials of 0 20 40 60 80 100 120
construction. Flow rate (L/min) per 10 in. (254 mm) nominal length cartridge
Note: Differential pressures are for liquids with a viscosity of 1 cP. Differential pressures for
liquids at other viscosities can be conservatively estimated by multiplying the indicated
differential pressure by the viscosity in cP. For cartridges of 20 in. (508 mm), 30 in. (762 mm) and
40 in. (1016 mm) nominal length, divide the differential pressure by 2, 3 and 4 respectively. To
obtain the total pressure drop of a complete filter assembly the housing pressure drop must be
added. Please refer to the relevant housing literature or contact Pall.

Ordering Information

MCY 1000 Style Double open-ended 70 mm (2.75 in.) diameter element with gaskets on both ends. Sealing is assured by using a tie rod and seal nut.

MCY 1000

Code Nominal Code Removal Code Filter Code Gasket Cartridge Sealing
Length Rating(2) Grade Option Arrangements
1 10 in. A010 1.0 µm(3) P Pharmaceutical* H4 Silicone MCY1000 AB Style
(254 mm) A015 1.5 µm(3) Omit General Use J Ethylene propylene Style (Other materials are
2 20 in. available on request)
A030 3 µm * Pall pharmaceutical-grade filters Other materials available on request.
(508 mm) 70 mm 70 mm 70 mm
A050 5 µm are designed for use in
3 30 in. conformance with CGMP in diameter diameter diameter
(762 mm) A100 10 µm Manufacturing, Processing,
A150 15 µm Packing or Holding of Drugs
4 40 in. (21CFR210) and CGMP for
(1016 mm) A200 20 µm finished Pharmaceuticals
(21CFR211.72) including batch
A400 40 µm
release certificate and full Flat gasket Code 7 Code 3
A700 70 µm traceability.
Double O-ring seal
A900 90 µm
AB Style Single open-ended element with double O-rings at one end.

AB

Code Nominal Code Removal Code Cartridge Code Filter Code Gasket
Length Rating(2) Style Grade Option
1 10 in. A010 1.0 µm(3) 3 Double 222 O-ring P Pharmaceutical* H4 Silicone
(254 mm) A015 1.5 µm(3) with flat end Omit General Use J Ethylene propylene
2 20 in. 70 mm (2.75 in.)
A030 3 µm diameter * Pall pharmaceutical-grade filters Other materials available on request.
(508 mm)
A050 5 µm are designed for use in
3 30 in. 7 Double 226 O-ring conformance with CGMP in
(762 mm) A100 10 µm with bayonet lock Manufacturing, Processing,
A150 15 µm and fin end. Packing or Holding of Drugs
4 40 in. 70 mm (2.75 in.) (21CFR210) and CGMP for finished
(1016 mm) A200 20 µm diameter Pharmaceuticals (21CFR211.72)
including batch release certificate
(2)
Absolute rating in this A400 40 µm
and full traceability.
publication means the A700 70 µm
value in microns at which
the modified OSU-F2 test A900 90 µm
gives a Beta value of
56 > 5000.
(3)
Extrapolated value.
 Starclear™ Filter Cartridges
The Only Composite Pleated Depth Filters with Positive Zeta Potential

Revolutionary New Construction • Positive zeta potential for the removal of

fine contaminants such as
Starclear pleated filters are constructed
using a totally new technique based on a ◆ bacteria
composite design. ◆ viruses
• The unique built-in depth prefiltration ◆ endotoxins
layer, constructed from pleated Profile
◆ haze particles
Star filter medium provides:
◆ Graded pore-size distribution from
Total Commitment to Quality and
coarse (upstream) to fine
Excellence
(downstream)
Starclear filters are manufactured under a
◆ Constant void-volume
Quality Management System certified to
◆ Exceptionally high dirt-holding ISO 9000.
capacity
• The inner section, constructed from Quality and Bio-Safety
Ultipor GF Plus glass fiber filter
Biological Tests
medium with a fine pore structure,
ensures high removal efficiency and • Meets USP Biological Reactivity,
long service life. In Vivo, for Class VI-121 °C plastics
Effluent Quality Tests*
Exceptional Performance • Meets Cleanliness per USP Particulates
in Injectables
Starclear filter cartridges provide reliable
and cost effective sub-micron filtration with • Non-Fiber-Releasing
the following benefits:
• Non-Pyrogenic per USP Bacterial
• Absolute filtration, ensuring Endotoxins (< 0.25 EU/mL)
◆ consistent, reproducible performance • Meets Total Organic Carbon and Water
Conductivity per USP Purified Water,
◆ no fiber shedding
pH per USP Sterile Purified Water
◆ no unloading
* Per lot sample soak or rinse-up flush aliquots.
• Built-in prefiltration for
◆ high dirt-holding capacity
◆ long-life
◆ smaller installations
• High flow-rates enabling
◆ faster production times
◆ smaller installations with less product
loss and lower costs

57
 Starclear Filter Cartridges
Technical Specifications

Materials of Construction Extractables(2)

Filter Medium Prefiltration Layer: Typical Aqueous Extractables 40 mg
Polypropylene per 10 in. (254 mm) Module

Final Filtration Layer: (2)

Non-volatile residues from autoclaved elements after 4 hours reciprocation in deionized
Positively-charged glass fiber water.

Support and Drainage Layers Polypropylene

Microbial and Particulate Removal Efficiency
Core and Cage Polypropylene
Challenge Contaminant Typical Removal Efficiency
Adapter and End Cap Polypropylene
Pseudomonas diminuta TR(3) > 102
O-rings Silicone or ethylene propylene
as standard Serratia marcescens TR > 105
Lactobacillus brevis TR > 108
Liquid Flow vs. Differential Pressure Saccharomyces cerevisiae TR > 1010
Filter Size 10 in. (254 mm) nominal length Aqueous Suspension of ß ≥ 5000 (> 99.98%) at 0.5 µm(5)
Flow Rate(1) at 16.7 L/min AC Fine Test Dust(4)
100 mbar (1.45 psi) ∆P (3)
Titer reduction (TR) = No. organisms incident on filter
The relationship between flow rate and differential pressure is linear. The ∆P at other flow No. organisms detected in effluent
rates can therefore be calculated using the above data e,g. for a flow rate of 50 L/min, (4)
Performance measured using Pall F2 test. Contact Pall for additional details.
the clean ∆P will be 300 mbar (4.4 psi).
(5)
ß= No particles ≥ given size in influent
(1)
For fluids of 1 cP viscosity. As a general guide, for other viscosities, multiply differential
No particles ≥ given size in effluent
pressure by viscosity in cP. For cartridges of 5 in. (127 mm), 20 in. (508 mm),
30 in. (762 mm) and 40 in. (1016 mm) nominal length, divide differential pressure by
0.5, 2, and 4 respectively.
Operating Limits(6)
Maximum Operating Up to 40 °C Up to 60 °C
Steam-sterilization Temperature (104 °F) (140 °F)
Steam-sterilizing Temperature 125 °C Maximum Differential 5 bar (72 psi) 3.4 bar (49 psi)
(in situ or autoclave) Pressure

Maximum Recommended 10 hours

(6)
In compatible liquids which do not soften, swell or adversely affect the filter or its
materials of construction.
Cumulative Steam Life
Additional details on steam-sterilization are available by contacting Pall.

Ordering Information

AB HAZ

Code Nominal Length Code Cartridge Style Code Filter Grade Code Seal Material
05(7) 5 in. (127 mm) 7 Double 226 O-ring with P Code outside US H4 Silicone
bayonet lock and
1 10 in. (254 mm) Omit Code in US only J Ethylene propylene
fin end
Supplied with Certificate of Test and Full
2 20 in. (508 mm)
2(8) Double 226 O-ring with Traceability
3 30 in. (762 mm) bayonet lock and flat end
4 40 in. (1016 mm) (8)
Available in cartridge type AB05 only.
Other cartridges available on request.
(7)
Available with cartridge option code 2 only.

58
Profile Filter Cartridges with Ultipleat Construction
® ®

Advanced Technology, Unsurpassed Performance

Profile Filters with Ultipleat construction Applications

are an upgrade from pleated depth filter
technology pioneered by Pall, and
incorporate a revolutionary new
crescent-shaped pleat geometry which
enables a 30% increase in effective
filtration area.
The crescent-shaped pleat construction,
which is unique to Pall, combined with
Profile depth filter medium provides a very
low clean pressure drop and an
unsurpassed service life.
Process Improvements
• Reduced operating costs and
downtime resulting from the
crescent-shaped pleat construction
allows optimization of filter area, giving
unsurpassed service life — thus
reducing the frequency of changeout
and providing substantial savings in the
costs of maintenance and consumables
• Consistent and reliable performance
is a benefit of the absolute and 100%
efficient removal rating along with the
fixed pore structure that prevents both
unloading of contaminants and media
migration
• Excellent chemical compatibility and
Profile Filters with Ultipleat construction
have advantages in the filtration of viscous
liquids or for high flow-rates when there
may be significant sizing and economic
benefits.
Quality and Bio-Safety
Biological Tests
• Meets USP Biological Reactivity,
In Vivo, for Class VI-121 °C plastics
Effluent Quality Tests*
• Meets Cleanliness per USP Particulates
in Injectables
• Non-Fiber-Releasing
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
• Meets Total Organic Carbon and Water
Conductivity per USP Purified Water,
pH per USP Sterile Purified Water
* Per lot sample soak or rinse-up flush aliquots.
Diagrammatic Comparison of
Various Filter Constructions

ease of disposal due to the

Conventional Pleat Ultipleat Laid-over
all-polypropylene construction which Geometry Pleat Geometry
leads to lower filter inventories and
allows complete incineration* of the
spent cartridge.
Note: In the Code 7 style there is a metal insert in the
adapter.

* Consult local and national regulations

Note: These filters are also available in Kleenpak Nova

capsule format.

Depth
Filter

59
 Profile Filter Cartridges with Ultipleat Construction
Technical Specifications

Operating Conditions in Compatible(1) Liquids Typical Liquid Flow Rates(2)

160
Maximum Differential 4.1 bar 3.4 bar 2.0 bar 1.0 bar

µm
Pressure (60 psi) (49 psi) (29 psi) (15 psi) µm
140 4.5

0
2.
2
Operating 30 °C 50 °C 70 °C 80 °C
Temperatures (86 °F) (122 °F) (158 °F) (176 °F) 120

Differential Pressure (mbar)

Differential Pressure (psi)

(1)
Fluids which do not soften, swell, or adversely affect the filter or materials of
100
construction.

80
Steam-sterilization
1
60 m
Up to 140 °C (284 °F) for AB style filter elements 6.0 µ

40 10 µm 20 µm

40 µm
20
70 µm 100 µm
0 0
0 25 50 75 100
Flow Rate (L/min) – 10 in. (254 mm) nominal length cartridge
(2)
Typical initial clean media ∆P 10 in. (254 mm) element, water at 20 °C (68 °F),
viscosity 1 cP. For assistance with filter assembly, sizing and housing
selection, contact your local Pall representative.

Ordering Information
PUY Style Double open ended 63mm (2.5in) diameter cartridge with gaskets both end. Cartridge sealed with tie rod and seal nut.

PUY Style: PUY UY 7

AB Style: AB UY 7

Code Nominal Code Removal Cartridge Style Code Filter Code Seal Options
Length Rating(3) Grade
1 10 in. (254 mm) 020 2.0 µm Double 226 O-ring P Pharmaceutical* J Ethylene
(extrapolated value) with bayonet lock propylene
2 20 in. (508 mm) Omit General Use
and fin end (Standard)
045 4.5 µm
3 30 in. (762 mm) * Pall pharmaceutical-grade filters H4 Silicone
060 6.0 µm are designed for use in
4 40 in. (1016 mm)
conformance with CGMP in H13 Buna-N
100 10 µm Manufacturing, Processing,
Packing or Holding of Drugs
200 20 µm (21CFR210) and CGMP for
400 40 µm finished Pharmaceuticals
(21CFR211.72) including batch
700 70 µm release certificate and full
traceability.
1000 100 µm
(3)
Absolute rating in this publication
means the value in microns at which
the modified OSU-F2 Test gives a Beta
Value of ≥ 5000 (> 99.98% removal
efficiency).

60
 HDC II Filter Cartridges
®

High Dirt Retention All-polypropylene Prefilters

Pall HDC II all-polypropylene filter Quality and Bio-Safety

cartridges incorporate proprietary HDC II
Biological Tests
tapered pore polypropylene depth media.
The single open-ended (SOE) AB filter • Meets USP Biological Reactivity Test,
cartridge style features a high-area pleated in vivo, for Class VI-121 °C Plastics
modular element construction designed to Effluent Quality Tests*
fit in sanitary filter housings.
• Meets Cleanliness per USP Particulates
HDC II filter cartridges are well-suited for a in Injectables
broad range of fine particle and prefiltration
• Non-Fiber-Releasing
applications where purity, economy and
Non-Pyrogenic per USP
reliability are critical. Typical applications
include biologicals, pharmaceuticals, • Bacterial Endotoxins (< 0.25 EU/mL)
fermentation feeds and intermediates, and • Meets Total Organic Carbon and Water
vaccines. Conductivity per USP Purified Water,
pH per USP Sterile Purified Water
Features and Benefits
* Per lot sample soak or rinse-up flush aliquots.
• All-polypropylene construction
• Resin-free, melt-sealed
• Constant density tapered pores
• High-capacity for long-life
• Fixed pore, non-shedding
• Low protein binding
• Low extractables
• Broad chemical compatibilities
• Autoclavable and steamable in situ
• Manufactured for use in conformance
with cGMP
• ISO 9000 Certified Quality System
• Pharmaceutical P optimized grades
with Certificate of Test provided
• FDA-listed materials per 21 CFR
Note: These filters are also available in Kleenpak Nova
capsule format.

61
 HDC II Filter Cartridges
Technical Specifications

Materials of Construction Typical Liquid Flow Rates(6)

Medium Polypropylene Flow Rate (L/min)
0 10 20 30 40 50 60 70
Support and Drainage Layers Polypropylene 0.8

45
00

60
J02
Core, Cage and End Caps Polypropylene J1

J0

J0
50
P Grade Code 7 Adapters Polypropylene with encapsulated
stainless steel ring 0.6

Differential Pressure (psid)

40

Differential Pressure (mbar)

O-ring Silicone(1)
0
(1)
Other polymers available J20
30
0.4
Removal Ratings (Liquid) (2)
J400
70 µm, 40 µm, 20 µm, 10 µm, 6 µm, 4.5 µm, 2.5 µm, 1.2 µm, 0.6 µm(3) 20
(2)
> 99.98% by modified OSU-F2 test. 0.6 to 20 µm in water, 40 and 70 µm in oil.
0.2
(3)
Extrapolated value. J500 10

Nominal Dimensions
0 0
Lengths 10 in. (254 mm), 20 in. (508 mm), 0 3 6 9 12 15 18
30 in. (762 mm), 40 in. (1016 mm) Flow Rate per 10 in. (254 mm) Filter (Gal/min)
Diameter 70 mm (2.75 in.)
Flow Rate (L/min)
0 10 20 30 40 50 60
Operating Conditions 8
AB1J006
Maximum Differential 5.5 bard (80 psid) to 50 °C (122 °F) 500
Pressure and Temperature(4) 4.1 bard (60 psid) to 80 °C (176 °F)
(4)
Using compatible fluids. 6
Differential Pressure (psid)

400

Differential Pressure (mbar)

Autoclaving and Steaming in situ(5)
300
Maximum Steam Temperature 140 °C (284 °F) 4 AB1J012
(5)
Filters should be qualified in actual use. Contact Pall for recommended procedures.
200

2
100

0 0
2 4 6 8 10 12 14 16
Flow Rate per 10 in. (254 mm) Filter (Gal/min)
(6)
Typical initial media ∆P 10 in. (254 mm) element; water at 20 °C (68 °F);
viscosity 1 cP. For assistance in filter assembly sizing and housing selection,
contact your local Pall representative.

Ordering Information

AB 7

Code Nominal Code Removal Nominal Filter Cartridge Code Filter Code Gasket
Length Rating Area(7) Style Grade Option

1 10 in. J006 0.6 µm 0.63 m2 (6.7 ft2) Double 226 O-ring P Pharmaceutical* H4 Silicone
(254 mm) with bayonet lock
J012 1.2 µm 0.70 m2 (7.5 ft2) Omit General Use Other materials available on
and fin end(8)
2 20 in. request.
J025 2.5 µm 0.88 m2 (9.5 ft2) * Pall pharmaceutical-grade filters
(508 mm) (8)
Other adapter codes are designed for use in
J045 4.5 µm 0.88 m (9.5 ft )
2 2 available. conformance with CGMP in
3 30 in. Manufacturing, Processing,
(762 mm) J060 6 µm 0.42 m2 (4.5 ft2) Packing or Holding of Drugs
(21CFR210) and CGMP for
4 40 in. J100 10 µm 0.55 m2 (6.0 ft2) finished Pharmaceuticals
(1016 mm) (21CFR211.72) including batch
J200 20 µm 0.55 m2 (6.0 ft2)
release certificate and full
J400 40 µm 0.38 m2 (4.0 ft2) traceability.

J700 70 µm 0.38 m2 (4.0 ft2)

(7)
Per 10 in. (254 mm) element.

62
 Ultipor GF Plus Filter Cartridges
®

Positive Zeta Potential for Enhanced Efficiency

Pall Ultipor GF Plus filter cartridges are Features and Benefits

made with positive Zeta modified glass
• Positive Zeta enhances efficiency
fiber media for enhanced efficiency.
The single open-ended (SOE) AB style • High-area pleated medium
cartridges feature a high-area pleated • High void-volume
element construction designed to fit in
sanitary style filter housings. A bio-safe low • Low differential pressure
extractables binder resin covalently • High-capacity for long-life
immobilizes the glass fibers and imparts a
• Fixed pore structure
strong positive charge in aqueous service.
In addition to the high particulate removal • Melt-sealed construction
efficiency and low pressure drops • Broad chemical compatibility
consistent with glass fiber media, the
added positive Zeta charge enables • Manufactured for use in conformance
Ultipor GF Plus filters to effectively remove with cGMP
submicron haze particles or endotoxins • IS0 9000 Certified Quality System
from a wide variety of aqueous biological
and pharmaceutical solutions.

Pharma Quality (P grade) for

Highest Quality Requirements
Ultipor GF Plus filters are manufactured in
accordance with ISO 9000 and GMP
requirements. Each P grade filter is
supplied with a certificate of test that
confirms suitability for use in
pharmaceutical applications.
Samples are tested for effluent quality to
meet the USP requirements regarding
• Total Organic Carbon
• pH shift
• Endotoxins
All components meet the specifications for
biological tests listed in the USP for
Class VI plastics at 121 °C.
Each box contains a certificate which
confirms the quality standards in
manufacturing, the traceability of all
components, and the above mentioned
safety tests.
Note: These filters are also available in Kleenpak Nova
capsule format.

63
 Ultipor GF Plus Filter Cartridges
Technical Specifications

Materials of Construction Typical Liquid Flow Rates(5)

Flow Rate (L/min)
Medium Bonded glass fiber,
0 5 10 15 20
positive Zeta potential
0.3 20

Z
10Z
Support and Drainage Polyester

Z
0Z

-20

30
-4

U0
U6

U0
U2
Core, Cage and End Caps Polypropylene
O-Ring Silicone(1) 15

Differential Pressure (psid)

Differential Pressure (mbar)

(1)
Other polymers available. 0.2

0Z
Removal Ratings (Liquid)(2) U10 10

1 µm, 2 µm, 3 µm, 6 µm, 10 µm, 20 µm, 40 µm

Z
(2)
> 99.98% by mod. OSU-F2 Beta test. 0.1 U200

U400Z 5
Endotoxin Removal Efficiency(3)
U010Z (1 µm) 99.998%
U2-20Z, U030Z 99.97% 0 0
0 1 2 3 4 5 6
(3)
Efficiency in deionized water with up to 55 – 70 mg E. coli 055-B5 endotoxin per
Flow Rate per 10 in. (254 mm) Filter (Gal/min)
10 in. (254 mm) modular element.
(5)
Typical initial clean media ∆P 10 in. (254 mm) element; water at 20°C (68°F);
viscosity 1 cP. For assistance in filter assembly, sizing and housing
Latex Bead Removal Efficiency(4) selection, contact your local Pall representative.

U010Z (1 µm) ≥ 99.99% for 0.29 µm beads to 2.8 gm

U2-20Z (20/2 µm) ≥ 99.99% for 0.8 µm beads to 22 gm Operating Conditions(6)
U030Z (3 µm) ≥ 99.99% for 1.1 µm beads to 22 gm Maximum Differential Pressure 5.5 bard (80 psid) to 50 °C (122 °F)
(4)
Efficiency in deionized water per 10 in. (254 mm) modular element. and Temperature 3.8 bard (55 psid) to 82 °C (180 °F)
(6)
Using compatible fluids.
Nominal Dimensions
Lengths 10 in. (254 mm), 20 in. (508 mm), Autoclaving and Steaming in situ(7)
30 in. (762 mm), 40 in. (1016 mm) Maximum Temperature to 140 °C (284 °F)
Diameter 70 mm (2.75 in.) (7)
Contact Pall for recommended procedures.

Ordering Information

AB Z 7

Code Nominal Code Removal Filter Cartridge Code Filter Code Gasket
Length Rating Area(8) Style(10) Grade Option

1 10 in. U010 1 µm 0.50 m2 (5.4 ft2) Double 226 O-ring P Code outside US H4 Silicone
(254 mm) with bayonet lock
U2-20 (9)
2 µm 0.65 m2 (7.0 ft2) Omit Code in US only Other materials available on
and fin end
2 20 in. request.
U030 3 µm 0.56 m2 (6.0 ft2) Supplied with Certificate of Test and
(508 mm) (10)
Other adapter codes Full Traceability
U6-40(9) 6 µm 0.56 m2 (6.0 ft2) available.
3 30 in.
(762 mm) U100 10 µm 0.49 m2 (5.3 ft2)

4 40 in. U200 20 µm 0.40 m2 (4.4 ft2)

(1016 mm) U400 40 µm 0.39 m2 (4.2 ft2)
(8)
Nominal filter area per 10 in. (254 mm) filter element.
(9)
Multi-layered graded composites; 20 to 2 µm and 40 to 6 µm respectively.
Z in part number designates positive zeta in aqueous service.

64
 PreFlow™ Filter Cartridges
Effective Protection for 0.2 µm and 0.1 µm Filters in Biological Fluids

Pall PreFlow filters have been expressly Quality and Bio-Safety

designed to bring a significant
Biological Tests
improvement to prefiltration technology.
The filter media utilized is based on our • Meets USP Biological Reactivity Test,
expertise in manufacturing rugged in vivo, for Class VI-121° C Plastics
resin-bonded glass fiber composites. Effluent Quality Tests*
These sanitary-style filter cartridges are
• Non-Pyrogenic per USP Bacterial
manufactured with pleated high-area
Endotoxins (< 0.25 EU/mL)
construction for long service life.
PreFlow filters are designed to reduce • Meets Total Organic Carbon and Water
costs and are especially suited for Conductivity per USP Purified Water;
biological prefiltration applications, pH per Sterile Purified Water
including serum, vaccines, tissue culture * Per lot soak or rinse-up flush aliquots.
media, and protein solutions.
Features and Benefits
• Unparalleled protection of final
membrane filters
• Fixed pore construction
• No unloading or media migration
• High-capacity for economy
• High-strength design
• A choice of particulate removal
efficiencies
• Autoclavable and steamable
• Manufactured for use in conformance
with cGMP
• ISO 9000 Certified Quality System
Note: These filters are also available in Kleenpak Nova
capsule format.

65
 PreFlow Filter Cartridges
Technical Specifications

Materials of Construction Typical Liquid Flow Rate(1) at 20 °C (68 °F)

Medium Resin-bonded glass fiber 3.0 200
UUA UB
Support and Drainage Polyester (nonwoven)
2.5
Core, Cage and End Caps Polypropylene

Differential Pressure (mbar)

Adapters Polypropylene with encapsulated

Differential Pressure (psi)

2.0
reinforcing ring
O-ring Silicone elastomer 2.0
100
Removal Ratings (Liquid) 1.5

Grade UUA 0.2 µm (nominal)

1.0
Grade UB 0.45 µm (nominal)

0.5
Nominal Filter Area per 10 in. (254 mm) Element
Grade UUA 0.57 m2 (6.2 ft2) 0 0
0 10 20 30 40 50 60 70
Grade UB 0.65 m (7.0 ft )
2 2
Flow Rate (L/min)
(1)
Typical initial clean media ∆P 10 in. (254 mm) element; water at 20°C (68°F);
viscosity 1 cP. For assistance in filter assembly, sizing and housing
Nominal Dimensions selection, contact your local Pall representative.
Lengths 10 in. (254 mm), 20 in. (508 mm),
30 in. (726 mm), 40 in. (1016 mm)
Operating Conditions
Diameter 70 mm (2.75 in.)
Maximum Operating 5.0 bard (72 psid) to 25 °C (77 °F)
Pressure and Temperature(2)
Extractables
(2)
Using compatible fluids. Compatible fluids are fluids which do not soften, swell, attack
Grade UUA Typically < 100 mg per 10 in. or adversely affect the filter or materials of construction
(254 mm) element

Grade UB Typically < 150 mg per 10 in. Steam and Autoclaving Sterilization(3)
(254 mm) element
Recommended Exposure 3 x 1-hour @ 125 °C (257 °F)
(3)
Laboratory tests establish resistance. Filters should be qualified in actual use.
Contact Pall for recommended procedures.

Ordering Information

AB 7

Code Nominal Length Code Removal Cartridge Code Filter Grade Code Gasket
Rating Style(4) Option
1 10 in. (254 mm) UUA 0.2 µm Double 226 O-ring P Code outside US H4 Silicone
with bayonet lock Other materials available
2 20 in. (508 mm) UB 0.45 µm Omit Code in US only
and fin end on request
3 30 in. (762 mm) Supplied with Certificate of Test and
(4)
Alternate AB adapter codes Full Traceability
4 40 in. (1016 mm) available
Note: Contact Pall for assistance with
part numbers.

66
Marksman™ Elements with Nexis A Series Filters
®

High-capacity Wide Diameter Depth Filters

Marksman elements with Nexis A Series Features and Benefits

Filters contain high-capacity melt-blown
Biological Tests
depth filter media in a 152 mm (6 in.) wide
diameter cartridge with in-to-out flow. They All components meet the specifications for
offer high flow and long filter life. The biological safety as per the USP Biological
unique push-in adapters enable direct Reactivity test, in vivo, for Class VI-121 °C
replacement of bag filters into most Plastics (gaskets excluded).
commercially available bag housings to Purity
give reduced filter changeouts, improved
Cartridges are free of adhesives.
filtrate quality and lower costs.
Rinse-up
The main features can be summarized as:
Rinse-up to 18 Megohm-cm with a
• New, large cartridge geometry minimum of throughput.
• Proprietary CoLD® fiber technology Sanitization
• Gradient pore structure Cartridges may be sanitized in hot water,
• Absolute retention-rated at 99.9% 77 – 79 °C (170 – 175 °F) for 20 minutes
efficiency with retention ratings from 3 (minimum).
to 70 µm
• Directly fits into bag housings with no
hardware changes
• Inside-out flow traps contaminant inside
the cartridge
• Unique sealing device adjusts to fit
cartridge into most bag filter housings
• Quick, easy changeouts
• Short length option to accommodate
shorter baskets

67
 Marksman Elements with Nexis A Series Filters
Technical Specifications

Materials of Construction Liquid Flow Specifications

Filter Media Polypropylene with polyethylene winding Filter Grade Psid/gal/min Psid/gal/min
Hardware Polypropylene (mbard/L/min) – (mbard/L/min) –
Water @ 20 °C (68 °F) Fluid with 40 cP
Gaskets Ethylene Propylene (EPDM) Viton(1) A, 1 cP viscosity
Buna N
Size 1 Size 2 Size 1 Size 2
Sealing Thermal Bond
(1)
Registered trademark of DuPont Dow (non-FDA material). NXAM 10 0.047 0.021 1.17 0.35
(0.86) (0.38) (21.3) (6.4)

Nominal Dimensions NXAM 70 0.004 0.0014 0.1 0.04

(0.07) (0.03) (1.82) (0.73)
Outside Flange Diameter 184 mm (7.25 in.)
Note: For kPa, multiply mbard by 0.1
(equal to Size 1 and Size 2 Bags)
Lengths Size 1 Bag, Size 2 Bag
Filter Diameter 152 mm (6 in.)
Surface Area Size 1:
Up to 0.16 m2 (1.7 ft2)

Size 2:
Up to 0.31 m2 (3.3 ft2)

Flow Capacity
Size Maximum Recommended(2)
1 114 L/min (30 gal/min) 95 L/min (25 gal/min)
2 227 L/min (60 gal/min) 189 L/min (50 gal/min)
(2)
For maximum filter life.

Performance Specifications
Maximum Forward To 2.9 bard (42 psid) @ 20 °C (68 °F)
Differential Pressure To 1.8 bard (26 psid) @ 54 °C (130 °F)
To 1.0 bard (15 psid) @ 79 °C (175 °F)

Recommended Changeout 2.4 bard (35 psid)

Differential Pressure(3)
(3)
Provided that the maximum differential pressure is not exceeded based on temperature
limits defined above.

Note: Stainless steel flange required for temperatures in excess of 43 °C (110 °F).

Part Numbering and Ordering Information

NXAM

Code Length Code Filter Code Nominal Code Gasket Code End Code Flange and
Grades Length Materials Configurations Gasket Styles

Blank Standard 3 3 µm 1 Size 1 Blank NF version PF Plastic self- A FSI side entry,
Bag N Buna N adjusting Flange Rosedale,
S Short 5 5 µm
Strainrite, Krystal,
2 Size 2 E EPDM SF Stainless steel Pall
10 10 µm
Bag (peroxide self-adjusting
20 20 µm flange (required B GAF
cured)
for temperatures C FSI over the top,
40 40 µm
V Viton A > 43 °C [110 °F]) Hayward over
70 70 µm the top
NF No flange (For
use with reusable
SS flange)

68
Marksman™ Elements with Poly-Fine XLD Series Filters
®

High-capacity Wide Diameter Pleated Polypropylene Filters

Marksman Elements with Poly-Fine XLD Features and Benefits

Series Filters contain pleated polypropylene
depth media in a wide diameter 152 mm
(6 in.) cartridge with in-to-out flow. They
offer high flow and long filter life. The
unique push-in adapters enable direct
replacement of bag filters into most
commercially available bag housings to
give reduced filter changeouts, improved
filtrate quality and lower costs.
The main features can be summarized as:
• New, wide diameter cartridge geometry
• Innovative combination of depth media
and pleated cartridge technologies
• High surface area, high-flow capacity
• Excellent retention of deformable
contaminants
• Proprietary gel guard media
• Absolute rated at > 99.9% efficiency
with retention ratings from 1.5 to 90 µm
Biological Tests
All components meet the specifications for
biological safety as per the USP Biological
Reactivity test, in vivo, for Class VI-121 °C
Plastics (gaskets excluded).
FDA-listed Materials
All materials are FDA-listed for food
contact, except Viton* A gaskets.
Purity
Cartridges are free of surfactants, resins,
binders, and adhesives.
Rinse-Up
Rinse-up to 18 Megohm-cm with a
minimum of throughput.
Sanitization
Cartridges may be sanitized in hot water,
77 – 82 °C (170 – 180 °F), for 20 minutes
(recommended).

• Directly fits into bag housings with no * Viton is a registered trademark of DuPont Dow
(non-FDA materials).
hardware changes
• In-to-out flow traps contaminant inside
the element
• Quick, easy changeouts
• All-polypropylene construction
• Short length option to accommodate
shorter baskets

69
 Marksman Elements with Poly-Fine XLD Series Filters
Technical Specifications

Materials of Construction Liquid Retention Ratings (µm) (by ASTM F-795 Test)
Filter Media Polypropylene Cartridge 90% > 99.9%
Hardware Polypropylene Designation Efficiency Efficiency

Support Material Polypropylene XLDM 1.5 0.7 1.5

Gaskets Ethylene Propylene (EPDM), XLDM 3 1 3

Viton* A, Buna N XLDM 4.5 3.5 4.5
Sealing Thermal Bond XLDM 10 5 10
* Registered trademark of DuPont Dow (non-FDA material).
XLDM 20 15 20
XLDM 30 18 30
Nominal Dimensions
XLDM 40 20 40
Outside Flange Diameter 184 mm (7.25 in.)
(equal to Size 1 and Size 2 Bags) XLDM 70 30 70
Outside Filter Diameter 152 mm (6 in.) XLDM 90 45 90
Lengths Size 1 Bag, Size 2 Bag
Surface Area: Size 1: Liquid Flow Specifications
Up to 0.93 m2 (10 ft2) Psid per 3.8 L/min Psid per 3.8 L/min
Size 2: (1 gal/min) – (1 gal/min) –
Up to 2.04 m2 (22 ft2) Water @ Fluid with
20 °C (68 °F) 40 cPs viscosity

Flow Capacity Filter Grade Size 1 Size 2 Size 1 Size 2

Size Maximum Recommended(1) 1.5 0.051 0.026 1.200 0.600

1 189 L/min (50 gal/min) 95 L/min (25 gal/min) 3 0.020 0.010 0.400 0.200
2 379 L/min (100 gal/min) 189 L/min (50 gal/min) 4.5 0.013 0.007 0.400 0.200
(1)
For maximum filter life.
10 0.009 0.005 0.310 0.160

Performance Specifications 20 0.006 0.003 0.240 0.120

Filter Grades 1.5, 3, 4.5, 10, 20, 30, 40, 70, 90 µm 30 0.006 0.003 0.180 0.090
(> 99.9% Retention Rating 40 0.006 0.003 0.150 0.080
by ASTM F-795 Test)
70 0.006 0.003 0.026 0.013
Maximum Differential Polypropylene Cage:
Pressure To 5.1 bard (75 psid) @ 20 °C (68 °F) 90 0.006 0.003 0.026 0.013
To 2.4 bard (35 psid) @ 54 °C (130 °F)
Note: For mbar values, multiply psid by 69
Stainless Steel Cage:
To 1.7 bard (25 psid) @ 80 °C (175 °F)

Recommended Change Out 2.4 bard (35 psid)

Differential Pressure(2)
Provided that the maximum differential pressure is not exceeded, based on
(2)

temperature limits defined above.

Note: Stainless steel flange required for temperatures in excess of 43 °C (110 °F).

Part Numbering and Ordering Information

XLDM

Code Length Code Filter Code Nominal Code Support Code Gasket
Grades Length Cage Materials

Blank Standard 1.5 1.5 µm 1 Size 1 Bag U Poly- Blank For NF version
propylene
S Short 3 3 µm 2 Size 2 Bag N Buna N
S Stainless E EPDM (peroxide
4.5 4.5 µm
Steel cured)
10 10 µm
V Viton A
20 20 µm
40 40 µm
70 70 µm
Code End Configurations Code Flange and Gasket Styles
90 90 µm
PF Plastic self-adjusting flange A Rosedale, Strainrite,
SF Stainless steel self-adjusting Krystal, Pall
flange (required for B GAF, FSI side entry
temperatures > 43 °C (110 °F) C FSI over the top,
NF No flange (For use with Hayward over the top
70 reusable SS flange)
Marksman™ Elements with Poly-Fine II Series Filters
®

High-capacity Wide Diameter Pleated Polypropylene Filters

Marksman Elements with Poly-Fine II Features and Benefits

Series Filters contain pleated polypropylene
media in a wide diameter 152 mm (6 in.)
cartridge with in-to-out flow. They offer
high flow and long filter life. The unique
push-in adapters enable direct
replacement of bag filters into most
commercially available bag housings to
give reduced filter changeouts, improved
filtrate quality and lower costs.
• New, wide diameter cartridge geometry
• High-flow capacity
• Proprietary media for highly consistent
filtration
• In-to-out flow traps contaminant inside
the cartridge
• Directly fits into bag housings with no
changes
Changes
• Unique sealing device adjusts to fit into
most bag filter housings
Biological Tests
All components meet the specifications for
biological safety as per the USP Biological
Reactivity test, in vivo, for Class VI-121 °C
Plastics (gaskets excluded).
FDA-listed Materials
All materials are FDA-listed for food and
beverage contact, except Viton* A gaskets.
Purity
Cartridges are free of surfactants, resins,
binders, and adhesives.
Rinse-Up
Rinse-up to 18 Megohm-cm with a
minimum of throughput.
Sanitization
Cartridges may be sanitized in hot water,
77 – 82 °C (170 – 180 °F) for 20 minutes
minimum.
* Viton is a registered trademark of DuPont Dow
(non-FDA materials).

• High surface area for filter stream life

• All-polypropylene construction
• Wide chemical compatibility
• Short length option to accommodate
shorter baskets

71
 Marksman Elements with Poly-Fine II Series Filters
Technical Specifications

Materials of Construction Liquid Retention Ratings (µm) (by ASTM F-795 Test)
Filter Media Polypropylene Cartridge 90% > 99.9 %
Hardware Polypropylene Designation Efficiency Efficiency

Support Material Polypropylene PFTM 1 0.5 1.2

Gaskets Ethylene Propylene (EPDM), PFTM 3 1 2.5

Viton* A, Buna N
PFTM 5 2 5
Sealing Thermal Bond
PFTM 10 5 10
* Registered trademark of DuPont Dow (non-FDA material).
PFTM 20 10 20
PFTM 40 20 40
Nominal Dimensions
PFTM 70 30 70
Outside Flange Diameter 184 mm (7.25 in.)
(equal to Size 1 and Size 2 Bags) PFTM 90 60 90

Outside Filter Diameter 152 mm (6 in.) PFTM 150 102 150

Lengths Size 1 Bag, Size 2 Bag

Surface Area Size 1:
Liquid Flow Specifications
Up to 2.32 m2 (25 ft2) Psid per 3.8 L/min Psid per 3.8 L/min
Size 2: (1 gal/min) – (1 gal/min) –
Up to 5.57 m2 (60 ft2) Water @ Fluid with
20 °C (68 °F) 40 cPs viscosity

Flow Capacity Filter Grade Size 1 Size 2 Size 1 Size 2

Size Maximum Recommended (1) 1 0.0470 0.0240 0.790 0.400

1 227 L/min (60 gal/min) 189 L/min (50 gal/min) 3 0.0130 0.0070 0.660 0.330

2 454 L/min (120 gal/min) 379 L/min (100 gal/min) 5 0.0070 0.0040 0.430 0.220
(1)
For maximum filter life. 10 0.0040 0.0020 0.260 0.130
20 0.0020 0.0010 0.230 0.120
Performance Specifications
40 0.0010 0.0005 0.070 0.035
Filter Grades 1, 3, 5, 10, 20, 40, 70, 90, 150 µm 70 0.0008 0.0004 0.030 0.015
(> 99.9% Retention Rating
by ASTM F-795 Test) 90 0.0008 0.0004 0.015 0.008

Maximum Forward 5.1 bard (75 psid) @ 20 °C (68 °F) 150 0.0006 0.0003 0.010 0.005
Differential Pressure 2.4 bard (35 psid) @ 54 °C (130 °F) Note: For mbar values, multiply psid by 69

Recommended Changeout 2.4 bard (35 psid)

Differential Pressure(2)
(2)
Provided that the maximum differential pressure is not exceeded based on temperature
limits defined above.
Note: Stainless steel flange required for temperatures in excess of 43 °C (110 °F)

Part Numbering and Ordering Information

PTFM

Code Length Code Filter Code Nominal Code Gasket Code End Configurations
Grades Length Materials

Blank Standard 1 1 µm 1 Size 1 Bag Blank For NF PF Plastic self-adjusting flange

version
S Short 3 3 µm 2 Size 2 Bag SF Stainless steel self-adjusting
N Buna N flange (required for
5 5 µm
E EPDM temperatures > 43 °C (110 °F)
10 10 µm (peroxide NF No flange (For use with
20 20 µm cured) reusable SS flange)
40 40 µm V Viton A

70 70 µm Code Flange and Gasket Styles

90 90 µm
150 150 µm A Rosedale, Strainrite,
Krystal, Pall
B GAF, FSI side entry
C FSI over the top,
Hayward over the top

72
 Emflon FM Filter Cartridges
®

Designed for Cost-effective Solvent Polishing

Pall Emflon FM filters are designed for Compatibility

cost-effective clarification of solvents used
This filter was specifically designed for
in the manufacture of antibiotics and other
improved compatibility and optimized
active pharmaceutical ingredients (APIs).
economics in polishing a broad array of
These pharmaceutical grade filters contain
challenging solvents, including:
a proprietary PTFE membrane and are
compatible with a broad range of • Acetic Acid, Glacial
chemicals. • Acetone
They can also be used to ensure the • Acetonitrile
cleanliness of high-purity solvents.
Applications include removal of carbon or • Dimethylacetamide (DMAC)
catalyst fines, and these filters are often • Dimethylformamide (DMF)
used downstream of bulk solids removal
• Dimethylsulfoxide (DMSO)
systems.
• Ethanol
Features and Benefits • Ethyl Acetate
• Broad chemical compatibility • Hexane
• Very high flow-rates • Hydrochloric mAcid 38%
• Low extractables • Isopropyl Alcohol (IPA)
• Tolerant of high operating temperatures • Methanol
• No cage option further reduces • Methylene Chloride
potential extractables
• Methyl Isobutyl Ketone (MIBK)

High Quality Standards • Methyl Tertiary Butyl Ether (MTBE)

• n Heptane
• Each filter supplied with a certificate of
test • Pyridine

• Lot number traceable • Sodium Hydroxide, 50%

• Meets USP Biological Reactivity Test, • Tetrahydrofuran (THF)

in vivo, for Class VI-121 °C Plastics • Toluene
• FDA-listed materials per 21 CFR • Water
Compatibility at 20 °C
• Xylene
This partial list is provided for general guidance only.

Note: Because so many factors (such as elevated

temperatures) can affect the chemical resistance of a
given product, you should pre-test under your own
operating conditions observing applicable safety
practices such as those given in the Material Safety Data
Sheet for each chemical. Pall Corporation can provide
specific compatibility guidance, testing and data upon
request.

73
 Emflon FM Filter Cartridges
Technical Specifications

Materials of Construction Typical Liquid Flow Rate(2)

Membrane Polytetrafluoroethylene (PTFE) 1000 14
Support and Drainage Layers Polypropylene
Core, Cage and End caps Polypropylene
O-ring (single open-end [SOE] Fluorinated Ethylene Propylene 750 11

Differential Pressure (mbar)

AB-style) (FEP) – encapsulated silicone

Differential Pressure (psi)

Other materials available 5
H1
Gasket (for double open-end Polytetrafluoroethylene (PTFE) 7P
M
industrial-style) Other materials available 1F
500
AB 7

Operating Parameters
250 3.5
Maximum Differential 4.1 bard (60 psid) @ 23 °C (74 °F)
∆P)
Pressure (∆ 2.1 bard (31 psid) @ 60 °C (140 °F)

Maximum Operating 95 °C (203 °F) at 1.0 bar (15 psi)

Temperature 0 0
0 100 200 300 400 500 600
Flow Rate (L/min)
Extractables(1)
(2)
Typical initial clean media ∆P 10 in. (254 mm) element; water at 20 °C
Water < 5 mg (68 °F); viscosity 1 cP. For assistance in filter assembly, sizing and housing
selection, contact your local Pall representative.
95% Ethanol 20 mg
Acetone 90 mg
Ethyl acetate 240 mg Removal Ratings
Methylene chloride 575 mg Particle Size Beta Ratio Efficiency

Toluene 515 mg 0.6 µm 100 99.0%

(1)
These typical extractables are based on tests of sampled 10 in. (254 mm) modules 1 µm 1000 99.9%
with cages at 20 °C (68 °F).
2 µm 5000 99.98%
3 µm > 5000 > 99.98%
Nominal Filter Area per 10 in. (254 mm) Element
4 µm > 5000 > 99.98%
0.58 m2 (6.2 ft2)
> 5 µm > 5000 > 99.98%

Ordering Information (Part number denotes one filter, minimum order quantity 12)

AB Style: A FM P

MCY 1000 Style: MCY100 FM P

Code Cage Option Code Nominal Length Code Cartridge Style Code Seal Option
B Polypropylene cage 1 10 in. (254 mm) 47 Single 226 O-ring with bayonet H15(3) FEP/Silicone
lock and fin end
BA No cage 2 20 in. (508 mm) (Fits in all code 7 housings) H2(4) PTFE
3 30 in. (762 mm)
(3)
AB style only.
7 Double 226 O-ring with bayonet (4)
MCY1000 style only.
4 40 in. (1016 mm) lock and fin end

74
Ultipor N66 Particulate and Bioreduction Filter Cartridges
®

Ideal Prefilters for Ultipor N66 Sterilizing Filters

Pall Ultipor N66 particulate/bioreduction Quality and Bio-Safety

filter cartridges are specifically engineered
Biological Tests
for fine filtration, prefiltration and bioburden
reduction of a wide range of • Meets USP Biological Reactivity test,
pharmaceutical and biological liquids. They in vivo, for Class VI-121 °C Plastics
incorporate versatile Ultipor N66 pure Effluent Quality Tests (AB Style)*
Nylon 6,6 membranes which are high-area
• Meets Cleanliness per USP Particulates
pleated into single open-ended (SOE) AB
in Injectables
style cartridges to fit in sanitary filter
housings, and provide reliable, economical • Non-Fiber-Releasing
and efficient particulate and bioburden • Non-Pyrogenic per USP
removal.
• Meets Total Organic Carbon and Water
Conductivity per USP Purified Water,
Features and Benefits
pH per USP Sterile Purified Water
• Intrinsically water wettable
* Per lot sample soak or rinse-up flush aliquots.
• Fixed pores, non-shedding
• Resin and surfactant-free
• Low filter extractables
• High-area for long-life
• Broad solvent compatibility
• High protein recovery from most protein
solutions
• Repeatedly steamable in situ
• Manufactured for use in conformance
with cGMP
• ISO 9000 Certified Quality System
• Pharmaceutical P optimized
• Certificate of Test provided
• Double open-ended (DOE) available
• FDA-listed materials per 21 CFR
Note: These filters are also available in Kleenpak Nova
capsule format.

75
 Ultipor N66 Particulate and Bioreduction Filter Cartridges
Technical Specifications

Materials of Construction Typical Liquid Flow Rates(4)

Flow Rate (L/min)
Membrane Nylon 6,6
0 5 10 15
Support, Drainage and Polyester 2 NL NA
NX
End Caps
120
Core and Cage Polypropylene
O-rings Silicone(1)

Differential Pressure (psid)

Differential Pressure (mbar)

(1)
Other polymers available. 90
NB

Microbial Removal Ratings 1

60
NK 0.65 µm particulate rated NK
NB 0.45 µm microbial-rated
(Typical Serratia marcescens TR > 104 – 6)
30
NX, NL 0.45 µm microbial-rated
(Lot samples retain > 107/cm2
Serratia marcescens)
0 0
NA 0.2 µm microbial-rated (Typical 0 1 2 3 4
Brevundimonas diminuta TR > 104 – 6) Flow Rate per 10 in. (254 mm) Filter (Gal/min)
(4)
Typical initial clean media ∆P 10 in. (254 mm) element; water at 20 °C
(68 °F); viscosity 1 cP. For assistance in filter assembly sizing and
Nominal Dimensions housing selection, contact your local Pall representative.
Lengths 10 in. (254 mm), 20 in. (508 mm),
30 in. (762 mm), 40 in. (1016 mm)
Autoclave and Steaming in situ(5)
Diameter 70 mm (2.75 in.)
Cumulative Steam Exposure 16 hours (1-hour cycles) at
121 °C
Configuration (AB Code 7) (2)

4 hours (1-hour cycles) at

Double 226 O-ring adapter
140 °C
Fin end with bayonet lock. (5)
Laboratory tests to establish multi-cycle resistance. Filters should be qualified in actual
(2)
Alternate adapter codes available. use. Contact Pall for recommended procedures.

Operating Conditions(3) Aqueous Extractables (NVR) per 10 in. (254 mm) Element(6)
Maximum Differential 5.5 bard (80 psid) to 50 °C (122 °F) Typically < 15 – 20 mg
Pressure and Temperature 4.1 bard (60 psid) to 80 °C (176 °F) (6)
In water at 20 – 25 °C (68 – 77 °F) after autoclaving.
2.1 bard (30 psid) to 125 °C (257 °F)
(3)
Using compatible liquids.

Ordering Information

AB

Code Nominal Code Removal Nominal Forward Flow(8) Code Filter Code Gasket
Length Rating Filter Area(7) mL/min at Grade Option
(mbar) psi

1 10 in. NA7 0.2 µm 0.84 m2 (9.0 ft2) 85 at 2260 (30) P Pharmaceutical* H4 Silicone
(254 mm) Other materials available
NX7 0.45 µm 0.46 m2 (5.0 ft2) 10 at 1720 (25) Omit General Use
on request.
2 20 in. NL7 0.45 µm 0.79 m2 (8.5 ft2) 15 at 1720 (25) * Pall pharmaceutical-grade filters
(508 mm) are designed for use in
NB7 0.45 µm 0.84 m (9.0 ft )
2 2
85 at 1240 (18) conformance with CGMP in
3 30 in. Manufacturing, Processing,
(762 mm) NB7W 0.45 µm 0.86 m2 (9.2 ft2) 50 at 1240 (18) Packing or Holding of Drugs
(21CFR210) and CGMP for
4 40 in. NK7W 0.65 µm 0.84 m2 (9.0 ft2) 25 at 1100 (16) finished Pharmaceuticals
(1016 mm) (7)
Per 10 in. (254 mm) cartridge. (21CFR211.72) including batch
(8)
Forward Flow allowable limit for one 10 in. (254 mm) cartridge at given test release certificate and full
pressure, water wet, air test gas. Please contact Pall for method details and test traceability.
parameters.

76
 Mini Kleenpak™ Sterilizing-grade Capsule Filters
Ideal for Scale-up and Scale-down

Pall’s Mini Kleenpak sterilizing capsule High Quality Standards

filters are compact pharmaceutical-grade
capsule filters featuring very low hold-up
volumes. They are expressly designed to
simplify scale-up and scale-down activities
and eliminate the need for multiple filter
evaluations.
Supor PES and Fluorodyne II PVDF
membranes are particularly suited for the
sterile filtration of a wide range of fluids,
including buffers, biological fluids, tissue
culture media and ophthalmic products.
The low protein and preservative binding of
the membranes ensures maximum
transmission of active ingredients.
Features and Benefits
• Validated with Brevundimonas diminuta
(ATCC 19146) at a challenge level of
107 cfu/cm2
• Fluorodyne II DJL validated with
Acholeplasma laidlawii (ATCC 28206)
Typical titer reduction 108 cfu
• 100% integrity-tested during
manufacturing
• Manufactured for use under GMP
• Pharmaceutical P optimized
• Each Filter supplied with a Certificate of
Test
• Comprehensive Validation Guide
available

• Smallest pleated membrane capsule

filters available
• Scalable to cartridges
• High flow-rates and throughputs
• Low protein and preservative binding
• Low extractables
• Gamma-irradiatable and autoclavable
versions available as well as
gamma-irradiated pre-sterilized versions
for maximum flexibility
• Minimal hold-up volume — typically
< 6 mL
• Fully integrity testable

77
 Mini Kleenpak Sterilizing-grade Capsule Filters
Technical Specifications

Materials of Construction Nominal Dimensions

Membrane Fluorodyne II: Overall Length 104 mm (4.1 in.)
Hydrophilic polyvinylidenedifluoride Housing Length 49 mm (1.9 in.)
(PVDF)
Housing Diameter 50 mm (2.0 in.)
Supor:
Polyethersulfone (PES) Inlet and Outlet 27 mm (1.1 in.)
Hose Barb Length
Support and Drainage Polypropylene
Capsule and Vent Polypropylene Extractables
Filling Bell (1)
Polycarbonate < 1.0 mg in water at 20 °C (68 °F) (for non-irradiated filter capsule)
Sealing Technology Thermal bonding without adhesives < 5.0 mg in water at 20 °C (68 °F) (for gamma-irradiated filter capsule)
(1)
Filling bell is removable for in-line use

Nominal Filtration Area

Operating Parameters(2) Fluorodyne II 0.02 m2 (0.21 ft2)
Maximum Operating 4.1 bard @ 38 °C (60 psid @ 100 °F) Supor 0.022 m2 (0.23 ft2)
Temperature and Pressure 2.1 bard @ 80 °C (30 psid @ 176 °F)
(2)
In compatible fluids which do not soften, swell, or adversely affect the filter or its Typical Flow Rates(4)
materials of construction.
Supor EKV 350 mL/min/100 mbar (241 mL/min/psi)
Sterilization(3) Supor EBV 322 mL/min/100 mbar (222 mL/min/psi)

Autoclave 3 x 30-minute cycles @ 140 °C (284 °F) Fluorodyne II DFL 225 mL/min/100 mbar (155 mL/min/psi)

Gamma-irradiation Maximum Dosage: 50 kGy Fluorodyne II DJL 100 mL/min/100 mbar (69 mL/min/psi)
(4)
For fluids at 1 cP viscosity @ 20 °C (68 °F). For other viscosities, divide flow rate by
(3)
Warning: Pre-sterilized units should not be re-irradiated or autoclaved. This product viscosity in centipoise. For assistance, contact your local Pall representative.
may not be sterilized by in situ steaming.

Ordering Information

KA02 P

Code Filter Type Code Inlet and Outlet Code Additional Options
EKV 0.2 µm rated Supor 2(5)
6 – 13 mm ( ⁄4 – ⁄2 in.)
1 1
G Non-sterilized version
stepped hose barb
EBV 0.2 µm rated Supor S Pre-sterilized version
DFL 0.2 µm rated
(5)
Bell on outlet is removable for in-line use.
Fluorodyne II

DJL 0.1 µm rated

Fluorodyne II

78
Kleenpak™ Capsules with Supor® EKV Membrane Assemblies
Optimized for Filtration of Buffers and Biological Fluids
Pall Kleenpak capsule filters with Supor
polyethersulfone membrane are validated,
0.2 µm sterilizing-grade filters with built-in
prefiltration to give longer filter life and
lower filtration costs. The capsules are
suitable for sterile filtration of a wide range
of fluids including buffers, biological fluids,
tissue culture media, ophthalmic products
and many others. They can be used for
scale-up or scale-down studies. The low
protein and preservative binding of the
Supor polyethersulfone membranes also
ensures maximum transmission of active
ingredients.
Features and Benefits
• Hydrophilic polyethersulfone membrane
for low adsorption and wide chemical
compatibility
• Easy to wet
• Built-in MachV prefilter layer with an
asymmetric membrane for long-life and
low filtration costs
• Low hold-up volumes (< 1 mL)
• Disposable format to avoid cleaning
and cleaning validation
• Available pre-sterilized by
gamma-irradiation or sterilizable by
autoclaving or gamma-irradiation
High Quality Standards
Validated with Brevundimonas diminuta
(ATCC 19146) at a challenge level of
107 cfu/cm2.
Every production batch is routinely
sampled for bacterial challenge.
Every filter is:
• Integrity-tested during manufacture with
results that are continually validated
against bacterial challenge
• Identified by a lot number and unique
serial number for complete traceability
of manufacturing history and for user’s
traceability system
• Supplied with a Certificate of Test
confirming the quality standards and
quality control tests performed by Pall
• Manufactured under a Quality
Management System certified to
ISO 9000
Quality and Bio-Safety
Biological Tests
• Meets USP Biological Reactivity test,
in vivo, for Class VI-121 °C Plastics
Effluent Quality Tests*
• Meets Cleanliness per USP Particulates
in Injectables
• Non-Fiber-Releasing
• Non-Pyrogenic per USP
Endotoxins (< 0.25 EU/mL)
• Meets Total Organic Carbon and Water
Conductivity per USP Purified Water,
pH per USP Sterile Purified Water
* Per lot sample soak or rinse-up flush aliquots.
A comprehensive validation guide is
available upon request.
79
 Kleenpak Capsules with Supor EKV Membrane Assemblies
Technical Specifications

Materials of Construction Nominal Dimensions

Membrane Hydrophilic Polyethersulfone (PES) Maximum Diameter of Bowl 109 mm (4.2 in.)
Support and Drainage Layers Polypropylene (including Valves)

End Cap, Core and Cage Polypropylene Length including 174 mm (6.8 in.)
Sanitary Connector

Nominal Surface Area Length including 210 mm (8.3 in.)

Hose Barb Connector
0.15 m2 (1.5 ft2)

Typical Liquid Flow Rates

Operating Conditions(1)
Water @ 20 °C (68 °F) 3.2 L/min @ 100 mbar (1.5 psi)
Maximum Differential 5.2 bard (75 psid) @ 40 °C (104 °F)
Pressure and Temperature
Typical Extractables
(1)
Using compatible fluids, which do not soften, swell or adversely affect the filter or its
materials of construction < 10 mg in water at 20 °C (68 °F)

Sterilization
Autoclave 5 x 60-minute cycles
@ 125 °C (257 °F)

Gamma-irradiation Maximum Dosage: 50 kGy

Warning: Kleenpak filters should not be sterilized in situ by passing steam under
pressure.

Ordering Information

KA EKV

Code Size and Area Code Filter Grade Code Inlet and Outlet Code Sterilization
Connections Grade

3 See above P Pharmaceutical* 1 38 mm (11⁄2 in.) G Non-sterilized version

dimensions table sanitary flange
* Pall pharmaceutical-grade filters are S Pre-sterilized version
designed for use in conformance with 6 14 mm (9⁄16 in.)
CGMP in Manufacturing, Processing,
Packing or Holding of Drugs (21CFR210)
single-barb hose barb
and CGMP for finished Pharmaceuticals
16 38 mm (11⁄2 in.)
(21CFR211.72) including batch release
certificate and full traceability. sanitary flange inlet and
14 mm (9⁄16 in.) single-barb
hose barb outlet

80
 Supor EKV Sterilizing-grade Filter Cartridges
®

Optimized for Filtration of Biological Fluids

Supor EKV polyethersulfone membrane Every filter is:

cartridges are validated, 0.2 µm
sterilizing-grade filters with a unique
combination of Pall Ultipleat filter
construction and optimized built-in
prefiltration to give longer filter life and
lower filtration costs. The filters are suitable
for sterile filtration of a wide range of fluids
including buffers, biological fluids, tissue
culture media, ophthalmic products and
many others. The low protein and
preservative binding of the Supor
polyethersulfone membrane also ensures
maximum transmission of active
ingredients.
Features and Benefits
• Integrity-tested during manufacture
• Identified by a lot number and a unique
serial number for complete traceability
of manufacturing history and for user’s
traceability system
• Supplied with a certificate of test
confirming the quality standards and
quality control tests performed by Pall
• Manufactured under a Quality
Management System certified to
ISO 9000
Quality and Bio-Safety
Biological Tests

• Hydrophilic polyethersulfone membrane • Meets USP Biological Reactivity Test,

for low adsorption and wide chemical in vivo, in accordance with USP Class
compatibility Vl-121 °C Plastics

• Easy to wet for a reliable integrity test Effluent Quality Tests*

• Patented Ultipleat filter construction for
high-area and good flow rates
• Built-in, MachV asymmetric prefilter
layer for long-life and low filtration costs
• High-strength construction tolerates up
to 1 bard (14.5 psid) differential
pressure during steam-in-place
sterilization
• High-strength design allows for multiple
autoclave cycles and extended use
High Quality Standards
• Meets Cleanliness per USP Particulate
Matter in Injections
• Non-Fiber-Releasing
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
• Meets Total Organic Carbon and Water
Conductivity per USP Purified Water,
pH per USP Sterile Purified Water
* Per lot sample soak or rinse-up flush aliquots.
A comprehensive validation guide is
available upon request.

Forward Flow value correlated with sterile

removal of Brevundimonas diminuta (ATCC
19146) at 107/cm2.
A comprehensive validation guide is
available upon request.
Note: These filters are also available in Kleenpak Nova
capsule format.

81
 Supor EKV Sterilizing-grade Filter Cartridges
Technical Specifications

Materials of Construction Typical Liquid Flow Rate(3)

Membranes Hydrophilic Polyethersulfone (PES) 300
4
Support and Drainage Polypropylene
250
Core and End Caps Polypropylene

Differential Pressure (mbar)

Differential Pressure (psi)

Cage Polypropylene with TiO2 (white-colored) 3
200
Internal Adapter Support Ring Stainless steel
AB1
O-rings Silicone elastomer 150
2
Sealing Technology Thermal bonding without adhesives
100 AB2
Operating Parameters(1)
1
AB3
Maximum Differential 5.5 bar (80 psi) @ 40 °C (104 °F) 50
Pressure (Forward Direction) 3.0 bar (43.5 psi) @ 80 °C (176 °F)

Maximum Differential 2.0 bar (29 psi) @ 40 °C (104 °F) 0 0

Pressure (Reverse Direction) 0 5 10 15 20 25 30
Flow Rate (L/min)
(1)
In compatible fluids which do not soften, swell, or adversely affect the filter or its
materials of construction.
(3)
Typical initial clean media ∆P 10 in. (254 mm) element; water at 20 °C
(68 °F); viscosity 1 cP. For assistance in filter assembly sizing and housing
selection, contact your local Pall representative.
Sterilization(2)
Typical Extractables(4) per 10 in. (254 mm) Element
Autoclave 30 x 60 minutes cycles at
125 °C (261 °F) - slow exhaust < 25 mg in water at 20 °C (68 °F) after 4 hours extraction
In Situ Steam 30 x 60 minutes cycles at
(4)
Tested on elements without pre-flushing
125 °C (261 °F)
5 x 60 minutes cycles at 142 °C (287 °F) Integrity Test Values for 10 in. (254 mm) Filter at 20 °C (68 °F)
(2)
Contact Pall for confirmation of extended sterilization conditions
Maximum differential pressure during steam sterilization is 1 bar (14.5 psi) in Maximum Allowable Water wet ≤ 17 mL/min
forward direction for the 10 in. and 300 mbar (4.5 psi) for the 5 in. cartridges. Filter Forward Flow (Air Test Gas) at 2760 mbar (40 psi)
must be fully wetted for sterilization.
Contact Pall for multi-element integrity test values and recommended test procedures.

Nominal Dimensions
Typical Effective Filtration Area(5)
Lengths 10 in. (254 mm), 20 in. (508 mm), 0.6 m2 (6.5 ft2) per 10 in. (254 mm) module
30 in. (762 mm), 40 in. (1016 mm)
0.26 m2 (2.8 ft2) per 5 in. (125 mm) module
Diameter 70 mm (2.75 in.)
(5)
5 in. (125 mm) filters are standard pleated.

Ordering Information

AB

Code Nominal Code Removal Code Cartridge Style Code Filter Grade Code O-ring
Length Rating Material
05 5 in. (125 mm) EKV 0.2 µm 2 Double 226 O-ring P Pharmaceutical* H4 Silicone elastomer
sterilizing-grade bayonet lock, Other materials available
1 10 in. (254 mm) * Pall pharmaceutical-grade filters are
without fin designed for use in conformance on request.
2 20 in. (508 mm) with CGMP in Manufacturing,
7 Double 226 O-ring Processing, Packing or Holding of
3 30 in. (762 mm) bayonet lock Drugs (21CFR210) and CGMP for
4 40 in. (1016 mm) and fin end finished Pharmaceuticals
(21CFR211.72) including batch
release certificate and full
traceability.

82
 Supor EBV Sterilizing-grade Filter Cartridges
®
Polyethersulfone (PES) Membrane Filter provides Broad pH Compatibility
Supor EBV polyethersulfone membrane
cartridges are validated, 0.2 µm
sterilizing-grade filters with a unique
combination of Pall Ultipleat filter
construction and built-in prefiltration to give
longer filter life and lower filtration costs.
The filters are suitable for sterile filtration of
a wide range of fluids including buffers,
biological fluids, tissue culture media,
ophthalmic products and many others.
The low protein and preservative binding of
the Supor polyethersulfone membranes
also ensures maximum transmission of
active ingredients.
Features and Benefits
• Hydrophilic polyethersulfone membrane
for low adsorption and wide chemical
compatibility
• Patented Ultipleat filter construction for
high-area and good flow rates
• Built-in prefilter layer for long-life and
low filtration costs
• High-strength construction tolerates up
to 1 bard (14.5 psid) differential
pressure during steam-in-place
sterilization
• Low hold-up volumes
• High-strength design allows for multiple
autoclave cycles and extended use
High Quality Standards
Validated with Brevundimonas diminuta
(ATCC 19146) at 107/cm2. Every production
batch is routinely sampled for bacterial
challenge.
Note: These filters are also available in Kleenpak Nova
capsule format.
Every filter is:
• Integrity-tested during manufacture and
results are continually validated against
bacterial challenge
• Identified by a lot number and a unique
serial number for complete traceability
of manufacturing history and for user’s
traceability system
• Supplied with a Certificate of Test
confirming the quality standards and
quality control tests performed by Pall
• Manufactured under a Quality
Management System certified to
ISO 9000
Quality and Bio-Safety
Biological Tests
• Meets USP Biological Reactivity Test,
in vivo, in accordance with USP Class
Vl-121 °C Plastics
Effluent Quality Tests*
• Meets Cleanliness per USP Particulate
Matter in Injections
• Non-Fiber-Releasing
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
• Meets Total Organic Carbon and Water
Conductivity per USP Purified Water,
pH per USP Sterile Purified Water
* Per lot sample soak or rinse-up flush aliquots.
A comprehensive validation guide is
available for inclusion with user’s validation
documentation.
83
 Supor EBV Sterilizing-grade Filter Cartridges
Technical Specifications

Materials of Construction Typical Liquid Flow Rate(3)

Membranes Hydrophilic Polyethersulfone (PES) 300
4
Support and Drainage Polypropylene
Core, Cage and End caps Polypropylene 250

Differential Pressure (mbar)

Internal Adapter Support Ring Stainless steel

Differential Pressure (psi)

3
200
O-rings Silicone elastomer
Sealing Technology Thermal bonding without adhesives
150
2

Operating Parameters(1)
100
Maximum Operating Pressure 5.5 bar (80 psi) @ 50 °C (122 °F)
(Forward Direction) 3.0 bar (43.5 psi) @ 80 °C (176 °F) 1
50
Maximum Operating Pressure 2.0 bar (29 psi) @ 50 °C (122 °F)
(Reverse Direction)
0 0
(1)
In compatible fluids which do not soften, swell, or adversely affect the filter or its 0 5 10 15 20 25 30
materials of construction.
Flow Rate (L/min)
(3)
Typical initial clean media ∆P 10 in. (254 mm) element; water at 20 °C
Sterilization(2) (68 °F); viscosity 1 cP. For assistance in filter assembly sizing and
housing selection, contact your local Pall representative.
Autoclave 5 x 60-minutes cycles at 125 °C
In situ Steam 5 x 30-minutes cycles at 142 °C (287 °F)
Typical Extractables(4) per 10 in. (254 mm) Module
(2)
Maximum differential pressure during steam-sterilization is 1 bar (14.5 psi). < 25 mg in water at 20 °C (68 °F) after 4 hours extraction
(4)
Tested on elements without pre-flushing,

Nominal Dimensions
Nominal Filtration Area per 10 in. (254 mm) Module
Lengths 10 in. (254 mm), 20 in. (508 mm),
30 in. (762 mm), 40 in. (1016 mm) 0.66 m2 (7.1 ft2)
Diameter 70 mm (2.75 in.)
Integrity Test Values for 10 in. (254 mm) Filter at 20 °C (68 °F)
Maximum Allowable Water wet ≤ 23 mL/min
Forward Flow (Air Test Gas) at 2760 mbar (40 psi)
Contact Pall for multi-element integrity test values and recommended test procedures.

Ordering Information

AB 7

Code Nominal Code Removal Cartridge Code Filter Grade Code O-ring
Length Rating Style Material
1 10 in. (254 mm) EBV 0.2 µm Double 226 O-ring P Pharmaceutical* H4 Silicone elastomer
sterilizing-grade bayonet lock Other materials available
2 20 in. (508 mm) * Pall pharmaceutical-grade filters are
and fin end designed for use in conformance with on request.
3 30 in. (762 mm) CGMP in Manufacturing, Processing,
Packing or Holding of Drugs (21CFR210)
4 40 in. (1016 mm) and CGMP for finished Pharmaceuticals
(21CFR211.72) including batch release
certificate and full traceability.

84
Kleenpak™ Capsules with Fluorodyne II Membrane Assemblies
®

Ideal for Sterile Filtration of Biopharmaceutical Fluids

Pall Kleenpak capsule filters with Quality and Bio-Safety

hydrophilic PVDF Fluorodyne II membrane
are rugged, self-contained sanitary filters
designed for small-batch sterile filtration of
most pharmaceutical solutions. They are
especially suitable for recovery of dilute
preservatives, proteins, or other critical
components, or may be used where higher
throughput/higher flow rate PVDF
membranes are preferred. A wide range of
sizes is available.
Features and Benefits
Biological Tests
Integrity
• Every filter tested during manufacture.
Test correlated to microbial retention
Biological Tests
• Meets USP Biological Reactivity Test,
in vivo, for Class VI-121 °C Plastics
Effluent Quality Tests*
• Meets Cleanliness per USP Particulates
in Injectables

• Higher flow rates and throughputs • Non-Fiber-Releasing

• Lowest binding membrane • Non-Pyrogenic per USP Bacterial

• 100% integrity and pressure tested
• Lowest filter extractables
• Compatible with caustic solutions
• Sanitary vent and drain valves with
non-twist hose barbs
• Low hold-up volumes (< 1 mL)
• Repeatedly autoclavable
Endotoxins (< 0.25 EU/mL)
• Meets Total Organic Carbon and Water
Conductivity per USP Purified Water;
pH per Sterile Purified Water
Autoclave Resistance
• Lot samples multi-cycle autoclave
challenged
* Per lot sample soak or rinse-up flush aliquots.

• Manufactured for use in conformance

with cGMP
• ISO 9000 Certified Quality System
• Pharmaceutical P optimized
• Certificate of Test provided

85
 Kleenpak Capsules with Fluorodyne II Membrane Assemblies
Technical Specifications

Materials of Construction Typical Liquid Flow Rates for DFL Media(5)

Flow Rate (L/min)
Membrane Polyvinylidenedifluoride (PVDF),
0 1 2 3 4 5 6 7 8
Double-layer
8 KA1 KA2
Support, Drainage, Core, Polypropylene 500
Cage, End Caps and Shell KA3

Vent and Drain Valve O-ring Ethylene Propylene (EPDM)

6

Differential Pressure (psid)

400

Differential Pressure (mbar)

Microbial Removal Ratings
DBL(1) 0.45 µm, microbial-rated 300
4
DFL(2) 0.2 µm, sterilizing-grade
DJL(3) 0.1 µm, mycoplasma-rated 200
KA4
sterilizing-grade
2
(1)
Typical Lactobacillus brevis titer reduction is > 106. 100
(2)
Assembly lot samples retain > 107 CFU/cm2 of Brevundimonas diminuta per mod.
ASTM F838-83 and FDA guidelines.
(3)
DJL grade filters have high removal efficiency for diminutive organisms (e.g., typical
titer reductions for Acholeplasma laidlawii is > 108. 0 0
0 0.5 1 1.5 2
Flow Rate (Gal/min)
Nominal Filter Areas (5)
Typical initial clean media ∆P per 10 in. (254 mm) element; water at 20 °C
(68 °F); viscosity 1 cP. For assistance in filter assembly sizing and
Size Code KA1 KA2 KA3 KA4 housing selection, contact your local Pall representative.

Effective 0.04 m 2
0.08 m 2
0.15 m 2
0.34 m2 Aqueous Extractables (NVR)(6)
Filter Area (0.4 ft2) (0.8 ft2) (1.5 ft2) (3.4 ft2)
KA1 and KA2 1 mg

Operating Conditions(4) KA3 2 mg

KA4 4 mg
Maximum Pressure and 5.2 barg (75 psig) to 40 °C (104 °F)
Temperature (6)
Water at 20 – 25 °C (68 °F – 77 °F) after autoclaving.

Maximum Differential 4.1 bard (60 psid) at 40 °C (104 °F)

Pressure Steam Autoclaving (Non-G and Non-S Grades)(7)
(4)
Using compatible liquids. Maximum 3.5 barg (50 psig) in air/gas service. Cumulative Autoclave Time 30 hours at 125 °C (257 °F)
10 hours at 140 °C (284 °F)

Sterilization (7)
Laboratory tests (1-hour cycles) establish multi-cycle.

Gamma-irradiation Maximum Dosage (G grade): 50 kGy Warning: Kleenpak filters must not be steam-sterilized in situ by passing steam through
under pressure.

Nominal Dimensions
Size Code KA1 KA2 KA3 KA4
Maximum Diameter of Bowl (including Valves) 94 mm (3.7 in) 94 mm (3.7 in) 109 mm (4.2 in.) 109 mm (4.2 in.)
Length (including Sanitary Connection [Code 1]) 117 mm (4.6 in.) 158 mm (6.2 in.) 174 mm (6.8 in.) 286 mm (11.2 in.)
Length (including Hose Barb Connection [Code 6]) 158 mm (6.2 in.) 199 mm (7.8 in.) 210 mm (8.2 in.) 325 mm(12.7 in.)

Ordering Information

KA P

Code Size and Area Code Removal Ratings Code Inlet and Outlet Connections Code Options
1 DBL 0.45 µm 1 38 mm (11⁄2 in.) sanitary flange Blank Autoclave service
2 See above DFL 0.2 µm sterilizing-grade 6 14 mm (9⁄16 in.) hose barb G Unsterilized,
dimensions Gamma-irradiatable
3 table DJL 0.1 µm sterilizing-grade
S Pre-sterilized
4

Notes: Contact Pall for specific part number availability.

DBL available in sizes KA1, KA2, KA3, and KA4 with Inlet and outlet 1 and 6 in autoclavable version. DBL is also available in KA2 size, G and S grade with 1 and 6 in inlet and outlet options.
DFL available in sizes KA1 and KA2 with inlet and outlet options 1 and 2 for G, S and autoclavable versions. DFL available in sizes KA3 and KA4 with inlet and outlet options 1 and 6 for G, S
and autoclavable versions. DJL available in sizes KA1, KA2, KA3, and KA4 with Inlet and outlet 1 and 6 in G and S versions.

86
 Fluorodyne II Hydrophilic PVDF Filter Cartridges
®

Ideal for Large-volume Sterile Filtration

Pall Fluorodyne II filter cartridges feature a • Built-in PVDF prefiltration layers

unique hydrophilic modified
• Repeatedly steamable in situ
polyvinylidenedifluoride (PVDF) membrane
with ultra-low binding properties, broad • 100% integrity-tested
chemical and temperature resistance, and • Individually serialized
higher flows than competitive PVDF or
• Manufactured for use in conformance
other membrane cartridges. High-area
with cGMP
pleated into single open-ended (SOE) AB
sanitary style cartridges, Fluorodyne II • ISO 9000 Certified Quality System
filters are available 0.45 µm rated for Pharmaceutical P optimized
stabilization, filtration of viscous fluids and • Certificate of Test provided
membrane prefiltration, 0.2 µm rated for
sterilization, and 0.1 µm rated for • Validation Guide available
sterilization and mycoplasma removal.
They are recommended for Quality and Bio-Safety
pharmaceuticals including ophthalmics and Biological Tests
other dilute preservative solutions, Integrity
biologicals including dilute protein
• Every filter tested during manufacture.
solutions, cold and hot WFI, chemicals,
Test correlated to microbial retention
aggressive solvents and sanitizing agents.
Biological Tests
Features and Benefits • Meets USP Biological Reactivity Test,
in vivo, for Class VI-121 °C Plastics
• Higher flows per cartridge for smaller
assemblies or reduced change-outs Effluent Quality Tests*
• DJL provides 0.1 µm retention with • Meets Cleanliness per USP Particulates
0.2 µm flow in Injectables

• Lower extractables • Non-Fiber-Releasing

• Stable in 90 °C (184 °F) WFI • Non-Pyrogenic per USP Bacterial

Endotoxins (< 0.25 EU/mL)
• High protein recoveries
• Meets Total Organic Carbon and Water
• Rapid preservative recoveries
Conductivity per USP Purified Water;
• Inherently water wettable pH per Sterile Purified Water
• Compatible with organic solvents, acids Steam Resistance
and chemicals(1). • Lot samples multi-cycle autoclave
• Resin and surfactant-free challenged
• Melt-sealed, non shedding * Per lot sample soak or rinse-up flush aliquots.

(1)
Except ketones and amides.

Note: These filters are also available in Kleenpak Nova

capsule format.

87
 Fluorodyne II Hydrophilic PVDF Filter Cartridges
Technical Specifications

Materials of Construction Typical Liquid Flow Rates(4)

Flow Rate (L/min)
Membrane Hydrophilic Polyvinylidenedifluoride
0 5 10 15
(PVDF)
4 DJ
Support, Drainage, Core, Polypropylene 250
Cage and End Caps
DF
Code 7 Adapter Polypropylene with encapsulated 3

Differential Pressure (psid)

100

Differential Pressure (mbar)

stainless steel reinforcing ring for
steaming in situ
O-rings Silicone(1) 150
2
(1)
Other polymers available.
DB
100
Microbial Removal Ratings(2)
1
DBL 0.45 µm microbial-rated
50
(Typical Serratia marcescens TR > 106)

DFL 0.2 µm sterilizing-grade

0 0
DJL 0.1 µm mycoplasma-rated, 0 1 2 3 4
sterilizing-grade (Typical Flow Rate (Gal/min)
Acholeplasma laidlawii TR > 108) (4)
Typical initial clean media ∆P per 10 in. (254 mm) element; water at 20 °C
(2)
Lot samples of sterilizing-grades retain >107 cfu/cm2 of Brevundimonas diminuta per (68 °F); viscosity 1 cP. For assistance in filter assembly sizing and
mod. ASTM F838-83 and FDA guidelines. housing selection, contact your local Pall representative.

Aqueous Extractables (NVR)(6) per 10 in. (254 mm) Element

Configuration (AB Code 2 and 7)(3)
Double 226 O-ring adapter
Fin end with bayonet lock
(3)
Alternate adapter codes available.
Nominal Dimensions
Lengths
Typically < 5 mg
(6)
In water at 20 – 25 °C (68 °F – 77 °F) after autoclaving.
Autoclavable or Steamable in situ(7)
Cumulative Steaming 30 hours (1-hour cycles) at
Exposure 125 °C (257 °F)
5 in. (127 mm), 10 in. (254 mm), 10 hours (1-hour cycles) at
20 in. (508 mm), 30 in. (762 mm) 140 °C (284 °F)

Diameter 70 mm (2.75 in.) Hot Water Sanitization To 90 °C (194 °F) at 0.5 bard (7 psid)

Nominal Filter Area per 10 in. (254 mm) Element Forward Flow(7)
DBL 13 mL/min at 1240 mbar (18 psi)
Size Code DBL DFL DJL
DFL 12 mL/min at 2760 mbar (40 psi)
Effective 0.55 m2 0.51 m2 0.51 m2
Filter Area (6 ft2) (5.5 ft2) (5.5 ft2) DJL 29 mL/min at 4475 mbar (65 psi)
(7)
Forward Flow allowable limit per 10 in. (254 mm) cartridge at given test pressure, water
wet, air test gas.
Operating Conditions(5)
Maximum Differential 5.3 bard (77 psid) to 50 °C (122 °F)
Pressure and Temperature 3.4 bard (49 psid) to 90 °C (194 °F)
(5)
Using compatible fluids.

Part Numbering and Ordering Information

AB

Code Nominal Code Removal Code Cartridge Code Filter Grade Code Gasket
Length Rating Style Option

05 5 in. DBL 0.45 µm 7 Double 226 O-ring with P Pharmaceutical* H4 Silicone

(127 mm) bayonet lock and fin end Other materials available
DFL 0.2 µm Omit General Use
on request.
1 10 in. DJL 0.1 µm 2(8) Double 226 O-ring with * Pall pharmaceutical-grade
(254 mm) bayonet lock and flat end filters are designed for use
in conformance with CGMP
2 20 in. (8)
AB05 size only.
in Manufacturing,
(508 mm)
Processing, Packing or
3 30 in. Holding of Drugs
(762 mm) (21CFR210) and CGMP for
finished Pharmaceuticals
(21CFR211.72) including
batch release certificate and
88 full traceability.
Kleenpak™ Capsules with Ultipor N66 Membrane Assemblies
®

0.1 µm and 0.2 µm Capsules with Excellent Wettability

Pall Kleenpak sterilizing-grade capsule Quality and Bio-Safety

filters with intrinsically hydrophilic Ultipor
N66 membrane are self-contained sanitary
filters designed for convenient small-batch
sterile filtration of most pharmaceutical
solutions. Rugged, compact design
ensures reliability.
Features and Benefits
• 100% integrity and pressure tested
• 0.2 micron NFP sterilizing-grade
• 0.1 micron NTP sterilizing-grade for
bacteria and mycoplasma removal
• Low filter extractables
• Excellent solvent compatibility
Biological Tests
Integrity
• Every filter tested during manufacture.
Test correlated to microbial retention
Biological Tests
• Meets USP Biological Reactivity test,
in vivo, for Class VI-121 °C Plastics
Effluent Quality Tests*
• Meets Cleanliness per USP Particulates
in Injectables
• Non-Fiber-Releasing
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)

• Sanitary vent and drain valves with • Meets Total Organic Carbon and Water
non-twist hose barbs Conductivity per USP Purified Water;
pH per Sterile Purified Water
• Low hold-up volumes (< 1 mL)
Autoclave Resistance
• Gamma-irradiatable, autoclavable, and
• Lot samples multi-cycle autoclave
pre-sterilized versions available for
challenged
maximum flexibility
* Per lot sample or rinse-flush aliquots.
• Autoclavable versions can be
repeatedly autoclaved
• Manufactured for use in conformance
with cGMP
• ISO 9000 certified Quality system
• Pharmaceutical P optimized
• Certificate of test provided

89
 Kleenpak Capsules with Ultipor N66 Membrane Assemblies
Technical Specifications

Materials of Construction Typical Liquid Flow Rates(4)

Membrane Nylon 6,6 Flow Rate (L/min)
0 1 2 3 4
Support and Drainage Polyester 20
Core and Cage Autoclavable Version: FP
1N 1250
Polypropylene KA

G and S Grades: 15

Differential Pressure (psid)

1100

Differential Pressure (mbar)

Polyester
End Caps and Shell Polyester
Valve O-rings Ethylene Propylene (EPDM ) 750
10
NFP
KA2
Microbial Removal Ratings(1) 600

NF 0.2 µm, sterilizing-grade, Brevundimonas diminuta.

5
NT 0.1 µm, sterilizing-grade,(2) Brevundimonas diminuta. KA3NFP 250
(1)
Assembly lot samples retain > 107 cfu/cm2 of Brevundimonas diminuta per modified
ASTM F838-83 and FDA guidelines.
(2)
Also retains > 107/cm2 Acholeplasma laidlawii mycoplasma. 0 0
0 0.25 0.5 0.75 1

Nominal Filter Areas Flow Rate (Gal/min)

(4)
Typical initial clean ∆P; water at 20 °C (68 °F), 1 cP. Values shown are for
Size Code KA1 KA2 KA3 KA4 38 mm (11⁄2 in.) sanitary flange connections. Values with other connections
Effective Filter Area are available on request. For assistance, contact your local Pall
representative.
NF: 0.05 m2 0.1 m2 0.2 m2 0.5 m2
(0.5 ft2) (1 ft2) (2 ft2) (5 ft2)
Aqueous Extractables (NVR)(5)
NT: 0.045 m2 0.08 m2 0.2 m2 0.4 m2
(0.4 ft2) (0.8 ft2) (2 ft2) (4 ft2) Size Code KA1 KA2 KA3 KA4
Non-irradiated 7 mg 10 mg 12 mg 20 mg
Nominal Dimensions Pre-sterilized 6 mg 12 mg 22 mg N/A
Size Code KA1 KA2 KA3 KA4 (5)
In water at 20 – 25 °C (68 – 77 °F) after autoclaving.
N/A = Filter not available.
Maximum Diameter 94 mm 94 mm 109 mm 109 mm
of Bowl (including Valves) (3.7 in.) (3.7 in.) (4.2 in.) (4.2 in.)

Length (including Sanitary 117 mm 158 mm 174 mm 286 mm

Steam Autoclaving(6)
Connection* [Codes 1 (4.6 in.) (6.2 in.) (6.8 in.) (11.2 in.) Cumulative Autoclave Time 16 hours at 125 °C (257 °F)
and 8]) 4 hours at 140 °C (284 °F)
Length (including Stepped 158 mm 199 mm (6)
Laboratory tests (1-hour cycles) establish multi-cycle resistance. Filters should be
Hose Barb Connection (6.2 in.) (7.8 in.) qualified in actual use. Contact Pall for recommended procedures.
[Code 2])
Warning: Kleenpak filters must be steamed in situ by passing steam through under
Length (including Hose 158 mm 199 mm 210 mm 325 mm pressure.
Barb Connection [Code 6]) (6.2 in.) (7.8 in.) (8.2 in.) (12.7 in.)
Sterilization
* Sanitary connection is Tri-Clamp compatible. Tri-Clamp is a trademark of Alfa Laval, Inc.
Gamma-irradiation Maximum Dosage (G grade): 50 kGy

Operating Conditions(3)
Maximum Pressure and 5.2 barg (75 psig) to 40 °C (104 °F) Note: Contact Pall for specific part number availability.
S and G grades available in KA1 and KA2 with inlet and outlet options 1 and 2; KA3 with
Temperature with inlet and outlet options 1 and 6.
Autoclavable grades available in KA1 and KA2 with inlet and outlet options 1 and 2; KA3
Maximum Operating 4.1 bard (60 psid) at 40 °C (104 °F)
and KA4 with with inlet and outlet options 1 and 6.
Differential Pressure
(3)
Using compatible liquids. Recommended maximum 3.5 barg (50 psig) in continuous air
and gas service. KA*NT filters may be forward flow tested at 5171 mbar (75 psig) at
ambient temperature.

Ordering Information

KA P

Code Size and Area Code Removal Ratings Code Inlet and Outlet Connections Code Options

1 NF 0.2 µm sterilizing-grade 1 1 – 11⁄2 in. sanitary flange Blank Autoclave service

2 See above
NT 0.1 µm sterilizing-grade 2 6 – 13 mm (1⁄4 – 1⁄2 in.) stepped G Unsterilized,
dimensions
hose barb Gamma-irradiatable
3 table
4 6 14 mm (9⁄16 in.) hose barb S Pre-sterilized

8 ⁄2 – ⁄4 in. fractional sanitary

1 3

flange
90
Option P8 available in KA2, autoclave service.
 Sealkleen™ Membrane Filter Cartridges
Sterilizing and Microbial Grade Junior Style Filters

Pall Sealkleen membrane filter cartridges Quality and Bio-Safety

are made with either Ultipor N66, Biological Tests
Posidyne, or Fluorodyne II membranes
Biological Tests
with a choice of retention ratings in two
high-area sizes. The unique Sealkleen • Meets USP Biological Reactivity Test,
assembly features a patented sealing in vivo, for Class VI-121 °C Plastics
design which eliminates the possibility of Effluent Quality Tests*
fluid bypass from upstream to down-
• Meets Cleanliness per USP Particulates
stream.
in Injectables
Sealkleen membrane cartridges are ideal
• Non-Fiber-Releasing
for most small volume or low flow liquid
prefiltration and sterilizing applications. • Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
Features and Benefits • Meets Total Organic Carbon and Water
Conductivity per USP Purified Water;
• Nylon 6,6 or PVDF membranes
pH per Sterile Purified Water
• Intrinsically water wettable
* Per lot sample soak or rinse-up flush aliquots.
• Range of surface properties
• Low extractables
• Broad chemical compatibilities
• Sterilizing-grades per FDA Guidelines
• Bioreduction and prefiltration grades
• Manufactured for use in conformance
with cGMP
• IS0 9000 Certified Quality System
• Pharmaceutical P optimized with
Certificate of Test provided

91
 Sealkleen Membrane Filter Cartridges
Technical Specifications

Materials of Construction Typical Liquid Flow Rates for SLK7002 Styles(4)

Media (Double-layer except where noted) Flow Rate (L/min)
0 2 4 6 8
Ultipor N66 Nylon 6,6 4 NX NNXZ
N66 Posidyne Nylon 6,6 with positive zeta potential
240
Fluorodyne II Hydrophilic polyvinylidenedifluoride (PVDF) NL

Differential Pressure (mbar)

Differential Pressure (psid)
Support, Drainage and End Caps 3

Ultipor N66 Polyester

160
N66 Posidyne Polyester 2
Fluorodyne II Polypropylene NB

Core and Cage Polypropylene 80

1

Microbial Removal Ratings

Ultipor N66 0.45 µm and 0.2 µm microbial(1) 0 0
0.2 µm and 0.1 µm sterilizing(2) 0 0.5 1 1.5 2
Flow Rate (Gal/min)
N66 Posidyne 0.45 µm microbial-rated
Flow Rate (L/min)
0.2 µm and 0.1 µm sterilizing(2)
0 2 4 6 8
Fluorodyne II 0.45 µm microbial-rated 6
NT, NTZ NR NF, NFZ 400
0.2 µm sterilizing(2) DFL
5

Differential Pressure (mbar)

Differential Pressure (psid)
1)
0.45 µm. NB: Typical Serratia marcescens TR 104 – 6 0.2 µm
NA: Typical Brevundimonas diminuta TR 104 – 6 300
NX, NL, NNXZ: Lot samples retain > 107 cfu/cm2 of Serratia marcescens 4
(2)
Lot samples retain > 107 cfu/cm2 (0.45 µm) of Brevundimonas diminuta (0.2 µm and
0.1 µm) per mod. ASTM F838-83 and FDA guidelines. 0.1 µm NT also retains > 107 NA
3 200
cfu/cm2 Acholeplasma laidlawii mycoplasma.

2
Configuration
100
Single open-ended cartridge 1

Integral flange on downstream End Cap

Nominal Dimensions
Lengths
Diameter
Operating Conditions(3)
Maximum Pressure Differential 5.5 bard (80 psid) at 50 °C (122 °F)
and Temperature
0 0
0 0.5 1 1.5 2
Flow Rate (Gal/min)
(4)
Typical initial clean ∆P, air at 20°C (68°F). Values shown are for 38 mm
SLK7001 SLK7002 (11⁄2 in.) sanitary flange connections. Values with other connections are
2.5 in. (64 mm) 5.2 in. (127 mm) available on request. For assistance in filter sizing, contact your local Pall
representative.
57 mm (2.5 in.) 57 mm (2.5 in.)
Autoclaving and Steaming in situ(5)
Cumulative Exposure Time Ultipor N66, N66 Posidyne:
16 hours at 125 °C (257 °F)
4.1 bard (60 psid) at 80 °C (176 °F) 4 hours at 140 °C (284 °F)

(3)
Using compatible fluids. Fluorodyne II:
30 hours at 125 °C (257 °F)
10 hours at 140 °C (284 °F)
(5)
Laboratory tests (1-hour cycles) establish multi-cycle resistance. Filters should be
qualified in actual use. Contact Pall for recommended procedures.

Ordering Information

SLK

Code Nominal Code Removal Nominal Filter Code Filter Forward Flow integrity Test Parameters
Length Rating Area(6) Grade
7001 2.5 in. NNXZ 1.2/0.45 µm 0.17 m2 (1.8 ft2) P Pharmaceutical* Part Number FF Test FF Limit
(64 min) Pressure* Value
NB 0.45 µm 0.30 m2 (3.2 ft2) Omit General Use
mbar (psi) (mL/min)
7002 5.2 in. NL 0.45 µm 0.29 m2 (3.1 ft2)
(133 mm) * Pall pharmaceutical-grade filters SLK7001NRP 2760 (40) 2.3
NX 0.45 µm 0.17 m2 (1.8 ft2) are designed for use in
SLK7001NFP 2760 (40) 3.5
Note: NA 0.45 µm 0.30 m2 (3.2 ft2) conformance with CGMP in
Manufacturing, Processing, SLK7001DFLP 2760 (40) 2
Ultipor N66 = NB, NL, NF 0.2 µm 0.27 m2 (2.9 ft2)
NX, NA, Packing or Holding of Drugs SLK7001NTP 5175 (75) 3.6
NF, NR, NR 0.2 µm 0.17 m2 (1.8 ft2) (21CFR210) and CGMP for
finished Pharmaceuticals
SLK7002NRP 2760 (40) 4.6
NT NFZ 0.2 µm 0.27 m2 (2.9 ft2)
Posidyne = NNXZ, (21CFR211.72) including batch SLK7002NFP 2760 (40) 7
NT 0.1 µm 0.25 m2 (2.7 ft2) release certificate and full
NFZ, SLK7002DFLP 2760 (40) 4
NTZ NTZ 0.1 µm 0.25 m2 (2.7 ft2) traceability.
SLK7002NTP 5175 (75) 5.9
Fluorodyne II = DFL DFL 0.2 µm 0.19 m2 (2.0 ft2)
* Please contact Pall for method details and test
parameters.
92
 Ultipor N66 Sterilizing-grade Filter Cartridges
®

Sterilizing-grade Filters for Large-scale Applications

Pall Ultipor N66 sterilizing-grade filter Quality and Bio-Safety*

cartridges feature high-strength pure Nylon
6,6 membranes for higher sterility
assurance. In wide use for almost 20
years, these filters have a proven record of
performance in the production of sterile
biologicals and pharmaceuticals. High-area
pleated into single open-ended (SOE) AB
sanitary style cartridges, Ultipor N66
sterilizing-grade filter cartridges are
available with ratings from 0.45 µm for
LVPs, reagents and viscous fluids,
0.2 µm for sterile products and
intermediates, 0.1 µm for sterilization and
mycoplasma removal from biologicals, to
0.04 µm for sterilization and virus reduction
from biologicals.
Features and Benefits
Integrity
• Every filter integrity tested during
manufacture. Test correlated to
microbial retention
Biological Tests
• Meets USP Biological Reactivity Test,
in vivo, for Class VI-121 °C Plastics
• Meets Cleanliness per USP Particulates
in Injectables
• Non-Fiber-Releasing per 21 CFR
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
• Meets Total Organic Carbon and Water
Conductivity per USP Purified Water,
pH per USP Sterile Purified Water

• Intrinsically water wettable Steam Resistance

• Lot samples multi-cycle autoclave
• Fixed pores, non-shedding
challenged
• Resin and surfactant-free
* Per lot samples soak or rinse-up flush aliquots.
• Broad solvent compatibility
• Low filter extractables
• High-area for long-life
• High protein recovery from most protein
solutions
• Repeatedly steamable in situ
Note: These filters are also available in Kleenpak Nova
capsule format.

93
 Ultipor N66 Sterilizing-grade Filter Cartridges
Technical Specifications

Materials of Construction Typical Liquid Flow Rates(4)

Flow Rate (L/min)
Membranes Nylon 6,6, double-layer
0 2 4 6 8
Supports, Drainage and Polyester 2
ND, NT NR NF
End Caps
120
Core and Cage Polypropylene
O-ring Silicone(1)

Differential Pressure (psid)

Differential Pressure (mbar)

(1)
Other polymers available. 90

Microbial Removal Ratings(2) 1

60
NR, NF 0.2 µm sterilizing-grade
NT 0.1 µm mycoplasma sterilizing-grade
ND 0.04 µm rated, sterilizing-grade 30
(Typical MuLV, HIV (retrovirus) TR 105)
(2)
Lot samples retain > 107 cfu/cm2 of an appropriate challenge organism per mod.
ASTM F838-83 and FDA guidelines; NR, NF, NT, ND: Brevundimonas diminuta; 0
0
NT also retains > 107 cfu/cm2 Acholeplasma laidlawii mycoplasma. 0 0.5 1 1.5 2
Flow Rate (Gal/min)
Nominal Dimensions (4)
Typical initial clean media ∆P 10 in. (254 mm) element; water at 20 °C (68°F);
viscosity 1 cP. For assistance in filter assembly sizing and housing
Lengths 10 in. (254 mm), 20 in. (508 mm), selection, contact your local Pall distributor.
30 in. (762 mm), 40 in. (1016 mm)
Diameter 2.75 in. (70 mm) Configuration (AB Code 7)(5)
Double 226 O-ring adapter
Operating Conditions(3) Fin end with bayonet lock
Maximum Differential 5.5 bard (80 psid) to 50 °C (122 °F)
(5)
Alternate adapter codes available.
Pressure and Temperature 4.1 bard (60 psid) to 80 °C (176 °F)
2.1 bard (30 psid) to 125 °C (257 °F) Autoclavable or steamable in situ(6)
(3)
Using compatible fluids. Cumulative Steam Exposure 16 hours (1-hour cycles) at
121 °C (250 °F)

4 hours (1-hour cycles) at

140 °C (284 °F)
(6)
Laboratory tests to establish multi-cycle resistance. Filters should be qualified in actual
use. Contact Pall for recommended procedures.

Aqueous Extractables (NVR) per 10 in. (254 mm) Element

Typically 15 – 25 mg

Ordering Information

AB

Code Nominal Code(7) Removal Nominal Forward Flow(9) Code Filter Code Gasket
Length Rating Filter mL/min at Grade Option
Area(8) mbar (psi)
05 5 in. NF 0.2 µm 0.79 m2 (8.5 ft2) 12 at 2760 (40) P Pharmaceutical* H4 Silicone
(127 mm)
NR 0.2 µm 0.46 m2 (5.0 ft2) 8 at 2760 (40) Omit General Use Other materials available
1 10 in. on request.
NT 0.1 µm 0.79 m2 (8.5 ft2) 14 at 5175 (75) * Pall pharmaceutical-grade filters
(254 mm) are designed for use in
ND 0.4 µm 0.81 m2 (8.7 ft2) 25 at 3440 (50) conformance with CGMP in
2 20 in. Manufacturing, Processing,
(508 mm)
(7)
Code 7 adapter is standard (except 05 length is Code 2 with flat cap). Packing or Holding of Drugs
(8)
Per 10 in. (254 mm) element. (21CFR210) and CGMP for
3 30 in.
(9)
Forward Flow allowable limit for one 10 in. (254 mm) cartridge at given test finished Pharmaceuticals
pressure, water wet, air test gas. Please contact Pall for method details and test (21CFR211.72) including batch
(762 mm) parameters. release certificate and full
4 40 in. traceability.
(1016 mm)

94
Kleenpak™ Capsules with Posidyne Membrane Assemblies
®

Positive Zeta Potential for Enhanced Retention of Fine Particles

Pall Kleenpak capsule filters with Quality and Bio-Safety

intrinsically hydrophilic positive zeta
potential Posidyne membrane are rugged,
self-contained sanitary filters designed for
small-batch sterile filtration of aqueous
pharmaceutical solutions. With a net
positive charge in most aqueous solutions
from pH 3 to 10, Kleenpak Capsules with
Posidyne Membrane Assemblies can be
effective in removing contaminants such as
cell debris and endotoxin smaller than the
filter rating.
Features and Benefits
• Positive Zeta potential for enhanced
efficiency in aqueous solutions
• Double-layer sterilizing membranes for
high reliability
• 100% integrity and pressure-tested
Biological Tests
• Meets USP Biological Reactivity Test,
in vivo, for Class VI-121 °C Plastics
Effluent Quality Tests*
• Meets Cleanliness per USP Particulates
in Injectables
• Non-Fiber-Releasing
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
• Meets Total Organic Carbon and Water
Conductivity per USP Purified Water;
pH per Sterile Purified Water
Autoclave Resistance:
• Lot samples multi-cycle autoclave
challenged
* Per lot sample soak or rinse-up flush aliquots.

• High protein recovery from serum and

most protein solutions
• 0.2 µm NF grade for sterilization
• 0.1 µm NT grade for diminutive bacteria
and mycoplasma removal
• Low filter extractables
• Sanitary vent and drain valves with
non-twist hose barbs
• Low hold-up volumes (< 1 mL)
• Repeatedly autoclavable
• Manufactured for use in conformance
with cGMP
• IS0 9000 Certified Quality System
• Pharmaceutical P optimized
• Certificate of Test provided

95
 Kleenpak Capsules with Posidyne Membrane Assemblies
Technical Specifications

Materials of Construction Typical Liquid Flow Rates(4)

Flow Rate (L/min)
Membrane Nylon 6,6, positively-charged
0 1 2 3 4
Support and Drainage Polyester 16
KA1NTZ KA2NTZ
KA1NFZ
Core and Cage Autoclavable Version: KA3NTZ 1000
14
Polypropylene
12

Differential Pressure (mbar)

Differential Pressure (psid)
G and S Grades:
Polyester 750
10
End Caps and Shell Polyester
8
Vent and Drain Valve O-ring Ethylene Propylene (EPDM ) KA2NFZ 500

6
Microbial Removal Ratings
4
NFZ 0.2 µm, sterilizing-grade(1) 250
KA3NFZ
NTZ 0.1 µm, sterilizing-grade (2)
2
(1)
Assembly lot samples retain > 107 cfu/cm2 of Brevundimonas diminuta per mod.
ASTM F838-83 and FDA guidelines. 0 0
(2)
Also retains > 107 cfu/cm2 Acholeplasma laidlawii mycoplasma. 0 0.25 0.5 0.75 1
Flow Rate (Gal/min)
(4)
Typical initial clean ∆P, water at 20 °C (68 °F), 1 cP. KA4NFZP ∆P flow is
Nominal Filter Areas
37 mbard/L per min (2.1 psid/gpm). Pressure drops at other flows are
directly proportional to flow. Values shown for 38 mm (11⁄2 in.) sanitary flange
Size Code KA1 KA2 KA3 KA4
connections. Values with other connections are available on request. For
assistance, contact your local Pall representative.
Effective 0.05 m2 0.1 m2 0.2 m2 0.5 m2
Filter Area (0.53 ft2) (1 ft2) (2.1 ft2) (5.3 ft2)

Nominal Dimensions Aqueous Extractables (NVR)(5) (Non G and S Grades)

Size Code KA1 KA2 KA3 KA4 Size Code KA1 KA2 KA3 KA4
Maximum Diameter 94 mm 94 mm 109 mm 109 mm
6 mg 12 mg 20 mg 40 mg
of Bowl (including Valves) (3.7 in.) (3.7 in.) (4.2 in.) (4.2 in.)
(5)
Water at 20 – 25 °C (68 – 77 °F) after autoclaving.
Length (including Sanitary 117 mm 158 mm 174 mm 286 mm
Connection [Code 1]) (4.6 in.) (6.2 in.) (6.8 in.) (11.2 in.)
Steam Autoclaving(6) (Non G and S Grades)
Length (including Stepped 158 mm 199 mm – –
Hose Barb Connection (6.2 in.) (7.8 in.) – – Cumulative Autoclave Time 16 hours at 125 °C (257 °F)
[Code 2])
4 hours at 140 °C (284 °F)
Length (including Hose – – 210 mm 325 mm
Barb Connection [Code 6]) – – (8.2 in.) (12.7 in.) Laboratory tests (1-hour cycles) establish multi-cycle.
(6)

Warning: Kleenpak filters must not be steam-sterilized in situ by passing steam through
under pressure.

Operating Conditions(3)
Sterilization
Maximum Pressure and 5.2 barg (75 psig) to 40 °C (104 °F)
Temperature Gamma-irradiation Maximum Dosage (G Grade): 35 kGy

Maximum Differential 4.1 bard (60 psid) at 40 °C (104 °F)

Pressure
(3)
Using compatible liquids. Maximum 3.5 barg (50 psig) in air/gas service.

Ordering Information

KA P

Code Size and Area Code Removal Ratings Code Inlet and Outlet Connections Code Options
1 NFZ 0.2 µm sterilizing-grade 1 38 mm (11⁄2 in.) sanitary flange Blank Autoclave service
2 See above NTZ 0.1 µm sterilizing-grade 2 6 – 13 mm (1⁄4 – 1⁄2 in.) G Unsterilized,
dimensions hose barb Gamma-irradiatable
3 table
6 14 mm (9⁄16 in.) hose barb S Pre-sterilized
4

Note: Contact Pall for specific part number availability.

S and G grades are available in KA2 with inlet and outlet option 1; KA3 with with inlet and outlet option 6.
Autoclavable grades available in KA1 and KA2 with inlet and outlet options 1 and 2; KA3 and KA4 with with inlet and outlet options 1 and 6.

96
 Posidyne Filter Cartridges
®

Positive Zeta Potential for Enhanced Retention of Fine Particles in Large-scale Processes

Pall Posidyne filter cartridges incorporate Quality and Bio-Safety

a patented covalent charge-modified
Nylon 6,6 membrane which exhibits a net
positively-charged Zeta potential in
aqueous solutions. This positive Zeta
potential provides enhanced retention of
fine particles smaller than the membrane’s
rating, such as endotoxins in water, in a
direct flow mode without the higher
pressure drop of finer filters. High-area
pleated into single open-ended (SOE) AB
sanitary-style cartridges, N66 Posidyne
filters are available in particulate and
bioreduction grades and in
sterilizing-grades.
Biological Tests
• Meets USP Biological Reactivity Test,
in vivo, for Class VI-121 °C Plastics
Effluent Quality Tests*
• Meets Cleanliness per USP Particulates
in Injectables
• Non-Fiber-Releasing
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
• Meets Total Organic Carbon and Water
Conductivity per USP Purified Water,
pH per USP Sterile Purified Water

Features and Benefits * Per lot sample soak or rinse-up flush aliquots.

• Inherently water wettable

• Resin and surfactant-free
• Positive Zeta potential
• Enhanced retention of particles smaller
than filter rating
• Removes endotoxins from water
• High protein recovery from sera and
most protein solutions
• Low filter extractables
• 100% integrity-tested
• Individually serialized
• Manufactured for use in conformance
with cGMP
• ISO 9000 Certified Quality System
• Pharmaceutical P optimized grades
with Certificate of Test provided
• Validation Guide available
Note: These filters are also available in Kleenpak Nova
capsule format.

97
 Posidyne Filter Cartridges
Technical Specifications

Materials of Construction Typical Liquid Flow Rate(5)

Membrane Nylon 6,6, covalently-modified positive Flow Rate (L/min)
Zeta 0 5 10 15
4
Z

Z
NF

Z
Supports, Drainage and Polyester 250

, NT

NI
,
End Caps AZ
NB

NDZ
Core and Cage Polypropylene
3 XZ 200

Differential Pressure (psid)

Differential Pressure (mbar)

O-ring Silicone(1) NN
(1)
Other polymers available.
Z 150
, NL
Microbial Removal Ratings(2) 2 NAZ

NNXZ 0.45 µm microbial-rated 100

(Typical Serratia marcesens TR > 109)
1
NXZ, NLZ 0.45 µm microbial-rated
50
NBAZ, NAZ 0.2 µm microbial-rated (Typical
Brevundimonas diminuta TR > 104 – 6)
0 0
NIZ 0.1 µm microbial-rated (Typical 0 1 2 3 4
Brevundimonas diminuta TR > 109)
Flow Rate (Gal/min)
NFZ 0.2 µm sterilizing-grade (5)
Typical initial clean media ∆P 10 in. (254 mm) element; water at 20°C (68°F);
viscosity 1 cP. For assistance in filter assembly sizing and housing
NTZ 0.1 µm sterilizing-grade selection, contact your local Pall representative.

NDZ 0.04 µm rated, sterilizing-grade

Autoclavable or steamable in situ(6)
(Typical MuLV, HIV (retrovirus) TR 105)
(2)
Lot samples retain > 107 cfu/cm2 of an appropriate challenge organism per mod.
Cumulative Steam Exposure 16 hours (1-hour cycles) at
ASTM F838-83 and FDA guidelines; NXZ, NLZ: Serratia marcescens; NFZ, NTZ, NDZ: 121 °C (250 °F)
Brevundimonas diminuta; NTZ also retains > 107 cfu/cm2 Acholeplasma laidlawii
mycoplasma. 4 hours (1-hour cycles) at
140 °C (284 °F)

Nominal Dimensions (6)

Laboratory tests to establish multi-cycle resistance. Filters should be qualified in actual
use. Contact Pall for recommended procedures.
Lengths 10 in. (254 mm), 20 in. (508 mm),
30 in. (762 mm), 40 in. (1016 mm)
Aqueous Extractables (NVR) per 10 in. (254 mm) Element
Diameter 2.75 in. (70 mm)
Typically 15 – 25 mg

Operating Conditions (3)

Particle Removal Efficiencies

Maximum Differential
Pressure and Temperature
(3)
Using compatible fluids.
Configuration (AB Code 7)(4)
Double 226 O-ring adapter
Fin end with bayonet lock
(4)
Alternate adapter codes available.
5.5 bard (80 psid) to 50 °C (122 °F)
4.1 bard (60 psid) to 80 °C (176 °F) Endotoxin Removal > 99.997% to 0.16 gm E. coli endotoxin
2.1 bard (30 psid) to 125 °C (257 °F) Efficiency(7)
Polystyrene Bead Efficiency(8) NLZ, NAZ, NIZ to > 1 gm loading:
> 99.99% for 0.04 µm beads
NFZ, NTZ to > 2 – 10 gm loading:
> 99.99% for 0.04 µm beads
(7)
Determined for 10 in. (254 mm) elements challenged in deionized water. No endotoxin
detectable in effluent using LAL reagent with sensitivity of < 0.5 EU/mL.
(8)
Determined for 10 in. (254 mm) elements challenged in deionized water. Capacity
determined at breakthrough (effluent turbidity).

Ordering Information

AB 7

Code Nominal Code Removal Filter Forward Flow Code Filter Code Gasket
Length Rating Area(7) mL/min at Grade Option
mbar (psi)(8)
1 10 in. NNXZ 1.2/0.45 µm 0.82 m2 (8.8 ft2) 22 at 1240 (18) P Pharmaceutical* H4 Silicone
(254 mm) NLZ 0.45 µm 0.82 m2 (8.8 ft2) 15 at 1725 (25) Omit General Use Other materials available
2 20 in. on request.
NAZ 0.2 µm 0.85 m2 (9.0 ft2) 85 at 2060 (30) * Pall pharmaceutical-grade filters
(508 mm)
NBAZ 0.45/0.2 µm 0.82 m2 (8.8 ft2) 20 at 2060 (30) are designed for use in
3 30 in. conformance with CGMP in
(762 mm) NFZ 0.2 µm 0.78 m2 (8.5 ft2) 12 at 2760 (40) Manufacturing, Processing,
NIZ 0.1 µm 0.85 m2 (9.0 ft2) 50 at 3440 (50) Packing or Holding of Drugs
4 40 in. (21CFR210) and CGMP for
(1016 mm) NTZ 0.1 µm 0.70 m2 (7.5 ft2) 14 at 5175 (75) finished Pharmaceuticals
(21CFR211.72) including batch
NDZ 0.04 µm 0.81 m2 (8.7 ft2) 25 at 3440 (50)
release certificate and full
(7)
Filter areas are per 10 in. (254 mm) element. All dimensions are nominal. traceability.
98 (8)
Forward Flow allowable limit for one 10 in. (254 mm) cartridges at given test
pressure, water wet, air test gas. Please contact Pall for method details and test
parameters
Novasip™ Liquid Sterilizing-grade Capsule Filters
The Clear Choice for Steaming-In-Place

Novasip filters are unique. Novasip filters Features and Benefits

combine Pall cartridge technology with
advanced polymers to produce an
all–plastic filter assembly that can provide
all of the benefits of a capsule filter and SIP
(steam-in-place) capability. Novasip filters
therefore provide an alternative to stainless
steel housings in many applications. This
enables filter users to reduce capital and
labor costs and minimize cleaning
validation.
• Low installation cost — up to 80% less
than a comparable stainless steel
system
• Steam-in-place capability with no
housing cleaning or maintenance
• Clear housing for easy venting
• Laser-etched serial number for easy
identification

Novasip filters consist of a • New design sanitary valves:

standard-design filter cartridge ◆ Non-removable for safety
permanently sealed in a clear
◆ Non-threaded for cleanliness
polyetherimide housing. Polyetherimide is
an advanced plastic selected for its • Integral Stäubli*-compatible vent valve
high-strength at elevated temperatures and enables direct on-line connection to
pressures. This ensures that Novasip electronic test equipment
filters can be used under a wide range of • Non-rotating hose barb drain for safe
operating conditions including and hygienic operation
steaming–in–place at 142 °C (287 °F).
• Available in a range of media and
Novasip filters are supplied with sanitary removal ratings including Fluorodyne® II
flange inlet and outlet connections and low-binding membrane
integral vent and drain valves for immediate
* Stäubli is a trademark of Stäubli AG.
installation.
Novasip filters for liquids are
purpose-designed for the sterile filtration of
pharmaceutical and biological products.

Comprehensive Validation
Documentation
Novasip filters have been extensively
tested to ensure consistent and reliable
performance under a range of process
conditions.
Installation and operating instructions
including information on steam-sterilization
are available from Pall.

99
 Novasip Liquid Sterilizing-grade Capsule Filters
Technical Specifications

Materials of Construction Typical Liquid Flow Rates

Part Number C05NFP1/C3NFP1 C3DFLP1/C3DJLP1 Flow Rate (Gal/min)
0 1 2 3 4 5
Membrane Nylon 6,6 Hydrophilic 1000
polyvinylidenedifluoride 14

FP1
1

1
LP

P1

LP
(PVDF) DF

NF

DJ
C05N
C3

C3

C3
12
Support and Drainage Polyester Polypropylene
750

Differential Pressure (mbar)

End Caps Polyester Polypropylene

Differential Pressure (psid)

10
V
EK
Core and Cage Polypropylene Polypropylene C3
8
Housing Bowl Polyetherimide Polyetherimide
500
Housing Head Polyetherimide Polyetherimide
6
with TiO2 with TiO2
O-rings Silicone elastomer Silicone elastomer 4
250

Maximum Accumulated Steam Life(1),(2) 2

Part Number C05NFP1/C3NFP1 C3DFLP1/C3DJLP1

0 0
Temperature 125 °C 135 °C 142 °C 125 °C 135 °C 142 °C 0 5 10 15 20
(257 °F) (275 °F) (287 °F) (257 °F) (275 °F) (287 °F) Flow Rate (L/min)
Note: Differential pressures are for liquids with a viscosity of 1 cP. Differential
Cumulative Steam 16 4 2 30 10 2
pressures for liquids at other viscosities can be conservatively estimated by
Exposure Time Hours Hours Hours Hours Hours Hours multiplying the indicated differential pressure by the viscosity in cP. For assis-
tance, contact your local Pall representative.
(1)
Validated using 30-minute cycles.
(2)
Maximum determined in laboratory test. Actual steam life may vary depending on the
conditions of use. Extractables(4)
Extractables in Deionized NF:
Operating Conditions(3) Water at 20 °C (68 °F) < 10 mg

Maximum Operating 6.5 barg (94 psig) at 40 °C (104 °F) DFL/DJL:

Pressure < 5 mg

Maximum Differential 5.3 bard (77 psid) at 40 °C (104 °F) (4)

Refer to validation guide for test conditions
Pressure
(3)
With fully compatible fluids which do not soften, swell or adversely affect the filter or its Nominal Dimensions
materials of construction.
Maximum Diameter 123 mm (4.8 in.)
Note: Maximum differential pressure during steam-sterilization at up to 142 °C (287 °F) is (including Valves)
300 mbar (4.3 psi).
Length 157 mm (6.1 in.)

Part Numbering and Ordering Information

C P

Code Nominal Filter Area Code Filter Medium Code Connection Options Code Vent, Drain and Valve
05(5) 0.056 m2 (0.60 ft2) NF 0.2 µm sterilizing-grade 1 26 – 38 mm (1 – 11⁄2 in.) Blank Vent: Quick connect and
Ultipor N66 sanitary clamp disconnect coupling
(compatible with Stäubli*
3 0.22 m2 (2.37 ft2) NF 0.2 µm sterilizing-grade fitting)
Ultipor N66 Valve drain: Hose barb for
3 0.15 m2 (1.62 ft2) DFL 0.2 µm sterilizing-grade 4 – 6 mm (1⁄8 – 1⁄4 in.)
Fluorodyne II i.d. tube, with valve

3 0.15 m2 (1.62 ft2) DJL 0.1 µm sterilizing-grade A Vent and drain: Quick
Fluorodyne II connect and disconnect
coupling (Stäubli*
(5)
NF Media only. compatible) with valve

B Vent and drain: 13 mm

(1⁄2 in.) sanitary flange
(compatible with Tri-Clamp*
fitting), no valve
* Stäubli is trademark of Stäubli AG.

100
Kleenpak™ Nova Sterilizing-grade and Virus Removal Capsule Filters
Improving Choice, Flexibility and Operation Costs for the Sterile Filtration of Liquids
The issues of effective cleaning and
cleaning validation result in disposable
equipment being the preferred option for
many processes. Disposable filters can
help eliminate cleaning problems,
especially where biological products are to
be filtered. In applications where hazardous
materials are being filtered, such as
cytotoxic drugs, capsule filters can play an
important role in helping protect operators.
Kleenpak Nova capsule filters are
designed to provide choice, cost
effectiveness and flexibility, while ensuring
ease of use for the operator.
Designed to Provide Choice and
Flexibility
Kleenpak Nova capsule filters are available
with either in-line or T-style configurations.
The T-style configuration is ideal for
manipulating multiple filters in series or in
parallel configuration.
Kleenpak Nova Capsule filters incorporate
either a 10 in. (254 mm), 20 in. (508 mm)
or 30 in. (762 mm) length standard Pall
cartridge filter which have traditionally been
installed in stainless steel housings. In
applications where a particular filter is
already specified, the user can switch from
a stainless steel housing to a fully
disposable assembly with minimal
requalification. This means the extensive
range of sterilizing-grade and virus filters
currently available from Pall can easily be
provided as a capsule filter, including:
• Low binding, high-flow Fluorodyne II
PVDF filters
• Ultipor N66 and positively-charged
Posidyne nylon 66 filters
• Supor polyethersulfone filters
• Ultipor VF DV20 and DV50 virus
removal filters
Kleenpak Nova capsules are especially
suited to pilot- and process-scale
applications. They can be autoclaved or
sterilized by Gamma-irradiation and can be
supplied as part of pre-sterilized
processing systems such as a
filter/tubing/bag set.
Kleenpak Nova capsules are used in a
wide range of critical applications including
the sterilization of BioPharmaceuticals,
biologicals, diagnostic reagents, serum,
tissue culture media, and culture-media
components.
Kleenpak Nova Filters Reduce
Operating Costs
Kleenpak Nova filters have a typical
installation cost that is 80% lower than a
similar sized stainless steel housing
system. Therefore, they offer an extremely
cost-effective alternative to housing and
cartridge systems. Kleenpak Nova filters
can also provide additional cost savings:
• No housing maintenance —
Lower maintenance costs
• No housing cleaning or cleaning
validation —
Lower labor costs
• Filter is pre-assembled —
Lower labor costs
• Filter can be provided pre-sterilized —
Lower energy costs
101
 Kleenpak Nova Sterilizing-grade and Virus Removal Capsule Filters
Technical Specifications

Operating Conditions(1) Kleenpak Nova NP Empty Capsule –

Typical Water Flow Rates at 20 °C (68°F)
Maximum Operating 40 °C (104 °F)
Flow Rate (Gal /min)
Temperature
5 10 15 20 25
600 8
Maximum Operating 3 barg (43.5 psig) at 40 °C (104 °F).
Pressure (6.2 barg (90 psig) at 40 °C (104 °F) for 7
up to a maximum of 10 hours)(2) 500

Differential Pressure (mbar)

Differential Pressure (psi)

P6 6
(1)
With compatible fluids which do not soften, swell or adversely affect the product or its
400
materials of construction. 5
(2)
Integrity test purposes only.
300 4

Capsule Materials of Construction 3

200
P9
Housing Bowl and Head (3)
Polypropylene 2
100
O-rings Silicone elastomer P1 1
(3)
Formulated with TiO2 whitener which does not contribute to organic extractables.
0 0
0 20 40 60 80 100
Flow Rate (L /min)
Sterilization • P6 Capsules (13 mm ( ⁄2 in.) hose barb)
1

• P9 Capsule (25 mm (1 in.) hose barb)

Autoclave (Maximum) 135 °C, for 1 hour • P1 Capsules (sanitary flange)

Gamma-irradiation Maximum Dosage: 50 kGy

Kleenpak Nova NT Capsule –
Consult Pall for procedures. Typical Water Flow Rates at 20 °C (68 °F)
Flow Rate (Gal /min)
5 10 15 20 25
Nominal Dimensions
2.5
P9
In-line NP6 NP7 NP8 160

Maximum Diameter 154 mm 154 mm 154 mm 140 P19 2

Differential Pressure (psi)

Differential Pressure (mbar)

(including Valves) (6.1 in.) (6.1 in.) (6.1 in.)

120
Length with Hose Barb 397 mm 644 mm 895 mm P1 1.5
100
Inlet and Outlet (15.6 in.) (25.4 in.) (35.2 in.)
80
Length with Sanitary 335 mm 584 mm 834 mm 1
Inlet and Outlet (13.2 in.) (23.5 in.) (32.8 in.) 60

T-style NT6 NT7 NT8 40 0.5

Maximum Diameter 240 mm 240 mm 240 mm 20
(including Valves) (9.5 in.) (9.5 in.) (9.5 in.)
0
00 20 40 60 80 90 100
Length 349 mm 598 mm 848 mm Flow Rate (L/min)
(13.7 in.) (23.5 in.) (33.4 in.) • P1 Capsules (sanitary flange)
• P19 Capsules (sanitary flange inlet, 25 mm (1 in.) hose barb outlet)
• P9 Capsule (25 mm (1 in.) hose barb)

Ordering Information
NP – In-line
NT – T-Style P

Code Filter Size Code Filter Type Code Connection Options Code Sterilization
6 AB1 10 in. (254 mm) Sterilizing State 1 25 – 38 mm (1 – 11⁄2 in.) State
7 AB2 20 in. (508 mm) DFL 0.2 µm rated Fluorodyne II filter sanitary flange inlet and outlet G Non-sterilized
8 AB3 30 in. (762 mm) DJL 0.1 µm rated Fluorodyne II filter 9 25 mm (1 in.) single-barb
hose barb inlet and outlet S Pre-sterilized
NF 0.2 µm rated Ultipor N66 filter
NT 0.1 µm rated Ultipor N66 filter 19 25 – 38 mm (1 – 11⁄2 in.) sanitary
flange inlet and 25 mm (1 in.)
NFZ 0.2 µm rated Posidyne filter
single-barb hose barb outlet
NTZ 0.1 µm rated Posidyne filter
Options for In-line Only
EKV 0.2 µm rated Supor filter
6 13 mm (1⁄2 in.) single-barb
92D 0.2 µm rated Suporlife(4) filter hose barb inlet and outlet
(3)
Note: Empty Kleenpak Nova
Virus Filters 16 25 – 38 mm (1 – 11⁄2 in.) sanitary
Capsule Housings for water at 20 °C LUDV50(4) Ultipor VF grade DV50 virus filter flange inlet and 13 mm (1⁄2 in.) Code Vent and Drain
(68 °F), 1 cP. For other liquids, LDV20(4) Ultipor VF grade DV20 virus filter single-barb hose barb outlet – Stäubli* vent and
multiply pressure times the viscosity
in centipoise. For complete Options for T-style Only stepped hose barb
(4)
L included in part number for in-line (NP) filters;
assembly, including AB-Style filter omitted for T-style filters (NT) 1H 25 – 38 mm (1 – 11⁄2 in.) sanitary drain
cartridge, add housing, and flange inlet and outlet, with
cartridge media pressure-drop A Stäubli* vent and
13 mm (1⁄2 in.) sanitary port on
values. Contact Pall for assistance. drain
inlet
Note: Partial list of part numbers. 1H9 25 – 38 mm (1 – 11⁄2 in.) sanitary * Stäubli is trademark of Stäubli
Contact Pall for specific flange inlet and 11⁄2 in. AG.
recommendations single-barb hose barb outlet,
with 13 mm (1⁄2 in.) sanitary port
102 on inlet
Novasip™ DV20 and DV50 Virus Removal Filter Capsules
Steam-In-Place Capsules for Virus Filtration

Novasip Ultipor VF capsule filters are Quality and Bio-Safety

disposable, Junior Style steamable Biological Tests
assemblies designed to remove
Integrity
parvoviruses and other viruses from protein
solutions. • Every filter integrity tested during
manufacture. Test correlated to viral
The Novasip DV20 grade capsule filter
(phage) retention
utilizes an Ultipor VF-grade DV20 grade
pleated membrane cartridge to remove Biological Tests
parvoviruses and other viruses as small as • Meets USP Biological Reactivity Test,
20 nm from protein solutions up to in vivo, for Class VI-121 °C Plastics
5 – 10 liters.
Effluent Quality Tests*
The Novasip DV50 grade capsule filter • Meets Cleanliness per USP Particulates
incorporates an Ultipor VF DV50 grade in Injectables
Ultipleat membrane cartridge for removal
of viruses 40 – 50 nm and larger. • Non-Fiber-Releasing

Novasip Ultipor VF capsule filters are • Non-Pyrogenic per USP Bacterial

supplied non-sterile and can also be Endotoxins (< 0.25 EU/mL)
Gamma-irradiated.* • Meets Total Organic Carbon and Water
Conductivity per USP Purified Water,
Features and Benefits pH per USP Sterile Purified Water

• ≥ 3 Log Titer Reduction (LTR) for 20 nm Autoclave Resistance

viruses • Lot samples multi-cycle autoclave
• ≥ 6 log LTR for ≥ 50 nm viruses challenged

• Robust size exclusion mechanism * Per lot samples soak or rinse-up flush aliquots.

• Narrow pore-size distribution

• Low binding for high protein yields
• Inherently water wettable
• Very low extractables
• Autoclavable or steamable in situ
• Gamma-irradiatable
• 100% integrity-tested
• Individually serialized
• Manufactured for use in conformance
with cGMP
• Pharmaceutical P optimized with
certificate of test provided
• Clear housing for easy venting
• New design sanitary valves:
◆ Non-removable for safety
◆ Non-threaded for cleanliness
103
* For Gamma-irradiated products and maximum
allowable dosage, please contact Pall.
 Novasip DV20 and DV50 Virus Removal Filter Capsules
Technical Specifications

Materials of Construction Aqueous Extractables (NVR)

Filter Medium
Support and Drainage
Core, Cage and Endcaps
Hydrophilic polyvinylidenedifluoride < 5 mg/capsule (Deionized water at 20 °C [68 °F])
(PVDF)
Polyester
Polypropylene
Flow/Pressure (Water, 25 °C [77 °F])

Housing Shell Polyetherimide 3.2 mL/min at 5860 mbar (85 psi) for CLM05DV20P1G

O-rings (1)
Silicone 0.3 L/min @ 2 bar (29 psi) for CL3DV50P1G
(1)
Other polymers available.
Sterilization
Nominal Dimensions Autoclavable and Steamable in situ for 3 x 1-hour cycles at up to
CLM05DV20 C3DV50 125 °C (257 °F) (non-irradiated product only). Gamma-irradiatable(2).
(2)
Contact Pall for recommended procedures.
Length 84 mm (3.3 in.) 157 mm (6.18 in.)
Diameter 123 mm (4.8 in.) 123 mm (4.8 in.)
Effluent Quality Tests (P Tests)
Nominal Filter Area 0.07 m2 (0.75 ft2) 0.4 m2 (4 ft2)
Meets Cleanliness per USP Particulates in Injectables.

Inlet and Outlet Non-Fiber-Releasing

26 – 38 mm (1 – 1 ⁄2 in.) sanitary flange

1 Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL)
Meets Total Organic Carbon and Conductivity per USP Purified Water, pH
per USP Sterile Purified waters.
Virus Removal
DV20 TR > 103 for 25 nm PP7 bacteriophage
TR ≥ 106 for 53 nm PR772 bacteriophage

DV50 TR ≥ 106 for 50 nm PR772 bacteriophage

Operating Conditions
Recommended Operating 1 – 2 bard (15 – 29 psid)
Pressure

Maximum Differential(1) 3 bard (43.5 psid).

Pressure
(1)
Note: Maximum assembly pressure is 6.0 bard (90 psid) for short-term integrity testing.

Ordering Information
Part Number Media Type Rating
CLM05DV20P1G Hydrophilic PVDF For viruses ≥ 20 nm
CL3DV50P1G Hydrophilic PVDF For viruses ≥ 50 nm
Note: For suggested qualification protocols, test/validation discs, sizing and sterilizing
recommendations, multi-element forward flow values or other information, please contact
Pall or your local Pall representative.

104
Ultipor VF Grade DV50 Virus Filter Cartridges – SBF Junior Style
®

Scaled-down Filter Cartridges for Virus Removal Filters

Pall Ultipor VF Grade DV50 virus removal Quality and Bio-Safety

filters are a robust means to remove Biological Tests
viruses from liquids by microfiltration, while
Integrity
permitting enhanced transmission of
proteins. SBF Junior Style pleated • Every filter integrity tested during
membrane mini-cartridges are designed for manufacture. Test correlated to viral
small-scale qualification and validation (phage) retention
studies and for small process batches up Biological Tests
to 10 – 20 liters. Typical applications for
• Meets USP Biological Reactivity Test,
these easy-to-use direct flow filters include
in vivo, for Class VI-121 °C Plastics
purification of BioPharmaceuticals, plasma
derivatives, protein or serum containing Effluent Quality Tests*
cell-culture media and diagnostic reagents. • Meets Cleanliness per USP Particulates
in Injectables
Features and Benefits • Non-Fiber-Releasing
• 6 log Titer Reduction (TR) for 50 nm • Non-Pyrogenic per USP Bacterial
viruses Endotoxins (< 0.25 EU/mL)
• Robust size exclusion mechanism • Meets Total Organic Carbon and Water
• Narrow pore-size distribution Conductivity per USP Purified Water;
pH per Sterile Purified Water.
• Easy-to-validate direct flow use
Autoclave Resistance
• Linear scale-up to larger batches
• Lot samples multi-cycle autoclave
• Low protein binding challenged
• Low filter extractables
* Per lot samples soak or rinse-up flush aliquots.
• 100% integrity-tested
• Pre-use testable with WFI
• Manufactured for use in conformance
with cGMP
• ISO 9000 Certified Quality System
• Pharmaceutical P optimized
• Certificate of Test provided
• Validation Guide available
• SBF style also available with 0.2 µm
Ultipor N66, Posidyne, Fluorodyne II
and Emflon PFR media

105
 Ultipor VF Grade DV50 Virus Filter Cartridges – SBF Junior Style
Technical Specifications

Materials of Construction Operating Conditions

Membrane Hydrophilic low protein binding Maximum Differential 3 bard (43.5 psid)
polyvinylidenedifluoride (PVDF) Pressure(4)
Support and Drainage Polyester Recommended 1 – 2 bard (15 – 29 psid)
Operating Pressure
Core, Cage and End Caps Polypropylene
O-ring Silicone(1) Maximum Differential 6.0 bard (90 psid)
Pressure for Integrity
(1)
Other polymers available. Test Performance (Short-term)
(4)
Viral TR pressure-independent.
Virus Removal Ratings(2)
TR ≥ 106 for viruses ≥ 50 nm Aqueous Extractables (NVR)
(2)
Lot samples retain log 10 TR 6 of 53 nm spherical non-enveloped bacteriophage
PR772. 1 mg per element in deionized water at 20 – 25 °C after autoclaving

Nominal Filter Area

0.074 m2 (0.8 ft2)

Nominal Dimensions
Length 62 mm (2.4 in.)
Diameter 43 mm (1.7 in.)

Configuration
Single open-ended cartridge
Sanitary style plug adapter
Double 116 O-ring

Autoclave and Steaming in situ(3)

Autoclavable at 125 °C
(3)
Contact Pall for recommended procedures.

Ordering Information(6)
Part Number Media Type Removal Rating
SBF1DV50PH4 Hydrophilic PVDF TR ≥ 106 for viruses
≥ 50 nm
(6)
H4 suffix = Silicone O-rings (standard). Ethylene Propylene and Fluoropolymer
Elastomer O-rings available. See Appendix for alternate O-ring polymer codes. P in part
number indicates optimized and qualified for pharmaceutical use including 100%
integrity test and Certificate of Test.

Note: For suggested qualification protocols, test and validation discs, sizing and
sterilizing recommendations, SBF style cartridges with 0.2 µm or other grade, please
contact Pall.

106
Ultipor VF Grade DV20 Virus Removal Filter Cartridges
®

Removal of Viruses as small as 20 nm

Pall Ultipor VF grade DV20 filter cartridges Quality and Bio-Safety

are integrity-testable, direct flow filters for
size exclusion removal of viruses as small
as 20 nm from biological solutions. The
innovative DV20 hydrophilic PVDF
microporous membrane also enables
> 95% transmission of proteins up to 160
kiloDaltons. Using a standard single
open-ended (SOE) AB sanitary style
cartridge design, Ultipor VF DV20 filters
achieve practical flows and pressure drops
in process-scale purification of
BioPharmaceuticals, tissue and plasma
derivatives and protein additives. Where
required, suitable prefilters employing the
same PVDF membrane material are
available, simplifying process optimization
and filtration system validation.
Features and Benefits
• Sanitary direct flow cartridges
• Robust size exclusion mechanism
• ≥ 3 log TR for > 20 nm viruses
• ≥ 6 log TR for > 50 nm viruses
• Low binding for high protein yields
• High transmission of albumin and IgG
• Very low extractables
• Autoclavable and Steamable in situ
(SIP)
• 100% integrity-tested (correlated to
virus retention)
• Manufactured for use in conformance
with cGMP
• Pharmaceutical P optimized with
Certificate of Test provided
• Validation Guide available
Claims based on challenges with bacteriophage (bacterial
viruses) PP7 (25 nm) and PR772 (53 nm) in 1% Bovine
Serum Albumin in phosphate-buffered saline at pH 7.4,
20 °C (68 °F).
Note: These filters are also available in Kleenpak Nova
capsule format.
Biological Tests
Integrity
• Every DV20 grade filter integrity tested
during manufacture. Test correlated to
viral (phage) removal
Biological Tests
• Meets USP Biological Reactivity Test,
in vivo, for Class VI-121 °C Plastics
Effluent Quality Tests*
• Meets Cleanliness per USP Particulates
in Injectables
• Non-Fiber-Releasing
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
• Meets Total Organic Carbon and
Conductivity per USP Purified Water;
pH per Sterile Purified Water
Autoclave Resistance
• Lot samples multi-cycle autoclave
challenged
* Per lot sample or rinse-flush aliquots.
Forward Flow Integrity Test
• Diffusional flow integrity test, carried out
by standard upstream or downstream
methods
• Correlated to 3 log TR for 25 nm PP7
phage and ≥ 6 log TR for 53 nm PR772
phage
• Test Wetting Fluid: 30% IPA (20%
EtOH values also available)
• Water or buffer-wet values for
installation confirmation can also be
provided
• Test Pressure: 85 psi (air test gas)
Contact Pall for cartridge values and
correlation data
• Validation Guide available

107
 Ultipor VF Grade DV20 Virus Removal Filter Cartridges
Technical Specifications

Materials of Construction Aqueous Extractables (NVR)

Membrane Hydrophilic modified < 5 mg per 10 in. (254 mm) element in deionized water at 20 °C (68 °F),
polyvinylidenedifluoride (PVDF) process-ready (after integrity testing in 30% IPA/water, water flush and
autoclaving).
Support and Drainage Polyester
Core, Cage and End Caps Polypropylene
Autoclave and Steaming in situ(1)
Code 7 Adapter Polypropylene with encapsulated
stainless steel reinforcing ring Maximum Temperature 125 °C (257 °F)
(1)
Contact Pall for recommended procedures to qualify filters under actual conditions of
O-rings Silicone use.

Configuration (AB Code 7) Typical Liquid Flow Rate(2)

Double 226 O-ring adapter
Fin end with bayonet lock.
Nominal Dimensions
Lengths
Diameter
15 L/h/10 in. (254 mm) module at 30 psid for 1% Bovine Serum Albumin in
phosphate-buffered saline at pH 7.4, 20 °C (68 °F)
(2)
Claims based on challenges with bacteriophage (bacterial viruses) PP7 (25 nm) and
PR772 (53 nm) in 1% Bovine Serum Albumin in phosphate-buffered saline at pH 7.4,
20 °C (68 °F).
10 in. (254 mm), 20 in. (508 mm),
30 in. (762 mm), 40 in. (1016 mm)
Removal Ratings
70 mm (2.75 in.)
3 Log TR for viruses > 20 nm

Operating Conditions 6 Log TR for viruses > 50 nm

Recommended Operating ∆P 1 – 2 bard (15 – 29 psid)

Maximum Differential 6.0 bard (90 psid) during integrity testing
Pressures 3.1 bard (45 psid) for continuous service

Nominal Filter Area

1.0 m2 (10.8 ft2) per 10 in. (254 mm) element

Part Numbering and Ordering Information

Part Number Nominal Length
AB1DV207PH4 10 in. (254 mm)
AB2DV207PH4 20 in. (508 mm)
AB3DV207PH4 30 in. (762 mm)
AB4DV207PH4 40 in. (1016 mm)

Ordering Information for Recommended Prefilters

AB 7

Code Nominal Code Rating Filter Type Code Filter Code Gasket
Length Grade Option
1 10 in. DV20 ≥ 3 log TR for viruses > 20 nm Ultipor VF P Pharmaceutical* H4 Silicone
(254 mm)
UDV50 ≥ 6 log TR for viruses > 50 nm Ultipor VF Omit General Use Other materials available
2 20 in. on request.
DVD Sub 0.1 µm virus prefilter Ultipor VF * Pall pharmaceutical-grade filters
(508 mm) are designed for use in
DJL 0.1 µm (+ 0.2 µm prefilter layer) Fluorodyne II conformance with CGMP in
3 30 in. Manufacturing, Processing,
(762 mm) DFL 0.2 µm (double-layer) Fluorodyne II Packing or Holding of Drugs
(21CFR210) and CGMP for
4 40 in. DBL 0.45 µm (+ 0.65 µm prefilter layer) Fluorodyne II finished Pharmaceuticals
(1016 mm) (21CFR211.72) including batch
release certificate and full
traceability.

108
Ultipor VF Grade DV50 Virus Removal Filter Cartridges
®
Optimized for Removal of 50 nm Viruses
Pall Ultipor VF virus removal filter
cartridges feature innovative hydrophilic
PVDF microporous membranes to remove
significant levels of viruses from biological
solutions, while enabling > 95%
transmission of proteins up to 300 kD or
larger. Using patented Ultipleat
crescent-shaped pleating technology, the
filters to incorporate 1.6 m2 (17.5 ft2) of filter
area per 10 in. (254 mm) element in
standard single open-ended (SOE) AB
sanitary style cartridges. Ultipor VF
cartridges achieve practical flows and
pressure drops while effectively removing
nanometer-size viral contaminants with
high protein yields.
An optional sub-0.1 µm rated prefilter
(Grade DVD) and Fluorodyne II filters
enhance throughputs and employ the
same PVDF membrane material for ease of
validation. Typical applications include
purification of BioPharmaceuticals, tissue
and plasma derivatives, protein additives,
culture media, diagnostic reagents, buffers
and diluents.
Features and Benefits
• Sanitary direct flow cartridges
• 6 log Titer Reduction (TR) for 50 nm
viruses (DV50 grade)
• Robust size exclusion mechanism
• PVDF microporous membranes
• Narrow pore-size distribution
• Inherently water wettable
• Low binding for high protein yields
• Very low extractables
• Steamable in situ
• 100% integrity-tested
• Individually serialized
• Manufactured for use in conformance
with cGMP
• ISO 9000 Certified Quality System
• Pharmaceutical P optimized
• Certificate of Test provided
• Validation Guide available
• Discs and mini-cartridges (SBF Junior
Style) available
Note: These filters are also available in Kleenpak Nova
capsule format.
Quality and Bio-Safety
Biological Tests
Integrity
• Every DV50 grade filter integrity tested
during manufacture. Test correlated to
viral (phage) retention.
Biological Tests
• Meets USP Biological Reactivity Test,
in vivo, for Class VI-121 °C Plastics
Effluent Quality Tests*
• Meets Cleanliness per USP Particulates
in Injectables
• Non-Fiber-Releasing
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
• Meets Total Organic Carbon and
Conductivity per USP Purified Water;
pH per Sterile Purified Water
Autoclave Resistance
• Lot samples multi-cycle autoclave
challenged
* Per lot sample or rinse-flush aliquots.
109
 Ultipor VF Grade DV50 Virus Removal Filter Cartridges
Technical Specifications

Materials of Construction Operating Conditions(4)

Membrane Hydrophilic modified Maximum Differential 6.0 bard (90 psid)
polyvinylidenedifluoride (PVDF) Pressure during
Integrity Testing
Support and Drainage Polyester
Maximum Differential 3 bard (43.5 psid)
Core, Cage and End Caps Polypropylene
Pressure for Continuous
Code 7 Adapter Polypropylene with encapsulated Service
stainless steel reinforcing ring for
steaming in situ Recommended Operating ∆P 1 – 2 bard (15 – 29 psid)

O-rings Silicone(1) (4)

Laboratory tests confirm viral TR is in independent of pressure differential to 3.1 bard
(45 psid).
(1)
Other polymers available.

Autoclave and Steaming in situ(5)

Removal Ratings
Maximum Temperature 125 °C (257 °F)
DVD Sub-0.1 µm prefilter
(5)
Laboratory tests confirm multi-cycle resistance. Filters should be qualified in actual
DV50 TR 106 for 50 nm viruses(2) use. Contact Pall for recommended procedures.
(2)
Lot samples retain log 106 TR of 53 nm spherical non-enveloped bacteriophage.
Aqueous Extractables (NVR) per 10 in. (254 mm) Element(6)
Configuration (AB Code 7) < 25 mg after autoclaving (water wet)
Double 226 O-ring adapters. Fin end with bayonet lock.
< 5 mg after installation integrity testing (30% IPA/water wet), water flush
and autoclaving.
Nominal Dimensions (6)
In water at 20 – 25 °C ( 68 – 77 °F) after autoclaving.
Lengths 10 in. (254 mm), 20 in. (508 mm),
30 in. (762 mm), 40 in. (1016 mm)
Diameter 70 mm (2.75 in.)

Nominal Filter Area(3)

DVD 0.9 m2 (9.5 ft2)
UDV50 1.63 m2 (17.5 ft2)
(3)
Per 10 in. (254 mm) element.

Typical Flow Rate

Clear water flow is 1 L/min @ 2 bard (29 psid)

Ordering Information for Recommended Prefilters

AB 7

Code Nominal Code Removal Code Filter Code Gasket

Length Rating Grade Option
1 10 in. DVD sub-0.1 µm prefilter P Pharmaceutical* H4 Silicone
(254 mm)
UDV50 106 for 50 nm viruses * Pall pharmaceutical-grade filters Other materials available
2 20 in. are designed for use in on request.
conformance with CGMP in
(508 mm)
Manufacturing, Processing,
3 30 in. Packing or Holding of Drugs
(21CFR210) and CGMP for
(762 mm) finished Pharmaceuticals
(21CFR211.72) including batch
4 40 in.
release certificate and full
(1016 mm) traceability.

110
Air and Gas Filtration
 Air and Gas Filtration
Pall air and gas filters have been developed
from a successful range of products that are
widely used in the pharmaceutical and
biotechnology industries.
Emflon filters have been designed and
liquid-validated for use as sterilizing filters for
air, gas, and vent service in critical ambient
and high-temperature applications in
BioPharmaceutical and bioprocess industries
such as product or hot WFI tank vents,
autoclaves, freeze dryers, and high-flow
applications such as fermenter inlet and
exhaust air.
Pall capsule filters combine process and
Junior-size cartridge technology with the latest
polymers in an all-plastic filter assembly that
offers the benefits of a disposable capsule for
air, gas and vent filtration. Pall capsule filters
can be autoclaved, even steamed-in-place or
gamma-irradiated, to provide a reliable, cost-
effective alternative to stainless steel housings.
Several different particle removal filters have
been designed for sanitary-style filter and
industrial-style housings and are often
recommended for clarification of air and gas
feeds. Pall particle removal filters can also
serve as an economical prefilter for high-flow
fermentation and other air-sterilizing
membrane cartridges.
112
Coalescing filters protect downstream
equipment and processes from compressor
wear products, lubrication oil, water or other
liquid droplets, corrosion products, and other
particulate contaminants, while reducing
maintenance costs.
® ®
Rigimesh sintered metal mesh, PSS sintered
®
metal powder and PMM metal membrane
filter cartridges can be used for both gas and
liquid service. Metal filters are also used for
steam filtration.
Note: It is important to maintain the integrity
of 0.2 µm sterilizing-grade filters. Pall
recommends integrity testing of all
sterilizing-grade filters prior to steaming, after
steaming, and after the filtration process to
ensure that the integrity of the filter has been
maintained. Contact Pall for recommended
procedures and Integrity test parameters.
Novasip™ Capsule with Emflon PFR Membrane Assemblies
®
The Clear Choice for Steam-in-Place of Air and Gas Filters
The unique Novasip capsule filter
combines Pall cartridge technology with
the latest engineered polymers in an
all–plastic filter assembly that can provide
all of the benefits of a capsule filter with
SIP (steam-in-place) capability. Novasip
filters, therefore, provide an alternative to
stainless steel housings in many
applications. This enables filter users to
reduce capital and labor costs and to
minimize maintenance costs.
Novasip filters consist of a standard
design filter cartridge permanently sealed in
a clear polyetherimide housing.
Polyetherimide is an advanced plastic
selected for its high-strength at elevated
temperatures and pressures. This ensures
that Novasip filters can be used under a
wide range of operating conditions
including multiple steam-in-place cycles.
Novasip filters are supplied with inlet/outlet
connections compatible with sanitary
flange fittings. Vents and drains are
available with integral valves.
Novasip filters with Emflon PFR filter
membranes are purpose-designed for use
in critical air and vent applications.
Comprehensive Validation
Documentation
Novasip filters with Emflon PFR filter
membrane have been extensively tested to
ensure consistent and reliable performance
under a range of process conditions.
A full validation guide is available on
request.
Installation and operating instructions,
including information on steam-sterilization,
are available from Pall.
Features and Benefits
• Low installation cost — up to 80% less
than a comparable stainless steel
system
• Integrity testable in situ using the water
intrusion test (WIT)
• Integral Stäubli-compatible vent valve
enables direct in-line connection to
electronic test equipment
• Repeatedly steam-sterilizable for long
service life and low operating costs
• Suitable for use in high pressure air
systems up to 6.5 barg (94 psig) at
temperatures up to 40 °C (104 °F)
• Supplied with a numbered disc which
can be fitted easily to the capsule and
used to help record the number of
times the filter is sterilized
High Quality Standards
• Validated in liquids with Brevundimonas
diminuta (ATCC 19146) at a challenge
level of 107 organisms/cm2 of filter area
• 100 % integrity tested during
manufacturing
• Identified by a lot number with a unique
serial number for complete traceability
of manufacturing history and for user
traceability systems
• Each filter supplied with a Certificate of
Test
• Comprehensive validation guide
available
• Manufactured under a Quality
Management System certified to
ISO 9000
• Meets USP Biological Reactivity
Tests in vivo, in accordance with
USP Class VI plastics at 121 °C
113
 Novasip Capsule with Emflon PFR Membrane Assemblies
Technical Specifications

Materials of Construction Typical Air Flow Rates(4)

Flow Rate (scfm)
Membrane Hydrophobic PTFE
0 5 10 15 20 25 30 35
Membrane Support and Polypropylene 120
Drainage Layer Assembly et let

de

e
nl

od
)i ) in

mo

m
Endcaps Polypropylene sig psig 1.5

nt
100

nt
p
(29

Ve
9

Ve
(2 rg
Core and Cage Polypropylene rg ba

Differential Pressure (mbar)

a

Differential Pressure (psi)

b 2
2
Housing Bowl Polyetherimide 80

Housing Head Polyetherimide with TiO2 1

O-rings Silicone elastomer 60

Maximum Accumulated Steam Life(1) 40

0.5
Temperature 125 °C (257 °F) 135 °C (275 °F) 142 °C (287 °F)
20
Maximum Steam 100 cycles 50 cycles 5 cycles
Exposure(2)
0 0
(1)
Validated using 30 minute cycles. 0 10 20 30 40 50 60
(2)
Maximum values determined in laboratory tests. Actual steam life may vary with
conditions of use. Flow Rate (Nm3/h)

= C3PFRP1 = C2PFRP1
Operating Conditions(3) (4)
Typical initial clean ∆P, air at 20 °C (68 °F).
Maximum Operating 6.5 barg (94 psig) at 40 °C (104 °F) Contact your local Pall representative for assistance.
Pressure

Maximum Differential 5.2 barg (75 psig) at 40 °C (104 °F)

Pressure Nominal Dimensions
Note: Maximum differential pressure during steam sterilization at up to 142 °C (287 °F) is Maximum Diameter 123 mm (4.84 in.)
300 mbar (4.3 psid). (Including Valves)
(3)
With fully compatible fluids that do not soften, swell or adversely affect the filter or its Length 157 mm (6.18 in.)
materials of construction.

Ordering Information

C P F R P 1

Code Nominal Filter Area Code Connection Code Vent, Drain and Valves
2 0.17 m2 (1.8 ft2) 1 25 – 38 mm (1 – 11⁄2 in.) Blank Vent: Quick connect and
Sanitary flange fittings disconnect coupling (compatible
3 0.23 m2 (2.5 ft2) with Stäubli* fitting) with valve
Drain: Hose barb for 4 – 6 mm
(1⁄8 – 1⁄4 in.) i.d. tube, with valve

A Vent and Drain: Quick connect

and disconnect coupling
(compatible with Stäubli fitting)
with valve

B Vent and Drain: 13 mm (1⁄2 in.)

sanitary flange, no valve
* Stäubli is a trademark of Stäubli AG.

114
Kleenpak™ Capsules with Emflon II Membrane Assemblies
®

Gamma-irradiation Tolerant Air and Gas Filters for Disposable Systems

Kleenpak capsule filters containing with Features and Benefits

hydrophobic polyvinylidenedifluoride (PVDF)
Emflon II membranes are especially
designed for the sterile filtration of air and
gas. These compact filter capsules provide
high air flows, resist blocking in wet
applications, and provide 100% removal of
bacteria and viruses from air and gases,
even in the presence of high humidity and
moisture.
Kleenpak capsules are manufactured
using gamma-irradiation tolerant materials
and offer the very highest standard of
filtration security and user convenience.
These filters can be integrated within
gamma-irradiatable or gamma-sterilized
complex systems such as bioreactors, filter
assemblies, or transfer sets where venting
is required.
Pre-sterilized Option
These Kleenpak filters can be supplied
sterilized by a validated gamma-irradiation
process reducing time and costs. Filter
capsules are then double-bagged and the
outlet is covered with a protective cap for
extra security.
Gamma-irradiatable Option
These capsules can also be supplied
non-sterile, allowing the connection to
tubing or any other type of equipment prior
to gamma irradiation. This allows users to
have a sterilized processing system without
the need for aseptic connections and the
associated risks of contamination.
• Highly retentive Emflon II membrane
• High flow-rates associated with low
Delta P enable the use of small filters —
reduction of installation and operating
costs
• Gamma-irradiatable or pre-sterilized for
maximum convenience
• Integral molded connections
• Fully integrity testable using the forward
flow test
High Quality Standards
• Validated in liquids with Brevundimonas
diminuta (ATCC 19146) at a challenge
level of 107 organisms/cm2 of filter area
• 100 % integrity tested during
manufacturing
• Identified by a lot number with a unique
serial number for complete traceability
of manufacturing history and for user
traceability systems
• Each filter supplied with a Certificate of
Test
• Comprehensive validation guide
available
• Manufactured under a Quality
Management System certified to
ISO 9000
• Meets USP Biological Reactivity
Tests in vivo, in accordance with
USP Class VI plastics at 121 °C

Custom-made Sets
We are happy to work with end-users to
provide custom-designed processing
systems which will integrate one or more of
our capsule ranges.

115
 Kleenpak Capsules with Emflon II Membrane Assemblies
Technical Specifications

Materials of Construction Typical Air Flow Rates(2)

Flow Rate (Nm3/h)
Membrane Hydrophobic PVDF
0 5 10 15 20
Support and Drainage Layers Polypropylene 4
KA1 KA2 KA1
End Cap Polypropylene 250
KA2
Core and Cage Polypropylene
3

Differential Pressure (mbar)

Differential Pressure (psid)
Outer Shell Polypropylene 200

Vent and Drain – Valve O-rings Ethylene Propylene (EPDM)

KA3 150
2
Nominal Dimensions
KA02 KA1 KA2 KA3 100
Maximum Diameter 51 mm 94 mm 94 mm 109 mm
(Including Valves) (2.0 in.) (3.7 in.) (3.7 in.) (4.2 in.) 1
KA3
50
Length with Hose Barb 104 mm NA NA NA
Connections (Code 2) (4.1 in.) – – –
0 0
Length with Sanitary NA 11.7 cm 15.8 cm 17.4 cm 0 2 4 6 8 10 12
Connections – (4.6 in.) (6.2 in.) (6.8 in.)
Flow Rate (scfm)
Nominal Filtration Area 200 cm2 500 cm2 1000 cm2 1500 cm2 = Vent = 2.1 barg (30 psig)
(0.21 ft2) (0.5 ft2) (1.0 ft2) (1.5 ft2) (2)
For gases other than air or nitrogen, contact your local Pall representative.

Operating Conditions(1) Sterilization

KA02 KA1/KA2/KA3 Gamma-irradiation Maximum Dosage (G option only):
Maximum Operating _ 40 °C Up to 50 kGy
Temperature

Maximum Operating 4.1 barg (60 psig) 5.2 barg (78 psig) Autoclave Sterilization
Pressure at 38 °C (100 °F) at 38 °C (100 °F) Gamma-irradiated Filters One 30-minute cycle at 125 °C
Maximum Differential 2.1 bard (30 psid) _ Non Gamma-irradiated Filters 3 x 1 hour cycles at 125 °C
Pressure at 80 °C (176 °F)
Warning: Kleenpak filters must not be in situ steam-sterilized by passing steam through
(1)
In air/nitrogen gas service or other compatible fluids, which do not soften, swell, or under pressure. The figures are maximum allowable figures determined by testing under
adversely affect the filter or its materials of construction. controlled laboratory conditions to the total number of hours indicated. Actual operating
conditions may affect the filters long-term response to sterilization. Filters should be
qualified for each process application.

Ordering Information

KA V002P

Code Nominal Length Code Connection Type Code Sterilization Status

02 1(3) 38 mm (11⁄2 in.) S Gamma-irradiated
sanitary flange
1 See above G Non-irradiated
dimensions 2 6 – 13 mm (1⁄4 – 1⁄2 in.) hose Barb
2 table
3 8(4) 13 mm (1⁄2 in.) sanitary flange
(3)
For KA1, KA2 and KA3 sizes only.
(4)
For KA02 size only.

116
Kleenpak™ Capsules with Emflon PFR Membrane Assemblies
®
High-strength, Long-life Sterilizing Filters for Air and Gas
Pall Kleenpak filters combine the widest
available range of filter media with specially
designed self-contained assemblies, to
satisfy the very highest standards of
filtration security and user convenience.
Emflon PFR Filter Medium
At the heart of every Kleenpak Emflon
PFR Capsule filter is a high-performance
pleated cartridge, containing proprietary
PTFE membrane. The high-strength PTFE
membrane is inherently hydrophobic,
chemically inert, and designed specifically
for removal of contaminating bacteria and
viruses. Emflon PFR filters have a
microbial removal rating of 0.2 µm in
liquids and a particulate removal rating of
0.003 µm in gases.
Emflon PFR filters meet the
ever-increasing demand for air filters with
greater strength and longer life.
Clean and Robust Design
The Kleenpak filter uses well-proven
proprietary Pall techniques for filter
construction and heat sealing.
• The highest possible security against
filter bypass is ensured, even under
conditions of pulsed flow
• High-strength design allows multiple
autoclave cycles for extended use and
maximum filter economy
• Polypropylene outer shell is designed to
provide long-term assurance of
pressure and temperature ratings
• A total absence of glues, binder resins
and surfactants results in very low filter
extractables and extremely clean filtrate
High Quality Standards
Every Pall Kleenpak filter is manufactured
to a very high standard of quality
assurance and cleanliness, and in
accordance to a quality system accredited
to ISO 9000.
For pharmaceutical use, the P designation
in the part number provides full traceability
supported by a certificate of test.
Quality and Bio-Safety
Biological Tests
• Meets USP Biological Reactivity Test,
in vivo for Class VI-121 °C Plastics
Effluent Quality Tests*
• Meets Cleanliness per USP Particulates
in Injectables
• Non-Fiber-Releasing
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
• Meets Oxidizables and pH per USP
Sterile Purified Water
* Per lot sample soak or rinse-up flush aliquots.
Features and Benefits
• Comprehensive validation assures
highest removal efficiency and highest
safety margins (validation guide
available on request)
• High flow-rates and low pressure drop
allow use of small systems, reducing
installation and running costs
• Robust construction ensure integrity
and reliability
• Long autoclave life and long service
offer low-cost filtration
117
 Kleenpak Capsules with Emflon PFR Membrane Assemblies
Technical Specifications

Materials of Construction Typical Air Flow Rates(2)

Membrane Double-layer hydrophobic PTFE 50 0.7
6
Support and Drainage Layers Polypropylene RP
1PF 0.6
40 KA

Differential Pressure (mbar)

End Cap Polypropylene

Differential Pressure (psi)

0.5
Core and Cage Polypropylene
30 P6
Outer Shell Polypropylene FR 0.4
1P
KA
Vent and Drain - valve O-rings Ethylene Propylene Rubber P6 0.3
20 PFR
KA2
P6 0.2
Nominal Dimensions PFR
KA2
10
KA1 KA2 KA3 0.1

Maximum Diameter 94 mm 94 mm 109 mm 0 0

(Including Valves) (3.7 in.) (3.7 in.) (4.2 in.) 0 1 2 3 4 5
Flow Rate (Nm3/h)
Length with 38 mm 117 mm 158 mm 174 mm
(11⁄2 in.) sanitary (4.6 in.) (6.2 in.) (6.8 in.)
= Vent condition = 2 barg (29 psig) inlet
connections

Length with hosetail 158 mm 199 mm 210 mm 250

connection (14 mm (6.2 in.) (7.8 in.) (8.2 in.)
(9⁄16 in.) single–barb)
Differential Pressure (mbar)
200 3

Differential Pressure (psi)

Maximum Cumulative Steam Autoclave Time
150
Up to 140 °C (284 °F) 50 hours P1 P1 2
FR FR
Warning: Kleenpak filters must not be in situ steam sterilized by passing steam through A3P A3P
K K
under pressure. The figures are maximum allowable figures determined by testing under 100
controlled laboratory conditions to the total number of hours indicated. Actual operating
conditions may affect the filters long-term response to sterilization. Filters should be 1
qualified for each process application. 50

Operating Conditions(1) 0 0
0 20 40 60 80 100
Maximum Operating 40 °C (104 °F)
Temperature Flow Rate (Nm3/h)

= Vent condition = 2 barg (29 psig) inlet

Maximum Operating 3.5 barg (50 psig)
Pressure
(2)
Typical initial clean ∆P, air at 20 °C (68 °F). Values shown are for 38 mm
(11⁄2 in.) sanitary flange connections. Values with other connections are
Maximum Differential 3.5 bard (50 psid) available upon request. For gases other than air or nitrogen, contact your
local Pall representative.
Pressure
(1)
In compatible fluids which do not soften, swell or adversely affect the filter or materials Nominal Filter Area
of construction.
Size Code KA1 KA2 KA3

Filter Integrity Test Recommendation Filter Area 0.05 m2 0.1 m2 0.2 m2

(0.5 ft2) (1 ft2) (2 ft2)
KA2 and KA3 Water Intrusion Test
* KA1, KA2 and KA3 are also testable with Forward Flow test after wetting with suitable
alcohol/water mixtures. Please contact Pall for test method parameters.

Ordering Information

KA PFRP

Code Nominal Length Code Connection Type

1 1 38 mm (11⁄2 in.)
See above sanitary flange
2 dimensions
table 6 14 mm (9⁄16 in.)
3
hose barb

118
Kleenpak™ Capsules with HDC II Gas Filter Assemblies
®

High-capacity Polypropylene Air and Gas Filters in the Most Convenient Form

Pall Kleenpak assemblies with HDC II Quality and Bio-Safety

media are compact, self-contained filters
Biological Tests
with a rugged all-polypropylene
construction. They provide up to • Meets USP Biological Reactivity Test,
HEPA-quality air and gas filtration with a in vivo for Class VI-121 °C Plastics
hydrophobic polypropylene graded-density Effluent Quality Tests*
depth medium which, with with superior
• Meets Cleanliness per USP Particulates
flow rates, lower pressure drops, higher
in Injectables
capacity and longer filter life, outperforms
other membrane filters. • Non-Fiber-Releasing
• Non-Pyrogenic per USP Bacterial
Features and Benefits Endotoxins (< 0.25 EU/mL)
• Hydrophobic polypropylene media • Meets Oxidizables and pH per USP
Sterile Purified Water
• High efficiency in air and gases
* Per lot sample soak or rinse-up flush aliquots.
• HEPA filtration with J012 grade
• No housing required
• Absolute particle-rated for reliability
• Low pressure loss
• Melt-sealed construction
• Repeatedly autoclavable
• Manufactured for use in conformity with
cGMP
• FDA-listed materials per 21 CFR
• ISO 9000 Certified Quality System
• Pharmaceutical P optimized
• Certificate of Test provided

119
 Kleenpak Capsules with HDC II Gas Filter Assemblies
Technical Specifications

Materials of Construction Typical Air Flow Rates (at 2 barg [30 psig] Inlet Pressure)(3)
Flow Rate (scfm)
Medium Polypropylene
0 5 10 15
Support, Drainage, Core, Polypropylene 250
KA1 KA1 KA2 KA2
Cage, End Caps and Shell
Vent and Drain Valve O-ring Ethylene Propylene (EPDM) 3
200

Differential Pressure (mbar)

Differential Pressure (psi)

Removal Ratings
Grade In Air(1) In Liquids(2) 150
2
J100 93% at 0.3 µm 10 µm
J060 99% at 0.3 µm 6 µm 100
J045 99.75% at 0.3 µm 4.5 µm
1
J025 99.95% at 0.3 µm 2.5 µm KA3
50
J012 99.99% at 0.3 µm 1.2 µm
(1)
% removal 0.3 µm DOP droplet aerosol. KA3
Due to the enhanced particle removal efficiencies in gases, the approximate ratings for 0 0
gas service can be calculated by dividing the liquid rating in µm by between 5 and 10. 0 5 10 15 20 25
(2)
> 99.98% by mod. OSU-F2 beta test.
Flow Rate (Nm3/h)

= J025P = J045P
Nominal Filter Areas
(3)
Typical initial clean ∆P, air at 20 °C (68 °F). Values shown are for 38 mm
Effective Size Code (11⁄2 in.) sanitary flange connections. Values with other connections are
Filter Area KA1 KA2 KA3 available on request. For gases other than air or nitrogen, contact your
local Pall representative.
J012, J025 0.06 m2 (0.6 ft2) 0.1 m2 (1.0 ft2) 0.2 m2 (2.0 ft2)
Connections (Inlet and Outlet)
J045 0.06 m2 (0.6 ft2) 0.11 m2 (1.2 ft2) 0.22 m2 (2.3 ft2)
KA1 and KA2 Styles 38 mm (11⁄2 in.) sanitary flange
J060 0.03 m2 (0.3 ft2) 0.05 m2 (0.5 ft2) 0.10 m2 (1.0 ft2) 6 – 13 mm (1⁄4 – 1⁄2 in.) hose barb

J100 0.03 m2 (0.3 ft2) 0.07 m2 (0.7 ft2) 0.13 m2 (1.4 ft2) KA3 Style 38 mm (11⁄2 in.) sanitary flange
14 mm (9⁄16 in.) hose barb

Nominal Dimensions
Operating Conditions (Gases)(4)
Size Code KA1 KA2 KA3
Maximum Diameter of 94 mm 94 mm 109 mm Maximum Operating 3.5 barg (50 psig) to 40 °C (104 °F)
Bowl (Including Valves) (3.7 in.) (3.7 in.) (4.2 in.) Pressure and Temperature

Nominal Length (Including 117 mm 158 mm 174 mm Maximum Differential 3.5 bard (50 psid) at 40 °C (104 °F)
1 in. Tri-Clover Connection) (4.6 in.) (6.2 in.) (6.8 in.) Pressure and Temperature

Nominal Length (Including 158 mm 199 mm –

(4)
In air/N2 service or other compatible gases.
Stepped Hose Barb (6.2 in.) (7.8 in.) –
Connection)
Steam Autoclaving
Nominal Length (Including – – 210 mm
Cumulative Autoclave Time(5) 50 hours (1-hour cycles) at
Hose Barb Connection) – – (8.2 in.)
140 °C (284 °F)
(5)
Laboratory tests to establish multi-cycle resistance. Filters should be qualified in
process conditions. Contact Pall for recommended procedures.

Warning: Kleenpak filters must not be steam sterilized in situ by passing steam through
under pressure.

Ordering Information

KA J

Code Nominal Code Removal Rating Code Filter Grade Code Connection This is a guide to the
part number structure
Length in Liquids* Type and possible options
only. For availability of
1 012 1.2 µm P Pharmaceutical** 1 38 mm (11⁄2 in.)
See above specific options, please
sanitary flange contact Pall.
2 dimensions 025 2.5 µm Omit General Use
table 2 6 – 13 mm
3 045 4.5 µm **Pall pharmaceutical-grade filters are
(1⁄4 – 1⁄2 in.)
designed for use in conformance
060 6.0 µm with CGMP in Manufacturing, stepped hose barb
100 10 µm Processing, Packing or Holding of
Drugs (21CFR210) and CGMP for 6 14 mm (9⁄16 in.)
* Due to the enhanced particle finished Pharmaceuticals hose barb
removal efficiencies in gases, the (21CFR211.72) including batch
approximate ratings for gas service release certificate and full
can be calculated by dividing the traceability.
120 liquid rating in µm by between 5 and
10.
 Emflon PFR Junior Style Filter Cartridges
®

High-flow, Hydrophobic Filters for Small-scale Sterile Gas and Vent Applications

Emflon PFR filters have been developed Scientific Validation

from the successful Emflon filter range
Emflon PFR filters have been extensively
launched in 1981 and are widely used as
scientifically validated using the most
air and gas-sterilizing filters in the
advanced methods and the most sensitive
pharmaceutical and biotechnology
equipment available. They have a microbial
industries. The Pall PTFE membrane is
removal rating of 0.2 µm in liquids and a
inherently hydrophobic, chemically inert
particulate removal rating of 0.003 µm in
and designed specifically for removal of
gases and have been validated by:
contaminating bacteria and viruses.
• Brevundimonas diminuta liquid
Emflon PFR filters meet the
challenge at 107/cm2
ever-increasing demand for air filters with
greater strength, longer life and the ability • Brevundimonas diminuta aerosol
to withstand the rigors of in situ steaming challenge
in the forward or reverse direction. • PP7 and MS-2 bacteriophage aerosol
challenge
Superior Performance
• Bacillus subtilus Var niger spores
Emflon PFR filters provide high assurance aerosol challenge
of filter integrity and long-life, even during
• Airborne sodium chloride aerosol
continuous use in hot air up to 60 °C
challenge at 100 L/min flow
(140 °F) and after repeated steamings for a
giving a 0.003 µm rating in gases
typical period of up to 12 months.
This is combined with high flow-rates and
excellent de-wetting characteristics
resulting in very economical filtration
through the use of smaller installations and
reduced energy costs. In addition, the
filters can be tested in situ by the Forward
Flow integrity test or by a Water Intrusion
test. Both tests are correlated to liquid
bacterial challenge — the ‘worst case’
challenge.

121
 Emflon PFR Junior Style Filter Cartridges
Technical Specifications

Materials of Construction Differential Pressure at 50 Nm3/h (30 ft3/min) Air Flow and
Membrane Hydrophobic PTFE 2 barg (29 psig) Inlet Pressure(2)

Support and Drainage Layers Polypropylene Part Number Differential Pressure

End Cap, Core and Cage Polypropylene MCY1110PFRPH4 500 mbard (7.25 psid)

O-rings Silicone elastomer MCY2230PFRPH4 200 mbard (2.9 psid)

(excluding SLK Styles) MCY3330PFRPH4 160 mbard (2.3 psid)
Internal Adapter Stainless steel MCY4440PFRPH4 120 mbard (1.7 psid)
Support Ring
(MCY2230/4463 Styles Only) MCY4463PFRPH4 180 mbard (2.6 psid)
SBF1PFRPH4 790 mbard (11.4 psid)
Cumulative Steam Life(1) SLK7001PFRP 175 mbard (2.5 psid)
Up to 142 °C (288 °F) and 0.3 bar (4.3 psi) ∆P SLK7002PFRP 80 mbard (1.1 psid)
MCY1110PFRPH4 100 hour (2)
Pressure drops are for filter elements only. To obtain the total pressure drop of a
complete assembly the housing pressure drop must be added. Please refer to the
MCY4440PFRPH4 relevant housing literature or contact Pall for specific sizing information.

MCY3330PFRPH4
MCY2230PFRPH4 50 hours Nominal Filter Area
MCY4463PFRPH4 Part Number Surface Area

SBF1PFRPH4 MCY1110PFRPH4 0.05 m2 (0.53 ft2)

SLK7001PFRP MCY2230PFRPH4 0.14 m2 (1.5 ft2)

SLK7002PFRP MCY3330PFRPH4 0.17 m2 (1.82 ft2)

(1)
Steam life validated using 1 hour cycles. MCY4440PFRPH4 0.23 m2 (2.47 ft2)
The steam life and service life data were determined by testing under controlled
laboratory conditions up to the time indicated. Actual operating conditions may affect MCY4463PFRPH4 0.28 m2 (3.01 ft2)
the filters long-term resistance to steam sterilization and hot air service.
SBF1PFRPH4 0.04 m2 (0.43 ft2)
Filters should be qualified for each process application.
SLK7001PFRP 0.14 m2 (1.5 ft2)
Maximum Differential Pressure SLK7002PFRP 0.28 m2 (3.01 ft2)
All Styles
4.1 bar (60 psi) up to 80 °C (176 °F)

Ordering Information See Also:

Part Numbers For details about cartridge and capsule configurations see
MCY1110PFRPH4(1) Filter Configurations and Dimensions on page 272.

MCY2230PFRPH4(1)
MCY3330PFRPH4(1)
MCY4440PFRPH4(1)
MCY4463PFRPH4(1)
SBF1PFRPH4
SLK7001PFRP
SLK7002PFRP
(1)
H4 suffix refers to silicone O-ring.

122
 Emflon PFR Sterilizing-grade Filter Cartridges
®

High-flow Hydrophobic Filters for Sterile Gas and Vent Applications

Pall Emflon PFR sterilizing-grade filter Quality and Bio-Safety

cartridges feature Pall’s advanced 0.2 µm
polytetrafluoroethylene (PTFE) double-layer
membranes. They are designed to
completely remove bacteria, viruses and
particles from air and gas streams, even in
the presence of humidity and moisture.
Pleated with very high area into sanitary
single open-ended (SOE) AB style
cartridges, Emflon PFR filters are built to
withstand adverse in situ steaming
conditions in either the forward or reverse
direction. Suitable applications are
fermenter inlet air and exhaust venting,
sterile process air, and sterile venting of
tanks, lyophilizers, and autoclaves.
Features and Benefits
• Pall PTFE membranes
Biological Tests
• Meets USP Biological Reactivity Test,
in vivo for Class VI-121 °C Plastics
Effluent Quality Tests*
• Meets Cleanliness per USP Particulates
in Injectables
• Non-Fiber-Releasing
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
• Meets Oxidizables and pH per USP
Sterile Purified Water
Steam Resistance
• Lot samples multi-cycle autoclave
challenged
* Per lot sample soak or rinse-up flush aliquots.

• Inherently hydrophobic
• Oxidation resistant hardware
• High-flow and low pressure drop
• 100% bacteria retentive in liquids
• 100% virus retentive in gases
• Melt-sealed construction
• Enhanced steaming resistance
• 100% Forward Flow tested
• Water intrusion testable
• Individually serialized
• Manufactured for use in conformance
with cGMP
• FDA-listed materials per 21 CFR
• ISO 9000 Certified Quality System
• Pharmaceutical P optimized
• Certificate of Test provided
• Validation Guide available

123
 Emflon PFR Sterilizing-grade Filter Cartridges
Technical Specifications

Materials Typical Air Flow Rates(5)

Flow Rate (scfm)
Membranes Double-layer PTFE
0 50 100 150
Support and Drainage Polypropylene, oxidation resistant 250

Core, Cage, End Caps and Polypropylene, oxidation resistant

Adapters 3.0
200
O-rings(1) Silicone

Differential Pressure (mbar)

Differential Pressure (psi)

(1)
Other polymers available 2.5

150
2.0
Removal Ratings
Air and Gases < 0.003 µm, particulate (2)
100 1.5
Liquids 0.2 µm, sterilizing(3)
1.0
(2)
By NaCl CNC particle analysis. Also retains 100% of Brevundimonas diminuta bacteria,
bacteriophage and virus aerosols. 50
(3)
Lot samples of assemblies retain > 107 cfu/cm2 of Brevundimonas diminuta in liquid per 0.5
mod. ASTM F838-83 and FDA guidelines.

0 0
0 80 160 240 320
Nominal Dimensions
Flow Rate (Nm3/h)
Lengths 127 mm (5 in.), 10 in. (254 mm),
= Vent = 2.1 barg = 4.1 barg
20 in. (508 mm), 30 in. (762 mm),
(30 psig) inlet (60 psig) inlet
40 in. (1016 mm)
(5)
Typical initial clean medium ∆P per 254 mm (10 in.) element, air at 20 °C
Diameter 2.75 in. (70 mm) (68 °F). For multi-element cartridges, divide pressure drop by number of
254 mm (10 in.) elements. Non-linear cartridge turbulence factors are
incorporated into housing pressure drop values. For complete assembly
Nominal Filter Area pressure drop, add filter cartridge medium value to housing value at
specified flow rate. For gases other than air or nitrogen, contact your local
0.8 m2 (8.6 ft2) per 10 in. (254 mm) element Pall representative.
0.4 m2 (4.1 ft2) per 5 in. (127 mm) element

Autoclave and Steaming

Operating Conditions(4)
Cumulative Steaming Time
Maximum Differential Pressure and Temperature
165 hours (1-hour cycles) to 140 °C (287 °F)
5.3 bard (77 psid) at 20 °C (68 °F)
Maximum Forward Steaming Conditions
4.1 bard (60 psid) to 80 °C (176 °F)
1.0 bard (15 psid) at 125 °C (257 °F)

Typical Continuous Air Service Life(4) 0.3 bard (4.3 psid) at 142 °C (287 °F)

12 months to 60 °C (166 °F) Maximum Reverse Steaming Conditions

Typical Vent Service Life 0.5 bard (7.3 psid) at 125 °C (257 °F)

6 months to 80 °C (176 °F) 0.2 bard (3.0 psid) at 142 °C (287 °F)
(4)
In air/N2 service or other compatible gases.
For continuous air flow above 60 °C (140 °F), Emflon CPFR filters are recommended. Integrity Test Values for one 10 in. (254 mm) Cartridge(6)
Emflon PFR can be operated at higher temperatures for shorter time periods.
Forward Flow (Air/Test/Gas) 60:40 IPA: Water wet (v:v)
15 mL/min at 1035 mbar (15 psi)
Aqueous Extractables (20 °C [68 °F])
Water Intrusion 0.33 mL/min at 2485 mbar (36 psi)
< 5 mg per 10 in. (254 mm) element after 1-hour steam at 125 °C (257 °F) (6)
Contact Pall for multi-element values. AB05PFR value is 7.8 mL/min at 2485 mbar
(36 psi).

Ordering Information

AB PFR V

Code Nominal Length Code Cartridge Style Code Filter Grade Optimization Code O-ring Material
05 5 in. (127 mm) 2(7) Double 226 O-ring with P Pharmaceutical* Oxidation-resistant H4 Silicone
bayonet lock and flat end polypropylene
1 10 in. (254 mm) Omit General Use Other materials available.
hardware
7 Double 226 O-ring with
2 20 in. (508 mm) * Pall pharmaceutical-grade
bayonet lock and fin end
filters are designed for use in
3 30 in. (762 mm) conformance with CGMP in
(7)
AB05 cartridges only.
4 40 in. (1016 mm) Manufacturing, Processing,
Packing or Holding of Drugs
(21CFR210) and CGMP for
This is a guide to the part number structure and possible options only.
finished Pharmaceuticals
For availability of specific options, please contact Pall.
(21CFR211.72) including
batch release certificate and
124 full traceability.
Emflon CPFR High-temperature Sterilizing-grade Filter Cartridges
®
Air, Gas and Vent Service in Critical High-temperature Applications
Pall Emflon CPFR High-temperature filters
have been developed from the long-life
and high-strength Emflon PFR filter
range. They have been designed and
liquid-validated as sterilizing filters for air,
gas and vent service in critical
high-temperature applications in the
BioPharmaceutical and bioprocess
industry, like fermentation inlet air, aseptic
packaging, or hot WFI tank vents.
The oxidation-resistant components
typically allow extended use in air up to
80 °C (176 °F) and for shorter periods up
to 120 °C (248 °F). The high-strength
cartridges can also withstand high
differential pressures in forward or reverse
direction during multiple steam-in-place
sterilization cycles. The filters incorporate a
double-layer (0.2 µm) of inherently
hydrophobic polytetrafluoroethylene (PTFE)
membrane, manufactured by Pall. Emflon
CPFR filters are identified by their unique
colored oxidation resistant components
and the easy-to-read laser-etched part
number and serial number.
Features and Benefits
Feature:
Validated in accordance with:
• Brevundimonas diminuta in liquid at
107 per cm2 according to modified
ASTM Standard Test Method F383-83
and FDA Guidelines on Sterile Drug
Products Produced by Aseptic
Processing (1987)
Benefit:
High validation standards ensure the
highest removal efficiency and safety
margins even in processes with
high-temperatures, humid conditions and
variable bioburden.
Feature
Correlation of challenge test data with:
• Forward Flow Test and
• Water intrusion test
Benefit
• Allows a safe, easy and fast
confirmation of filter integrity for
assurance of sterile filtration in critical
applications.
Feature
• Lot tests for multi-cycle autoclave
challenges
Benefit
• Repeat steamability in situ and robust
construction optimized for air, gas and
vent service with enhanced life at
high-temperatures
Certified P Quality
Emflon CPFR cartridges have been
designed and qualified for pharmaceutical
use. The provided P Certificate meets and
confirms pharmaceutical requirements on
the effluent regarding:
Effluent Quality Tests (P Tests)
• Cleanliness per USP Particulates in
injectables
• Non Fiber-Releasing
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
• Meets oxidizables and pH per USP
Sterile Purified Water
Biological Tests
• Meets USP Biological Reactivity Test,
in vivo for Class VI-121 °C Plastics
The quality management system for
manufacturing of Emflon CPFR occurs in
conformance with Certified Quality System
ISO 9000.
Each filter is 100% integrity tested and fully
traceable by individual laser marked lot and
serial number. 125
 Emflon CPFR High-temperature Sterilizing-grade Filter Cartridges
Technical Specifications

Materials of Construction Typical Air Flow at 20 °C (68 °F) and 2 barg (30 psig) Inlet
Pressure(2)
Membrane Double-layer proprietary hydrophobic
PTFE Flow Rate (scfm)
0 50 100 150 200 250
Drainage Layers Specially developed, resin impregnated 300
polyaramid non-woven material 4.0
End Cap, Core and Cage Pigmented polypropylene 250
3.5
Adapter Pigmented polypropylene with

Differential Pressure (mbar)

Differential Pressure (psi)

encapsulated stainless steel 3.0
200
reinforcing ring
2.5

Nominal Filter Area 150

2.0
AB1CPFR7PVH4 0.72 m2 (7.7 ft2)
100 1.5

Maximum Differential Pressure 1.0

50
Maximum Forward Differential Pressures in Air, Nitrogen or other 0.5
Compatible Gas Service are:
0 0
5.4 bard at 50 °C (80 psid at 122 °F) 0 100 200 300 400 500
4.1 bard at 80 °C (60 psid at 176 °F) Air Flow Rate (Nm /h)
3

3.4 bard at 90 °C (50 psid at 194 °F)
Maximum Operating Temperature (In Compatible Gases)
120 °C (248 °F)
Maximum Forward Steaming Conditions
1 bard at 125 °C (15 psid at 257 °F)
0.3 bard at 142 °C (4.3 psid at 288 °F)
Maximum Reverse Steaming Conditions
0.5 bard at 125 °C (7.3 psid at 257 °F)
0.2 bard at 142 °C (3.0 psid at 288 °F)
Integrity Test Values(1)
Forward Flow Test
Water Intrusion Test
(1)
Values are for one 10 in. (254 mm) filter at 20 °C (68 °F). Please contact Pall for
multi-element integrity test values.
(2)
Typical initial clean medium ∆p per 254 mm (10 in.) element, air at 20 °C
(68 °F). For multipleat cartridges, divide pressure drop by number of 254 mm
(10 in.) elements. Contact Pall for assistance in sizing.
Typical Service Life in Continuous Flowing Air Service(3)
1 year at 100 °C (212 °F)
6 months at 110 °C (230 °F)
2 months at 120 °C (248 °F)
(3)
For continuous air flow above 60 °C (140 °F), in air/N2 service or other compatible
gases, Emflon CPFR filters are recommended. Emflon CPFR can be operated at
higher temperatures for longer time periods.
Typical Cumulative Steam Life(4)
100 hours (1-hour cycles) at 140 °C (284 °F)
(4)
The steam life and service life data were determined by testing under controlled
laboratory conditions up to the time indicated. Actual operating conditions may affect
the filter’s long-term resistance to steam sterilization and hot air service. Filters should
With 60/40 IPA/Water wet (v:v) be qualified for each process application.
and air as test gas
14 mL/min at 1040 mbar (15 psi)
0.3 mL/min at 2500 mbar (36 psi)

Ordering Information

AB CPFR V

Code Nominal Length Code Cartridge Style Code Filter Grade Optimization Code O-ring Material
05 5 in. (127 mm) 2(5) Double 226 O-ring with P Pharmaceutical* Oxidation resistant H4 Silicone
bayonet lock and flat end polypropylene
1 10 in. (254 mm) * Pall pharmaceutical-grade Other materials available.
hardware
7 Double 226 O-ring with filters are designed for use in
2 20 in. (508 mm) conformance with CGMP in
bayonet lock and fin end
Manufacturing, Processing,
3 30 in. (762 mm) Packing or Holding of Drugs
(5)
AB05 cartridges only.
(21CFR210) and CGMP for
finished Pharmaceuticals
(21CFR211.72) including
This is a guide to the part number structure and possible options only.
batch release certificate and
For availability of specific options, please contact Pall.
full traceability.

126
 Emflon PFA Filter Cartridges
®

High-flow Economical Filters for the Sterilization of Air and Gas

Emflon PFA filters are a further addition
to the successful Emflon filter range.
The filters contain a proprietary
pleated hydrophobic PTFE membrane
and are designed for the removal of
micro-organisms and particles from air
and gases.
Emflon PFA filters:
• Offer exceptionally high-flow rates to
ensure low installation and operating
costs
Optimized pleating configuration and
membrane support, together with a wide
bore cartridge core and adapter, ensure
that this high-flow performance can be
exploited to the fullest.
Typical Applications
• Large-scale fermenter air
• Intermediate product vessel venting
• Autoclave vacuum break

• Have been validated for bacterial • Instrument air

removal in air at an aerosol challenge • Air and gas service lines
level of 107 Brevundimonas diminuta
ATCC 19146 per 254 mm (10 in.) Features and Benefits
length cartridge
• High-flow rates and low pressure drop
• Are integrity testable by the Water
allow the use of smaller systems,
Intrusion test or alcohol wet Forward
minimizing installation, filter
Flow test
replacement, and energy costs
• Can also be steam sterilized repeatedly
• In situ integrity testable by Water
in situ to provide long service life
Intrusion or Forward Flow methods for
maximum convenience and security
Better by Design
• Long steaming life offering low-cost
The heart of the filter is a PTFE membrane filtration
with exceptional flow properties. Equally
important is Pall’s unrivalled expertise in
cartridge construction drawing on many
years experience in making PTFE
membrane filters.

127
 Emflon PFA Filter Cartridges
Technical Specifications

Materials of Construction Typical Air Flow Rates – Vent Application(3)

Components Material 200 4
180
Membrane Hydrophobic PTFE AB1
160
Support and Drainage Layers Polypropylene 3
140

Differential Pressure (mbar)

End Cap, Core and Cage Polypropylene

Differential Pressure (psi)

120
Code 7 Adapter Polypropylene with encapsulated
100 2
stainless steel reinforcing ring
80 AB1

60 AB2
Nominal Filter Area 1
40 AB3
AB1PFA7PV 0.8 m (8.6 ft )
2 2

20 AB2
0
Maximum Differential Pressure(1) AB3
Temperature Maximum Differential Pressure
Forward Direction
0 50 100 150 200 250 300 350 400
Steam up to 125 °C (257 °F) 0.3 bar (4.3 psi) Air Flow Rate
(1)
Validated using 1-hour cycles.
= Nm3/h = ft3/min

Cumulative Steam Life(2)

Up to 125 °C (257 °F) 100 hours (3)
Typical initial clean medium ∆p per 254 mm (10 in.) element, air at 20 °C (68 °F). For
multipleat cartridges, divide pressure drop by number of 254 mm (10 in.) elements.
Up to 140 °C (284 °C) 40 hours Contact Pall for assistance in sizing.
(2)
Validated using 1-hour cycles.
The steam life and service life data were determined by testing under controlled
laboratory conditions up to the time indicated. Actual operating conditions may affect
the filters’ long-term resistance to steam sterilization and hot air service. Filters should
be qualified for each process application

Service Life in Air

Temperature Service Life
60 °C (140 °F) Pressurized Air Typically 12 months
80 °C (176 °F) Vent Service Typically 6 months

Ordering Information

AB PFA V

Code Nominal Length Code Cartridge Style Code Filter Grade Optimization Code O-ring Material
05 5 in. (127 mm) 2(4) Double 226 O-ring with P Pharmaceutical* Oxidation resistant H4 Silicone
bayonet lock and flat end polypropylene
1 10 in. (254 mm) Omit General Use hardware
7 Double 226 O-ring with
2 20 in. (508 mm) * Pall pharmaceutical-grade
bayonet lock and fin end
filters are designed for use in
3 30 in. (762 mm) conformance with CGMP in
(4)
AB05 cartridges only.
Manufacturing, Processing,
Packing or Holding of Drugs
(21CFR210) and CGMP for
This is a guide to the part number structure and possible options only.
finished Pharmaceuticals
For availability of specific options, please contact Pall.
(21CFR211.72) including
batch release certificate and
full traceability.

128
 Ultipor GF Plus Air and Gas Filters
®

High Capacity, Long Life Filters for Air and Gas Service

Pall Ultipor GF Plus filter cartridges are Features and Benefits

made with high voidage glass fiber media
for enhanced filter life.
The cartridges feature a high area pleated
element construction designed to fit in
sanitary-style filter housings. A bio-safe low
extractables binder resin covalently
immobilizes the glass fibers and imparts
high-strength and reliable removal
efficiency. Due to the high particulate
removal efficiency and low pressure drops
consistent with glass fiber media, Ultipor
GF Plus filters effectively protect
sterilizing-grade filters in air and gas
applications.
• High area pleated medium
• Low differential pressures
• Absolute particle-rated in liquids
• High-capacity for long-life
• Fixed pores prevent unloading
• Choice of AB (SOE) sanitary or (DOE)
cartridge styles
• Manufactured for use in conformance
with cGMP
• FDA-listed materials per 21 CFR
• ISO 9000 Certified Quality System

Pharma Quality for Highest Quality

Requirements
Ultipor GF Plus filters are manufactured in
accordance with ISO9000 and GMP
requirements. Each filter is supplied with a
certificate of test that confirms suitability
for use in pharmaceutical applications.
Samples are tested for effluent quality to
meet the USP requirements regarding
• Total Organic Carbon
• pH shift
• Endotoxins
All components meet the specifications
for biological tests listed in the USP for
Class VI plastics at 121 °C.
Each box contains a certificate which
confirms the quality standards in
manufacturing, the traceability of all
components, and the above mentioned
safety tests.

129
 Ultipor GF Plus Air and Gas Filters
Technical Specifications

Materials of Construction Operating Conditions(1)

Filter Medium Resin-bonded glass-fiber Maximum Operating 4 bar (58 psi) at 80 °C (176 °F)
Pressure
Support and Drainage Polyester
(1)
In compatible liquids which do not soften, swell or adversely affect the filter or
Core, cage and Endcaps Polypropylene materials of construction

Steam Sterilization
Up to 140 °C (284 °F)

Ordering Information and Selection Guide(5)

AB

MCY100

Code Nominal Filter Removal Nominal Cartridge Code Filter Code O-ring
Length Medium Rating in Liquids* Filter Area(6) Style Grade Option

1 10 in. (254 mm) U010Z 1 µm 0.50 m2 (5.3 ft2) Double 226 O-ring P Code outside US** H4 Silicone
with bayonet
2 20 in. (508 mm) U2-20Z 2 µm 0.65 m (6.9 ft )
2 2
Omit Code in US only H13 Nitrile
lock and fin end
3 30 in. (762 mm) U6-40Z 6 µm 0.55 m2 (5.9 ft2) Other materials available
**Supplied with Certificate of Test
on request.
and Full Traceability.
4 40 in. (1016 mm) U200Z 20 µm 0.49 m2 (5.2 ft2)
* Due to the enhanced particle removal efficiencies in gases, the approximate ratings for gas
service can be calculated by dividing the liquid rating in µm by between 5 and 10.

SLK

MCY4440

MCY4463

Code Filter Removal Nominal Code Filter Code O-ring

Medium Rating in Liquids* Filter Area(6) Grade Option

7001 U010Z 1 µm 0.20 m2 (2.1 ft2) P Code outside US H4 Silicone

7002 U2-20Z 2 µm 0.22 m (2.3 ft )
2 2
Omit Code in US only H13 Nitrile
U6-40Z 6 µm 0.20 m2 (2.1 ft2) Other materials available
Supplied with Certificate of Test
on request.
and Full Traceability
U200Z 20 µm 0.18 m2 (1.9 ft2)
(5)
This is a guide to the part number structure only.
(6)
For SLK7002 and MCY4463 style.

130
 HDC II Gas Filter Cartridges
®
High Dirt Retention All-polypropylene Filters
Pall HDC II filters are constructed using a
proprietary technique that varies the fiber
diameter instantaneously and continuously
to produce a pore-size distribution from
coarse (upstream) to fine (downstream)
while maintaining constant void-volume
throughout the depth of the filter medium.
This unique construction means that more
contaminants are trapped in the outer and
inner regions of the medium, thereby
substantially increasing the dirt-holding
capacity and the service life of the filter.
HDC II AB style and MCY 1000 style filters
are available in a range of removal ratings
and in four nominal cartridge lengths:
10 in. (254 mm), 20 in. (508 mm), 30 in.
(762 mm) and 40 in. (1016 mm). Their
all-polypropylene construction makes them
compatible with an extremely wide range
of gaseous fluids. Cartridges are also
available as P option which are optimized
for pharmaceutical applications.
All materials of construction are FDA-listed
and all components have been tested
according to USP Class VI biological tests
for plastics at 121 °C.
Features and Benefits
High Removal Efficiency
• 99.9998% efficiency at 0.3 µm for finest
grade
Varied Fiber Diameter
• Extraordinarily high dirt-holding capacity
• Lowest cost per liter of filtered fluid
Fixed Pore Structure
• No solids unloading under variations in
flow or pressure differential
• Fibers will not migrate or become
dislodged and contaminate the process
fluid
All-Polypropylene Construction
• Extremely good chemical compatibility
with a wide range of gaseous fluids
• No surfactants
• Meets USP Biological Reactivity Tests
(in vivo) in accordance with USP Class
VII Plastics at 121°C
• Cartridge can be in situ steam-sterilized
or autoclaved
• Media melt-sealed to endcaps without
the use of binder resins
P Optimization for Pharmaceuticals
• Statistical testing of filter effluent for:
◆ particle and fiber counts
◆ endotoxins using LAL test
◆ pH shift test
◆ Total organic carbon and water
conductivity tests
131
 HDC II Gas Filter Cartridges
Technical Specifications

Operating Limits(1) Steam Sterilization

Operating Temperature Maximum Differential Pressure Maximum Cumulative Steam Sterilizing Temperature of AB
50 °C (122 °F) 5.5 bard (80 psid) Steaming Exposure Code 3 (P Grade Only) and AB Code 7
(In situ or Autoclave)
80 °C (176 °F) (Maximum) 4.1 bard (60 psid)
50 hours Up to 140 °C (284°F)
(1)
In compatible fluids which do not soften, swell or adversely affect the filter medium or
materials of construction.

Retention Ratings
Liquids Gas Flow Rates per 10 in. (254 mm) Cartridge(2)
Code Absolute Retention (90%) Efficiency(3) Nominal Filter For Air
Rating for 0.3 µm Aerosols Area(4) m3/h
∆P = 10 mbar
(0.15 psi)(4)
J006 0.6 µm(3) < 1.0 µm(3) 99.9998 % 0.62 m2 (6.67 ft2) 4.0
J012 1.2 µm < 1.0 µm(3) 99.996 % 0.69 m2 (7.43 ft2) 10.0
J025 2.5 µm < 1.0 µm(3) 99.75 % 0.86 m2 (9.26 ft2) 14.0
J045 4.5 µm 1.2 µm 99.95 % 0.86 m2 (9.26 ft2) 17.0
J060 6.0 µm 3.0 µm 99 % 0.40 m2 (4.31 ft2) 24.0
J100 10.0 µm 5.4 µm 93 % 0.52 m2 (5.6 ft2) 39.0
J200 20.0 µm 10.0 µm – 0.53 m2 (5.7 ft2) –
J400 40.0 µm 22.0 µm – 0.37 m2 (3.98 ft2) –
J700 70.0 µm 35.0 µm – 0.37 m2 (3.98 ft2) –
(2)
For fluids of 1 cP viscosity. As a general guide for viscosities multiply pressure drop by viscosity in cP. For cartridges of 508, 762 and 1016 mm nominal length, divide differential
pressure by 2, 3, and 4 respectively.
(3)
Based on mineral oil test.
(4)
For 10 in. (254 mm) nominal length cartridge
(5)
Extrapolated value.

Ordering Information(5)
MCY 1000 style Double open-ended 70 mm (2.75 in.) diameter element with gaskets on both ends. Sealing is assured by using a tie rod and seal nut.
MCY 100

Code Nominal Length Code(4) Removal Rating(5) in Liquids* Code Gasket Options Cartridge Sealing Arrangements
1 10 in. (254 mm) J006 0.6 µm H13 Nitrile 1000 style AB style
2 20 in. (508 mm) J012 1.2 µm J Ethylene
3 30 in. (762 mm) J025 2.5 µm propylene
4 40 in. (1016 mm) J045 4.5 µm Other materials available on request.
(5)
For availability of specific options, J060 6.0 µm Flat Code 7 Code 3
contact Pall J100 10.0 µm Gasket Double O-ring seal
(6)
Absolute rating means the value in
microns at which the OSU-F2 test J200 20.0 µm
gives a beta value of > 5000. J400 40.0 µm
* Due to the enhanced particle removal
efficiencies in gases, the approximate J700 70.0 µm
ratings for gas service can be
calculated by dividing the liquid rating
in µm by between 5 and 10.

AB style Single open-ended 70 mm (2.75 in.) diameter element with double O-ring at one end

AB

Code Nominal Code Removal Rating Code Cartridge Code Filter Code O-ring
Length in Liquids* Style Grade Option
1 10 in. (254 mm) J006 0.6 µm 3 Double 222 O-ring P Pharmaceutical* H4 Silicone
2 20 in. (508 mm) J012 1.2 µm with flat end J Ethylene
Omit General Use
3 30 in. (762 mm) J025 2.5 µm 7 Double 226 O-ring propylene
with bayonet * Pall pharmaceutical-grade filters
4 40 in. (1016 mm) J045 4.5 µm lock and fin end are designed for use in Other materials available on
conformance with CGMP in request.
J060 6.0 µm
Manufacturing, Processing,
J100 10.0 µm Packing or Holding of Drugs
(21CFR210) and CGMP for
J200 20.0 µm finished Pharmaceuticals
J400 40.0 µm (21CFR211.72) including batch
release certificate and full
132 J700 70.0 µm traceability.
 Pallcell Air and Gas Filter Cartridges
®
Economical Air Prefiltration for High-flow Fermentation Applications
Pallcell filter cartridges for air and gas
service feature a binder-free pure cellulose
filter medium which is pleated with
all-polypropylene hardware into either
single open-ended (SOE) modular AB style
cartridges designed for sanitary-style filter
housings, or economical double
open-ended (DOE) modular cartridges
designed for industrial DOE style housings.
Pallcell filters are recommended for
clarification of air and gas feeds and as an
economical prefilter for high-flow
fermentation air-sterilizing membrane
cartridges.
Features and Benefits
• Absolute (liquid) rated for reliability
• Fixed pore structure for consistent
effluent quality
• Low pressure drop
• High-capacity for long-life
• Non-fiber-releasing
• Resin-free melt-sealed construction
• Broad chemical compatibility
• Low extractables
• Choice of AB (SOE) sanitary or (DOE)
cartridge styles
• ISO 9000 Certified Quality System
• Manufactured for use in conformance
with cGMP
• FDA-listed materials per 21 CFR
133
 Pallcell Air and Gas Filter Cartridges
Technical Specifications

Materials of Construction Typical Air Flow Rates(4)

Medium 100% pure cellulose Flow Rate (scfm)
0 30 60 90
Support and Drainage Layers Polypropylene 6
DC DE DC DG DE
Core, Cage and End Caps Polypropylene 0.08

5
0.07
Seals(1)

Differential Pressure (mbar)

Differential Pressure (psi)

AB Style Silicone O-rings 0.06
4
DG
DOE style Ethylene Propylene gaskets 0.05
(1)
Other polymers available. 3
0.04

Removal Ratings (Liquid) (2)

2 0.03

8 µm, 14 µm and 35 µm 0.02

(2)
> 99.98% by mod. OSU-F2 Beta test 1
Due to the enhanced particle removal efficiencies in gases, the approximate ratings for 0.01
gas service can be calculated by dividing the liquid rating in µm by between 5 and 10.
0 0
0 40 80 120 160
Configurations Flow Rate (Nm /h)
3

AB Code 7 Style(3) Single open-end, Double 226 O-ring = 3.4 barg = 6.9 barg
adapter with bayonet lock and (50 psig) inlet (100 psig) inlet
finned end (4)
Typical initial clean medium ∆P per 10 in. (254 mm) element, air at 20 °C
Uni Cap Cartridge Double open-end, male and female (68 °F). For multi-element cartridges, divide pressure drop by number of
end caps and flat gasket seal 10 in. (254 mm) elements. Non-linear cartridge turbulence factors are
incorporated into housing pressure drop values. For complete assembly
(3)
Alternate adapter codes available. pressure drop, add filter cartridge medium value to housing value at
specified flow rate. For gases other than air or nitrogen, contact your
local Pall representative.
Nominal Filter Area per 10 in. (254 mm) Element
Operating Conditions
0.44 m2 (4.7 ft2)
Maximum Differential 5.5 bard (80 psid) at 50 °C (122 °F)
Pressure and Temperature(5)
Nominal Dimensions
AB Style 4.1 bard (60 psid) at 80 °C (176 °F)
Lengths 10 in. (254 mm), 20 in. (508 mm),
30 in. (762 mm), 40 in. (1016 mm) DOE Style 3.1 bard (45 psid) at 82 °C (180 °F)
(5)
In air/N2 service or other compatible gases.
Diameters AB Style:
70 mm (2.75 in.)

DOE Style:
64 mm (2.5 in.)

Ordering Information

AB

PUY

Code Nominal Code Removal Ratings Code Filter Code O-ring

Length in Liquids* Grade Option

1 10 in. (254 mm) DC 8 µm P Pharmaceutical* H4 Silicone

2 20 in. (508 mm) DE 14 µm Omit General Use J Ethylene
propylene
3 30 in. (762 mm) DG 35 µm * Pall pharmaceutical-grade filters
are designed for use in Other materials available
4 40 in. (1016 mm) conformance with CGMP in on request.
Manufacturing, Processing,
Note: AB Style is recommended if cartridges are to be heated and then cooled by 20 °C
Packing or Holding of Drugs
(68 °F) before filtration. For sizing assistance, or for steaming in situ, requiring AB style P
(21CFR210) and CGMP for finished
option with stainless steel ring reinforced adapter option, contact your local pall
Pharmaceuticals (21CFR211.72)
representative.
including batch release certificate
* Due to the enhanced particle removal efficiencies in gases, the approximate ratings for and full traceability.
gas service can be calculated by dividing the liquid rating in µm by between 5 and 10.

134
 LG Liquid and Gas Coalescing Filter Cartridges
Removal of Oil and Water Droplets in Critical Gas Service
Pall LG coalescing filter cartridges are
designed for critical air or gas service
applications where high-efficiency removal
of oil or water droplets and particulate
solids is required. Via a series of graded
non-wettable media, droplets are captured,
coalesced, and drained to the bottom of
the housing, preventing filtered droplet
re-entrainment into the downstream gas
flow.
LG coalescing filters protect downstream
equipment and processes from
compressor wear products, lubrication oil,
water or other liquid droplets, corrosion
products and other particulate
contaminants, while reducing maintenance
costs.
Features and Benefits
• Remove oil and water droplets from air
and gas streams
• Fixed-pore and non-shedding media
• High separation efficiency
• HEPA-quality air effluent
• Prevents wet-out blockage of
downstream membranes
• High filter area for prolonged life
• Low saturated pressure drop reduces
operating costs
• Rapid from liquid surges recovery
• Range of sizes for most applications
• Protects equipment and processes
• Reduces downtime and labor costs
• Manufactured for use in conformance
with cGMP
• ISO 9000 Certified Quality System
135
 LG Liquid and Gas Coalescing Filter Cartridges
Technical Specifications

Materials Nominal Dimensions

Medium Specially-treated resin-bonded glass Lengths CC05 CC1 CC3 CS
fiber–hydrophobic and oleophobic 5 in. 10 in. 30 in. 40 in.
(127 mm) (254 mm) (762 mm) (1016 mm)
Support and Drainage CC05, CC1, CC3LGA, CC3LG0, CS:
Polyester Diameters CC05 CC1 CC3 CS
CC3LGB: 57 mm 70 mm 70 mm 152 mm
Polypropylene (2.25 in.) (2.75 in.) (2.75 in.) (6 in.)
Core 304 Stainless Steel
Cage CC1, CC3: Operating Conditions and Sizing(5)
PVC coated glass mesh
Changeout Differential 0.83 bard (12 psid) +
CC05, CS: Pressure Clean Differential Pressure
Stainless Steel
Maximum Gas Temperature
Side Seal Polypropylene
CC05, CC1, CC3LGA, CC3LG0, CS:
End Caps CC1, CC3 (Single open-end, SOE):
Polypropylene, glass filled With water droplets/vapor 60 °C (140 °F)
CC3 (Double open-end, DOE): Water droplet/vapor-free 82 °C (180 °F)
Acetal
CC3LGB:
CC05, CS (SOE): Water droplet/vapor-free 82.2 °C (180 °F)
Stainless Steel
(5)
Note: Assembly pressure drop designed to customer specification using Pall
O-rings and gaskets Buna-N(1) LGSIZER2™ software program. Contact Pall for part number and assembly sizing
recommendations.
(1)
Other polymers available.

Liquid (Oil) Coalescing Efficiency

< 0.01 ppmw of oil in effluent(2)
(2)
Based on standard Pall Liquid Aerosol Separation Efficiency (LASE) test.

Particle Removal Rating (Air and Gas)

0.3 µm particulate(3),(4)
(3)
CC05: > 99.99% removal of 0.3 µm DOP aerosol.
(4)
CC1, CC3, CS: > 99.99% removal of 0.2 µm NaCl aerosol.
> 99.97% removal of 0.3 µm DOP aerosol.

Ordering Information(5)
Part Nominal Length Nominal Configuration, Operating Service
Number Filter Area Adapter and Seal Design Pressure

CC05LGH13 5 in. (127 mm) 0.08 m2 (0.84 ft2) SOE, Internal O-ring Low/High > 17.2 barg (250 psig)
CC1LGA7H13 10 in. (254 mm) 0.26 m2 (2.8 ft2) SOE, Piston O-ring Low > 17.2 barg (250 psig)
CC3LGA7H13 30 in. (762 mm) 0.88 m2 (9.5 ft2) SOE, Piston O-ring Low > 17.2 barg (250 psig)
CC3LGB7H13 30 in. (762 mm) 0.80 m2 (8.6 ft2) SOE, Piston O-ring Low/High > 17.2 barg (250 psig)
CC3LG02H13 30 in. (762 mm) 0.88 m2 (9.5 ft2) DOE, Gasket seals Low/High > 17.2 barg (250 psig)
CS604LGH13 40 in. (1016 mm) 2.60 m2 (28 ft2) SOE, Piston O-ring Low/High > 17.2 barg (250 psig)
(5)
CC05LGH13 replaces PFS4463ZMH13; CC3LGB7H13 is recommended in amine/ammonia gas service. H13 suffix indicates Buna-N O-ring material (standard).
See Appendix for alternate polymers and codes.
Note: For sizing coalescer assemblies or other information, please contact your local Pall representative.

136
 Rigimesh Sintered Metal Mesh Filter Cartridges
®
High-flow Pleated Metal Cartridges for Liquid and Gas Service
Pall Rigimesh sintered metal mesh filter
cartridges are constructed from fine-woven
stainless steel wire mesh which is sintered
at each wire contact point in a
Pall-patented process to produce an
extremely strong surface-sieving porous
material with extremely narrow pore size
distribution. Unlike unsintered meshes,
Rigimesh media will not shift under stress.
Sintering also enables the use of finer wires
to produce more pores per unit area for
higher flow rates and higher contaminant
loading capacity. Rigimesh media is
pleated to form double open-ended (DOE)
MBS1000 style filter cartridges with
applications in bulk active pharmaceutical
chemical purification processes such as
catalyst solids recovery and decolorizing
carbon removal.
Single open-ended (SOE) AB sanitary and
threaded styles are also available.
Features and Benefits
• All-stainless steel construction
• Sintered mesh screen media
• Pleated for high-capacity
• Consistent and fixed pore size
• Corrosion resistant
• High pressure resistant
• Withstands high reverse-flows
• High-temperature capabilities
• Repeatedly cleanable
• No soluble polymeric extractables
• No unloading or shedding
• Absolute rated for reliable performance
• ISO 9000 Certified Quality System
• Manufactured for use in conformance
with cGMP
• FDA-listed materials per 21 CFR
137
 Rigimesh Sintered Metal Mesh Filter Cartridges
Technical Specifications

Materials of Construction Typical Liquid Flow Rates(6)

Flow Rate (L/min)
Medium 304 L stainless steel (1)

0 25 50 75 100 125 150

Core and End Caps 304 stainless steel (1) 0.4
RZ
25
Gaskets Buna-N(2)

Differential Pressure (mbar)

Differential Pressure (psid)
(1)
Also available with type 316 L medium and type 316 hardware or with other alloys 0.3 20
(special order). RK
(2)
Other polymers available.
15
0.2
Configuration(3) RJ
Double open-ended (DOE) 10

Flat gasket seals 0.1

5
(3)
Single open-ended sanitary AB and threaded styles available.

0 0
Nominal Dimensions 0 10 20 30 40
Flow Rate (gpm)
Diameters 64 mm (2.5 in.)
Flow Rate (L/min)
0 25 50 75 100 125 150
Operating Conditions 0.008
RM
RR 5
Maximum Differential Pressure and Temperature(4)

Differential Pressure (mbar)

Differential Pressure (psid)
Forward Flow Direction 8.6 bard (125 psid) to 232 °C (450 °F) 0.006 4
RS
Reverse Flow Direction 0.7 bard (10 psid) to 232 °C (450 °F)
(4)
Minimum collapse differential pressure. Temperature limit with Buna-N gaskets: 3
0.004
121 °C (250 °F). Other gasket materials to 232 °C (450 °F). For Reinforced for 50 psid
(3.4 bard) Reverse-flow option, temperatures to 316 °C (600 °F), or in other alloys to
677 °C (1250 °F), contact your local Pall distributor. 2

0.002
1
Recommended Maximum Flow Densities(5)
Grade Aqueous Air 0 0
L/min (gal/min) Nm3/hr (acfm) 0 10 20 30 40

RA 14 (3.7) 47 (300) Flow Rate (gpm)

(6)
Typical initial clean medium ∆P per 10 in. (254 mm) element, water at
RT 11 (2.9) 38 (240) 20 °C (68 °F), 1 cp. For assistance in sizing and housing selection, contact
RS 8.8 (2.3) 32 (200) your local Pall representative.

RR 7.0 (1.8) 24 (150)

RM 3.3 (0.8) 16 (100)
RJ 3.5 (0.9) 13 (80)
RK 2.8 (0.7) 11 (69)
RZ 1.8 (0.5) 6.3 (40)
(5)
Aqueous (water, 1 cp) and air flows per 10 in. (254 mm) cartridge.

Ordering Information

MBS100

Code Nominal Length Filter Area Code Liquid Ratings(7) Gas Ratings(7) Code Gasket Options
1 10 in. (254 mm) 0.9 m (1.0 ft )
2 2
RA 450 µm 350 µm H13 Buna-N gaskets (Standard)
2 20 in. (508 mm) 0.19 m2 (2.0 ft2) RT 225 µm 175 µm H Viton*
3 30 in. (762 mm) 0.28 m2 (3.0 ft2) RS 105 µm 85 µm J Ethylene Propylene
4 40 in. (1016 mm) 0.37 m2 (4.0 ft2) RR 70 µm 55 µm J7 Ethylene Propylene (Steam Service)
RM 45 µm 25 µm Other materials available on request.
* Viton is a registered trademark of DuPont Dow
RJ 25 µm 18 µm (non-FDA materials).

RK 18 µm 13 µm
RZ(8) 15 µm 2 µm
(7)
Liquids: > 99.98% by mod. OSU-F2 test.
Gases: 100% for hard spherical particles.
(8)
Supramesh® (Sintered powdered metal and mesh composite
medium).
138
 PSS Porous Metal Filter Cartridges
®

Sintered Metal Powder Filters for Liquid and Gas Service

Pall PSS porous metal filter cartridges are
made from fine stainless steel powders
sintered to form rugged high voids and
fixed pore filters with high-temperature,
pressure, and solvent resistance. P Series
cartridges begin as flat porous sheets
which are shaped and welded into
cylindrical elements. S Series cartridges
are produced in cylindrical form with higher
voids and narrower pore size distributions
for greater flows at comparable ratings.
Double open-ended (DOE) style cartridges
are standard. They are recommended for
steam service and well suited for liquid or
gas applications including solvents,
chemical intermediates, heat transfer and
cryogenic fluids, polymers,
pharmaceuticals, and high-temperature
gases. Single open-ended (SOE) AB
sanitary and threaded styles are also
available.
Features and Benefits
• All-stainless steel construction
• Controlled and fixed pore size
• PH grade for clean steam
• Up to 2x life of competitive filters
• High pressure and corrosion resistant
• Withstands high reverse-flows
• High-temperature capabilities
• Repeatedly cleanable
• No soluble polymeric extractables
• No unloading or shedding
• Absolute rated for reliable performance
• ISO 9000 Certified Quality System
• Manufactured for use in conformance
with cGMP
• FDA-listed materials per 21 CFR

139
 PSS Porous Metal Filter Cartridges
Technical Specifications

Materials of Construction Typical Liquid Flow Rates(6)

Flow Rate (L/min)
Medium Type 316L stainless steel (1)

0 5 10 15 20 25 30
End Caps Type 316 stainless steel (1) 3.2
P05 P09 PH
200
Gasket Buna-N (Standard)(2)

Differential Pressure (mbar)

Differential Pressure (psid)
(1)
Other grades and alloys available 2.4
(2)
Other Polymers available. 150

Configuration(3) 1.6
100
Double open-ended (DOE), flat gasket seals
(3)
Single open-ended AB sanitary and threaded styles available. PF
0.8 50

Nominal Dimensions PD, PE

Diameters P Series: 2.5 in. (64 mm) 0 0

0 2 4 6 8
S Series: 2.38 in. (60.5 mm) Flow Rate (gpm)
Flow Rate (L/min)

Operating Conditions 0 8 16 24 32
3.6
S050 S100
Maximum Differential Pressure(4) 240

Forward and Reverse 3.4 bard (50 psid) to 232 °C (450 °F)

Differential Pressure (mbar)

Differential Pressure (psid)
2.7 200
Flow Direction
(4)
Minimum collapse differential pressure. Temperature limit with Buna-N gaskets: 160
121 °C (250 °F). Other gasket materials to 232 °C (450 °F). For temperatures to 316 °C
(600 °F), or in other alloys to 677 °C (1250 °F), contact your local Pall distributor. 1.8
120

Recommended Maximum Flow Densities(5) 80

0.9 S200
Grade Aqueous Air 40
L/min (gal/min) Nm3/hr (acfm) S350
P Series 0 0
0 1 2 3 4 5 6 7 8 9
PD 3.5 (0.9) 13 (80) Flow Rate (gpm) per 10 in. (254 mm) filter
PE 2.5 (0.7) 9.5 (60) (6)
Typical initial clean medium ∆P per 10 in. (254 mm) element, water at
20 °C (68 °F), 1 cp. For assistance in sizing and housing selection, contact
PF 2.1 (0.6) 7.9 (50) your local Pall representative.
PH 1.4 (0.4) 6.3 (40)
P09 1.1 (0.3) 4.7 (30)
P05 0.7 (0.2) 1.6 (10)
S Series
S350 3.5 0.9) 13 (80)
S200 2.5 (0.7) 7.9 (50)
S100 1.8 (0.5) 6.3 (40)
S050 1.1 (0.3) 3.2 (20)
(5)
Ratings are absolute particulate in liquids and gases. Aqueous water, 1 cp and air
flows per 10 in. (254 mm) cartridge.

Ordering Information

MBS100

Code Nominal Length Filter Area Code Liquid Ratings(7) Gas Ratings(7) Code Gasket Options
1 10 in. (254 mm) 0.05 m (0.5 ft )
2 2
PD 55 µm 20 µm H13 Buna-N gaskets (Standard)
PE 35 µm 11 µm
2 20 in. (508 mm) 0.09 m2 (1.0 ft2) H Viton*
PF 20 µm 2.8 µm
3 30 in. (762 mm) 0.14 m2 (1.5 ft2) J Ethylene Propylene
PH 13 µm 1.3 µm
J7 Ethylene Propylene (Steam Service)
P09 9 µm 0.8 µm
Other materials available on request.
P05 5 µm 0.4 µm * Viton is a registered trademark of DuPont Dow
S35 35 µm 11 µm (non-FDA materials).
S200 20 µm 2.8 µm
S100 10 µm 0.8 µm
S050 5 µm 0.4 µm
140 (7)
Liquids: > 99.98% by mod. OSU-F2 test.
Gases: 100% for hard spherical particles.
 PMM Metal Membrane Filter Cartridges
®
Pleated Composite Metal Media for High-removal Efficiency
Pall PMM metal membrane media
combine the best qualities of Pall’s PSS
and Rigimesh media by incorporating a
thin matrix of ultra-fine stainless steel
powders sintered within the pore structures
of fine sintered stainless steel woven wire
mesh. This combination of technologies
enables production of highly permeable
metal membranes with greater strength
and finer grades than either method alone.
PMM media can be pleated to form
double open-ended (DOE) MBS1000 style
membrane filter cartridges with high area
and fine ratings making it an excellent
choice for steam service and other fine
solids recovery/removal applications in
both liquid and gas applications.
Features and Benefits
• All-stainless steel construction
• Controlled and fixed pore size
• High area pleated cartridges
• Efficiencies to 2 µm absolute in liquids
• Ultra-clean steam service
• Efficient cake formation and solids
recovery
• Corrosion resistant
• High pressure resistant
• Withstands high reverse-flows
• High-temperature capabilities
• Repeatedly cleanable
• No soluble polymeric extractables
• No unloading or shedding
• Absolute rated for reliable performance
• ISO 9000 Certified Quality System
• Manufactured for use in conformance
with cGMP
• FDA-listed materials per 21 CFR
141
 PMM Metal Membrane Filter Cartridges
Technical Specifications

Materials of Construction Typical Liquid Flow Rates(6)

Flow Rate (L/min)
Medium Type 316L stainless steel (1)

0 3 6 9 12 15
End Caps Type 304 stainless steel (1) 0.54
M020 M050 M100 35
Gasket Buna-N (standard)(2) M150
(1)
Other grades and alloys available. 30
(2)
Other polymers available. 0.405

Differential Pressure (mbar)

Differential Pressure (psid)
25

Configuration(3)
20
Double open-ended (DOE), flat gasket seals 0.27
(3)
Single open-ended AB sanitary and threaded styles available. 15
M200

Nominal Dimensions 0.135 10

Diameters 2.5 in. (64 mm)

5

Operating Conditions 0 0
0 1 2 3 4
Maximum Differential Pressure and Temperature(4)
Flow Rate (gpm)
Forward Flow Direction 8.6 bard (125 psid) to 232 °C (450 °F) (6)
Typical initial clean medium ∆P per 10 in. (254 mm) element, water at
Reverse Flow Direction 0.7 bard (10 psid) to 232 °C (450 °F) 20 °C (68 °F), 1 cp. For assistance in sizing and housing selection, contact
your local Pall representative.
(4)
Minimum collapse differential pressure. Limit with Buna-N gaskets: 121 °C (250 °F).
Other gasket materials to 232 °C (450 °F). For Reinforced for 3.4 bard (50 psid)
Reverse Flow option, temperatures to 316 °C (600 °F), or in other alloys to 677 °C
(1250 °F), contact your local Pall distributor.

Recommended Maximum Flow Densities(5)

Grade Aqueous Air
L/min (gal/min) Nm3/hr (acfm)
M200 1.4 (0.37) 4.7 (30)
M150 1.1 (0.29) 3.9 (25)
M100 0.4 (0.1) 3.2 (20)
M050 0.3 (0.08) 1.6 (10)
M020 0.3 (0.08) 1.6 (10)
(5)
Ratings are absolute particulate in liquids and gases. Aqueous (water, 1 cp) and air
flows per 10 in. (254 mm) cartridge.

Ordering Information

MBS100

Code Nominal Length Filter Area Code Liquid Ratings(7) Gas Ratings(7) Code Gasket Options
1 10 in. (254 mm) 0.14 m (1.5 ft )
2 2
M200 20 µm 55 µm H13 Buna-N gaskets (Standard)
2 20 in. (508 mm) 0.28 m2 (3.0 ft2) M150 15 µm 25 µm H Viton*
3 30 in. (762 mm) 0.42 m2 (4.5 ft2) M100 10 µm 18 µm J Ethylene Propylene
4 40 in. (1016 mm) 0.56 m2 (6.0 ft2) M050 5 µm 13 µm J7 Ethylene Propylene (Steam Service)
M020 2 µm 2 µm Other materials available on request.
* Viton is a registered trademark of DuPont Dow
(7)
Liquids: > 99.98% by mod. OSU-F2 test. (non-FDA materials).
Gases: 100% for hard spherical particles.

142
Filter Housings
 Filter Housings
Pall has over 35 years of successful
experience in designing and manufacturing
filter housings for a wide range of applications.
All Pall housings allow optimal product flow at
minimal pressure drop to offer users the
advantages of reduced energy costs, safer
operation, and the longest possible filter
service life.
TM
The Pall Advanta line of sanitary housings is
specially designed for applications in the
pharmaceutical and biotechnology industries.
There are no removable tube sheets in these
housings, therefore enabling Clean-in-Place
operation. The housing design is flexible,
providing various inlet and outlet options and
vent and drain configurations. The number of
welds is minimized to reduce the chances of
residual deposit. The interior and exterior
surfaces are electro-polished to meet the
most stringent surface requirements.
Pall’s expertise in BioPharmaceutical filtration
and separation ensures that Advanta
housings meet all GMP requirements.
Supported by the state-of-the-art
manufacturing technology, Pall is the leader in
providing the most reliable and technologically
advanced filter housings to the industry. In this
section, you will find complete product data
for following Pall air/gas and liquid service filter
housings.
144
TM
• Junior Style and Sealkleen stainless
steel filter housings for laboratory use
and process development
TM
• Pall Advanta Junior housings for small
to medium volume sanitary applications
• Pall Advanta single-round sanitary
housings with aseptic design and
engineered for the filtration of gases and
fluids in today’s manufacturing
processes
• Pall Advanta multi-round sanitary
housings for high-flow liquid applications
TM
• Veladisc filter housings for Supradisc
depth filter modules
• Junior Style industrial housings for small
flow applications
• IOL and IDL industrial single cartridge
filter housings
• PCY polypropylene housings for liquid
filtration applications
TM
• Megaplast plastic housings that can be
utilized safely at high pressures for
high-flow rate applications
 Junior B series Filter Housings
Small-scale Stainless Steel Housings for High-flow Gas or Liquid Filtration

To meet the increasing demand for Applications

small-scale filters for laboratory use and
process development, Pall has developed
the the Junior B series housings. These are
some of the smallest stainless stainless
steel housings on the market, yet they can
Above: BLS7001G23J
achieve very high-flow rates using specially
developed Pall SBF-style pleated
cartridges. For small-scale filtration this
Junior range is less cumbersome than
larger housings or difficult-to-use disc
holders. All styles are suitable for in situ
steam-sterilization in sterile processes.
• Small batches of biological and
biochemical fluids
• Filtration of compressed gases
• A variety of processes requiring filtration
of small flows of liquids or gases
• Sterile air for small and medium
fermentation systems
• Sterile venting of small tanks and
vessels

Features and Benefits

• Minimal size and weight makes these
filter housings ideal for bench-top use,
or for installing into processing
equipment, for both gas and liquid
filtration up to 10 bar (145 psi)
operating pressure
• The electropolished crevice-free
surfaces give maximum cleanliness for
sterile processes. In situ
steam-sterilization and steam
autoclaving up to 140 °C (284 °F) can
be employed
• Housings are made of 316L stainless
steel, and are therefore resistant to a
wide variety of chemicals
• Maximizes product recovery, particularly
important when filtering small-batch or
high value products.
• Plug-in double O-ring cartridges in a
selection of Pall filtration media are
available to give maximum filtration
quality, economy and performance for
individual applications
• Available in T-flow or inline styles with
butt weld or sanitary inlet and outlet
connections

145
 Junior B series Filter Housings
Technical Specifications

Materials of Construction Typical Liquid Flow Rates for Typical Air Flow Rates for
BLS/BTS 7001 Housing* BLS/BTS 7001 Housings*
Housing 316L stainless steel except the
10000 10000
closure ring which is 431 stainless steel
Seal Material Ethylene Propylene
Vessel Closure Closure ring

Differential Pressure (mbar)

Differential Pressure (mbar)
Surface Finish Electro-polishing 1000 1000
Inlet and Outlet a) 1 in. Sanitary flange
Connection Options b) 15 mm Butt weld

Vent Connection BTS Housing:

Male Stäubli* 100 100
Drain Connection BTS Housing:
Hose barb

BLS Housing:
Hose barb 10 10
1 10 100 1 10 100
Design Code Designed and manufactured to Pall Flow Rate (L/min) Flow Rate (Nm3/h)
industrial standards which includes:
a) A minimum design capability of * 1 bar = 14.5 psi, 1 Nm3/h = 0.59 scfm
5 x maximum operating pressure
b) Hydrostatically testing each unit to
at least 1.5 x maximum operating Nominal Dimensions
pressure
BLS7001G23J BLS7001G22J BTS7001G23J
* Stäubli is a registered trademark of Stäubli AG.
Dimension A 121 mm 218 mm 218 mm
(4.76 in.) (8.6 in.) (8.6 in.)
Operating Conditions Dimension B 64 mm 64 mm 64 mm
Maximum Operating -1(1) to 10 barg (2.52 in.) (2.52 in.) (2.52 in.)
Pressure (-14.5(1) to 150 psig) Dimension C 75 mm 75 mm 75 mm
Maximum Operating and 140 °C (284 °F) (2.95 in.) (2.95 in.) (2.95 in.)
Steaming Temperature Dimension D 49 mm 49 mm 49 mm
(1)
Full vacuum. (1.93 in.) (1.93 in.) (1.93 in.)

Use with Steam: This housing may be steam-sterilized and used for steam filtration up Dimension E – 66 mm 66 mm
to a temperature of 140 °C (284 °F). Operating limits for steam service may be (2.60 in.) (2.60 in.)
influenced by filter cartridge specifications. Refer to appropriate literature for Pall filter
cartridges. Weight 1.3 kg 1.3 kg 1.3 kg
(2.87 lbs) (2.87 lbs) (2.87 lbs)

Pressure Drop Volume 0.1 L 0.1 L 0.1 L

The water flow and pressure drop characteristics refer to the empty housing only for (3)
Length across.
water flow at 20 °C (68 °F). For other liquids multiply pressure drop by the relative
density. The air flow and pressure drop characteristics refer to the empty housing only for
air flow at 20 °C (68 °F). Flow rates relate to air (in Nm3/hour/scfm) at 2 bar gauge (3 bar
(43.5 psi) absolute). Pressure drops for other pressures may be obtained by multiplying
the figure taken from the bar gauge graph with the factor shown in the following table:
BLS 7001 Housing BTS 7001 Housing

Working Pressure (Barg) (2)

1 2 3 4 5
Factor to Apply 1.50 1.00 0.75 0.60 0.50 Required Clearance C Required Clearance C
for Cartridge Removal for Cartridge Removal
Working Pressure (Barg) 6 7 8 9 10
Factor to Apply 0.42 0.37 0.33 0.30 0.2 ØD
To obtain the total pressure drop of a complete filter assembly, the cartridge pressure
drop must be added. Please refer to the relevant filter cartridge literature or contact Pall.
(2)
1 bar = 14.5 psi. A ØD

Ordering Information Inlet and Outlet

Connection

B S7001G J B E

Code Housing Type Code Inlet and Outlet

B
L In-Line 22 15 mm Butt weld
T T-flow 23 1 in. sanitary flange
Housings use Pall SBF1 style filter
cartridges, and are supplied without
cartridges

146
 Sealkleen™ Filter Housings
Versatile In-line Filter Housings for Small-scale Production

Sealkleen filter housings are versatile in- Features and Benefits

line filter housings for small-scale
• Aseptic design — with electropolished
production. In-line filter housings are ideally
surfaces giving typical internal
suited for bench top applications and
Ra-values of ≤ 0.4 µm (≤ 15 µin.)
processes where minimal hold-up volumes
without crevices or deadlegs
are required to maximize product yields.
Left: ZLK702G10NKH4
The Pall Sealkleen housing combines this • High product yields by low hold-up
Right: ZLK702G23LHKH4 key requirement with a unique production volumes
safety concept. • Valve designed for easy operation,
Its patented sealing mechanism ensures maintenance and filter integrity testing
that the downstream section of the filter • Variants for integration into automated
is essentially never contaminated with systems
unfiltered fluid. Designed for GMP use,
these housings are easy to use and benefit • Wide range of connection options
from low installation and maintenance
costs.
Pall Sealkleen filter housings are made
from stainless steel grade AISI 316L.
Advanced manufacturing technologies
including CNC machining and orbital
welding ensures a robust and highly
sanitary design.
Features of this housing range include high
quality electropolished internal surfaces, a
design optimized for CIP/SIP requirements,
design variants for easy automation, as
well as convenient filter integrity testing.

147
 Sealkleen Filter Housings
Technical Specifications

Materials of Construction Typical Gas Flow Rates

All Product Wetted Parts AISI 316L Flow Rate (scfm)
0 30 60 90
V-Clamp AISI 316L, Nitronic 60 300
GNW15 and G10 4.0
Seals Silicone elastomer
Surface Finish All electropolished 250

Differential Pressure (mbar)

Differential Pressure (psi)

Internal: 3.0
Ra ≤ 0.4 µm (≤ 15 µin.) (typical) 200

External:
Ra ≤ 0.8 µm (≤ 32 µin.) (typical) 150 2.0
Documentation Certificate type 2.3 to EN10204
100
1
Operating Conditions 50
G23L
Maximum Operating -1 to 10 barg
(1)

Pressure (-14.5(1) to 150 psig) 0 0

0 20 40 60
Maximum Operating 150 °C (300 °F)
Flow Rate (Nm /h) 3

Temperature
(1)
Full vacuum. Typical Water Flow Rates
Flow (gal/min)
Nominal Dimensions 0 1 2 3 4 5
200
Part Number A(2)
B C
(3)
Weight Volume GNW15 and G10
ZLK702G23LHKH4 202 mm 63.5 mm 135 mm 1.1 kg 0.5 L 2.5
Differential Pressure (mbar)

Differential Pressure (psi)

ZLK702G23LDDH4 (8.0 in.) (2.5 in.) (5.3 in.) (2.42 lbs) 150
ZLK702GNW15NKH4
2.0
ZLK702G10NKH4 270 mm 63.5 mm 135 mm 1.1 kg 0.5 L
(10.7 in.) (2.5 in.) (5.3 in.) (2.42 lbs) 100 1.5
(2)
SLK7001 variant may be possible, please contact Pall for details.
(3)
For use with Sealkleen SLK7002 filter elements. Where SLK7001 type filters are used, 1
the clearance requirement reduces to 75 mm (3.0 in.).
50
Gas flow and differential pressure characteristics refer to the empty housing only for air at G23L
0.5
2 barg pressure and 20 °C (68 °F). Pressure drops for other pressure ratings may be
obtained by multiplying the pressure drop at 2 barg by the factors shown in table below.
0 0
0 5 10 15 20
Pressure Comparisons Flow Rate (L/min)
Working Pressure (barg) 1 2 3 4 5 6
Working Pressure (psi)(3) 15 30 45 60 75 90 Filter Styles and Dimensions
Factor to Apply 1.50 1 0.75 0.60 0.50 0.42 C
(3)
psi rounded figure. Clearance for
Cartridge removal
Main Accessories and Spares B

Part Number(4) Description

ACS0598CM Diaphragm valve for 1⁄2 in. sanitary flange

Overall Height
connections including clamp and
silicone gasket A
ACS0272EU Silicone housing gasket

SLK1VG23H4 Downstream gasket (silicone)

ACS0718EU Housing valve gasket (silicone)

ZLK702G23LHKH4 ZLK702G23LDDH4 ZLK702GNW15NKH4 ZLK702G10NKH4
ACS0224DA V – Clamp housing closure

ORH4P-335 Silicone housing closure gasket

(4)
For steam jacketed housing option, please contact Pall.

Ordering Information

ZLK 702 G H4(5)

Code Inlet and Outlet Code Vent Code Drain

23L For 11⁄2 in. sanitary flange(5) D For 1⁄2 in. sanitary flange(5) D For 1⁄2 in. sanitary flange(6)
NW15 Dairy fitting NW15 to DIN 11851 H Sanitary valve with quick release K Sanitary hose barb valve
10(7) Hosetail for 13 mm (1⁄2 in.) i.D. tubing fitting for Stäubli* couplings(6) for 6 mm (1⁄4 in.) I.D. tubing
K Sanitary hose barb valve (5)
Gasket material silicone, other materials available on request.
for 6 mm (1⁄4 in.) i.D. tubing(7) (6)
Available for sanitary flange inlet and outlet connections only.
(7)
Care should be taken to fit hoses to the housing in a
N No vent
secure manner suitable to withstand the maximum
148 * Stäubli is a trademark of Stäubli AG. operating pressure of 10 barg (150 psig).
 Pall Advanta™ Junior Filter Housings
Advanced Sanitary Housings for Small to Medium Applications

Pall Advanta Junior filter housings are

designed for small to medium volume
sanitary applications. Four complete series
— AGT, ALI, ALT and AVL — provide
optimal performances for gas filtration of
up to 100 Nm3/hour (60 SCFM) and liquid
filtration of up to 7.5 L/min (2 gal/min). Pall
Advanta Junior housings are made from
stainless steel grade AISI 316L and are
available in in-line, L flow and T flow
configurations.
Developed for GMP implementation, these
low upstream volume housings enable high
product yields, low installation costs, low
maintenance costs and operational
simplicity. Advanced manufacturing
technologies including CNC machining,
automatic orbital welding and
electro-polishing ensure a robust and
highly sanitary design that meets the most
stringent requirements.
Top: Pall Advanta Junior Housing — Liquid
Bottom: Pall Advanta Junior Housing — Gas

Applications
Series AGT ALI ALT AVL
Applications Air and Gas Air and Gas, Air and Gas, Air and Gas,
Liquid Liquid Liquid

Filter MCY4463 MCY 1110 – MCY 4440 MCY 1110 –

Cartridges MCY4440 MCY4440 MCY 4440
Configurations T Flow Inline Flow T Flow L Flow

Specification
Maximum Operating Pressure -1 to 10 barg (-14.5* to 150** psig)

Maximum Operating Temperature 150 °C (300 °F)

Materials of Construction
All Product Wetted Parts AISI 316L
V-Clamp AISI 316L, Nitronic 60
Seals Silicone elastomer
Surface Finish All electropolished
Internal: Ra ≤ 0.4 µm (≤ 15 µin.) (typical)
External: Ra ≤ 0.8 µm (≤ 32 µin.) (typical)

Inspection Documentation Certificate type 2.3 to EN10204

* Full vacuum.
** With compatible fluids, which do not soften, swell or adversely affect the gasket materials. 149
 Pall Advanta Junior Gas Filter Housings
Technical Specifications

High quality sanitary T-style housings for general purpose small-scale Typical Air Flow Rates(4)
gas filtration. Flow Rate (Nm3/h)
0 20 40 60 80 100 120 140 160
Features of this housing range for use in sanitary gas applications are 4.4 300
A B
• A: Vent
high quality electropolished internal surfaces, a design optimized for • B: 1 barg (15 psig)
• C: 2 barg (29 psig)
CIP/SIP requirements, design variants for easy automation, as well as • D: 3 barg (44 psig) C
convenient filter integrity testing with the Water Intrusion Test method

Differential Pressure (mbar)

Differential Pressure (psi)
for hydrophobic filters. 2.9 200

Features and Benefits D

• Aseptic design — with electropolished surfaces giving typical

internal Ra-Values of ≤ 0.4 µm (≤ 15 µin.) without crevices or 1.5 100

deadlegs and fully self draining

• In situ water intrusion test without additional upstream gas buffer
volumes
0 0
• New valve design for easy operation, maintenance and filter 0 10 20 30 40 50 60 70 80 90
Flow Rate (scfm)
integrity testing
(4)
Gas flow and differential pressure characteristics refer to the empty
• Variants for integration into automated systems housing only for air at 20 °C (68 ° F). Pressure drops for other pressure
ratings may be obtained by multiplying the pressure drop at the pressure
• Cartridge fixes to internal spigot and sealed by single O-ring stated by the factors shown in the table.

• Every housing supplied with a quality certificate and manufactured

to ATEX Directive 94/9/EC (Group ll Category 2) Pressure Comparisons
Working Pressure (barg) 1 2 3 4 5 6

Nominal Dimensions Working Pressure (psi)(3) 15 30 45 60 75 90

Factor to Apply 1.50 1 0.75 0.60 0.50 0.42
Part Number(1) Face to Face Overall(2) Clearance
Width Height Required (3)
Psi rounded figure.

AGT463G05HKH4 151 mm 308 mm 112 mm

AGT463G23HKH4 (5.9 in.) (12.1 in.) (4.4 in.)
Main Accessories and Spares
AGT463GNW15HKH4
AGT463GB21HKH4 Part Number Description
AGT463G05DDH4 151 mm 226.5 mm 112 mm ACS0598CM Diaphragm valve for 1⁄2 in. sanitary flange
(5.9 in.) (8.9 in.) (4.4 in.) connections to ISO 2852 including
clamp and silicone gasket
AGT463GB21NEH4 151 mm 211 mm 112 mm
(5.9 in.) (8.3 in.) (4.4 in.) ORH4P-150 Silicone housing closure gasket
ACS0718EU Housing valve gasket kit
AGT463GB21NNH4 151 mm 187 mm 112 mm
(5.9 in.) (7.3 in.) (4.4 in.) ACS0224DA V Clamp housing closure
(1)
Pall Advanta Junior AGT463 housings are not designed to be fitted with MCY2230 Further spares and accessories available upon request.
filter elements. For special Pall Advanta Junior housings accepting MCY2230 filter
elements, please contact Pall.
(2)
When MCY2230 elements are used, please consult Pall.

Ordering Information

AGT 463 G H4(5)

Code Design Code Inlet and Outlet Code Vent Code Drain
– To European Pressure 05 For 3⁄4 in. sanitary flange D For 1⁄2 in. sanitary flange D For 1⁄2 in. sanitary flange
Equipment Directive to ISO 2852 to ISO 2852 to ISO 2852

D To European Pressure
Equipment Directive with
enhanced documentation
including 3.1b stamped
material and certification
150
23 For 1 in. sanitary flange E Butt weld H Sanitary valve with
to ISO 2852 13.5 x 1.6 mm to ISO 1127 quick release fitting for
Stäubli couplings
NW15 Dairy fitting NW15 to H Sanitary valve with
DIN11851 quick release fitting for K Sanitary valve with
Stäubli* couplings hose barb for 6 mm
B21 Butt weld 21.3 x 1.6 mm (1⁄4 in.) i.D. tubing
to ISO1127 N No vent
E Butt weld 13.5 x
Gasket material silicone, other gasket
(5)
1.6 mm to ISO 1127
materials available on request.
Please contact Pall. N No drain
* Stäubli is a trademark of Stäubli AG.
 Pall Advanta Junior F Liquid Filter Housings
Technical Specifications

High quality versatile sanitary T-style housings for all small-scale gas Typical Water Flow Rates(3)
filtration.
Typical Water Flow Rate (gpm)
Features of this housing range are high quality electropolished internal 0 5 10 15 20
500 7
surfaces, a design optimized for CIP/SIP requirements, design
variants for easy automation, as well as convenient filter integrity
6
testing. 400

Differential Pressure (mbar)

Differential Pressure (psi)

5
Features and Benefits
300
4
• Aseptic design — with electropolished surfaces giving typical
internal Ra-Values of ≤ 0.4 µm (≤ 15 µin.) without crevices or 3
200
deadlegs and fully self draining
• New valve design for easy operation, maintenance and filter 2

integrity testing 100

1
• Variants for integration into automated systems
0 0
• Wide range of connection options 0 20 40 60 80

• Cartridge retained by built-in flanges and double O-ring seal Typical Water Flow Rate (L/min)

• Housings accept up to four cartridge sizes for flexibility (3)

Water flow and differential pressure drop characteristics refer to the empty
housing only for water at 20 °C (68 °F). For other liquids please multiply
• Every housing supplied with a quality certificate and manufactured pressure drop by specific gravity.

to ATEX Directive 94/9/EC (Group ll Category 2)

Nominal Dimensions
Part Number(1) Face to Face Overall(2) Clearance Main Accessories and Spares
Width Height Required Part Number Description
ALT440G05HKH4 151 mm 314 mm 112 mm ACS0598CM Diaphragm valve for 1⁄2 in. sanitary clamp
ALT44GNN15HKH4 (5.9 in.) (12.4 in.) (4.4 in.) compatible connections to ISO 2852
ALT440GA15HKH4 including clamp and silicone gasket
ALT440GB21HKH4
ALT440G23HKH4 ORH4P-150 Silicone housing closure gasket
ACS0718EU Housing valve gasket kit
ALT440G05DDH4 151 mm 227 mm 112 mm
(5.9 in.) (8.9 in.) (4.4 in.) ACS0224DA V Clamp housing closure
(1)
MCY2220 and MCY1110 variants may be possible, refer to Pall. Further spares and accessories available upon request.
(2)
For MCY4440 filters, where smaller filter elements are used, please consult for nominal
length information.

Ordering Information

ALT 440 G H4*

Code Design Code Inlet and Outlet Code Vent Code Drain
– To sound engineering 05 For 3⁄4 in. sanitary D For 1⁄2 in. Tri-Clamp* D For 1⁄2 in. sanitary
practice clamp to ISO 2852 to ISO 2852 clamp to ISO 2852

D To sound engineering 23 For 1 in. sanitary H Sanitary valve with K Sanitary valve with
practice with enhanced clamp to ISO 2852 quick release fitting for hose barb for 6 mm
documentation including Stäubli* couplings (1⁄4 in.) i.D. tubing
3.1b stamped material A15 Aseptic thread connections
and certification to DIN11864-1 * Gasket material silicone, other gasket
materials available on request.
NW15 Dairy fitting NW15 to Please contact Pall.
DIN11851 * Stäubli is a trademark of Stäubli AG.

B21 Butt weld 21.3 x 1.6 mm

to ISO1127

151
 Pall Advanta Junior F Gas Filter Housings
Technical Specifications

Versatile high quality sanitary T-style housings for all small-scale gas Typical Air Flow Rates(4)
filtration. Flow Rate (Nm3/h)
0 20 40 60 80 100 120 140 160
Features of this housing range for use in sanitary gas applications are 4.4 300
A B
• A: Vent
high quality electropolished internal surfaces, a design optimized for • B: 1 barg (15 psig)
• C: 2 barg (29 psig)
CIP/SIP requirements, design variants for easy automation, as well as • D: 3 barg (44 psig) C
convenient filter integrity testing with the Water Intrusion Test method

Differential Pressure (mbar)

Differential Pressure (psi)
for hydrophobic filters. 2.9 200

Features and Benefits D

• Aseptic design — with electropolished surfaces giving typical

internal Ra-Values of ≤ 0.4 µm (≤ 15 µin.) without crevices or 1.5 100

deadlegs and fully self draining

• In situ water intrusion test without additional upstream gas buffer
volumes
0 0
• New valve design for easy operation, maintenance and filter 0 10 20 30 40 50 60 70 80 90
integrity testing Flow Rate (scfm)
• Variants for integration into automated systems (4)
Gas flow and differential pressure characteristics refer to the empty
housing only for air at 20 °C (68 ° F). Pressure drops for other pressure
• Wide range of connection options ratings may be obtained by multiplying the pressure drop at the pressure
stated by the factors shown in the table.
• Cartridge retained by built in flanges and double O-ring seal
• Housings accept single cartridges in four different lengths for
increased flexibility
Pressure Comparisons
• Every housing supplied with a quality certificate and manufactured
to ATEX Directive 94/9/EC (Group ll Category 2) Working Pressure (barg) 1 2 3 4 5 6
Working Pressure (psi)(3) 15 30 45 60 75 90
Nominal Dimensions Factor to Apply 1.50 1 0.75 0.60 0.50 0.42
(3)
Psi rounded figure.
Part Number (1)
Face to Face Overall (2)
Clearance
Width Height Required

AGT440G05HKH4 151 mm 312.5 mm 112 mm

AGT440G23HKH4 (5.9 in.) (12.3 in.) (4.4 in.)
AGT440GNW15HKH4
Main Accessories and Spares
AGT440GA15HKH4 Part Number Description
AGT440G05DDH4 151 mm 228.5 mm 112 mm ACS0598CM Diaphragm valve for 1⁄2 in. sanitary flange
(5.9 in.) (8.9 in.) (4.4 in.) compatible connections to ISO 2852
including clamp and silicone gasket
AGT440GB21ENH4 151 mm 213 mm 112 mm
(5.9 in.) (8.4 in.) (4.4 in.) ORH4P-150 Silicone housing closure gasket

AGT440GB21NNH4 151 mm 190.5 mm 112 mm ACS0718EU Housing valve gasket kit

(5.9 in.) (7.5 in.) (4.4 in.) ACS0224DA V Clamp housing closure
(1)
MCY2220 and MCY1110 variants may be possible, refer to Pall. * Further spares and accessories available upon request.
(2)
For MCY4440 filters, where smaller filter elements are used, please consult for nominal
length information

Ordering Information

AGT 440 G H4(5)

Code Design Code Inlet and Outlet Code Vent Code Drain
– To sound engineering 05 For 3⁄4 in. sanitary flange D For 1⁄2 in. sanitary flange D For 1⁄2 in. sanitary flange
practice to ISO 2852 to ISO 2852 to ISO 2852

D To sound engineering
practice with enhanced
documentation including
3.1b stamped material
and certification
NW15
152
23 For 1 in. sanitary flange E Butt weld H Sanitary valve with
to ISO 2852 13.5 x 1.6 mm to ISO 1127 quick release fitting for
Stäubli couplings
A15 Aseptic thread connections H Sanitary valve with
to DIN11864-1 quick release fitting for K Sanitary valve with
Stäubli* couplings hose barb for 6 mm
Dairy fitting NW15 to (1⁄4 in.) i.D. tubing
DIN11851 N No vent
E Butt weld 13.5 x
B21 Butt weld 21.3 x 1.6 mm * Stäubli is a trademark of Stäubli AG.
1.6 mm to ISO 1127
to ISO1127
N No drain
(5)
Gasket material silicone, other gasket
materials available on request. Please
contact Pall.
 Pall Advanta™ ALT Liquid Filter Housings
Advanced Sanitary T-Style Filter Housings for Liquid Applications
The Pall Advanta range of filter housings
has been specifically designed and
engineered for today’s manufacturing
processes. These advanced housings are
manufactured from 316L stainless steel
and are engineered to meet the
requirements of the BioPharmaceutical
industry. State-of-the-art manufacturing
technologies are used to construct a
housing ideal for the most critical of
applications.
Fine filtration of liquids is a key part of
many production processes. These Pall
Advanta housings have been specifically
designed to meet the many requirements
of this demanding application. During the
design process critical features were
optimized to ensure trouble-free use and
low installation and maintenance costs.
Areas such as surface finish, suitability for
CIP and SIP, integrity testing and
incorporation into automated production
processes are included:
Features and Benefits
• Aseptic design
◆ Crevice-free electropolished surfaces
with an internal Ra value of ≤ 0.4 µm
(≤ 15 µin.)
◆ Fully self draining
◆ No dead legs
• Low hold-up volumes for maximum
product recovery
• Quick fit Stäubli*-type connections for
easy filter integrity testing
• Easy to use low point sanitary drain
valve
• Range of options to aid use in
automated production systems
• CE marking shows design review to
European Pressure Directive 97/9/EC
• Every housing supplied with a quality
certificate and manufactured to ATEX
Directive 94/9/EC (Group ll Category 2)
• Variety of connection styles, vents and
drains offer choice and convenience
• Filter cartridge accepts single
open-ended Pall Code 7 and Code 2
AB style 5 in. (127 mm), 10 in.
(254 mm), 20 in. (508 mm), and 30 in.
(762 mm) height filter cartridges
* Stäubli is a trademark of Stäubli AG.
153
 Pall Advanta ALT Liquid Filter Housings
Technical Specifications

Materials of Construction Typical Water Flow Rates(3)

Flow Rate (Gal/min)
Wetted Parts AISI 316L stainless steel
0 5 10 15 25
Clamp AISI Nitronic* 60 300

O-ring Silicone — FDA-listed 4

250
Steam-sterilizable Up to 150 °C (300 °F)

Differential Pressure (mbar)

Surface Finish All electropolished

Differential Pressure (psi)

3
Internal: 200
Ra ≤ 0.4 µm (≤ 15 µin.) (typical)

External: 150
Ra ≤ 0.8 µm (≤ 32 µin.) (typical) 2

Inspection Documentation Test report type 2.3 to EN10204 100

Conformance to EC PED(1)
1
(1)
With compatible fluids, which do not soften, swell or adversely affect the materials.
50
* Nitronic is a registered trademark of Armco Inc.

0 0
Nominal Dimensions 0 10 20 30 40 50 60 70 80 90 100
Part Number(2) Face to Face Overall Clearance Flow Rate (L/min)
Width Height Required (3)
The flow and pressure drop characteristics refer to the empty housing only
for water at 20 °C (68 °F). For other liquids multiply pressure drop by relative
ALT105G23CBH4 190 mm 378 mm 160 mm density. To obtain the total pressure drop of a complete filter assembly, the
(7.4 in.) (14.8 in.) (6.2 in.) cartridge pressure drop must be added. Please refer to the relevant filter
cartridge literature or contact Pall.
ALT11G23CBH4 190 mm 514 mm 320 mm
ALT11GNW25CBH4 (7.4 in.) (20.2 in.) (12.5 in.)

ALT11G23CDH4 190 mm 519 mm 320 mm

(7.4 in.) (20.4 in.) (12.5 in.) Operating Conditions
ALT11G23DDH4 190 mm 437 mm 320 mm Maximum Operating -1 to 10 barg
(7.4 in.) (17.2 in.) (12.5 in.) Pressure (-14.5(4) to 150(5) psig)

ALT11GA25ABH4 190 mm 517 mm 320 mm Maximum Operating 150 °C (300 °F)

(7.4 in.) (20.3 in.) (12.5 in.) Temperature

ALT12G23CBH4 190 mm 765 mm 570 mm (4)

Full vacuum.
(7.4 in.) (30.1 in.) (22.4 in.)
(5)
With compatible fluids, which do not soften, swell or adversely affect the materials.

ALT13G23CBH4 190 mm 1039 mm 820 mm

ALT13GNW25CBH4 (7.4 in.) (40.9 in.) (32.2 in.)
(2)
These part numbers represent the most commonly used housing variants with the
shortest lead times. Many other variants are available (see ordering information).
Please contact Pall for further information.

Ordering Information

ALT 1 G H4(6)

Code Design Code Cartridge Type Code Inlet and Outlet Code Vent Code Drain
– To European Pressure 05 AB05 code 2 23 1 in. sanitary A Sanitary valve B Sanitary valve with
Equipment Directive flange to ISO 2852 fitting for Stäubli hosebarb
1 AB1 code 7 type couplings
D To European Pressure NW25 Dairy fitting NW 25 D ⁄2 in. sanitary flange
1
2 AB2 code 7
Equipment Directive to DIN 11851 C 111⁄2 in. sanitary flange connection to
with enhanced 3 AB3 code 7 connection to ISO 2852
documentation A25 Aseptic thread ISO 2852 with side
connection N No drain
including 3.1b sanitary valve with
stamped material and NW 25 to quick release fitting (6)
Silicone elastomer seal material.
certification DIN 11864-1 for Stäubli type other materials available upon
request.
95 ISO butt weld couplings
33.7 x 2.0 mm D 11⁄2 in. sanitary flange
to ISO 1127 compatible with
side sanitary valve
with fitting for
Stäubli type
couplings

E ISO butt weld

13.5 x 1.6 mm
to ISO 1127
* Stäubli is a trademark of Stäubli AG.
154
Pall Advanta™ In-Line Liquid and Gas Filter Housings
Advanced Sanitary In-Line Filter Housings for Liquid and Gas Applications
The Pall Advanta range of filter housings
has been specifically designed and
engineered for today’s manufacturing
processes. These advanced housings are
manufactured from 316L stainless steel
and are engineered to meet the
requirements of the BioPharmaceutical
industry. State-of-the-art manufacturing
technologies are used to construct a
housing ideal for the most critical of
applications.
Fine filtration of liquids and gases is a key
part of many production processes. These
Pall Advanta housings have been
specifically designed to meet the many
requirements of these demanding
applications. Optimization of critical
features during the design process has
provided a housing range which ensures
trouble-free use and low installation and
maintenance costs. Areas included in this
process were:
• Surface finish
• Suitability for CIP and SIP
• Integrity testing
• Incorporation into automated
production processes
Features and Benefits
• Aseptic design
◆ Crevice-free electropolished surfaces
with an internal Ra value of ≤ 0.4 µm
(≤ 15 µin.)
◆ Fully self draining
◆ No dead legs
• Low hold-up volumes for maximum
product recovery
• Quick fit Stäubli* type connections for
easy filter integrity testing
• Easy to use low point sanitary drain
valve
• Range of options to aid use in
automated production systems
• Every housing supplied with a quality
certificate and manufactured to ATEX
Directive 94/9/EC (Group ll Category 2)
• CE marked in accordance with
Pressure Equipment Directive 97/23/EC
* Stäubli is a trademark of Stäubli AG.
155
 Pall Advanta In-Line Liquid and Gas Filter Housings
Technical Specifications

Materials of Construction Typical Air Flow Rates(3)

Flow Rate (scfm)
Housing AISI 316L Stainless Steel
0 11 23 35 47 58
0.04 1
Clamp 431 Stainless Steel • 1 barg (15 psig)
• 2 barg (29 psig)
Seals Silicone elastomer
• 4 barg (58 psig)

Differential Pressure (mbar)

Differential Pressure (psi)

Surface Finish All electropolished 0.03 0.75
Internal:
Ra ≤ 0.4 µm (≤ 15 µin.) (typical)
0.02 0.5
External:
Ra ≤ 0.8 µm (≤ 32 µin.) (typical)
Documentation Certificate type 2.3 to EN10204 0.01 0.25

Operating Conditions
0 0
0 10 20 30 40 50 60 70 80 90 100
Maximum Operating -1(1) to 10 barg
Pressure (-14.5(1) to 150(2) psig) Flow Rate (Nm3/h)

Maximum Operating 150 °C (300 °F)

Temperature Typical Water Flow Rates(3)
(1)
Full vacuum. Flow Rate (gal/min)
(2)
With compatible fluids, which do not soften, swell or adversely affect the gasket 0 6 11 16 20 27
70 1
materials.
60
Differential Pressure (mbar)

Differential Pressure (psi)

Nominal Dimensions 0.75
50
Part Number Overall Clearance Weight
Height Required 40
0.5
ALI105G23LABH4 301 mm 150 mm 2.2 kg 30
ALI105G23LDDH4 (11.8 in.) (5.9 in.) (4.8 lbs)
20
ALI11G23LAAH4 437 mm 310 mm 2.6 kg 0.25
ALI11G23LABH4 (17.2 in.) (12.2 in.) (5.7 lbs) 10
ALI11GA23LDDH4
0 0
ALI12G23LABH4 688 mm 564 mm 3.5 kg 0 10 20 30 40 50 60 70 80 90 100
ALI12G23LDDH4 (27 in.) (22.2 in.) (7.7 lbs) Flow Rate (L/min)

ALI13G23LABH4 961 mm 818 mm 4.3 kg

ALI13G23LDDH4 (37.8 in.) (32.2 in.) (9.47 lbs) Main Accessories and Spares
(3)
The flow and pressure drop characteristics refer to the empty housing only for water at Part Number Description
20 °C (68 °F). For other liquids multiply pressure drop by relative density. To obtain the
total pressure drop of a complete filter assembly, the cartridge pressure drop must be ACS5098CM Diaphragm valve kit for 1⁄2 in. sanitary
added. flange connections including clamp and
silicone gasket
Gas Filtration: This housing style is suitable for use in the filtration of gases and the in-
line design ensures that the pressure drops are exceptionally low. Pall recommend using ORH4P-238 Silicone housing closure gasket
the cartridge pressure drop when calculating the system pressure drops. Please refer to
the relevant cartridge literature or contact Pall. ACS0602EM Silicone housing valve gasket kit
Contact your Pall representative or local representative for other spares and accessories.

Ordering Information

ALI 1 G H4(4)

Code Design Code Filter Height Code Inlet and Outlet Code Vent Code Drain
– To European Pressure 05 AB05 code 2 23L 1 in. Tri-clamp* A Sanitary valve A Sanitary valve
Equipment Directive fittings to ISO2852 coupling to coupling to Stäubli
1 AB1 code 7 Stäubli** type type RBE.03
D To European Pressure 94 33.7 mm (1.33 in.) RBE.03
2 AB2 code 7
Equipment Directive O.D x 2.0 mm B Sanitary valve with
with enhanced 3 AB3 code 7 (0.079 in.) wall butt D ⁄2 in. sanitary
1
hosetail for 6 mm
documentation weld to ISO 1127 flange connection (1⁄4 in.) ID tubing
including 3.1b to ISO 2852
* Tri-Clamp is a trademark of D ⁄2 in. sanitary flange
1
stamped material and
Alfa-Laval, Inc. ** Stäubli is a trademark of connection to
certification
Stäubli AG. ISO 2852
(4)
Gasket material — silicone, other
gasket materials available on
request. Please contact Pall.

156
 Pall Advanta™ Jacketed Housings
T-Style and In-Line Housings with Jacket for Temperature Control

Jacketed Filter Housings are fabricated • Fewer welds — results in an extremely

with either T-Type or In-Line flow designs sanitary design
and AB style Code 7 fitting configurations
• Automated orbital welding — produces
for single open-ended (SOE) sanitary AB
consistent high quality welds
style filter cartridges. They offer the added
feature of a 316L stainless steel jacket for • Non-rotating vent and drain — prevent
temperature control using hot water or twisted hoses and allow hard piping
steam, and are suitable for gas service or • Manufactured for use in conformance
liquid flows to 20 gal/min (75 L/min) with with cGMP
minimal pressure drops.
• 3-A Sanitary Standard Symbol for
optimized CIP/cleanable design
Features and Benefits
• Manufacturing Quality System Certified
• Corrosion resistant 316 L Stainless to ISO 9000 Standards
steel jacket for temperature control
• In-Line or T-Type flow designs
• Entire housing electropolished
• Internal surfaces with ≤ 0.4 µm
(≤ 15 µin.) Ra surface finish
Top: T-Line Style Filter Housing
• External surfaces with ≤ 0.8 µm
Bottom: In-Line Style Filter Housing
(≤ 32 µin.) Ra surface finish
• Low hold-up volume — maximizes
product recovery
• Easy-draining features, including
downward sloping internal contour and
low-point drain — allows easy removal
of CIP solution or product

157
 Pall Advanta Jacketed Housings
Technical Specifications

Materials of Construction Typical Water Flow Rates(3)

Housing 316L Stainless Steel Flow Rate (gal/min)
Design Pressure and 10 barg at 140 °C (150 psig at 284 °F) 0 6 11 16 20 27
70 1
Temperature Jacket:
4.9 barg at 140 °C (72 psig at 284 °F) 60

Differential Pressure (mbar)

Differential Pressure (psi)

Nominal Diameter 114.5 mm (41⁄2 in.) 50
0.75

Number of Cartridges 1
40
Cartridge Style AB Code 7 0.5
Inlet and Outlet Connections 11⁄2 in Sanitary coupling 30
Jacket:
20
1
⁄2 in. NPT 0.25

Standard Gasket Ethylene Propylene 10

O-ring Material
0 0
0 10 20 30 40 50 60 70 80 90 100
Legs and Support ALT:
Stand available Flow Rate (L/min)

ALI:
None
Closure Style Vee-band clamp
Flow Configuration ALT:
Tee

ALI:
In-Line

Operating Conditions
Maximum Operating -1(1) to 10 barg
Pressure (-14.5(1) to 150(2) psig)

Maximum Operating 150 °C (300 °F)

Temperature
(1)
Full vacuum.
(2)
With compatible fluids, which do not soften, swell or adversely affect the gasket
materials.

Ordering Information

ALT1 J23 H4

ALI1 J23L H4

Code Cartridge Type Code Vent Code Drain

1 AB1 code 7
2 AB2 code 7
A Sanitary valve with B Sanitary valve with 8 mm
quick-release coupling (0.314 in.) hosetail
B Sanitary valve with 8 mm D ⁄2 in. sanitary coupling
1

3 AB3 code 7 (0.314 in.) hosetail N None

4 AB4 code 7 C 11⁄2 in. Sanitary flange connection
to ISO2852
D 1
⁄2 in. Sanitary coupling
N None

158
 Pall Advanta™ AGT Gas Filter Housings
Advanced T-style Housings for Sanitary Applications

This range of Pall filter housings has been
specifically designed and engineered for
the filtration of air and gases. The design
complements the high-flow capacities of
the Pall Emflon range of sterilizing gas filter
cartridges to ensure reliable and cost
efficient filtration.
These advanced gas filter housings are
from the Pall Advanta range of housings.
Manufactured from 316L stainless steel,
Pall Advanta housings are engineered to
meet the requirements of the
BioPharmaceutical industry. Advanced
manufacturing technologies are used to
construct a robust housing, incorporating a
high degree of automated orbital welding.
Features and Benefits
• Crevice-free internal surface finish of
≤ 0.4 µm (≤ 15 µin.) Ra is ideal for all
sanitary applications
• Designed for in-line steaming and
integrity testing with Water Intrusion and
Forward Flow
• Non-rotation valve connections for easy
condensate draining
• Optional vent valve with integrated
Stäubli* compatible connector for easy
connection to Palltronic test equipment
• Low dynamic pressure drop to assist in
energy conservation

Features of this advanced sanitary housing • CE marking shows design review to

such as the surface finish, steam
sterilizability, and ease of filter integrity
testing have been tuned to match today’s
exacting requirements both technically and
economically.
European Pressure Directive 97/9/EC
• Every housing supplied with a quality
certificate and manufactured to ATEX
Directive 94/9/EC (Group ll Category 2)
• Variety of connection styles, vents and
drains offer choice and convenience
• Filter cartridge accepts single
open-ended Pall Code 7 and Code 2
AB style 5 in. (127 mm), 10 in.
(254 mm), 20 in. (508 mm), and 30 in.
(762 mm) height filter cartridges
* Stäubli is a trademark of Stäubli AG.

Main Accessories and Spares

Part Number Description
ACS5098CM Diaphragm valve kit for 1⁄2 in. sanitary flange connections including
clamp and silicone gasket

ORH4P-238 Silicone housing closure gasket

ACS0602EM Silicone housing valve gasket kit

ACS0457FA Pressure gauge kit -1 to 10 barg for 11⁄2 in. sanitary clamp connection
to ISO 2852 (includes clamp and gasket)
Contact your Pall representative or local representative for other spares and accessories.

159
 Pall Advanta AGT Gas Filter Housings
Technical Specifications

Materials of Construction Typical Flow Rates(3)

Wetted Parts AISI 316L stainless steel 150
NW50
Clamp AISI Nitronic 60 NW25 2

O-ring Silicone — FDA-listed

Differential Pressure (mbar)

Differential Pressure (psi)

Steam-sterilizable Up to 150 °C (300 °F) 100
Surface Finish All electropolished
Internal:
Ra ≤ 0.4 µm (≤ 15 µin.) (typical)
1
External: 50
Ra ≤ 0.8 µm (≤ 32 µin.) (typical)

Inspection Documentation Test report type 2.3 to EN10204

Conformance to EC PED(2)

0
Operating Conditions
0 100 200 300 400 500
Maximum Operating -1 to 10 barg
Pressure (-14.5(1) to 150(2) psig) Flow Rate (Nm3/hour)
Vent mode 2 barg inlet 4 barg inlet
Maximum Operating 150 °C (300 °F) (29 psi) (58 psi)
Temperature NW25
(1)
Full vacuum. NW50
(2)
With compatible fluids, which do not soften, swell or adversely affect the materials. (3)
The flow pressure drop characteristics refer to empty housings only for air at
20 °C (68 °F). To obtain the pressure drop of a complete assembly, the cartridge
pressure drop must be added. 1 Nm3/h = 0.59 scfm.
Nominal Dimensions
Part Number Face to Face Width Overall Height Clearance Required Weight Volume
AGT105G94EEH4 240 mm 9.4 in. 345 mm 13.6 in. 180 mm 7.08 in. 2.5 kg 5.5 lbs 1.5 L
AGT11G95EEH4 240 mm 9.4 in. 528 mm 20.7 in. 340 mm 13.3 in. 3.6 kg 7.9 lbs 3.0 L
AGT12G95EEH4 240 mm 9.4 in. 779 mm 30.6 in. 590 mm 23.3 in. 4.4 kg 9.6 lbs 4.6 L
AGT13G95EEH4 240 mm 9.4 in. 1054 mm 41.4 in. 840 mm 33.0 in. 5.3 kg 11.6 lbs 6.2 L
AGT105GNW25ABH4 190 mm 7.4 in. 431 mm 16.9 in. 180 mm 7.08 in. 2.5 kg 5.5 lbs 1.5 L
AGT11GNW50ABH4 190 mm 7.4 in. 591 mm 23.2 in. 340 mm 13.3 in. 3.6 kg 7.9 lbs 3.0 L
AGT12GNW50ABH4 190 mm 7.4 in. 842 mm 33.1 in. 590 mm 23.2 in. 4.4 kg 9.7 lbs 4.6 L
AGT13GNW50ABH4 190 mm 7.4 in. 1117 mm 43.9 in. 840 mm 33.0 in. 5.3 kg 11.6 lbs 6.2 L
AGT105G23ABH4 190 mm 7.4 in. 431 mm 16.9 in. 180 mm 7.08 in. 2.5 kg 5.5 lbs 1.5 L
AGT11G31ABH4 190 mm 7.4 in. 591 mm 23.2 in. 340 mm 13.3 in. 3.6 kg 7.9 lbs 3.0 L
AGT12G31ABH4 190 mm 7.4 in. 842 mm 33.1 in. 590 mm 23.2 in. 4.4 kg 9.7 lbs 4.6 L
AGT13G31ABH4 190 mm 7.4 in. 1117 mm 43.9 in. 840 mm 33.0 in. 5.3 kg 11.6 lbs 6.2 L
AGT105G23CDH4 190 mm 7.4 in. 365 mm 14.3 in. 180 mm 7.08 in. 2.5 kg 5.5 lbs 1.5 L
AGT11G31CDH4 190 mm 7.4 in. 521 mm 20.5 in. 340 mm 13.3 in. 3.6 kg 7.9 lbs 3.0 L
AGT12G31CDH4 190 mm 7.4 in. 776 mm 30.5 in. 590 mm 23.3 in. 4.4 kg 9.7 lbs 4.6 L
AGT13G31CDH4 190 mm 7.4 in. 1051 mm 41.3 in. 840 mm 33.0 in. 5.3 kg 11.6 lbs 6.2 L

Ordering Information

AGT 1 G H4(4)

Code Design Code Cartridge Type Code Inlet and Outlet Code Vent Code Drain
– To European Pressure 05 AB05/AB02 23 1 in. sanitary flange A Sanitary valve with A Sanitary valve with
Equipment Directive Code 2 to ISO 2852 fitting for Stäubli fitting for Stäubli*
D To European Pressure 1 AB1 Code 7 NW25 NW25 to DIN 11851 type couplings couplings
Equipment Directive 2 AB2 Code 7 94 ISO butt weld B Sanitary hose barb B Sanitary hose barb
with enhanced 33.7 x 2.0 mm to valve for 8 mm valve for 8 mm i.D.
documentation 3 AB3 Code 7 i.D. tubing tubing
ISO 1127
including 3.1b C 1 in. sanitary flange D ⁄2 in. sanitary flange
1

stamped material and 31 2 in. sanitary flange

to ISO 2852 with side sanitary E Butt weld
certification valve with fitting for
NW50 NW50 to DIN 11851 13.5 x 1.6 mm
Stäubli* type (4)
Seal Material — Silicone
95 ISO butt weld couplings elastomer. Other materials
60.0 x 2.3 mm to E Butt weld available upon request.
ISO 1127 13.5 x 1.6 mm Please contact Pall.
to ISO 1127
* Stäubli is a trademark of Stäubli AG.
160
Pall Advanta™ AVL Liquid and Gas Filter Housings
Pall Advanta AVL series filter housings are
L-flow pattern (in the side, out the bottom)
sanitary stainless steel housings. They
accommodate one single open-ended
Code 7 filter cartridge of 5, 10, 20, or 30
inches (127 mm, 254 mm, 508 mm or
762 mm) nominal length. The Pall Advanta
AVL series housings are used for either gas
or liquid applications, and are designed to
meet the stringent requirements of the
BioPharmaceutical industry. These
housings are commonly used for venting
applications because of their convenient
flow pattern and low pressure-loss.
L-Flow Sanitary Filter Housings
Features and Benefits
• Convenient L-flow pattern facilitates
piping and solves many head-space
limitations
• Low-point drain facilitates drainage of
steam-condensate, product or CIP
fluids
• Crevice-free internal surface finish of
≤ 0.4 µm (≤ 15 µin.) Ra is ideal for
sanitary applications
• Purpose-design enables inline
steaming and integrity testing (by water
intrusion — WIT — and forward flow)
• CE marking shows design-review to
European Pressure Equipment Directive
97/23/EC (housings with volumes
> 2.5 L)
• Every housing supplied with a quality
certificate and manufactured to ATEX
Directive 94/9/EC (Group ll Category 2)
• Variety of connection-styles, vents and
drains offers choice and convenience
161
 Pall Advanta AVL Liquid and Gas Filter Housings
Technical Specifications

Materials Typical Air Flow Rates at 20 °C (68 °F)

Housing AISI 316L stainless steel Flow Rate (scfm)
0 50 100 150
V-band Clamp AISI 316L Nitronic* 60 180 C
• A: Vent

Estimated Differential Pressure (mbard)

Estimated Differential Pressure (psid)

• B: 1 barg (15 psig)
A B D 2.5
O-ring Seal FDA-listed silicone • C: 2 barg (29 psig)
150
(other elastomers also available) • D: 3 barg (44 psig) E 2.0
• E: 4 barg (58 psig)
Surface Finishes Internal: 120 • F: 7 barg (102 psig)
Polished to 0.4 µm (15 µin.) Ra (typical)
1.5
90 F
External:
Polished to 0.8µm (32 µin.) Ra (typical) 1.0
60
Interior and Exterior Electropolished
* Nitronic is a registered trademark of Armco, Inc. 30 0.5

Nominal Dimensions of Selected Housings(1) 0 0

0 50 100 150 200 250
Flow Rate (Nm3/hour)
Part Number Overall Clearance Weight Volume
Height Required(2) (Empty) Typical Liquid Flow Rates at 20 °C (68 °F)
Flow Rate (Gal/min)
AVL105G23LABH4 364 mm 150 mm 2.5 kg 1.5 L
0 5 10 15 20 25
AVL105G23LDDH4 (14.3 in.) (5.9 in.) (5.5 lbs) (0.4 US gal) 200

Estimated Differential Pressure (mbard)

AVL105G94ABH4

Estimated Differential Pressure (psid)

AVL105G94DDH4 2.5

AVL11G23LABH4 500 mm 340 mm 3.0 kg 2.3 L 150

2.0
AVL11G23LDDH4 (19.7 in.) (13.4 in.) (6.6 lbs) (0.6 US gal)
AVL11G94ABH4
AVL11G94DDH4 100 1.5

AVL12G23LABH4 751 mm 590 mm 3.9 kg 3.8 L

1.0
AVL12G23LDDH4 (29.6 in.) (23.2 in.) (8.6 lbs) (1.0 US gal)
50
AVL12G94ABH4
AVL12G94DDH4 0.5

AVL13G23LABH4 1025 mm 840 mm 4.8 kg 5.4 L 0 0

AVL13G23LDDH4 (40.3 in.) (33.1 in.) (10.6 lbs) (1.4 US gal) 0 10 20 30 40 50 60 70 80 90 100
AVL13G94ABH4 Flow Rate (L /min)
AVL13G94DDH4
Main Accessories and Spares
(1)
All dimensions are nominal. Sales drawings showing +/- tolerances are available on Part Number Description
request. Please contact your Pall representative or local distributor for current sales
drawings. ACS5098CM Diaphragm valve kit for 1⁄2 in. sanitary
(2)
Suggested clearance is based on completely lifting the bowl over the top of an flange connection. Compatible with 1⁄2 in.
installed filter. Alternative methods of filter change-out allow operation with more fractional sanitary flange connection.
limited “head-space”. Contact Pall for assistance. Includes clamp and gasket.
ACS0602EM Valve seal kit (contains ten silicone
Operating Conditions O-rings and ten PTFE O-rings)
CC41608C00 Valve stem
Maximum Operating -1 to 10 barg
Pressure (-14.5(3) to 150(4) psig) LY00381 Valve knob cap
ACS0609DA Closure clamp
Maximum Operating 150 °C (300 °F)
Temperature ACS0428EX EPR closure seal
(3)
Full vacuum. ORH4P-238 Silicone housing closure gasket
(4)
With compatible fluids, which do not soften, swell or adversely affect the materials.
Contact your Pall representative or local representative for other spares and accessories.

Ordering Information

AVL 1 G

Code Design Code Cartridge Code Inlet and Code Vent Code Drain Code Seal
Type Outlet Material(5)
– To European 05 AB05 23L For 11⁄2 in. A Quick-connect and A Quick-connect and H4 FDA-
Pressure code 2 sanitary disconnect male disconnect male listed
Equipment 1 AB1 code 7 flange to connector connector Silicone
Directive ISO2852 (compatible with (compatible with
2 AB2 code 7 Stäubli* coupling) Stäubli* coupling) Other elastomer
(5)

D To European 94 33.7 mm materials are

Pressure 3 AB3 code 7 (1.33 in) with valve with valve available. Contact
Equipment O.D. x B Valve with 8 mm B Valve with 8 mm Pall for information.
Directive with 2.0 mm (0.31 in.) hose barb (0.31 in.) hose barb * Stäubli is a
trademark of
enhanced (0.079 in.) D For 1⁄2 in. sanitary D For 1⁄2 in. sanitary Stäubli AG.
documentation wall butt flange connection flange connection
including 3.1b weld to
stamped ISO1127 N None N None
162 material and
certification
 Pall Advanta™ ALT4 Multi-round Housings
Advanced Multi-round Sanitary Filter Housings for Liquid Applications
The Pall Advanta filter housings have been
specifically designed and engineered for
today’s manufacturing processes. These
advanced housings are manufactured from
316L stainless steel and are engineered to
meet the requirements of the
BioPharmaceutical industry.
State-of-the-art manufacturing
technologies are used to construct a
housing ideal for the most critical of
applications.
This multi-round version of the Pall
Advanta housing range is designed to
allow up to four filter elements in parallel
arrangement.
During the design process, critical features
were optimized to ensure trouble-free use
and low installation and maintenance
costs. Areas included in this process were:
• Surface finish
• Suitability for CIP and SIP
• Integrity testing
• Incorporation into automated
production processes
Features and Benefits
• Aseptic design
◆ Crevice-free electropolished surfaces
with an internal Ra value of ≤ 0.4 µm
(≤ 15 µin.)
◆ Fully self draining
◆ No dead legs
• Low hold-up volumes for maximum
product recovery
• Quick fit Stäubli-type* connections for
easy filter integrity testing
• Easy to use low-point sanitary drain
valve
• Range of options to aid use in
automated production systems
• Options available for use with CIP spray
cleaning device
• Every housing supplied with a quality
certificate and manufactured to ATEX
Directive 94/9/EC (Group ll Category 2)
• Design variants to ASME and European
Pressure Equipment Directive, CE
marking available
* Stäubli is a trademark of Stäubli AG.
163
 Pall Advanta ALT4 Multi-round Housings
Technical Specifications

Materials of Construction Typical Water Flow Rates(2)

Flow Rate (Gal/min)
Housing AISI 316L Stainless Steel
0 10 20 30 40 50 60 70 80 90 100 110 120 130
Clamp AISI 316L and Nitronic* 60 700 10
Stainless Steel
Seals Silicone elastomer 600
8
Surface Finish Internal:

Differential Pressure (mbar)

Ra ≤ 0.4 µm (≤ 15 µin.) (typical)

Differential Pressure (psi)

500

External: 6
400
Ra ≤ 0.8 µm (≤ 32 µin.) (typical)
Inspection Documentation Certificate type 2.3 to EN10204 300
4
* Nitronic is a registered trademark of Armco, Inc.
200
Operating Conditions 2
100
Maximum Operating -1 to 10 barg
Pressure (-14.5(1) to 150 psig)
0 0
Maximum Operating and 150 °C (300 °F) 0 100 200 300 400 500
Steaming Temperature Flow Rate (L/min)
(1)
Full vacuum.
(2)
The flow and pressure drop characteristics refer to the empty housing only
for water at 20 °C (68 °F). For other liquids multiply pressure drop by relative
density. To obtain the total pressure drop of a complete filter assembly, the
cartridge pressure drop must be added. Please refer to the relevant filter
Nominal Dimensions cartridge literature or contact Pall.
Part Number Width Overall Clearance
(Face to Face) Height Required
ALT41G31ABH4 319 mm 528.5 mm 310 mm Main Accessories and Spares
(12.6 in.) (20.8 in.) (12.2 in.)
Part Number Description
ALT41G31CBH4 319 mm 486.5 mm 310 mm
ALT41G31CDH4 (12.6 in.) (19.2 in.) (12.2 in.) ACS0598CM Diaphragm valve for 1⁄2 in. sanitary flange
compatible connections including clamp
ALT41G31DDH4 319 mm 476.5 mm 310 mm and silicone gasket
(12.6 in.) (18.8 in.) (12.2 in.)
ACS0457FA Pressure gauge kit -1 to 10 barg for
ALT41GNW50ABH4 319 mm 528.5 mm 310 mm 11⁄2 in. sanitary flange connection to
ALT41GA50ABH4 (12.6 in.) (20.8 in.) (12.2 in.) ISO 2852 (includes clamp and gasket)
ALT41G95ABH4 368 mm 528.5 mm 310 mm ORH4P-676 Silicone housing closure gasket
(14.5 in.) (20.8 in.) (12.2 in.)
ACS0602EM Silicone housing valve gasket kit
ALT42G31ABH4 319 mm 777.5 mm 564 mm
(12.6 in.) (30.6 in.) (22.2 in.) LY00381 Valve knob cap
ALT43G31ABH4 319 mm 1025.4 mm 818 mm CC41608CC00 Valve stem
(12.6 in.) (40.4 in.) (32.2 in.)
ACS0364DA V-clamp housing closure
ALTA41G31ABH4 373 mm 526 mm 310 mm
ALTA41G31CBH4 (14.7 in.) (20.7 in.) (12.2 in.) ACS0814AS CIP Spray Device
ALTA41G31CDH4 * Further spares and accessories available upon request.
ALTA41G31DDH4 373 mm 487 mm 310 mm
(14.7 in.) (19.2 in.) (12.2 in.)

Ordering Information

ALT 4 G H4

Code Design Code Cartridge Code Inlet and Outlet Code Vent Code Drain
Type

– To European 05
Pressure Equipment
Directive
A To ASME Code
D To European
Pressure Equipment
Directive with
enhanced
AB05 code 2 G31 50 mm (2 in.) OD A Sanitary valve with B Sanitary valve with
tubing with sanitary quick release fitting for hosebarb for 8 mm
1 AB1 code 7 flange to ISO 2852 Stäubli* type couplings ID tubing
2 AB2 code 7 GNW50 Dairy fitting NW50 C For 11⁄2 in. sanitary flange D For 1⁄2 in. sanitary
to DIN 11851 connection to ISO 2852 flange connection
3 AB3 code 7 with side sanitary valve
GA50 Aseptic thread N No drain
4 AB4 code 7 connection NW50 with quick release fitting
to DIN 11864-1 for Stäubli* type couplings Wall thickness as specified in
(3)

ISO1127.
documentation G95 Butt weld D For 1⁄2 in. sanitary flange * Stäubli is a trademark of
including 3.1b 60.3 x 2.3 mm(3) E Butt weld 13.5 x 1.6 mm(3) Stäubli AG.
stamped material
and certification G34 50 mm (2 in.) S For 11⁄2 in. sanitary flange
NB SCH10 connection to ISO 2852
with side connection for
1
⁄2 in. sanitary flange
164 N No vent
 Veladisc™ Depth Filter Module Housings
Filter Housings for Supradisc™ Depth Filter Modules

Features and Benefits Finishes and Customization

Pall Veladisc housings have been
developed for Supradisc Depth Filter
Modules. These housings are fabricated
from stainless steel with different heights to
accommodate modules in 300 mm (12 in.)
or 400 mm (16 in.) diameter
• 316L Stainless Steel Construction
• 8.6 barg/860 kPa (125 psig) @ 120 °C
(250 °F) maximum operating pressure
• Single or split dome option
• Closed system insures product purity
• Electropolished surface finish as
standard
Pharmaceutical Version Surface
Finishes
Crevice-free construction with internal inner
surface:
Standard: Ra < 0.65 µm (< 25 µin.)
Option: Ra ≤ 0.4 µm (≤ 15 µin.)
Customization
Housings can be engineered to meet the
specific needs of the process and
installation including ASME Code
Certification. Please contact our Technical
Services Department for assistance.

• V-band clamp — 300 mm (12 in.) —

only or bolt closure sealing system
available for 300 mm (12 in.) to
400 mm (16 in.)
• Models Available for Filter Areas from
0.46 m2 (5 ft2) to 14.8 m2 (160 ft2)

165
 Veladisc Depth Filter Module Housings
Technical Specifications

Materials of Construction Nominal Dimensions

Housing Standard: Model Overall Dome Clearance
316L Stainless Steel Height Height Required

Inlet and Outlet Connections 300 mm (12 in.) Housing: P12-01 768 mm 464 mm 330 mm
11⁄2 in. sanitary flange (30.25 in.) (18.25 in.) (13 in.)

406 mm (16 in.) Housing: P12-02 1073 mm 768 mm 635 mm

2 in. sanitary flange (42.25 in.) (30.25 in.) (25 in.)

Drain on Inlet and Outlet ⁄2 in. sanitary flange on

1
P12-03 1378 mm 1073 mm 940 mm
300 mm (12 in.) and 400 mm (16 in.) (54.25 in.) (42.25 in.) (37 in.)

Dome Vent 11⁄2 in. sanitary flange on P12-04 1683 mm 1378 mm 1270 mm
300 mm (12 in.) and 400 mm (16 in.) (66.25 in.) (54.25 in.) (50 in.)

O-rings Standard: P16-02 1132 mm 805 mm 686 mm

EPDM (food grade) (44.56 in.) (31.68 in.) (27 in.)

Optional: P16-03 1437 mm 1110 mm 1003 mm

Viton* 1 A (56.56 in.) (43.68 in.) (39.5 in.)
* Viton is a registered trademark of DuPont Dow (non-FDA material). P16-04 1741 mm 1414 mm 1321 mm
(68.56 in.) 55.68 in.) (52 in.)
Operating Conditions
Maximum Operating 8.6 barg/860 kPa (125 psig)
Pressure @ 120 °C (250 °F)

Housing Weights and Flow Rates

Model Dome Maximum
Weight Flow Rate
P12-01 7.3 kg (15 lbs) 72 L/min (19 gal/min)
P12-02 13.6 kg (30 lbs) 144 L/min (38 gal/min)
P12-03 22.7 kg (50 lbs) 216 L/min (57 gal/min)
P12-04 31.8 kg (70 lbs) 288 L/min (76 gal/min)
P16-02 52.6 kg (116 lbs) 303 L/min (80 gal/min)
P16-03 64.9 kg (143 lbs) 454 L/min
(120 gal/min)

P16-04 76.7 kg (169 lbs) 606 L/min

(160 gal/min)

Ordering Information

Code Application Code Nominal Code Number of Code Closing Code Adapter
Module Diameter Modules System Style
P Pharmaceutical 284 300 mm (12 in.) 00 Half Height C V-band clamp 00 Flat gasket
Module 300 mm (12 in.)
410 400 mm (16 in.) 88 Double O-ring
01 1 Module H Rathmann Clamp
closure
02 2 Modules
03 3 Modules Bolt closure
400 mm (16 in.)
04 4 Modules (Standard)
300 mm (12 in.)
(Engineered Option)

ASME code stamped

with bolt closure

Code Connections Code Inlet and Outlet

TC Sanitary flange 040 DN40 DIN 32676

connection
050 DN50 DIN 32676

166
 Pall Advanta™ Electrical Trace Heater
For Enhanced Temperature Control

The ability to control the temperature of a • Large LED display of actual

filter system is beneficial in many temperature — measured by PT100
applications. These include: thermocouple
• Hot water tank vents-elimination of • Separate IP54 rated control box allows
condensate to comply with current full control independent of the housing
GMP location
• Freeze dryer vacuum break filters — • Low overall installation cost — no
removal of residual water after steaming expensive steam valves, piping and
or integrity testing pressure regulators required
• Filtration of ointment bases-reduction of • Easy removal or access for changeout
viscosity or liquidification of filter elements
• Bulk active ingredient * Please contact Pall for further details.
production-temperature control to
avoid crystalization during filtration Ordering Information
Advanta Trace Heater System for Housings
In these and many other applications, the to hold 10 in. (254 mm) Filter Elements
electrical trace heaters for Pall Advanta Part Number Description
housings offer a number of advantages. ACS0681AM 240 V (50 Hz), UK Plug
• Easy installation — allowing simple ACS0682AM 250 V (50 Hz),
European Plug
upgrade of existing housings — the
ACS0685AM Extension Lead set
preformed cylindrical silicone jacket is
(10 m [33 ft])
with the Pall Advanta housing bowl. It
Advanta Trace Heater System for Housings
can also be used on housings with to hold 20 in. (508 mm) Filter Elements
100 mm nominal diameter bowls* Part Number Description
• Simple temperature adjustment — ACS0677AM 240 V (50 Hz), UK Plug
control box has a digital input from ACS0678AM 250 V (50 Hz),
European Plug
ambient to 140 °C
ACS0685AM Extension Lead set
(10m [33 ft])

Heating Jacket Temperature Control Unit

Jacket Material Silicone Rubber Housing Material Polycarbonate
Insulation Material Silicone Foam Operating Voltage 240 V (50 Hz) or 110 V (60 Hz)
Operating Voltage 240 V (50 Hz) or 110 V (60 Hz) Recommended Temperature Ambient to 140 °C (284 °F)(3)
Power Output 305 mm (11.8 in.) long = 300 W(1) Setting Range
559 mm (22 in.) long = 600 W(2) Maximum Environmental 55 °C (131 °F)
Maximum Temperature 200 °C (392 °F) Temperature for Controller
De-energized Maximum Output — Current 7A
Temperature Sensor PT100 Over Current Protection @ 4 seconds @ 12A
Thermal Cut-out 150 °C ± 5 °C (302 °F ± 41 °F) 23 °C Ambient 1 seconds @ 24A
Temperature Setting Set Temperature Display 8 mm (0.31 in.) red LED display
Testing Voltage 1500 VΩ Actual Temperature Display 10 mm (0.39 in.) green LED display
Insulation Value Greater than 100 MΩ PID (Proportional Integral Derivative
control via Autotune parameters
Protection Rating IP65 set by the user)
Design Standard EN 60519-1 and EN 60519-2 Protection Rating IP54
Lead Length 1 m (3.3 ft) Design Standards EN61010-1
(1)
For 10 in. (254 mm) filter elements. (3)
Consult filter element specifications for maximum operating temperatures.
(2)
For 20 in. (508 mm) filter elements. 167
 MDS Junior Style Industrial Housings
Junior Style Industrial Housings for 4463- and 2230-style Cartridges

Pall MDS filter housings are recommended

for small flow applications involving filtration
of either liquids or gases. MDS series
housings accommodate MC* or MD*
4463- and 2230-style cartridges with liquid
flow rates up to 7.5 L/min (2 gal/min) and
gas flows up to 100 Nm3/hour (60 scfm).

Features and Benefits

• High-temperature rated
• High pressure rated
• Easy mounting and change-out
• Electropolished stainless steel for ease
of cleaning
• Manufacturing Quality System Certified
to ISO 9000 Standards

Materials of Construction
Housing 316L Stainless Steel
Standard Gasket Silicone
O-ring Material

Design Pressure and Temperature

5.1 barg (75 psig) and full vacuum at 93 °C (200 °F)

Other Specifications
Number of Elements Around 1
Number of Elements High 1
Cartridge Style 4463
Legs and Support None
Vent 3 mm (1⁄8 in) NPT
Ordering Information Drain 6 mm (1⁄4 in.) NPT
Closure Style Vee band clamp
MDS4463 MFH4
ASME Code No
Code Inlet and Outlet Connections Flow Configuration Tee
N4 6 mm (1⁄4 in.) NPT Replaceable Tube Sheet No
N8 13 mm ( ⁄2 in.) NPT
1
Davitor No

168
 IOL and IDL Single-round Industrial Housings

Pall IOL and IDL Single-round Housings IDL Style - Features and Benefits
are constructed of stainless steel and are
• Single cartridge housings accepts
designed for industrial applications (such
Double open-end, RF and MCY 1000
as filtration of fluids in utilities areas).
Style Filters

IOL Style - Features and Benefits • All Stainless Steel materials of

construction
• Single cartridge housing accepts
AB style, single open-end filter elements • Accepts 4 in. (102 mm), 10 in.
(254 mm), 20 in. (508 mm) and 30 in.
• All stainless steel materials of (762 mm) lengths
construction
• 2 Closure Styles offered — Through
• Accepts 5 in. (127 mm), 10 in. Bolt or V-band Clamp
(254 mm), 20 in. (508 mm) or 30 in.
(7620 mm) Code 3, Code 7, Code 8 or • V-Band Clamp Style features a Quick
Code 18 Filter Cartridges Opening T-Handle

• Quick opening T-Handle V-Band Clamp • Variety of Inlet and Outlet sizes and
facilitates Filter Change Out O-ring Seal Options Offered

• Wide Choice of Inlet and Outlet sizes • Optional Mounting Brackets available
and O-ring Seal options
Top: IOL Series Filter Housing
Bottom: IDL Series Filter Housing • Passivated for purity.

Nominal Dimensional Data

Model Typical Height Clearance Required Volume Weight Empty
Flow Rate(1) Threaded Nozzle Flanged Nozzle
IOL Series
IOL05 19 L/min (5 gal/min) 198 mm (7.8 in.) 102 mm (4 in.) 0.4 L (0.10 gals) 2.3 kg (5.1 lbs) 5.4 kg (11.9 lbs)
IOL31 38 L/min (10 gal/min) 419 mm (16.5 in.) 321 mm (12.6 in.) 1.6 L (0.42 gals) 2.7 kg (5.9 lbs) 5.8 kg (12.8 lbs)
IOL32 76 L/min (20 gal/min) 667 mm (26.3 in.) 572 mm (22.5 in.) 3.1 L (0.82 gals) 3.1 kg (6.9 lbs) 6.2 kg (13.7 lbs)
IOL33 114 L/min (30 gal/min) 918 mm (36.1 in.) 822 mm (32.4 in.) 4.6 L (1.22 gals) 3.6 kg (7.9 lbs) 6.7 kg (14.7 lbs)
IOL71 38 L/min (10 gal/min) 419 mm (16.5 in.) 321 mm (12.6 in.) 1.6 L (0.42 gals) 2.7 kg (5.95 lbs) 5.8 kg (12.8 lbs)
IOL72 76 L/min (20 gal/min) 667 mm (26.3 in.) 572 mm (22.5 in.) 3.1 L (0.82 gals) 3.1 kg (6.9 lbs) 6.2 kg (13.7 lbs)
IOL73 114 L/min (30 gal/min) 918 mm (36.1 in.) 822 mm (32.4 in.) 4.6 L (1.22 gals) 3.6 kg (7.9 lbs) 6.7 kg (14.7 lbs)
IOL81/IOL181 38 L/min (10 gal/min) 419 mm (16.5 in.) 321 mm (12.6 in.) 1.6 L (0.42 gals) 2.7 kg (5.95 lbs) 5.8 kg (12.8 lbs)
IOL82/IOL182 76 L/min (20 gal/min) 667 mm (26.3 in.) 572 mm (22.5 in.) 3.1 L (0.82 gals) 3.1 kg (6.9 lbs) 6.2 kg (13.7 lbs)
IOL83/IOL183 114 L/min (30 gal/min) 918 mm (36.1 in.) 822 mm (32.4 in.) 4.6 L (1.22 gals) 3.6 kg (7.9 lbs) 6.7 kg (14.7 lbs)
IDL Series
IDLD04 15 L/min (4 gal/min) 203 mm (8 in.) 153 mm (6 in.) 0.4 L (0.11 gals) 2.3 kg (5.1 lbs) 5.4 kg (11.9 lbs)
IDLD1 38 L/min (10 gal/min) 362 mm (14.2 in.) 321 mm (12.6 in.) 1.3 L (0.34 gals) 2.6 kg (5.7 lbs) 5.7 kg (12.5 lbs)
IDLD2 76 L/min (20 gal/min) 516 mm (24.2 in.) 572 mm (22.5 in.) 2.8 L (0.74 gals) 3.1 kg (6.7 lbs) 6.1 kg (13.5 lbs)
IDLD3 114 L/min (30 gal/min) 870 mm (34.2 in.) 822 mm (32.4 in.) 4.3 L (1.14 gals) 3.5 kg (7.7 lbs) 6.6 kg (14.5 lbs)
IDL104 15 L/min (4 gal/min) 203 mm (8 in.) 153 mm (6 in.) 0.4 L (0.11 gals) 2.3 kg (5.1 lbs) 5.4 kg (11.9 lbs)
IDL11 38 L/min (10 gal/min) 362 mm (14.2 in.) 321 mm (2.6 in.) 1.3 L (0.34 gals) 2.6 kg (5.7 lbs) 5.7 kg (12.5 lbs)
IDL12 76 L/min (20 gal/min) 516 mm (24.2 in.) 572 mm (22.5 in.) 2.8 L (0.74 gals) 3.1 kg (6.7 lbs) 6.1 kg (13.5 lbs)
IDL13 114 L/min (30 gal/min) 870 mm (34.2 in.) 822 mm (32.4 in.) 4.3 L (1.14 gals) 3.5 kg (7.7 lbs) 6.6 kg (14.5 lbs)
IDLT04 15 L/min (4 gal/min) 200 mm (7.8 in.) 153 mm (6 in.) 0.4 L (0.11 gals) 2.3 kg (5.1 lbs) 5.4 kg (11.9 lbs)
IDLT1 38 L/min (10 gal/min) 359 mm (14.1 in.) 321 mm (12.6 in.) 1.3 L (0.34 gals) 2.6 kg (5.7 lbs) 5.7 kg (12.5 lbs)
IDLT2 76 L/min (20 gal/min) 613 mm (24.1 in.) 572 mm (22.5 in.) 2.8 L (0.74 gals) 3.1 kg (6.7 lbs) 6.1 kg (13.5 lbs)
IDLT3 114 L/min (30 gal/min) 867 mm (34.1 in.) 822 mm (32.4 in.) 4.3 L (1.14 gals) 3.5 kg (7.7 lbs) 6.6 kg (14.5 lbs)
(1)
Dependent on inlet and outlet selection.
169
 IOL and IDL Single-round Industrial Housings
Technical Specifications

Materials of Construction Typical Air Flow Rates at 20 °C (68 °F)

Flow Rate (scfm)
Head 316L Stainless Steel
0 50 100 150 200 250 300 350
10 700
Bowl 316 Stainless Steel • A: 2.7 barg (40 psig) A B C
• B: 4.1 barg (60 psig)
• C: 5.5 barg (80 psig) 600

Differential Pressure (mbar)

8

Differential Pressure (psid)

Design Ratings
500
IOL 27.5 barg (400 psig) @ 40 °C (100 °F)
6
24.1 barg (350 psig) @ 150 °C (300 °F) 400

IDL Through Bolt Design: 300

4
8.2 barg (120 psig) @ 40 °C (100°F)
200
V-band Clamp Design:
2
27.5 barg (400 psig) @ 40 °C (100 °F) 100
24.1 barg (350 psig) @ 150 °C (300 °F)
0 0
Note: Above ratings apply to housing only. Cartridge and housing O-ring selection may 0 100 200 300 400 500 600
impose different and narrower limitations.
Flow Rate (Nm3/h)

Connections Typical Liquid Flow Rates

Flow Rate (Gal/min) at 20 °C (68 °F)
Inlet and Outlet Both Styles: 0 5 10 15 20 25 30 35
19 mm (0.375 in.) NPT, 25 mm (1 in.) 10 700
NPT, 19 mm (0.375 in.) BSPT, 25 mm
(1 in.) BSPT, 600

Differential Pressure (mbar)

8
Differential Pressure (psid)

IOL Only: 500

25 mm (1 in.) BSPP
6 400
Flange Option 300 lbs. ANSI raised face
flanges for 25 mm (1 in.) IOL and IDL 300
Housings or BS4504 flanges for 25 mm 4
(1 in.) IDL Housings 200
Vent and Drain 6 mm (0.25 in.) NPT, BSPT or BSPP 2
100
Shell O-rings Viton* A, FEP Encapsulated Viton A,
Silicone Elastomer, Buna N, Ethylene 0 0
0 20 40 60 80 100 120
Propylene, Ethylene
Flow Rate (L /min)
Propylene for Steam Service Stainless steel brackets are available
Bracket Option as a standard option
* Viton is a registered trademark of DuPont Dow Elastomers L.L.C (non-FDA material).

Ordering Information

IOL G

Code Cartridge Style Code Nominal Cartridge Code Inlet and Outlet Vent and Drain Code Seal Materials
Length
3 Code 3 05 5 in. (127 mm) N12 19 mm (3⁄4 in.) NPT 6 mm (0.25 in.) NPT H Viton A
7 Code 5 1 10 in. (254 mm) N16 25 mm (1 in.) NPT 6 mm (0.25 in.) NPT H1 FEP Encapsulated
8 Code 8 2 20 in. (508 mm) B12 19 mm (3⁄4 in.) BSPT 6 mm (0.25 in.) BSPT Viton A

18 Code 18 3 30 in. (762 mm) B16 25 mm (1 in.) BSPT 6 mm (0.25 in.) BSPT H4 Silicone

B17 25 mm (1 in.) ANSI Flange 6 mm (0.25 in.) BSPT H13 Buna N

N17 25 mm (1 in.) ANSI Flange 6 mm (0.25 in.) NPT J Ethylene Propylene

P17 25 mm (1 in.) ANSI Flange 6 mm (0.25 in.) BSPP J7 Ethylene Propylene

for Steam Service
P19 25 mm (1 in.) BSPP 6 mm (0.25 in.) BSPP
B35 25 mm (1 in.) BS4504 Flange 6 mm (0.25 in.) BSPT
P35 25 mm (1 in.) BS4504 Flange 6 mm (0.25 in.) BSPP

IDL G

Code Cartridge Code Nominal Cartridge Code Inlet and Outlet, Code Housing Options Code Seal Materials
Style Length Vent and Drain
D DOE/RF V-band 04 4 in. (102 mm) See above IOL Style table – Blank See above IOL Style table
1 MCY 1001 V-band 1 10 in. (254 mm) C2 Passivated
T DOE/RF 2 20 in. (508 mm) C9 Clean for
Through Bolt 3 30 in. (762 mm) Oxygen Service

170
 PCY Polypropylene Filter Housings

Pall PCY filter housings are manufactured Applications

from reinforced polypropylene and
For the filtration of a wide variety of liquids
incorporate several innovative features.
including water, acids, bases, compatible
Four styles of cartridge fitting are available,
solvents and deionized water, where
each welded into the head to eliminate the
corrosion resistance and economy of
risk of bypass. The ability to utilize a range
operation are required.
of Pall filter cartridge styles incorporating
secure sealing mechanisms together with a
high pressure rating allows for flexibility and
security in a wide range of process
applications. Housing features include the
following:
• Flow rates up to 100 L/min (20 gal/min)
• 25 mm (1 in.) connections for high-flow
rates and low pressure drops
• Pressure rating up to 150 psig (10 barg)
• Welded fittings for different styles of Pall
filter cartridges
• Provision for drain, vent and mounting
bracket
Multi-cartridge Housings
For larger flows, multi-cartridge housings in
stainless steel and plastic are also available
from Pall.

Features and Benefits

• Sturdy reinforced polypropylene designs
for rugged liquid service and long-life
• Broad chemical compatibility
• Choice of filter cartridge styles and
lengths

171
 PCY Polypropylene Filter Housings
Technical Specifications

Materials of Construction Typical Water Flow Rates

Material Glass-reinforced polypropylene 1000

Seal Material Options Nitrile, FDA approved Viton* and

general purpose Viton

Connection Options 25 mm (1 in.) BSPT or

Differential Pressure (mbar)

25 mm (1 in.) BSP female

Vent and Drain 6 mm (1⁄4 in.) BSPT or (1⁄4 in.) BSP

Connection Options with plug 100
Note: Polypropylene housings are not suitable for use with gases.
* Viton is a registered trademark of DuPont Dow.
50

Nominal Dimensions
Length PCY1 Housing:
440 mm (17.3 in.)
10
PCY2 Housing: 10 50 100
688 mm (27 in.) Flow Rate (L/min) (log scale)
Diameter Both Styles: = RF/RMF and = AB Code 7 and
147 mm (5.7 in.) MCY 1000 styles Code 3 styles

Design Pressure and Temperature

10 barg (150 psig) @ 37 °C (100 °F) Main Accessories and Spares
Part Number Description
Other Specifications SAN1DV04H2 Stainless steel vent and drain valve
6 mm (0.25 in.) BSPTr
Number of Cartridges 1
SAN1PG04 Stainless steel pressure gauge
Connections 25 mm (1 in.) NPT
ACS0018BA T-Piece:
Standard Gasket Nitrile 6 mm (0.25 in.) BSPT female
O-ring Material 6 mm (0.25 in.) BSPT female
6 mm (0.25 in.) BSPT male
Vents 6 mm (1⁄4 in.) NPT
Drain 6 mm (1⁄4 in.) NPT
Replacement Parts
Closure Style Threaded
Housing Gasket Kit
ASME Code No
GK1344PB01 Nitrile
Flow Configuration Tee
GK1344PH01 FDA approved Viton

ACS0284EE General purpose Viton

Vent and Drain Plug Kit

ACS0067AY X Option

ACS0182AY Y Option

Ordering Information

PCY G

Code Cartridge Nominal Code Inlet and Outlet Code Seal Material Code Vent and Drain
Style Length
1001 DOE MCY1000 10 in. (254 mm) 16 25 mm (1 in.) BSPT H13 Nitrile – No tappings
H FDA approved Viton Y Head and bowl tapped
1002 DOE MCY1000 20 in. (508 mm) 19 25 mm (1 in.) BSP
HB General purpose Viton 6 mm (0.25 in.) BSPT
1RF DOE RF/RMF 10 in. (254 mm) (female with plug)
2RF DOE RF/RMF 20 in. (508 mm)
X Head and bowl tapped
13 SOE AB code 3 10 in. (254 mm) 6 mm (0.25 in.) BSP
(female with plug)
23 SOE AB code 3 20 in. (508 mm)
17 SOE AB code 7 10 in. (254 mm)
27 SOE AB code 7 20 in. (508 mm)
172
 Megaplast™ Plastic Filter Housings
Pall Megaplast housings are manufactured
from PFA (Perfluoroalkoxy), PVDF
(Polyvinylidenedifluoride) or polypropylene.
This range represents a significant advance
in filter housing design. The housings are
crevice-free and can be used at high
pressures (with suitable safety measure
implemented), and their filter cartridges can
be installed and changed quickly and
easily.
As a result of computer-aided design and
high technology plastic molding
techniques, Megaplast housings can be
used for high flow-rate applications with
very low corresponding pressure drops.
All fluid contact surfaces are molded rather
than machined, to provide very smooth
surfaces with a high level of particulate
cleanliness when compared with other
currently available plastic filter housings.
Easy to use, Megaplast housings are
constructed from three parts – head,
bowl,and collar. The screw-threaded
closure provides a positive and effective
seal, and is not wetted by the fluid being
filtered (i.e., no potential contaminant are
traps introduced), and the design avoids
unnecessary stress being placed on the
internal closure O-ring. The coarse collar
thread allows quick one-handed operation,
without thread galling.
Easy to install, the inlet and outlet
connections are either non-wetted
international standard DIN, or butt weld.
DIN connections enable the housing to be
fitted to or removed from pipework
systems without disturbing existing
pipework. Megaplast housings also
incorporate a 6 mm (1⁄4 in.) BSP parallel
female vent and drain port as part of the
bowl, complete with plug and seal. seal
protected non-wetted threads eliminate
potential sources of contamination.
The housings accommodate either one Pall
AB Code 3 style filter cartridge which
features a high security double O-ring
sealing mechanism, or the RF style
Profile II filter cartridge which employs a
knife edge seal, tie-rod and seal nut. PVDF
housings are available in two lengths to
accommmodate either 10 in. (254 mm) or
20 in. (504 mm) nominal length filter
cartridges. PFA and natural polypropylene
housings are designed to use one 10 in.
(254 mm) nominal length filter.
Features and Benefits
• Three part construction (head, collar
and bowl)
• DIN outlet and inlet connections (natural
polypropylene and PVDF housings only)
• 6 mm (1⁄4 in.) butt weld inlet and outlet
connections (PFA housings only)
• Threads not wetted by process fluid
• All product wetted surfaces are molded
(not machined), providing a very
smooth, high quality surface finish
• Constructed from PFA, PVDF or natural
polypropylene
• AB Code 3 fitting molded into head
design
• Plug-in element secured in position by
bowl
• Mounting bracket is part of the head
molding (PFA housings), or can be fitted
(PVDF and natural polypropylene
housings)
• Choice of Pall AB Code 3 or RF style
filter cartridges
173
 Megaplast Plastic Filter Housings
Technical Specifications

Materials of Construction Typical Water Flow Rates

Vessel Closure Coarse thread closure ring 1000

Closure Seal Material Ethylene propylene (natural

polypropylene and PVDF housings),
FEP encapsulated fluorocarbon (PVDF

Differential Pressure (mbar)

and PFA housings)
100
Inlet and Outlet Natural Polypropylene and PVDF
Connections Housings:
DIN 25 male to DIN 8063 part 3

PFA Housings:
6 mm (1⁄4 in.) butt weld(1) 10

Vent and Drain Connections Bowl:

All materials — 6mm (1⁄4 in.)
BSP parallel female

Head:
1
Polyproylene — supplied blank 1 10 100 1000
PVDF — supplied blank or 6 mm (1⁄4 in.)
Flow Rate (L/min)
BSP parallel female
PFA — 6 mm (1⁄4 in.) BSP parallel female = TAAC = TRX = TAX/TAV

A 18 mm (3⁄4 in.) Flaretek* inlet and outlet connection option is also available.
(1)

Please contact Pall for further details.

* Flaretek is a registered trademark of Entegris, Inc.

Maximum Allowable Pressure and Temperature

Material Applications
Polypropylene Water:
5 barg (72.5 psig) at temperatures up to 40 °C (104 °F).

Chemical(2):
Not suitable for use above 40 °C (104 °F).

PVDF Water:
(TAVW housing) 10 barg (145 psig) at temperatures up to 40 °C (104 °F). 7.5 barg (108 psig) at temperatures between 40 °C (104 °F)
and 80 °C (176 °F). Not suitable for use above 80 °C (176 °F)

Chemicals:
(TAVC housings) 3.5 barg (50.7 psig) at temperatures up to 40 °C (104 °F). Not suitable for use above 40 °C (104 °F).

PVA Water:
Not applicable

Chemical:
5.6 barg (81 psig) at temperatures up to 30 °C (86 °F) 2.8 barg (40.6 psig) at temperatures between 30 °C (86 °F) and 95 °C (203 °F).
Not suitable for use above 95 °C (203 °F).
(2)
Compatible chemicals are defined as those which do not soften, swell or attack any of the housing components.

Ordering Information

T 01 G

Code Cartridge Code Housing Code Application Code Nominal Code Inlet and
Style Material Cartridge Length Outlet
A AB Code 3 A* PFA C Compatible 1 10 in. (254 mm) 26 Din 25 to
R RF Style V* PVDF chemicals 2 20 in. (508 mm) DIN 8063
W Water part 3 (male)(3)
X Polypropylene
53 6 mm (1⁄4 in.)
* Only available in AB1 code 3. Butt weld(4)

Code Seal Material Code Vent and Drain

J Ethlene Propylene(3) – Supplied blank(3)
H1 FEP Encapsulated D Drilled, tapped
Fluorocarbon(4) and plugged
6 mm (1⁄4 in.)
(3)
Polypropylene and PVDF
BSP parallel
housings only
174 (4)
PFA housings only female(4)
Tangential Flow Filtration
 Tangential Flow Filtration (TFF)
Pall offers the most comprehensive selection
of tangential flow filtration platforms to meet
the increasing diversity of biological and
biopharmaceutical processes and
applications.
These platforms are:
Membrane Cassettes and Hardware
Ultrafiltration: Pall membrane cassettes and
their associated hardware and systems are
the preferred choice in applications that
require gentle processing and precise tailoring
of membrane characteristics to the
application. Predominant use is biotechnology
and biologicals for labile molecules.
Microfiltration: Open channel cassettes or
cassettes with suspended screens can be
used in batch applications for the harvesting
of bacterial, mammalian, or insect cells.
Microza Hollow Fiber Modules
Ultrafiltration: Hollow fibers are the preferred
choice for larger volume processes with more
robust molecules such as enzymes,and for
clarification of materials where small molecules
such as antibiotics are the target. Also the
choice for both pure water applications, and
raw water treatment.
Microfiltration: Simple flow geometry and
steam sterilizability make hollow fibers an
excellent option for culture techniques such as
perfusion culture.
176
TM
Membralox Ceramic Modules
Ceramics are the preferred choice when
operating conditions are outside the limits
tolerable by plastics due to extremes of
temperature, or chemical compatibility. In
many high solids applications, such as natural
extracts, the ability to clean ceramics with
harsh cleaning agents can give required
process cost advantages.
TM
Pallsep Vibrating Membrane Filters
Pallsep membrane filters are an enabling
technology for difficult processes where the
security of a polymeric barrier process is
required, but where feed materials are very
high in complex mixtures of biomolecules and
viscosities may be elevated. Examples are
direct processing of mycelial fermentation
broths without pretreatment, recovery of cell
wall fractions from chemically lysed
recombinant bacterial systems used to
produce vaccines.
Plate and Frame Sheet Membranes
Bulk processes in the manufacturing of APIs
often require extensive membrane areas of
predominantly ultrafiltration membrane. Pall
membranes are available to retrofit most
pre-existing systems.
 Tangential Flow Filtration Technology
Pall has many years of experience in
the design and manufacturing of
state-of-the-art systems. We work closely
with our clients to evaluate and supply the
best technical solution for each application
using proven features, designs and
engineering know-how.
For TFF applications, systems can be
designed to automatically perform all
phases of a typical process including,
flushing, sanitization, draining, buffer
conditioning, concentration, diafiltration,
product recovery and clean-in-place (CIP)
operations. See “Tangential Flow Filtration
Automated Systems” on page 195 for
additional details.
Applications in TFF
Tangential Flow Filtration (TFF) is an
efficient method for concentrating,
desalting, or buffer exchanging solutions of
biomolecules ranging in volume from
several milliliters to thousands of liters. It
can be used to fractionate large from small
biomolecules,depyrogenate buffer
solutions, harvest cell suspensions, and
clarify fermentation broths and cell lysates.
TFF is utilized to perform various steps on
a wide range of applications in the
biopharmaceutical industry. Examples of a
few typical applications are listed below:
• Concentrate and desalt solutions of
proteins,peptides and oligonucleotides
• Purify and recover antibodies or
recombinant proteins from cell culture
media
• Vaccine concentration and diafiltration
• Fractionate protein mixtures
• Concentration and diafiltration in blood
plasma fractionation and purification
• Clarify cell lysates or tissue
homogenates
• Recover products expressed into the
media from cell culture
• Continuously perfuse out spent media
and product from cell culture
• Recover products from natural extracts
of plants or animal origin
• Depyrogenate water, buffers and media
solutions
• Prepare samples (concentrate, desalt,
or buffer exchange) prior to or following
column chromatography
177
 Ultrafiltration and Microfiltration TFF Cassette Membranes
Top: Maxisette Membrane Cassettes
Bottom: Centrasette Membrane Cassettes
178
Membranes for UF and MF TFF
Pall’s ultrafiltration (UF) membranes have
been developed and manufactured to give
consistent performance. Products are
available for laboratory, development, pilot,
and production-scale TFF applications.
Pall’s microfiltration (MF) membranes are
optimized for product clarification and
recovery in biotechnology and
pharmaceutical applications.
Membrane Types
Pall offers four distinct membrane types
that provide superior performance and
stability to meet the challenges of each
unique TFF application. Membrane Types
include: Omega™, Alpha™, Regen™, and
Supor® TFF membranes. Each membrane
is available in a broad range of cassette
types and configurations.
Omega Membrane
Omega polyethersulfone (PES) membranes
have been specifically modified to minimize
protein binding to the surface and
interstitial structure of the membrane. This
polymeric membrane is stable against
biological and physical degradation due to
the unique chemical properties of PES.
Omega membranes have an anisotropic
structure, a thin skin-like top layer with a
highly porous underlying support. The
structure of the skin determines the
porosity and permeability characteristics of
the membrane. Anisotropic membranes
have higher water permeability and can
typically be cleaned quicker and easier
than membranes with a uniform,
sub-micron depth structure.
Damage to the skin of anisotropic
membranes is easily detected with an
integrity test. This may not be the case for
membranes with sub-micron porous
underlayers.
Features and Benefits
• Low affinity and adsorption
characteristics resulting in higher
product recovery
• Available in a wide variety of cassette
configurations, for easy and direct
scale-up/scale down
• Greatest selection of ultrafiltration
membrane rating available:
650 Da – 1000 kDa to fit specific
application needs
• Compatible with acids, bases and a
variety of other cleaning agents to
optimize for example cleaning
procedures
Alpha Membrane
Alpha membrane is a PES membrane
modified to minimize the flux depression
caused by antifoam agents (such as
silicone and polyglycols) that might effect
especially membranes with smaller cut offs.
Alpha membranes typically clean up
quicker and easier after contact with these
agents.
Features and Benefits
• Proprietary membrane chemistry
reduces non-specific adsorption,
minimizes membrane fouling and
increases product recovery
• Exceptional membrane recovery and
stability after cleaning which results in a
longer lifetime of the membrane
 Ultrafiltration and Microfiltration TFF Cassette Membranes
Regen Membrane
Regen membrane is regenerated cellulose. This hydrophilic
membrane is characterized as low protein binding with a broad
chemical compatibility. Regenerated cellulose membranes have lower
water permeability compared to PES membranes but may give
higher, consistent process flux rates especially if antifoam agents or
polysaccharides are present in the process fluid.
Features and Benefits
• Good for processing hydrophobic proteins where the low binding
characteristic increases the performance of the membrane
• Maintains high process flux rates in presence of antifoams and
polysaccharides which can lead to shorter process time
• Broad solvent compatibility to handle also applications where PES
membranes can not be used
May be substituted where regenerated cellulose is specified and
validated to minimize the effort of revalidation
Supor TFF Membrane
Supor TFF membrane is a micron-rated pore, modified
polyethersulphone membrane with a uniform depth structure. The
membrane is optimized for microfiltration TFF applications including
harvest, concentration and clarification of cell cultures and
fermentation broths. Use Supor TFF membranes to harvest bacterial,
mammalian, and insect cells; separate red blood cells from
hemoglobin; and clarify yeast broth and bacterial lysates.
Features and Benefits
• Low non-specific adsorption due to its hydrophilic chemistry
which leads to higher product yields
• Wide range of membrane pore sizes to optimize the process
• Compatible with acids, bases, oxidizing agents and variety of
other cleaning agents to fit different application needs
179
 Matching Membrane Cassettes to Applications

Pall offers a broad range of membrane cassettes for TFF to cover the
growing range of potential applications and process volumes.
There are four cassette formats for UF and MF applications –
Centramate™, Centrasette™, Maximate™ and Maxisette™.
It is important to consider your specific requirements in order to
select the most appropriate cassette and format for your application.
Choosing A Membrane Cassette
Process Objectives
It is necessary to clearly define process requirements including the
following in order to be able to determine the required membrane
molecular weight cut-off (MWCO) and area for a process:
• Is Product in Concentrate or filtrate?
• Total process volume
• Required concentration factor
• Diafiltration requirement
• Process temperature
• Process time
You must also evaluate the process fluid characteristics
(concentration, viscosity, impurities, additives, presence of
particulates, etc) and how they may affect the process.
Membrane Molecular Weight Cutoff (MWCO) vs.Molecular
weight of sample molecules to be retained/passed
As a general rule to maximize product recovery, choose a MWCO
that is 3 – 6 times smaller than the MW of molecules to be retained. If
performing concentration only, a difference of 3 – 4 times is sufficient.
If process includes diafiltration, use 4 – 6 times, favoring the higher
factor with increasing number of diafiltration volumes (DV).
The same 3 – 6 times rule applies for product passage (transmission).
In this case, choose a MWCO that is 3 – 6 times larger than the MW
of molecules to be passed. The pH and ionic strength of the process
fluid can have a significant affect on transmission of specific
molecules, including low MW species.
Fractionation – separation of large from smaller molecules – can be
achieved by choosing a MWCO that is at least 2 times lower than the
MW of molecules to be retained and 2 times greater than the MW of
molecules to be passed. The higher MW molecules will be
concentrated while the lower MW molecules have to be diafiltered out
to affect a complete separation. There may have to be a compromise
between recovery and complete separation when the difference in
MW is too small.
Membrane Area Requirements
The process volume and concentration, filtrate flux rate and time
requirements must all be considered in order to determine the
membrane area required for a specific process. Specify range of
expected volumes and calculate area based on largest volume.
• Filtrate Volume – total filtrate volume collected from concentration
and diafiltration steps. Filtrate volume can be estimated from the
total process volume, concentration factor and diafiltration
volumes required.
• Time Requirements – specify the maximum allowable process
time
• Filtrate Flux Rate (FFR) – the rate of liquid passing through the
membrane e.g. L/m2/h (LMH). Trials are required to determine the
actual FFR for a product under a specified set of operating
parameters including transmembrane pressure (TMP), cross flow
flux rate (CFF) and temperature.
To estimate membrane area required for a process, use the following
equation;
Required Membrane Area = filtrate volume ÷ [average filtrate flux rate
x process time]
From the Required Membrane Area calculated, a cassette holder with
sufficient capacity can be selected.
Scale-up/Scale-down
Processes are often developed on a scaled-down system to
conserve sample. It is best to develop a process using a cassette
format that has the same pathlength and channel configuration as the
full scale system. This allows direct scale-up following a simple rule –
increase membrane area and retentate flow rate in direct proportion
to increase in sample volume. If this is followed, the TMP,Cross Flow
Flux Rate and process time will not change appreciably. If pathlength
is changed, then additional optimization will be required.

180
 Minimate™ Tangential Flow Filtration Capsules
The easy to use Minimate TFF capsule is
a valuable tool for any laboratory requiring
tangential flow filtration of small process
volumes. Sample batch sizes of up to one
liter can be reduced to as low as 5 mL.
Sample concentration and diafiltration
(desalting) can take place sequentially
using the same device and system, saving
time and avoiding product loss associated
with transfer steps.
The Minimate TFF Capsules contain a
robust, polyethersulfone, ultrafiltration (UF)
membrane. The Omega UF membrane
offers low non-specific adsorption
characteristics resulting in high product
recovery. The Minimate TFF capsules are
available with a wide range of molecular
weight cut-offs. They can be used in a
variety of biological applications in
biotechnology, molecular biology, protein
chemistry, microbiology and immunology.
Features
• Ready to use – Minimate TFF capsule
includes all fittings and tubing to
simplify installation into filtration setups.
This versatile, self-contained device
works with most laboratory pumps
• Cost-effective design – The plastic
construction of the Minimate TFF
capsule and chemical compatibility of
the Omega membrane facilitate
cleaning and reuse
• Scalable – The Minimate TFF capsules
have the same path length and similar
materials of construction as larger
Centramate and Centrasette
cassettes used in pilot and production
scale. Several Minimate TFF capsules
may be connected in parallel for
increased membrane area Predictable
performance saves time when scaling
up a process.
• High Product Recovery – Optimized
flow path design coupled with low
protein binding Omega membrane
minimize non-specific binding
• Efficient – Concentration and desalting
processes can be performed on the
same system with minimal user
intervention. Achieve high concentration
factors in a single processing step due
to the low hold-up volume of the device
• Disposable – This economically priced
device can be dedicated to a single
batch or process eliminating the time
required for cleaning
• Confidence – Each pharmaceutical
grade Minimate capsule is 100%
integrity tested during manufacture to
ensure reliable performance. For critical
applications the user can re-test the
integrity after initial use. A Certificate of
Quality is included with each capsule
Applications
• Concentrate and desalt proteins,
peptides, or nucleic acids (DNA, RNA,
oligonucleotides)
• Recover antibodies or recombinant
proteins from clarified cell culture media
• Process metal sensitive enzymes and
other biomolecules
• Separate (fractionate) large from small
biomolecules
• Concentrate viruses or gene therapy
vectors
• Prepare samples prior to column
chromatography
• Concentrate samples after gel filtration
• Depyrogenate water, buffers, and media
solutions
181
 Minimate Tangential Flow Filtration Capsules
Technical Specifications

Technical Data Materials of Construction

Effective Filtration Area 50 cm2 (0.05 ft2) Filter Media Omega membrane
Recommended Crossflow 60 – 70 mL/min (polyethersulfone)

Operating Temperature 5 – 50 °C (41 – 122 °F) Housing Polypropylene, Glass reinforced

Range Screens, Housing Sealing Polypropylene
Ring and Fittings
Maximum Operating Pressure 4 bar (400 kPa, 60 psi)
Membrane Plate and Filtrate Polyethylene
pH Range 1 – 14
Channels
Product Hold-up Volume Approximately 1.6 mL
Internal Gasket Ethylene Propylene Elastomer
Forward Flow < 7/mL/min at 0.75 bar (10 psi)
Air Integrity Value

Nominal Dimensions 200 mm x 38 mm x 18 mm

(Length x Width x Height) (8 in. x 1.5 in. x 0.7 in.)

Ordering Information The Minimate TFF Capsule comes with threaded luer plugs in each of
Part Number Description the four ports. A fitting package with the following components is
OAD65C12 Minimate TFF Capsule included.
with 650 Da Omega membrane

OA001C12 Minimate TFF Capsule Accessories

with 1 kDa Omega membrane
Part Number Description
OA003C12 Minimate TFF Capsule
88216 Minimate Fittings kit
with 3 kDa Omega membrane
Contains:
OA005C12 Minimate TFF Capsule 2 Male luer to 3.2 mm (1⁄8 in.)
with 5 kDa Omega membrane hose barb
2 Female luer to 3.2 mm (1⁄8 in.)
OA010C12 Minimate TFF Capsule hose barb
with 10 kDa Omega membrane 120 cm (3.9 ft) Tubing 3.2 mm (1⁄8 in.) i.d.
1 Retentate screw clamp
OA030C12 Minimate TFF Capsule
4 Tubing clamps
with 30 kDa Omega membrane
1 Adhesive strips (loop and hook)
OA050C12 Minimate TFF Capsule
with 50 kDa Omega membrane

OA070C12 Minimate TFF Capsule

with 70 kDa Omega membrane

OA100C12 Minimate TFF Capsule

with 100 kDa Omega membrane

OA300C12 Minimate TFF Capsule

with 300 kDa Omega membrane

OA500C12 Minimate TFF Capsule

with 500 kDa Omega membrane

OA990C12 Minimate TFF Capsule

with 1000 kDa Omega membrane

182
 Minimate™ TFF System
Streamlining Laboratory-scale Concentration, Desalting, and Buffer Exchange Processes

Designed to work with the Minimate TFF Features

Capsule, this easy-to-use system can
• Ready to Use – Plug in a Minimate
process sample volumes up to 1L or more
TFF capsule, add sample and turn on
and efficiently concentrate samples to as
the pump to start processing. The
little as 5 mL. Subsequent desalting or
Minimate TFF system includes all the
buffer exchange steps can be run on the
hardware, tubing and fittings needed to
same system with minimal user
get your TFF process up and running
intervention.
quickly
The ready-to-use Minimate TFF System
• High Concentration Factors – The low
includes a variable speed peristaltic pump,
system working volume achieved
as well as a 0 – 4 bar (0 – 60 psi) pressure
through the use of a conical bottom
gauge, valves, 500 mL reservoir with
reservoir and compact design enable
magnetic stir bar, and stir plate all
high concentration factors from up to
assembled on a compact drip tray. The
1L or more of sample to be achieved.
use of a peristaltic pump with disposable
Concentrate your sample down to as
tubing and fittings minimizes sample
little as 5 mL
cross-contamination while providing gentle
processing for biomolecules. All wetted • Secure – All wetted components are
parts meet USP Class VI testing. made from low protein-binding,
chemically resistant, USP Class VI
The reservoir is designed to hold up to
materials The system has a very low
500 mL of sample and provides efficient
volume and interior fluid contact area.
mixing of product. The tapered bottom and
Fluid does not pass through and is not
optimally located feed and return ports
retained in the pump mechanism, as it
reduce the system hold-up volume, which
does with diaphragm or piston pumps.
allows high concentration factors to be
If cross-contamination is a concern,
achieved. The reservoir lid seals tightly
simply change the tubing between
allowing additional sample volume or
samples. The Easy-Load® pump head
diafiltration solution to be drawn into the
makes it easy to replace the system
reservoir by vacuum created as filtrate is
tubing.
generated through the TFF device.
This allows continuous diafiltration to be • Gentle Processing – Roller head
performed and eliminates the need for a peristaltic pumps are the choice for
transfer pump. When it’s time to retrieve critical applications such as fragile
your sample, simply open the valve on the biomolecules. Alternative pumps use
reservoir outlet and pump out your sample. direct mechanical action on the fluids,
and increase the possibility of damage
to cells or proteins
• Easy Cleaning and Maintenance –
System components are designed for
easy assembly and disassembly, no
tools required. Tubing and fitting
replacement is simple and quick. Slip
See Also: nuts for luer locks eliminate tubing kinks
Refer to “Matching Cassettes to Applications”
on page 180 and “Tangential Flow Filtration
Membrane Cassettes” on pages 185 – 189 for * Easy-Load is a trademark of Cole-Palmer.
additional details.

183
 Minimate TFF System
Technical Specifications

All fittings are simple and inexpensive to replace. Three-way valves at Materials of Construction
the reservoir inlet and outlet can be used for sample recovery or spill Reservoir Polysulfone
free addition of rinse and cleaning fluids. Reservoir Cover Polypropylene
• Efficient – Continuous diafiltration for desalting or buffer exchange Reservoir O-ring EP Rubber
can be performed unattended. The diafiltration buffer container is Magnetic Stir Bar PTFE coated
connected to the lid of the feed reservoir. By simply pulling a
Gauge Wetted Parts 316L stainless steel
vacuum on the feed reservoir, new buffer is drawn into the feed
reservoir at the same rate filtrate is generated. The stir plate Gauge Mounting Block Polypropylene

ensures adequate mixing of the buffer addition Luer Fittings Polypropylene and stainless steel
Tubing C-flex* and Pharmed*
• Compact Design – Saves valuable bench space, making the
entire fluid path easily accessible for built-in flexibility Four-way Valves Polycarbonate body, polyethylene core
Drip Tray Urethane
• Process Monitoring – Pressure gauge enables monitoring of feed
* C-Flex is a registered trademark of Consolidated Polymer Technologies, Inc.
pressure to ensure reproducible process parameters for consistent Pharmed is a registered trademark of Saint-Gobain Performance Plastics Corp.
runs

Applications
• Concentrate and desalt proteins, peptides or nucleic acids (DNA,
RNA, oligonucleotides)
• Recover antibodies or recombinant proteins from clarified cell
culture media
• Process metal sensitive enzymes and molecules
• Separate (fractionate) large from small biomolecules
• Concentrate viruses or gene therapy vectors
• Prepare samples prior to column chromatography
• Concentrate samples after gel filtration
• Depyrogenate water, buffers, and media solutions

Ordering Information
Description Part Number Part Number

115V AC 50/60 Hz version OAPMP110 OARES110

230V AC 50/60 Hz version OAPMP220 OARES220

Minimate TFF System Minimate TFF Reservoir

Assembly Only

Includes Peristaltic pump, pressure gauge, Pressure gauge, valves,

valves, reservoir with stir bar, reservoir with stir bar, built in stir
built in stir plate on a drip tray plate on a drip tray.(1)

Dimensions 307 mm wide x 482 mm deep 307 mm wide x 203 mm deep

x 208 mm high x 208 mm high
(12.1 in. wide x 19 in. deep (12.1 in. wide x 8.0 in. deep
x 8.2 in. high) x 8.2 in. high)
Weight 6.0 Kg (13.3 lbs.) 1.0 Kg (2.3 lbs.)
Maximum Inlet Pressure 4.1 bar (410 kPa, 60 psi) 4.1 bar (410 kPa, 60 psi)
Operating Temperature Range 0 – 50 °C (0 – 106 °F) 0 – 50 °C (0 – 106 °F)
Recirculation Flow Rate 10 – 240 mL/min 10 – 240 mL/min
Minimum System Working Volume < 5 mL < 5 mL
User will need to supply their own MasterFlex L/S Variable-Speed pump with Easy-Load pump head or equivalent.
(1)

* Masterflex and L/S are registered trademarks of Cole-Parmer.

184

Top: Centramate Membrane Cassettes
Bottom: Centrasette Membrane Cassettes
Tangential Flow Filtration Membrane Cassettes
Centramate™, Centrasette™, Maximate™, and Maxisette™ Cassettes
Centramate Cassettes
Centramate cassettes are perfect for
laboratory scale and development
applications in TFF. Small area formats with
0.009 m2 and 0.018 m2 may be used with
the LV Centramate holder for process
volumes of a few liters down to a few
milliliters. The 0.09 m2 format is used with
the Centramate Stainless Steel or
Centramate PE holders. Centramate
cassettes are available in a range of
channel formats and membranes to meet
every application requirement. The
cassettes are supplied with the same
membrane and construction materials as
used in the Centrasette Membrane
cassettes.
Applications developed on a Centramate
cassette can be easily scaled up by adding
cassettes to a Centramate holder or by
switching to the Centrasette cassette
format with identical path length and
channel format.
Refer to Tables 1 – 4 on page 187 for a list
of membranes and formats available for
Centramate cassettes
Cassette Holders and approximate
Membrane Area Capacity and Working
Volumes are listed in the table Choosing a
Cassette Holder on page 188.
Centrasette and Centrasette II
Feed Port Comparison
Centrasette and Centrasette II
Cassettes
Centrasette cassettes,available in the
same range of membrane and screen
formats as the Centramate cassettes,
have been widely used for years in various
process applications including
concentration and diafiltration by the
biopharmaceutical industry. Centrasette
cassettes are available with membrane
areas of 0.46, 1.9, and 2.3 m2 (5, 20, and
25 ft2). Larger cassette areas simplify
installation in large TFF systems, reducing
the number of gaskets required and
minimizing risk of leakage
Pall continues to improve membrane
cassettes to meet the more rigid
requirements of today’s applications.
The Centrasette II membrane cassette
uses the same components as in the
original Centrasette. Therefore revalidation
may not be necessary.
Feed ports in the Centrasette II have been
enlarged to twice the size of the
Centrasette and membrane area has been
increased by about 10%. The larger fluid
port design will enhance the membranes
performance by:
• Improving fluid flow distribution between
and through cassettes
• Allowing more efficient cleaning
• Reducing the pressure profile across
the feed/retentate channels
Both types of Centrasette cassettes are
available with 3 different membrane area
options to meet small scale and larger
process volume requirements. The
Centrasette cassettes fit in a variety of
Centrasette holders as well as similar
holders from other manufacturers.
185
 Tangential Flow Filtration Membrane Cassettes
Technical Specifications

Maximate Membrane Cassette General Information

The Maximate membrane cassette offers the opportunity to simulate There are four cassette formats for UF and MF applications –
the performance of the larger Maxisette membrane cassette on a Centramate, Centrasette, Maximate and Maxisette.
smaller scale. The path length in Maximate membrane cassettes is
Pall TFF membrane cassettes are available in a range of molecular
identical to that used in the Maxisette format but the membrane
weight cut-offs from 650 Da to 1000 kDa and pore sizes from 0.1 µm
surface area and hold up volume are proportionately lower, meaning
to 1.2 µm to meet every application requirement. Featured membrane
that processing and optimization studies may be performed on
types include:
smaller batches.
• Omega

Maxisette • Alpha
• Supor TFF
The Maxisette format has some distinct benefits that make it
advantageous for large volume processes. Most important is that the • Regen
volumetric flow rate required is 40 % lower compared to cassette Cassette Channel Configurations
formats like the Centrasette. This translates to a smaller pump and
Cassettes are available in fine, medium and suspended screen
piping diameter required for the same membrane area with a
channel formats to best meet the specific requirements of each
corresponding reduction in energy cost. The larger porting in the
application.
Maxisette (almost 50% larger feed and retentate ports than the
Centrasette II Cassette) provides lower resistance to high feed flow Select a cassette channel configuration based on the following
rates which results in lower pressure drops and easier cleaning. criteria:

Channel Configuration Selection Criteria

Fine Screen Clarified, dilute solutions
Final concentration below 2%
(20 mg/mL)
MWCO below 300K

Medium Screen Clarified solutions; low – medium

viscosity
Final concentration < 30% (300 mg/mL)

Suspended Screen/ Particles/cells/cell debris in solution

Open Channel High viscosity

Maxisette Membrane Cassettes

Storage Agents
Omega, Alpha, Supor TFF and Regen cassettes are shipped wet, in
liquid containing a humectant and bactericidal storage solution. This
solution consists of 15 – 20% glycerin, and 0.05 – 0.1% sodium
azide.
The storage solution must be removed and the cassette flushed well
with water prior to use to prevent product contamination.
Cassettes are also available with circa 0.3N sodium hydroxide as the
storage agent.

Traceability
Each membrane cassette has a unique serial number for full
traceability. Each cassette is supplied with:
• Certificate of quality
• Membrane Cassette Care and Use Procedures
• Material Safety Date Sheet (MSDS) for cassette preservative
• Two platinum cured silicon gaskets

Materials of Construction
Membrane Choice of 4:
Omega, Alpha, Supor TFF or Regen
Encapsulant Polyurethane
Screens Polyester
Spacers Polyolefin/PES
186 Cassettes pass current USP biological safety tests for Class VI plastics at 70 °C.
 Tangential Flow Filtration Membrane Cassettes
Technical Specifications and Ordering Information

How to Order Membrane Cassettes Typical Examples:

1. Choose a membrane type from Table 1 (e.g. OS, AS, CS or PS). O S 0 1 0 F 0 6 A F P S M 2 0 G 0 2 X X

2. Choose a MWCO from Table 2 or a µm rating code from Table 3,

as appropriate (e.g. 010 = 10 kD, M20 = 0.2 µm). Membrane Omega Membrane Supor

3. Choose a format code from Table 4 (e.g., C10, C11, or C12). MWCO/Rating 10 kD MWCO/Rating 0.2 µm
Format Centrasette II Format Maximate

Table 1 – Membrane Type Feed Channel Medium Screen Feed Channel Medium

Code Membrane Comments Area 0.5 m (5.4 ft )

2 2
Area 0.18 m2 (2 ft2)

OS Omega Low protein-binding Special Format NaOH Special Format None

modified polyethesulfone Storage Agent

AS Alpha Antifoam-resistant
modified polyethersulfone

CS Regen Low protein-binding Table 2 – Available MWCOs for Ultrafiltration Membranes

Regenerated Cellulose
Code MWCO Omega Alpha Regen
PS Supor TFF Microfiltration-optimized (kD) (OS) (AS) (CS)
polyethersulphone D65 0.65 ● – –
001 1 ● – –
Table 3 – Available Micron Ratings for Microfiltration
Membranes 003 3 ● – –
005 5 ● – –
Code Pore Size Supor Omega
(µm) (PS) (OS) 010 10 ● ● ●

M10 0.1 ● – 030 30 ● ● ●

M20 0.2 ● – 050 50 ● – ●

M45 0.45 ● – 070 70 ● – –

M65 0.65 ● – 100 100 ● – –
M80 0.8 ● – 200 200 ● – –
M12 1.2 ● – 300 300 ● – –
994 0.16 – ● 500 500 ● – –
990 1000 ● – –

Table 4 – Cassette and Screen Formats

Nominal Area Fine Screen(1) Medium Screen Suspended Screen
Code Code Code
Cassette Format
Centramate 0.01 m2 (0.1 ft2) – C12P1 C11P1
0.02 m2 (0.2 ft2) – C12P2 C11P2
0.1 m (1.0 ft )
2 2
C10 C12 C11
Centrasette 0.46 m2 (5.0 ft2) C05 C06 C07
1.86 m2 (20 ft2) C20 C21 C22
2.32 m2 (25 ft2) C25 C26 C27
Centrasette II 0.5 m (5.4 ft )
2 2
F05 F06 F07
2.0 m2 (22 ft2) F20 F21 F22
2.5 m2 (27 ft2) F25 F26 F27
Maximate 0.04 m2 (0.4 ft2) – G01P2 G02P2
0.19 m2 (2.0 ft2) G10 G01 G02
Maxisette 2.8 m2 (30 ft2) C50 C51 C52
(1)
Fine Screen channel not available in any MWCOs greater than 200 kDa.

187
 Tangential Flow Filtration Membrane Cassette Holders
Choosing a Cassette Holder

Designed for optimum performance and Operators must use calibrated torque
product recovery Pall TFF cassette holders wrenches (supplied with the holder) to
are available in a variety of sizes to meet effect required compression of cassettes
every application requirement. This way and gaskets in a manual torque cassette
applications that are developed on a small holder. Auto-torque cassette holders
Centramate Housing with 3-Gauge, 2-Valve Fitting
Kit and Torque Wrench
system using a Centramate or Maximate automatically compensate for cassette
cassette can be easily scaled up, either by compression and temperature reduction.
adding additional cassettes to the holder
They also eliminate variability in technique
or by scaling into a larger cassette format
between operators. Auto-torque cassette
and holder configuration with identical flow
holders are recommended for
path like the Centrasette/Centrastak or
process-scale validated processes.
Maxisette holders.
Sanitary stainless steel holders may be
TFF cassette holders for the medium and
sterilized by steam or autoclaving without
large-scale production environment have a
cassettes installed.
small footprint, yet still are capable of
holding large areas of membrane. All Complete fittings kits consisting of
stainless steel holders are engineered to pressure gauges, valves, filtrate manifold,
precise specifications with a high standard connectors, gaskets and clamps are
internal and external surface finish and are available for most cassette holders.
available with either manual torque (MT) or Ordering a complete fitting kit with the
auto torque (AT) compression systems for cassette holder simplifies installation into a
Holder Fittings Kits system and avoids potential delays in
ease of use.
Complete fittings kits consisting of starting your process due to missing parts.
pressure gauges, valves, filtrate manifold,
connectors, gaskets and clamps are Choosing a Cassette Holder
available for most cassette holders. The following table lists cassette holders with relative area capacities and working volumes. The
Ordering a complete fitting kit with the Minimate TFF Capsule is also included to complete the range of lab scale products.
cassette holder simplifies installation into a Product Membrane Area Working Volumes*
system and avoids potential delays in Lab and Development Scale
starting your process due to missing parts. (Scale-up and Scale-down studies) Starting Final
Minimate TFF 0.005 m2 0.05 ft2 25 – 500 mL 25 mL
Capsule
Centramate LV 0.01 – 0.02 m2 0.1 – 0.2 ft2 25 – 2,000 mL 10 mL
Centramate PE 0.01 – 0.37 m 2
1 – 4 ft2 0.5 – 80 L 150 mL
Centramate 0.01 – 0.46 m2 1 – 5 ft2 0.5 – 100 L 150 mL
Maximate 0.19 – 1.11 m2 2 – 12 ft2 1 – 250 L 350 mL
Pilot Scale (Process Development)
Centrasette LV 0.46 – 2.3 m2 5 – 25 ft2 2.5 – 500 L 400 mL
Centrasette P 0.46 – 2.3 m 2
5 – 25 ft2 2.5 – 500 L 400 mL
Centrasette 5 0.46 – 4.6 m2 5 – 50 ft2 2.5 – 1,000 L 1,000 mL
Process Scale (Production)
Centrastak 100 0.9 – 18.5 m2 10 – 200 ft2 10 – 4,000 4L
Centrastak 200 1.85 – 37.2 m2 20 – 400 ft2 20 – 8,000 10 L
Centrastak 300 2.8 – 55.8 m2 30 – 600 ft2 30 – 12,000 15 L
Centrastak 400 3.7 – 74.0 m 2
40 – 800 ft2 40 – 16,000 20 L
Maxisette 25 2.8 – 27.9 m2 30 – 300 ft2 30 – 6,000 15 L
Maxisette 50 5.6 – 55.8 m2 60 – 600 ft2 60 – 12,000 30 L
Maxisette 100 5.6 – 92.9 m2 60 – 1,000 ft2 60 – 20,000 40 L
(1)
Fewer suspended screen cassettes will fit due to increased thickness. Some holders can fit more membrane area than
can be operated at required cross flow rates due to high pressure drops. Do not use more than the recommended area in
these holders.Manual (MT) and auto-torque (AT) version holders are available for Pilot and Process Scale applications.
(2)
Working Volumes are based on an average filtrate flux rate of about 50 LMH and process time of 5 hours. Starting Range
covers minimum to maximum area installed for screen channel cassettes. Final process volume represents final
concentration volume or minimum working volume for the system. Actual volumes depend on system hold-up volume
and operating parameters. Piping (tubing) lengths and internal diameters significantly affect the final volume.
188
 Tangential Flow Filtration Membrane Cassette Holders
Centramate LV Holder
The Centramate LV holder is fabricated
from Stainless Steel (316L) with female luer
fittings for use with 0.01 m2 (0.1 ft2) and
0.02 m2 (0.2 ft2) Centramate cassettes.
The holder can accommodate up to
0.04 m2 (0.4 ft2) of screen channel or
0.02 m2 (0.2 ft2) of open channel
Centramate cassettes at recommended
cross flow rates. A range of luer fittings
and valves are available as well as pressure
gauges or transducers to set-up a
complete TFF system.
Centramate PE Holder
The Centramate PE holder has a
polyethylene manifold with 1⁄4 in. NPT
threaded ports sandwiched between 304
stainless steel outer plates for support. It
will accommodate up to 4 screen channel
(3 suspended screen channel) 0.09 m2
(1 ft2) cassettes. The use of several
spacers on the tie rods makes it easy to
apply and tighten the nuts with minimal
threading if only one cassette is installed.
As additional cassettes are added, spacers
can be removed. The Centramate PE
holder is recommended for use in
applications where metal contact must be
avoided. A plastic, NPT threaded fitting
kit,with either 2 or 3 pressure gauges is
available.
Centramate Stainless Steel Holder
The Centramate stainless steel cassette
holder (316L) comes with 1⁄2 in. sanitary
flanges on feed and filtrate ports. The
holder is supplied with surface and weld
certification. Up to 5 screen channel (4
suspended screen channel) 0.09 m2 (1 ft2)
cassettes can be accommodated. Holder
is supplied with both 1 in. and 2 in.
spacers on the tie rods to simplify cassette
Top to Bottom: Centramate LV Holder installation and to apply the required
Centramate PE Holder
torque. Spacers can be removed to
Centramate Stainless Steel Holder
Centrasette LV Holder
Centrasette P Holder
compensate for the height difference as
additional cassettes are added to the
holder. Sanitary fitting kits with either 2 or 3
pressure gauges are available.
Centrasette LV Holder
The Centrasette LV Holder is
manufactured using highly polished 316L
stainless steel. This holder has 3⁄4 in.
sanitary fractional fitting on the
feed/retentate and permeate ports which
minimizes the hold-up volume. It is ideal for
use in systems that use Centrasette
cassettes when total membrane area will
be less than 2.5 m2 (27 ft2) of screen
channel cassettes or 1.5 m2 (16 ft2) of
suspended screen cassettes.
Centrasette P Holder
The Centrasette P Holder has a
polypropylene center manifold and end
plate,for use when product contact with
metal is not desirable or prohibited by your
application; for example when processing
certain metal sensitive enzymes or
oligonucleotides. The manifold and end
plate are housed between stainless steel
plates to supply the necessary rigidity
when operating at higher pressures.Luer
fittings on the 3⁄4 in. sanitary polypropylene
ports can be used for connection to plastic
pressure transducers for monitoring
pressures, again without metal contact.
The low-cost plastic manifold and end
plate can be replaced to avoid cleaning
validation or dedicated to a specific
application along with a set of cassettes to
prevent any risk of cross-contamination.
The Centrasette P holder like the
Centrasette LV holder is intended for use
with Centrasette cassettes when total
membrane area will be less than 2.5 m2
(27 ft2) of screen channel cassettes or
1.5 m2 (16 ft2) of suspended screen
cassettes.
189
 Tangential Flow Filtration Membrane Cassette Holders
Centrasette 5 and Centrasette 5AT Holders
The Centrasette 5 holder is intended for use in pilot and process
scale applications with up to 5 m2 (54 ft2) screen channel Centrasette
or Centrasette II cassettes or 4 m2 (43 ft2) of suspended screen
cassettes. The feed/retentate channels have tapered bores
engineered to maintain uniform cross flow and pressure drops across
the membrane cassettes. Two permeate ports, one near the feed and
the other near the retentate, are designed to reduce backpressure on
the permeate side of the membrane. This is especially important
when operating at high flux rates. Pressure on the permeate side
effectively reduces transmembrane pressure and lowers filtrate flux
rates. The highly polished 316L stainless steel unit has ports that
mate up with 1 in. sanitary connectors. A calibrated torque wrench
and socket is supplied with the holder, as it is with other manual
torque holders.
Top : Centrasette Holder with Manual Torque
Bottom: Centrasette Holder with Auto Torque
190
Centrastak Holders
Processes developed at bench scale on Centramate and
Centrasette cassettes can be scaled up to process volumes in
excess of 10,000 L using a Centrastak system. The Centrastak
range of cassette holders have been designed for optimal
performance in large-scale production environment. The small
footprint makes them ideal for use in process skids and
manufacturing suites where space is at a premium. Each level in a
Centrastak holder can hold up to 10 m2 (107 ft2) of Centrasette
cassettes on each side of a central manifold or effectively 20 m2
[215 ft2] per level. A single center-manifold significantly reduces
hold-up volumes.
Feed flow direction is from bottom to top allowing air to be easily
expelled from the system. Four Centrastak holders are available:
• Centrastak 100AT – 20 m2 (215 ft2) capacity
• Centrastak 200AT – 40 m2 (430 ft2) capacity
• Centrastak 300AT – 60 m2 (645 ft2) capacity
• Centrastak 400AT – 80 m2 (861 ft2) capacity
All Centrastak holders are available in auto-torque format with a
hydraulic system,including stainless steel pistons and pump,for
maintaining optimal and uniform compression on the installed
cassettes. A pressurized air supply is required to operate the
hydraulic pump (60 psi minimum,125 psi maximum). All wetted
surfaces are electropolished, 316L stainless steel. Holder is supplied
with surface and weld certification to support I/Q validation.
Top: Centrastak 200 AT
Bottom: Hydraulic Pump for AutoTorque Holders
Tangential Flow Filtration Membrane Cassette Holders

Maximate Holders Maxisette holders are available in

auto-torque format with a hydraulic
Maximate holders are designed for use
system, including six pistons and a pump,
with Maximate membrane cassettes. The
for maintaining optimal and uniform
316L stainless steel holder has 3⁄4 in.
compression on the installed cassettes. A
sanitary feed/retentate ports and 1⁄2 in.
pressurized air supply is required to
permeate ports. Up to 6 screen channel
operate the hydraulic pump (60 psi
cassettes (4 suspended screen channel
[4.1 bar] minimum, 125 psi [8.6 bar]
cassettes), 0.19m2 (2ft2) will fit into the
maximum). All wetted surfaces are
holder accommodating process fluid
electropolished, 316L stainless steel.
volumes from a few hundred milliliters up
to over a hundred liters. Maxisette holders are available in three
different sizes:
Maximate cassettes are chosen for
scale-up studies when process-scale • Maxisette 25: 28 m2 (300 ft2) capacity,
volumes will be processed using a screen channel
Maxisette system that has the same • Maxisette 50: 56 m2 (600 ft2) capacity,
feed/retentate channel path length. screen channel
• Maxisette 100: 89 m2 (960 ft2) capacity,
Maxisette Holders
screen channel
The Maxisette holder has been designed All Maxisette Holders are supplied with
for optimal performance in a large-scale surface and weld certification.
production environment. The longer path
length of a Maxisette cassette compared
with a Centrasette cassette allows a 40%
reduction in cross flow rate (retentate flow
rate), therefore requiring a smaller pump
with a corresponding reduction in heating,
energy costs and space requirements. The
small footprint makes it ideal for use in
process skids and manufacturing suites
where space is at a premium. Feed flow
direction is from bottom to top allowing air
to be easily expelled from the system.
Port design in the Maxisette cassette
results in a significant reduction in pressure
drops and a more uniform pressure profile
at operating cross flow rates compared to
other cassette formats. This results in
higher performance during production and
more efficient cleaning. Processes
developed at bench scale on Maximate
cassettes can be efficiently scaled up to
process volumes in excess of 10,000L.

191
 Tangential Flow Filtration Membrane Cassette Holders
Technical Specifications

Centramate Cassette Holders

Cassette Holder Centramate LV Centramate PE Centramate
Feed and Retentate Ports Female luer SS 1
⁄4 in. NPT Fitting (female) ⁄2 in. Sanitary, 9.6 mm (0.38 in.) bore
1

Filtrate Port Female luer SS 1

⁄4 in. NPT Fitting (female) ⁄2 in. Sanitary, 8.1 mm (0.32 in.) bore
1

Maximum Membrane Area

Screen 0.04 m2 (0.4 ft2) 0.37 m2 (4 ft2) 0.46 m2 (5 ft2)
Suspended Screen 0.02 m2 (0.2 ft2) 0.28 m2 (3 ft2) 0.37 m2 (4 ft2)

Nominal Dimensions 12 x 23 x 6.6 cm 9.4 x 24 x 19 cm 13 x 23 x 16 cm

(Width x Length x Depth) (41⁄2 x 9 x 21⁄2 in.) (33⁄4 x 91⁄2 x 71⁄2 in.) (51⁄4 x 9 x 61⁄4in.)

Weight 4 kg (8.75 lbs) 8.6 kg (19 lbs) 6.4 kg (14 lbs)

Maximum Operating Temperature (2)

50 °C (121 °F) 80 °C (175 °F) 80 °C (175 °F)(3)

Maximum Operating Pressure 5 bar (75 psi) 6 bar (90 psi) 6 bar (90 psi)

Centrasette Cassette Holders

Cassette Holder Centrasette LV Centrasette P Centrasette 5,* 5AT*

Feed and Retentate Ports ⁄4 in. sanitary SS

3 3
⁄4 in. sanitary PP 1 in. sanitary SS

Filtrate Port ⁄4 in. sanitary SS

3 3
⁄4 in. sanitary PP 1 in. sanitary SS

Maximum Membrane Area (1)

Screen 2.0 m2 (22 ft2) 2.0 m2 (22 ft2) 5 m2 (54 ft2)

Suspended Screen 1.5 m2 (16 ft2) 1.5 m2 (16 ft2) 4 m2 (43 ft2)

Nominal Dimensions 26 x 25 x 21 cm 30 x 20 x 34 cm 26 x 25 x 27 mm
(Width x Length x Depth) (101⁄4 x 10 x 81⁄2 in.) (12 x 8 x 131⁄2 in.) (101⁄4 x 10 x 103⁄4 in.)

Weight 28 kg (62 lbs) 25 kg (55 lbs) 30 kg (66 lbs)

Maximum Operating Temperature (2)

80 °C (175 °F) (3)
50 °C (121 °F) 80 °C (175 °F)(3)

Maximum Operating Pressure 6 bar (90 psi) 5 bar (75 psi) 6 bar (90 psi)
* Extended tie rods available to increase membrane capacity to 5 m (54 ft ) for suspended screen channel cassettes.
2 2

Centrastak Cassette Holders

Cassette Holder Centrastak 100 Centrastak 200 Centrastak 300 Centrastak 400
Feed and Retentate Ports 2 in. sanitary 2 in. sanitary 2 in. sanitary 2 in. sanitary
Filtrate Port 1 in. sanitary 1 in. sanitary 1 in. sanitary 1 in. sanitary
Maximum Membrane Area(1)
Screen 20 m2 (216 ft2) 40 m2 (430 ft2) 60 m2 (645 ft2) 80 m2 (860 ft2)
Suspended Screen 15 m2 (161 ft2) 30 m2 (323 ft2) 45 m2 (484 ft2) 60 m2 (645 ft2)

Nominal Dimensions 39 x 91 x 59 cm 39 x 91 x 95 cm 39 x 91 x 107 cm 39 x 91 x 120 cm

(Width x Length x Height) (151⁄2 x 36 x 231⁄4 in.) (151⁄2 x 36 x 371⁄2 in.) (151⁄2 x 36 x 42 in.) (151⁄2 x 36 x 471⁄2 in.)

Weight 155 kg (340 lbs) 255 kg (560 lbs) 314 kg (690 lbs) 409 kg (900 lbs)

Maximum Operating 80 °C (175 °F) 80 °C (175 °F) 80 °C (175 °F) 80 °C (175 °F)
Temperature(2, 3)

Maximum Operating 6 bar (90 psi) 6 bar (90 psi) 6 bar (90 psi) 6 bar (90 psi)
Pressure
(1)
Cassette blocks (2 m2 [21.6 ft2] or 2.5 m2 [26.9 ft2]) are recommended. If 0.5 m2 [5.3 ft2] cassettes are used, stabilizer plates must be used between every 5 cassettes (fine/medium screen) or
3 cassettes (suspended screen).
(2)
Maximum operating temperature may be restricted by cassette operating temperature limit.
(3)
Holder may be steamed with compatible cassettes, or without cassettes at up to 142 °C (287.6 °F).

192
 Tangential Flow Filtration Membrane Cassette Holders
Technical Specifications and Ordering information

Maximate and Maxisette Cassette Holders

Cassette Holder Maximate Maxisette 25 Maxisette 50 Maxisette 100
Feed and Retentate Ports 3
⁄4 in. sanitary 2 in. sanitary 21⁄2 in. sanitary 21⁄2 in. sanitary
Filtrate Ports 11⁄2 in. sanitary 11⁄2 in. sanitary 11⁄2 in. sanitary 11⁄2 in. sanitary
Maximum Membrane Area(1)
Fine/Medium Screen 1.1 m2 (12 ft2) 28 m2 (300 ft2) 56 m2 (600 ft2) 89 m2 (960 ft2)
Suspended Screen 0.74 m2 (8 ft2) 28 m2 (300 ft2) 56 m2 (600 ft2) 56 m2 (600 ft2)
Dimensions 16 x 44 x 22 cm 47 x 105 x 57 cm 47 x 105 x 97 cm 47 x 105 x 117 cm
(Width x Length X Height) (61⁄4 x 171⁄2 x 83⁄4 in.) (181⁄2 x 411⁄2 x 221⁄2 in.) (181⁄2 x 411⁄2 x 38 in.) (181⁄2 x 411⁄2 x 46 in.)
Approximate Weight 13.3 kg (29.2 lbs) 455 kg (1000 lbs) 566 kg (1245 lbs) 566 kg (1245 lbs)
Maximum Operating 80 °C (176 °F) 80 °C (176 °F) 80 °C (176 °F) 80 °C (176 °F)
Temperature(2, 3)
Maximum Operating 6 bar (87 psi) 6 bar (87 psi) 6 bar (87 psi) 6 bar (87 psi)
Pressure
(1)
Cassette blocks (2 m2 [21.6 ft2] or 2.5 m2 [26.9 ft2]) are recommended. If 0.5 m2 [5.3 ft2] cassettes are used, stabilizer plates must be used between every 5 cassettes (fine/medium screen) or
3 cassettes (suspended screen).
(2)
Maximum operating temperature may be restricted by cassette operating temperature limit.
(3)
Holder may be steamed with compatible cassettes, or without cassettes at up to 142 °C (287.6 °F).

Materials of Construction for Wetted Parts

Centramate PE Centramate LV Centramate/Maximate Centrasette P Centrasette/Maxisette
Plates UHMW polyethylene 316L Stainless Steel 316L Stainless Steel Polypropylene 316L Stainless Steel
Flow Distribution UHMW polyethylene 316L Stainless Steel 316L Stainless Steel Polypropylene 316L Stainless Steel
Manifold
Other Components EPDM O-ring on SS EPDM sanitary
threaded Luer connector gaskets

Ordering Information
The following table lists individual cassette holders as well as holders sold in combination with fittings packages. Additional combinations and a
variety of other accessories are available. For complete descriptions and additional offerings, contact your local Pall representative.

Description Part Number

Centramate
Centramate PE Holder, Including torque wrench and socket FS002K10
Centramate PE Holder, Including fittings package with 3 pressure gauges FS013K10
Centramate LV Holder, Including torque wrench and socket FS003K10
Centramate SS Holder, Including torque wrench and socket FS001K10
Centramate SS Holder, Including torque wrench,fittings package with 3 pressure gauges, 2 diaphragm valves FS011K10
Centrasette 5 manual torque Including torque wrench and socket FS001K05
Centrasette
Centrasette P Holder Including torque wrench and socket FS039K05
Centrasette LV Holder Including torque wrench and socket FS044K05
Centrasette LV holder,Including torque wrench and socket,fittings package with 3 pressure gauges,2 diaphragm valves FS046K05
Centrasette 5 Including torque wrench and socket FS001K05
Centrasette 5 holder,Including torque wrench and socket,fittings package with 3 pressure gauges,2 diaphragm valves FS014K05
Centrasette 5AT Holder FS020K05
Centrasette 5AT holder,Including torque wrench and socket,fittings package with 3 pressure gauges,2 diaphragm valves FS022K05
Centrastak
Centrastak 100 AT FS050K05
Centrastak 200 AT FS034K05
Centrastak 300 AT FS036K05
Centrastak 400 AT FS038K05
Maximate
Maximate holder,including torque wrench and socket FS001G01
Maximate fitting package, Including torque wrench and socket,fittings package with 3 pressure gauges and 2 diaphragm valves FS003G01
Maxisette
Maxisette 25 AT FS009K50
Maxisette 50 AT FS013K50
Maxisette 100 AT FS016K50 193
 Pilot and Process Development Capabilities

Pall offers a range of tangential flow filtration systems from small scale
and process development to full-scale process systems. These
include standard systems such as the Minimate, Centramate Pilot,
and Centrasette 5AT Systems as well as standard and custom
engineered process systems that meet the most stringent control and
validation requirements. Various levels of automation from simple
manual systems to full automation control and data acquisition are
available or can be custom-developed to meet specific requirements.
Contact Pall for further details.
• Scalable design
• Multiple membrane formats
Maxim benchtop TFF System
• Ease of use
for process development and
Microza* Benchtop System
pilot scale applications
Pall Engineering
• Mechanical Design
ASME BPE
Clean In Place (CIP)
Sterilize In Place (SIP)
• Electrical Design
Explosion-proof (XP)design
UL508 Panel fabrication
National Electric Code (NEC) UL
CSA and cUL standards.

Controls
• GAMP-compliant
• PLC /PC based
• SCADA Packages
• DCS
• Standard Package modifications Centrastak Workstation

Project Support
• Process Development
• Project Management
• System Fabrication
• Documentation

Service
• Factory Acceptance Test
• Site Acceptance Test
• Installation Qualification
• Operation Qualification
• Start-up/Commissioning
• Operator Training
Large Process system with automated valves and process control for up to 800 ft2
• Maintenance of membrane.
• Troubleshooting and Support

* Microza is a trademark of Asahi Kasei Corporation

194

Top and Middle: Centramate Pilot Automated
Development and Optimization Systems
Bottom: System Overview Display
Tangential Flow Filtration Systems
Pre-Designed Systems for Scalable Processing
Pall offers scalable, pre-designed systems
to suit your specific process needs. Pall
Standard systems are ready-to-use,
engineered systems with integrated recipe
management tools to expedite your
approval processes and reduce your time
to market.
The pilot system includes the flexibility of
both semi and full automation, a UV
detector, a pH monitor, an Integrity
Analyzer, and an integrated tank. The
system expedites the development and
scale-up of filtration processes in
accordance with FDA cGMP regulations
and guidelines.
Pall Pre-designed Pilot Systems
Pall offers a range of pre-designed systems
to meet your process goals.
These include:
• Centramate 0.1 – 0.5 m2 (1 – 5 ft2)
• Maximate 0.2 – 0.9 m (2 – 10 ft ) 2 2
• Centrasette(1) 0.5 – 7.0 m2 (5 – 75 ft2)
• Centrastak(1) 0.9 – 18.6 m2
(10 – 200 ft2)
(1)
Autotorque hardware included and optional
Instrumentation for UV, pH, Conductivity, Integrity,
and Auxiliary Pump. Tanks also available.
Features
• Intuitive Automated Control System
• Fully scalable design and components
• Complete validation package with
comprehensive IQ/OQ documentation
• Compact sanitary ergonomic design for
enhanced cleanability, portability, and
accessibility
• Optional AutoTorque™ (AT) hardware
provides uniform cassette sealing
• Comprehensive Recipe Management
• Adheres to ASME BPE, ANSI ISA, and
cGMP standards
• Time-saving
Process Automation
Puts Control in the Hands of your
Process Engineers
User-friendly recipe management tools
include a suite of default recipes for
pre-production, production, and
post-production operations. Your process
experts can make applications work
without waiting for programmers to sift
through cryptic proprietary software code.
The flexible software design enables users
to build recipes and develop processes
without PLC programming expertise. Our
software is ideal for use in a variety of
environments, including process:
• Development
• Optimization
• Production
Streamlined Validation
Our recipes are configured from modules
which are tested configuration-based
sequences that reduce the number of
validation steps.
Operations
From a touch screen,any authorized user
can create and store recipes so an
operator can run process tasks simply,
easily, and accurately.
Pall’s pre-programmed recipes can be
used to automatically sanitize, concentrate,
recover product, and clean in place.
Data Storage
• 21 CFR Part 11 compliant
data-handling
• Convenient data storage and retrieval
• Outputs to electronic or printed formats
Reports
• Real-time trend analysis
• Historic Trend Overlays
• Comprehensive Batch Reports
• Exports common text and table formats
195
 Tangential Flow Filtration Systems
Pre-Designed Systems for Scalable Processing

Left: Centrasette System

Middle: Maxisette System
Right: Centrastak System

Engineered Solutions Process Design

Pall engineers are available to help you design and build systems to Making your process work reliably and repeatably is our goal. Pall
accommodate your specific process needs. Decades of experience in Process engineers are available to work with you throughout the
the BioProcess Industry has proven our ability to provide innovative, entire development phase. Some of the typical activities our process
cost-effective solutions. experts can help you with are:
Our team of process engineers and design specialists work with you • Membrane screening trials
every step of the way to ensure that systems meet your application
• Initial scale-up work
needs and delivery requirements.
• Process optimization
Design • Cleaning

Our patented designs provide higher process efficiency, enhanced
process control, lower pressure drops, and minimized holdup
volumes to ensure:
• Maximum yield
• Cleanability and Recovery
• Compact cost-effective systems – more membrane area per
square-foot of floor space
• Autotorque device offers consistent pressure for a reliable seal on
cassettes to ensure batch process repeatability with minimal labor
overhead
• Scale-down studies
• Process Audits
Project Execution
To ensure that our entire project team understands your needs, our
Process Engineers will manage your project throughout the entire
design, build, and commissioning cycle. Our process engineers will
direct the project team to meet your process requirements on time
every time.

Pre-Engineered Systems
Centramate Pilot Maximate Pilot Centrasette 5 SAT Centrastak 100 SAT
Feed Flow Range 7 7 65 120
(L/Min) @ 60 psig

Membrane Area 0.1 –0.5 m2 (1 – 5 ft2) 0.2 – 0.9 m2 (2 – 10 ft2) 0.5 – 7.0 m2 (5 – 75 ft2) 0.9 – 18.6 m2 (10 – 200 ft2)

Connections ⁄2 in. Sanitary Flange

1 1
⁄2 in. Sanitary Flange 11⁄2 in. Sanitary Flange 11⁄2 in. Sanitary Flange

Membrane Holder Manual Torque Manual Torque Auto Torque Auto Torque

Optional Instrumentation UV, pH, UV, pH, UV, pH, UV, pH,
Conductivity, Integrity, Conductivity, Integrity, Conductivity, Integrity, Conductivity, Integrity,
Auxiliary Pump, Tanks Auxiliary Pump, Tanks

Hold-up Volume 275 mL 275 mL < 2.5 L < 3.5 L

196
TFF Polymeric Hollow Fiber Membranes and Ceramic Modules
For Demanding Duties in Ultrafiltration and Microfiltration
Polymeric Membranes
Pall’s polymeric hollow fiber membranes
and modules comprise the Microza* range.
Microza membranes are durable, industry-
leading fibers available in a wide variety of
ratings and polymers for applications as
diverse as clarification, concentration and
purification of bulk enzyme solutions,to
optimized designs for long-term sterility
maintenance and performance in critical
mammalian cell culture perfusion.
Available ratings span the range from low
molecular weight ultrafiltration through to
microfiltration. All Microza membranes are
supplied as self-contained modules, with
no additional requirement for housings,
enabling simplicity of system design.
Modules are available that can be
autoclaved, and many can be
live-steamed, facilitating aseptic operation
through the use of SIP.
* Microza is a trademark of Asahi Kasei Corporation
All membranes are available in modules
ranging in size from a few square
centimeters of surface area through
multiple square meters in a single module
to cover every scale of operation from the
laboratory to the largest manufacturing
plant with consistent fiber geometry.
Membrane modules can be cleaned for
multiple re-use, the simple design
facilitating such cleaning or, because of the
convenience of the stand-alone modular
design, may be treated as single-use items
for many critical applications, such as the
production of recombinant proteins in
perfusion cell culture.
Systems
Pall’s experience with systems built to
utilize Microza membranes, is second to
none, and includes construction of some
of the largest and most complex process
unit operations in the bioprocessing
industry.
197
 Microza Membranes
Technical Specifications

Polymeric Membrane Morphology Microza Module Types

Microza* ultrafiltration membranes are unique in their construction. Microza hollow fiber modules are available with housings made from
Every membrane has an asymmetric structure,with a membrane layer polysulfone (native, clear), filled polysulfone (white, opaque), and
both on the inside, and on the outside of the fiber, overlaying a core polyvinylchloride (PVC). Polysulfone modules will withstand
comprising a very open support for excellent flow characteristics, and autoclaving and in some cases steaming. Clear polysulfone modules
a central strengthening layer for outstanding fiber durability in are recommended for more critical pharmaceutical applications. Filled
long-term service. Microza ultrafiltration membranes are resistant to polysulfone and PVC modules are ideally suited to long term
flow in both directions, so there is no risk of delamination or installations where light might cause biofilm to form, or for bulk
membrane rupture during accidental back-pressure. In fact, in many processes involving light sensitive materials. PVC modules are ideal
installations, backpulsing can be used to maintain flux during for use in feed water systems and bulk processes.
extended run times.
Microza modules are available with industry standard clamp fittings
Microza micofiltration membranes have smooth inner and outer on the feed and retentate side, and some with quick connects. All
membrane skins with a highly porous symmetrical support structure steamable modules designed for long term use in critical applications
giving high-flow rates. These modules can also be backflushed. such as perfusion have sanitary clamp connections on the
feed/retentate and filtrate sides, or filtrate hose barbs on laboratory
All Microza membranes have surfaces that minimize entrapment and
scale modules.
facilitate cleaning. All Microza membranes are manufactured in a
single step, and are not composed of laminates. Membranes and
modules are subjected to rigorous quality control to ensure Retrofitting Existing Applications
consistency of performance, durability in service, and module integrity To retrofit an existing application,membrane rating should be chosen
for the most demanding applications. to be equivalent or superior in performance. For ultrafiltration
membranes, this may require testing more than a single cut-off.
Membrane Types Differences in membrane area and lumen diameter can typically be
accommodated by adjustments to operating conditions to ensure
Polysulfone (PS)
that trans-membrane pressure and fluid velocity conditions at the
Polysulfone membranes exhibit excellent resistance to pressure, membrane surface are similar. Hollow fiber modules can be joined
temperature and aggressive cleaning regimes. Very low affinity and end-to-end as required to create similar path length systems. Small
adsorption characteristics results in high product recoveries, and long adjustments to physical dimensions, and differences in connection
service life. type are accomplished using adapters. Please contact Pall for
Polyacylonitrile (PAN) assistance with selecting the right modules to retrofit an existing
PAN membranes are ideally suited to bulk process applications, such installation.
as the purification of enzymes. They exhibit high-strength, coupled The following pages list modules firstly by membrane material, and
with high flux rates, minimizing installation size. PAN has a low fouling then within each material by rating, available sizes and available
characteristic for these applications, simplifying cleaning. connection types.
Polyvinylidene Fluoride (PVDF)
PVDF membranes are widely used for the filtration of biological
solutions. In hollow fiber format, these membranes show excellent
retention characteristics, allowing use in critical applications where
absolute removal over long periods is required. Lower non-specific
binding than many PS membranes used in protein recovery
applications ensures excellent results in leading-edge biotechnology
processes. PVDF membranes are steamable in situ for additional
process security. PVDF exhibits superior chemical resistance to many
other polymers used in microfiltration processes.
Polyolefin (P)
Polyolefin membranes are a good choice for bulk clarification
processes where sterility is not essential. Nevertheless, P-membranes
have good retention characteristics coupled with high flux rates.
Availability in fine microfiltration retention ratings ensures protection of
downstream processing equipment.

* Microza is a trademark of Asahi Kasei Corporation

198
 Microza Membranes
Polysulfone Membranes – Technical Specifications

Microza SP, SV and VP series hollow fiber ultrafiltration modules have Key Features
a unique double-skinned proprietary polysulfone (PS) membrane with • Combination of high-strength and high-flow due to unique
dense internal layer. Currently available in 3000, 4000, 6000, and membrane construction
10000 molecular weight cut-offs, the modules are used in a range of
• Double-skin provides assurance of removal rating
pharmaceutical applications including pyrogen removal from water,
buffer solutions active ingredients such as antibiotics, and • High-strength fiber allows reverse filtration to assist cleaning in
concentration of protein solutions. SV modules are used for clarifying difficult applications
antibiotic and other broths used for small molecule API production. • Available in a range of sizes from 0.015 m2 (0.16 ft2) to more than
12 m2 (125 ft2)
Materials of Construction • All SP and VP modules may be hot water sanitized: up to 95 °C
(203 °F) – SIP and SLP, or 90 °C (194 °F) – SEP and SAP; and all
Membrane Polysulfone (with silicone coating on
ends in VIP–3017S) may run continuously at 80 °C (176 °F)
Housing Native clear polysulfone (P) or PVC (V) • SP Modules may be autoclaved in single use applications
Potting Material Epoxy resin • VIP 6000 MWCO version steam-sterilizable up to 50 cycles at
Gasket Silicone (P) or butyl rubber (NBR) (V) 125 °C (257 °F) at a differential pressure of 100 mBar
Bacteriostat Glycerin 65%, ethanol 2%, • SV modules are designed for maximized recovery in bulk
water balance fermentation, limited to 50 °C (122 °F)
Connectors and Adapters Contact Pall for wide range of fittings for • Compatible with a wide range of cleaning agents, up to 5000 ppm
these modules
sodium hypochlorite or 4% sodium hydroxide

Connectors and Adapters • Meets the specification for biological tests listed in the current
For available connections, please refer to table on p202.
revision of USP for class VI plastics at 121 °C (249 °F)
• pH range 1 – 14

Part Number(1)
Rating Fiber Nominal Membrane Clean Crossflow Maximum Volume Volume Feed/ Permeate
(MWCO, ID Length(2) Area Water Flux Rate for Pressure Feed Permeate Retentate Connection
Daltons) Lh -1 bar 1ms-1 fluid (barg) at Side(3) Side(3) Connection
velocity 50 °C (mL)
(122 °F)
SEP-0013 3000 0.8 mm 130 0.017 2.5 181 1/1/1 9 9 A2 A1
SEP-1013 3000 0.8 mm 347 0.2 25 724 3/3/2 90 120 B1 B1
SEP-2013 3000 0.8 mm 552 1.0 130 1629 5/3/2 300 500 C4 C3
SEP-3013 3000 0.8 mm 1129 4.7 650 3655 5/3/3 1200 3700 C5 C4
SAP-0013 4000 0.8 mm 130 0.017 3.6 181 1/1/1 9 9 A2 A1
SAP-1013 4000 0.8 mm 347 0.2 36 724 3/3/2 90 120 B1 B1
SAP-3013 4000 0.8 mm 1129 4.7 900 3655 5/3/3 1200 3700 C5 C4
SAV-3013 4000 0.8 mm 1126 5.6 1100 4343 5/3/3 1200 3700 C7 D2
SAV-5013 4000 0.8 mm 1126 12.1 2400 9950 5/3/3 3800 5300 C8 D3
SIP-0013 6000 0.8 mm 130 0.017 4.0 181 1/1/1 9 9 A2 A1
SIP-1013 6000 0.8 mm 347 0.2 40 724 3/3/2 90 120 B1 B1
SIP-1023 6000 0.8 mm 347 0.2 44 724 3/3/2 90 130 B1 B1
SIP-2013 6000 0.8 mm 552 1.0 200 1629 5/3/2 300 500 C4 C3
SIP-3013 6000 0.8 mm 1129 4.7 1000 3655 5/3/3 1200 3700 C5 C4
SIP-3023 6000 0.8 mm 1129 7.2 1700 5610 5/3/3 700 3700 C5 C4
VIP-3017S 6000 0.8 mm 1129 4.7 1000 3655 5/3/3 1200 3700 C5 C4
SLP-0053 10000 1.4 mm 130 0.015 5.7 277 1/1/1 11 9 A2 A1
SLP-1053 10000 1.4 mm 347 0.1 40 776 3/3/2 85 120 B1 B1
SLP-2053 10000 1.4 mm 552 0.6 150 1773 5/3/2 310 500 C4 C3
SLP-3053 10000 1.4 mm 1129 4.5 1500 5819 5/3/3 1850 3700 C5 C4
(1)
Third letter represents housing material: P – Clear native Polysulfone with silicone gasket, V – white PVC with butyl rubber gasket.
(2)
Nominal length is flange to flange, or to ends of connectors on quick-connect modules. Detailed drawings available upon request.
(3)
Guideline module filling volume to allow calculation of minimum system working volumes when added to volumes of attached piping and other components.
Drained residual volumes are considerably less.
(4)
VIP-3017S – Maximum Inlet pressure for steam at 121 °C is 1.1 barg, max TMP 0.1 barg, filtrate pressure 0 (open steaming, no back pressure).
199
 Microza Membranes
Polyacrylonitrile Membranes – Technical Specifications

The AP and AV series of Microza hollow fiber ultrafiltration modules Key Features
feature unique double-skinned proprietary polyacrylonitrile (PAN)
• Hydrophilic polyacrylonitrile membrane provides low fouling and
membranes with dense internal layer. Available in 6,000, 13,000,
excellent flux recovery
50,000 and 80,000 molecular weight cut-offs, the modules are used
in a range of pharmaceutical applications especially in purification and • Combination of high-strength and high-capacity due to unique
processing of aqueous enzymes and protein solutions. 80,000 membrane construction
MWCO modules are especially useful for raw water pretreatment to • High-strength fiber allows reverse filtration to assist cleaning in
pharmaceutical water purification plant. difficult applications
• Available in a range of sizes from 0.012 m2 (0.13 ft2) to more than
Materials of Construction 40 m2 (425 ft2)
Membrane Polyacrylonitile • Compatible for continuous operation up to 50 °C (122 °F)
Housing Native clear polysulfone (P) or PVC (V)
• Easily cleanable in most biological applications using minimum
Potting Material Epoxy Resin chemicals or detergents
Gasket Silicone (P) or butyl rubber (NBR) (V)
• Meets the specifications for biological tests listed in the current
Bacteriostat Glycerin 65%, Ethanol 2%,
revision of USP for class VI plastics at 121 °C (249 °F)
water balance
• LGV and LOV modules especially optimized for raw water duty

Connectors and Adapters • pH 2 -10

For available connections, please refer to table on p202.

Part Number(1)
Rating Fiber Nominal Membrane Clean Crossflow Maximum Volume Volume Feed/ Permeate
(MWCO, ID Length(2) Area Water Flux Rate for Pressure Feed Permeate Retentate Connection
Daltons) Lh -1 bar 1ms-1 fluid (barg) at Side(3) Side(3) Connection
velocity 50 °C (mL)
(122 °F)
AIP-0013 6000 0.8 mm 130 0.017 1.0 181 1/1/1 9 9 A2 A1
AIP-1010 6000 0.8 mm 347 0.2 10 724 3/3/2 90 120 B1 B1
AIP-2013 6000 0.8 mm 552 1.0 50 1629 5/3/3 300 500 C4 C3
AIP-3013 6000 0.8 mm 1129 4.7 160 3655 5/3/3 1200 2700 C5 C4
AIV-3010 6000 0.8 mm 1126 4.7 170 3655 3/3/3 1200 2700 C7 D2
AIV-5010 6000 0.8 mm 1126 12.3 700 10134 3/3/3 3800 5300 C8 D3
ACP-0013 13000 0.8 mm 130 0.017 3.4 181 1/1/1 9 9 A2 A1
ACP-0053 13000 1.4 mm 130 0.012 1.9 222 1/1/1 10 9 A2 A1
ACP-1010 13000 0.8 mm 347 0.2 10 724 3/3/2 90 120 B1 B1
ACP-1050 13000 1.4 mm 347 0.12 19 776 3/3/2 90 120 B1 B1
ACP-2013 13000 0.8 mm 552 1.0 160 1629 5/3/3 300 500 C4 C3
ACP-2053 13000 1.4 mm 552 0.6 90 1773 5/3/3 310 500 C4 C3
ACP-3013 13000 0.8 mm 1129 4.7 750 3655 5/3/3 1200 2700 C5 C4
ACP-3053 13000 1.4 mm 1129 3.1 360 3990 5/3/3 1200 2850 C5 C4
ACV-3010 13000 0.8 mm 1126 4.7 830 3655 3/3/3 1200 2700 C7 D2
ACV-3050 13000 1.4 mm 1126 3.1 420 3990 3/3/3 1200 2700 C7 D2
ACV-5010 13000 0.8 mm 1126 12.3 2200 10134 3/3/3 3800 5300 C8 D3
ACV-5050 13000 1.4 mm 1126 7.8 1100 11084 3/3/3 3800 5300 C8 D3
LGV-3010 13000 0.8 mm 1126 7.6 500 3257 3/3/3 – – C7/D2 C7
LGV-5210 13000 0.8 mm 2227 41 4000 8686 3/3/3 – – C8/D3 C8
AHP-0013 50000 0.8 mm 130 0.017 8.3 181 1/1/1 9 9 A2 A1
AHP-1010 50000 0.8 mm 347 0.2 82 724 3/2/2 90 120 B1 B1
AHP-2013 50000 0.8 mm 552 1.0 460 1629 4/2/2 300 500 C4 C3
AHP-3013 50000 0.8 mm 1129 4.7 2250 3655 4/2/2 1200 2700 C5 C4
AHV-3010 50000 0.8 mm 1126 4.7 2500 3655 3/3/3 1200 2700 C7 D2
LOV-3010 80000 0.8 mm 1126 7.6 1500 3257 3/3/3 – – C7/D2 C7
LOV-5210 80000 0.8 mm 2227 41 7000 8686 3/3/3 – – C8/D3 C8
(1)
Third letter represents housing material: P – Clear native Polysulfone with silicone gasket, V – white (gray – LGV, LOV) PVC with butyl rubber gasket
(2)
Nominal length is flange to flange, or to ends of connectors on quick-connect modules. Detailed drawings available upon request.
(3)
Guideline module filling volume to allow calculation of minimum system working volumes when added to volumes of attached piping and other components.
200 Drained residual volumes are considerably less.
 Microza Membranes
Polyvinylidenedifluoride Membranes – Technical Specifications

The U series of Microza hollow fiber microfiltration modules feature Key Features
unique proprietary membranes in specially resistant PVDF for
• Low non-specific protein binding for long term flux maintenance in
microfiltration applications. Available in 0.2 µm (UM series) and
cell culture applications
0.65 µm (UJ series) rating, the modules are used in a range of
pharmaceutical applications especially in cell harvesting, perfusion cell • Available different fiber diameters allows optimization to different
culture, viral vector production, and clarification of microbial extracts. particulate or colloidal loadings
• Superior chemical resistance of Microza PVDF ensures
Materials of Construction compatibility in a broad range of processing and cleaning
Membrane Polyvinyldenedifluoride applications
Housing Native clear polysulfone (P) • Highly characterized,optimized void structure ensures reproducible
or filled polysulfone (W) separation efficiency and high throughput
Potting Material Epoxy Resin
• High-strength fiber allows reverse filtration to optimize yield and
Gasket Silicone (P) performance in difficult applications
Bacteriostat Glycerin 65%, Ethanol 2%,
water balance • Available in a range of sizes from 0.02 m2 (0.21 ft2) to 5 m2 (54 ft2)
• U series can operate continuously in processes up to 80 °C
Connectors and Adapters (176 °F) and may be steamed in situ at 125 °C (257 °F) for 20
cycles
For available connections, please refer to table on p202.
• Meets the specification for biological tests listed in the current
revision of USP for Class VI plastics at 121 °C (249 °F)
• pH 2 – 10

Part Number(1)
Rating Fiber Nominal Membrane Clean Crossflow Maximum Volume Volume Feed/ Permeate
(MWCO, ID Length(2) Area Water Flux Rate for Pressure Feed Permeate Retentate Connection
Daltons) Lh -1 bar 1ms-1 fluid (barg) at Side(3) Side(3) Connection
velocity 50 °C (mL)
(122 °F)
UMP-053 0.2 2.6 mm 130 0.015 1.5 287 1/1/1 1/1/1 12 9 A2/A1
UMP-153 0.2 2.6 mm 347 0.08 8 956 3/3/3 3/3/3 90 120 B1/B1
UMP-353 0.2 2.6 mm 1129 2.2 200 5161 3/3/3 3/3/3 1700 2700 C5/C4
UMW-553 0.2 2.6 mm 1172 5.0 500 12424 3/3/3 3/3/3 3800 5400 C6/C5
UMP-0047R 0.2 1.4 mm 314 0.02 19 116 3/3/1.5 2/2/1 23 30 C1/A2
UMP-1047R 0.2 1.4 mm 316 0.09 80 554 3/3/1.5 2/2/1 202 – C2/C1
UMP-1147R 0.2 1.4 mm 546 0.19 180 554 3/3/1.5 2/2/1 360 – C2/C1
UMP-1147M 0.2 1.4 mm 546 0.33 330 953 3/3/1.5 2/2/1 297 – C2/C1
UMP-2147R 0.2 1.4 mm 546 0.77 750 2216 3/3/1.5 2/2/1 – – C4/C2
UMP-3147R 0.2 1.4 mm 630 2.0 2000 – 3/3/1.5 2/2/1 – – C4/C3
UMP-3247R 0.2 1.4 mm 1129 4.0 4000 – 3/3/1.5 2/2/1 – – C4/C3
UJP-0047R 0.65 1.1 mm 314 0.02 24 92 3/3/1.5 2/2/1 23 33 C1/A2
UJP-1047R 0.65 1.1 mm 316 0.10 120 462 3/3/1.5 2/2/1 204 – C2/C1
UJP-1147R 0.65 1.1 mm 546 0.19 230 428 3/3/1.5 2/2/1 370 – C2/C1
UJP-1147M 0.65 1.1 mm 546 0.32 380 708 3/3/1.5 2/2/1 310 – C2/C1
UJP-2147R 0.65 1.1 mm 546 0.73 850 1625 3/3/1.5 2/2/1 – – C4/C2
UJP-3147R 0.65 1.1 mm 630 1.9 2300 – 3/3/1.5 2/2/1 – – C4/C3
UJP-3247R 0.65 1.1 mm 1129 3.8 4600 – 3/3/1.5 2/2/1 – – C4/C3
(1)
Third letter represents housing material: P – Clear native Polysulfone with silicone gasket, V – white (gray – LGV, LOV) PVC with butyl rubber gasket
(2)
Nominal length is flange to flange, or to ends of connectors on quick-connect modules. Detailed drawings available upon request.
(3)
Guideline module filling volume to allow calculation of minimum system working volumes when added to volumes of attached piping and other components.
Drained residual volumes are considerably less.

201
 Microza Membranes
Polyolefin Membranes – Technical Specifications

The P series of Microza hollow fiber microfiltration modules feature Key Features
unique proprietary membranes in polyolefin for general microfiltration
• Available different internal fiber diameters provides suitability for
applications. Available in 0.1 µm rating, the modules are used in a
processes with varying particulate or colloidal loading
range of pharmaceutical applications especially in clarification of
microbial cultures for enzyme production, clarification of natural • Broad chemical resistance ensures compatibility in a wide range of
product extracts, and nutraceutical production. processing and cleaning conditions
• Highly characterized,optimized void structure ensures reproducible
Materials of Construction separation efficiency and high throughput
Membrane Polyolefin • High-strength fiber allows reverse filtration to optimize yield and
Housing Native clear polysulfone (P)or PVC (V) performance in difficult applications
Potting Material Epoxy resin • Available in a range of sizes from 0.09 m2 (1 ft2) to over 8 m2
Gasket Silicone (P) (85 ft2)
Bacteriostat Glycerin 65%, ethanol 2%, • P series compatible for continuous operation up to 50 °C (122 °F)
water balance
• Meets the specification for biological tests listed in the current
revision of USP for Class VI plastics at 121 °C (249 °F)
Connectors and Adapters
A – A1 Small hose barb 4.5 mm (3⁄16 in.),
A2 Small hose barb 6 mm (1⁄4 in.)
B – B1 Quick-connect.
To convert feed/retentate to 11⁄2 in. sanitary clamp order
part no. 0450163 (fits in body of module), to 1⁄4 in. sanitary
clamp order part no. 2055675 (fits in body of module),
to 1⁄4 in. hose barb (fits on quick-connect),
order part 2055999 no. (polypropylene), and to 1⁄4 in.
FNPT (fits on quick-connect), order part no. 2089150
(316L stainless steel).

C – C3 1 in. sanitary flange (ferrule face 34 mm, [1.34 in.])

C4 11⁄2 in. sanitary flange (ferrule face 50 mm [1.98 in.])

C5 2 in. sanitary flange (ferrule face 64 mm [2.52 in.])

C7 4 in. sanitary flange (ferrule face 117 mm [4.61 in.])

C8 6 in. sanitary flange (ferrule face 157 mm [6.18 in.])

D – D2 Cap Nut, 38.5 mm diameter
D3 Cap Nut, 48.5 mm diameter

Part Number(1)
Rating Fiber Nominal Membrane Clean Crossflow Maximum Volume Volume Feed/ Permeate
(MWCO, ID Length(2) Area Water Flux Rate for Pressure Feed Permeate Retentate Connection
Daltons) Lh -1 bar 1ms-1 fluid (barg) at Side(3) Side(3) Connection
velocity 50 °C (mL)
(122 °F)
PSP-103 0.1 0.7 mm 347 0.2 25 554 3/2.2/2 90 120 B1 B1
PSP-113 0.1 1.9 mm 347 0.1 7 714 3/2.5/2 110 110 B1 B1
WSP-143 0.1 1.4 mm 347 0.09 13 554 3/2.5/2 90 120 B1 B1
PSP-303 0.1 0.7 mm 1129 6.0 700 3879 5/2.2/3 1200 2700 C5 C4
PSV-303 0.1 0.7 mm 1126 6.0 700 3879 5/2.2/3 1200 2700 C7 D3
PSV-313 0.1 1.9 mm 1126 2.9 240 4900 5/2.5/3 1500 2600 C7 D3
WSP-543 0.1 1.4 mm 1172 8.2 930 11083 4/2.5/4 3800 5300 C7 C6
(1)
Third letter represents housing material: P – Clear native Polysulfone with silicone gasket, V – white (gray – LGV, LOV) PVC with butyl rubber gasket
(2)
Nominal length is flange to flange, or to ends of connectors on quick-connect modules. Detailed drawings available upon request.
(3)
Guideline module filling volume to allow calculation of minimum system working volumes when added to volumes of attached piping and other components.
Drained residual volumes are considerably less.

202

Pall’s Membralox ceramic membrane
®
elements are ideal for applications that
involve extreme processes, such as high
solids bulk processes, the use of high
temperatures or pressures, or aggressive
solvents, and where significant long-term
durability is required.
Available ratings start at very low molecular
weight ultrafiltration used for duties such as
unwanted protein removal from antibiotic
solutions, through to open (up to 5 µm)
microfiltration membranes that can be
used to process difficult materials such as
microspheres, or clarify solvent-based
plant extracts in transgenic processes.
Membralox membrane elements are
available in 3 different channel diameters to
allow optimization for solids loading. Some
configurations are available with unique
longitudinal permeability gradients, that
facilitates the control of permeate rate
along the length of the module.
Membrane elements are available in sizes
ranging from small laboratory devices
through individual modules of over 20
square meters surface area, ensuring the
ability to evaluate and scale up processes
to any size.
Ceramic Membrane Structure;
Electron Micrograph showing Membralox
membrane layers on top of
a more open support layer
Membralox Ceramic Membrane Products
®
For Long Service Life even under Extreme Conditions
Membralox ceramic membranes comprise
a highly controlled surface membrane layer
that is formed on the inner (feed-side)
surface of a more open support layer.
Three different types of materials are
available, ultrapure, µalumina, zirconia and
titania. All of these materials are FDA-listed
for suitability in pharmaceutical processes.
Ceramic membranes exhibit near zero non-
specific adsorption of biological materials.
Membralox ceramic elements featuring an
asymmetric membrane structure combine
a unique design and manufacturing
process resulting in a product ideally suited
for applications involving chemicals,
including solvents, extremes of pH, high
temperatures and pressure processing of
and fermentation broths.
The compact multi-channel geometry and
high permeability are optimized for bulk
processing applications. Multiple modules
each comprising a number of membrane
elements can be easily assembled on
manifolds to handle any scale of operation.
Features and Benefits
• Reliability
• Ease of use
• High flux
• Proven long operational life
• Wide chemical and pH (0 – 14)
compatibility
• Excellent thermal stability
• Sanitizable and sterilizable
• Element burst pressure > 50 bar
• Ability to withstand high frequency
backpulsing cycles
• Components are FDA-listed in 21 CFR
Part 11
• 100% bubble point integrity-tested
Applications
• Clarification of bulk fermentation broths
• Protein removal from antibiotics
• Processing of alginates and other
excipients
• Clarification of solvent extracts
• Pyrogen and bacteria removal in high
purity systems
Membrane Module Versatility
Membralox membrane elements are
assembled in housings containing modules
with up to 60 elements per module. This
versatility simplifies system designs,
allowing optimal sizing of membrane area
for each application.
Membralox GP Ceramic
Microfiltration Membranes
The Membralox GP range of ceramic
membrane elements have a calibrated
longitudinal permeability gradient, that
maintains a constant and uniform flux
along all parts of the element. This
optimizes the microfiltration of complex,
transmission sensitive feed streams.
• Stability of the filtration regime
• Standard modules accommodate these
unidirectional flow directional
membranes
• Uniform transmembrane pressure
simplifies system designs
• A wide range of calibrated permeability
gradient options are available to suit
different feedstream characteristics
203
 Membralox Ceramic Membrane Products
Technical Specifications

Membralox SD Modules Membrane Element Configurations

Element Type P37 – 30 P19 – 40 P19 – 60
The Membralox SD module features a fully sanitary design for
stringent pharmaceutical processes. All wetted components are Channel Diameter 3 mm 4 mm 6 mm
swept by cleaning solutions ensuring compliance with requirements Number of Channels 37 19 19
of cleaning validation. Module hardware and gaskets are available in Filtration Surface 0.35 m2 0.24 m2 0.36 m2
materials that meet the demands of all cleaning regimes. Area (3.77 ft2) (2.58 ft2) (3.88 ft2)
Length 1020 mm 1020 mm 1020 mm
• All wetted parts fully accessible by cleaning chemicals
Material Ultrapure α alumina (> 99.7%)
• Vertical operating position enables total drainage
• High-performance sealing assembly with gasket leak detection, Membrane Pore Sizes
eliminates by-pass possibility between retentate and permeate side
Microfiltration 5.0, 2.0, 1.4*, 0.8*, 0.5*, 0.2*, 0.1* µm
• Modules and membrane components fully traceable, materials (α alumina)
certificate available upon request Ultrafiltration 100, 50, 20 nm (zirconia)
5000, 1000 Da MWCO (titania)
• Long-life, stable and reliable performance
* Available in Membralox GP membrane version.

Membralox HCB Modules

Operating Limits in Aqueous Liquids
The Membralox HCB module range takes advantage of the unique Temperature 95 °C (203 °F)
hexagonal shape of the Membralox ceramic membrane elements to
Pressure 8 – 10 barg(1)
obtain a high membrane packing density up to 240 m2/m3
Differential Back Pressure 8 bard
(2583 ft2/ft3), thus significantly reducing filtration system costs.
(1)
Depending on module selected. Contact Pall for additional information.
Features of the HCB module – increased surface area, reduced
permeate hold-up volume, PTFE gaskets for a wider chemical Membralox SD Sanitary Modules
compatibility – provide economical solutions in bulk fermentation
Element Type P19 – 60 P19 – 40/P37 – 30
broth clarification and pharmaceutical effluent treatment.
Number of Membranes 1 – 3 – 12 – 22 1 – 3 – 7 – 19 – 37
• Highly compact for cost-effective system design and small Filtration Surface Area up to 7.9 m2 up to 13.0 m2
footprint (85 ft2) (140 ft2)

• Reduced permeate hold-up volume Permeate Connections Sanitary clamps/3A gaskets

• Proprietary built-in gasketing solution to ensure perfect sealing Construction of 316L SS, ceramic, EPDM or FPM
Wetted Materials
• Wide chemical compatibility
• Long service life Membralox HCB Industrial Modules
Part Number 36P2 60P1
Membralox T1-70 Modules Element Type P19-60 P19-40/P37-30

Potential applications can be conveniently evaluated using this Number of Membranes 36 60

laboratory scale module with integrated ceramic membrane element. Filtration Surface Area 13.0 m2 14.4/21.0 m2
Feasibility testing allows the appropriate membrane pore size to be Retentate Connections Bolt flanges with O-rings
selected for pilot scale studies. The module has a low permeate
Permeate Connections Bolt flanges with flat gaskets
hold–up volume of 7 mL.
Construction of 316L SS, ceramic, PTFE
Wetted Materials
Membralox Pilot Scale Systems
Membralox T1-70 Modules(2)
Pilot-scale evaluation of Membralox technology with full scale
modules can be performed on pilot plant systems. Several options Channel Diameter 7 mm
are available on request. Length 250 mm
Surface Area Filtration 0.005 m2 (0.054 ft2)
Housing Material 316L SS
(2)
The T1-70 module housing holds individual ceramic tubes; please specify desired
membrane pore size at time of order in accordance with membrane pore size selection
chart. This module is suitable for use with Pall laboratory and pilot-scale test systems.
Contact Pall for additional information.

204
 Pallsep™ Vibrating Membrane Filtration Technology

Pallsep filtration technology represents a Applications

significant innovation in membrane
filtration. In the Pallsep system, controlled
horizontal oscillation moves the membrane
elements through the feed fluid over 50
times per second. The oscillation
Above: Pallsep PS400 and
a System
generates vibrational energy at the
membrane surface, giving shear (higher
than that typically generated in
conventional TFF systems) that is limited to
a small boundary layer above the
membrane surface, and which is not
applied to the bulk of the fluid. This
ensures that even in high solids feed
streams, the membranes do not cake with
the retained species. Fluids are processed
in a very gentle manner through an open
flow path with minimal pressure drop and
even transmembrane pressure distribution.
Very high suspended solids levels can be
The technology can be successfully
applied to clarification applications where
high product transmission through the
membrane is essential and not easily
achieved with conventional TFF systems,
and harvesting applications where product
loss with conventional TFF/centrifugation is
unacceptably high.
• Recovery of therapeutic proteins from
recombinant mycelial cultures
• Clarification of high suspended solids
fermentation broths such as Picha
pastoris and Saccharomyces
• Processing of plant and animal extracts
from transgenic or natural sources
* Wet cell weight – see Postlethwaite et al. Journal of
Membrane Science 228 (2004), 89 – 101.

achieved (> 60% w/v*) maximizing recovery

of the permeate. In some applications it is
possible to concentrate solids in a single
pass with no recirculation. Both the
concentrated solids and the filtrate can be
recovered from the system if required by
the application.
All Pallsep machines consists of a stack of
membrane elements, which are mounted
on a torsion bar. Kinetic energy from a
small motor is efficiently converted to PS10 in use with a Pall System
vibrational energy in the stack
There are three Pallsep variants: PS10 and
PS400 representing nominal installed
membrane areas of 1, and 40 m2
respectively per machine.

Features and Benefits

• Very low recirculation rates
• Energy efficient
• Tolerant of viscous feeds
• Processing to high suspended solids
• Gentle processing
• Small system footpaint
• Low system hold-up volume 205
 Pallsep Vibrating Membrane Filtration Technology
Technical Specifications

Pallsep Membrane Elements Pallsep PS400

The membrane elements are a composite of 0.45 µm PTFE coated Operating Conditions
onto flexible stainless steel plates. Typical Range Limit
System Pressure 0.4 – 3 barg 8.3 barg
(5.8 – 43.5 psi) (120.3 psi)
Materials of Construction(1, 2)
Trans-membrane 0.2 – 1.5 barg 4 barg
Membrane Emflon PTFE(3) Pressure (2.9 – 21.7 psi) (58 psi)
Other Fluid Contact 316L stainless steel Operating 4 – 50 °C 55 °C
Materials Polyphenyl sulfide Temperature (39 – 122 °F) (131 °F)
Polyethylene
Ethylene propylene Fluid Recirculation 60 – 120 L/m Dependent on
EPDM for 40 m2 (400 ft2) feed and system
Silicone
Other Technical Information
(1)
Full material traceability is available if required.
(2)
All polymeric contact surfaces have passed USP XXI class VI testing. Process Connections Feed/ 38 mm (1.5 in.)
(3)
Contact Pall for further information. Retentate: Sanitary Clamp
Permeate: 25 mm (1 in.)
Pallsep PS10 Sanitary Clamp

The PS10 is an ideal device for process development departments to Electrical Requirement US: 480V 440V, 400V, 60 Hz, 3 phase
demonstrate the feasibility of Pallsep technology for larger scale Europe: 380V, 50 Hz 3 phase
processes. The unit can work with an installed area of between 0.1 Nominal Dimensions Membrane Element:
and 1 m2. This range makes the device suitable for use with the Diameter 610 mm (24 in.)
QuattroFlow pump and several Pall systems. Base Machine, Stack and Pipework:
Height 3338 mm (119 in.)
Width 1600 mm (63 in.)
Operating Conditions Depth 1177 mm (46 in.)
Typical Range Limit Weight Base Machine Only:
1452 kg (3200 lbs)
System Pressure 0.4 – 3 barg 4 barg
(5.8 – 43.5 psi) (58 psi) Assembled Membrane Stack:
544 kg (1200 lbs)
Trans-membrane 0.2 – 1.5 barg 4 barg
Pressure (2.9 – 21.7 psi) (58 psi)

Operating 4 – 50 °C 55 °C
Temperature (39 – 122 °F) (131 °F)

Fluid Recirculation 0.5 – 10 L/m Dependent on

dependent on feed and system
installed area

Other Technical Information

Process Connections Feed, Retentate and Permeate:
13 mm (1⁄2 in.) Sanitary Clamp

Electrical Requirement Base Machine:

Single phase, 240/110 volts, 50/60 Hz, 20 A

Nominal Dimensions Membrane Element:

Diameter 300 mm (12 in.)
Machine, Stack and Pipework:
Height 2108 mm (83 in.)
Width 870 mm (35 in.)
Depth 870 mm (35 in.)

Weight Base Machine:

180 kg (397 lbs)

Membrane Housing:
25 kg (55 lbs)

206
 Sheet TFF Membranes
For Bulk Pharmaceutical and Bio-Industrial Processes

A significant number of established large Longer membrane life therefore results in

volume processes use ultrafiltration and significant savings in labor costs, and
microfiltration membranes in a variety of allows equipment to be operational for a
sheet formats. These sheets are fitted into longer period of time – improving process
specialized suppliers’ holding devices, economics.
typically called “plate and frame” systems
Proprietary Membranes
(i.e., DDS/DOW, DSS).
Polyethersulfone membranes available from
Pall are the low protein binding, high flux
Range of Membranes
Omega (OM) with the largest range of
Pall offers three basic types of membrane Molecular Weight Cut-off ratings in the
for flat sheet applications with ultrafiltration industry; Alpha (AM) — specifically
membranes rated from 650 Da to designed to offer resistance to fouling by
1000 kDa and microfiltration membranes. antifoams and Supor TFF (PM) for
Both the ultrafiltration and microfiltration microfiltration.
Above: M38 membranes can be supplied to fit most
existing equipment. Standard part numbers
are listed overleaf. If the retrofit is not listed,
please contact Pall.
Superior Performance
Evaluation work carried out with customers
has shown that Pall membranes may
exhibit superior flux and provide superior
resistance to commonly used cleaning
agents, allowing maximum re-use and a
longer working life than other membranes.
Such systems, with their large number of
individual membranes, are time-consuming
to re-sheet.
Left: M39

207
 Sheet TFF Membranes
Ordering Information

Table 1 – Ultrafiltration Membranes

Code D65 001 003 005 010 030 050 070 100 200 300 500 990
MWCO 0.65 1 3 5 10 30 50 70 100 200 300 500 1000
(kDa)
Alpha AM – – – – ● ● – – – – – – –
Omega OM ● ● ● ● ● ● ● ● ● ● ● ● ●

Table 2 – Microfiltration Membranes

Code M10 M20 M45 M65 M80 M12 994
Pore size 0.1 0.2 0.45 0.65 0.8 1.2 0.16
(µm) abr.
Supor PM ● ● ● ● ● ● –
Omega OM – – – – – – ●

Table 3 – Flat Sheet Format

Code Format Comments
M38 DDS/DOW or DSS hardware Oval
M39 DDS/DOW or DSS hardware Rectangle To Order, choose:
1. Membrane type from Tables 1 and 2 above (e.g. OM, AM or PM)
Table 4 – Membrane Backing(1) 2. Choose MWCO or µm rating code from Tables 1 or 2 as
appropriate (e.g. 010 = 10 kD, M20 = 0.2 µm)
Code Membrane Backing
3. Choose format code from Table 3 left (e.g. M38)
P Polypropylene 4. Add substrate code from Table 4 left (always P for AM and PM
T Polyolefin T membrane, T for OM)
(1)
P backing for AM and PM membrane, T backing for OM membrane. 5. Add pack size required from Table 5

Table 5 – Pack Size

Code Number of Sheets
Typical Examples:
010 10
A M 0 1 0 M 3 8 P 1 0 0 P M M 2 0 M 3 9 P 0 5 0
050 50
100 100
Membrane Alpha Membrane Supor
MWCO/Rating 10 kD MWCO/Rating 0.2 µm
Format M38 Format M39
Substrate Polypropylene Substrate Polypropylene
Pack Quantity 100 Pack Quantity 50

208
Chromatography
 Chromatography
Column chromatography is a well-established
bioprocessing purification method. Ion-exchange
resin columns have been especially effective and
reliable parts of successful purification. Affinity,
hydrophobic interaction and other media effect high
resolution purifications of specific target molecules.
But column-packing and packing validation can be
time-consuming and expensive. The high cost of
process columns, along with the cost of associated
equipment, cleaning, and storage validation can
impact process economics. Pall’s ideally placed to
give guidance on the most effective purification
strategy for your product.
Processing biomolecules for initial capture of target
product, purification of the target molecule, and the
removal of potentially harmful contaminants from
the purified product, all place different demands on
the chromatography process. A single technology
will not address all of these issues. Therefore, Pall
offers chromatography users a variety of
chromatography process options to optimize
separation efficiency and your economics.
Membrane Chromatography
®
Mustang membranes are an innovative
ion-exchange support containing functional
quaternary amine (Q) or sulfonic acid (S) groups.
The large pores of Mustang membranes allow
biomolecules to access all the binding sites by
direct fluid convection, rather than being dependent
on the restrictions imposed by diffusive flow, the
method of operation of chromatography resins. This
results in high dynamic flow, very steep break-
through curves, equivalent or higher capacity than
resins for most target species, and process flow
rates that can be as high as 25 to 50 column
volumes per minute.
210
Mustang ion-exchange chromatography capsules
are prepacked, single-use systems specifically
designed to provide high throughputs. Therefore, no
column packing or cleaning is required, resulting in
significantly shorter processes cycles. Because of the
high dynamic binding capacities of Mustang
capsules, they are particularly well-suited for use in
the initial purification of the target molecule, or for
removing contaminating molecules, such as DNA or
viruses, in the final polishing steps. Mustang E is
used to remove endotoxin from water, saline, and
buffer solutions.
Mustang starter kits, coins, and modules can be
used to determine the suitability of Mustang
technology and the determination of optimal
process conditions, including binding and elution.
Column Chromatography
Pall offers a complete range of chromatography
columns and packing stations. Resolute® columns
are available with acrylic or stainless steel tubes,
with fixed or variable bed heights, with manual or
pneumatically actuated packing nozzle, and are
buttressed by range of support equipment including
integral column hydraulic systems for simple yet
safe column maintenance or column packing.
Pall can offer expertise in packing most
commercially available sorbents. For availability of
chromatography media in a wide range of types and
chemistries, please contact Pall, or visit
www.pall.com.
Whatever your requirement for a chromatography
system, Pall has the products, the support, and the
experience to help you optimize your process and
your budget.
Mustang Membrane Chromatography Starter Kits
®

Disposable Membrane Chromatography Units

Features and Benefits • Mustang E membrane features

propriety membrane surface
Disposable Membrane Chromatography
modifications to effectively remove
units are designed for the rapid selection of
endotoxin from water, saline and buffer
appropriate chemistry and method
solutions.
development.
Typical binding capacities for
The Mustang membrane chromatography
Mustang E membranes are:
starter kit includes both strong anion and
Approximately 500,000 EU/Acrodisc or
cation exchange membrane
approximately 4 x 106 EU/mL
chromatography Acrodisc® units, as well as
membrane volume
specific endotoxin removal Acrodisc units.
These allow both the rapid selection of the Under the following conditions: 0.9%
appropriate chemistry for your application, sodium chloride
and the opportunity to quickly screen for Minimum challenge level:
optimal process parameters to enhance 10,000 EU/ml
and simplify your process method
Minimum challenge volume: 60 mL
development.
Endotoxin source: Escherichia coli
Starter Kit Contents strain 055:B5 (no dispersing agents).

• Mustang Q membrane is a strong

Applications
anion exchanger that effectively binds
plasmid DNA, negatively-charged • The rapid identification of the correct
proteins, and viral particles. membrane chemistry for a specific
application
Typical binding capacities for
Acrodisc units with Mustang Q • Rapid screening of key process
membranes are: parameters
DNA: 3.6 – 4.5 mg/Acrodisc or
20 – 25 mg/mL membrane volume
BSA: 9 – 11 mg/Acrodisc or
50 – 60 mg/mL membrane volume
• Mustang S membrane is a strong
cation exchanger that effectively binds
positively-charged proteins and viral
particles.
Typical binding capacities for
Acrodisc units with Mustang S
membranes are:
Lysozyme 8 – 9 mg/Acrodisc or
45 – 50 mg/mL membrane volume

211
 Mustang Membrane Chromatography Starter Kits
Technical Specifications

Materials of Construction
Media Mustang membrane of appropriate
chemistry
Housing Polypropylene

Membrane Bed Volume

Mustang S and Q 0.18 mL
Mustang E 0.12 mL

Inlet and Outlet Connections

Female Luer-Lok* inlet, male slip luer outlet
* Luer-Lok is trademark of Becton-Dickenson & Co.

Operating Pressures
Typical Differential Pressure < 0.07 bard @ 1 mL/min
(< 1.0 psid @ 1 mL/min)

Maximum Operating 5.5 bar (80 psi)

Pressure and Temperature at 21 – 24 ºC (70 – 75 ºF)
2.1 bar (30 psi) at 60 °C (140 °F)

The following Charts and Graphs Demonstrate the High Resolution and High Dynamic Binding Capacities of
Mustang Membrane Chromatography Units

Mustang S Membrane

25 mm (1 in.) Acrodisc Unit with Mustang S Membrane 25 mm (1 in.) Acrodisc Unit with Mustang S Membrane
Resolution with Cytochrome C and Lysozyme Dynamic Binding with Lysozyme
250 450
Absorbance Lysozyme Elution Peak
Conductivity 400

200
Absorbance 280 mm (11 in.) (in AU)

350

300
Protein (µg/mL)

150
250

200
100
150

Cytochrome C
100
50 52 mg/mL at 0
breakthrough
50

0 0
0 1 2 3 4 5 6 0 5 10 15 20 25
Time (min) Time (min)

The conditions used to generate data for the graph above include buffer:
10 mM MES pH 5.5; salt: 1M NaCl in 10 mM MES pH 5.5; gradient: 0 to 1M NaCl in
50 column volume (cv); flow rate: 2.3 mL/min (13 cv/min).
A solution of 0.512 mg/mL Lysozyme was pumped through the Acrodisc unit at
2.3 mL/min. Breakthrough occurred at 8.0 minutes and was calculated as 52 mg/mL
using:
(flow rate [2.3 mL/min] X initial protein Lysozyme concentration
[0.512 mg/mL] X time [8.0 min])
membrane bed volume of Mustang S in 25 mm (1 in.) Acrodisc unit (0.18 mL)

212
 Mustang Membrane Chromatography Starter Kits
Technical Specifications

Mustang Q Membrane

25 mm (1 in.) Acrodisc Unit with Mustang Q Membrane 25 mm (1 in.) Acrodisc Unit with Mustang Q Membrane
Resolution with BSA and Goat IgC Dynamic Binding with BSA
30 1800
Elution Peak
Absorbance
Conductivity Goat IgG 1600
25
1400
Absorbance (280 mm (11 in.))

BSA
20 1200

1000
15
800
unbound protein
from Goat IgG 600
10

400

5 54 mg/mL at 0
200 breakthrough

0
0 0 5 10 15 20 25
0 1 2 3 4 5 6
Time (min)
Time (min)

The conditions used to generate data for the resolution graph above include buffer:
25 mM Tris pH 8.0; salt: 1M NaCl in 25 mM Tris pH 8.0; gradient: 0 to 0.5M NaCl in
50 column volume (cv); flow rate: 2.3 mL/min (13 cv/min); sample loading: 4% of total
binding capacity.
A solution of 0.524 mg/mL BSA was pumped through the Acrodisc unit at 2.3 mL/min.
Breakthrough occured at 8.1 minutes and was calculated as 54 mg/mL using:
(flow rate [2.3 mL/min] X initial protein BSA concentration
[0.524 mg/mL] X time [8.1 min])
membrane bed volume of Mustang Q in 25 mm (1 in.) Acrodisc unit (0.18 mL)

Mustang E Membrane

Effect of [NaCl] in 25 mM Tris (pH 8) on Endotoxin Dynamic Effect of pH on Endotoxin Dynamic Binding Capacity to
Binding Capacity to Acrodisc Unit with Mustang E Membrane Acrodisc Unit with Mustang E Membrane

>7.03E+07 >6.98E+07 6.6E+07

1.0E+08 1.0E+08 4.04E+07 4.1E+07
4.1E+07
1.87E+07 1.86E+07
1.12E+07
+07 +07
Endotoxin Binding (EU/mL MV)

Endotoxin Binding (EU/mL MV)

1.72E+06
+06 +06

+05 +05

+04 +04

+03 +03

+02 +02

+01 +01
0 0.15 0.5 1 2 5 6 7 8 9
NaCl (M) pH

213
 Mustang Membrane Chromatography Starter Kits
Technical Specifications

Ordering Information
Product No. Description Packaging
MSTG25KIT Mustang Starter Kit 4 per package Acrodisc 25 mm (1 in.) with
Mustang Q membrane (MSTG25Q6)
4 per package Acrodisc 25 mm (1 in.) with
Mustang S membrane (MSTG25S6)
2 per package Acrodisc 25 mm (1 in.) with
Mustang E membrane (MSTG25E3)

Complementary Products
Product No. Description Packaging
MSTG25Q6 Acrodisc 25 mm (1 in.) with Mustang Q membrane 10 per package
MSTG25S6 Acrodisc 25 mm (1 in.) with Mustang S membrane 10 per package
MSTG25E3 Acrodisc 25 mm (1 in.) with Mustang E membrane 10 per package
MSTG18H16 Mustang Coin Holder 1 per package
MSTG18Q16 Mustang Q Coin, 0.35 mL bed volume 10 per package
MSTG18S16 Mustang S Coin, 0.35 mL bed volume 10 per package
CLM05MSTGQP1 Mustang Q Capsule, 10 mL bed volume 1 per package
CLM05MSTGSP1 Mustang S Capsule, 10 mL bed volume 1 per package
CLM05MSTGEP1 Mustang E Capsule, 10 mL bed volume 1 per package
CL3MSTGQP1 Mustang Q Capsule, 60 mL bed volume 1 per package
CL3MSTGSP1 Mustang S Capsule, 60 mL bed volume 1 per package
CL3MSTGEP1 Mustang E Capsule, 40 mL bed volume 1 per package
NP6MSTGQP1 Mustang Q Capsule, 260 mL bed volume 1 per package
NP6MSTGSP1 Mustang S Capsule, 260 mL bed volume 1 per package
NP6MSTGEP1 Mustang E Capsule, 160 mL bed volume 1 per package
NP7MSTGQP1 Mustang Q Capsule, 520 mL bed volume 1 per package
NP7MSTGSP1 Mustang S Capsule, 520 mL bed volume 1 per package
NP8MSTGQP1 Mustang Q Capsule, 780 mL bed volume 1 per package
NP8MSTGSP1 Mustang S Capsule, 780 mL bed volume 1 per package

214

Ideal for Method Development for Mustang Q and S Membrane Units
The disposable Mustang Coin Unit is the
companion product to Mustang capsules
and cartridges.
Mustang membranes are an innovative
new ion exchange support with pendant
quaternary amine groups or sulfonic
functional groups in a cross-linked
polymeric coating. The pores in Mustang
membranes are large enough to allow
molecules as large as DNA access to all
the binding sites by direct fluid convection.
This produces a very high dynamic binding
capacity in comparison to chromatography
beads with diffusive pores.
Combining this high-capacity membrane
with a unique pleated design resulted in
the highly efficient Mustang product line.
Each coin unit contains 16 layers of
membrane. Mustang capsules and
cartridges are specifically designed to be
disposable to eliminate cleaning, cleaning
validation, and cross-contamination.
Designed for Scale-Up
Capabilities
The Mustang Coin Unit uses the same
16-layer construction as the larger capacity
elements. It has been designed to allow
direct scale-up or scale-down studies to
the larger capsules. The coin is placed
directly into a specially designed stainless
steel housing, where the flow is uniformly
distributed across the membrane coin.
The Mustang Coin Unit is the ideal tool for
modeling scale-up of DNA clearance.
Mustang coins and capsules will eliminate
requalification since there is no need to
change membrane materials during the
transition from lab to production scale.
Mustang Coin Unit
®
Features and Benefits
Disposable — No cleaning or cleaning
validation.
Binding Efficiency — Biomolecules are
bound in a single pass.
Speed — High-flow rates allow fast
processing of large volumes.
Scalability — Linear scale-up from
laboratory to process scale.
Cost — Lower operating costs and capital
investment compared to conventional
columns that need validated packing.
High Quality Standards
Manufactured to high quality assurance
standards in accordance with ISO 9000.
• Membrane lots tested for dynamic
protein binding capacities; peak
positions are verified with standard
proteins
• Certificate of conformance is supplied
with each unit
• Extensive validation ensures consistent
and reliable performance
• Comprehensive validation guide is
available for process scale units
Applications
• Scale-up and scale-down studies
• Determination of optimal binding and
elution conditions
• Determination of breakthrough curves
• Identification of process operating
parameters
215
 Mustang Coin Unit
Technical Specifications

Materials of Construction DNA Breakthrough Curve on Mustang Q Coin Unit

Membrane Modified hydrophilic polyethersulfone 100

Housing 316 L stainless steel

Support Frit 316 B stainless steel 80
Herring Sperm DNA

sUV Absorbance (260 nm)

Housing Clamp 300 series stainless steel housing
25 nM Tris-HCI, pH 8.0
O-rings Silicone elastomer
60

Operating Characteristics(1)
40
Maximum Temperature 38 °C (100 °F)
Maximum Sanitization 1 N NaOH for 30 minutes
Conditions (one cycle only)
20
(1)
With fully compatible fluids that do not soften, swell, or adversely affect the membrane
or its materials of construction.

0
0 30 60 90 120
Size and Capacity
mL
Membrane Bed Volume 0.35 mL DNA breakthrough curves such as the one above, demonstrate the high
Typical Herring Sperm DNA 20 – 25 mg/mL of bed volume dynamic capacity of Mustang Q coin for DNA.
Dynanic Binding Capacity A sonicated solution of herring sperm DNA at a concentration of 129 µg/mL in
Mustang Q 25 mM Tris HCI, pH 8.0 was passed through a coin at a flow rate of
3.5 mL/min, and the A260 absorbance measured downstream.
Typical BSA Binding Capacity 50 – 60 mg/mL of bed volume
Mustang Q

Typical Lysozyme Binding 45 – 50 mg/mL of bed volume

Capacity Mustang S

Typical IgG Binding Capacity 60 mg/mL of bed volume Nominal Dimensions

Nominal Flow Rate 3.2 mL/min at 0.5 bar (2) Coin Unit 18 mm (0.7 in.) outer diameter
(2)
For liquid of 1 cP. For other liquids divide the flow rate by the viscosity expressed in cP. Housing 51 mm (2 in.) height
Fittings M6 male to 15 mm (0.625 in.) OD tubing
and M6 male to luer lock female fittings

Ordering Information
Part Number Description Membrane Accessible Flow @ 10 psi Typical Coin Pack Size
Volume Capacity

MSTG18S16 Mustang S coins for 0.35 mL > 3.5 mL/min 16 – 18 mg for Lyzozyme 10
method development

MSTG18Q16 Mustang Q coins for 0.35 mL > 3.5 mL/min 7 – 9 mg for DNA 10
method development 17.5 – 21 mg for BSA
MSTG18H16 Mustang Coin Housing 1

216
 Mustang Chromatography Capsules and Cartridges
High Throughput Pleated Units for Process Scale Ion-exchange Chromatography
Combining high-capacity ion-exchange
Mustang membranes, with a unique
16-layer open pleat design, results in
high-flow rate, high-capacity, single-use,
versatile, range of pleated products that
can be used for a wide range of
applications. This 16-layer construction is
held constant from the laboratory scale
Mustang coin unit to the largest industrial
process scale capsule, ensuring constant
chromatography bed depth in all formats.
Mustang E capsules use 3 layers of a
standard pleat format membrane to
remove endotoxin from process
feedstreams. The 3-layer construction is
held constant from the Mustang E
Acrodisc format to the largest industrial
process scale capsule.
The ease of linear scale up ensures a
shortened process development time by
significantly reducing the re-optimization
required between scale up steps. These
units are specifically designed to be
single-use. This eliminates cleaning and the
costs associated with cleaning validation.
Mustang capsules are fully self contained
units that connect directly into a system
using 18 mm (1.5 in.) sanitary flange
connectors. Mustang cartridges require
the use of a Code 7 housing which
requires cleaning and reassembly after
each use.
®
Mustang Q Membrane Convenience — Ready to use,
Mustang Q membrane is an anion autoclavable and disposable to eliminate
exchange support with pendant quaternary potential packing, cleaning, validation and
amine functional groups in a cross-linked cross-contamination issues.
polymeric coating on a 0.8 µm pore size Flexible — Available in capsule or
membrane. This gives high dynamic cartridge format.
capacities for high molecular weight
Cost — Lower operating costs and capital
products such as DNA, plasmids or even
investment compared to conventional
particles as large as viruses.
columns that need validated packing and
Mustang S Membrane cleaning.
Mustang S membrane is a cation
exchange support with pendant sulfonic High Quality Standards
functional groups in a cross-linked
• Manufactured to high quality assurance
polymeric coating on a 0.8 µm pore size
standards in accordance with ISO 9000
membrane. This gives high dynamic
capacities for high molecular weight • Membrane lots tested for dynamic
products such as IgG, Factor VIII and protein binding capacity, and peak
some viruses. position using standard proteins
Mustang E Membrane • Identified by lot number and a unique
Mustang E membrane is a highly serial number for complete traceability
cross-linked quaternized amine charge of manufacturing history, satisfying
polymer coating based on stringent QC/QA requirements
polyethyleneimine on a 0.2 µm pore size • Supplied with Certificate of Analysis to
membrane. This gives very high dynamic confirm the quality and quality control of
capacities, under selected conditions for Pall
the removal of endotoxin from process
• Meets USP Biological reactivity tests in
feedstreams, buffers and water
vivo in accordance with USP Class VI
50 ºC and all materials listed in Drug
Features and Benefits Master File submitted to the FDA
Binding Efficiency — Charged
Comprehensive Validation
biomolecules are readily bound in a single
pass.
• Extensive validation to ensure
Speed — High-flow rates enable the consistent and reliable performance
processing of large volumes in less than a
• A comprehensive validation guide is
single working shift. Mustang units
available for each of the membrane
typically operate at flow rates between 10
chemistries, Q, S and E on request.
to 40 membrane volumes per minute,
making them much faster than
conventional columns which typically
operate at 0.5 column volumes per minute.
Scalability — A full range of sizes
accommodates the different volumes and
capacities required in BioPharmaceutical
processing.
217
 Mustang Chromatography Capsules
Technical Specifications

Materials of Construction Capsules Operating Characteristics(2)

CLxMSTG*P1 NPxMSTG*P1 Maximum Operating 4.1 bar (59.5 psi) at 38 °C (100 °F)
Membrane Modified hydrophilic Modified hydrophilic Pressure
polyethersulfone polyethersulfone
Maximum Differential 4.1 bar (59.5 psi) at 38 °C (100 °F)
Membrane Support Polypropylene Polypropylene Pressure
and Drainage Layer
Maximum Sanitization 1 N NaOH for 30 minutes for
Assembly
Conditions one cycle only
Core and Cage Polypropylene Polypropylene
Maximum Autoclave 121 °C (250 °F) for 30 minutes
Endcaps and Adapters Polyester Polyester Conditions for one cycle only
Housing Bowl Polyetherimide Polypropylene (2)
With fully compatible fluids that do not soften, swell or adversely affect the capsule or
its materials of construction.
Housing Head Polyetherimide Polypropylene
with TiO2 with TiO2
O-rings Silicone elastomer Silicone elastomer
Note:
For CLxMST*P1, x =
M05 for a Q, S or E unit with a bed volume of 10 mL
3 for a Q or S unit with a bed volume of 60 mL or an E unit with a bed volume of 40 mL

For NpxMSTG*P1, x =
6 for a Q or S unit with a bed volume of 260 mL or an E unit with a bed volume of 160 mL
7 for a Q or S unit with a bed volume of 520 mL or an E unit with a bed volume of 320 mL
8 for a Q or S unit with a bed volume of 780 mL or an E unit with a bed volume of 480 mL

*=
Q for a unit with Q (quaternary amine) chemistry membrane
S for a unit with S (sulfonic acid) chemistry membrane
E for a unit with E (polyethyleneimine) chemistry membrane

Nominal Dimensions for Capsules

Capsule Type CLM05MSTG*P1 CL3MSTG*P1 NP6MPSTG*P1 NP7MSTG*P1 NP8MSTG*P1
Maximum Diameter 123 mm 123 mm 154 mm 154 mm 154 mm
(Including Valves) (4.8 in.) (4.8 in.) (6.1 in.) (6.1 in.) (6.1 in.)

Length with Sanitary 84 mm 157 mm 335 mm 581 mm 831 mm

Flange Fittings (3.3 in.) (6.2 in.) (13.2 in.) (22.9 in.) (32.7 in.)

Bed Volume 10 mL Q and S = 60 mL Q and S = 260 mL Q and S = 520 mL Q and S = 780 mL

E = 40 mL E = 160 mL E = 320 mL E = 480 mL
* Q for a unit with Q (quaternary amine) chemistry membrane
S for a unit with S (sulfonic acid) chemistry membrane
E for a unit with E (polyethyleneimine) chemistry membrane.

Typical Capsule Binding Characteristics

Chemistry Molecule MW or Size Typical Mustang Membrane Capacity for
CLM05 CL3 NP6 NP7 NP8
Q BSA 65 kD 0.5 – 0.6 g 3.0 – 3.6 g 13 – 16 g 26 – 31 g 39 – 47 g
Q Thyroglobulin 650 kD 0.3 g 1.8 g 7.8 g 15.6 g 23.4 g
Q DNA 0.20 – 0.25 g 1.2 – 1.5 g 5.2 – 6.5 g 10.4 – 13.0 g 15.6 – 19.5 g
Q Plasmid DNA 4.5 kb plasmid 0.15 g 0.9 g 3.9 g 7.8 g 11.7 g
Q Plasmid DNA 12 kb plasmid 0.15g 0.9 g 3.9 g 7.8 g 11.7 g
Q Adenovirus 70 – 90 nm 5 x 1013 3 x 1014 1.3 x 1015 2.6 x 1015 3.9 x 1015
viral particles viral particles viral particles viral particles viral particles

S Lysozyme 14.3 kD 0.45 – 0.50 g 2.7 – 3.0 g 11.7 – 13.0 g 23.4 – 26.0 g 35.1 – 39.0 g
S Human IgG 160 kD 0.2 g 1.2 g 5.2 g 10.4 g 15.6 g
E Endotoxin Units 4 x 107 1.6 x 108 6.4 x 108 1.28 x 109 1.92 x 109
EU/capsule EU/capsule EU/capsule EU/capsule EU/capsule

218
 Mustang Chromatography Cartridges
Technical Specifications

Nominal Dimensions for Cartridges

Materials of Construction Cartridge Type Diameter Length Bed Volume
ABxMSTG*7PH4 AB1MSTG*7PH4 70mm 254 mm 260 mL
(2.75 in.) (10 in.)
Membrane Modified hydrophilic polyethersulfone
Membrane Support and Polypropylene AB2MSTG*7PH4 70 mm 508 mm 520 mL
Drainage Layer Assembly (2.75 in.) (20 in.)

Core and Cage Polypropylene AB3MSTG*7PH4 70 mm 762 mm 780 mL

(2.75 in.) (30 in.)
Endcaps, Adapters and Polyester
Bomb Fins * = Q for a cartridge with Q (quaternary amine) chemistry membrane
S for a cartridge with S (sulfonic acid) chemistry membrane.
O-rings Silicone elastomer
x = 1 for a 10 in. (254 mm) Q or S unit with a bed volume of 260 mL
2 for a 20 in. (508 mm) Q or S unit with a bed volume of 520 mL
3 for a 30 in. (762 mm) Q or S unit with a bed volume of 780 mL

* = Q for a unit with Q (quaternary amine) chemistry membrane

S for a unit with S (sulfonic acid) chemistry membrane

Cartridge Operating Characteristics(3)

Maximum Operating 3 bar (43.5 psi) at 38 °C (100 °F)
Pressure

Maximum Differential 3 bar (43.5 psi) at 38 °C (100 °F)

Pressure

Maximum Sanitization 1 N NaOH for 30 minutes for

Conditions one cycle only

Maximum Autoclave 121 °C (250°F) for 30 minutes

Conditions for one cycle only
(3)
With fully compatible fluids that do not soften, swell or adversely affect the cartridge or
its materials of construction.

Typical Cartridge Binding Characteristics

Chemistry Molecule MW or Size Typical Mustang Membrane Capacity for
AB1 AB2 AB3
Q BSA 65 kD 13 – 16 g 26 – 31 g 39 – 47 g
Q Thyroglobulin 650 kD 7.8 g 15.6 g 23.4 g
Q DNA 5.2 – 6.5 g 10.4 – 13.0 g 15.6 – 19.5 g
Q Plasmid DNA 4.5 kb plasmid 3.9 g 7.8 g 11.7 g
Q Plasmid DNA 12 kb plasmid 3.9 g 7.8 g 11.7 g
Q Adenovirus 70 – 90 nm 1.3 x 1015 2.6 x 1015 3.9 x 1015
viral particles viral particles viral particles
S Lysozyme 14.3 kD 11.7 – 13.0 g 23.4 – 26.0 g 35.1 – 39.0 g
S Human IgG 160 kD 5.2 g 10.4 g 15.6 g

219
 Mustang Chromatography Capsules and Cartridges
Ordering Information

Capsules Ordering Information

Chemistry Bed Volume Pack Quantity Part Number Description
Q 10 mL 1 CLM05MSTGQP1 38 mm (1.5 in.) sanitary connectors, in-line capsule
Q 60 mL 1 CL3MSTGQP1 38 mm (1.5 in.) sanitary connectors, in-line capsule
Q 260 mL 1 NP6MSTGQP1 38 mm (1.5 in.) sanitary connectors, in-line capsule
Q 260 mL 1 NT6MSTGQP1 38 mm (1.5 in.) sanitary connectors, T-style capsule
Q 520 mL 1 NP7MSTGQP1 38 mm (1.5 in.) sanitary connectors, in-line capsule
Q 520 mL 1 NT7MSTGQP1 38 mm (1.5 in.) sanitary connectors, T-style capsule
Q 780 mL 1 NP8MSTGQP1 38 mm (1.5 in.) sanitary connectors, in-line capsule
S 10 mL 1 CLM05MSTGSP1 38 mm (1.5 in.) sanitary connectors, in-line capsule
S 60 mL 1 CL3MSTGSP1 38 mm (1.5 in.) sanitary connectors, in-line capsule
S 260 mL 1 NP6MSTGSP1 38 mm (1.5 in.) sanitary connectors, in-line capsule
S 520 mL 1 NP7MSTGSP1 38 mm (1.5 in.) sanitary connectors, in-line capsule
S 780 mL 1 NP8MSTGSP1 38 mm (1.5 in.) sanitary connectors, in-line capsule
E 10 mL 1 CLM05MSTGEP1 38 mm (1.5 in.) sanitary connectors, in-line capsule
E 40 mL 1 CL3MSTGEP1 38 mm (1.5 in.) sanitary connectors, in-line capsule
E 160 mL 1 NP6MSTGEP1 38 mm (1.5 in.) sanitary connectors, in-line capsule
E 320 mL 1 NP7MSTGEP1 38 mm (1.5 in.) sanitary connectors, in-line capsule
E 480 mL 1 NP8MSTGEP1 38 mm (1.5 in.) sanitary connectors, in-line capsule

Cartridge Ordering Information

Chemistry Bed Volume Pack Quantity Part Number Description
Q 260 mL 1 AB1MSTGQ7PH4 10 in. (254 mm) cartridge element with Code 7 adapter
Q 520 mL 1 AB2MSTGQ7PH4 20 in. (508 mm) cartridge element with Code 7 adapter
Q 780 mL 1 AB3MSTGQ7PH4 30 in. (762 mm) cartridge element with Code 7 adapter
S 260 mL 1 AB1MSTGS7PH4 10 in. (254 mm) cartridge element with Code 7 adapter
S 520 mL 1 AB2MSTGS7PH4 20 in. (508 mm) cartridge element with Code 7 adapter
S 780 mL 1 AB3MSTGS7PH4 30 in. (762 mm) cartridge element with Code 7 adapter

220
 Resolute* Chromatography Columns
Process Columns for Fast, Contained and Reproducible Operation
Resolute columns are ideally suited for
process purification in the
BioPharmaceutical industry. A patented
nozzle valve provides all column functions
required for packing, unpacking and
running of the column in a closed system.
Based on established and well proven
designs, the Resolute column provides
improved column performance and true
linear scalability combined with
reproducible column packing methods for
today’s high performance media. Euroflow,
inventor of the pack in place sanitary
nozzle valve in 1994, continues to work
closely with the BioPharmaceutical
manufacturing industry to advance the
state of the art for both chromatographic
performance and productivity. The packing
process is controlled by a slurry packing
system which, combined with a Resolute
column, offers a complete solution for
process chromatography from
development to manufacturing scale.
Features and Benefits
• Standard column diameters from
280 mm to 1200 mm – all with
selectable bed heights from 100 mm up
Below: 800M Hydraulic Column to 600 mm
• Bed Height: fixed or adjustable
(200 mm adjustment)
• Nozzle Valve: choice of manually
operated Resolute DM, or
pneumatically actuated Resolute DP
columns
• Choice of bed supports in polyethylene
or stainless steel
• Piston seal and precision bore tube
eliminates need for additional
mechanical compression or pneumatic
activation of adjuster seals
• Compatible with a wide range of
Chromatographic Media
* Resolute is a trademark of Euroflow (UK) Limited.
Sanitary Design
• Fully flushed flow path and adjuster seal
for clean-in-place (CIP)
• Minimum dead space fixed cell seal
arrangement
• Reduced risk of corrosion
◆ non metallic nozzle flow path for high
salt and low pH conditions
◆ forged stainless steel tube eliminates
weld seams on tube wall and flanges
• Visible valve flow path aids detection of
entrapped air
• Sanitary clamp terminations
• Leachate free acrylic tube — no
phthalates
• Peroxide cured seals — no sulphur
containing leachate
• Process wetted materials meet
regulatory requirements
Column Options
Standard Columns
• Actuated nozzle valve; fits 400 to
1200 mm diameter columns
• Bed supports:
◆ Polyethylene 10/20/60 µm
◆ Stainless steel 10/20/50 µm
• Lockable castors and adjustable feet
supplied as standard*
* Up to 1000 mm diameter only.
Engineered Columns
• Operating pressure up to 10 bar
• Columns from 400 mm to 2000 mm
diameter
• Certification to ASME Div VIII sec 1 or
PD5500.CE where applicable
• Service frames for piston end cell
maintenance
• Alternative materials: Hastalloy C22,
Stainless Steel 1.4435, 1.4439
• Hydraulic Actuators — see technical
specifications for operating modes 221
 Resolute Chromatography Columns
Technical Specifications – Resolute Fixed and Adjustable Columns (280 – 1200 mm diameter)

Material Specifications Column Specifications

Process Wetted Components Resolute Fixed and Adjustable Columns
Column Tube Acrylic (cast PMMA) 180 – 1200 mm (7 – 47 in.) diameter
or Stainless Steel 316L (1.4404)
Operating Pressure 180 – 280 mm (7 – 11 in.):
Distribution Cell Polypropylene 5 bar (73) psi

Nozzle Body PVDF/Acrylic(1) 400 – 1200 mm (15.7 – 47 in.):

3 bar (44) psi
Process Terminations and PEEK
Slurry Nozzle Tip Operating Temperature 2 – 30 ºC (35 – 86 °F)
Slurry Inlet Port 180 and 280 mm columns:(2) PEEK Bed Support, Type Stainless Steel Mesh:
and Rating 10, 20, 50 µm
400 to 1200 mm columns: (2)

Stainless Steel 316L Polyethylene Sinter:

10, 20, 60 µm
Bed Support Polyethylene sinter or
Stainless Steel mesh Product Flow Path Stainless Steel surface finish
< 0.6 µm Ra, Electropolished
Seals EPDM (Peroxide cured)
FEP encapsulated silicone Exterior Components Stainless Steel surface finish
< 0.9 µm Ra, Electropolished
Wiper Blade PTFE
Pressure Retaining Plates Stainless Steel surface finish
External Components
< 1.5 µm Ra, 240 (UK) Grit Sateen
Stand, Adjustable Feet Stainless Steel 316L
Column Frame Stainless Steel surface finish
Castor Stainless Steel 304L Bright polished
Castor Tyre Polyurethane Media Transfer Nozzle DM:
(1)
PVDF/PVDF version available for increased chemical resistance. Manual actuation
(2)
Components not in mobile phase flow path.
DP:
Manual control with pneumatic actuation

Hydraulic Actuators (Optional)

Type Mode of Operation Application
HEP Hydraulic linear actuator when column is empty or Set up prior to Pack in Place and Maintenance
Hydraulic Endcell Positioning primed and has an open flow path with < 1 bar
column pressure

DAP Hydraulic linear actuator when column is empty or Flow Packing at optimal linear velocity
Dynamic Axial Packing filled with slurry and has an open flow path with
< 3.0 bar column pressure

/M Option Actuators and integral support and safety devices Access to top and bottom bed supports and seals
Hoist-free Maintenance move and secure Top Adjuster and Column Tube for changeout
(/M option available for either HEP or DAP model)

Column Capacity and Ordering Information

Description Diameter CSA Adjustable Height Adjustable Capacity Operating Pressure
Resolute 280 280 mm (11.in.) 620 cm2 100 – 300 mm 6.2 – 18.5 L 5 bar (73 psi)

Resolute 400 400 mm (15.7 in.) 1260 cm2 100 – 300 mm 12.6 – 37.7 L 3 bar (44 psi)

Resolute 600 600 mm (23.6 in.) 2830 cm 2

100 – 300 mm 28.3 – 84.8 L 3 bar (44 psi)

Resolute 800 800 mm (2.6 ft) 5030 cm2 100 – 300 mm 50.3 – 150 L 3 bar (44 psi)

Resolute 1000 1000 mm (3.2 ft) 7850 cm2 100 – 300 mm 79 – 235 L 3 bar (44 psi)

Resolute 1200 1200 mm (3.9 ft) 11310 cm 2

100 – 300 mm 113 – 339 L 3 bar (44 psi)

Resolute 1400 1400 mm (4.6 ft) 15390 cm2 100 – 300 mm 154 – 461 L 3 bar (44 psi)

Resolute 1600 1600 mm (5.2 ft) 20110 cm 2

100 – 300 mm 201 – 603 L 3 bar (44 psi)

Resolute 1800 1800 mm (5.9 ft) 25450 cm2 100 – 300 mm 255 – 763 L 3 bar (44 psi)

Resolute 2000 2000 mm (6.6 ft) 31420 cm 2

100 – 300 mm 314 – 942 L 3 bar (44 psi)
For alternative column capacities and complete product ordering information please contact your local representative.
(1)
Variable bed heights are also available in the ranges: 200 – 400 mm, 300 – 500 mm and 400 – 600 mm, as well as fixed capacity columns from 180 mm diameter.

222
 Resolute* Slurry Packing Systems
Integrated systems for Scalable Packing and Unpacking of Process Chromatography Columns

Resolute slurry packing systems (SPS) are Compatible with a wide range of
optimized for use with Resolute columns. Chromatographic Media
With the flexibility of 4 systems in the
Increasingly, new types of chromatographic
series, column packing and unpacking can
media with specific packing methods are
be optimized for one or multiple columns
specified for purification processes now in
up to 2000 mm diameter. The Resolute
development. Packing an efficient column
SPS provides simple control of the column
requires a comprehensive understanding of
packing and unpacking process within a
the media characteristics as well as a
cGMP environment. The proven design
packing system with adequate flow
provides scalable packing performance
capacity and flow control. Resolute
for column diameters from 400 mm to
systems deliver excellent performance with
2000 mm with most commonly used
a wide range of media types and column
media types. A range of ancillary
configurations including axial compression
equipment integrates all aspects of the
techniques.
packing and unpacking process.

Features and Benefits

Optimized for Pilot and
Manufacturing Operation Efficient User-friendly Control Interface
To reduce the burden of transferring The simple control panel provides:
packing methods during scale-up, each • Operating controls and parameters in
system in the series has an output capacity one place
matched to both packing and unpacking
• User-friendly calibration
flow rates as column diameter is increased.
Effective removal of all media from the • Motive air supply regulator for effective
column during the unpacking process pump flow control
requires increased flow rates compared
• Panel mounted valve selector switch for
with packing flow rates. To meet the
fluid circuit configuration
requirements for all commonly used media
types the Resolute SPS series offers • Valve status indicators
packing flow rates from as low as 4 L/min • Emergency stop button
and up to 500 L/min at 0.5 bar with a
• Convenient packing and effective
maximum pressure limit of 5 bar.
unpacking
Selecting a suitable model for your process
• Integrated pulse dampener improves
depends upon the column linear velocity,
bed homogeneity
column diameter and media
characteristics. An integrated pulse • Compact footprint with multi-column
dampener further enhances homogeneity operation capability
of the packed bed by providing a steady • Validated for most media types
flow of media into the column towards the
end of the packing cycle. This, together • Vessel and hose sets maximize
with the selection of proven system performance and media recovery
components at all scales, assures
reproducible packing conditions at all
column diameters and significantly reduces
the validation effort during commissioning. * Resolute is a trademark of Euroflow (UK) Limited.

223
 Resolute Slurry Packing Systems
Technical Specifications

Operating Conditions
Model SPS-M1 SPSM2/2E SPS M3
Dimensions 1300 x 875 x 1300 x 875 x 1400 x 875 x
(L x W x H) 1259 mm 1259 mm 1292 mm
(51 x 34 x 49 in.) (51 x 34 x 49 in.) (55 x 34 x 50 in.)

Weight 175 Kg 200 Kg 290 Kg

(385 lbs) (440 lbs) (639 lbs)

System Capacity 4 – 107 10 – 270 (M2) 18 – 500

L/min @ 4 – 270 (M2E)
3 bar (44 psi)

System Pressure 10 bar 10 bar 10 bar

Rating (146 psi) (146 psi) (146 psi)

Materials 316L SS, 316L SS, 316L SS,

Process Wetted PTFE, EPDM PTFE, EPDM PTFE, EPDM

Maximum Air(1) 20 scfm 30 scfm 40 scfm

Consumption @
6 bar (90 psi)
(1)
Instrument air filtered to 20 micron, -20 ºC (68 °F) dew point, oil free.

Ordering Information Packing Accessories

Slurry Packing System (2) Transfer Adapter Kit
High performance PTFE lined tube with stainless steel braid and external EDA13A123A99 TAK-1 Component i.d. suitable for use with
EPDM rubber cover. 400 mm ø column
Part Number Model Description EDA13A137A99 TAK-2 Component i.d. suitable for use with
600, 800 and 1000 mm ø columns(3)
EBA12A125A99 SPS-M1 Minimum and maximum capacity (L/min):
3 @ 3 bar/107 @ 0.5 bar) EDA13A138A99 TAK-3 Component i.d. suitable for use with
1000 and 1200 mm ø columns(4)
EBA12A126A99 SPS-M2 Minimum and maximum capacity (L/min): Pressure Gauge and Flow Meter Kit
10 @ 3 bar/270 @ 0.5 bar)
EKA14A123A99 PFK-1 Component i.d. suitable for use with
EBA12A127A99 SPS-M2E Minimum and maximum capacity (L/min): 400 mm ø column
3 @ 3 bar/270 @ 0.5 bar) EKA14A130A99 PFK-2 Component i.d. suitable for use with
EBA12A128A99 SPS-M3 Minimum and maximum capacity (L/min): 600 mm ø column
18 @ 3 bar/500 @ 0.5 bar) EKA14A124A99 PFK-3 Component i.d. suitable for use with
800 mm ø column
Transfer Hose Set
EKA14A131A99 PFK-4 Component i.d. suitable for use with
EKA12A126A12 TH-1 Hose Kit with 3 meter (9.8 ft) length 1000 mm ø column
hoses (6) and sanitary TC connectors.
Connects SPS-1 to 400 and 600 mm ø EKA14A125A99 PFK-5 Component i.d. suitable for use with
column and SPS-2 to 400, 600, and 1200 mm ø column
800 mm ø column Media Slurry Tanks
TH-1C As TH-1 except with Heavy wall wire EDA11A123A99 SV-1 500 litre (132 gal) nominal capacity
reinforced PVC hose EKA12A126A15 EDA11A124A99 SV-2 1000 litre (264 gal) nominal capacity
EKA12A127A12 TH-2 Hose Kit with 4 meter (13 ft) length EDA11A125A99 SV-3 2000 litre (528 gal) nominal capacity
hoses (6) and sanitary TC connectors. (2)
Requires Transfer Host Set and Transfer Adapter Kit matched to column size.
Connects SPS-2 to 600, 800 and (3)
Select TAK-2 for use with 1000 mm column and SPS 2.
1000 mm ø column and SPS-2E to 400, (4)
Select TAK-3 for use with 1000 mm column and SPS 3.
600, 800 and 1000 mm ø column

TH-2C As TH-2 except with Heavy wall wire

reinforced PVC hose EKA12A126A15

EKA12A128A12 TH-2 Hose Kit with 4 meter (13 ft) length

hoses (6) and sanitary TC connectors.
Connects SPS-3 to 1000 and 1200 mm
ø column

TH-3C As TH-3 except with Heavy wall wire

reinforced PVC hose EKA12A126A15

224
 PK Chromatography Skids
Improving Choice, Flexibility and Operating Costs for Purification Processes
Pall’s standard PK chromatography
systems are based on consistent design
principles and quality components that
assure:
• Adherence to process requirements
• Conformance to regulatory demands
• A reduction in downtime
• Increased process efficiency
To complement the standard PK systems
Pall offers fully customized
chromatography equipment and services,
ranging from Process Development scale
to manufacturing scale.
Each Pall chromatography system is
supplied in accordance with specific
process requirements. Our automation,
engineering and process packages are
designed with efficiency, flexibility and easy
scale-up in mind. With the ever-increasing
trend of manufacturing processes being
sited around the world, Pall can provide
technical support and advice as necessary
on a global basis, assuring reliable system
and process performance regardless of
location.
Each Pall system is designed to provide:
• Conformance to critical industry
standards
• Reduction in time spent in process
development and manufacturing
applications
• Optimum flexibility for changing process
demands
• Efficient installation and ease of use
• Segmented system and operator
control structure facilitates remote
operation
• Designed for full CFR 21 part 11
compliance GAMP Compliance
• System design is in recognition of the
GAMP guide, to ensure that all process
application and regulatory requirements
are met and documented to GMP
criteria
• Documentation and protocols include
DQ, IQ/OQ and FAT are used to verify
compliance to user requirements
• Customized solutions based on
industry-standard PK system
platform.Pall provides a complete family
of control systems for chromatography-
supporting ion exchange, affinity,
hydrophobic and gel permeation
applications.
PK systems are based on a consistent
layout for true linear scale-up of
chromatography processes. Available in
four sizes: PK10 (10 – 100 LPH),
PK25 (25 – 400 LPH),
PK50 (50 – 1000 LPH) and
PK300 (300 – 4000 LPH), the broad flow
range for each system(1), coupled with
optimized design and components,
enables a range of applications from
pilot/small scale to production scale with
excellent chromatography results for a
range of column diameters.
[1]
Customized versions of this design extend the
capability to larger flow ranges where needed.
225
 PK Chromatography Skids
Technical Specifications
Hardware Features and Benefits
Sanitary Multi-port
Valve Technology
316L Stainless Steel
Wetted Flow Path
Two-pump Gradient and
In-line Dilution
Designed for CIP
Flow through Instrumentation
Industry Standard
Instrumentation
Conformance to ASME, BPE
FDA Conforming
Non Metallic Parts
System Drain
Diaphragm Pump (4-piston)
No Manual Pump-stroke
Adjustment
System Validation
Documentation
Easily Accessible Parts
Standard Skid Range uses
Consistent Layout Philosophy
and Components
System Sizes
System
Flow Range (L/H)
Piping id
Pipe Connections
Dimensions
Uncrated Weight
226
System Ratings (Applicable to all)
Reduces dead-legs to a minimum Working Pressure 6 barg (87 psig)
Compacts flow path Working Temperature 2 – 60 °C (36 – 140 °F)
Robust, chemically-resistant flow path Surface Finish Internal:
In-line valve fabrication minimizes clamp 0.4 µm (16 µ-in.) Ra + Electro-polish
connections
Operating Environment Temperature and Humidity:
Precise in-line mixing 30 °C (86 °F) maximum, 95% humidity
Fast accurate step and gradient
formation Electrical Ratings IP54/NEMA 13
Electrical and Safety CE and UL
Turbulent Flow velocities achievable in
Approvals
pipe work
Extended temperatures possible Quality Systems ISO 9000
Instrumentation flow cell in-line, Design Standards ASME BPE, GAMP
eliminating dead-legs and minimizing CFR 21 Part 11 Compliance Yes
hold-up volume
Reliable monitoring and control of
process conditions
Major components designed for
conformance to BPE for inherent
sanitary design
Validation and compatibility with
pharmaceutical manufacturing
requirements
Post-pump system fully drainable for
storage
Pump head design gives virtually
pulsation-free flow
Fully automated control – repeatable
setting with reduced operator
intervention
Testing protocols, including DQ, IQ/OQ
and FAT support, for fast track validation
and system start-up
Comprehensive support documentation
in accordance with GAMP guidelines
Easy maintenance and replacement.
Consistent scale-up
PK10 PK25 PK50 PK300
10 – 100 25 – 400 50 – 1000 300 – 4000
4.6 mm (0.18 in.) 12.5 mm (0.5 in.) 15.7 mm (0.62 in.) 34.8 mm (1.4 in.)
6 mm (0.25 in.) 12.5 mm (0.5 in.) 18 mm (0.75 in.) 38 mm (1.5 in.)
Sanitary Clamp Sanitary Clamp Sanitary Clamp Sanitary Clamp
900 mm x 1300 mm 950 mm x 1300 mm 950 mm x 1300 mm –
x 1400 mm x 1400 mm x 1400 mm
(35 in. x 51 in. (37 in. x 51 in. (37 in. x 51 in.
x 55 in.) x 55 in.) x 55 in.)
250 kg (550 lbs) 275 kg (606 lbs) 300 kg (660 lbs) –
Palltronic® Instruments
 Palltronic Instruments
®

Palltronic Instruments are designed to

provide precise, accurate and reliable results
in the most demanding production and
laboratory environments.

These compact, splash-proof instruments are

designed for ease of use and convenient
service. And most important, each instrument
comes with extensive validation
documentation, including hardware and
software qualification, that can help ensure
compliance with industry and regulatory
standards.

228
 Palltronic Flowstar XC Filter Integrity Test Instruments
®

Palltronic Flowstar XC instruments Features and Benefits

perform accurate and precise
• Direct-flow measurement eliminates
measurement of the upstream Forward
errors and time associated with
Flow, Bubble Point, Water Intrusion and
traditional pressure hold test technology
combined Forward Flow/Bubble Point
tests. • Extensive validation documentation and
qualification of hardware and software
The Palltronic Flowstar XC instrument is a
ensures compliance with industry and
unitized, compact and splash-proof filter
regulatory requirements
integrity test instrument especially
designed for use in the most demanding • Easy-to-follow commands for
production environments. user-friendly operation
Featuring the latest in touch-screen • Data security and electronic signature
technology, the Palltronic Flowstar XC features compliant with CFR 21 part 11
system is extremely user-friendly, with • Unitized, durable construction with
simple menu-driven data input. The new splash-proof design allows testing in
Palltronic XC system can store up to 500 any environment
test programs and up to 10,000 test
results, which makes it ideal for • Large, graphic LCD display enables
large-volume manufacturing and easy reading of real time test
multi-product processes in the measurements
pharmaceutical industry. Its increased • Unique external vent valve prevents
memory capacity provides maximum liquid back flow into the unit for
data-handling flexibility and security. increased service reliability
In addition, an ethernet port is available in • Hard copy printout, with date and time
the Palltronic Flowstar XC unit that allows displayed, facilitate documentation
a high-speed PC link for a rapid data requirements
backup.
• Password-protected for added security
The Palltronic Flowstar XC instrument
• Self-Test verifies proper functioning of
incorporates direct flow measurement
software and internal components to
technology, which can reduce testing times
streamline maintenance and labor
by 50% or more, without compromising
requirements
the validity of test results.
The Palltronic High-flow Flowstar XC
instrument is expressly designed for filter
systems requiring high-flows, is capable of
providing flow rates up to 2000 mL/min
without any reduction in flow measurement
accuracy.

See Also:
Palltronic Flow Check Device p. 233
229
Palltronic Training Program p. 234
 Palltronic Flowstar XC Filter Integrity Test Instruments
Technical Specifications

Physical Dimensions Electrical Requirements

Weight 9.8 kg (21.5 lbs) Input Voltage Adjustable between 100 – 240 VAC
Size 160 x 365 x 370 mm Input Frequency 50/60 Hz
(6.3 x 14.4 x 14.6 in.)
Power Input 50 watts (typically)
Fuse 1.6A (inert)
Filter Tests
Forward Flow, Bubble Point, Water Intrusion and Combined Forward Flow
Touch Screen
and Bubble Point
Size Diagonal 239 mm (9.4 in.) 640 x 480 Pixel
Software Function Tests Display Black and White
Self-Test and Flow Check Test Background Illuminated
Contrast Adjustable
Additional Software Functions
Air Clean Program, Auto-Test Mode, Storage, 500 Test Programs, Printer
10,000 Test Results and 250 User IDs Type Thermal
Resolution 832 Dots/Line
Language Options
Printout Lifetime 10 Years
English (US), English (UK), French, German, Italian, Spanish and Japanese
Speed 25 – 50 mm/sec
(Katakana with English)
Paper Width 112 mm (4.4 in.)
Electronic Interface Paper Roll Diameter 50 mm (1.9 in.)
Ports
COM Two (2) Serial RS232C Pneumatic Specifications
(V24)/Asynchronous/DB9 Auxiliary Test Gas Clean Dry Air or Nitrogen
For Remote Operation Maximum Inlet Pressure 8000 mbar (116 psi)
Data One (1) RSJ45 for high-speed data Minimum Pressure Above Testing Pressure
transfer
Standard Flow Range:
0.01 – 60 mL/min 1000 mbar (14.5 psi)
Test Measuring Ranges 61 – 120 mL/min 1500 mbar (22.8 psi)
Palltronic Flowstar XC 121 – 200 mL/min 2000 mbar (29.0 psi)

Forward Flow 0.1 – 200 cc/min High-flow Flow Range:

0.01 – 200 mL/min 1000 mbar (12.5 psi)
Water Intrusion 0.05 – 50 mL/min 200 – 1000 mL/min 2000 mbar (29.0 psi)
Bubble Point 700 – 6000 mbar (10 – 87 psi) 1000 – 1500 mL/min 3000 mbar (43.5 psi)
1500 – 2000 mL/min 4000 mbar (58 psi)
Palltronic Flowstar High-flow XC
Test Pressure Range 50 – 6000 mbar (0.7 – 87 psi)
Forward Flow 0.1 – 2,000 mL/min
Water Intrusion 0.05 – 50 mL/min
Bubble Point 700 – 6000 mbar (10 – 87 psi)
Connections
Inlet Stäubli* Nipple
Accuracy Outlet Stäubli* Coupling

Forward Flow ± 3% or ± 0.05 mL/min Vent Hose Connection 8 mm (0.31 in.) Outer Diameter
(whichever is greater)

Water Intrusion Test ± 3% or 0.02 mL/min Environmental Options

Calibration Limits
Flow Measurement
Pressure Measurement
(whichever is greater) Splashproof IP54 Regulation (DIN 40050 Standard)
Operating Temperature 5 °C – 50 °C (41 °F – 122 °F)
Storage Temperature 20 °C – 70 °C (-4 °F – 158 °F)
± 3% of measurement
Humidity 95% Relative Humidity
± 0.33% of full scale (No Condensation)

Resolution Ordering Information

Forward Flow Test Standard FFSXC
Measured Flow < 10 mL/min, 0.01 mL/min Flowstar HighFlow FFSXCH
Measured Flow > 10 mL/min, 0.1 mL/min Standard Flowstar (US) FFSXCAM
Standard Flowstar (Japan) FFSXCJ
High-flow (US) FFSXCHAM

230 High-flow (Japan) FFSXCHJ

* Stäubli is a trademark of Stäubli AG.

See Also:
Palltronic Flow Check
Pall Advanta Gas Housings
Pall Advanta AGT
Single Round Housings
Pall Advanta AVL
Single Round Housings
Emflon PFR Filter Cartridges
and Capsules
Palltronic Aquawit XC System
The Palltronic Aquawit XC system offers
major benefits for integrity-testing of
hydrophobic gas filters. All stages of the
water intrusion test can now be performed
fully automatically on gas filters — and on
line. The operator simply connects the
Palltronic Aquawit XC unit to the filter
system, inputs test parameters on the easy
to use touchscreen and starts the test
sequence. The filling, testing, draining and
drying is performed without further
operator involvement and a detailed test
result is saved and printed.
With Pall direct flow measurement
technology and a hydraulic bridge link to
the test filter, accurate and reproducible
results are ensured even during changes in
environmental temperature.
Features and Benefits
Accuracy and Reliability
In validation studies flow was measured at
different environmental temperatures using
a small filter with a typical water intrusion
flow rate of 0.04 mL/min to represent
worst case conditions. Even under
conditions where the environmental
temperature of the filter as 20 °C (36 °F)
higher than water temperature, an accurate
test result was obtained.
Validation work has also shown that
accurate measurements can be performed
using filter installations at a distance of at
least 10 m (33 ft) and a height of 2.5 m
(8 ft) or more. Pall can assist in qualifying
the Palltronic Aquawit XC system for
individual purposes.
p. 243
p. 165
p. 167
p. 127
®
Hydraulic Bridge
The hydraulic bridge removes all air from
the upstream filter system and tubing. Flow
measurement is then performed in a more
controlled environment within the
Palltronic Aquawit unit. Stable results can
be obtained even when environmental
temperatures are changing by 10 °C
(18 °F) or more. Direct flow and real time
measurement further adds to the accuracy,
speed and reliability of the test result.
Versatility
The Palltronic Aquawit XC system has
been designed to test vent filters in
positions with difficult access where
environmental temperatures may be
fluctuating. The hydraulic bridge permits
the Water Intrusion test to be performed
on:
• Filters in elevated positions, for
example, product storage and WFI
tanks
• Filters which are inside equipment, for
example lyophilizers or sterilizers which
are difficult to access
• Several different filter installations
testing from a fixed point
Variable Environmental Temperature
Palltronic direct flow Air space
measurement system replaced
by water
Air space
Measurement
chamber
Hydraulic bridge
Water tank
Palltronic Aquawit XC System
231
 Palltronic Aquawit XC System
Technical Specifications
Physical Dimensions
Weight Empty
Height, Width and Depth
Water Tank Volume
Filter Tests
Water Intrusion Test (fully-automatic), Water Intrusion Test
(semi-automatic), Forward Flow Test (semi-automatic), Bubble Point Test
(semi-automatic) and Combined FF and BP Test (semi-automatic)
Function Tests
Self Test, Flow Check Test and Valve Check
Other Functions
Air Clean program, Test Program memory capacity of 500 programs, Test
result memory capacity, 10,000 test results and User ID memory capacity
of 250 users
Language Options
English, French, German, Italian, Spanish, US English and Japanese
(Katakana with English)
Electronic Interface
Ports
COM
For Remote Operation
Data
Measuring Range
Water Intrusion Test
Forward Flow Test
Bubble Point Test
Accuracy
Forward Flow Test
Water Intrusion Test
Calibration Limits
Flow Measurement
Pressure Measurement
Resolution
Water Intrusion Test
Forward Flow Test
Bubble Point Test
232
Electrical Data
100 kg (220 lbs) Mains Voltage 90 – 230 Volts
1100 mm, 580 mm and 840 mm Mains Frequency 50 – 60 Hz
(43 in., 22 in. and 33 in.)
Power 200 W
14 Liters (3.7 US gallons)
Interface 1 x RS232C, serial,
asynchronous, DB9 auxiliary
External Vent Valve 24 V
Touch Screen Specifications
Size 238 mm (9.4 in.) 640 x 480 pixel
Features Black and white, illuminated
background and adjustable contrast
Materials
Stainless Steel – Water Wet DIN 1.4404(1)
Stainless Steel – Frame DIN 1.4301(2)
Seals EPDM
Connections
Compressed Air Inlet
Staübli Nipple RBE03.6150
Compressed Air Outlet
Staübli Coupling RBE03.2904
Water Line to Fill Filter 25 mm (1 in.) Sanitary clamp
Two (2) Serial RS232C
(V24)/Asynchronous/DB9 Auxiliary Water Line to Fill Tank 25 mm (1 in.) Sanitary clamp
Water Drain (Bottom Level) 25 mm (1 in.) Sanitary clamp
One (1) RSJ45 for high-speed data
transfer Environmental Conditions
Splash Proof IP54
Operating Temperature +5 °C to +40 °C (+41 °F to +104 °F)
0.05 – 50 mL/min
Storage Temperature -20 °C to +70 °C (-4 °F to +158 °F)
Standard:
0.1 – 200 mL/min Humidity 95% rh (no condensation)
High-flow:
0.1 – 2,000 mL/min Printer
700 – 6000 mbar (10 – 87 psi) Type Thermal
Printout Lifetime 10 Years
Paper Width 112 mm (4.4 in.)
+/- 3% or +/- 0.05 mL/min, Paper Roll Diameter 50 mm (1.9 in.)
whichever is the greater
+/- 3% or +/- 0.02 mL/min, Pneumatic Specifications
whichever is the greater
Test Gas Clean Dry Air or Nitrogen
Maximum Inlet Pressure 8000 mbar (116 psi)
Minimum Pressure Above Testing Pressure
+/- 3% of measurement
Standard Flow Range:
+/- 0.33% of full scale 0.01 – 60 mL/min 1000 mbar (14.5 psi)
61 – 120 mL/min 1500 mbar (22.8 psi)
121 – 200 mL/min 2000 mbar (29.0 psi)
0.01 mL/min Test Pressure Range 50 – 6000 mbar (0.7 – 87 psi)
Measured Flow >10 mL/min:
0.1 mL/min
Ordering Information
Measured Flow <10 mL/min:
0.01 mL/min Standard High-flow
50 mbar (0.72 psi) Part Number AW02XC AW02XCH
(1)
DIN 1.4404 element composition limits are comparable to 316L.
(2)
DIN 1.4301 element composition limits are comparable to 304.

The Palltronic Flow Check device enables
allows a fast and simple check to be
performed on an integrity test instrument
to show that it is measuring flow correctly.
A Flow Check test can be performed as
often as the user requires in order to
ensure complete confidence in the integrity
test instrument. The user simply connects
the device to their integrity test instrument,
performs a Flow Check test (available with
Palltronic Flowstar and Aquawit
instruments), or a Forward Flow or
Diffusion Test. The flow measured by the
integrity test instrument is then compared
with the calibrated flow of the Flow Check
device. Each Palltronic Flow Check unit is
supplied with a Calibration Certificate, with
the calibrated flow value permanently
marked on the device. Full operating
instructions and Stäubli* fittings are
supplied with every device.
Nominal Dimensions
Weight
Size (H x W x D)(1)
(1)
L = maximum length including Staübli* connection)
Environmental Conditions
Operating Temperature
Storage Conditions
Pneumatic Specifications
Operating Pressure
Maximum Inlet Pressure
Test Gas
Flow Range
Connections
Inlet
Outlet
* Stäubli is a registered trademark of Stäubli AG.
Ordering Information
Part Number
Palltronic Flow Check Device
®
Features and Benefits
• Allows for fast and simple checks of
integrity test instrument flow
measurement
• Fully portable, lightweight and easy to
use
• Can be used with all integrity test
instruments which give a flow value
• High precision capillary, with calibrated
flow, ensures accurate readings
• Internal Pall Gaskleen® filter protects
components for increased service life
• Robust, sanitary stainless steel design
makes it ideal for the
BioPharmaceutical industry
• Easy to use Stäubli connections and
fittings
* Stäubli is a trademark of Stäubli AG.
1.67 kg (3.68 lbs)
90 x 150 x 180 mm (3 in. x 5 in. x 6 in.)
20 °C ± 2 °C (68 °F ± 35 °F)
Room temperature in dry conditions
2 barg (29 psig)
3.0 barg @ 40 °C (44 psig @ 104 °F)
Clean, dry, compressed air or nitrogen
1 – 10 mL/min
Stäubli* nipple RBE03.6150
Hose Connection:
8 mm (0.25 in.) outer diameter
FC01
233
 Palltronic Training Program
®
The Missing Piece from your 21 CFR 11 Compliance Puzzle
Part I. Basics of Integrity Test –
Classroom Presentation
• Why integrity test?
• Types of integrity tests:
Bubble Point, Forward Flow,
Pressure Hold and Water Intrusion
• Factors influencing integrity-testing:
Temperature, Upstream Volume and
Wetting Agent
• Automated vs. Manual integrity-testing
• Design features of automated device
234
Part II. Hands-on Lab
Operating Instructions and SOP
• Perform BP, FF and/or WIT
• External Vent Valve Assembly
• Flow Check device
Maintenance and Troubleshooting
• Cleaning procedures and practices
• Review error messages and fixes
• Look for filter failure mode
• Line pressure requirements
FDA specifies in its 21 CFR Part 11
regulation that procedures should be
employed to ensure:
“Determination that persons who develop,
maintain, or use electronic
record/electronic signature systems have
the education, training, and experience to
perform their assigned tasks.”
 Drivers for Palltronic Filter Integrity Test Instruments
®

Controlled Integrity-testing with a Programmable Logic Controller

Introduction Features and Benefits

Within the pharmaceutical industry there is • Process automization can minimize
a growing use of automated manufacturing operator involvement, saving time and
techniques, electronic signatures and reducing errors
storage of critical batch records.
• Integrity test results can easily be
In order to help satisfy the industry’s needs incorporated into batch records and
for more centralized control, Pall has stored centrally on the PLC or SCADA
developed a range of drivers for Palltronic system
integrity test devices.
• Full integration of the Palltronic device
into the normal operation of the plant
Description allows control of the test device from
Drivers for the Palltronic filter integrity test outside critical or difficult-to-access
instruments enable a PLC to remotely areas
control the integrity test device. The • The PLC or SCADA system can be
Programmable Logic Controller (PLC) can configured to be compliant with
initiate a self test or filter test and when 21 CFR 11 Part 11 when storing test
completed, the Palltronic device transmits results
the test result, the device serial number
and other information back to the PLC.
This information can then be stored in a
Supervisory Control and Data Acquisition
(SCADA) system using the data received
by the PLC to form part of a
comprehensive batch record.
A standard package includes: driver
software supplied on CD-ROM, full
installation instructions and a 2 m (26 ft)
communications cable between the PLC
and integrity test device.
Standard drivers are available for Siemens,
Mitsubishi and Allen Bradley PLCs. Drivers
for other PLC manufacturers can be
developed on request.
The software has been developed and
tested according to the latest GAMP
guidelines.

See Also:
Palltronic Flowstar p. 239
235
Aquawit Instruments p. 241
 Drivers for Palltronic Filter Integrity Test Instruments
Technical Specifications

Schematic
The schematic below shows signals and data transfer between the
Palltronic test device, PLC and SCADA systems

SCADA

Serial Number
Software Version
Last Calibration Date
Self Test Result
Flowrate or BP Measurement
Result

PLC Test Start

Command
Self Test Start Command

Serial Number Serial Number Test Time

Software Version Software Version Test Pressure
Flowrate or BP Measurement Last Calibration Date Maximum Flow Rate
Result Self Test Result Minimum BP
Status Test Mode

Driver
Palltronic Device Operation
Test Running

Ordering Information(1)
Part Number Palltronic Device PLC Other Requirements
SDFFS02 Palltronic Flowstar FFS02 Siemens S7-300 RS232 communications module
and XC instruments FFS02 device and S7-400

MDFFS02 Palltronic Flowstar FFS02 Mitsubishi A Series Serial communication module

and XC instruments FFS02 device

ADFFS02 Palltronic Flowstar FFS02 Allen Bradley Serial communication module

and XC instruments FFS02 device SLC500 series

PDFFS02 Palltronic Flowstar FFS02 or Siemens S7-300 or Profibus DP module

XC Instrument S7-400

CDFFSXC Palltronic Flowstar XC OPC Server Any PC package which supports OPC Serial communication port (RS232C)
(1)
This is a guide to the part number structure only. For availability of specific options, please contact Pall or your local Pall representative.
Drivers for other Palltronic models and PLC manufacturer makes and models can be developed on request. Please contact your local Pall company or distributor for further information.
A Palltronic Flowstar FFS02 interface description for remote operation and on-line data logging is available. Pall literature reference USTR2148.

236
 Palltronic Filter Manager
®

Automated Filterability Test Unit

The Palltronic Filter Manager is an
automated filterability test unit which can
be used to test direct flow filters either at
constant pressure or at constant flow. This
allows to simulate exactly your processes,
and such a unit can be used for modeling
of filtration processes either during
scale-up or during scaling down for trouble
shooting processes or validation test work.
Palltronic Filter Manager, an instrument
especially designed for laboratory
environment is compact, flexible and
splash-proof. The latest touch-screen
technology makes the unit extremely user-
friendly with simple menu-driven data
input.
• Hard copy printout with date and time
displayed helps documentation
requirement
• Provides the technological controls to
meet the regulatory requirements of
21 CFR Part 11
• Automatic Self Test to check proper
functioning of software and internal
components
• Extensive validation documentation and
qualification of hardware and software
for compliance with industry and
regulatory requirements
• Designed for easy servicing

Features and Benefits

• Designed to perform either constant
flow test or constant pressure test Constant Flow Test Configuration
Pressure Pressure
• Up to 2 filters can be tested in series Transducer 1 Transducer 2

• Available in 3 different conformations for

ease of use
Peristaltic
Filter Filter
Pump
• Results displayed in both tabular and Holder 1 Holder 2

Temperature
graphical format Transducer

• Output (in L/m2 of membrane area) will

be calculated for each filter
Fluid Collecting
Vessel Vessel
• Splash proof design allows testing in a
Balance
laboratory environment
• Storage of up to 50 tests in the hard
drive Constant Pressure Test Configuration
Pressure Pressure
Transducer 1 Transducer 2
Temperature
Transducer

Fluid Filter Filter

Vessel Holder 1 Holder 2

Collecting
Control Air Supply Vessel
Panel (Unregulated)
Balance

237
 Palltronic Filter Manager
Technical Specifications

Physical Dimensions (Nominal – Control Panel Only) Electrical Data

Weight 10 kg (22 lbs) Main Voltage Automatically adjusted between
Height, Width and Depth 470 x 330 x 195 mm 100 – 240 V AC
(18.5 x 13.0 x 7.7 in.)
Main Frequency 50 Hz or 60 Hz

Filterability Tests Power Input – Typically 440W

Constant Flow Test P cap
Fuse 4A
Constant Pressure Test V cap
Interface RS232C x 2
External Valve 24V DC
Function Test
Self-test
Screen
Size Diagonal — 264 mm (10.4 in.),
Language Options
640 x 480 pixels
English (US), English (UK), French, Spanish, Dutch, Italian and German
Features Full color display and touch screen
functionality
Communication Ports
RS 232C port for PC Pneumatic Specifications
Maximum Gas 6000 mbar/87 psi
Accuracy Supply Pressure
Pressure ±1% full scale
Temperature Monitoring ± 2 °C (35 °F)
Internal Printer
Mass ±1g
Life Time of Printout Up to 15 years (depending on paper
type and storage conditions)
Instrument Measuring Range
Paper Width 112 mm (4.4 in. approximately)
Mass (Including beaker) 0.005 – 6 kg (0.2 oz – 13lb 3 oz)
(approx.) Paper Roll Diameter 50 mm (2 in. approximately)
Pressure 0 – 6000 mbarg (0 – 87 psig)
Environmental Conditions
Temperature 0 °C to +100 °C (32 °F to +212 °F)
Note: System operating temperature range +5 °C to +40 °C/+41 °F to +104 °F) only. Splash Proof IP54
Operating Temperature +5 °C to 40 °C (+41 °F to +104 °F)
Peristaltic Pump Storage Temperature -20 °C to + 60 °C (-4 °F to + 140 °F)
Speed Range 10 – 600 rpm Humidity 95% RH (no condensation)
Flow Rate 0.6 – 36 mL/min with 0.8 mm (0.03 in.)
internal diameter tubing

8 – 480 mL/min with 3.2 mm (0.125 in.)

internal diameter tubing

Ordering Information
Manual Palltronic Filter Manager UM01M
(Test stand and disc holders)

Automated Palltronic Filter Manager UM01P

(Test stand, disc holder, control panel, instruments and load cell: will run Constant Pressure tests only)

Complete Palltronic Filter Manager UM01F

(Test stand, disc holders, control panel, instruments, load cell and pump: will run Constant Pressure and Constant Flow tests)
Load cell for Palltronic UpScale Manager system to upgrade P to F system UM01B
IQ/OQ documents for UM01P PGGUMPD
IQ/OQ documents for UM01F GGUMFD
Design documentation package documents for Palltronic UpScale Manager (for UM01P and UM01F) GMPUM01
System Acceptance Test documents for Palltronic UpScale Manager (made to order — P or F system to be specified) GSUMD
Paper Roll ACS0664BA

238
Pall Technical Services
 Pall Technical Services

With over 50 years of experience in separation
technologies, and global reach, Pall provides a
comprehensive range of technical and
consultative services:
• Validation of filtration processes
• Aseptic connector validation
• Disposable systems validation
• Validation of integrity test equipment
Pall’s Total Fluid Management program
provides a full range of products, services and
support to meet your fluid processing needs.
We maintain thirty five well equipped
laboratories worldwide to help solve your
filtration, separation and purification problems
and provide access to more than four
hundred trained Pall scientists and engineers,
as well as links with many specialists in
industry and academia.

• Contamination analysis and control

• Process development and optimization

• Training

• Pre-inspection reviews

• Troubleshooting and consultancy

services

• Qualification of integrity test equipment

• Contract technical services

240
 Process-Specific Filter Validation

Pall fully appreciates the stringent The Filter Validation Package

regulatory demands for filter validation
The filter validation package will be tailored
documentation in the BioPharmaceutical
to meet your specific needs and may
industry and maintains a comprehensive
include some or all of the following:
global filter validation service to help meet
these demands. • Compatibility assessment
Many of Pall’s Validation Laboratories are • Challenge viability study
stand-alone facilities where specialists • Bacterial, mycoplasma, or
working to GLP principles perform specific bacteriophage retention study
customer tests. To date, in excess of 2000
customer validation studies have been • Extractables analysis
completed in these facilities. • Evaluation of adsorptive effects
First-time regulatory approval of the • Generation of product wet integrity
filtration validation package is our mission. test data
Pall’s close links with industry and
We can also develop customized
regulatory agencies ensure we can adhere
microbiological procedures using your
to current good manufacturing processes
specific process isolates.
and respond to the most recent regulatory
guidelines. Prior to the start of any test, a protocol
detailing the test methodology and
Validation Objectives acceptance criteria will be issued for
approval.
To prove the suitability of the filter for a
At the conclusion of testing, a
process, the following questions must be
comprehensive report including all
answered:
experimental data is provided.
• Does the product affect the filter?
• Does the filter affect the product?
• Does the product affect microbial
retention by the filter?
To achieve these objectives, Pall uses a
Parametric Approach to ensure that filter
validation is performed taking into account
all critical product attributes and process
parameters. This is in line with regulatory
expectations and the recommendations of
PDA Technical Report 26.

241
 Process-Specific Filter Validation
Technical Specifications

Ordering Information
Test Summary Test Requirements Part Numbers
Compatibility Assessment
To be suitable for use in the manufacture of a pharmaceutical drug product, a – Full process information PTS01CA
filter cartridge must be both chemically and physically resistant to the process – Full product composition
stream and operating conditions. Laboratory tests can be used to establish – Approximately 2000 mL of product
chemical compatibility.
Product Viability Study
Many pharmaceutical products are bactericidal. This test verifies the survival – Full process information PTS01VA (Basic)
capacity of the organism selected for microbial challenge testing, in the whole – Full product composition PTS01VB (Mid)
product or a suitable product simulant, for the process time. – Approximately 200 mL of product PTS01VC (Complex)
Microbial Retention Study
This is to qualify the ability of the filter media to produce sterile filtrate in the – Full process information PTS01BA (Basic)
process. A solution of the product or simulant will be inoculated with the – Full product composition PTS01BB (Mid)
challenge organism at a concentration > 1 x 107 viable organisms/m2 of filter – Approximately 1000 mL of product PTS01BC (Complex)
membrane area. The challenge is carried out on three filter membranes from
different production batches, with at least one being at minimum specification.
Extractables Analysis
Both quantitative and qualitative information on extracted materials must be – Full process information PTS01EA (Generic)
generated. Commonly, extractables cannot be evaluated directly in the actual – Full product composition PTS01EB (Laboratory tests)
product, but a “Model Solvent” approach must be developed. The Pall
Validation Laboratories use a filter cartridge tested with the appropriate
“Model Solvent” to reproduce a worst case situation.
Evaluation of Adsorptive Effects
It is critical that filters are selected to minimize adsorption and loss of product – Full process information PTS01AA
components. Laboratory scale tests can be used to generate adsorption – Full product composition
profiles to help with filter selections and process qualification. – Approximately 1000 mL of product
– Analytical test methods
Generation of Product Wet Integrity Test Parameters
Integrity tests performed on critical filters immediately before and after batch – Full product composition PTS01PA
filtration confirm performance to specification. In order to optimize processing – Approximately 1000 mL of product
it may be more convenient to integrity test the filter cartridge wet with the
product. Pall Validation Services Groups can provide users with the integrity
test data for these specific products.

Charges What’s the Next Step?

Wherever possible, we provide a fixed price in advance for the
project. Where this is not possible, we will give an estimate to assist
you in budgeting and cost control. The final invoice gives details on
items such as labor, and materials.
Contact your local Pall representative. They will discuss
your specific requirements with you and forward your enquiry to
Pall Validation Services Teams. We recommend you do this well in
advance of a regulatory audit to ensure there is adequate time to
generate appropriate test data.

242
 Kleenpak™ Connector Validation
The Kleenpak aseptic connector
represents the latest in connection
technology, allowing for the dry connection
of two separate fluid pathways while
maintaining the sterile integrity of both.
Much of the validation of the Kleenpak
connector can be applied generically and
is provided in the product Validation Guide.
Users often supplement this data with
application and product-specific validation
studies and training. Pall’s Aseptic
Connector Validation Services aim to
ensure a smooth implementation
without delay.
The Kleenpak Connector Validation
Services are an extension of the
established Pall Validation Services and are
an integral part of the user’s validation of
Pall disposable systems. The services are
always backed by Pall’s expertise and
scientific resources.
Pall’s close links with the industry and the
regulatory agencies ensure that your
protocols and documentation can adhere
to current good manufacturing processes
and respond to the most recent regulatory
guidelines.
Male and Female Connector Assemblies
prior to Connection
Collection Bag
Supply Bag
Clamp
Validation Objectives
The objective is to prove the suitability of
the Kleenpak connector for the selected
fluid transfer process by answering the
following questions:
• Does the product affect the Kleenpak
connector?
• Does the Kleenpak connector affect
the product?
• Does the product affect the aseptic
connection connector?
Pall leverages its design knowledge of the
Kleenpak connector to ensure that these
validation objectives are met by taking into
account all critical product attributes and
process parameters.
The Validation Package
The validation package will be tailored to
meet your specific needs and will include
some or all of the following:
• Compatibility Assessment
• Extractables Analysis
• Soiling Test
Prior to the start of any test, a protocol
detailing the test methodology and
acceptance criteria will be submitted for
approval. Upon completion of testing, a
comprehensive report including all
experimental data will be provided.
Female Connector
Tubing
Male Connector
243
 Kleenpak Connector Validation
Technical Specifications

Ordering Information
Test Summary Part Numbers
Compatibility Assessment
The Kleenpak connector is considered compatible with a product if exposure under process conditions does not PTS01CG
alter its ability to perform intended functions.
Tests that evaluate the physical integrity of the Kleenpak connector, such as the pressure exposure test can be used to
establish compatibility with specific product or process conditions. During the pressure exposure test, the connector is
exposed to process pressure conditions for a suitable duration at process temperature.
Dimensions are measured to verify conformance to specifications under process conditions.
Soiling Test
The soiling test was developed to evaluate the ability of the Kleenpak connector to produce a sterile fluid path after the
protective peel-away strips of the male and female connectors have been intentionally contaminated with a Geobacillus
stearothermophilius spore suspension. After the deliberate contamination, the connection is made and sterile trypticase
soy broth (TSB) is passed through the connector to a collection container. The container is incubated and analyzed for
contamination. The results of this soiling test are reported in the Validation Guide of the Kleenpak connector.
Process-specific soiling tests can be developed and performed as below:
Fluid specific: standard organism (Geobacillus stearothermophilius), specific product fluid PTS01SA
Organism specific: process specific organism, standard fluid (TSB) PTS01SB
Full process specific: process specific organism and fluid PTS01SC
Extractables Analysis
Extractables analysis can be performed on the Kleenpak connector by choosing suitable model solvents as the PTS01EJ
extracting agent to represent a range of buffers, media and process fluids. Quantitative and qualitative analysis
can be performed. TOC, pH value and conductivity can be determined as well.
Note: To ensure timely and accurate analytical work, Pall laboratories require complete information on product specification and process conditions such as pressure, temperature and
duration before commencing analysis. Each of the validation projects also requires approximately 2000 – 3000 mL of product.

Charges What’s the Next Step?

Wherever possible, we provide a fixed price in advance for the
project. Where this is not possible, we will give an estimate to assist
you in budgeting and cost control. The final invoice gives details on
items such as labor, and materials.
Contact your local Pall representative. They will discuss
your specific requirements with you and forward your enquiry to
Pall Validation Services Teams. We recommend you do this well in
advance of a regulatory audit to ensure there is adequate time to
generate appropriate test data.

244
 Disposable Filtration System Validation

Disposable filtration systems typically Validation Services Available to a

consist of disposable components such as Disposable System
capsule filters, aseptic connectors, bags
• Capsules
and piping or tubing. As an integrator of
disposable systems, Pall can provide ◆ Bacterial Challenge
reliable validation assistance to the users of ◆ Compatibility
disposable systems. Pall has the product
knowledge and laboratory analytical ◆ Product Viability
expertise to complete validation projects ◆ Product Wet Integrity Testing
for disposable systems of a wide range of
• System
sizes and materials of construction. Pall's
close link with industry and regulatory ◆ Extractables
agencies ensures an up-to-date validation • Bags
approach reflecting the latest thinking, thus
achieving an effective and successful ◆ Extractables
validation. ◆ Compatibility
• Kleenpak Connector
Approaches
◆ Extractables
Analytical work can be performed for
◆ Compatibility
individual components or to the entire
disposable system. A model system is
Case Study:
used for the validation analysis. This model
Extractables analysis for
system is composed of the same materials
disposable bags
of construction as those of the user system
and is assembled as it is used in process. Pall can perform analyses and provide
If the actual system is sterilized by comprehensive reports on the quantification
gamma-irradiation before use, then the test and identification of extractable materials
is performed on an irradiated system. from a disposable system. The type and
the amount of extractable material found
In the case of extractables study, a model
following storage of filled bags is typically
solvent approach is used to select a
included in these studies. The tests are
suitable extracting solvent for analysis.
done for real time storage, with interim tests
For example, worst-case solvents can be
performed for disposable systems that are
selected to represent a range of buffers
stored for extended periods of time.
with varying pH values. For applications
An appropriate storage temperature is used
that involve a filter attached to a bag or a
throughout the storage period.
filter attached to a bag with an aseptic
connector, the model solvent is filtered into A number of analytical methods can be
the bag according to the specific process used to analyze the fluid after extraction.
steps and then stored for the appropriate The selection of methods will depend on
period. Typical models for buffer solutions the requirements of the application.
include: water for injection (WFI) pH Examples of methods include:
adjusted to > 9, < 9, and WFI at neutral pH • GC-MS or LC-MS
(5 – 7). A similar approach can be used for
• Total Organic Carbon (TOC)
media and for product.
• Particulate analysis
• pH
• Conductivity 245
 Disposable Filtration System Validation
Further Information

The Validation Package Charges

The validation package will be tailored to meet the client’s specific
needs and will include some or all of the following evaluations
depending on the disposable components being tested:
• Compatibility Assessment
• Extractables Analysis
• Soiling Test
• Bacterial Challenge
• Product wet integrity testing
Prior to the start of any test, a protocol detailing the test methodology
and acceptance criteria will be submitted for approval. Upon
completion of testing, a comprehensive report including all
experimental data will be provided.
Wherever possible, we provide a fixed price in advance for the
project. Where this is not possible, we will give an estimate to assist
you in budgeting and cost control. The final invoice gives details on
items such as labor, and materials.
What’s the Next Step?
Contact your local Pall representative. They will discuss
your specific requirements with you and forward your enquiry to
Pall Validation Services Teams. We recommend you do this well in
advance of a regulatory audit to ensure there is adequate time to
generate appropriate test data.

An Example of the Final Report

1. Introduction: An overview of the project and objectives of the
project.
2. Summary: A description of the general experimental approach.
3. Methods: A description of the specific techniques used.
4. Results: Detailed data tables with explanations of data, as
needed.
5. Discussion: An analysis of the data with conclusion for each test.
6. Appendices: Detailed explanation of test methods

Ordering Information
Test Services Part Numbers
Capsules Microbial Retention PTS01BA (Basic)
PTS01BB (Mid)
PTS01BC (Complex)
PTS01BD (Cartridge challenge studies)
PTS01BE (Process specific bacteria)
PTS01BF (Cytotoxics)

Compatibility PTS01CA (Basic)

PTS01CB (Complex)

Product Viability PTS01VA (Basic)

PTS01VD (Process specific)
PTS01VE (Cytotoxics)

Product-wet Integrity Test Parameters PTS01PA (One pressure source)

PTS01PB (Two pressure sources)
PTS01PC (Cytotoxics)

Extractables PTS01EA (Generic)

PTS01EB (Lab tests)
PTS01EC (Complex tests)
Disposable Bags Extractables PTS01EH
Compatibility PTS01CF
Kleenpak Connectors
Extractables PTS01EJ
Compatibility PTS01CG
Soiling tests (for details, see Kleenpak Connector Validation data sheet) PTS01SA (Fluid specific)
PTS01SB (Organism specific)
PTS01SC (Full process specific)
System Extractables PTS01EK

246

The presence of unexpected particulate or
microbial contaminants in process fluids
can lead to system failure, batch
reprocessing, or even batch rejection.
It is critical that these contaminants be
quickly isolated and identified, so that
possible sources can be traced and
corrective actions applied to the process.
How Can Pall Help?
Pall has over fifty years experience in
contamination analysis and control and
offers a range of standard services for
analysis of particulate and microbial
contaminants.
In the simplest form, we can often provide
the necessary advice and corrective
actions by telephone or via e-mail.
Alternatively, samples can be sent to a Pall
facility for analysis or we can sample on
site. These investigations will be fully
documented and a technical report is
supplied following conclusion of the test
work and process review, to ensure that
any change control is correctly managed
and implemented.
Microbiological Contaminants
The isolation and identification of microbio-
logical contaminants from process fluids
requires specialist laboratory facilities and
expertise, all of which can be offered by
Pall Life Sciences.
Typical microbiological studies include:
• Total bacterial count
• Bioburden analysis
• Identification and review of process
isolates
Contamination Analysis
Particulate Contaminants
Pall Life Sciences have available a wide
range of microscopic and analytical
equipment for the analysis of particulate
and/or amorphous contaminants including:
• Optical microscopy
• Scanning electron microscopy
• X-Ray emission spectroscopy
• Computer-enhanced image analysis
Analysis of Process Bioburden
The full quantification and identification of
natural process bioburden is of increasing
regulatory interest. Some bacteria, when
subjected to particular environmental
conditions, are known to produce
particularly diminutive forms capable of
penetrating 0.2 µm sterilizing grade filter
cartridges.
A typical analysis procedure is as follows:
• Filter samples through 47 mm diameter
analysis discs
• Place discs on nutrient agar plates and
incubate
• Count colonies to quantify bioburden
Strike out individual colony types
• Examine colony morphology
• Gram stain and examine
microscopically
• Perform biochemical tests to establish
identity
• Document and report results
247
 Contamination Analysis
Further Information

Typical Investigation Procedure for SEM showing contamination retained by filter

Particulate Contaminants in a Water System membrane
Sample Points Set Up

Silt Density Index (SDI) Test Performed

Contaminant Collected

Chemical – Physical Analysis

Optical Microscopy
Scanning Electron Microscopy
with X-ray Emission Spectroscopy
Charges
Wherever possible, we provide a fixed price in advance for the
project. Where this is not possible, we will give an estimate to assist
you in budgeting and cost control. The final invoice gives details on
items such as labor, and materials.

What’s the Next Step?

Final Report and Recommendations
Simply contact your local Pall representative. They will discuss
your specific requirements with you and forward your enquiry to
Pall contamination analysis specialists.

Part Number Structure

PTS 04 **

Pall Technical Contamination Type of

Services Analysis Analysis

Typical Part Number: PTS04AE

Contamination analysis with scanning electron microscopy and XES

248
 Process Development and Optimization

Pall has the capability to support our Typical Services Available

customers in development of separation
Services available as individual or
and purification processes. Whether driving
combined activities include:
to bring new products to market or
streamlining and troubleshooting existing • Membrane and module selection tests
processes, Pall Life Sciences can provide • System-design optimization tests
flexible solutions and high quality
documentation to back it up. • Cleaning cycle development
Pall specialists operating in the field can • Analytical services
quickly access dedicated Pall
• Qualification of disposable process
technologists, equipment, and laboratories
for services ranging from simple advice to • Process modelling
pilot investigations or full detailed research • Systems design
proposals.
• Inspection and report

Unit Operations for an Integrated • Engineering services for vessels and

Process pipework

Since Pall is the largest provider of

separation and purification media,
hardware and both automated and
disposable systems, we are uniquely
positioned to quickly optimize solutions for
each customer.
The technologies upon which we focus
include:
• Direct flow depth and membrane
filtration
• Tangential (cross) flow membrane
filtration
• Dynamic membrane separations
• Membrane chromatography
• Coalescing filters
• Specialized R&D processes (for
example, novel uses of membranes for
affinity based separation techniques)
• Water treatment and purification
equipment
In addition to the above, and for the
purpose of process integration, we have
established links to a wide range of other
suppliers who can provide support for
implementation of complementary
technologies.

249
 Process Development and Optimization
Further Information

Facilities Charges
Pall's Scientific and Laboratory Services (SLS) is represented by thirty Each project is assessed individually. Wherever possible, we provide a
five laboratory facilities at strategic locations world-wide. Many of fixed price in advance. Where this is not possible, we will offer an
these laboratories have their own process wet test area where estimate to assist you in budgeting and cost control.
customer fluids or simulated products can be tested. Equipment can
The final invoice gives details on items such as labor, and materials.
also be rented for trials.
This laboratory network is backed by specific centers of expertise in What’s the Next Step?
downstream processing and has direct access to core R&D centers
where more advanced customer liaison. Contact your local Pall representatives. They will discuss your specific
requirements with you and forward your enquiry to Pall technical
In response to the increasing importance of biotechnology processes specialists.
and products, specialized biologics laboratories have been created in
Portsmouth (UK) and in Florida and New York (USA). Capabilities
include mammalian cell culture and bacterial fermentation with
qualification to handle genetically modified organisms to Class 2,
equipment for optimization of downstream processes including
membrane chromatography, development of disposable systems,
and many aspects of bioanalytical support.

Time is Valuable
Pall recognizes customers’ increasing requirement to reduce the time
to take products to market. Pall has over 50 years of innovation and
development experience with proven solutions, for membrane
purification and separation. Whether it is direct flow filtration,
tangential flow filtration, chromatography or disposable systems, Pall
can deploy a range of scalable and reproducible products for every
application. This is backed with the capability to provide complete
documentation for every test protocol or complete unit operation.
Delegating process development to Pall technologists can
substantially reduce process-development time.

Part Number Structure

PTS 07 **

Pall Technical Process Type of

Services Development Work

Typical Part Number: PTS07AA

Process development involving membrane/module selection tests

250
 Training

Effective training of personnel at all levels is Features and Benefits

important for maintaining a profitable
Benefits of Pall’s training courses:
operation and meeting the needs of
regulatory authorities. For example, lack of • Courses designed and led by experts
qualified training can and has resulted in • Each course customized to ensure
manufacturers being issued with warning maximum relevance to your operation
letters by the FDA.
• Optimum use of training budgets
International GMP regulations state that
personnel should receive training • Can be held locally or at Pall’s
appropriate to the duties assigned to them specialized facilities
and continuing training should be given.
Training Course Topics
Pall Life Sciences Technical Group Topics most commonly covered are:
Training is given by experts in filtration • Introduction to filtration
processes who have extensive experience
• Filter system operation
in applications in pharmaceutical
manufacturing operations and awareness • Integrity testing
of the latest regulatory expectations. • Filter validation and regulatory
They are able to provide a range of training requirements
courses to ensure operators and managers
attain the optimum level of competence in • Introduction to separation technology
all filtration and separation disciplines. • Operation of downstream processing
systems
Customized Training Courses • Basic or advanced tangential flow
To ensure that the training is relevant to filtration
your operation and provides value for We can also work with your local training
money, courses can be customized to department to develop a course that
meet each client's specified needs. meets any requirement you have.
Information on theory and application is
carefully balanced to keep the content
interesting. Courses are designed to
ensure maximum participation by the
trainees, and, where appropriate, practical
exercises can be introduced.
Depending on your requirements, courses
can be arranged at (or near) the site of
operation or at one of Pall’s specialized
training facilities.

251
 Training
Example Training Courses

Introduction to Integrity Testing Filter Validation and Regulatory Requirements

Who should attend Who should attend
Operators, supervisors and managers requiring a working knowledge Key personnel from Quality Assurance, Regulatory Compliance,
of integrity testing. Technical Support, R&D and Manufacturing Departments.
Course Objectives Course Objectives
To ensure attendees: Provide those who have a responsibility for ensuring that the
sterilizing filtration process meets current regulatory requirements,
• Understand the importance of testing critical filters
with the knowledge they require to review and improve existing
• Understand how the theory and practice of the range of available procedures.
integrity tests differ
Course Content
• Have practical experience of operating manual and automatic
• Core validation, continuous validation and process specific
integrity test devices
validation — how they differ
Course Content
• Recent changes in regulatory requirements
• Destructive versus non-destructive tests
• Current regulatory requirements
• Different non-destructive methods: Forward Flow, Bubble Point,
• Documentation requirements
and Water Intrusion Tests
• Practical approaches to process validation
• Regulatory requirements
Course Duration
• Correlation of integrity tests to filter performance
Typically 1⁄2 day
• Operating manual and automated test devices
Location
Course Duration
On site or at Pall's local training facility
Typically 1 day
Location Charges
On-site or at Pall’s local training facility
Wherever possible, we provide a fixed price in advance based on
course requirements. Where this is not possible, we will an estimate
to assist you in budgeting and cost control. The final invoice gives
details on items such as labor and materials.
For more information and to discuss your training requirements,
please contact your local Pall Life Sciences representative.

Part Number Structure

PTS 03 **

Pall Technical Training Type of

Services Services Training

Typical Part Number: PTS03AA

Training on the basic principles of filtration for a half day at customer
site

252

Filtration is often seen as a critical process
in the manufacture of pharmaceutical
products, especially if the filter is used
towards the end of the production
process. Therefore regulatory authorities
often review and inspect the equipment,
procedures, and documentation
associated with users’ filtration processes.
Pre-Inspection Reviews
Pall Life Sciences can assist you in being
fully prepared for inspections by both
internal and external auditors by offering
pre-inspection reviews. This includes a
review of the process, procedures, and
documentation. Where appropriate, we
provide recommendations of additional
work required.
Pall Life Sciences Technical
Services
Pre-inspection reviews* are carried out by
experts in filtration applications who have
extensive experience with of applications in
pharmaceutical manufacturing operations
and are familiar with the key regulatory
expectations. The reviewers spend time
on-site with operators and managers to
assess key areas such as:
• Technical data
• Validation data
• Filter selection
• Product certification
• System design
• Operating procedures
• Sterilization procedures
• Integrity testing practice
Pre-Inspection Reviews
Features and Benefits
• Reviews are carried out by experts in
filtration processes to:
◆ Ensure that users are employing the
most suitable filtration system and
optimal procedures are employed
◆ Reduce risk of adverse reports from
regulatory inspections
◆ Give personnel more time to focus on
other critical activities
• The Pre-inspection review is
accompanied by a report containing
recommendations of corrective actions
◆ Ensures that the pharmaceutical
manufacturer has time to implement
suggested changes prior to regulatory
inspection
• Support for implementing corrective
actions and process improvements
◆ Vital help where resources are short
or required elsewhere
• Review ensures all filters are optimal for
each specific application
◆ Minimizes operating costs and risk of
process failures
* The review of filtration processes is a comprehensive
technical assessment of these areas. It is the user’s
responsibility to ensure that all aspects critical to
regulatory compliance are assessed in preparation for
inspection.
253
 Pre-Inspection Reviews
Technical Data and Filter Selection

Regulatory authorities will expect BioPharmaceutical manufacturers to
understand the technical specifications of the filters that they use and
to be able to justify that each filter is appropriate for the process.
Pall specialists will:
• Document all the filters you use, by part number and application
• Assess whether the filters are suitable for the operation in which
they are being used
• Ensure you have key technical data and filter qualification reports
available in a form ready for audit
Validation Data
Regulatory authorities expect that the users of sterilizing-grade filters
have assessed and confirmed that:
• The filter does not alter the product adversely
• The product does not affect the filter adversely
• The process conditions do not affect the filter adversely
This usually involves a range of process simulation tests involving
techniques such as bacterial retention, extractables analysis, active
ingredient adsorption etc.
We will advise you of the current filter validation requirements as part
of the review, assess your current documentation, and recommend
any additional testing.
Product Certification
Operating and Sterilization Procedures
Processing limits for critical filters (temperature and pressure, for
example) are provided by Pall in its technical documentation. It is
necessary to understand how these limits relate to the process in
which the filter is being used. This is important to avoid damage to
the filter and possible adverse effects on the product being
processed. This therefore can form part of a regulatory authority
audit.
Our experts will review the types of filters being used, review the
processes being operated, and review the documentation supporting
the processes. We will then detail any improvements recommended
and, if requested, will help with the rewriting of documents such as
Standard Operating Procedures.
Integrity Testing Procedures
Integrity testing is a mandatory requirement for critical production
filters. Regulatory audits would normally include a review of:
• Integrity test method employed
• Test parameters
• Temperature range
• Integrity test equipment used
• Documentation available to support test instruments
We review all these areas and can recommend possible
improvements.

Where Pall filters are supplied for critical processes they are
supported by a manufacturer's certificate of test. Regulatory
authorities expect this certificate to be checked before the filter is
used and referenced in batch documentation. As part of the pre-
inspection review, we will ensure the user understands the data
supplied and discuss how it should best be used.
Charges
Wherever possible, we provide a fixed price in advance for the
project. Where this is not possible, we will give an estimate to assist
you in budgeting and cost control.
The final invoice gives details on items such as labor, and materials

What’s the Next Step?

Simply contact your local Pall representatives. They will then discuss
Part Number Structure your specific requirements with you and forward your enquiry to Pall
technical specialists. We recommend you do this well in advance of a
regulatory audit to ensure there is adequate time to review all the key
PTS 05 **
areas and put into place any corrective actions.

Pall Technical Pre-inspection Type of

Services Review Review

Typical Part Number: PTS05AA

Pre-inspection review for one day

254
 Filter Integrity Test Equipment Validation
Filter integrity testing can be one of the
most critical procedures in a filtration
process and may be an essential
requirement for batch release of a product.
The increasing requirement for accuracy
and documentation has resulted in a wider
use of automated integrity test equipment.
Use of such equipment must be validated
to ensure that it satisfies both process and
regulatory requirements.
How Can Pall Assist?
Expertise
We have over twenty years experience in
the design, manufacture and qualification
of Palltronic integrity test equipment.
Time and cost saving
Our approach to instrument validation
minimizes time and costs.
Quite simply, we make instrument
validation, IQ, OQ and PQ easier for
you.
Validation Tests
Installation Qualification IQ
We check all the equipment components
and documentation. The suitability of the
testing environment and services are also
checked if the instrument is qualified on
your site.
Operational Qualification OQ
We offer two options.
1. GAMP* guidelines state that the OQ of
standard instruments such as integrity
test units can be divided into two parts.
A completed OQ1 containing extensive
qualification studies on a reference
instrument. A shorter OQ2 protocol on
your specific instrument is then
performed, saving both time and cost.
2. Alternatively, all OQ tests in the form of
a standard system acceptance test
(SAT) can be performed on your
specific instrument. A customized SAT
protocol can also be prepared for you if
required.
Performance Qualification PQ
We can also assist in generating
customized PQ protocols and, if required,
perform the tests.
Features and Benefits
• Pall’s expertise ensures instrument
validation of your integrity test
instruments will meet the latest industry
and regulatory requirements
• All materials, measuring equipment and
labor supplied by Pall for trouble-free
testing
• Completed GAMP OQ1 document on
reference instruments saves time and
costs
• Tests can be performed on-site or
off-site for maximum flexibility
• The ultimate benefit to you is a faster
and more secure validation process to
meet regulatory requirements
* Good Automated Manufacturing Practice guidelines
issued by the GAMP Forum and ISPE.
255
 Filter Integrity Test Equipment Validation
Further Information

Where are Tests Performed? Documentation

At a Pall site Standard Qualification and Validation Documents
We perform the tests in our purpose-designed laboratories. Standard protocols for IQ/OQ2 or SAT can be purchased from Pall.
If required, you can view the testing. Completed OQ1 documents are also available together with validation
support documentation based on GAMP guidelines.
On your site
We set up and perform the tests at your location. Customized Protocols
We work closely with your personnel to ensure that the format and
Equipment and Materials content of customized protocols meet your requirements.

We have all the necessary equipment to ensure that qualification tests Reports
are performed accurately and reliably. We also supply materials such On completion of the tests, the final reports are reviewed, approved
as filters. This capability means that we can offer a fast, professional and signed by a competent Pall specialist. The full documentation is
and cost-effective service. then submitted to you for approval.

Range of Qualification Service Charges

The service covers the Palltronic Flowstar and Palltronic AquaWIT
instruments. Specialized versions of these instruments can also be
qualified as appropriate.
In most cases, we can provide a fixed price in advance for the
service.
For some special requirements, we provide an estimate to assist you
in budgeting and cost control. The final invoice will itemize actual
costs including labor and materials.

Part Number Structure

PTS 02 **

Pall Technical Qualification of Test Type of

Services Equipment Qualification

Typical Part Number: PTS02AB

IQ/OQ2 Qualification at Pall Site

256
 Troubleshooting and Consultancy Services

Filtration, separation, and purification We can develop with you intranet/internet

systems, when correctly designed and
installed, should operate successfully
without problems.
Even the best systems, however, may be
affected by unpredictable events such as
variations in the quality of process fluid or
environmental factors — and often at the
most critical time. Such events can result
in costly down-time or even loss of a
product batch.
systems to assist troubleshooting and
information exchange
Features and Benefits
• An approach to troubleshooting that is
quick and cost effective
• A unique consultancy service that can
achieve improved process efficiency
and cost savings

In addition, continuous improvement is a • A global capability that ensures local

necessary requirement today, with support when and where you need it
increasing pressure on process efficiency
and costs. Whether your needs are for Typical Projects
troubleshooting or process improvements, • Plant filtration surveys
Pall Life Sciences’ specialized advice and
expect troubleshooting experts can bring • Improved life of filtration system
significant benefits and cost savings. • Investigating non-sterility in a sterile
filtration process
What Can Pall Offer? • Evaluation of integrity test methodology
A unique and cost-effective • Variable product activity after
troubleshooting and consultancy service purification
based on:
• Poor separation of protein components
• More than fifty years experience in
• Reduction of endotoxin contamination
process separation systems
in final product
• A capability and response unparalleled
• Malfunction of control sensor in process
in the filtration and separations field
• Improved steam-in-place procedures
How Can Pall Solve Your • Filter steaming process validation
Problems?
• Scale-up of processes
Our specialists provide the best available
professional advice to ensure a rapid and
effective investigation.
We have state-of-the art equipment to
assist in problem solving and process
monitoring.
Our worldwide laboratories offer analytical
services for the widest range of fluids.
Our specialists can visit your site to review
the process in more detail and to perform
studies locally.

257
 Troubleshooting and Consultancy Services
Further Information

Facilities
Laboratories
We maintain thirty five laboratories well equipped worldwide to help
solve your filtration, separation, and purification problems
People
We are a network of more than four hundred trained scientists within
Pall as well as links with many specialists in industry and academia.
Equipment
Our equipment includes scanning electron microscopy, HPLC, mass
spectrometry, TOC analysis, FTIR spectroscopy, GC, filterability kits,
integrity test units…and many more.
Databases
We maintain a comprehensive range of internal databases for
troubleshooting. We also subscribe to external databases to ensure
the broadest capability and fastest response.
Communications
We operate a Lotus Notes and Intranet system to ensure fast and
efficient communications worldwide twenty four hours a day.
Documentation
In all cases, the report will be reviewed, approved and signed by the
Pall specialist. You may choose to countersign the document as
confirmation of receipt and acceptability of content.
Our aim is to ensure not only that your problems are resolved or
processes improved, but that the investigations are fully documented
and comply with appropriate manufacturing practices.
If required, we will present the basis of the report in a formal meeting
with you.
Charges
The variable nature of troubleshooting and consultancy work means
that we have to assess projects individually. Wherever possible, we
provide a fixed price in advance. Where this is not possible, we will
give an estimate to assist you in budgeting and cost control.
The final invoice gives details on items such as labor, and materials.
What’s the Next Step?
Contact your local Pall representatives. They will discuss your specific
requirements with you and forward your enquiry to Pall technical
specialists.

Our investigations are fully documented in the form of a technical

report. This report can be of special importance in regulatory audits
and in management of change control.
The report can be prepared to your specific format, if required, to
maintain consistency within your documentation.

Part Number Structure

PTS 06 **

Pall Technical Consultancy and Type of

Services Troubleshooting Service

Typical Part Number: PTS06AB

Consultancy work for two days

258
Systems
 Systems

Pall’s capabilities include a variety of system

solutions using the full range of technologies
described in this catalog.

From manual to fully automated, from

stand-alone packages to fully integrated total
processes and from single-use plastic to long
life fully validated cleanable stainless steel
hardware fit for biopharmaceutical, biological,
and chemical pharmaceutical demands.

Details on standard TFF systems can be

found in the Tangential Flow Filtration section
and details on chromatography systems can
be found in the Chromatography section.
Other systems are described in the Systems
section.

Additional information on fully integrated or

customized processes to meet any demand
are available on request.

260
 Pall Process Engineered Systems
Automated Separation and Purification Systems
The requirements for a new process are
seldom the same. Therefore, we begin
each enquiry with a project review based
on the individual requirements.
Our product portfolio and technology
platform is comprehensive and allows us to
always offer the best technical approach
for each application. We use proven
features, proven designs and proven
packages wherever appropriate.
Short Timescales — Best Results
The time-span from drug development to
market introduction is crucial for
commercial success. with our extensive
experience and production capabilities, pall
can help to keep this time to a minimum.
our project teams focus on your
requirements and directly interlink with your
team over the whole project from
specification to commissioning. This
approach helps to build each system to
your user documentation in the shortest
possible time.
Process Automation for Cost
Savings
With GMP and documentation
requirements increasing, process
automation is a good investment to
optimize overall production costs:
Less operator interference makes
processes run smoothly, validation easier
and with minimum downtime.
Pall’s automation solutions are designed for
process integration and interfacing, in
compliance with 21 CFR 11, from simple
data logging to full batch records with
electronic signatures.
Expert Application Knowledge for
Our Customers
Pall has a large multi-disciplinary team of
engineers and scientists with in-depth
knowledge of applications and operating
parameters for separation systems in
biological, BioPharmaceutical and chemical
processes. Operating within the PASS (Pall
Advanced separations Systems) group for
projects and within the SLS (Scientific and
Laboratory Services) and R&D
organizations for longer term development
and analysis, they enhance the total
package for process development and
advanced solutions.
GMP and GAMP Approach
We manage our projects and design our
systems in accordance with industry
guidelines to ensure customer and
regulatory requirements are met.
The GMP requirements on validation and
documentation for automated systems in
BioPharmaceutical production are defined
in Annex 15 of the EC Guide to Good
Manufacturing Practice of Drug Products
and in other international regulatory
guidelines. For the US market, 21 CFR
Part 11 further influences the design of
electronic recording systems. In addition,
the ISPE Forum has published its
comprehensive GAMP Guide to create a
common project design approach for
industry users and
vendors, from a formal user requirement
specification to system commissioning and
ongoing maintenance of a validated
system. The ASME Bioprocessing and
European (EHEDG) guidelines are also
important reference points for specific
equipment.
261
 Pall Process Engineered Systems

Over and above these general guidelines, Pall brings its long-standing
experience in design and manufacture of purification and separation
systems for GMP applications. This unique combination of experience Enquiry or
Tender
in implementation of sanitary design and regulatory requirements
together with process technology know-how provides reassurance of Early Process & Initial System Design In Depth System
Engineering Design & Accurate Budget & Process Design
our ability to meet quality targets. Technical Review Cost Submittal Review

Process
During the whole qualification phase of a new project, Pall is ready Development
and willing to provide support services. we routinely provide a clear
understanding of the scope of responsibilities, develop formal Final System Design
Contract Review
Regular Project
& Fixed Price Review & Update
validation plans and are prepared to assist with all stages of Meeting
Submittal Meetings, Reports
qualification from factory acceptance through to site installation.
When in operation, your Pall system can be monitored continuously
to predefined parameters and all relevant process data logged in a System FAT Delivery & SAT
(Factory Acceptance (Site Acceptance Ongoing Support
comprehensive batch record file to assure the consistency of your Test) Test)
process in accordance with cGMP criteria.

Customer Support
Pall is organized functionally and geographically to give us the closest
link to our customers and fastest response times.

Pall Advanced Separation System

Retirement
Pall Advanced Separation Systems (PASS)
is the applications, engineering and
procurement entity for Pall’s global process
Planning Operation &
Maintenance systems business. To successfully deliver
integrated solutions that meet industry and
customer requirements this group has
Process Performance excellence in:
Requirement Qualification
• Process system design
Verifies
• project management
Equipment Control Operational
URS System URS Qualification
• Systems fabrication
• Documentation
GxP and Installation
Safety Review Qualification • Risk analysis
• Validation/qualification

Control Operational
• Installation support
Equipment FS
System FS Check
• Operator training
• After-market service
Mechanical and Operating Control Installation
Electrical Design Interface Design System Design Check • Service contracts

FAT & SAT • Spare parts provision

Design Review and Approval Module Integration and

Development Testing

Mechanical and
Electrical Build

Operating
Interface Build

Control System
Programming

GMP and GAMP Approach

262
 DGM Plate and Frame Filter Systems
With the Membraplan® DGM filter press
system, a new generation of sheet filters
was developed, setting new standards for
modern pharmaceutical and
biotechnological production. It can be used
for a wide range of applications from initial
cell harvest to down stream clarification
steps.
The Membraplan DGM is a multiple sheet
filter for filtration with depth filter sheets. It
Above: DGM Filter Plates
is the first system of its kind allowing for
complete CIP cleaning and sterilization and
thus meeting all requirements for
pharmaceutical equipment.
The key to the success of the
Membraplan DGM lies in the unique
design of the filter plates. Each filter plate is
sealed with an O-ring at the outer edge of
the plate. This allows for zero leakage from
the filter press during processing and CIP
cleaning and eliminates any product
contact with the surrounding environment.
The Membraplan DGM is available as a
plate and frame (DG) or as a plate and
frame with mechanical dehydration (DGM)
design. The DGM version allows for
mechanical squeezing of the filter cake
with an elastic membrane thus increasing
yields by reduction of moisture in the
solids. This results in a dry and compact
filter cake, which can be easily removed
from the frame.
Features and Benefits
• Totally enclosed sheet filter system
eliminating undesirable product loss
• Enclosed design allows for CIP cleaning
and SIP* sterilization
• Mechanical dehydration (DGM) ensures
higher yield and reduction of residual
moisture in the filter cake
• Mechanical dehydration (DGM) allows
for a dry compact cake in a short time
when compared to typical gas drying
• Utilizes standard depth filter sheets for
maximum selectivity
• Sizes from 300 x 300 mm (11.8 x
11.8 in.) to 1000 x 1000 mm (39.3 x
39.3 in.) for maximum scalability
• Cake washing plates available for
maximum product recovery
• Can be equipped with automatic plate
shifters and cleaning portals for
800 x 800 mm (31.4 x 31.4 in.) and
1000 x 1000 mm (39.3 x 39.3 in.)
designs
• Filter plate and frames materials in USP
certified polypropylene or 316 stainless
steel
* (Stainless steel version only).
263
 DGM Plate and Frame Filter Systems
Technical Specifications

Applications
• Plasma fractionation
• Cell harvest
• Clarification of therapeutical proteins, vaccines, diagnostics,
enzymes, and antibiotics
• Removal of activated carbon
• Activated carbon filter
• Removal of filter aids
• Removal of catalysts
Due to the enclosed design of the Membraplan DGM, for the first
time a complete CIP cleaning can be carried out, which — in
combination with manual precleaning-guarantees the reproducibility
of the cleaning method by the FDA Inspection Guide on Cleaning
Validation. The filer plate design was specially developed for strict
requirements on hygiene and cleanliness in the biotechnological and
pharmaceutical industry taking the recommendations and regulations
of FDA, GMP and 3-A into consideration. Closing of the filter pack is
carried out via hydraulic cylinder with mechanical locking.
The pneumatically operated hydraulics are installed on the cross
member and are explosion proof as standard (no electrical
components).

Technical Specifications
Membraplan DGM DG Filter Press DGM Plate and Frame
Size 300 = 300 x 300 mm 600 = 600 x 600 mm
(11.8 x 11.8 in.) (23.6 x 23.6 in.)
400 = 400 x 400 mm 800 = 800 x 800 mm
(1.7 x 15.7 in.) (31.4 x 31.4 in.)
1000 = 1000 x 1000 mm
(39.3 x 39.3 in.)

Materials K = Polypropylene P = Stainless Steel

Chassis Size 30 60
50 100
150
200
Note: Please contact Pall Corporation for additional technical information for sizing and
selection of the correct Membraplan DGM filter press system.

264
 ZHF Centrifugal Discharge Filter System

The ZHF centrifugal discharge filter is a • No emissions due to enclosed system

totally enclosed filter that is designed for
• Cake-washing possible
automatic discharge of filter cake by
rotation of the filter bundle. • Filter elements can be equipped with
different types of septums
ZHF filters are used for filtrate and or cake
recovery. The filter solids can be treated • Available with lip seals or mechanical
(washed, dried, extracted) in place within seals
the filter. Solids are then discharged using
an integral mechanical discharge aid as a Applications
dry cake or as a slurry. The ZHF filter can
• Activated carbon recovery
be operated with or without filter aids
depending on the characteristics of the • Activated carbon filter
cake being developed. • Precious metal catalyst recovery
Sizes are available from 0.3 m – 150 m of
2 2
• Enzyme clarification
filter area and are available in 316, 316L
• Cell harvest
and 904 L stainless steel and Hastelloy C
construction.
Complete systems are available for
automation of the entire ZHF filter plant.

Advantages
• Totally enclosed system for safe
operation
• Short down time by automatic
discharge of filter cake
• Even distribution of filter cake by the
horizontal filter element arrangement
• Easy installation and reduced filter
height due to bottom mounted filter
drives
• Minimal liquid phase loss due to
recovery via scavenge filtration system
• Easy assembly and low maintenance
using wearing sleeves on all dynamic
seal areas
• Seals and bearing can be changed
without removing the filter internals
• Filtration possible with or without use of
filter aids

265
 ZHF Centrifugal Discharge Filter System
Technical Specifications

Ordering Information
Filter Type Number of Filter Area of Number of Scavenge Scavenge Total Theoretical
Filter Elements Main Elements Filter Elements Filter Area Filter Area Cake Volume
ZHF-SR 2.5 13 2.2 m2 (23.6 ft2) 2 0.35 m2 (3.76 ft2) 2.55 m2 (27.4 ft2) 70 L
ZHF-SR 5.0 10 4.7 m2 (50.5 ft2) 2 0.94 m2 (10.11 ft2) 5.64 m2 (60.7 ft2) 170 L
ZHF-SR 10 21 9.87 m2 (106.2 ft2) 2 0.94 m2 (10.11 ft2) 10.81 m2 (116.3 ft2) 300 L
ZHF-SR 15 32 15.04 m (161.8 ft )
2 2
2 0.94 m (10.11 ft )
2 2
15.98 m2 (172.0 ft2) 450 L
ZHF-SR 20 28 19.88 m2 ((213.9 ft2) 2 1.42 m2 (15.2 ft2) 21.3 m2 (229.2 ft2) 600 L
ZHF-SR 25 35 24.85 m2 (267.4 ft2) 2 1.42 m2 (15.2 ft2) 26.27 m2 (282.7 ft2) 760 L
ZHF-SR 30 28 30.1 m (323.9 ft )
2 2
3 2.1 m (22.6 ft )
2 2
32.2 m (346.5 ft )
2 2
900 L
ZHF-SR 40 37 39.77 m2 (428.0 ft2) 4 2.8 m2 (30.1 ft2) 42.57 m2 (458.2 ft2) 1200 L
ZHF-SR 50 47 50.52 m2 (543.7 ft2) 4 2.8 m2 (30.1 ft2) 53.32 m2 (573.9 ft2) 1500 L
ZHF-SR 60 55 59.12 m2 (636.6 ft2) 5 3.5 m2 (37.6 ft2) 62.62 m2 (674.0 ft2) 1800 L
ZHF-SR 80 61 64.66 m (695.9 ft )
2 2
6 4.2 m (45.2 ft )
2 2
68.86 m (741.2 ft )
2 2
1900 L
ZHF-SR 90 72 76.32 m2 (821.5 ft2) 6 4.2 m2 (45.2 ft2) 80.52 m2 (866.7 ft2) 2300 L
ZHF-SR 100 81 85.86 m2 (924.2 ft2) 7 6.36 m2 (68.4 ft2) 92.22 m2 (992.6 ft2) 2600 L
ZHF-SR 110 59 97.35 m2 (1047.8 ft2) 6 6.36 m2 (68.4 ft2) 103.71 m2 (1116.3 ft2) 2900 L
ZHF-SR 130 69 113.85 m2 (1225.4 ft2) 6 6.36 m2 (68.4 ft2) 120.21 m2 (1293.9 ft2) 3400 L
ZHF-SR 150 77 123.2 m (1326.1 ft )
2 2
7 7.21 m (77.6 ft )
2 2
130.41 m2 (1403.7 ft2) 3700 L
Note: Maximum usable volume is 2/3 of theoretical volume.

266
 PEF Multi Purpose Processor

Equipment Features and Benefits

The PEF Multiprocessor is unique • Combines multi-processes into one
processor that all allows for reaction and piece of equipment (reaction and
mixing, crystallization, filtration and mixing, crystallization, filtration and
cake-drying all in one piece of equipment. drying)
It is essentially a pivoted pressure vessel
• Optimized drying due to efficient design
suspended in a frame. The vessel can be
heated or cooled and is fitted with a filter • Excellent agitation and mixing
septum over its base. properties due to special agitator
design
The vessel is fitted with a reversible and
retractable agitator equipped with a • Maximum removal of solids
specially designed stirring arm. With the • Low contamination with no product
hydro-mechanically operated pivoted transfers between steps
system using integral safety brake, the
• Filter septum acts as dust filter during
vessel can be smoothly and infinitely
drying
variable swung into the required position.
To change the filter media or any worn • Fully automatic process possible
parts, the filter base can be hydraulically • IP cleanable (all instruments and valves
lowered and swung on its hinge for access included) — turn-key unit)
to the filter internals. All operating and
control gear is grouped for easy access on
the main frame panel. The solid discharge
port is positioned to suit different
requirements.

267
 PEF Multi Purpose Processor
Technical Specifications

Possibilities in Filter Position Possibilities in Reactor Position

• Receive slurries • Receive slurries
• Filter • Receive solutions
• Smooth/dewater cake • Discharge slurries
• Wash cake • Discharge solutions
• Plough cake • Prepare solutions
• Re-slurry cake • Crystallize or precipitate slurries
• Dissolve cake • Reactions
• Evaporations
Basic Chemical Methodology
• Dry solids
1. Reaction (including dissolutions)
• Discharge solids
2. Crystallization (including precipitations)
3. Transfers Comparison between a Multi-purpose Processor and
Filter Dryer
4. Filtration
1. Enlarged heat exchange area — reduction of drying time of up to
5. Slurry
80 %
6. Drying
2. More complete discharge
7. Sieving, grinding and blending
3. All process steps can be carried out in one unit
A Multi-purpose processor is the only single piece of equipment that
4. No dust filter necessary — filter medium acts as dust filter
can perform steps 1 to 6 and is excellent at all 7.
5. Drying is not done on the filter media — no blocking
6. Special designed agitator with helix — excellent mixing and
blending properties

Technical Specifications
Materials Stainless steel, Hastelloy, Titanium
Pressure Rating Up to 6 bar
(higher pressures upon request)

Sizes and Materials

Type Filter Area Effective Filter Cake Filter Cake Stirrer Est. Con. Weight Dimensions
Volume Volume Height (rpm) Load (KW) Empty (t) (L x W x H)

450 0.15 m2 120 L 30 L 200 mm 5 – 26 2.2 1.1 1800 x 1420 x 2800 mm

(1.61 ft2) (7.87 in.) (71 x 56 x 110 in.)

600 0.26 m2 250 L 65 L 250 mm 5 – 28 8.0 1.9 2860 x 1720 x 2760 mm

(2.80 ft2) (9.84in.) (112 x 68 x 109 in.)

800 0.48 m2 550 L 120 L 250 mm 5 – 28 9.5 2.9 3260 x 1920 x 3500 mm
(5.17 ft2) (9.84 in.) (128 x 76 x 138 in.)

1000 0.78 m2 850 L 234 L 300 mm 2.5 – 22 15.5 3.4 4160 x 2200 x 3580 mm
(8.40 ft2) (11.8 in.) (164 x 87 x 141 in.)

1250 1.2 m2 1300 L 420 L 350 mm 2 – 15 15.5 6.5 4215 x 2000 x 3700 mm
(12.9 ft2) (13.8 in.) (166 x 79 x 146 in.)

1600 2.0 m2 2300 L 840 L 420 mm 2 – 15 23.0 9.6 4110 x 2500 x 4380 mm
(21.5 ft2) (16.5 in.) (162 x 98 x 172 in.)

2000 3.0 m2 3800 L 1260 L 420 mm 2 – 12 36.0 12.7 4900 x 2820 x 5000 mm
(32.3 ft2) (16.5 in.) (193 x 111 x 197 in.)

268

Pall’s high-purity water systems are
designed to comply with international
codes and regulations governing medicinal
product manufacture referred to in various
regional Pharmacopeia as, for example,
USP, EP, and JP. These regulations specify
standards of purity for a number of waters
including Purified Water, Highly Purified
Water, and Water For Injection. These
waters are used in the preparation of
compendial doseage forms in a variety of
applications from bulk primary processing,
media make up, equipment and container
rinsing to use in final formulations. Controls
include microbial and total organic carbon
Top: Aria Microfiltration System
Bottom: USP 24-WFI System
(TOC) and in the latter cases, endotoxin.
Non-compendial water used in
pharmaceutical processing must also meet
specified criteria. This water may be used
applied in early stages of synthesis or
cleaning and as the feedwater to high
purity water treatment systems. Typically
this water must meet at least potable
(drinking water) standards and usually has
additional limits specified (for example
hardness, silica, total bacteria count).
Pretreatment
Raw water supply varies in quality. Typical
impurities which need to be reduced or
controlled include
• Particulates
• Inorganics
• Micro organisms
• Dissolved gases
• Organic compounds
Pretreatment reduces the effect of potential
variations in feedwater quality, minimizing
the operating and maintenance
requirements in the final treatment stages.
Typically it has little effect on some
parameters indicative of final water quality
such as anions, total bacteria count, TOC
and volatile components but pretreatment
must be effective to minimize plant
operating costs.
Water Systems
Microfiltration
Crossflow microfiltration (MF) is a highly
efficient way to remove small suspended
solids, large colloids, and micro-organisms
from large volumes of water.
New generations of membranes in robust
materials and large area format, which are
unique to Pall, provide excellent economy
and exceptionally stable performance
independent of variability in feed water.
Operating pressures are lower than UF
(typically 1 to 2 bar) and the systems use
backwash and air scrubbing techniques to
minimize requirements for chemical
regeneration.
• Removes turbidity, suspended solids,
bioburden
• Reduces silt density index (SDI) to
protect RO/NF and ion exchange
• Compatible with chlorine and other
chemicals which may be present in
feed
• Minimal waste stream
• Low operating cost
• Stable filtrate and low chemical
compared to multimedia filters
Ultrafiltration
Ultrafiltration membranes, when
incorporated in our systems, retain
particles, bacteria, viruses, pyrogens
(endotoxins), colloids and large organic
molecules. Dissolved salts and smaller
organic molecules pass freely through
these systems. A wide variety of
proprietary membranes are available to
Pall, but the two most common
applications for pharmaceutical water
processing are in pretreatment (eg colloid
removal) and for pyrogen control in both
low and high temperature distribution using
both hollow fiber and ceramic
technologies.
269
 Water Systems
Full process review and skilled design optimization mean that Pall can
apply UF in its systems with considerable advantages to end-users.
Benefits include
• Excellent protection when used in prefiltration
• Steam in place options available for pyrogen applications
• Sanitary and cleanable designs where required in final processing
Reverse Osmosis
Reverse osmosis (RO) is the finest level of membrane separation in
liquids. The RO membranes used in Pall systems act as an efficient
barrier to all dissolved salts and inorganic molecules as well as most
organic compounds (organics typically greater than 100 Daltons in
molecular weight).
Water passes freely through, while salts are rejected typically from
98% to over 99%.
Pall has optimized the pretreatment, design and staging of RO
systems in single or multipass arrangements for stable and low
fouling performance and for extremely high recovery (water
conversion) rates without the use of chemicals.
Benefits include
• Compact and modular design
• No added chemicals
• Very high rejection rates producing high purity filtrate
• Maximum efficiency in throughput
• Recovery rates as high as 95%
Nanofiltration
Pall also uses nanofiltration (NF) water technology with similar but
slightly more open membranes than RO. The modules have higher
unit capacity and lower operating pressures for greater economy
where higher passage of monovalent ions and some small organics is
not an important factor.
These systems are used typically to produce softened process water
and for removal of high levels of common organic compounds found
in some waters.
Other Technologies
Membrane systems listed above can meet most requirements for
process water, purified water and highly purified water or water for
injection (WFI) quality.
Some regulations still demand that WFI must be prepared using
distillation. Pall systems can be used in parallel or in series with
distillation and are often employed to take load off existing distillation
installations. Distillation can be incorporated into systems when
required.
270
Other important features of Pall’s high purity water systems include,
according to process requirements, ozone dosing, ultraviolet (UV)
treatment, carbon filters, ion exchange (softeners) and chemical
dosing. Pall’s own cartridge filters are also employed to protect tank
vents, and as highly effective prefiltration or point-of-use guard filters.
Storage and Distribution
Total system design ensures that water is purified, stored and
distributed with quality maintained to specification all the way. Tank
designs take into account sizing, choice of material and microbiogical
considerations. Additional components such as heat exchangers,
filters, UV, ozone and point-of-use valves are selected on technical
merit, simplicity, efficiency and cost effective maintenance. Loop
pressure and flow rates are carefully designed and controlled to meet
microbiological and safety considerations.
Microbiological Protection
High quality water has to be properly handled and protected from
contamination right up to point-of-use.
The hydrophobic vent filters in Pall systems provide high sterility
assurance and generous air flow rates with minimum risk of blockage
by wetting. Integrity testing of the filters is achieved with minimum
fuss and maximum confidence.
Final water quality at point-of-use is ensured by high flow rate, long
life sterilizing grade filters capable of absolute removal of even the
smallest organisms which may be encountered in practice.
Pall Advanced Separations Systems
Pall Advanced Separations Systems (PASS) is an independent
engineering and procurement entity for Pall’s global separations
systems business. To successfully deliver high purity water systems
that meet stringent customer requirements we have excellence in:
• Process System Design
• Documentation
• Systems Fabrication
• Project Management
PASS will provide the following:
• Installation Support
• Systems Design
• Document Preparation
• Validation/Qualification
• Risk Analysis
• Operator Training
• Spare Parts
• Service Contracts
• After-Market Service
Appendix
 Filter Configurations and Dimensions

AB Series – Dimensions (Length)

mm mm Adapter Code 2 Adapter Code 3
AB02 87 AB1 254
AB04 102 AB2 508
AB05 147 AB3 762 Ø Ø
AB1 254 AB4 1016
Length Length

Adapter Code 7
Diameters of Adapters
Code 2 56.4 mm (2.22 in.)
Ø Code 3 44.2 mm (1.74 in.)
Code 7 56.4 mm (2.22 in.)
Length

1000 Series – Dimensions (Length)

mm mm RF, RMF, PFY MBS, and MCS MCY1001
R05 F 127 MCY 1003 762
R1 F 254 MCY 1004 1016
R2 F 510 MCS 1001 254 Ø 63.5 Ø 70

R3 F 768 MBS 1001 254

R4 F 1022 MBS 1002 508 Length Length
RM1 F 254 MBS 1003 762
RM2 F 508 MBS 1004 1016
RM3 F 762 PFY1 254
RM4 F 1016 PFY2 508
MCY 1001 254 PFY3 762
MCY 1002 508 PFY4 1016

Sealkleen – Dimensions (Length)

mm mm Sealkleen SLK
SLK7001 66 SLK7002 133

Length

Junior – Dimensions (Length)

mm mm MCY2230, MCY4463, and MCS4463 MCY1110, 2220, and 4440
MCY2230 76 MCS4463 133
MCY4463 136 SBF 62
MCY1110 48 AVF021 66
MCY2220 57 AVF022 133
MCY4440 120 Length
Length

SBF1 AVF

Length Length

272
 Filter Configurations and Dimensions
(Continued)

Kleenpak – Dimensions (Height)

mm mm Kleenpak Nova – In-Line with Nova – In-Line with Nova – T-Style
KA1 107 KA3 175 Sanitary Flange Hose Barb

KA2 158 KA4 286

Nova – Dimensions (Height)

mm mm
NP6 332 NT6 349
NP7 581 NT7 598
NP8 831 NT8 848 Height Height Height Height

Nova – Typical Configurations

Nova Nova Nova
10 in. with 20 in. with 30 in. with
Sanitary Flange Sanitary Flange Sanitary Flange

Height Height Height

Novasip – Dimensions (Height)

mm mm PCF Novasip – CM5 Novasip – C3
CM5 84 C3 157

PCF – Dimensions (Height)

mm
PCF 170

Height
Height

Height
Note
In this catalog, any reference to sanitary
flanges for housings or disposable filters
pertains to ferrules designed for use in
connection with mating Tri-Clamp* fittings of
the same dimension, unless otherwise
specified.
* Tri-Clamp is a registered trademark of Alfa Laval, Inc.

273
 O-ring and Gasket Reference Guide

Cartridge O-rings and Gaskets

Code Materials Cartridge Styles
H FKM(1) O-rings:
AB codes 7, 8, 2 and 3, Juniors

Gaskets:
1001 style, 1201 style, Uni Loc

H1 FEP-encapsulated FKM(1), (2) O-rings:

AB codes 7, 8, 2 and 3, Juniors

H2 PTFE(3) Gaskets:
1001 style and Uni Loc

H4 Silicone O-rings:
AB codes 7, 8, 2 and 3, Juniors

Gaskets:
1001 style, 1201 style, Uni Loc

H13 Buna-N O-rings:

Juniors

Gaskets:
1001 style, 1201 style, Uni Loc

H15 FEP-encapsulated Silicone(2) O-ring:

AB codes 7, 8, 2 and 3, Juniors

J Ethylene Propylene O-rings:

AB codes 7, 8, 2 and 3, Juniors

Gaskets:
1001 style, Uni Loc

J7 Ethylene Propylene for Steam Gaskets:

1001 style

Housing O-rings and Gaskets

Code Material Temperature Limits
H FKM(1) -29 °C to +232 °C (-20 °F to +450 °F)
H1 FEP-encapsulated FKM(2),(1) -29 °C to +204 °C (-20 °F to +400 °F)
H2 PTFE(3) -29 °C to +232 °C (-20 °F to +450 °F)
H4 Silicone -29 °C to +232 °C (-20 °F to +450 °F)
H13 Buna-N -29 °C to +121 °C (-20 °F to +250 °F)
H15 FEP-encapsulated Silicone (2)
-29 °C to +204 °C (-20 °F to +400 °F)
J Ethylene Propylene -29 °C to +149 °C (-20 °F to +300 °F)
J7 Ethylene Propylene for Steam -29 °C to +191 °C (-20 °F to +375 °F)
Note: Temperature ratings apply for compatible fluids at steady state process conditions. Maximum temperature limit for
housing seal material may exceed maximum temperature limit for selected filter cartridge(s). See cartridge data sheet for
maximum assembly operating and steaming temperatures.
(1)
FKM = Fluorocarbon Elastomer.
(2)
FEP = Fluoronated Ethylene Propylene.
(3)
PTFE = Polytetrafluoroethylene.

274
 Index
Acids – Capsules

A
Acids – filtration of Auxiliaries and Water Purification 10 Bubble Point Test
Sterilizing-grade Capsules Integrity Test Instruments
Kleenpak™ Capsules with Supor® EKV Palltronic® Aquawit XC System 231
B
Membrane Assemblies 79 Palltronic® Flowstar XC Filter Integrity
Kleenpak™ Nova Sterilizing-grade and Bacterial Challenge Tests Test Instruments 229
Virus Removal Capsule Filters 101 Disposable Filtration System Validation 245 Test Parameters
Novasip™ Liquid Sterilizing-grade Process-Specific Filter Validation 241 Process-Specific Filter Validation 241
Capsule Filters 99 Bacterial Contamination Analysis Buffer Exchange
Sterilizing-grade Cartridges Contamination Analysis 247 Tangential Flow Filtration Membrane Cassettes 185
Fluorodyne® II Hydrophilic PVDF Filter Cartridges 87
Supor® EBV Sterilizing-grade Filter Cartridges 83 Bacterial Removal – air and gas applications Buffer Filtration
Supor® EKV Sterilizing-grade Filter Cartridges 81 Capsules Capsules
Kleenpak™ Capsules with Emflon® II Kleenpak™ Capsules with Supor® EKV
Activated Carbon Removal and Recovery Membrane Assemblies 115 Membrane Assemblies 79
DGM Plate and Frame Filter Systems 263 Kleenpak™ Capsules with Emflon® PFR Kleenpak™ Nova Sterilizing-grade and 101
Rigimesh® Sintered Metal Mesh Membrane Assemblies 117 Virus Removal Capsule Filters
Filter Cartridges 137 Novasip™ Capsules with Emflon® PFR Mini Kleenpak™ Sterilizing-grade
Supracap™ 200 Encapsulated Membrane Assembles 113 Capsule Filters 77
Depth Filter Modules 33 Cartridges Cartridges
Supracap™ 60 Depth Filter Capsules 31 Emflon® CPFR High-temperature Supor® EBV Sterilizing-grade Filter Cartridges 83
Supradisc™ Depth Filter Modules 27 Sterilizing-grade Filter Cartridges 125 Supor® EKV Sterilizing-grade Filter Cartridges 81
Supradisc™ II Modules 29 Emflon® PFR Junior Style Filter Cartridges 121
ZHF Centrifugal Discharge Filter Systems 265 Bulk Chemical for Filtration for APIs
Emflon® PFR Sterilizing-grade Filter Cartridges 123
Emflon® FM Filter Cartridges 73
Activated Carbon Trap Filter Bacterial Removal – liquid applications Marksman™ Elements with Nexis® A
Emflon® FM Filter Cartridges 73 Capsules Series Filters 67
Marksman™ Elements with Nexis® A Kleenpak™ Capsules with Fluorodyne® II Marksman™ Elements with Poly-fine® II
Series Filters 67 Membrane Assemblies 85 Series Filters 71
Marksman™ Elements with Poly-fine® II Kleenpak™ Capsules with Posidyne® Marksman™ Elements with Poly-fine® XLD
Series Filters 71 Membrane Assemblies 95 Series Filters 69
Marksman™ Elements with Poly-fine® XLD Kleenpak™ Capsules with Supor® EKV
Series Filters 69 Membrane Assemblies 79
Profile® Filter Cartridges with Ultipleat® Kleenpak™ Capsules with Ultipor® N66
C
Construction 59 Membrane Assemblies 89 Cake-drying
Profile® Star Filter Cartridges 55 Kleenpak™ Nova Sterilizing-grade and 101 PEF Multi Purpose Processor 267
Activated Carbon – depth filters with Virus Removal Capsule Filters Calibration
Supracap™ 200 Encapsulated Mini Kleenpak™ Sterilizing-grade Capsule Filters 77 Palltronic® Flow Check Device 233
Depth Filter Modules 33 Novasip™ Liquid Sterilizing-grade
Supracap™ 60 Depth Filter Capsules 31 Capsule Filters 99 Capsules – chromotography
Supradisc™ Depth Filter Modules 27 Cartridges Mustang® Chromatography Capsules
Fluorodyne® II Hydrophilic PVDF Filter Cartridges 87 and Cartridges 217 – 220
After-market Service Mustang® Membrane
Posidyne® Filter Cartridges 97
Pall Process Engineered Systems 261 Chromatography Starter Kits 211 – 214
Sealkleen™ Membrane Filter Cartridges 91
Air-Gas Filtration 111 – 142 Supor EBV Sterilizing-grade Filter Cartridges
®
83 Capsules – depth filter
Amine Charged Polymer Supor EKV Sterilizing-grade Filter Cartridges
®
81 Supracap™ 200 Encapsulated
Mustang® Chromatography Capsules Ultipor® N66 Sterilizing-grade Filter Cartridges 93 Depth Filter Modules 33
and Cartridges 217 – 220 Bacterial Retention Studies Supracap™ 60 Depth Filter Capsules 31
Analytical Services Process-Specific Filter Validation 241 Capsules – direct-flow filtration
Contamination Analysis 247 Bacteriophage retention studies Prefilters – air and gas
Disposable Filtration System Validation 245 Process-Specific Filter Validation 241 Kleenpak™ Capsules with HDC® II
Filter Integrity Test Equipment Validation 255 Gas Filter Assemblies 119
Bases – filtration of Prefilters – liquid
Kleenpak™ Connector Validation 243
Sterilizing-grade Capsules Kleenpak™ Capsules with HDC® II
Process Development and Optimization 249
Kleenpak™ Capsules with Supor® EKV Filter Assemblies 47
Process-Specific Filter Validation 241
Membrane Assemblies 79 Kleenpak™ Nova Particulate and Prefilter
Anion Exchange Kleenpak™ Nova Sterilizing-grade and 101 Capsule Filters 41
Mustang® Chromatography Capsules Virus Removal Capsule Filters Mini Profile® Capsule Filters 45
and Cartridges 217 – 220 Kleenpak™ Ultipor® N66 Sterilizing-grade PreFlow™ Capsule Filters 43
Mustang® Membrane Capsule Filters 89 Sterile Filters – air, gas, and vent
Chromatography Starter Kits 211 – 214 Novasip™ Liquid Sterilizing-grade Kleenpak™ Capsules with Emflon II ®

Antibiotics Capsule Filters 99 Membrane Assemblies 115

Air and Gas Filtration 111 – 142 Sterilizing-grade Cartridges Kleenpak™ Capsules with Emflon® PFR
Depth Sheet Filters and Modules 13 – 34 Supor® EBV Sterilizing-grade Filter Cartridges 83 Membrane Assemblies 117
Systems 259 – 270 Supor® EKV Sterilizing-grade Filter Cartridges 81 Novasip™ Capsules with Emflon® PFR
Tangential Flow Filtration 175 – 208 Ultipor® N66 Sterilizing-grade Filter Cartridges 93 Membrane Assembles 113
Antifoam Resistance Binding and Elution Sterile Filters – liquid
Alpha Membranes 178 Mustang® Chromatography Capsules Kleenpak™ Capsules with Fluorodyne® II
Regen™ Membrane 179 and Cartridges 217 – 220 Membrane Assemblies 85
Bioburden Analysis Kleenpak™ Capsules with Posidyne®
API (Active Pharmaceutical Ingredients) 6 Membrane Assemblies 95
Contamination Analysis 247
Appendix 271 – 284 Kleenpak™ Capsules with Supor® EKV
Bioburden Reduction Membrane Assemblies 79
Aqueous Enzymes Processing Ultipor® N66 Particulate and Bioreduction
Microza Membranes 198 – 202 Kleenpak™ Nova Sterilizing-grade and 101
Filter Cartridges 75 Virus Removal Capsule Filters
Aseptic Connections BioSeries Depth Filter Sheets 15 Kleenpak™ Ultipor® N66 Sterilizing-grade
Kleenpak™ Connectors 39 Capsule Filters 89
Biotechology and Cell Culture 2
Aseptic Connector Validation Mini Kleenpak™ Sterilizing-grade Capsule Filters 77
Kleenpak™ Connector Validation 243 Blood Products and Fractionation 4 Novasip™ Liquid Sterilizing-grade
Bonded Glass Fiber – Positive Zeta Capsule Filters 99
Aseptic Packaging Validation
Formulation and Filling 8 Capsules
Kleenpak™ Nova Particulate and Prefilter Disposable Filtration System Validation 245
Autoclave Vacuum Break Capsule Filters 41 Process-Specific Filter Validation 241
Emflon® PFA Filter Cartridges 127 PreFlow™ Capsule Filters 43 Virus Removal Filters
Emflon® PFR Sterilizing-grade Filter Cartridges 123 Cartridges Kleenpak™ Nova Sterilizing-grade and 101
Autoclaves – sterile venting PreFlow™ Filter Cartridges 65 Virus Removal Capsule Filters
Emflon® PFR Sterilizing-grade Filter Cartridges 123 Ultipor® GF Plus Filter Cartridges 63 Novasip™ DV20 and V50 Virus Removal
Filter Capsules 103
Automated systems Breakthrough Curves
Capsules – tangential flow filtration
See Systems Chromatography 209 – 226
Minimate™ Tangential Flow Filtration Capsules 181
275
 Index
Carbon Removal – Emflon® FM Filter Cartridges

Carbon Removal Cassettes Compatibility Assessment

See Activated Carbon Removal and Recovery Centramate™ 185 Disposable Filtration System Validation 245
Carbon-containing Depth Filters Centrasette™ 185 Kleenpak™ Connector Validation 243
See Activated Carbon – depth filters with Maximate™ 186 Process-Specific Filter Validation 241
Maxisette™ 186 Concentration
Cartridges
Chromatography Cassettes – tangential flow filtration Depth Sheet Filters and Modules 13 – 34
Mustang® Chromatography Capsules Tangential Flow Filtration DGM Plate and Frame Filter Systems 263
and Cartridges 217 – 220 Membrane Cassettes 185 – 187 Tangential Flow Filtration 175 – 208
High-temperature Gas Service Catalyst Fines – removal Connector for Disposable Systems
Emflon CPFR High-temperature
®
Emflon® FM Filter Cartridges 73 Kleenpak™ Connectors 39
Sterilizing-grade Filter Cartridges 125 Catalyst Recovery and Removal Contamination Analysis 247
PMM® Metal Membrane Filter Cartridges 141 DGM Plate and Frame Filter Systems 263 Cross-flow Filtration
PSS Porous Metal Filter Cartridges
®
139 Rigimesh® Sintered Metal Mesh See Tangential Flow Filtration
Rigimesh® Sintered Metal Mesh Filter Cartridges 137 Filter Cartridges 137
Metal Cryogenic Fluid
Supracap™ 200 Encapsulated PSS® Porous Metal Filter Cartridges 139
PMM® Metal Membrane Filter Cartridges 141 Depth Filter Modules 33
PSS® Porous Metal Filter Cartridges 139 Supracap™ 60 Depth Filter Capsules 31 Crystal Recovery
Rigimesh Sintered Metal Mesh Filter Cartridges 137
®
Supradisc™ Depth Filter Modules 27 Membralox® Ceramic Membrane Products 203
Prefilters – air, gas, and vent Supradisc™ II Modules 29 Crystallization
HDC® II Gas Filter Cartridges 131 ZHF Centrifugal Discharge Filter Systems 265 PEF Multi Purpose Processor 267
LG Liquid and Gas Coalescing Filter Cartridges 135
Pallcell® Air and Gas Filter Cartridges 133 Cation Exchange
Ultipor® GF Plus Air and Gas Filter Cartridges 129 Mustang® Chromatography Capsules D
Prefilters – liquid and Cartridges 217 – 220
Mustang® Membrane Deionized Water – filtration of
Emflon™ FM Filter Cartridges 73
Chromatography Starter Kits 211 – 214 Water Systems 269
HDC® II Filter Cartridges 61
HDC® II Junior Style Filter Cartridges 49 Cell Culture Perfusion Depth Sheet Filters and Modules
Marksman™ Elements with Nexis A ®
Microza Membranes 198 – 202 Capsules
Series Filters 67 Supracap™ 200 Encapsulated
Cell Harvest and Product Separation Depth Filter Modules 33
Marksman™ Elements with Poly-fine® II
BioSeries Depth Filter Sheets 15 Supracap™ 60 Depth Filter Capsules 31
Series Filters 71
DGM Plate and Frame Filter Systems 263 Disposables
Marksman™ Elements with Poly-fine® XLD
E-Series Depth Filter Sheets 25 Supracap™ 200 Encapsulated
Series Filters 69
Matching Membrane Cassettes to Applications 180 Depth Filter Modules 33
PreFlow™ Filter Cartridges 65
Membralox® Ceramic Membrane Products 203 Supracap™ 60 Depth Filter Capsules 31
Profile Filter Cartridges with Ultipleat
® ®

Minimate™ Tangential Flow Filtration Capsules 181 Modules

Construction 59
Pallsep™ Vibrating Membrane Filtration Supracap™ 200 Encapsulated
Profile® II Filter Cartridges 51
Technology 205 Depth Filter Modules 33
Profile® II Plus Filter Cartridges 53
P-Series Depth Filter Sheets 17 Supradisc™ Depth Filter Modules 27
Profile Star Filter Cartridges
®
55
Supradisc™ Depth Filter Modules 27 Supradisc™ II Modules 29
Starclear™ Filter Cartridges 57
Tangential Flow Filtration Sheets
Ultipor® GF Plus Filter Cartridges 63
Membrane Cassette Holders 189 – 193 BioSeries Depth Filter Sheets 15
Ultipor® N66 Particulate and Bioreduction
Tangential Flow Filtration E-Series Depth Filter Sheets 25
Filter Cartridges 75
Membrane Cassettes 185 – 187 K-Series Depth Filter Sheets 19
Sterile Filters – air, gas, and vent
Tangential Flow Filtration Systems 195 P-Series Depth Filter Sheets 17
Aerosol challenge
Ultrafiltration and Microfiltration T-Series Depth Filter Sheets 21
Emflon® PFA Filter Cartridges 127
Membranes for Cassettes 178 Z-Series Depth Filter Sheets 23
Sterile Filters – air, gas, and vent
ZHF Centrifugal Discharge Filter Systems 265 Systems
Liquid Challenge
Emflon® CPFR High-temperature Ceramic Modules DGM Plate and Frame Filter Systems 263
Sterilizing-grade Filter Cartridges 125 Membralox® Ceramic Membrane Products 203 Depyrogenation
Emflon® PFR Junior Style Filter Cartridges 121 Ceramic – tubular See Endotoxin Removal
Emflon® PFR Sterilizing-grade Filter Cartridges 123 Membralox® Ceramic Membrane Products 203
Sterile Filters – liquid DGM Plate and Frame Filter Systems 263
Fluorodyne® II Hydrophilic PVDF Filter Cartridges 87 Challenge Viability Studies Diafiltration
Posidyne® Filter Cartridges 97 Disposable Filtration System Validation 245 See Tangential Flow Filtration
Sealkleen™ Membrane Filter Cartridges 91 Process-Specific Filter Validation 241
Direct Flow Liquid Filtration 35 – 110
Supor® EBV Sterilizing-grade Filter Cartridges 83 Chromatography
Supor EKV Sterilizing-grade Filter Cartridges
®
81 Capsules Direct Flow Measurement
Ultipor® N66 Sterilizing-grade Filter Cartridges 93 Mustang® Chromatography Capsules Palltronic® Aquawit XC System 231
Virus Removal Filters and Cartridges 217 – 220 Palltronic® Flowstar XC Filter Integrity
Ultipor® VF Grade DV20 Virus Removal Cartridges Test Instruments 229
Filter Cartridges 107 Mustang® Chromatography Capsules Disposable Filtration System Validation 245
Ultipor® VF Grade DV50 Virus and Cartridges 217 – 220
Filter Cartridges – SBF Junior Style 105 Disposable Systems
Coin devices
Ultipor® VF Grade DV50 Virus Removal Disposable Systems 37
Mustang® Coin Units 215
Filter Cartridges 109 Kleenpak™ Connectors 39
Columns
Cassette Capsules Resolute™ Chromatography Columns 221 Disposables
Minimate™ Tangential Flow Filtration Capsules 181 Packing Systems See Capsules
Resolute™ Slurry Packing Systems 223 Downstream Processing Systems
Cassette Holders Skids
Polypropylene PK Chromatography Skids 225
PK Chromatography Skids 225 Systems 195, 261
Centrasette™ P 189 Starter Kits
Polyethylene Mustang® Membrane Drivers for Palltronic® Filter Integrity
Centramate™ PE 189 Chromatography Starter Kits 211 – 214 Test Instruments 235
Stainless Steel Systems
Centramate™ 189 PK Chromatography Skids 225
Centramate™ LV 189
E
Centrasette™ 189 Clarification E-Series Depth Filter Sheets 25
Maximate™ 189 See Depth Sheet Filters and Modules
See Prefiltration Emflon® CPFR High-temperature
Maxisette™ 189
Sterilizing-grade Filter Cartridges 125
Cassette Membranes Cleaning Cycle Development
Process Development and Optimization 249 Emflon® II Filters 115
Tangential Flow Filtration
Membrane Cassettes 185 – 187 Columns – standard and engineered Emflon® PFA Filter Cartridges 127
Ultrafiltration and Microfiltration Resolute Chromatography Columns 221 Emflon® PFR Junior Style Filter Cartridges 121
Membranes for Cassettes 178
Combined Forward Flow and Bubble Point Test Emflon® PFR Sterilizing-grade Filter Cartridges 123
Palltronic® Flowstar XC Filter Integrity
Emflon® FM Filter Cartridges 73
276 Test Instruments 229
 Index
Endotoxin Contamination – Gamma-irradiatable

Endotoxin Contamination Supracap™ 60 Depth Filter Capsules 31 Polyvinylidenedifluoride (PVDF)

Troubleshooting and Consultancy Services 257 Supradisc™ Depth Filter Modules 27 Fluorodyne® II Hydrophilic PVDF Filter Cartridges 87
Endotoxin Removal Supradisc™ II Modules 29 Kleenpak™ Capsules with Emflon® II
Kleenpak™ Capsules with Posidyne® T-Series Depth Filter Sheets 21 Membrane Assemblies 115
Membrane Assemblies 95 Ultrafiltration and Microfiltration Kleenpak™ Capsules with Fluorodyne® II
Minimate™ Tangential Flow Filtration System 183 Membranes for Cassettes 178 Membrane Assemblies 85
Mustang® Chromatography Capsules Z-Series Depth Filter Sheets 23 Microza Membranes 198 – 202
and Cartridges 217 – 220 Glass Fiber Mini Kleenpak™ Sterilizing-grade
Mustang® Membrane LG Liquid and Gas Coalescing Capsule Filters 77
Chromatography Starter Kits 211 Filter Cartridges 135 Novasip™ Liquid Sterilizing-grade
Posidyne® Filter Cartridges 97 PreFlow™ Capsule Filters 43 Capsule Filters 99
Profile® II Plus Filter Cartridges 53 PreFlow™ Filter Cartridges 65 Sealkleen™ Membrane Filter Cartridges 91
P-Series Depth Filter Sheets 17 Starclear™ Filter Cartridges 57 Ultipor VF Grade DV20 Virus Removal
®

Starclear™ Filter Cartridges 57 Ultipor® GF Plus Air and Gas Filter Cartridges 107
®
Ultipor GF Plus Filter Cartridges 63 Filter Cartridges 129 Ultipor® VF Grade DV50 Virus
Z-Series Depth Filter Sheets 23 Nylon 6,6 Filter Cartridges – SBF Junior Style 105
Kleenpak™ Ultipor® N66 Sterilizing-grade Ultipor® VF Grade DV50 Virus Removal
Engineering Services Capsule Filters 89 Filter Cartridges 109
Process Development and Optimization 249 Novasip™ Liquid Sterilizing-grade Stainless Steel – 304L
Ethanol Filtration Capsule Filters 99 Rigimesh® Sintered Metal Mesh Filter Cartridges 137
Emflon® PFR Sterilizing-grade Filter Cartridges 123 Sealkleen™ Membrane Filter Cartridges 91 Stainless Steel – 316L
Emflon® PFR Junior Style Filter Cartridges 121 Ultipor® N66 Particulate and Bioreduction PMM® Metal Membrane Filter Cartridges 141
Kleenpak™ Capsules with Emflon® PFR Filter Cartridges 75 PSS® Porous Metal Filter Cartridges 139
Membrane Assemblies 117 Ultipor® N66 Sterilizing-grade Filter Cartridges 93 Titania
Nylon – positively charged Membralox® Ceramic Membrane Products 203
Evaluation of Adsorptive Effects
Kleenpak™ Capsules with Posidyne® Zirconia
Process-Specific Filter Validation 241
Membrane Assemblies 95 Membralox Ceramic Membrane Products
®
203
Exhaust Venting Posidyne® Filter Cartridges 97 Filter Selection
See Capsules – gas Polyacrylonitrile Filter Selection 12
See Cartridges – gas Microza Membranes 198 – 202 Pre-Inspection Reviews 253
Extractables Analysis Polyethersulfone – chromatography
Mustang Chromatography Capsules
® Filter System Operation
Disposable Filtration System Validation 245
and Cartridges 217 – 220 Training 251
Kleenpak™ Connector Validation 243
Process-Specific Filter Validation 241 Mustang® Coin Units 215 Filter Validation
Polyethersulfone – filtration Disposable Filtration System Validation 245
Kleenpak™ Capsules with Supor® EKV Filter Integrity Test Equipment Validation 255
F Membrane Assemblies 79 Process-Specific Filter Validation 241
Fermentation Mini Kleenpak™ Sterilizing-grade Training 251
See Cell Culture Capsule Filters 77
Filterability Test Instruments
Sheet TFF Membranes 207
Filter Aid Removal Palltronic® Filter Manager 237
Supor® EBV Sterilizing-grade Filter Cartridges 83
Depth Sheet Filters and Modules 13 – 34 Supor® EKV Sterilizing-grade Filter Cartridges 81 Filtration Principles
DGM Plate and Frame Filter Systems 263 Ultrafiltration and Microfiltration Training 251
Filter Configurations and Dimensions 273 Membranes for Cassettes 178 Filtration System Enhancements
Polyethylene Troubleshooting and Consultancy Services 257
Filter Housings 143
Marksman™ Elements with Nexis® A
Filter Integrity Test Equipment Validation 255 Series Filters 67 Flat Sheet Tangential Flow Filtration
Polyolefin Membranes
Filter Integrity Test Instruments
Microza Membranes 198 – 202 Sheet Tangential Flow Filtration Membranes 207
Flow Measurement
Palltronic® Flow Check Device 233 Polypropylene Flow Measurement
Palltronic® Aquawit XC System 231 HDC II Filter Cartridges
®
61 Palltronic® Flow Check Device 233
Palltronic® Flowstar XC Filter Integrity 229 HDC® II Gas Filter Cartridges 131
Fluorodyne® II Capsules
Test Instruments HDC® II Junior Style Filter Cartridges 49
Kleenpak™ Capsules with Fluorodyne® II
Process Automization Kleenpak™ Capsules with HDC® II
Membrane Assemblies 85
Drivers for Palltronic® Filter Integrity Filter Assemblies 47
Mini Kleenpak™ Sterilizing-grade
Test Instruments 235 Kleenpak™ Capsules with HDC® II
Capsule Filters 77
Remote Control Gas Filter Assemblies 119
Fluorodyne® II Hydrophilic PVDF
Drivers for Palltronic® Filter Integrity Marksman™ Elements with Nexis® A
Filter Cartridges 87
Test Instruments 235 Series Filters 67
Validation Marksman™ Elements with Polyfine® II Formulation and Filling 8
Filter Integrity Test Equipment Validation 255 Series Filters 71 Forward Flow Test
Marksman™ Elements with Polyfine® XLD Palltronic® Aquawit XC System 231
Filter Integrity Test Methodology Series Filters 69
Troubleshooting and Consultancy Services 257 Palltronic® Flowstar XC Filter Integrity
Mini Profile® Capsule Filters 45 Test Instruments 229
Filter Integrity Tests Profile® Filter Cartridges with Ultipleat®
Disposable Filtration System Validation 245 Construction 59 Fractionation
Palltronic® Training Program 234 Profile® II Filter Cartridges 51 Blood Products and Fractionation 4
Pre-Inspection Reviews 253 Profile® II Plus Filter Cartridges 53 Freeze-dryer Vacuum Break Filters
Process-Specific Filter Validation 241 Profile® Star Filter Cartridges 55 Air and Gas Filtration 111 – 142
Training 251 Polypropylene and Polyethylene
Marksman™ Elements with Nexis® A
Filter Media G
Series Filters 67
Activated Carbon
Polypropylene and Positively-charged Gamma-irradiatable
Supracap™ 200 Encapsulated
Glass Fiber Disposable Systems 37
Depth Filter Modules 33
Starclear™ Filter Cartridges 57 Kleenpak™ Capsules with Emflon® II
Supracap™ 60 Depth Filter Capsules 31
Polysulfone Membrane Assemblies 115
Supradisc™ Depth Filter Modules 27
Microza Membranes 198 – 202 Kleenpak™ Capsules with Fluorodyne® II
Alumina
Polytetrafluoroethylene (PTFE) Membrane Assemblies 85
Membralox® Ceramic Membrane Products 203
Emflon® CPFR High-temperature Kleenpak™ Capsules with Posidyne®
Bonded Glass Fiber – positive Zeta
Sterilizing-grade Filter Cartridges 125 Membrane Assemblies 95
Ultipor® GF Plus Filter Cartridges 63
Emflon® PFA Filter Cartridges 127 Kleenpak™ Capsules with Supor® EKV
Cellulose
Emflon® PFR Junior Style Filter Cartridges 121 Membrane Assemblies 79
BioSeries Depth Filter Sheets 15
Emflon® PFR Sterilizing-grade Filter Cartridges 123 Kleenpak™ Connectors 39
E-Series Depth Filter Sheets 25
Emflon® FM Filter Cartridges 73 Kleenpak™ Nova Particulate and Prefilter
K-Series Depth Filter Sheets 19
Kleenpak™ Capsules with Emflon® PFR Capsule Filters 41
Pallcell® Air and Gas Filter Cartridges 133
Membrane Assemblies 117 Kleenpak™ Nova Sterilizing-grade and 101
P-Series Depth Filter Sheets 17
Novasip™ Capsules with Emflon® PFR Virus Removal Capsule Filters
Supracap™ 200 Encapsulated
Membrane Assembles 113 Kleenpak™ Ultipor® N66 Sterilizing-grade
Depth Filter Modules 33
Pallsep™ Vibrating Membrane Capsule Filters 89
277
Filtration Technology 205
 Index
Gamma-irradiatable – Low-volume Parenterals

Mini Kleenpak™ Sterilizing-grade Perfluoroalkoxy (PFA) Installation Qualification

Capsule Filters 77 Megaplast™ Plastic Filter Housings 173 Integrity Test Instruments
Novasip™ DV20 and V50 Virus Removal Plastic Housings Filter Integrity Test Equipment Validation 255
Filter Capsules 103 Megaplast™ Plastic Filter Housings 173 Systems
Gas and Liquid Filtration – housings PCY Polypropylene Filter Housings 171 Pall Process Engineered Systems 261
Junior B series Filter Housings 145 Polypropylene
Megaplast™ Plastic Filter Housings 173 Instrument Air – filtration of
Pall Advanta™ In-Line Liquid and Gas Emflon® PFA Filter Cartridges 127
Filter Housings 155 Polyvinylidine
Pall Advanta™ Jacketed Housings 157 Megaplast™ Plastic Filter Housings 173 Integrity Test Data
Pall Advanta™ Junior F Gas Filter Housings 152 Sanitary Depth Filter Module Housing Process-Specific Filter Validation 241
Pall Advanta™ Junior Gas Filter Housings 150 Veladisc™ Module Housings 165
Integrity Test Equipment Validation
Sealkleen™ Filter Housings 147 Sanitary Housings
Filter Integrity Test Equipment Validation 255
Junior B Series Filter Housings 145
Gas Filtration Pall Advanta™ AGT Gas Filter Housings 159 Integrity Test Instruments 227 – 236
See Air, Gas, and Vent Filtration Pall Advanta™ ALT Liquid Filter Housings 153 See also Filter Integrity Test Instruments
Gene Therapy Pall Advanta™ ALT4 Multi-round Housings 163 and Filter Integrity Tests
See Cell Culture Pall Advanta™ AVL Liquid and Integrity Test Methodology
Gas Filter Housings 161 Troubleshooting and Consultancy Services 257
GMP Requirements
Pall Advanta™ In-Line Liquid and
Pall Process Engineered Systems 261 IOL and IDL Single-round Industrial Housings 169
Gas Filter Housings 155
Pall Advanta™ Jacketed Housings 157 Ion Exchange
H Pall Advanta™ Junior F Liquid Filter Housings 151 Mustang® Chromatography Capsules
Pall Advanta™ Junior Filter Housings 149 and Cartridges 217 – 220
Hastelloy*
Sealkleen™ Filter Housings 147 Mustang® Coin Units 215
PEF Multi Purpose Processor 267
Sanitary Housings – accessories Mustang® Membrane
ZHF Centrifugal Discharge Filter Systems 265
Pall Advanta™ Electrical Trace Heaters 167 Chromatography Starter Kits 211 – 214
Haze and Colloid Particle Removal Small-scale Production Resolute Chromatography Columns 225
Profile® II Plus Filter Cartridges 53 Junior B Series Filter Housings 145 Resolute Slurry Packing Systems 223
Starclear™ Filter Cartridges 57 Pall Advanta™ Junior F Gas Filter Housings 152
Ultipor® GF Plus Filter Cartridges 63 IQ
Pall Advanta™ Junior Filter Housings 149
See Installation Qualification
HDC II Filter Cartridges
®
61 Pall Advanta™ Junior Gas Filter Housings 150
Sealkleen™ Filter Housings 147
HDC® II Filters Stainless Steel J
Kleenpak™ Capsules with HDC® II IOL and IDL Single-round Industrial Housings 169
Filter Assemblies 47 Junior B Series Filter Housings 145
Junior B Series Filter Housings 145
Kleenpak™ Capsules with HDC® II MDS Junior Style Industrial Housings 168 Junior Style
Gas Filter Assemblies 119 Pall Advanta™ AGT Gas Filter Housings 159 Cartridges
HDC® II Gas Filter Cartridges 131 Pall Advanta™ ALT Liquid Filter Housings 153 Emflon® PFR Junior Style Filter Cartridges 121
Pall Advanta™ ALT4 Multi-round Housings 163 HDC® II Junior Style Filter Cartridges 49
HDC® II Junior Style Filter Cartridges 49 Sealkleen™ Membrane Filter Cartridges 91
Pall Advanta™ AVL Liquid and
HEPA-quality Air and Gas Filtration Gas Filter Housings 161 Ultipor® VF Grade DV50
Kleenpak™ Capsules with HDC® II Pall Advanta™ In-Line Liquid and Virus Filter Cartridges – SBF Junior Style 105
Filter Assemblies 47 Gas Filter Housings 155 Housings
High Cell Concentration Pall Advanta™ Jacketed Housings 157 See Housings – junior style
Pallsep™ Vibrating Membrane Filtration Pall Advanta™ Junior F Gas Filter Housings 151
Technology 205 Pall Advanta™ Junior Filter Housings 149 K
Sealkleen™ Filter Housings 147
High-temperature Use Veladisc™ Module Housings 165 Kleenpak™ Capsules with Emflon® II
See Cartridges – high-temperature T-flow Membrane Assemblies 115
Holders IOL and IDL Single-round Industrial Housings 169 Kleenpak™ Capsules with Emflon® PFR
See Cassette Holders MDS Junior Style Industrial Housings 168 Membrane Assemblies 117
Megaplast™ Plastic Filter Housings 173
Hollow Fiber Kleenpak™ Capsules with Fluorodyne® II
Pall Advanta™ AGT Gas Filter Housings 159
Microza Membranes 198 – 202 Membrane Assemblies 85
Pall Advanta™ ALT Liquid Filter Housings 153
TFF Polymeric Hollow Fiber Membranes
Pall Advanta™ ALT4 Multi-round Housings 163 Kleenpak™ Capsules with HDC® II Gas Filter
and Ceramic Modules 197
Pall Advanta™ Junior F Gas Filter Housings 151 Assemblies 119
Hot Water Tank Vent Trace Heaters Pall Advanta™ Junior Filter Housings 149
Kleenpak™ Capsules with Posidyne®
Pall Advanta™ Electrical Trace Heaters 167 PCY Polypropylene Filter Housings 171
Membrane Assemblies 95
Hot WFI Vents Veladisc™ Module Housings 165
Kleenpak™ Capsules with Supor® EKV
Emflon® CPFR High-temperature Hydrophobic Filters
Membrane Assemblies 79
Sterilizing-grade Filter Cartridges 125 Emflon® CPFR High-temperature
Sterilizing-grade Filter Cartridges 125 Kleenpak™ Connector Validation 243
Housings
Industrial Housings Emflon® PFA Filter Cartridges 127 Kleenpak™ Connectors 39
IOL and IDL Single-round Industrial Housings 169 Emflon® PFR Junior Style Filter Cartridges 121
Emflon® PFR Sterilizing-grade Filter Cartridges 123 Kleenpak™ Nova Particulate and Prefilter
MDS Junior Style Industrial Housings 168 Capsule Filters 41
In-line Emflon® FM Filter Cartridges 73
Junior B series Filter Housings 145 HDC® II Gas Filter Cartridges 131 Kleenpak™ Nova Sterilizing-grade and 101
Pall Advanta™ In-Line Liquid and Kleenpak™ Capsules with Emflon® II Virus Removal Capsule Filters
Gas Filter Housings 155 Membrane Assemblies 115 Kleenpak™ Ultipor® N66 Sterilizing-grade
Pall Advanta™ Jacketed Housings 157 Kleenpak™ Capsules with Emflon® PFR Capsule Filters 89
Pall Advanta™ Junior Filter Housings 149 Membrane Assemblies 117
Novasip™ Capsules with Emflon® PFR K-Series Depth Filter Sheets 19
Sealkleen™ Filter Housings 147
Jacketed Membrane Assembles 113
Pall Advanta™ Jacketed Housings 157 Hydrophobic Filters – integrity testing L
Junior Style Palltronic® Aquawit XC System 231 Large Process Volumes
Junior B Series Filter Housings 145 Palltronic® Flowstar XC Filter Integrity Tangential Flow Filtration
MDS Junior Style Industrial Housings 168 Test Instruments 229 Membrane Cassettes 185 – 187
Pall Advanta™ Junior Filter Housings 149
Sealkleen™ Filter Housings 147 L-flow Housings
L-flow I See Housings – L-flow
Junior B Series Filter Housings 145 In-line Housings LG Liquid and Gas Coalescing Filter Cartridges 135
Pall Advanta™ AVL Liquid and See Housings – in-line
Gas Filter Housings 161 Liquid Direct Flow Filtration
Inoculum Transfer See Direct Flow Liquid Filtration
Kleenpak™ Connectors 39
Low-volume Parenterals
Inspections Ultipor® N66 Sterilizing-grade Filter Cartridges 93
Pre-Inspection Reviews 253
278 Process Development and Optimization 249
 Index
Lyophilizers – Pre-reverse Osmosis Filtration

Lyophilizers – sterile venting Mycoplasma Removal Pallsep™ Vibrating Membrane

Emflon® CPFR High-temperature Fluorodyne® II Hydrophilic PVDF Filtration Technology 205
Sterilizing-grade Filter Cartridges 125 Filter Cartridges 87 Palltronic® Aquawit XC System 231
Emflon® PFR Filters and Sealkleen Ultipor® N66 Sterilizing-grade Filter Cartridges 93
Cartridges with Emflon® PFR Membrane Palltronic® Flow Check Device 233
Mycoplasma Retention Studies
Emflon® PFR Junior Style Filter Cartridges 121 Process-Specific Filter Validation 241 Palltronic® Flowstar XC Filter Integrity
Emflon® PFR Sterilizing-grade Filter Cartridges 123 Test Instruments 229
Kleenpak™ Capsules with Emflon® PFR
N Palltronic® Instruments 227 – 238
Membrane Assemblies 117
Nanofiltration Palltronic® Training Program 234
Lysates
Profile® II Filter Cartridges 51 Water Systems 269 PAN
Profile® Star Filter Cartridges 55 Novasip™ DV20 and V50 Virus See Filter Media – polyacrylonitrile
Tangential Flow Filtration 175 – 208 Removal Filter Capsules 103 Parenterals – filtration of
Novasip™ Capsules with Emflon® PFR Formulation and Filling 8
M Membrane Assembles 113 Particle Removal
Mammalian Cell Culture Perfusion Novasip™ Liquid Sterilizing-grade See Capsules and Cartridges – prefiltration
Microza Membranes 198 – 202 Capsule Filters 99 Particulate Analysis
Marksman™ Elements with Nexis A ® Contamination Analysis 247
Series Filters 67 O PCY Polypropylene Filter Housings 171
Marksman™ Elements with Poly-fine® II Oil Droplet Removal PEF Multi Purpose Processor 267
Series Filters 71 LG Liquid and Gas Coalescing Filter Cartridges 135 Perfluoroalkoxy (PFA)
Marksman™ Elements with Poly-fine® XLD Oleophobic Filters Megaplast™ Plastic Filter Housings 173
Series Filters 69 LG Liquid and Gas Coalescing Filter Cartridges 135 Performance Qualification
MDS Junior Style Industrial Housings 168 Operating Procedures Filter Integrity Test Equipment Validation 255
Media and Buffer Sterile Filtration Pre-Inspection Reviews 253 PES
Fluorodyne® II Hydrophilic PVDF Filter Cartridges 87 Operational Qualification See Filter Media – polyethersulfone
Kleenpak™ Capsules with Fluorodyne® II Filter Integrity Test Equipment Validation 255
Membrane Assemblies 85 PFA
Kleenpak™ Capsules with Supor® EKV Operator Training See Filter Media – perfluoroalkoxy (PFA)
Membrane Assemblies 79 Pall Process Engineered Systems 261 Pilot and Process Development Capabilities 194
Kleenpak™ Nova Sterilizing-grade and 101 Training 251
PK Chromatography Skids 225
Virus Removal Capsule Filters Ophthalmics
Supor® EKV Sterilizing-grade Filter Cartridges 81 Fluorodyne® II Hydrophilic PVDF Plant Filtration Surveys
Filter Cartridges 87 Troubleshooting and Consultancy Services 257
Megaplast™ Plastic Filter Housings 173
Kleenpak™ Capsules with Fluorodyne® II Plasma Derivatives – virus filtration
Melt-blown Depth Filter Elements Membrane Assemblies 85 Ultipor® VF Grade DV20
Marksman™ Elements with Nexis® A Kleenpak™ Capsules with Supor® EKV Virus Removal Filter Cartridges 107
Series Filters 67 Membrane Assemblies 79 Ultipor® VF Grade DV50
Membralox Ceramic Membrane Products
®
203 Kleenpak™ Nova Sterilizing-grade and 101 Virus Filter Cartridges – SBF Junior Style 105
Virus Removal Capsule Filters Ultipor® VF Grade DV50
Membrane Selection
Mini Kleenpak™ Sterilizing-grade Virus Removal Filter Cartridges 109
Process Development and Optimization 249
Capsule Filters 77
Matching Membrane Cassettes Plasma Fractionation
Profile® II Filter Cartridges 51
to Applications 180 Blood Products and Fractionation 4
Profile® Star Filter Cartridges 55
Membranes – ceramic Supor® EBV Sterilizing-grade Filter Cartridges 83 PLC
Membralox® Ceramic Membrane Products 203 Supor® EKV Sterilizing-grade Filter Cartridges 81 Drivers for Palltronic® Filter Integrity
Test Instruments 235
Membranes – vibrating Optimization
Pallsep™ Vibrating Membrane Filtration Process Development and Optimization 249 PMM® Metal Membrane Filter Cartridges 141
Technology 205 OQ Posidyne® Capsules
Microbial Retention Studies See Operational Qualification Kleenpak™ Capsules with Posidyne®
Process-Specific Filter Validation 241 Membrane Assemblies 95
Ordering Information
Microbiological Studies Posidyne® Filter Cartridges 97
Organic Solvents – filtration of
Contamination Analysis 247 Emflon® FM Filter Cartridges 73 Positive Zeta Potential
Microza Membranes 198 – 202 Kleenpak™ Capsules with Posidyne®
O-rings
Membrane Assemblies 95
Mini Kleenpak™ Sterilizing-grade O-ring and Gasket Reference Guide 275
Posidyne® Filter Cartridges 97
Capsule Filters 77 Profile® II Plus Filter Cartridges 53
Mini Profile® Capsule Filters 45 P Starclear™ Filter Cartridges 57
Ultipor® GF Plus Filter Cartridges 63
Minimate™ Tangential Flow Filtration Capsules 181 Packing Systems – chromatography
Z-Series Depth Filter Sheets 23
Resolute Slurry Packing Systems 223
Minimate™ Tangential Flow Filtration System 183 PQ
Pall Advanta™ AGT Gas Filter Housings 159
Mixing See Performance Qualification
PEF Multi Purpose Processor 267 Pall Advanta™ ALT Liquid Filter Housings 153
Prefilters – liquid
Modules Pall Advanta™ ALT4 Multi-round Housings 163 See Capsules – prefilters, liquid
Depth Filter Pall Advanta™ AVL Liquid and See Cartridges – prefilters, liquid
Supracap™ 60 Depth Filter Capsules 31 Gas Filter Housings 161 See Depth Sheet Filters and Modules
Supradisc™ Depth Filter Modules 27 Prefilters – air, gas, and vent
Supradisc™ II Modules 29 Pall Advanta™ Electrical Trace Heaters 167
See Capsules – prefilters, air, gas and vent
Selection Pall Advanta™ In-Line Liquid and Gas See Cartridges – prefilters, air, gas and vent
Process Development and Optimization 249 Filter Housings 155
PreFlow™ Capsule Filters 43
Mustang® Chromatography Pall Advanta™ Jacketed Housings 157
Capsules and Cartridges 217 – 220 PreFlow™ Filter Cartridges 65
Pall Advanta™ Junior F Gas Filter Housings 152
Mustang® Coin Units 215 Pre-Inspection Reviews 253
Pall Advanta™ Junior F Liquid Filter Housings 151
Mustang® Membrane Pre-reverse Osmosis Filtration
Pall Advanta™ Junior Filter Housings 149 Marksman™ Elements with Nexis® A
Chromatography Starter Kits 211 – 214
Pall Advanta™ Junior Gas Filter Housings 150 Series Filters 67
Mycel Separation Marksman™ Elements with Poly-fine® II
Membralox® Ceramic Membrane Products 203 Pall Process Engineered Systems 261
Series Filters 71
Pall Technical Services 239 – 258
Pallcell® Air and Gas Filter Cartridges 133

279
 Index
Pre-reverse Osmosis Filtration – Tangential Flow Filtration

R
Marksman™ Elements with Poly-fine® XLD Reaction Spare Parts Provision
Series Filters 69 PEF Multi Purpose Processor 267 Pall Process Engineered Systems 261
Press System Regulatory Approval Starclear™ Filter Cartridges 57
DGM Plate and Frame Filter Systems 263 See Validation Steam Service
Pretreatment for Water Regulatory Inspections PMM® Metal Membrane Filter Cartridges 141
Water Systems 269 Pre-Inspection Reviews 253 PSS® Porous Metal Filter Cartridges 139
Prion Removal Regulatory Requirements Rigimesh® Sintered Metal Mesh
Mustang® Chromatography Capsules Training 251 Filter Cartridges 137
and Cartridges 217 – 220 Removal of Activated Carbon Steaming Process Validation
Virus Filters 103 – 110 See Activated Carbon Removal and Recovery Troubleshooting and Consultancy Services 257
P-Series Depth Filter Sheets 17 Removal of Catalysts Steam-in-place Procedures
Process Automation See Catalyst Fines – removal Troubleshooting and Consultancy Services 257
Drivers for Palltronic® Filter Integrity Removal of Filter Aids Sterile Filtration – air, gas, and vent
Test Instruments 235 See Filter Aid Removal Liquid Challenge
Pall Process Engineered Systems 261 Emflon® CPFR High-temperature
Removal of Mammalian Cells Sterilizing-grade Filter Cartridges 125
Process Chromatography 209 – 226 See Cell Culture Emflon® PFR Junior Style Filter Cartridges 121
Process Development and Optimization 249 Resolute Chromatography Columns 221 Kleenpak™ Capsules with Emflon® II
Membrane Assemblies 115
Process Modeling Resolute Slurry Packing Systems 223
Kleenpak™ Capsules with Emflon® PFR
Process Development and Optimization 249 Retention Studies Membrane Assemblies 117
Process Purification Process-Specific Filter Validation 241 Novasip™ Capsules with Emflon® PFR
Chromatography 209 – 226 Reverse Osmosis Membrane Assembles 113
Process Scale-up Water Systems 269 Sterile Filtration – liquid
Troubleshooting and Consultancy Services 257 Rigimesh® Sintered Metal Mesh Fluorodyne® II Hydrophilic PVDF Filter Cartridges 87
Process Simulation Filter Cartridges 137 Kleenpak™ Capsules with Fluorodyne® II
Palltronic® Filter Manager 237 Membrane Assemblies 85
Risk Analysis Kleenpak™ Capsules with Posidyne®
Process System Design Pall Process Engineered Systems 261 Membrane Assemblies 95
Pall Process Engineered Systems 261 Kleenpak™ Capsules with Supor® EKV
Process Troubleshooting S Membrane Assemblies 79
Process Development and Optimization 249 Kleenpak™ Nova Sterilizing-grade and 101
Sampling Virus Removal Capsule Filters
Process-Specific Filter Validation 241 Kleenpak™ Connectors 39 Kleenpak™ Ultipor® N66 Sterilizing-grade
Product Activity after Purification Sanitizing Agents Capsule Filters 89
Troubleshooting and Consultancy Services 257 See Acids – filtration of Mini Kleenpak™ Sterilizing-grade
Product Certification See Bases – filtration of Capsule Filters 77
Pre-Inspection Reviews 253 Novasip™ Liquid Sterilizing-grade
Scale-up
Capsule Filters 99
Product Vessel Venting Troubleshooting and Consultancy Services 257
Posidyne® Filter Cartridges 97
Air and Gas Filtration 111 – 142 Scientific and Laboratory Services Sealkleen™ Membrane Filter Cartridges 91
Product Viability Studies Process Development and Optimization 249 ®
Supor EBV Sterilizing-grade Filter Cartridges 83
Disposable Filtration System Validation 245 Screening
®
Supor EKV Sterilizing-grade Filter Cartridges 81
Process-Specific Filter Validation 241 Mustang® Membrane
®
Ultipor N66 Sterilizing-grade Filter Cartridges 93
Production Temperature Control Chromatography Starter Kits 211 – 214 Sterilization Procedures
Pall Advanta™ Electrical Trace Heaters 167 Palltronic® Filter Manager 237 Pre-Inspection Reviews 253
Profile® Filter Cartridges with Ultipleat® Sealkleen™ Filter Housings 147 Supor® EBV Sterilizing-grade Filter Cartridges 83
Construction 59 Sealkleen™ Membrane Filter Cartridges 91 Supor® EKV Sterilizing-grade Filter Cartridges 81
Profile® II Filter Cartridges 51 Service Contracts Supracap™ 200 Encapsulated
Profile® II Plus Filter Cartridges 53 Pall Process Engineered Systems 261 Depth Filter Modules 33
Profile® Star Filter Cartridges 55 Service Lines – air and gas Supracap™ 60 Depth Filter Capsules 31
Emflon® PFA Filter Cartridges 127
Programmable Logic Controller Supradisc™ Depth Filter Modules 27
Drivers for Palltronic® Filter Integrity Sheet Tangential Flow Filtration Membranes 207
Supradisc™ II Modules 29
Test Instruments 235 Sheets – depth filters
Systems
Project Management BioSeries Depth Filter Sheets 15
Automated Systems
Pall Process Engineered Systems 261 E-Series Depth Filter Sheets 25
Pall Process Engineered Systems 261
K-Series Depth Filter Sheets 19
Protection for Sterile Filter Membranes Centrifugal Discharge Filter Systems
P-Series Depth Filter Sheets 17
See Prefiltration PEF Multi Purpose Processor 267
T-Series Depth Filter Sheets 21
Chromatography
Protein Recovery Z-Series Depth Filter Sheets 23
PK Chromatography Skids 225
Tangential Flow Filtration 175 – 208 Single-use Systems Design
PS Disposable Systems 37 Process Development and Optimization 249
See Filter Media – polysulfone Skids – Chromatography Disposable Systems 37
P-Series Depth Filter Sheets 17 PK Chromatography Skids 225 Fabrication
Pall Process Engineered Systems 261
PSS® Porous Metal Filter Cartridges 139 SLS PEF Multi Purpose Processor 267
PTFE See Scientific and Laboratory Services Plate and Frame Filter Systems
See Filter Media – polytetrafluoroethylene (PTFE) Soiling Tests DGM Plate and Frame Filter Systems 263
Disposable Filtration System Validation 245 Sheet Filters
Purification of Bulk Enzyme Solutions
Kleenpak™ Connector Validation 243 DGM Plate and Frame Filter Systems 263
TFF Polymeric Hollow Fiber Membranes
Tangential Flow Filtration Systems 195
and Ceramic Modules 197 Solvent Filtration for APIs
Validation
PVDF Emflon® FM Filter Cartridges 73
Disposable Filtration System Validation 245
See Filter Media – polyvinylidenedifluoride (PVDF) Marksman™ Elements with Nexis® A
Water Systems 269
Series Filters 67
Pyrogen Removal Marksman™ Elements with Poly-fine® II
See Endotoxin Removal Series Filters 71 T
Marksman™ Elements with Poly-fine® XLD
Tangential Flow Filtration 175 – 208
Q Series Filters 69
Capsules
Profile® Filter Cartridges with Ultipleat®
Qualification Minimate™ Tangential Flow Filtration Capsules 181
Construction 59
See Validation Profile® Star Filter Cartridges 55

280
 Index
Tangential Flow Filtration – Z-Series Depth Filter Sheets

Cassettes and Holders TFF Polymeric Hollow Fiber Membranes and Validation Data
Tangential Flow Filtration Membrane Cassettes 185 Ceramic Modules 197 Pre-Inspection Reviews 253
Tangential Flow Filtration T-flow Housings Veladisc™ Module Housings 165
Membrane Cassette Holders 188 See Housings – T-flow
Cell Harvest and Product Separation Virus Concentration
Tissue Culture Media Capsules
Tangential Flow Filtration Membrane Cassettes 185 Kleenpak™ Capsules with Supor® EKV
Ceramic Modules Minimate™ Tangential Flow Filtration Capsules 181
Membrane Assemblies 79 Cassettes
Membralox® Ceramic Membrane Products 203 Kleenpak™ Nova Sterilizing-grade and 101
High Cell Concentration Pall Tangential Flow Filtration Cassettes 185 – 187
Virus Removal Capsule Filters
Pallsep™ Vibrating Membrane Filtration Mini Kleenpak™ Sterilizing-grade Virus Removal
Technology 205 Capsule Filters 77 Capsules
Hollow Fibers PreFlow™ Filter Cartridges 65 Novasip™ DV20 and DV50 Virus Removal
Microza Membranes 198 – 202 Supor® EBV Sterilizing-grade Filter Cartridges 83 Filter Capsules 103
Lab-scale Systems Supor® EKV Sterilizing-grade Filter Cartridges 81 Cartridges
Minimate™ Tangential Flow Filtration System 183 Ultipor® VF Grade DV50 Virus Removal Ultipor® VF Grade DV20 Virus Removal
Tangential Flow Filtration Technology 194 Filter Cartridges 109 Filter Cartridges 107
Large Process Volumes Ultipor® VF Grade DV50
Tangential Flow Filtration Membrane Cassettes 185 Trademarks Virus Filter Cartridges – SBF Junior Style 105
Membranes – ceramic Legal Warranty and Trademarks 282 Ultipor® VF Grade DV50 Virus Removal
Membralox® Ceramic Membrane Products 203 Troubleshooting and Consultancy Services 257 Filter Cartridges 109
Membranes – hollow fiber
Troubleshooting Processes
Microza Membranes 198 – 202
Process Development and Optimization 249 W
Membranes – sheet
Sheet Tangential Flow Filtration Membranes 207 T-Series Depth Filter Sheets 21 Water Droplet Removal
Membranes – vibrating LG Liquid and Gas Coalescing Filter Cartridges 135
Pallsep™ Vibrating Membrane Filtration
U Water for Injection
Technology 205
Ultipor® GF Plus Air and Gas Filter Cartridges 129 Water Systems 269
Mycel Separation
Membralox® Ceramic Membrane Products 203 Ultipor® GF Plus Filter Cartridges 63 Water Intrusion Test
Pilot Scale Palltronic® Aquawit XC System 231
Centramate™ Cassettes and Holders 185 Ultipor® N66 Particulate and Palltronic® Flowstar XC Filter Integrity
Research and Pilot Studies Bioreduction Filter Cartridges 75 Test Instruments 229
Centramate™ Cassettes and Holders 189 – 193 Ultipor® N66 Sterilizing-grade Filter Cartridges 93 Water Purification
Minimate™ Tangential Flow Filtration Capsules 181 Water Systems 269
Ultipor® VF Grade DV20
Systems
Virus Removal Filter Cartridges 107 Water Storage and Distribution
Pilot and Process Development Capabilities 194
Tangential Flow Filtration Systems 195 Ultipor® VF Grade DV50 Water Systems 269
Virus Filter Cartridges – SBF Junior Style 105 Water Systems 269
Training 251 Ultipor® VF Grade DV50 WFI
Tangential Flow Filtration Membrane Virus Removal Filter Cartridges 109 See Water for Injection
Cassette Holders 189 – 193
Tangential Flow Filtration Systems 195 Ultrafiltration WIT
Matching Membrane Cassettes to Applications 180 See Water Intrusion Test
Tanks – sterile venting Membralox® Ceramic Membrane Products 203
Emflon® CPFR High-temperature Minimate™ Tangential Flow Filtration Capsules 181
Sterilizing-grade Filter Cartridges 125 Sheet Tangential Flow Filtration Membranes 207 Z
Emflon® PFR Junior Style Filter Cartridges 121 Tangential Flow Filtration Membrane ZHF Centrifugal Discharge Filter Systems 265
Emflon® PFR Sterilizing-grade Filter Cartridges 123 Cassette Holders 189 – 193
Kleenpak™ Capsules with Emflon® PFR Z-Series Depth Filter Sheets 23
Tangential Flow Filtration Systems 195
Membrane Assemblies 117 TFF Polymeric Hollow Fiber Membranes
Technical Data and Ceramic Modules 197
Pre-Inspection Reviews 253 Water Systems 269
Technical Training and Services Ultrafiltration and Microfiltration
Analysis and Review Membranes for Cassettes 178
Contamination Analysis 247 UpScale™ Products
Pre-Inspection Reviews 253 Disposable Systems 37
Process Development Kleenpak™ Capsules with Emflon® II
Process Development and Optimization 249 Membrane Assemblies 115
Test Instruments Kleenpak™ Capsules with Fluorodyne® II
Palltronic® Training Program 234 Membrane Assemblies 85
Training Kleenpak™ Capsules with Posidyne®
Palltronic® Training Program 234 Membrane Assemblies 95
Troubleshooting Kleenpak™ Capsules with Supor® EKV
Troubleshooting and Consultancy Services 257 Membrane Assemblies 79
Validation Kleenpak™ Ultipor® N66 Sterilizing-grade
Disposable Filtration System Validation 245 Capsule Filters 89
Filter Integrity Test Equipment Validation 255 Mini Kleenpak™ Sterilizing-grade
Kleenpak™ Connector Validation 243 Capsule Filters 77
Process-Specific Filter Validation 241 Mini Profile® Capsule Filters 45
Temperature Control for Hot Water or Steam ®
Mustang Coin Units 215
Pall Advanta™ Jacketed Housings 157 ®
Mustang Membrane
Chromatography Starter Kits 211 – 214
Test Instruments
PreFlow™ Capsule Filters 43
Filter Integrity Test Instruments
Supracap™ 60 Depth Filter Capsules 31
Palltronic® Aquawit XC System 231
Palltronic® Flowstar XC Filter Integrity
Test Instruments 229 V
Filterability Test Instruments
Vaccines
Palltronic® Filter Manager 237
Tangential Flow Filtration Membrane
Process Automization
Cassette Holders 189
Drivers for Palltronic Filter Integrity
®
Tangential Flow Filtration
Test Instruments 235
Membrane Cassettes 185 – 187
Remote Control
Tangential Flow Filtration Systems 195
Drivers for Palltronic® Filter Integrity
Test Instruments 235 Validation
Verification of Flow for Integrity Test Instruments Aseptic Connectors 243
Palltronic Flow Check Device
®
233 Disposable Filtration System Validation 245
Filter Integrity Test Equipment
Palltronic® Instruments 227 – 236 281
 Trademarks

Trademarks The Following trademarks, also used in this

publication, are the property of the
Pall and are registered trademarks
companies listed below.
of Pall Corporation.
ATTC: American Type Culture Collection
The following trademarks or service marks
used in this publication are the property of C-Flex: Consolidated Polymer
Pall Corporation. Technologies, Inc.

The following are registered trademarks of Easy-Load Cole-Palmer Instrument Co.

Pall Corporation: Flaretek: Entegris, Inc.
Acro Acrodisc Hastelloy: Haynes International, Inc.
Emflon Fluorodyne
L/S Cole-Palmer Instrument Co.
Gaskleen HDC
Membralox Membraplan Luer-Lok: Becton, Dickenson & Company
Mustang Nexis Masterflex: Cole-Palmer Instrument Co.
Nova Pallcell
Palltronic PMM Microza: Asahi Kasei
Poly-Fine Posidyne Nitronic: Armco, Inc.
Profile PSS
Pharmed Saint-Gobain Performance
Rigimesh Supor
Plastics Corp.
Supradur Suporlife
Ultipleat Ultipor Resolute: Euroflow (UK) Ltd.

The following are trademarks of Pall Santoprene: Advanced Elastomer

Corporation: Systems, LP,
an ExxonMobil Chemical Affiliate.
AcroPak Alpha
Centramate Centrasette Stäubli: Stäubli AG
Centrastak Kleenpak Swagelok: Cranford Fitting Company
Marksman Maxim
Maximate Maxisette Tri-Clamp, Tri-Clover: Alfa Laval, Inc.
Megaplast Omega Viton: DuPont Dow Elastomers L.L.C.
Novasip Pall Advanta
Pallsep PreFlow
Pall Corporation’s North American
Regen Sealkleen
Manufacturing, Engineering, Sales and
Starclear Supracap
Marketing Operations have received
Supradisc
ISO 9001 Certification from Lloyd's
The following are service marks of Pall Register Quality Assurance Limited.
Corporation:
ISO 9001 is the most comprehensive
Pall Advanced Separations System standard since only it includes the design
Upscale and development functions as well as
Filtration. Separation. Solution production and installation, the latter
covered in ISO 9002. This complements
© 2005 Pall Corporation extensive ISO 9000 Certifications by the
same registrar for several Pall groups in
Europe. This is independent recognition
that Pall’s quality systems are designed to
meet customer requirements.

282
 International Offices

Argentina Pall Corporation-Argentina

Riobamba 1236. Piso 8 of “C” 1116 Buenos Aires
Tel: 54.1.814.4730, Fax: 54.1.814.4724

Australia Pall Corporation-Australia

Melbourne Office: 1-2 Wandarri Court, Cheltenham VIC 3192
Tel: 61.39.5848100, Fax: 61.39.5846647 E-mail: CustServ_Australia@pall.com
Sydney Office: Unit 2, 11-13 Orion Road, Lane Cove, Sydney, NSW 2066
Tel: 61 02 9424 3000, Fax: 61 02 9420 3388

Austria Pall Austria Filter GmbH

Seeböckgasse 59, 1160 Wien
Tel: 43.1.49192.0, Fax: 43.2.49192.400, E-mail: Bart_groeninckx@pall.com

Belgium Pall Belgium

Leuvensesteenweg 633-unit C, B-1930 Zaventem, Belgium
Tel: 32.2.755.91.74, Fax: 32.2.755.91.70

Canada Pall (Canada) Ltd.

Ontario Office
7205 Millcreek Drive, Mississauga, Ontario L5N 3R3
Tel: 905.542.0330, 800.263.5910 (Canada only)
Fax: 905.542.0331, 800.943.4455 (Canada only)
Quebec Office
2535 De Miniac, Ville St.Laurent, Quebec, H4S 1E5
Tel: 514.332.7255, Alternate Tel: 800-435-6268 (Canada only)
Fax: 514.332.0996, Alternate Fax: 800-808-6268 (Canada only)

China Pall Filter (Beijing) Co., Ltd.

B706-709 Pengrun Building No.26, Xiaoyun Road,
Chaoyang District, Beijing 100016, PR China
Tel: 86.10.8458.4010, Fax: 86.10.8458.4001
3/F Bailing Bldg.
No.1 Zuojiazhuang Qianjie, Chaoyang Dist., Beijing 100028
Tel: 86.10.6464.9156/9157, Fax: 86.10.6464.9139
Changchun Regional Office: Rm.1508, Tonghui Building,
No.60, Tongzhi Street, Changchun 130021
Tel: 86.431.566.8333, Fax: 86.431.563.2856
Guangzhou Regional Office: Rm.C, 8/F, Haiyun Building,
No.308, Binjiang Zhonglu, Haizhu District, Guangzhou 510220
Tel: 86.20.8410.2211, Fax: 86.20.8410.2033
Hong Kong Office: Rm 1407 and 1409,14/F, Tung Ying,
Building 100, Nathan Road, Tsim Sha Tsui, Kowloon, Hong Kong
Tel: 852.2583.9610, Fax: 852.2511.5773
Shanghai Regional Office of Pall China
Room 1008-1014, 10/F, Tower A, City Center of Shanghai,
No.100 Zunyi Road, Changning District, Shanghai 200030
Tel: 86.21.6237.1988. Fax: 86.21.6237.2088

France Pall France

3 rue des Gaudines, BP 5253, 78175 Saint-Germain-en-Laye Cedex, France
Tel: 33.1.30.61.38.00, Fax: 331.30.61.57.08, E-mail: Biopharm-FR@pall.com

Germany Pall GmbH, Geschaftsbereich BioPharmaceuticals

Phillipp-Reis Strasse 6, D-63303 Dreieich
Tel: 49.6103.3070, Fax: 49.6103.34037, E-mail: pugdp@pall.com

India Pall India Pvt. Ltd.

Sahney Kirkwood Compound, 1st Floor
27, Kirol Vidyavihar (West), Mumbai 400086
Tel: 91.22.55995555, Fax: 91.22.55995556

Indonesia Pall Filtration Pte Ltd Indonesia Rep. Office

Menara Imperium 1t, 20, Suite C & D Metropolitan Kuningan, Superblok Kav 1,
J1 H R Rasuna Said, Jakarta 12980
Tel: 62.21.8379.5442/43, Fax: 62.21.8379.2549

Italy Pall Italia s.r.l.

Via G., Bruzzesi 38/40, 20146 Milano, Italia
Tel: 39.0247.7961, Fax: 39.0241.22985, E-mail: Massimo_Golia@Pall.com

Japan Nihon Pall Ltd.

6-8-1, Nishishinjuku, Shinjuku-ku, Tokyo, 163-6017, Japan
Tel: 81.3.6901.5800, Fax: 81.3.5322.2134

283
 International Offices

Korea Pall Korea Limited

Il-dong Building – 4th Floor, 968-5, Daechi-3dong, Gangnamgu, Seoul, 135-736 Korea
Tel: 82.2.560.7833, Fax: 82.2.569.9092

Malaysia Pall (Malaysia) Sdn Bhd, (Penang Branch Office)

B-4-16, Krystal Point, 303, Jalan Sultan Azlan Shah, 11900 Bayan Baru, Penang
Tel: 60.4.642.2648, Fax: 60.4.642.2869
Pall (Malaysia) Sdn Bhd (Johor Bahru Branch Office)
38, Jalan Teratai 8, Taman Johor Jaya, 81100 Johor Bahru
Tel: 60.7.353.8477, Fax: 60.7.355.2095
Pall Malaysia Sdn Bhd
23, Jalan Pengacara U1/48, Temasya Industrial Park, Glenmarie 40150
Shah Alam, Selangar Darul Ehsan
Tel: 60.3.5569.4892, Fax: 60.3.5569.4896

New Zealand 27 Kaimiro Street, PO Box 10 492, Hamilton

Tel: 64.7.957.9510, Fax: 64.7.957.9513

Norway Pall Norge AS

Barbroveien 6, N-3511 Hoenfoss
Tel: 47.32.18.1470, Fax: 47.32.18.1487, E-mail: pall_norge@pall.com

Philippines Pall Filtration Pte Ltd, Philippine Representative Office

Unit 509, 5th Floor, Prestige Tower Cond., Emerald Avenue, Ortigas Center
Pasig City,
Tel: 63.2.6353620, Alternate Tel: 63.916.571.9258, Fax: 63.2.6353560

Poland Pall Poland, Ltd.

ul.Kasprowicza 151 pok.315, 01-949 Warszawa
Tel: 48.22.834.81.86, Fax: 48.22.835.83.83, E-mail: pall_Poland@pall.com

Russia Pall GmbH, Moscow Representative Office

Vyatskaya Street 27, Building 13-14, 127015 Moscow
Tel: 7.095.787.76.14, Fax: 7.095.787.76.15

Singapore Pall Filtration Pte Ltd

17 Changi Business Park Central 1, #06-01/04, Honeywell Building
Singapore, 486073
Email: sgcustomerservice@pall.com
Customer Service Hotline: +65 6388 8688, Tel: +65 6389 6500
Alternate Tel: +65 6388 8688, Fax: +65 6389 6501

South Africa Pall South Africa Pty, Ltd.

33 New Road, Grand Central, Midrand 1685, Johannesburg
Tel: 27.11.266.2300, Fax: 27.11.315.3243

Spain Pall España

Edificio Mendez, C/Isla de Corcega, No.2 Alcobendas, 28100, Madrid, Spain
Tel: 34.91.657.9800, Fax: 34.91.657.9837, E-mail: Mar_Martinez@pall.com

Switzerland Pall (Schweiz) AG

Schaeferweg 16, CH-4057 Basel, Switzerland
Tel: 41.61.638.3900, Fax: 41.61.638.3940, E-mail: infoch@pall.com

Taiwan Taipei Liaison Office

Customer Service Center, 18, Lane 607, Kuang-Fu Rd.Sec 1, Hsin Chu City, Taiwan
Tel: 03.579.8326, Fax: 03.577.9187

Thailand Pall Thailand

Unit 2501 Rasa Tower 25th Floor, Phaholyothin Road, Kwang/Khet Chatuchak,
Bangkok 10900 Thailand
Tel: 66.2.937.1055, Fax: 66.2.937.1066

United Arab Emirates Pall Middle East

PO Box 38124 Dubai,
Tel: 971.4.340.6204, Fax: 971.4.340.6205

United Kingdom Pall Life Science

Europa House, Havant Street, Portsmouth, Hampshire, PO1 3PD
Tel: 44.23.9230.3303, Fax: 44.23.9230.2506, E-mail: BioPharmUK@pall.com

United States Pall Corporation

2200 Northern Boulevard, East Hills, NY 11548
Tel: 516-484-5400, Fax: 516-801-9548, E-mail: BioPharm@pall.com

284

2200 Northern Boulevard
East Hills, New York 11548-1289
+1 800.717.7255 toll free
+1 516.484.5400 phone
+1 516.801.9548 fax
pharmafilter@pall.com e-mail
Europa House, Havant Street
Portsmouth PO1 3PD, United Kingdom
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com e-mail
Pall has the most comprehensive
family of scalable separation products.
Visit us on the web at www.pall.com/biopharmaceutical
Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands,
New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, Spain, South Africa,
Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
 USD 2293

Supor ® UEAV Filter Cartridges

For Extended Service Life and High Flow Rates
Supor UEAV Filter Cartridges
For Extended Service Life and High Flow Rates
High area 0.2 µm filter with bioburden and particle removal capability for extended
service life and high flow rates in biologic fluids, cell culture media and buffers
New and advanced best-process technology,
such as the Pall Supor UEAV range of filters,
is more and more important to meet
expectations.
Pall Supor UEAV filter cartridges incorporate
a new hydrophilic and asymmetric machV
technology polyethersulfone membrane for
superior dirt load capacity for even finest
particles combined with a broad pH
compatibility.
Moreover, the patented Ultipleat® technology,
with a narrow core and mechanically robust
filter configuration, offers maximum membrane
area and extended service life with the most
complex biologic fluids, as well as very short
processing times in case of high-volume
buffers, cell culture media or supernatants.
The amalgamation of new and advanced
design and construction concepts contribute
to significantly higher service life and lower
pressure drops in all kinds of biologic process
applications.
In biotech, blood product, vaccine and buffer
applications, these membrane and design
benefits mean higher yield, higher process
safety, less time, less handling and less cost.
Quality and Bio-Safety (P Grades)
Supor UEAV high flow, long life cartridges
have been specially designed and qualified
for use in applications with buffers, as well as
biologic and biotech fluids. The “P” Certificate
meets and confirms pharmaceutical
requirements on the effluent regarding:
Effluent Quality Tests
• Cleanliness per USP Particulates in
injectables on Fiber-Releasing per 21 CFR
• Non-Pyrogenic per USP Bacterial
Endotoxins (< 0.25 EU/mL)
• Meets total organic carbon (TOC) and
conductivity per USP Purified Water, pH
per USP Sterile Purified Water
• Meets pH-shift per USP Sterile Purified
Water
Biological Tests
• Meets USP biological reactivity, in vivo,
for Class VI 121°C plastics
The quality management system for
manufacturing of Supor UEAV filter cartridges
occurs in an controlled environment and in
conformance with Certified Quality System
ISO 9001.
Each filter is 100% integrity tested and fully
traceable by individual marked lot and serial
number.
 Supor UEAV Filter Cartridges
Technical Specifications

Features Typical Liquid Flow Rates at 20°C (68°F)*

• Ultipleat filter cartridge configuration with crescent-shaped pleat gpm
structure and narrow diameter polypropylene core results in a 0oo 5 10 15
300
higher membrane area within a compact membrane package
4
• Supor machV technology incorporates hydrophilic asymmetric 250
Differential Pressure (mbar)

polyethersulfone membrane

Differential Pressure (psi)

3
• Filters that pass the appropriate Forward Flow test have been 200
shown in laboratory tests to typically provide titer reductions in
excess of 1 x 106 when challenged with aqueous suspensions of 150
2
Brevundimonas diminuta (ATCC 19146)
• Cartridge integrity testable by Forward Flow test 100
1
Benefits 50
• Smaller housings and fewer filter cartridges to be changed out for
given flow and pressure drop requirements 0 0
0oo 10 20 30 40 50 60
• Fewer cartridges or capsules needed to maintain required flow
L/min per 254 mm (10 in.) module
• Additional service life combined with minimum pressure drop when * For fluids at 1 cP viscosity. For other viscosities, divide flow rate by
using the maximum number of filter cartridges per housing viscosity in cP. Determined on unused filters in laboratory testing.

• Exceptionally high flow rates and superior service life for

processing large fluid volumes
• Excellent retention of microorganisms, for superior protection of
final filters and downstream equipment such as tangential flow or
chromatographic systems
• Polyethersulfone filter medium minimizes unspecific adsorption
effects or unwanted enzyme activation as known from certain filter
or fiber materials
• Broad pH compatibility allows the use of polyethersulfone
membrane in a full range of biological fluids and buffers
• Bioburden reduction efficiency for processes with variable
bioburden and critical applications with high flow requirements
• The Forward Flow test allows safe, easy and fast confirmation of
filter integrity after steaming and filtration
Supor UEAV Filter Cartridges
Technical Specifications

Materials of Construction Typical Cumulative Steam Life(1)

Membrane Hydrophilic, asymmetric polyethersulfone 10 hours (1 hour cycles) at 125°C (257°F)
(0.2 µm particulate rating) (1) The steam life and service life data were determined by testing under controlled laboratory
conditions up to the time indicated. Actual operating conditions may affect the filter’s long
Drainage Layers Polypropylene
term resistance to steam sterilization and hot air service. Filters should be qualified for
each process application.
End Cap and Cage Polypropylene

Core Polypropylene

Adapter Polypropylene with internal stainless steel

Maximum Forward Steaming Conditions
reinforcing ring 300 mbard ∆p at 125°C (4.4 psid at 257°F)

Effective Surface Area Maximum Temperature and Differential Pressure(2)

AB1UEAV7PH4 Typically 1.06 m2 (11.4 ft2) Maximum forward differential pressures in compatible fluids are:
AB2UEAV7PH4 Typically 2.12 m2 (22.8 ft2) 5.5 bard at 40°C (80 psid at 104°F)
AB3UEAV7PH4 Typically 3.18 m2 (34.2 ft2) 3.0 bard at 80°C (43 psid at 176°F)
AB4UEAV7PH4 Typically 4.24 m2 (45.6 ft2) (2) In compatible fluids which do not soften, swell, or adversely affect the filter or its materials
of construction.

Typical Extractables per 254 mm (10 inch) module

Forward Flow Integrity Test Values(3)
≤ 50 mg in water at 20°C (68°F) after a 1 hour autoclave cycle and 4 hours
extraction time With water wet cartridges and air as test gas ≤ 50 mL/min at 2060 mbar
(30 psi). Preflush at 5 L/min per module for 10 minutes prior to Forward Flow
testing.
(3) Please contact Pall for multi-element integrity test values.
Values are for one 254 mm (10 inch) filter at 20°C (68°F).

Ordering Information(4)

Pall Part Number: AB UEAV P

Code Nominal Length Code Cartridge Style Code O-ring Material

1 254 mm (10 inch) 2 Double O-ring with bayonet lock and flat end H4 Silicone

2 508 mm (20 inch) 7 Double O-ring with bayonet lock and finned end J EPR

3 762 mm (30 inch)

4 1016 mm (40 inch)

(4) This is a guide to the part number structure only.
For availability of specific options, please contact
Pall or your local Pall distributor.

Pall has the most comprehensive

family of scaleable separation products.
New York - USA
+1 516 484 5400 phone Visit us on the web at www.pall.com/biopharmaceutical
+1 516 801 9548 fax
pharmafilter@pall.com e-mail Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Portsmouth - Europe Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands,
New Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain,
+44 (0)23 9230 3303 phone
Sweden, Switzerland, Taiwan, Thailand, United Kingdom, the United States and Venezuela.
+44 (0)23 9230 2506 fax Distributors are located in all major industrial areas of the world.
BioPharmUK@europe.pall.com e-mail
Because of developments in technology these data or procedures may be subject to change. Consequently we advise
users to review their continuing validity annually. , Pall, Ultipleat and Supor are trade marks of Pall Corporation.
Filtration. Separation. Solution. and UpScale are service marks of Pall Corporation.
Part Numbers quoted above are protected by the Copyright of Pall Europe Limited.
® indicates a trademark registered in the USA.
© 2004, Pall Europe Limited.
09.2004
 PRODUCT NOTE

Q & CM HyperZ™ Ion Exchange Sorbents

High Productivity Expanded Bed Adsorption Chromatography.
• Direct capture from crude, unclarified feedstock.
• Limited dilution required for efficient binding.
™

• Small bead produces more rapid binding and higher capacity.

BIOSEPRA Q & CM HYPERZ

• High density allows operation with higher flow rates and higher biomass loads.
• Outstanding chemical resistance.

Table 1: HyperZ™ Sorbents Main Properties.

Q HyperZ CM HyperZ
Average particle size (µm) 75 75
Nature of ionic groups Quaternary amine (Q) Carboxymethyl (CM)
Ionic capacity (µeq/ml) 100-180 100-180
Particle size distribution 40-105 40-105
Mean particle density 3.2 g/ml 3.2 g/ml
Binding capacity (mg/ml) 80 (BSA)* ~ 50 (hu IgGs)**
Degree of expansion (H/H0) 2 at 300 cm/h 2 at 300 cm/h
Chemical stability Stable in all commonly used aqueous buffers and also 2 M NaOH,
1 M HCl, 20 % ethanol, 6 M guanidine-HCl
Working pH range 4-13 4.13
Cleaning pH 1-14 1-14
Packaging Dry form (2 g ~ 1 ml) Dry form (2 g ~ 1 ml)
Stabilizer contained in the sorbent Glycerol Glycerol
(*) Breakthrough capacity at 10% using 5 mg BSA/ml in 50 mM Tris-HCl buffer, pH 8.6, 150 mM NaCl.
®

(**) Breakthrough capacity at 10% using 5 mg hu IgG/ml in 50 mM sodium acetate buffer, pH 4.7, 150 mM NaCl.

Expanded bed adsorption (EBA) chromatog-
raphy is a technology ideally suited for rapid
processing of large volumes of crude biolog-
ical feedstocks and for the purification of
plasmids, IgG and various recombinant
proteins. Rapid, direct capture of target
proteins by expanded bed adsorption offers
considerable operational benefits:
• Significantly reduces process cycle time by
eliminating post-fermentation clarification,
• Improves product quality and yield,
• Reduces total capture-step costs by 20-40%.
Existing ion exchange sorbents for EBA have
not been designed for optimal productivity
in industrial operations. Protein binding typi-
cally requires significant feedstock dilution,
unacceptably increasing process volumes
and load times. In addition, these sorbents
are incompatible with high biomass loads
(>10% ww/v); exceeding these levels can
only be achieved by a reduction in operat-
ing flow rates, substantially increasing
process cycle duration.
BioSepra® Q and CM HyperZ™ are members
of a new family of high-density sorbents
from Pall®, specifically designed for high
productivity expanded bed chromatography
and efficient capture of biomolecules direct-
ly from crude, unclarified feedstocks in a
single pass operation.

1
 PRODUCT NOTE

Higher biomass and flow rate without Figure 1. Structure of HyperZ sorbents.
sacrificing capacity.
The HyperZ™ product range has been
designed to deliver the broadest useful linear
flow range possible of any commercial
expanded bed sorbents. Due to a high
charge density in its hydrogel moiety, the
CM HyperZ™ sorbent has unique protein
™

binding properties in the presence of salt.

BIOSEPRA Q & CM HYPERZ

This provides significant benefits at process

scale, like avoiding or limiting the dilution
of large volumes of feedstream.

• High density particles: Faster flow rates.

Figure 2 shows the hydrodynamic behavior
of Q and CM HyperZ™ sorbents, and a stan-
Scanning electron micrograph image of HyperZ bead and surface
dard profile for an SP EBA sorbent: ~2 times prior to introduction of the hydrogel.
higher linear flow velocities can be used
with CM HyperZ™ without risk of particle
elutriation. Typically, bed expansions of 2-3
Figure 3). This is of critical importance when
are obtained with HyperZ™ sorbents at lin-
highly concentrated feedstocks need to be
ear velocities of 300 cm/h. Under similar
processed directly.
conditions, conventional EBA sorbents,
which have lower densities and larger parti- Figure 4 shows that linear velocities exceed-
cle sizes, show much higher degrees of bed ing 300 cm/h are obtained at bed expan-
sions of 2-3, even with very high density cell
expansion, leading to a particle elutriation
culture (12 x 106 cells/ml).
or upper frit clogging. 75 µm average parti-
cle size also improves mass transfer as well • Scale up: Use any commercially avail-
as resolution when the sorbent is used in able EBA column and improve produc-
packed bed mode. tivity.
HyperZ sorbents can be easily packed in any
• Higher biomass loads.
®

type of EBA column and offer substantial

CM HyperZ™ can operate in the presence of benefits of bed stability. Figure 5 shows an
high biomass loads while maintaining rea- example of the excellent packing consisten-
sonable (2-3) bed expansion rates (see cy, from 5 cm to 30 cm I.D. commercially
available columns.

Figure 2. Comparison of hydrodynamic behavior in

the presence of 9% glycerol. Figure 3. Bed expansion as a function of biomass.
Bed Expansion

Conventional Conventional
Bed expansion

SP EBA sorbent CM HyperZ EBA sorbent

HyperZ sorbent

Q HyperZ

Linear velocity (cm/h) Biomass (% wet weight)

2
Figure 4. CM HyperZ expansion in the presence of different
mammalian cell concentrations.
Bed expansion
12 x 106 cells/ml
Linear velocity (cm/h)
Column:1 cm I.D., 10 cm settled bed height CM HyperZ sorbent. Sample:
crude high density hybridoma cell culture diluted with equilibration buffer
(50 mM acetate / 5 mM citrate, 75 mM NaCl, pH 4.7).
Figure 5. Scale-up with Q and CM HyperZ sorbents.
Bed Expansion
5 cm I.D. 20 cm I.D.
10 cm I.D. 30 cm I.D.
20 cm settled bed height. Conditions: 50 mM acetate / 5 mM citrate,
pH 4.5 or 50 mM Tris-HCl, pH 8.6.
Maximum flexibility: Packed bed or
Expanded Bed, in any commercially avail-
able column.
Establishing and maintaining a basic purification
process and choice of chromatography sorbents
throughout development, pilot studies and pro-
duction can significantly reduce process re-opti-
mization time and effort during scale-up.
HyperZ™ sorbents provide the ultimate in process
flexibility. With clarified feedstocks, HyperZ™ can
be used in conventional packed bed mode for
process optimization, scale-up and even in very
large-scale production settings. The relatively small
particle size of HyperZ® (75 µm, to be compared
to 200 µm for conventional EBA sorbents) increas-
es efficiency and resolution of the separation when
the sorbent is used in a regular packed bed col-
umn (Figure 6), while still operating at low back-
pressure.
Figure 6. Efficient separation of a mixture of proteins in
packed bed mode using CM HyperZ sorbent.
3 x 106 cells/ml
A280
No cells, acetate buffer
Time (min)
Column: 1.1 cm I.D., 8 cm packed bed height. Sample: 1 ml load (15
mg/ml ovalbumin (A), 3 mg/ml cytochrome c (B) and 5 mg/ml lysozyme
(C)). Conditions: Linear gradient 50 mM acetate, pH 4.5, 0-120 mM NaCl.
Short residence times, high dynamic bind-
ing capacity: Increase throughput.
HyperZ™ are composite sorbents which represent
an extension of the well-known HyperD® family of
enhanced diffusion sorbents. These unique sor-
bents are composed of a high-capacity hydrogel
polymerized within the pores of a rigid inert bead.
The hydrogel moiety has a very high number of
ionic binding sites. Proteins diffuse quickly within
the hydrogel, and are rapidly "captured" by these
Linear velocity (cm/h)
highly accessible charges.
Residence time gives a broad measure of produc-
tivity and sorbent performance, independently of
column geometry. Figure 7 illustrates that short
residence times are needed for protein capture on
CM HyperZ™. Only a modest reduction of the
dynamic binding capacity (DBC) is observed if res-
idence time is decreased from 10 min. to 5 min.,
in contrast to conventional EBA sorbent.
Figure 7. Dynamic capacity vs. residence time.
CM HyperZ
DBC 10% (mg/ml)
Conventional
EBA sorbent
Residence time (min)
Sample: 5 mg/ml hu IgG in 50 mM acetate / 5 mM citrate, 150 mM NaCl,
pH 4.5. Studied performed in packed bed columns.
3
 PRODUCT NOTE

With Q HyperZ™ (data not shown), residence Figure 8. HyperZ sorbent dynamic capacity.
times of 2-5 min. are also sufficient to reach CM HyperZ Q HyperZ
the operation capacity of the sorbent.

DBC hu IgG (mg/ml)

DBC BSA (mg/ml)

As illustrated in Figures 8 and 9, CM HyperZ™
is particularly well suited to direct IgG cap-
ture from crude feedstock: routinely, capaci-
ties from 25 to 60 mg/ml of IgG are
obtained, even in the presence of moderate
™

salt (150 mM NaCl, or conductivity from 14

BIOSEPRA Q & CM HYPERZ

to 19 mS/cm).
With Q HyperZ™, average capacities of 80
mg/ml of BSA are obtained in a Tris pH 8.6 % breakthrough % breakthrough
buffer at 300 cm/h. 1 cm I.D. EBA column, 11 cm settled bed height. Linear velocity:
300 cm/h (2X bed expansion). Equilibration buffer:
- CM HyperZ: 50 mM acetate / 5 mM citrate, 150 mM NaCl, pH
CM HyperZ™: An IgG Capture tool, 4.5. Sample: 5 mg/ml hu IgG.
- Q HyperZ: 50 mM Tris-HCl, pH 8.6. Sample : 5 mg/ml BSA.
with minimal feedstock dilution.
With conventional cation exchange sorbents,
Figure 9. Direct capture of hu IgG in the presence of salt
significant feedstock dilution (2-5 fold) with
using CM HyperZ sorbent.
water or low-salt buffer is required to
achieve reasonable protein binding capacity.

DBC hu IgG (mg/ml)

These dilution steps significantly contribute
to processing time, cost and product quali-
ty. CM HyperZ™ can be used for the direct
harvest of proteins from undiluted or mini-
mally diluted feedstock, resulting in shorter
cycle time and lower cost.
Figure 9 shows the adsorption performance
NaCl concentration (mM)
of CM HyperZ™ for hu IgG measured at pH
4.5 in various salt conditions. Remarkably 1.1 cm I.D. column, 8 cm packed bed height. Equilibration buffer:
50 mM acetate / 5 mM citrate, pH 4.5. Adjusted in NaCl as indi-
high capacities are observed at relatively cated. Linear flow rates: 100 cm/h. Dynamic binding capacities
high salt concentration (> 60 mg/ml with recorded at 10% breakthrough. Sample: 5 mg/ml hu IgG in equili-
bration buffer.
150 mM NaCl).
®

Q HyperZ™ : A new tool for anion
exchange EBA.
Expanded bed anion exchange adsorption
has been used to purify natural and recom-
binant proteins and enzymes from various
sources, including E.coli fermentation,
unclarified crude yeast homogenates, plas-
ma and milk from transgenic animals. The
broad use of EBA anion exchange has been
limited by the fact that animal cells as well
as cell debris of yeast homogenates or DNA
tend to be adsorbed by Q or DEAE function-
al groups, resulting in fouling and decrease
of sorbent capacity. Recent work (EBA 2002
meeting) suggests that special care given to
cell disruption methods could improve the
results.
Increased sorbent life time due to out-
standing chemical resistance.
The HyperZ™ product range is designed for
use in expanded bed operations where
maximal sorbent fouling can occur. Q and
CM HyperZ™ sorbents have been engi-
neered to withstand very harsh clean-in-
place treatments. Long term storage data of
CM HyperZ™ are shown in Figure 10.
Other experiments (data not shown) have
demonstrated that continuous storage of
HyperZ™ in hot solutions of NaOH (1 M at
55°C) for several days does not impact sor-
bent performance. Agents such as 20%
ethanol, 30% isopropanol or mixtures (20%
ethanol/1 M NaOH) or acidic mixtures can
also be used for regeneration and cleaning.

4
Figure 10. CM HyperZ sorbent long-term stability to NaOH. • Application 2. Purification of recombinant
endostatin on CM HyperZ™ after method
optimization on CM ProteinChip® Arrays.
DBC hu IgG (mg/ml)

Courtesy of Dr. Joseph Shiloach, NIDDK, NIH, Bethesda, MD

Days of storage in 2 M NaOH
Capacity at 10% breakthrough hu IgG determined at 100 cm/h in packed
bed columns. Sample: 5 mg/ml hu IgG in 50 mM acetate / 5 mM citrate,
150 mM NaCl, pH 4.5.
(USA)
Figure 11 (upper part) shows a chromatographic
purification of recombinant endostatin from a
crude P. pastoris fermentation extract. The binding
and elution conditions were first optimized on a
CM ProteinChip® Array (data not shown). The "on-
chip" optimized conditions were transferred on a
CM HyperZ™ sorbent : adsorption of endostatin
was done at pH 5.0, and desorption achieved by a
two-step gradient of NaCl (200 and 800 mM).
Linear flow rate was 300 cm/h. Collected fractions

Applications. Figure 11. Capture of endostatin from P. pastoris fermentation broth on CM HyperZ
sorbent and fraction analysis using the ProteinChip® technology.
Typical applications for CM and
Q HyperZ™ sorbents include :
- Direct capture of IgG and IgG
fragments from a variety of
A280

feedstocks.
- Purification of intracellular and
extracellular enzymes.
- Purification of recombinant
proteins from E. coli or yeast fer-
mentation. RC-MS analysis on NP20
ProteinChip® arrays
- Recombinant proteins from
transgenic milk or plant extracts.
- Potential alternative to packed
bed ion exchange sorbents.

• Application 1. Protein cap-

ture in the presence of high
E. coli biomass.
Table 2 shows comparative cap-
ture of lysozyme from E. coli
lysate at 2.5% and up to 11.5%
ww/v concentrations. In con- Table 2: Purification of lysozyme from E. coli lysate.
trast to the conventional EBA CM HyperZ CM HyperZ SP Agarose SP Agarose
sorbent (SP agarose), CM HyperZ™ 11.5% 2.5% 11.5% 2.5%
biomass biomass biomass biomass
tolerates biomass loads up to
11.5%, without significant Loading time (28 CV) 180 min at 83 min at 350 min at 228 min at
120 cm/h 260 cm/h 65 cm/h 100 cm/h
decrease of the linear flow.
Estimated lysozyme
Acceptable bed expansion can
binding capacity (mg/ml) 19 25 11 23
be maintained and process time
Estimated recovery (%) 68 89 62 84
decreased. Recovery >80% and
purity of >65% were achieved in 1 cm I.D. column, 13 cm settled bed height. Equilibration: 50 mM acetate/5mM citrate, 50 mM
NaCl, pH 4.5; Elution: same buffer + 1 M NaCl.
a single pass.

5
 PRODUCT NOTE

were analyzed (lower part of figure) by Figure 12. Purification of mu IgG1 from hybridoma
SELDI-TOF-MS (Surface Enhanced Laser serum-free medium supernatant on CM HyperZ sorbent.
Desorption-Ionization, combined to Time-
of-Flight Mass Spectrometry), using the
ProteinChip® reader. CM HyperZ™ demon-

A280nm

Conductivity (mS/cm)
strated a fast and efficient capture of the
protein, with a 10X concentration factor in
one step.
™
BIOSEPRA Q & CM HYPERZ

• Application 3. Direct Capture of Murine

IgG1 from Hybridoma Cell Culture
Figure 12 shows a typical monoclonal anti-
body purification, without feedstock dilu-
tion. The Mouse monoclonal IgG1 was con-
centrated 30X in a single step, with purity
>85% (GPC) and 95% recovery.

• Application 4. Purification from unclari- Volume (ml)

fied yeast lysate at 20% ww/v biomass

loads.
Courtesy of M. Jahanshahi & A. Lyddiatt, Biochemical
Recovery Group, University of Birmingham (U.K.)
Figure 13 shows the purification of cyto-
1 cm I.D. x 15 cm height column. Equilibration: 50 mM acetate,
pH 4.5, 120 mM NaCl; Flow rate: 300 cm/h (2.5X bed expansion
in presence of cells). Sample: 3 L, undiluted, hybridoma cell culture
supernatant. (1x106 cells/ml) adjusted to pH 4.5. Conductivity:
18 mS/cm. Elution: 50 mM acetate, pH 4.5, 1 M NaCl in expanded
bed mode.

chrome c from unclarified lysates of baker

yeast prepared by wet-milling of cell paste
suspended in buffer. Capacities, flow rates and low elution vol-
The upper part of the figure shows the umes demonstrate excellent performance of
Dynamic Binding Capacity per ml of CM CM HyperZ™ in the presence of very high
HyperZ™ at C/C0=0.1 (C and C0 represent biomass.
the cytochrome c concentration in the efflu-
ent and the feedstock respectively).
®

Figure 13. Effect of linear flow rate on dynamic binding capacity of CM HyperZ sorbent in presence of 20% biomass.
C/C0

Cytochrome C (mg/ml)

400 cm/h, DBC 3.9 mg/ml

300 cm/h, DBC 5.3 mg/ml
250 cm/h, DBC 6.0 mg/ml

Cytochrome C challenge (mg/ml settled adsorbent) Volume (ml)

1 cm I.D. column, 20 cm bed height. Sample: Unclarified yeast lysate. 20% (wet weight) biomass. Cytochrome C represents only 1-2% of
total protein present in sample. Binding: 10 mM Tris-HCl, pH 7.5. Elution: 60 mM NaCl, 50 cm/h in packed bed. > 90% recovery of
bound cytochrome C in all studies. Typical elution volumes: 1.3-1.5 CV. Concentrations of lysates are expressed as the frozen wet weight of
original undisrupted cells, relative to the suspension volume (ww/v). Cytochrome c was quantified by spectrophotometric assay.

6
• Application 5. Purification of a lipase from
Y. lipolytica on Q HyperZ™.
Courtesy of Prof. R.M. Willemot, INSA Toulouse, France.
Figure 14 shows direct capture of a recombinant
lipase from a crude clarified fermentation broth of
Yarrowia lipolytica. Adsortion of the enzyme was
performed at pH 9.0 with diluted sample for
reduction of the ionic strength below 6 mS/cm.
Elution was peformed by use of an NaCl linear
gradient from 0 to 1 M in one hour. Flow rate was
300 cm/h. Collected fractions analyzed both by
SDS-PAGE and RC-MS (Ciphergen Biosystems)
indicate that lipase (# 36kDa) was efficiently cap-
tured on Q HyperZ™ sorbent.

Figure 14. Capture of lipase from Y. lipolytica fermentation broth on Q HyperZ sorbent.

Flowthrough Elution RC-MS Analysis on ProteinChip® Arrays SDS-PAGE Analysis

A280 nm

Lipase

Load

FT
Regeneration Lipase
Wash

Elution
20000 40000 60000 80000

0 40 80 120 160
Time (min) MM Load FT W EL

0.7 ml Q HyperZ packed bed column; Equilibration: 50 mM Tris-HCl , pH 9.0 ; Sample (2 ml) is diluted 3 times; Linear flow rate 300 cm/h; Elution in
50 mM Tris-HCl, 1 M NaCl, pH 9.0 at 150 cm/h; Regeneration: 1 M NaOH.

Large-scale manufacturing, Regulatory and References

Validation support
HyperZ™ sorbents are manufactured at large-scale 1. Trinh, L., et al., Bioseparation 9 (2000) 223.
2. Voute, N., et al., IJBC Vol. 5/1 (2000) 49.
under ISO 9001 at the BioSepra Process Division 3. Voute, N. and Boschetti, E., Bioseparation 8 (1999) 115.
of Pall. Regulatory support documents and plant 4. BioSepra Process Proteomics Product Note LPN PN702-001:
audits are available on request. "Q, S, DEAE, CM Ceramic HyperD® ion exchange sorbents"
(01/2002).

Ordering Information

Product Cat. No. Size

Q HyperZ™ 21012-010 50 g (~25 ml )

21012-020 250 g (~125 ml)
21012-030 1 kg (~500 ml)
21012-040 4 kg (~2 L)
21012-050 10 kg (~5 L)
CM HyperZ™ 21011-010 50 g (~25 ml )
21011-020 250 g (~125 ml)
21011-030 1 kg (~500 ml)
21011-040 4 kg (~2 L)
21011-050 10 kg (~5 L)

2 grams are approximately equivalent to 1 ml.

Custom packaging available on request.

7

2200 Northern Boulevard
East Hills, New York 11548-1289
+1 800.717.7255 toll free
+1 516.484.5400 phone
+1 516.801.9548 fax
pharmafilter@pall.com
Europa House, Havant Street
Portsmouth PO1 3PD, United Kingdom
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com
BioSepra SA
48 avenue des Genottes
95800 Cergy Saint Christophe, France
+33 (0)1 34 20 78 00 phone
+33 (0)1 34 20 78 78 fax
PRODUCT NOTE
About BioSepra® Products & Collaborative
Services
BioSepra process chromatography sorbents are manu-
factured and marketed by Pall Life Sciences. They great-
ly simplify protein purification development and signifi-
cantly improve biopharmaceutical manufacturing pro-
ductivity.
Over the past 25 years, BioSepra® chromatography
products and services have earned an outstanding
reputation for product innovation and technical support.
Our expanded R&D sorbent program, ISO 9001 manu-
facturing plant and HyperCel™ sorbents represent our
latest commitment to the biopharmaceutical industry.
With the acquisition of BioSepra® products and services,
Pall combines chromatography development expertise
with Ciphergen®'s SELDI-based ProteinChip® technology
to set in motion an entirely new approach to protein
purification development.
This single-step, on-chip approach dramatically acceler-
ates and simplifies purification development and analy-
sis. The future of Process Proteomics begins with Pall.
Pall has the most comprehensive
family of scaleable separation products.
Visit us on the web at www.pall.com/biopharmaceutical
These products are for laboratory research use only and are not intended for human
or animal diagnostic, therapeutic, or other clinical uses, unless otherwise stated. The
information contained in this brochure are subject to change without notice.
Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand,
Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
, Pall, BioSepra, HyperZ, Hypercel are registered trademarks of Pall Corporation.
Filtration. Separation. Solution. and UpScale are service marks of Pall Corporation.
ProteinChip is a trademark of Ciphergen Biosystems, Inc.
LPN PN702-003 - 12/2004
8
 PRODUCT NOTE

Q, S, DEAE, CM Ceramic HYPERD®

Ion Exchange Sorbents
• High Dynamic Binding Capacity at high flow rates.
• High-efficiency capture from dilute feedstock.
• Rigid, non-compressible sorbent – easy to pack.
®
BIOSEPRA Ceramic HYPERD

• Easy cleaning with sodium hydroxide.

• Regulatory Support Files (RSF) available.

Improve throughput with Ceramic HYPERD enhanced diffusion

chromatography sorbents.

High productivity from rigid, composite Figure 1. The “Gel-in-a-Shell” Design.

sorbents.
Molecules with Molecules with
Q, S, DEAE, CM Ceramic HYPERD ion opposite charge same charge
exchangers are high capacity sorbents spe- are drawn into the bead as bead are excluded
cially designed for the efficient and scaleable
Protein
purification of biomolecules from a variety of binding sites
feedstocks. Of particular value in process-
scale application, these sorbents are
designed to maintain high dynamic binding
capacity (DBC) under conditions where con-
ventional sorbents display significant capaci-
ty or productivity limitations.

• The "Gel in a Shell" design provides

rapid mass transfer and effective bind-
ing.
®

BIOSEPRA Ceramic HYPERD ion exchangers Ceramic

employ a high-capacity hydrogel polymer-
ized within the gigapores of a rigid ceramic
bead. As shown in Figure 1, this design
combines the desirable characteristics of a
soft, high-capacity hydrogel with the
absolute dimensional stability of a rigid
ceramic bead. Ceramic HYPERD sorbents do
not shrink or swell with changes in pH or
conductivity. Abundant ion exchange sites in
the hydrogel are highly accessible to protein
molecules. Proteins diffuse rapidly within the
hydrogel, facilitating rapid uptake of prod-
uct. This mechanism of mass-transfer –
known as enhanced diffusion – allows the
sorbent to operate free of operational con-
straints typically encountered with conven-
tional macroporous ion exchange sorbents.
backbone
Hydrogel
Ceramic HYPERD sorbents deliver outstanding dynamic capacity
and exceptional dimensional stability. This translates into unsur-
passed productivity.
• Capture product at high linear velocity.
Feedstock can be processed rapidly and effi-
ciently. Dynamic binding capacity with
Ceramic HYPERD ion exchangers is virtually
independent of linear velocity at values typi-
cally used – or sought – in laboratory or
process scale separations. The pronounced
flow-dependent behavior associated with
traditional ion exchangers is not observed.

1
 PRODUCT NOTE

TABLE 1: Ceramic HYPERD Ion Exchangers Main Properties.

Type of Ceramic HYPERD Q S Q S DEAE CM
Grade 20 20 F F F F
Average particle size (µm) ~20 ~20 ~50 ~50 ~50 ~50
Dynamic binding capacity (mg/ml) BSA lysozyme BSA lysozyme BSA IgG
10% breakthrough at 200 cm/h ≥ 85* ≥ 85** ≥ 85* ≥ 75** ≥ 85* ≥ 60***
Amount of ionic groups (µeq/ml) ≥ 250 ≥ 150 ≥ 250 ≥ 150 ≥ 200 250 - 400
Working pH 2-12
®
BIOSEPRA Ceramic HYPERD

Cleaning pH 1-14
Volumes changes due to pH and ionic strength Non compressible
Pressure resistance 20 grade: F grade:
200 bar (3,000 psi) >70 bar (1,000 psi)
* Sample: 5 mg/ml BSA in 50 mM Tris-HCl buffer, pH 8.6.
** Sample: 5 mg/ml lysozyme in 50 mM sodium acetate , pH 4.5.
*** Sample: 5 mg/ml hu IgG in 50 mM sodium acetate, 100 mM NaCl, pH 4.7.

• Efficient harvest from dilute feedstock. TABLE 2. Examples of Volumetric Flow vs.
Using Ceramic HYPERD ion exchange sor- Linear Flow Rate.
bents, higher dynamic binding capacity is Flow rate (ml/min)
obtained with dilute feedstock than with Col. Ø 100 cm/h 300 cm/h 500 cm/h
concentrated feedstock (see Figure 6). This 9 cm 110 320 533
behavior – contrary to that observed with
18 cm 420 1,270 2,120
traditional sorbents – illustrates that these
novel materials operate by a mechanism 30 cm 1,180 3,530 5,880

that is fundamentally distinct from that 45 cm 2,650 7,950 13,250

associated with classical macroporous sor-
bents. In many applications, product can be Figure 2. Pressure vs. Flow rate Curve on Q Ceramic
harvested from dilute feedstock without HYPERD F.
need for preliminary concentration, thereby psi bar
enhancing the productivity of the overall
Pressure

30 2.0
purification scheme. 1.6
20
®

1.2
• Recover product from feedstock of 0.8
moderate ionic strength. 10
0.4
The extraordinarily high ligand density pres-
0 100 200 300 400 500 600
ent within the hydrogel of the CM Ceramic
Flow rate (cm/h)
HYPERD F ion exchange sorbent allows for
effective binding even when product is Column: 9 cm ID x 16 cm; Buffer: 50 mM Tris-HCl, 0.5 M NaCl,
pH 8.6.
present in feedstock of moderate ionic
strength. For example, monoclonal anti-
body has been harvested from feedstock of at pressures up to 70 bar. Since the bead
19 mS conductivity – equivalent to does not deform under fluid flow, the sor-
180 mM salt. Thus, in many applications bent provides linear pressure/flow behavior,
feedstock can be applied without prelimi- and has characteristics well suited to opera-
nary diafiltration or dilution. tion using low-pressure columns and equip-
ment (see Figure 2 and Table 2). For
• Absolute dimensional stability, excellent example, in a pilot-scale column (9 cm ID x
pressure/flow characteristics, easy to 16 cm) operated at 500 cm/h, operating
pack. pressure generated by the sorbent is less
Ceramic HYPERD ion exchangers form very than 2 bar. Equally important, column pack-
stable beds. They do not swell or shrink in ing is accomplished quickly and easily
response to changes in pH, ionic strength owing to the dense nature of the Ceramic
or flow rate. Indeed, the sorbents are stable HYPERD beads.

2
 TABLE 3. Lot-to-lot Consistency of Q Ceramic HYPERD F Sorbents.
Lot No. 1 2 3 4 5 6 7 8 9 10 11
Ionizable groups (µeq/ml) 375 329 314 317 322 342 349 349 329 318 338
Dynamic binding capacity for BSA
(mg/ml), 10% breakthrough:
- at 200 cm/h 105 102 97 118 94 103 102 104 97 115 107
- at 600 cm/h 109 93 89 111 89 92 91 89 89 109 96

• Robust, safe and documented for vali-
dation.
Ceramic HYPERD sorbents are manufactured
in BIOSEPRA S.A. ISO 9001 registered manu-
facturing facility. Extensive experience on
batch-to-batch reproducibility (see Table 3)
guarantees the reliable performance and
supply you need for your process. The sor-
bents can be treated with NaOH for effi-
cient cleaning and sanitization.
Ceramic HYPERD sorbents are used in a num-
ber of registered products, as well as in
many clinical and preclinical trials, in
columns larger than 500 liters. All grades of
BIOSEPRA ion exchange Ceramic HYPERD have
Drug Master Files (DMF) :
- Q/S Ceramic HYPERD 20, F: DMF No. 13241
- DEAE Ceramic HYPERD F: DMF No. 13242
- CM Ceramic HYPERD F: DMF No. 11856
and for numerous chromatography sorbents,
and provides full documentation to support
regulatory validation.
Ceramic HyperD is supplied in 1 M NaCl
containing 20% ethanol / 1.2 mM EDTA. It
is available in a range of package sizes.
Custom packaging to meet specific manu-
facturing requirements is available on request.
The enhanced diffusion concept.
Traditional macroporous ion exchangers
operate on the basis of classical pore diffu-
sion. Pore diffusion is characterized by rap-
idly decreasing binding capacity with
increased flow rate. In contrast, the unique
structure of Ceramic HYPERD supports a
more rapid mechanism of mass transfer,
known as enhanced diffusion. Rapid mass
transfer overcomes classical flow rate
dependence. Since product is bound
throughout the gel-filled pore – not merely
at the interior surface of the pore – total
binding capacity is enhanced.
Binding of protein within the hydrogel is
illustrated by the electron micrograph in
Figure 3. Structure of Ceramic HYPERD Ion Exchange
Sorbents.
Ceramic backbone Gold-labeled albumin
High rigidity
Derivatized hydrogel
High capacity
Figure 3. A cross section through the bead
shows binding of gold-labeled albumin.
Notice that the hydrogel completely fills the
pores within the ceramic shell, and that
gold-labeled albumin – visible as dense
black dots – is distributed homogeneously
throughout the hydrogel.
The hydrogel carries an extraordinarily high
concentration of ion-exchange functional
groups : 150-400 µeq/ml. The average dis-
tance between charged sites on the hydro-
gel is ~20 Å. Thus, a protein molecule with-
in the gel is simultaneously in contact with
a large number of ion exchange sites. It
remains in contact with a similar number of
sites no matter where it moves within the
three-dimensional structure of the hydrogel.
As a result, the protein is energetically
unconstrained and may migrate freely.
Protein diffuses rapidly within the hydrogel
to give a homogeneous distribution, facili-
tating uptake of additional material from
solution. Under binding conditions, strong
attractive electrostatic forces between the

3
 PRODUCT NOTE

Figure 4. Dynamic Binding Capacity vs. Flow rate on highly substituted hydrogel and the protein
Q Ceramic HYPERD F. drive entry of protein into the gel.
The productivity-enhancing operational
100
characteristics that this novel structure and
Dynamic Binding Capacity
(mg/ml) mechanism provides are illustrated below.
75

Go fast without sacrificing capacity :

50
higher loads, better throughput.
®

Ceramic HYPERD ion exchangers deliver high

BIOSEPRA Ceramic HYPERD

25
dynamic binding capacity at high linear
velocity. As shown in Figure 4, there is only
0 100 200 300 400 500 600 700
a modest decline in DBC for BSA as linear
velocity is increased from 50 cm/h to more
Linear velocity (cm/h)
than 650 cm/h. This behavior is further
Column: 6.6 cm ID x 16 cm; BSA (5 mg/ml) in 50 mM Tris-HCl, demonstrated by data in Table 1, compar-
pH 8.6; Dynamic binding capacity at 10% breakthrough.
ing DBC values determined at 200 and
600 cm/h.
For a broad-based measure of productivity,
Figure 5. Binding Capacity vs. Residence Time of Q many process-developers prefer to examine
Ceramic HYPERD F. the influence of residence time on DBC.
This approach allows assessment of sorbent
characteristics without reference to details
Dynamic Binding Capacity
(mg/ml)

125 of column geometry. At a residence time of

100 only 0.4 min, DBC for BSA is over 85 mg/ml
at 10% breakthrough for Q Ceramic HYPERD
75
F. As shown in Figure 5, there is only mod-
50 est reduction in DBC as residence time is
reduced from 3 min to 0.4 min. DBC values
25
ranging from ~85 to 120 mg BSA/ml were
achieved over the range of conditions stud-
0 0.5 1.0 1.5 2.0 2.5 3.0
ied. The inherently high binding capacity of
Time (min) Ceramic HYPERD sorbents permits operation
Dynamic binding capacity at 10% (•) and 50% (n) breakthrough
using columns of moderate volume. By
®

for BSA (0.5 mg/ml) in 50 mM Tris-HCl, pH 8.6. reducing bed volume requirements, buffer
volume requirements may also be reduced.
High flow velocity, short residence time,
reduced bed volume, reduced buffer vol-
Figure 6. Binding Capacity of S Ceramic HYPERD F vs. ume – all of these factors support high pro-
Sample Concentration. ductivity and enhanced process economics.

100
Simplify the process by eliminating
Dynamic Binding Capacity
(mg/ml)

preliminary concentration of dilute

0.5 mg/ml
feedstock.

50
With traditional macroporous sorbents,
10 mg/ml dynamic binding capacity declines if protein
concentration in the feedstock is reduced.
In contrast, Ceramic HYPERD sorbents pro-
vide higher binding capacity with dilute
0 1,000 2,000 3,000
feedstock. This unique behavior is a func-
tion of enhanced diffusion, and arises
Linear velocity (cm/h) because the absolute rate of uptake into the
Column: 0.2 cm ID x 15 cm; Sample: Hu IgG in 50 mM acetate,
sorbent is independent of protein concen-
pH 4.6. tration in the feedstock.

4
This useful behavior is illustrated in Figure 6.
Over a broad range of linear velocity values,
higher DBC is observed for feedstock con-
taining 0.5 mg hu IgG/ml than for that con-
taining 10 mg hu IgG/ml. With Ceramic
HYPERD used for product capture, it is possi-
ble to reduce or eliminate the need for pre-
liminary concentration of feedstock. Indeed,
a column of Ceramic HYPERD can serve as a
device for both concentration and initial
purification of the target protein.
Simplify the process by eliminating pre-
liminary diafiltration or dilution of feed-
stock containing moderate concentra-
tions of salt.
With its highly substituted hydrogel, the
CM Ceramic HYPERD F ion exchange sorbent
binds effectively even in the presence of
moderate concentrations of salt. As shown
in Figure 7, IgG1 was harvested from 31 L of
clarified cell culture supernatant (CCS) using
a 330 ml column of CM Ceramic HYPERD F.
Prior to loading, the pH of the CCS was
adjusted to pH 4.7. Conductivity of the
feedstock was 19 mS/cm, equivalent to
about 180 mM sodium chloride. The con-
centration of IgG in the feedstock was
modest : 150 µg/ml. At a linear velocity of
260 cm/h, loading was accomplished in
112 min, and chromatography was com-
plete in 164 min. Residence time was only
1 min. Isolated IgG was >90% pure.
Eliminating the need for preliminary diafil-
tration or dilution will simplify the process
and enhance productivity of the scheme.
Achieve high flow velocities using
standard chromatography equipment.
The rigid ceramic skeleton of Ceramic
HYPERD F allows work at high linear veloci-
ties (typically over 300 cm/h) with low or
moderate backpressures (typically less than
3 bar) without compression or shrinkage.
Standard low pressure chromatography
pumps and columns can be used, contribut-
ing to overall process economy. Figure 2
shows pressure vs. flow rates curves for
Q Ceramic HYPERD F, and Table 2 gives
examples of volumetric flow rates of
different column diameters.
5
Figure 7. One-step Capture of Mouse IgG1 from CCS
on CM Ceramic HYPERD F.
IgG1
NaOH
Elution
O.D.
U.V.
I.S.
Time (min)
IgG1 purity: 90%; Column: 9 cm ID x 5.2 cm (330 ml); Load: 31 L
CCS 100-150 µg/ml adjusted to pH 4.7; Equilibration and post-
load wash: 50 mM sodium acetate, 0.1 M NaCl, pH 4.7; Elution:
same buffer + 1.5 M NaCl; Duration: 164 min; Residence time:
1 min; Linear velocity: 260 cm/h.
Stability and Cleaning.
• Chemical stability.
Ceramic HYPERD F ion exchangers can be
easily sanitized using NaOH (i.e. 5 column
volumes of 0.5 M NaOH for 1 hour contact
time at room temperature). Data from
Regulatory Support Files demonstrate long
term resistance (over 200 cycles) and no
significant modification of the sorbent per-
formance of Ceramic HYPERD F.
Other chemical agents such as 20%
ethanol/1 M acetic acid mixtures can also
be used for cleaning in place (for other
chemical agents, contact our Technical
Service).
• Thermal stability.
The cation exchange Ceramic HYPERD sor-
bents are stable over a wide range of tem-
peratures. They can be autoclaved (121°C
for 20 min). Caution needs to be taken with
the anion exchangers however, due to the
progressive degradation of the tertiary and
quaternary amine groups.
Regulatory and Validation Support.
Ceramic HYPERD ion exchange sorbents are
manufactured under ISO 9001. They are
available in a 20µm grade (“20”) for pilot
scale and polishing applications and a 50µm
grade (“F”) for full scale production.
Regulatory support can be provided to
customers to help qualify the material and
 PRODUCT NOTE

the chromatographic purification in Applications.

regulated processes.
Ceramic HYPERD F sorbents are fully validat-
ed products, presently used in the clinical
production of several biopharmaceuticals,
including full scale manufacturing of FDA-
registered products.
An example of the typical batch-to-batch
®
Ceramic HYPERD F sorbents are ideally suited
for purification of biomolecules in research,
scale-up and full-scale pharmaceutical man-
ufacturing.
The Ceramic HYPERD 20 particle size is
more adapted for polishing steps or rapid
separations when a higher resolution is

consistency of Ceramic HYPERD sorbents is required.

BIOSEPRA Ceramic HYPERD

shown in Table 3. The data are part of the - Direct capture of biomolecules from a
Regulatory Support File for Q Ceramic variety of feedstocks.
HYPERD F. - Polypeptides, IgG, albumin purification.
- Large-scale purifications.
- Purification of monoclonal antibodies from
Figure 8. Purification of Hexokinase and 3-phospho-
ascites or cell culture.
glycerate-Phosphokinase on Q Ceramic HYPERD 20.
- Plasmid purification.
0.27
- Process polishing steps.
- Rapid high resolution purification (20µm
O.D.

3-Phosphoglycerate-Phosphokinase
0.23 grade).
0.19
• Direct one-step Capture of an IgG1
0.16
from diluted cell culture supernatant
(CCS) on CM Ceramic HYPERD F.
0.12 CM Ceramic HYPERD F can be applied for a
0.08
direct, one-step capture of monoclonal anti-
Hexokinase
body from cell culture supernatant (see
0.04 Figure 7).

0 4.6 9.2 13.8 16.4 • Rapid purification of yeast proteins on

Q Ceramic HYPERD 20.
Time (min)
The 20µm grade allows rapid method
Column: 0.5 cm ID x 10 cm (1.7 ml); Adsorption, washing, equili-
development for enzyme separation using a
bration in 50 mM Tris-HCl / Tris base, pH 7.2; Elution by 0 to 1 M
NaCl gradient; Protein concentration: 1 mg/ml; Linear velocity: salt gradient (see Figure 8).
®

1,223 cm/h (4 ml/min).

Figure 9. Two-step Purification of IgG1 from Ascites Fluid on MEP HYPERCEL followed by DEAE Ceramic HYPERD F.
IgG1 IgG1
(purity 80%) (purity 98%) adsorbed
O.D.

WASH

WASH

impurities

1 2 3

Time (min)
Capture on MEP HYPERCEL Polishing on DEAE Ceramic HYPERD F

MEP HYPERCEL column: First wash with 50 mM Tris-HCl buffer, pH 8, second wash with 25 mM sodium caprylate in same buffer
(arrow 1), followed by a water wash (arrow 2), to remove albumin. Elution with 50 mM sodium acetate, pH 4.0. The IgG1 enriched
fraction is added with Tris base up to pH 8.8 and ionic strength of 7.4 mS/cm, and injected onto the DEAE Ceramic HYPERD F column.
Wash with same buffer to collect the antibody. DEAE Ceramic HYPERD column: 0.6 cm ID x 10 cm; Equilibration: 50 mM Tris-HCl,
pH 8.8; Linear velocity: 160 cm/h. IgG do not bind, adsorbed impurities are eluted by 1 M NaCl (arrow 3).

6
• Polishing step on DEAE Ceramic HYPERD
F after monoclonal antibody capture on
MEP HYPERCEL.
DEAE Ceramic HYPERD F has been used in a
two-step process for a polishing step to
purify a mouse IgG1 from ascites fluid (see
Figure 9). The first step is a capture of the
IgG1 on a MEP HYPERCEL column (Hydro-
phobic Charge Induction Chromatography
– HCIC –), which results in a good initial
capture of the IgG1 (93%).
A purity of 98% for the IgG1 is achieved in
two steps.
• More Regulatory Support information.
Regulatory Support Files are updated
periodically. Please contact your local represen-
tative.
• Information from Regulatory Support
Files.
- Long term storage data,
- Material Safety Data Sheets,
- Lot-to-lot consistency information,
- Detailed Quality Control procedures,
- Chemical stability in various media,
- Cleaning in place (CIP) studies,
- Extractives and leachables quantification.

References Ordering Information

1. Duval, M., et al., Job Life Sciences 316 (1993) 1463. Product Cat. No. Size
2. Boschetti, E., et al., J. Biochem. Biophys. Meth. 32
(1996) 15. Q Ceramic HYPERD 20 20040-051 5 ml
3. Coffman, J.L., Boschetti, E., Bioseparation & Biopro- 20040-044 25 ml
cessing, Wiley-VCH Verlag Press, Vol. 1 (1998) 157. 20040-036 100 ml
4. Necina, R., Amatschek, K., Jungbauer, A., Biotech- 20040-028 500 ml
nology and Bioengineering Vol. 60/6 (1998) 689. 20040-010 1L
5. Hanser, E., Mollerup, I., J. Chromatogr. A827 (1998),
259. S Ceramic HYPERD 20 20038-055 5 ml
6. Hahn, R., et al., J. Chromatogr. A795 (1998) 277. 20038-048 25 ml
7. Moure, F., Rendueles, M., Diaz, M., ECCE2 (Second 20038-030 100 ml
European Congres of Chemical Engineering) (1999) 20038-022 500 ml
Montpellier. 20038-014 1L
8. Fernandez, A., et al., J. Chrom. A 746 (1996) 169.
9. Boschetti, E. & Jungbauer, A., Separation Science & Q Ceramic HYPERD F 20066-098 5 ml
20066-031 25 ml
Technology, Academic Press Vol. 2 (2000) 535.
20066-023 100 ml
10. Riedel, K.-U., et al., Eur. J. Biochem. 231 (1995) 742.
20066-015 1L
11. Jouanneau, Y., et al., Eur. J. Biochem. 267 (2000) 780.
20066-064 5L
12. Sookkheo, B., et al., Protein Expression and
20066-056 10 L
Purification 20 (2000) 142.
13. Couriol, C., et al., Chromatographia 52/7-8 (2000) S Ceramic HYPERD F 20062-089 5 ml
465. 20062-030 25 ml
20062-022 100 ml
20062-014 1L
20062-048 5L
20062-055 10 L

DEAE Ceramic HYPERD F 20067-070 5 ml

20067-039 25 ml
20067-021 100 ml
20067-013 1L
20067-054 5L
20067-047 10 L

CM Ceramic HYPERD F 20050-084 5 ml

20050-035 25 ml
20050-027 100 ml
20050-019 1L
20050-050 5L
20050-043 10 L

7

2200 Northern Boulevard
East Hills, New York 11548-1289
+1 800.717.7255 toll free
+1 516.484.5400 phone
+1 516.801.9548 fax
pharmafilter@pall.com
Europa House, Havant Street
Portsmouth PO1 3PD, United Kingdom
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com
BioSepra SA
48 avenue des Genottes
95800 Cergy Saint Christophe, France
+33 (0)1 34 20 78 00 phone
+33 (0)1 34 20 78 78 fax
PRODUCT NOTE
About BioSepra® Products & Collaborative
Services
BioSepra process chromatography sorbents are manu-
factured and marketed by Pall Life Sciences. They great-
ly simplify protein purification development and signifi-
cantly improve biopharmaceutical manufacturing pro-
ductivity.
Over the past 25 years, BioSepra® chromatography
products and services have earned an outstanding
reputation for product innovation and technical support.
Our expanded R&D sorbent program, ISO 9001 manu-
facturing plant and HyperCel™ sorbents represent our
latest commitment to the biopharmaceutical industry.
With the acquisition of BioSepra® products and services,
Pall combines chromatography development expertise
with Ciphergen®'s SELDI-based ProteinChip® technology
to set in motion an entirely new approach to protein
purification development.
This single-step, on-chip approach dramatically acceler-
ates and simplifies purification development and analy-
sis. The future of Process Proteomics begins with Pall.
Pall has the most comprehensive
family of scaleable separation products.
Visit us on the web at www.pall.com/biopharmaceutical
These products are for laboratory research use only and are not intended for human
or animal diagnostic, therapeutic, or other clinical uses, unless otherwise stated. The
information contained in this brochure are subject to change without notice.
Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand,
Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
, Pall, BioSepra, HyperD, Hypercel are registered trademarks of Pall Corporation.
Filtration. Separation. Solution. and UpScale are service marks of Pall Corporation.
ProteinChip is a trademark of Ciphergen Biosystems, Inc.
LPN PN702-001 - 12/2004
8
 PRODUCT NOTE

DEAE, CM and SP Trisacryl M/LS ®

Ion Exchange Chromatography Sorbents

• Excellent resolution
• Superior dynamic capacity
• Fast reequilibration and regeneration
• Wide stability range
• Long lifetime
®

BioSepra DEAE, CM, SP Figure 1: Chemical structure of available ionizable groups of Trisacryl ion exchangers.
BioSepra Trisacryl

Trisacryl® M, LS sor-
bents are high capacity
DEAE Trisacryl® M, LS CM Trisacryl® M, LS SP Trisacryl® M, LS
ion exchange sorbents
dedicated to a broad
CH OH
range of applications at CH OH 2 CH OH
2 2

CH – CONH C – CH OH CH – CONH – C – CH OH CH – CONH – C – CH OH

large scale. Trisacryl® 2 2 2

CH OH 2 CH CH OH
2 CH OH
2
ion exchangers are CH 2
CH – CH CH – CH
2
CH 2
2 3 2 3 CH3
CH--COOH
spherical semi-rigid CH – CONH – (CH ) – N – (CH ) – N
2 2 2 2 CH – CONH – C – CH – SO H
2 3
– CH CH OH
microbeads of acrylic CH – CH
2 CH – CH
3 2 3
2
CH3
– CH CH – CONH – C – CH OH – CH
copolymers. The CH OH 2
2 2
CH OH
2
CH CH OH
2
strongly bound ion CH – CONH C – CH OH 2
2
CH – CONH – C – CH OH
2
CH – COOH
exchange groups which CH 2
CH OH 2
CH
CH OH
2
2
CH – CH CH
are an integral part of 2 3 3
®

CH – CONH – (CH ) – N CH – CONH – C – CH – SO H

the polymer structure 2 2 2 3

CH – CH
2 3 CH3
are found within its CH 2

three dimensional
structure (See Figure 1).
Each Trisacryl® polymer
sub-unit possesses
hydrophilic groups which ensure biocompatibility
and prevent non-specific adsorption. Trisacryl® ion
exchangers are macroporous. Their open structure
provides several advantages such as a rapid diffusion
of macromolecules due to the high mass transfer, the
easy access to ionizable groups and the absence of
molecular sieving.
Capacity
The protein adsorption capacity of Trisacryl sorbents
® tivity level of the support. These two factors are both
is affected by general rules for the ion exchange
mechanism. The capacity depends on a number of
factors, including buffer pH and ionic strength, the
nature of the counter-ion, and the characteristics of
the protein such as molecular weight and isoelectric
point. Variations in pH modify the ionization of the
support groups and thus modify the available num-
ber of groups for protein adsorption. The adsorption
capacity is particularly affected by the ionic strength
and the pH of the buffer, which in turn modifies the
net charge of the protein. Usually, an increase of
ionic strength will result in a capacity decrease for a
given protein. The adsorption capacity and flow rate
are indicative features in the performance of an ion
exchange support since they determine the produc-
taken in consideration when discussing productivity,
since a flow rate increase often results in a capacity
decrease. The adsorption capacity remains high as
the flow rate increases. This phenomenon is attrib-
uted to the macroporous nature of the support,
which provides a greater availability of the protein to
ionizable groups.

1
 PRODUCT NOTE

Mechanical Stability Table 1. Main Properties of Trisacryl M, LS ion exchangers.

Trisacryl® sorbents are semi-
rigid and highly resistant to DEAE CM SP
support collapse due to the Particle size (µm) 40-80 (M grade) ; 80-160 (LS grade)
three-dimensional structure Exclusion limit (dt)* > 10 7
obtained under specific poly- Nature of ionizable groups diethylaminoethyl carboxymethyl sulfopropyl
merization conditions. Their
Amount of ionic groups (µEq/ml) 320-370 190-230 190-250
physical and chemical fea-
pK of ionic groups 6.2 ; 10.7 4.7 1
tures provide high flow rates
in large columns. Binding capacity (mg/ml) > 75 (BSA)** > 135 (lysozyme)*** > 80 (lysozyme)***
Working pH 1 - 11
Under high flow rates, the
column equilibration, separa- Microbial stability Excellent
®

tion and regeneration may be Chemical stability Stable to all solvents commonly used in liquid
chromatography (6 M guanidine hypochloride, 8 M urea)
BioSepra Trisacryl

performed rapidly and effi-

ciently. The contact time of
labile biochemical with the
sorbent can be minimized,
thus avoiding possible prob-
lem of denaturation.
Thermal stability -20°C to +121°C
Reequilibration volume (cv) 1.5 - 1.8
* For globular proteins ** 10 mM Tris-HCl, pH 8.6, sample: 10 mg/ml BSA solution
*** Sodium acetate, pH 5 containing 300 mM NaCl; Sample: 2.5 mg/ml lysozyme solution
**** Very short period of time

Chemical Stability Choice of Initial Separation Conditions

Trisacryl® sorbents are insoluble in all commonly For the fractionation of an unknown sample, the fol-
used solvents in low and medium pressure chro- lowing procedure is recommended:
matography, and have a good resistance to alkaline ■ Equilibrate a small column (5 to 20 cm height) in a

solutions. Additionally, the matrix is resistant to low ionic strength buffer (0.01-0.05 M), e.g. acetate
denaturing agents commonly used in biochemistry for CM and SP Trisacryl® and Tris-HCl for DEAE
®

(8 M urea, 6 M guanidine hypochloride and other
chaotropic agents) and to non-ionic detergents such
as triton X-100, octylglucoside, and Tween 80.
Trisacryl® ion exchangers are acid-resistant, they can
be used with inorganic acids (i.e. 1 M HCl), as well
as organic acids, e.g. for the separation of peptides.
These sorbents are resistant to highly acidic solutions
– contrary to polysaccharide-based supports – to
highly alkaline solutions – contrary to most synthetic
supports – and to enzymatic attack due to their syn-
thetic origin.
All these properties are particularly important in
large scale applications since they permit efficient
sanitization and depyrogenation of the sorbent.
Thermal Stability
Trisacryl® sorbents tolerate high thermal variations
from -20°C to +121°C (the sorbents may be auto-
claved during 20 min) without modification of their
properties.
Biological Stability
Trisacryl® is a totally synthetic sorbent and is therefore
completely resistant to enzymatic and microbial
degradation.
Trisacryl®. Recommended pH ranges are as follows:
- pH 2-6 for SP Trisacryl®
- pH 4-6 for CM Trisacryl®
- pH 7-9 for DEAE Trisacryl®
■ Inject the sample, starting with 2 mg of protein for
1 ml of sorbent.
■ Wash the column with at least 1 cv of the same
buffer and collect the non-adsorbed protein fraction.
■ Generate an ionic strength gradient with 0 to 1 M
NaCI in the same low ionic strength buffer. The gra-
dient slope should range from 5 to 10 mM/cm.
These experiments will allow optimization of the elu-
tion conditions and selection of pH and ionic strength
for stepwise elutions.
Choice of the Counter-lons
Salt elution gradients are usually performed by an
increase of the NaCI concentration. In this case, the
elution depends on the competition with Na+ for the
cation exchangers (CM and SP Trisacryl®), and Cl-
for the anion exchangers (DEAE Trisacryl®). However,
other counter-ions can be used, giving different sep-
aration profiles, as shown on Figure 2.

2
Figure 2. Separation on DEAE Trisacryl M of a mixture of cytochrome c (A), human hemoglobin Figure 3. Separation of oligomers of 5'(d)-TMP
(B), ovalbumin (C) and β-lactoglobulin (D) according to the counter-ion. on DEAE Trisacryl M.

NaCl [E]
A B

Conc.
DI
[E] b [E] 0.5
b d
a TRI
Conc.

Conc.
a d 0.5 c 0.5 0.4
c
TETRA 0.3
PENTA 0.2
0.1

0 20 100 150 (ml)

0 50 100 Vr 0 50 100 Vr
C D
Column: 1.6 x 18.4 cm; Sample: 4 mg of oligonu-
[E] [E]
a b cletides in 1 ml buffer; 0.025 M sodium acetate,
Conc.

Conc.

a b 0.5 0.5
c d c 0.2 M NaCl, pH 5.3; Elution gradient: NaCl from
d 0.2 to 0.5 M; Flow rate: 30 cm/h.

0 50 100 Vr 0 50 100 Vr

E = concentration in Eq./L; Vr = retention volume; Column dimensions: 1.6 cm I.D. x 10 cm; Buffers: Tris-PO4---
(A), Tris-SO4-- (B),Tris-Cl - (C), Tris-CH3COO - (D), pH 8.6; Gradient slope: 10 mE/cm; Flow rate: 32.5 cm/h .

The affinity order of different counter- 5. Calculate the column cross-sectional References
ions is as follows: area and diameter.
1. Lebart, M.C., et al., J. of Biol. Chem. Vol. 268, No. 8
■ For cation exchangers: (1993) 5642.

Ca++ > Mg++ > Na+ > NH4+ > K+ Applications 2. Tousch, D., et al., Biochrom. 5 (1990) 30.
3. Séné, C., et al., ChimicaOggi (03/1990), 15.
■ For anion exchangers: Trisacryl® ion exchangers have proven 4. Corthier, G., et al., J. Immunol. Meth. 66 (1984) 75.
to be very efficient on the laboratory 5. Girot, P., Boschetti, E., J. Chrom. 213 (1981) 389.
Citrate > PO4- - - > SO4- - > Br - > Cl - 6. Veau, B., et al., Biochim. Biophys. Acta 1428 (1999)
level due to their excellent resolution,
> CH3COO - 39.
and also on industrial scale due to their
high productivity performance.
Scaling Up a Process
DEAE, CM, and SP Trisacryl® sorbents
The choice of the equipment size and are commonly used for the fractionation
operating parameters for a pilot- or pro- of proteins from various origins and at Ordering Information
duction-scale chromatography step is different scales. DEAE Trisacryl® is cur-
not an easy task. To help determine the rently used in 500 L columns for the Product Cat. No. Size
sorbent volume requirements for a production of insulin.
given process, BioSepra’s basic guide- DEAE Trisacryl M 25079-013 300 ml
lines are as follows: An example of separation obtained on
25079-054 1L
different Trisacryl® ion exchangers is 25079-039 10 L
1. Determine, by experiments, the opti-
shown in Figure 3. CM Trisacryl M 26708-016 300 ml
mal dynamic capacity and linear velocity.
26708-032 1L
2. Determine, by experiments, the opti- Validation 26708-024 10 L
mal column height. SP Trisacryl M 25910-019 300 ml
Drug Master Files are available for dif-
25910-027 1L
3. Based on the linear velocity and the ferent types of Trisacryl® ion exchangers: 25910-035 10 L
column height, determine the duration - DMF No. 7830 for DEAE Trisacryl® DEAE Trisacryl LS 26710-012 1L
of one cycle, and the number of cycles - DMF No. 8039 for SP Trisacryl®. 26710-020 10 L
to be run per day.
Trisacryl® ion exchangers are currently CM Trisacryl LS 20030-011 1L
4. Knowing the number of cycles per used by pharmaceutical companies for
20030-037 10 L
day, calculate the volume of sorbent the production of injectables. SP Trisacryl LS 26711-010 1L
needed. 26711-028 10 L

3

2200 Northern Boulevard
East Hills, New York 11548-1289
+1 800.717.7255 toll free
+1 516.484.5400 phone
+1 516.801.9548 fax
pharmafilter@pall.com
Europa House, Havant Street
Portsmouth PO1 3PD, United Kingdom
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com
BioSepra SA
48 avenue des Genottes
95800 Cergy Saint Christophe, France
+33 (0)1 34 20 78 00 phone
+33 (0)1 34 20 78 78 fax
PRODUCT NOTE
About BioSepra® Products & Collaborative
Services
BioSepra process chromatography sorbents are manu-
factured and marketed by Pall Life Sciences. They great-
ly simplify protein purification development and signifi-
cantly improve biopharmaceutical manufacturing pro-
ductivity.
Over the past 25 years, BioSepra® chromatography
products and services have earned an outstanding
reputation for product innovation and technical support.
Our expanded R&D sorbent program, ISO 9001 manu-
facturing plant and HyperCel™ sorbents represent our
latest commitment to the biopharmaceutical industry.
With the acquisition of BioSepra® products and services,
Pall combines chromatography development expertise
with Ciphergen®'s SELDI-based ProteinChip® technology
to set in motion an entirely new approach to protein
purification development.
This single-step, on-chip approach dramatically acceler-
ates and simplifies purification development and analy-
sis. The future of Process Proteomics begins with Pall.
Pall has the most comprehensive
family of scaleable separation products.
Visit us on the web at www.pall.com/biopharmaceutical
These products are for laboratory research use only and are not intended for human
or animal diagnostic, therapeutic, or other clinical uses, unless otherwise stated. The
information contained in this brochure are subject to change without notice.
Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand,
Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
, Pall, BioSepra, Trisacryl, Hypercel are registered trademarks of Pall Corporation.
Filtration. Separation. Solution. and UpScale are service marks of Pall Corporation.
ProteinChip is a trademark of Ciphergen Biosystems, Inc.
LPN BT203112 - 12/2004
4
 PRODUCT NOTE

DEAE & SP Spherodex® LS

Silica/dextran composite ion exchangers for liquid
chromatography of biologicals.

DEAE and SP Spherodex® LS ion Figure 1. Structure of Spherodex ion exchangers.

exchangers are stable composites
comprised of two polymers: an inor-
®

ganic silica matrix which provides a O DEAE

BIOSEPRA Spherodex

HO
CH2
high degree of rigidity to support O
high flow rates, and an organic dex- O
tran component that provides (CH2)2 OH
O
hydrophilicity and biocompatible R--N--R
+
functional groups.
The resulting interpenetrated poly-
mer network has several advantages O
HO
CH2 SP
such as good chemical stability and
O
bed stability in both aqueous and O
organic solvents. The sorbent does SO3 OH
not shrink or swell with pH or ionic O
strength, and withstands pressure
generated even when exceeding 600
cm/h. The unique network also elimi- The porous silica matrix is coated with a continuous layer of ionizable dextran
nates non-specific sorption of proteins. to yield high exchange capacity and improved stability.

These sorbents were developed

®

specifically for large scale process

chromatography of therapeutic pro- Table 1. Properties of Spherodex LS Ion Exchangers.
teins and industrial enzymes. DEAE (dry) SP (wet)
Spherodex® ion exchange sorbents
are presently used in column sizes Particle size (µm) 100-300 100-300
from 20 to 3,000 L. Exclusion limit (dt) (1) 10 - 10
6 7 106 - 107
SP Spherodex LS is supplied in wet Ionized groups/volume (µeq/ml) (2) 100 150
form, in an aqueous suspension con- pK of ionic group 6.5 ; 10 1
taining 1 M NaCl and 20% EtOH. Operating pH range 1-12 1-12
DEAE Spherodex LS is supplied in dry Stability to detergents and excellent excellent
form. denaturing agents
The most important properties of Heat stability good excellent
these ion exchange sorbents are: Microbial stability excellent excellent
■ Stable bed at very high flow rate. Volume changes due to pH and none none
ionic strength
■ Stable to pressure (> 50 bar).
Capacity for BSA(3) ≥ 75 mg/ml -
■ Stable in acidic solutions.
■ Highly porous and hydrophilic. Capacity for lysozyme (4) - ≥ 60 mg/ml
■ Low non-specific adsorption.
(1) For globular macromolecules. (2) Average.
■ No swelling or shrinking, due to (3) Determined using 10 mg/ml BSA solution in 10 mM Tris-HCl buffer, pH 8.6. (4)
aqueous or organic solvents. Determined using 5 mg/ml lysozyme solution in 50 mM acetate buffer, pH 5.

1

Chemical composition and structure.
Spherodex sorbents are rigid spherical ion
®
exchange matrices comprised of a network of silica
and ionizable dextran. The particle size ranges from
100 and 300 µm. The derivatized dextran is uni-
formly distributed within the pore structure of the
silica skeleton (Figure 1). The silica surface is totally
covered by dextran, eliminating the activity of active
silanol groups. This results in improved stability
towards extremes of pH. Additionally, any possible
non-specific adsorption on silanols is eliminated.
®
The dextran polymer carries the classical ionizable
BIOSEPRA Spherodex
groups tightly anchored onto the polymer:
- DEAE (diethylaminoethyl).
- SP (sulfate).
Additionally, the entire structure is stabilized by
chemical cross-linking of the polysaccharide via pro-
prietary patented technology.
Porosity.
The structure of the Spherodex network is macrop-
®
orous, as a result of a specific silica polymerization
technology. This open structure offers the following
advantages:
■ Absence of molecular sieving phenomena.
■ Rapid diffusion of macromolecules into the beads
(high mass transfer).
®
Chemical stability.
Spherodex® LS sorbents are insoluble in all solvents.
They are also stable to acidic and alkaline solutions,
to strong denaturing media, detergents, chaotropic
agents, and other organic products.
Classical chemical treatment for sanitization and
pyrogen removal can be effected without modifying
the ion exchange properties of Spherodex® ion
exchangers.
Thermal stability.
Spherodex® LS ion exchangers are stable over a wide
range of temperatures. They can be safely frozen, or
autoclaved at 121ºC. However, it is not advisable to
heat DEAE Spherodex® repeatedly at 121ºC because
of the progressive degradation of the substituted ter-
tiary amine.
2
PRODUCT NOTE
Figure 2. Pressure vs. Flow Rate curve generated with a DEAE
Spherodex LS column.
Pressure (bar)
2
1
L/h
50 150 250
cm/h
100 200 300
Flow rate
Column: 30 cm I.D. x 78 cm containing 55 L of sorbent; Eluent:
1 M sodium chloride; Throughput at 1 bar: 2.3 cv/h.
Mechanical stability.
Spherodex® ion exchangers are non-compressible
and may be submitted to pressures over 50 bar.
Pressure thus presents an easy method for increasing
the linear column flow rate (Figure 2). This excellent
mechanical stability offers additional advantages:
■ No variation of the column volume as the ionic
strength, pH, or flow rates values are changed.
■ Greater flexibility in selecting the working flow
rate and changing it during the different phases of
the chromatographic cycle.
Protein sorption capacity.
The protein sorption capacity of Spherodex® ion
exchangers follows the general rules of the ion
exchange mechanism. This sorption capacity
depends on a series of factors including pH of the
buffer, ionic strength, temperature, nature of the
counter ion and intrinsic characteristics of the pro-
tein (isoelectric point and molecular weight).
The sorption capacity is primarily affected by the
ionic strength of the buffer which controls the ion
exchange equilibrium. Typically, an increase in ionic
strength leads to a decreased capacity for a given
molecule. Temperature increases the rate of
exchange and has potential to improve resolution.
Differences in counter ion binding constants can
provide options to improve resolution.
Changes in pH modify the net charge of the protein
and the ionization of the ion exchange functional
group as well.
Applications.
Spherodex LS sorbents have proven to be very efficient in
®
the laboratory as well as in production scale fractionation of
proteins. DEAE Spherodex® has been used for many years at
production scale in the fractionation of human plasma pro-
teins and placenta extracts. It has been used at column scale
of 1,500 L in the purification of albumin. It was also suc-
cessfully used in production scale for the purification of IgG
and transferrin from human plasma.
In other fields of protein fractionation, Spherodex® ion
exchangers were described as being very efficient when used
as such or when chemically modified. DEAE Spherodex® has
Separation of a protein mixture on SP Spherodex®.
The strong anionic character of this sorbent permits the
separation of a mixture of three well-known proteins.
Impurities are found in the flowthrough (they do not inter-
act with the sorbent). The three other sample proteins
adsorbed to the column are eluted using a linear sodium
chloride gradient in the starting buffer (Figure 4).
Figure 4. Separation of a mixture of (a) β-lactoglobulin, (b) Ovalbumin,
(c) Cytochrome c, and (i) impurity on an SP Spherodex column.

Conc.
been used for the separation of gangliosides and lipid-like c
molecules. It was also used as a matrix for affinity chro- [NaCl]
matography at laboratory scale as well as at large scale for
1
the separation of tetanus toxin after immobilization of gan-
glioside GM-1 on partially modified DEAE Spherodex® and b
for the isolation of antitetanus toxin antibodies.
a

Albumin separation from human plasma. i

In this example (Figure 3), the prepurified albumin is eluted
in an acetate buffer, pH 4.7. The albumin fraction thus
0
obtained displays an electrophoretic purity of 90 to 93%.
This prepurified albumin is then chromatographed on two 20 40 60 ml
other additional columns to obtain pure albumin.
Column: 1.1 cm I.D. x 9 cm; Buffer: 0.05 M acetate, pH 4.5; Elution gradi-
ent: sodium chloride from 0 to 1 M; Flow rate: 30 ml/h.
Figure 3: Example of large scale application of DEAE Spherodex LS,
purification of albumin from human plasma.

2
Liters/h

1
3

4
5 Ordering Information

50 100 150 Liters Product Cat. No. Size

DEAE Spherodex LS 26455-023 100 g

26455-031 1 kg
26455-049 10 kg
26455-056 25 kg
SP Spherodex LS 20080-024 100 ml
20080-016 1L
20080-032 10 L
20080-040 25 L

Column dimensions: 100 cm I.D. x 1400 cm (1050 L); Sample volume:

10,000 L/day; Equilibration buffer: 0.01 M phosphate, pH 5.25;
Albumin elution buffer: 0.025 M acetate, pH 4.7; Washing with 1 M
NaCl (peak 3), with 0.1 M HCl (peak 4) with a mixture of 60% ethanol
in 0.5 M acetic acid; Flow rate: 1250 L/h (150 cm/h).
Courtesy of Pasteur Merieux Connaught, Lyon, France.

3

2200 Northern Boulevard
East Hills, New York 11548-1289
+1 800.717.7255 toll free
+1 516.484.5400 phone
+1 516.801.9548 fax
pharmafilter@pall.com
Europa House, Havant Street
Portsmouth PO1 3PD, United Kingdom
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com
BioSepra SA
48 avenue des Genottes
95800 Cergy Saint Christophe, France
+33 (0)1 34 20 78 00 phone
+33 (0)1 34 20 78 78 fax
PRODUCT NOTE
About BioSepra® Products & Collaborative
Services
BioSepra process chromatography sorbents are manu-
factured and marketed by Pall Life Sciences. They great-
ly simplify protein purification development and signifi-
cantly improve biopharmaceutical manufacturing pro-
ductivity.
Over the past 25 years, BioSepra® chromatography
products and services have earned an outstanding
reputation for product innovation and technical support.
Our expanded R&D sorbent program, ISO 9001 manu-
facturing plant and HyperCel™ sorbents represent our
latest commitment to the biopharmaceutical industry.
With the acquisition of BioSepra® products and services,
Pall combines chromatography development expertise
with Ciphergen®'s SELDI-based ProteinChip® technology
to set in motion an entirely new approach to protein
purification development.
This single-step, on-chip approach dramatically acceler-
ates and simplifies purification development and analy-
sis. The future of Process Proteomics begins with Pall.
Pall has the most comprehensive
family of scaleable separation products.
Visit us on the web at www.pall.com/biopharmaceutical
These products are for laboratory research use only and are not intended for human
or animal diagnostic, therapeutic, or other clinical uses, unless otherwise stated. The
information contained in this brochure are subject to change without notice.
Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand,
Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
, Pall, BioSepra, Spherodex, Hypercel are registered trademarks of Pall Corporation.
Filtration. Separation. Solution. and UpScale are service marks of Pall Corporation.
ProteinChip is a trademark of Ciphergen Biosystems, Inc.
LPN BT205102 - 12/2004
4
 PRODUCT NOTE

QMA Spherosil M & LS ®

Silica-based hydrophobic ion exchangers for liquid chromatography

Introduction Figure 1. Structure (left) and internal porous structure (right) of QMA Spherosil.

BioSepra QMA Spherosil® M, LS

ion exchange chromatography
sorbents are composed of silica CH3
beads grafted with polymer
®

+
N CH3
specifically designed for biochemi-
BioSepra Spherosil

CH3
cal use. The polymer provides
Silica
ionic and slightly hydrophobic
properties to the sorbent. This
unique mix mode chromatogra-
phy allows the purification of pro-
Polymer layer
teins difficult to isolate on classical
sorbents.
QMA Spherosil M, LS ion exchan-
gers are available in dry form. Table 1. Main Properties of QMA Spherosil sorbents.

Particle size (µm): M grade . . . . . . . . . . . . . . . . . . . . . 40-100

LS grade . . . . . . . . . . . . . . . . . . . . 100-300
Chemical composition
Exclusion limit (dt) (1) . . . . . . . . . . . . . . . . . . . . . . . . . . 106 - 107
and structure Average porous volume (cm3/g) . . . . . . . . . . . . . . . . . . 1
Average surface specific area (m2/g) . . . . . . . . . . . . . . . 25
®

QMA Spherosil® are rigid beads Nature of ionizable group . . . . . . . . . . . . . . . . . . . . . . Quaternary amine
based on porous silica. The parti- Average ionized groups (µeq/g) . . . . . . . . . . . . . . . . . . 300
cle size ranges between 100 and pk of ionizable group . . . . . . . . . . . . . . . . . . . . . . . . . 11
Working pH range . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
300 µm for LS grade (M grade,
Stability to detergents and denaturing agents . . . . . . . . Excellent
with particle size of 40-100 µm is Heat stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Good
available on request). The silanols Microbial stability . . . . . . . . . . . . . . . . . . . . . . . . . . . . Excellent
covering the pore surface are Volume changes due to pH and ionic strength . . . . . . . None
linked to functionalized polymers Capacity for BSA (µeq/g) (2) . . . . . . . . . . . . . . . . . . . . . 30
(this occurs by covalent binding).
(1) For globular macromolecules. (2) Determined in 0.025 M phosphate buffer, pH 6.
The polymer provides the ionic
and slightly hydrophobic proper-
ties to the sorbent. QMA is a qua- require the modification of parameters typically selected in hydrophilic
ternary amine (see structure in ion exchange. The ability to manipulate two physical properties during
Figure 1). Silica allows for the chromatography makes possible the purification of proteins which have
combination of high rigidity and been previously difficult or impossible to isolate on classical gels.
high porosity, whereas the role of
the cationic polymer is to adsorb Porosity
the protein to be purified.
The sorbent structure is macroporous, due to the specific technology of
Regardless of whether the gel is
silicate polymerization used (Figure 1). It offers following advantages:
polyanionic or polycationic, it
- Absence of molecular sieving phenomenon,
additionally demonstrates some
- Rapid diffusion of molecules inside the network (high mass transfer).
hydrophobic character. This allows
adsorption and elution, but may

1

Stability
Chemical stability
QMA Spherosil® sorbents are
insoluble in all solvents. They are
resistant to denaturing agents,
detergents, chaotropic agents
and other organic solvents.
Their stability in acidic and alka-
line solutions is determined by
maintaining the sorbent in 1 M
HCI or NaOH at room tempera-
®
ture for one hour. QMA Sphero-
BioSepra Spherosil
sil® sorbents are not sensitive to
acids but are sensitive to extreme
alkaline pH. When alkaline buffers
are required, the sorbents should
be washed rapidly using diluted
bases only (e.g. 0.1 M).
Thermal stability
Since they are based on silica and
synthetic polymers, QMA
Spherosil® sorbents are stable
over a wide range of tempera-
tures. They can be frozen and tol-
erate temperatures of 80-90°C.
Autoclaving is not recommended.
®
Mechanical stability
QMA Spherosil® sorbents are non
compressible and therefore with-
stand pressures of several dozen
bar. The pressure is an easy way
of increasing the column linear
flow rate (Figure 3). Additionally,
Figure 3. Inlet pressure as a functlon of
the flow rate in a QMA Spherosil® col-
umn.
Flow rate
L/h cm/h
30
300
20
150
10
0 0.2 0.4
Pressure (bar)
Column dimensions: 10.5 cm I.D. x 101
cm length. Particle size: 100-300 µm.
PRODUCT NOTE
this offers the following advan- Protein sorption capacity
tages:
The sorption capacity of QMA
- No variation of the column vol-
Spherosil® sorbents varies accord-
ume as the ionic strength, pH or
flow-rate values are changed. ing to several parameters. The
- Greater flexibility in selecting the most important one is the work-
working flow rates. ing pH. Table II and Figure 5
show the results from experi-
Biological stability ments to determine the amount
Since QMA Spherosil® sorbents of proteins adsorbed per ml of
have a mineral and synthetic com- hydrated support. The test was
position, they are not sensitive to performed with three acidic pro-
bacterial and enzymatic attack. teins (albumin, ovalbumin and
thyroglobulin). The capacity
increases when the pH of the
Figure 4. Titration curve.
buffer decreases. However, thy-
pH roglobulin does not adsorb on
Uncoated sorbent
11 S1 O 2 QMA Spherosil®.
9
7
Applications
5
3
QMA Spherosil® sorbents are
QMA Spherosil designed for the separations of
1
5 15 25 35 45 ml
proteins on the laboratory and
industrial scale. They represent a
Titration solutions: 0.1 M HCl or 0.1 M significant step in the resolution
NaOH.
of flow rates problems still
encountered today with soft
material. For example, these sor-
Figure 5. Adsorption capacity as a
bents allow the chromatography
function of pH.
of proteins on a very large scale
(Figure 7), making use of
Capacity (mg/ml)
columns with capacities of several
hundreds liters under acceptable
50
hygienic conditions for the pro-
duction of injectables.
25 Purification of human placenta
albumin has already been realized
in installations that are capable of
separating 180 kilos of albumin
6 7 8 9 pH
per cycle.
Capacity determined for bovine albumin in
0.025 M phosphate buffer using 5 mg/ml
protein solution.
Table II. Adsorption capacity of QMA Spherosil LS for acidic
proteins.
Protein Adsorption capacity (mg/ml of sorbent)*
pH 6 pH 7 pH 8 pH 9
Bovine albumin 53 27 10 11
0.6 Ovalbumin 86 66 39 34
Thyroglobulin 0.8 0.9 ND 0.9
* Determined in 0.025 M phosphate buffer by frontal analysis.
2
Other applications in fluidized beds
have been reported. Fluidized beds
constitute an excellent means for the
separation of specific proteins from
turbid solutions.
Example I. Separation of sweet whey
proteins on QMA Spherosil®.
Courtesy of S. Stefanos & J. Wietzerbin, Mary
Ann Liebert Inc. Publications, NY.
a b
O.D. 280 nm
O.D. 280 nm
β-lactoglobulin
α-lactalbumin
Time Time
Figure 6. HPLC analysis of sweet whey proteins
separated on QMA Spherosil® LS sorbent.
(a) Chromatographic profile before separation.
(b) Protein profile after separation.
Column: TSK-G-3000 SW; Buffer: 0,05 M phos-
phate, pH 7.5 containing 0.15 M sodium chloride;
Flow rate 1 ml/min.
This example shows a simple and effi-
cient method for the separation of
α-lactalbumin and β-lactoglobulin
from crude sweet whey:
- Equilibrate a column (6 mm I.D.)
containing 5 g of QMA Spherosil® in a
solution of 0.05% sodium chloride
(about 0.01 M).
- Inject 120 ml of sweet whey (80 g/L)
into the column.
- Wash the column with 0.05 M NaCI,
elute with 0.1 M HCI. This should be
performed at a flow rate of 80 ml/h.
- Reequilibrate the column with 0.05 M
NaCI.
HPLC analysis shows that the HCI elut-
ed fraction includes mainly α-lactalbu-
min and β-lactoglobulin.
Beyond the described applications, The following examples are illustrative
there is a great potential both on the of some of the numerous applications
laboratory and industrial level. of Spherosil®.
Example II. Continuous adsorption For continuous sorption operation, a
of bovine serum albumin in fluidized counter-current fluid bed column
bed columns of QMA Spherosil® LS. (100x3 cm) is equipped with a num-
Courtesy of Dr. J.P. Van der Wiel, Delft ber of perforated plates to suppress sil-
University of Technology, The Netherlands. ica beads mixing. The QMA Spherosil®
LS sorbent used here is transported
downward by temporarily reversing
6
2 the liquid flow as detailed in Figure 7.
9
Figure 8 shows that the pH has an
10
3
effect on the continuous adsorption
1
process. At pH 6, the adsorption phe-
nomenon is quicker and makes the
continuous separation of albumin pos-
sible, even from unfiltered cloudy solu-
5
7
tion. This represents a significant
8 advantage over packed bed chro-
4 matography.
Figure 7. Experimental set-up for fluidized bed
continuous adsorption.
1: column; 2: sorbent loading vessel; 3: sorbent
container; 4: sorbent collector; 5: pulsation unit;
6: sorbent inlet; 7: sorbent outlet; 8: liquid inlet;
9: liquid outlet; 10: sorbent transport water.
N
References
mg
C (g/L) a ( (
m2 S
b
1. Grandgeorge, N., Tayot, J.L., Proceedings
1.5 1.5 "Colloque technologie sur la purification des
pH 6
protéines", Paris (1984) 303.
pH 7
2. Tayot, J.L., et al., Proceeding IABS Congress,
Melbourne (1986).
1 1
3. Van der Wiel, Engineering Foundation confer-
ence, Uppsala, May 1986.
4. Cueille, G., Tayot, J.L., Proceeding Biotech'85,
0.5 0.5 Geneva (1986).
5. Veron, J.L., et al., Biotechnology of Blood
Proteins 227 (1993) 183.
1 5 9 Tray No. 1 5 9 Tray No.
Figure 8. Continuous adsorption of bovine serum
albumin on QMA Spherosil® LS in counter-current
column. Ordering Information
Buffer: 1 mM Tris-HCI, pH 8 or 7; Liquid flow:
49.8 ml/min; Sorbent flow: 1.54 ml/min. Product Cat. No.
(a) Steady-state concentration profile at different
pH. (b) Amount of protein adsorbed per plate. QMA Spherosil M ®
26165
QMA Spherosil® LS 26099
3

2200 Northern Boulevard
East Hills, New York 11548-1289
+1 800.717.7255 toll free
+1 516.484.5400 phone
+1 516.801.9548 fax
pharmafilter@pall.com
Europa House, Havant Street
Portsmouth PO1 3PD, United Kingdom
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com
BioSepra SA
48 avenue des Genottes
95800 Cergy Saint Christophe, France
+33 (0)1 34 20 78 00 phone
+33 (0)1 34 20 78 78 fax
PRODUCT NOTE
About BioSepra® Products & Collaborative
Services
BioSepra process chromatography sorbents are manu-
factured and marketed by Pall Life Sciences. They great-
ly simplify protein purification development and signifi-
cantly improve biopharmaceutical manufacturing pro-
ductivity.
Over the past 25 years, BioSepra® chromatography
products and services have earned an outstanding
reputation for product innovation and technical support.
Our expanded R&D sorbent program, ISO 9001 manu-
facturing plant and HyperCel™ sorbents represent our
latest commitment to the biopharmaceutical industry.
With the acquisition of BioSepra® products and services,
Pall combines chromatography development expertise
with Ciphergen®'s SELDI-based ProteinChip® technology
to set in motion an entirely new approach to protein
purification development.
This single-step, on-chip approach dramatically acceler-
ates and simplifies purification development and analy-
sis. The future of Process Proteomics begins with Pall.
Pall has the most comprehensive
family of scaleable separation products.
Visit us on the web at www.pall.com/biopharmaceutical
These products are for laboratory research use only and are not intended for human
or animal diagnostic, therapeutic, or other clinical uses, unless otherwise stated. The
information contained in this brochure are subject to change without notice.
Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand,
Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
, Pall, BioSepra, Spherosil, Hypercel are registered trademarks of Pall Corporation.
Filtration. Separation. Solution. and UpScale are service marks of Pall Corporation.
ProteinChip is a trademark of Ciphergen Biosystems, Inc.
LPN BT205101- 12/2004
4
 PRODUCT NOTE

HA Ultrogel®
Hydroxyapatite Chromatography Sorbent
• Effective purification mechanism in a variety of processes
• High porosity
• Easy cleaning
• Used in large scale step

Biosepra HA Ultrogel sorbent available from Pall

Table 1. HA Ultrogel Main Properties.
®

is a hydroxyapatite agarose composite sorbent

BIOSEPRA HA ULTROGEL

for the separation of biomolecules from research Particle size 60-180 µm

Hydroxyapatite content 40 %
and development scale to manufacturing.
Agarose (weight/volume) 4%
Hydroxyapatite chromatography is considered Exclusion limit > 5,000,000 dt
to be a “pseudo-affinity” chromatography, or Working pH 5-13
“mixed-mode” ion exchange. It has proven to Cleaning pH 5-14
Thermal stability 4-121°C
be an effective purification mechanism in a vari-
Capacity for cytochrome c* > 7 mg/ml
ety of processes, providing biomolecule selectiv-
Capacity for BSA** < 7 mg/ml
ity complementary to more traditional ion
exchange or hydrophobic interaction techniques. * Determined using 5 mg/ml cytochrome c diluted 50/50
HA Ultrogel is easy scaleable and is currently in 1 mM phosphate buffer, pH 6.8 at 30 cm/h.
used in research scale to multi-liter column ** Determined using 1 mg/ml BSA diluted 50/50 in 1 mM
phosphate buffer, pH 6.8 at 12.5 cm/h.
applications.
HA Ultrogel hydroxyapatite sorbent is com-
posed of cross-linked agarose beads with micro-
crystals of hydroxyapatite entrapped in the
agarose mesh. The particle size ranges between Figure 1. Separation of a mixture of ribonuclease and
®

60 and 180 µm. The agarose moiety in HA PHA-ELs.

Ultrogel is chemically stabilized with epichloro- PO4--- [M]
%T (282 nm)
hydrin under strongly alkaline conditions. Thus 0.5
50
HA Ultrogel can be regularly treated with 0.1-
1.0 M NaOH for regeneration and sanitization.
This creates glycerol bridges between the poly- Ribonuclease
0.3
PHA-ELs
saccharide chains and gives the sorbent beads
an excellent rigidity and stability to pH and
ionic strength changes, as well as to high tem- 0.1

perature.
10 40 80 100 ml
HA Ultrogel porosity is comparable to an
agarose gel, with an exclusion limit for globular Column: 1.6 x 6.5 cm; Sample: 1 mg of protein mixture
proteins of 5,000,000 daltons. This macroporos- composed of ribonuclease (MW 14,700) and PHA-ELs
(Erythroagglutinating and lymphostimulating Phyto-
ity avoids any moleculear sieving effect during hemagglutinin) (MW 128,000) from Phaseolus vulgaris, in
the separation (see figure 1). 1 ml of 5 mM potassium phophate, pH 6.8; Elution gradi-
ent: 5 mM to 500 mM potassium phosphate, pH 6.8;
The sorbent is shipped in 1 M NaCl containing
Flow rate: 14.4 cm/h.
20% ethanol and is available in a range of pack-
age sizes. Special packaging to meet specific
manufacturing requirements is available on
request.

1

Stability
The recommended flow rates to be used with
HA Ultrogel sorbent depend on the column
geometry and on the separation phase (cap-
ture, elution or washing steps). At process scale,
typical flow rates from 30 to 200 cm/h are cur-
rently applied with multi-liter column sizes.
Hydroxyapatite crystals are naturally resistant to
most chemical agents, except solutions with a
pH less than 4 and complexing agents.
®
BIOSEPRA HA ULTROGEL
Hydroxyapatite is dissolved by acidic solutions,
while EDTA, citrate and other complexing
agents decrease the adsorption capacity of the
resin. Complexing agents may be used in
extreme cases, e.g. when the desorption of cer-
tain compounds irreversibly bound to the
matrix is required.
HA Ultrogel sorbent is resistant to denaturing
agents: it can be treated with 8 M urea, 6 M
guanidine-HCl, 1% SDS and chaotropic agents
such as 3 M KSCN.
The agarose moiety of HA Ultrogel sorbent is
chemically stabilized by cross-linking with
epichlorohydrin in a strong alkaline medium.
HA Ultrogel sorbent is stable in alkaline condi-
®
tions, and can be regularly treated with 0.1 to
1M sodium hydroxide for regeneration and
depyrogenation. The chromatographic behav-
ior of the sorbent was not significantly modified
of after 5 weeks of incubation in 1M NaOH,
pH 13.
HA Ultrogel sorbent should not be treated with
solutions at pH <4 due to the nature of the
hydroxyapatite crystals.
HA Ultrogel sorbent is stable a high tempera-
ture (up to 121°C). It can be sterilized by auto-
claving without undergoing any changes to its
chromatographic properties. However, the
operation should be performed in buffered con-
ditions at pH 7 to avoid the presence of phos-
phate which may precipitate.
HA Ultrogel sorbent should never be frozen.
2
PRODUCT NOTE
Applications
Hydroxyapatite adsorption chromatography
can be used in a variety of applications, includ-
ing the separation of proteins, peptides and
nucleic acids,from pilot to production scale (see
figures 2, 3, 4).
For proteins, the most well-known application
of hydroxyapatite is the separation of basic pro-
teins (cytochrome c, lysozyme, etc.) and phos-
phoproteins. HA Ultrogel sorbent can be used
for the separation of human serum proteins
and plant proteins such as lectins, glycopro-
teins, glycosidases, phospholipidases, sulfohy-
drolases, sphingomyelinases, transferases, treha-
lases and kinases.
As a phosphate-containing sorbent, HA Ultrogel
can be used for the separation of phosphate-
dependent proteins and enzymes as well as
DNA-dependent enzymes.
HA Ultrogel sorbent provides an efficient tool
for IgG purification in a one step chromato-
graphic purification by separation with phos-
phate buffer. This approach is very mild (neutral
pH, physiological conditions) compared to tra-
ditional elution in acidic solutions, and pre-
serves the biological activity of the antibody.
HA Ultrogel has been used for the separation
of:
- Synthetic polypeptides (acidic polypeptides
such as poly-L-glutamate, poly-L-aspartate).
- Basic polypeptides such as poly-L-lysine, poly-
L-ornithine.
- Neutral polypeptides such as poly-L-proline.
It can be used for the separation of various
types of nucleic acids, including transfer RNA
and low molecular weight glyoxylated deriva-
tives of DNA, with reproducibility, stability and
reliability (see figure 2 and 3).
Figure 2. Separation of glycohydrolases from a crude enzyme Figure 4. Separation of trypsin and chymotrypsin from a porcine
extract of buckwheat. pancreatic enzyme extract.
A282 nm
PO---
4 [M]

Spec. Ac.
%T (282 nm)
0.8
70 tr.

0.15
ch.

20 200
0.5
90

10 100 0.05
1 2 3 4 5

0.2
e 30 60 ml

a b c d
Column: 1.6 x 5 cm; Sample: 30 mg protein in 1 ml of 5 mM phosphate
100 200 300 ml
buffer, pH 6.8; Gradient: 5 to 200 mM sodium phosphate, pH 6.8; Flow
Column: 2 x 6 cm; Sample: 40 mg of lyophilized extract in 1 ml of rate: 10 cm/h; Temperature: 10°C; Histogram with broken line: trypsin
1 mM phosphate buffer, pH 6.8; Discontinuous elution gradient of phos- activity; Histogram with solid line: chymotrypsin activity.
phate buffer; Flow rate: 7.1 cm/h; Temperature: 4°C. Peak a: proteins Spec. Ac.: specific activity in U/mg. tr: trypsin, ch: chymostrypsin.
with no glycohydrolase activity; peak b: β-glucosidase. Trypsin activity was primarily found in the peak eluted by 50 mM phos-
Courtesy of R. Rourbouze & F. Percheron, Biochemistry Lab., Faculty of phate where the chymotrypsin was eluted by 100 mM phosphate. The
Pharmacy, Paris. final yield was approximately 50%.

Figure 3. Purification of damage-specific DNA binding protein from References

human placenta.
1. Séné, C. et al., ChimicaOggi 8 (1990) 30.
Units/ml
Kphos (M) (103)
2. Galand, G., Biochim. Biophys. Acta 789 (1984) 10.
0.15 M 0.5 M
3. Huitorel, P. et al., Eur. J. Biochem. 144 (1984) 233.
A280 Kphos Kphos 4. Fournier, N. et al., Biochem. Biophys. Res. Commun. 111 (1983) 326.
5. Ek, K. et al., J. Biochem. Biophys. Meth. 8 (1983).
0.3 12 6. Rousson, R. et al., Biochimie 65 (1983) 115.
7. Nari, J. et al., Plant Sci. Lett. 28 (1983) 307.
0.5 8. Gegenheimer, P. et al., J. Biol. Chem. 258 (1983) 8365.
9. Ait, N. et al., J. Gen. Microbiol. 128 (1982) 569.
0.2 6 10. Nelson, W.J. and Traub, P., J. Biol. Chem. 257 (1982) 5544.
11. Verger, R. et al., Biochemistry 21 (1982) 6883.
0.3 12. Feldberg, R.S. et al., J. Biol. Chem. 257 (1982) 6394.
13. Leblanc, J.P. et al., J. Biol. Chem. 257 (1982) 3477.
0.1 2 14. Sim, R.B. and Discipio, R.G., J. Biochem. 205 (1982) 285.
15. Ryan, D.E. et al., Arch. Biochem. Biophys. 216 (1982) 272.
0.1
16. Degranges, C. et al., Biochim. Biophys. Acta 654 (1981) 211.
17. Rowe, T.C. et al., J.Biol, Chem. 256 (1981) 10354.
18. Akiki, C. et al., J. Chrom. 188 (1980) 435.
20 40 60 80 100 Frac.
19. Monsigny, M. et al., Eur. J. Biochem. 98 (1979) 39.
20. Monsigny, M. et al., Biochimie 60 (1978) 1315.
The sample was previously prepurified from human placenta by ammo-
nium sulfate precipitation, ion exchange chromatography and gel filtra-
tion.
Column: 2.5 x 6 cm; Initial buffer: 10 mM potassium phosphate, Ordering Information
pH 8 containing 5% glycerol and 13 mM 2-mercapto-ethanol;
1st elution (arrow): 0.15 M potassium phophate buffer; Product Cat. No. Size
2nd (arrow): 0.5 M potassium phosphate buffer; Fraction volume: 1.8
ml. ●—● A280 nm ■—■ DNA binding activity o—o conductivity. HA Ultrogel 24775-025 100 ml
Courtesy of R.S. Feldberg, et al., J. Biol. Chem. 257 (1982) 6394-401. 24775-017 500 ml
24775-041 1L
24775-058 10 L
24775-066 20 L

3

2200 Northern Boulevard
East Hills, New York 11548-1289
+1 800.717.7255 toll free
+1 516.484.5400 phone
+1 516.801.9548 fax
pharmafilter@pall.com
Europa House, Havant Street
Portsmouth PO1 3PD, United Kingdom
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com
BioSepra SA
48 avenue des Genottes
95800 Cergy Saint Christophe, France
+33 (0)1 34 20 78 00 phone
+33 (0)1 34 20 78 78 fax
Filtration. Separation. Solution . SM
4
PRODUCT NOTE
About BioSepra® Products & Collaborative
Services
BioSepra process chromatography sorbents are manu-
factured and marketed by Pall Life Sciences. They
greatly simplify protein purification development and
significantly improve biopharmaceutical manufacturing
productivity.
Over the past 25 years, BioSepra® chromatography
products and services have earned an outstanding
reputation for product innovation and technical support.
Our expanded R&D sorbent program, ISO 9001 manu-
facturing plant and HyperCel™ sorbents represent our
latest commitment to the biopharmaceutical industry.
With the acquisition of BioSepra® products and services,
Pall combines chromatography development expertise
with Ciphergen®'s SELDI-based ProteinChip® technolo-
gy to set in motion an entirely new approach to protein
purification development.
This single-step, on-chip approach dramatically acceler-
ates and simplifies purification development and analy-
sis. The future of Process Proteomics begins with Pall.
Pall has the most comprehensive
family of scaleable separation products.
Visit us on the web at www.pall.com/biopharmaceutical
These products are for laboratory research use only and are not intended for human
or animal diagnostic, therapeutic, or other clinical uses, unless otherwise stated. The
information contained in this brochure are subject to change without notice.
Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New
Zealand, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain,
Sweden, Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
, Pall, BioSepra, Ultrogel, Hypercel are registered trademarks of Pall Corporation.
Filtration. Separation. Solution. and UpScale are service marks of Pall Corporation.
ProteinChip is a trademark of Ciphergen Biosystems, Inc.
LPN BT200909 - 12/2004
 PRODUCT NOTE

Trisacryl GF05 M, LS®

Size Exclusion Chromatography Sorbents

Trisacryl® GF05 sorbent is composed of a Figure 1: Chemical structure of Trisacryl GF05 sorbents.
highly hydrophilic copolymer designed
BioSepra Trisacryl GF05

for medium pressure gel filtration chro-

CH2OH CH2OH
matography. I I
Trisacryl® GF05 is designed for desalting NH – C – CH2OH NH – C – CH2OH
I I I I
and for the separation of small molecules. CO CH2OH CO CH2OH
Trisacryl® GF05 provides a wide range of I I
advantages over existing gels : – CH – CH2 – CH – CH2 – CH – CH2 – CH – CH2 –
I I
■ High separation efficiency. CO CH2OH CO CH2OH
I I I I
■ Large desalting capacity, up to 33% NH – C – CH2OH NH – C – CH2OH
®

of the gel volume. I I

■ Small particle size (40-80 µm for M CH2OH CH2OH
grade) with narrow bead size distribu-
tion for laboratory use.
■ Large particle size (80-160 µm for LS

grade) for fractionation at high flow Table 1. Main properties of Trisacryl GF05 sorbents.
with low pressure, designed for industri-
Particle size .......................................... M grade: 40 - 80 µm
al scale. LS grade: 80 -160 µm
■ Ready and easy to use.
Exclusion limit ....................................... 3,000 dt*
■ High flow rates.
Linear fractionation range ........................ 200 -2,500 dt
■ Non biodegradable.
Resolution power ................................... 2,500 plates/m
■ Highly stable in acidic media. Desalting capacity .................................. 33 % gel volume
These characteristics allow Trisacryl® Pressure resistance .................................. up to 3 bar (44 psi)
®

GF05 sorbents to perform chromato- Stability to detergents and dissociating agents .. Excellent
graphic separations quickly and with Thermal stability ..................................... Up to 121°C
great selectivity under medium pressure, pH stability ........................................... 1 - 11
sterile conditions, and in the absence
* Calculated on the basis of a standard experimental curve.
of any non-specific interactions with
the matrix.

Chemical composition and Porosity.

structure. The modification of relative concentrations of the monomer and
the cross-linking agent allow precise control of Trisacryl® GF05
Trisacryl GF05 is a highly hydrophilic
®

porosity.
copolymer formed by the copolymeriza-
tion of N-acryloyl-2-amino-2-hydrox- The exclusion limit of Trisacryl® GF05 (determined using oligonu-
ymethyl-1,3-propanediol, and a hydrox- cleotides) is 3,000 dt.
ylated acrylic bifunctional monomer. Close control over the polymerization reaction guarantees not
See chemical structure in Figure 1. only a regular porosity inside each bead, but also excellent repro-
The molecule features a high degree of ducibility from lot to lot.
hydrophilicity contributed by a second-
ary amide group, and by the presence
of three primary hydroxymethyl groups
per repeating unit.

1
 PRODUCT NOTE

Chemical stability. Figure 2. Flow rate variation of a Trisacryl GF05 M column as

a function of pressure.
Trisacryl® GF05 is insoluble in chromatographic sol-
vents commonly used in biochemistry (8 M urea, 6 M
guanidine), as well as in detergents (Triton X-100,
200

Flow rate (cm/h)

SDS, lubrol, ...).
Trisacryl® GF05 is resistant to acid treatments, mak-
ing it an ideal matrix for peptide separations which 100
require the use of acetic or hydrochloric acids. The
BioSepra Trisacryl GF05

matrix is not modified by incubation in the presence

of 1 M HCl for several hours. However, Trisacryl®
1 2 3 (bar)
GF05 is sensitive to strong alkaline agents such as
sodium hydroxide. Sensitivity to alkaline medium is 10 20 30 40 (psi)
Pressure
minimal in 0.1 M NaOH at +4ºC for a maximum of
one hour. If the NaOH concentration or the temper- Column dimensions : 1.4 cm I.D. x 10 cm. The column was packed
ature are increased, the sorbent undergoes progres- under pressure from 0 to 2 bar; Flow rates were measured under pres-
sive hydrolysis of amide groups to give carboxyl sures from 2 to 0 bar.

groups. This will introduce some ion exchange

®

properties.

Thermal stability. column for a molecule eluted in the total available

Trisacryl® GF05 is stable at high temperature (up to
+121ºC). It can be sterilized by autoclaving without
undergoing any change in its chromatographic
properties. However, the operation must be per-
formed in buffered conditions, pH 7 in the absence
of oxidizing agents.
Mechanical stability.
Due to its chemical composition which imparts
rigidity, Trisacryl® GF05 is resistant to pressures up to
®
gel volume).
The resolution power of Trisacryl® GF05 depends on
the flow rate and varies with the molecular size of
the product used. The flow rate needed to obtain
optimal separation ranges from 2 to 3 cm/h.
Because the height equivalent of a theoretical plate
(HETP) increases very slowly as a function of flow
rate (2-3 times less rapidly than with soft sorbents),
Trisacryl® GF05 provides excellent resolution power
for proteins (see Figure 3).

2-3 bar. This exclusive property permits elevated

flow rates.

Resistance to micro-organisms. Figure 3. HETP variation of Trisacryl GF05 M (height equiv-

alent to a theoretical plate) as a function of the flow rate.
Due to its synthetic matrix, Trisacryl GF05 is resist-
®

ant to microbial and enzymatic degradation.

HETP (mm)

1.0

Fractionation range. 0.8

The effective fractionation range for Trisacryl® GF05
is between 200 and 2,500 dt. This was determined 0.6

with globular proteins below 1000 Kd and extrapo- 0.4

lates up to the exclusion limit.
0.2
Resolution power.
The resolution power of the M grade of Trisacryl® 0 5 10 15
GF05 (expressed by the number of theoretical plates Flow rate (cm/h)
per meter of column under normal running condi-
Column: 1.6 cm I.D. x 36 cm. Sample : 5 mg NAD (nicotinamide ade-
tions) is relatively high — about 2,500 plates per nine dinucleotide, MW 700) in 1 ml buffer; Buffer: 0.1 M phosphate
meter or HETP (height equivalent to a theoretical buffer, pH 7.4 containing 0.5 M NaCl; Temperature: +20ºC.
plate) = 0.4 mm (value obtained using a 40 cm

2
Applications Figure 4. Steps from an automatic desalting of Fractionation and purification of bio-
human plasma on a Trisacryl GF05 LS column. logical molecules on Trisacryl® GF05.
Desalting on Trisacryl® GF05. Trisacryl® GF05 permits the separation
Trisacryl GF05 is particularly suitable to
®
of a variety of complex mixtures (see
rapid desalting of large solution volumes. Figure 6) such as :

D.Pl.

D.Pl.

D.Pl.

D.Pl.

D.Pl.

D.Pl.

D.Pl.

D.Pl.

D.Pl.

D.Pl.
■ Pressure resistance allows high flow - Polypeptides
rates. - Oligonucleotides
1 2 3 4 5 6 7 8 9 10 Cycles
■ Provides a low dilution factor (about - Oligosaccharides
1.05 - 1.1). Column dimensions: 44 cm I.D. x 40 cm (60 L of gel); - Small proteins
■ Provides large desalting capacity (up
Buffer: 0.05 M Tris-HCl, pH 8.4; Flow rate: 80 L/h; - Polynucleotides
Sample volume: 12.5 L; Desalting time per cycle: 75
- Small water-soluble polymers
to 33% gel volume). min (including equilibration time). Volume/h: 1.3.
Pressure: 0.7 bar (average). D.Pl. = desalting plasma The best resolution is obtained with a
These desalting properties are illustrated fraction. (Courtesy of Mr. J. Saint-Blancard, CTSA
sample volume between 0.5 and 4% of
by the results obtained in the use of Clamart, France).
gel volume.
Trisacryl® GF05 for human plasma frac-
tionation: 17 L of human plasma were
FIgure 6 : Fractionation of peptides obtained
run through a 60 L Trisacryl® GF05 col-
from trypsin hydrolysis of bovine thyroglobulin.
umn (44 cm I.D. x 40 cm) and desalted Determination of the molecular
within 1.5 hour. Linear flow rate was weight of an unknown molecule.

Conc.
35 cm/h, corresponding to a volumetric The measurement of molecular weight
flow rate of 36 L/h. The volume of can be performed by comparing the
desalted plasma was 18 L, correspon- Kav of the studied molecule to the Kav
ding to a dilution factor of 1.059. relative to standard molecular markers
Similar results are illustrated in Figure 4. obtained on Trisacryl® GF05 selectivity
Trisacryl® GF05 can be applied to sever- curve (see Figure 5). In this case, it is
0
al other "desalting" operations such as important to notice that the selectivity 20 40 60 80 ml

removal of small aromatic molecules, curve must be determined using mole- Buffer: 0.1 M KH2PO4, 0.15 M KCl, pH 7.4; Sample:
separation of fluorochromes after pro- cules from the same species as the stud- 1 ml. U.V; Detection: 280 nm; Flow rate: 11.5 cm/h;
tein labelling, elimination of detergents Column: 1.6 x 45 cm; Experiment time: 8 hours.
ied molecule. For example, the stan-
in protein solutions, separations of sug- dard molecules must be performed with
ars, elimination of peptides. known oligosaccharides if the studied
Trisacryl® GF05 has an appreciable time molecule is a sugar. References
advantage over dialysis for desalting.
1. Brown, E., et al., Proc. Int. Symp. Aff. Chromatogr.,
Desalting by gel chromatography is Strasbourg (1979) 37.
presently the only available method for Figure 5. Selectivity curve determined using a 2. BoschettI, E., et al., Sci. Tools 30 (1983) 27.
mixture of 5'-TMP oligomers on Trisacryl GF05. 3. Girot, P., et al., J. Chromatogr. 213 (1981) 389.
removing salts from very labile biologi-
4. Pasero, L., et al., Biochim. Biophys. Acta 869
cal substances. Vo 2 (1986) 147.
3
Specially designed for preparative chro-
1 5. De Caro, A., et al., Biochem. J. 222 (1984) 669.
4
Kav 5
6. Eloy, C., et al., J. Chromatogr. 321 (1985) 235.
matography, Trisacryl® GF05 LS offers 1 6 7. Iberg, N., et al., J. Biol. Chem. 261 (1986) 13542.
increased flow rate, while retaining the .8 8. Viallard, J.L., et al., Clin. Chim. Acta 161 (1986) 1.
properties of Trisacryl® GF05 M. 2 Ve 9. Saint-Blancard, J., et al., Proc. Int. Symp. Aff.
.6 Chromatogr., Veldhoven (1981) 305.
3
Flow rates over 80 cm/h are commonly
4
used for this type of gel in installations .4
5
using columns of 50 to 200 L, with 6 Ordering Information
.2
backpressures less than 1 bar (see Product Cat. No. Size
Figure 4).
3 4 5 6 7 8 9 10 20 MW 103
Trisacryl GF 05 M 25914-060 100 ml
The range of molecular weight exploited ranges 25914-037 1L
between 306 (monomer) and 1836 (hexamer). 25914-045 10 L
Column: 1.6 cm I.D. x 40 cm; Sample volume: 1 ml; Trisacryl GF 05 LS 25916-040 100 ml
Buffer: 0.05 M Tris-HCl, pH 7.4 containing 0.17 M 25916-016 1L
sodium chloride; Linear flow rate: 5 cm/h. The insert 25916-032 10 L
represents the complete chromatogram obtained.

3

2200 Northern Boulevard
East Hills, New York 11548-1289
+1 800.717.7255 toll free
+1 516.484.5400 phone
+1 516.801.9548 fax
pharmafilter@pall.com
Europa House, Havant Street
Portsmouth PO1 3PD, United Kingdom
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com
BioSepra SA
48 avenue des Genottes
95800 Cergy Saint Christophe, France
+33 (0)1 34 20 78 00 phone
+33 (0)1 34 20 78 78 fax
PRODUCT NOTE
About BioSepra® Products & Collaborative
Services
BioSepra process chromatography sorbents are manu-
factured and marketed by Pall Life Sciences. They great-
ly simplify protein purification development and signifi-
cantly improve biopharmaceutical manufacturing pro-
ductivity.
Over the past 25 years, BioSepra® chromatography
products and services have earned an outstanding
reputation for product innovation and technical support.
Our expanded R&D sorbent program, ISO 9001 manu-
facturing plant and HyperCel™ sorbents represent our
latest commitment to the biopharmaceutical industry.
With the acquisition of BioSepra® products and services,
Pall combines chromatography development expertise
with Ciphergen®'s SELDI-based ProteinChip® technology
to set in motion an entirely new approach to protein
purification development.
This single-step, on-chip approach dramatically acceler-
ates and simplifies purification development and analy-
sis. The future of Process Proteomics begins with Pall.
Pall has the most comprehensive
family of scaleable separation products.
Visit us on the web at www.pall.com/biopharmaceutical
These products are for laboratory research use only and are not intended for human
or animal diagnostic, therapeutic, or other clinical uses, unless otherwise stated. The
information contained in this brochure are subject to change without notice.
Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand,
Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
, Pall, BioSepra, Trisacryl, Hypercel are registered trademarks of Pall Corporation.
Filtration. Separation. Solution. and UpScale are service marks of Pall Corporation.
ProteinChip is a trademark of Ciphergen Biosystems, Inc.
LPN BT202915 - 12/2004
4
 PRODUCT NOTE

Ultrogel AcA ®

Size Exclusion Chromatography Sorbents

• High resolution
• Semi-rigid particles
• Narrow particle size distribution
• Narrow pore size distribution
BIOSEPRA ULTROGEL AcA

Table 1. Main Properties of Ultrogel AcA Sorbents.

AcA 22 AcA 34 AcA 44 AcA 54 AcA 202

Particle size (µm) 60-140 60-140 60-140 60-140 60-140

Acrylamide (%) 2 3 4 5 20
Agarose (%) 2 4 4 4 2
Exclusion limit (dt)* 3,000,000 750,000 200,000 90,000 22,000
®

Linear fractionation range (dt) 100,000-1,200,000 20,000-350,000 10,000-130,000 5,000-70,000 1,000-15,000

Resolution power (plates/m) 1,500 1,500 1,500 1,500 3,000
Desalting capacity - - - - 45% gel vol.
Working pH 3-10 3-10 3-10 3-10 3-10

BioSepra Ultrogel AcA sorbents from Pall® are a
range of composite sorbents for size exclusion
of biological macromolecules. They consist of
polyacrylamide and agarose gel matrix and pos-
sess good mechanical and chromatographic
properties when compared to classical size
exclusion sorbents. They are suitable for medi-
®
34 sorbent contains 3% polyacrylamide (Ac)
and 4% agarose (A). The particle size is com-
prised between 60 and 140 µm.
In addition to the superior physicochemical
properties of Ultrogel AcA, this sorbent provides
excellent separation efficiency, demonstrated by
the low HETP (Height Equivalent to a

um and large scale applications. The principal
characteristics of Ultrogel AcA are a narrow par-
ticle size distribution and a narrow pore size dis-
tribution. The particles are semi-rigid.
These characteristics combine to provide high
resolution at high flow rates. In addition,
Ultrogel sorbents can be simply and rapidly
packed. Ultrogel AcA sorbents offer a choice
between maximum resolution at recommended
flow rates or rapid separations at higher flow
rates with minimal loss of resolution. Five differ-
ent types of Ultrogel AcA are available allowing
the fractionation of molecules with molecular
weights ranging from 1,000 and 1,200,000.
The sorbent is mainly dedicated for fractiona-
tion, purification and molecular weight purifica-
tion.
The concentration of polyacrylamide and
agarose in the Ultrogel AcA beads vary with the
sorbent designation. For instance, Ultrogel AcA
Theoretical Plate). The HETP of approximately
0.15 mm corresponds to over 1,500 theoretical
plates per meter; excepted for Ultrogel AcA 202
the HETP is 0.3 mm (eq. 3,000 plates per
meter). There are only moderate HETP varia-
tions as a function of flow rate.
In order to obtain optimum separation of the
sample components, Ultrogel AcA sorbent
should be chosen so that the molecular weights
of all sample solutes to be purified fall within its
fractionation range. If the molecular weights
are unknown, the optimum sorbent type can
be determined on an analytical scale empirically.
The sorbents are shipped in 1 M sodium chlo-
ride containing 20% ethanol* and are available
in a range of package sizes. Special packaging
to meet specific manufacturing requirements is
available on request.
* Ultrogel AcA 202 is supplied in 1 M sodium chlo-
ride, 20% ethanol and 5 mM EDTA.

1

Stability
Ultrogel AcA sorbents are semi-rigid particle
sorbents, which possess good mechanical prop-
erties. They can be used at high flow rate while
maintaining a good resolution.
Ultrogel AcA sorbents are chemically stable in
buffer solutions between pH 3 and 10. Any
conventional buffer for biochemical separation
purposes can be used. A high concentration of
denaturing agents such as urea or guanidine
hydrochloride, or detergents such as SDS,
BIOSEPRA ULTROGEL AcA
should be avoided. As with all gel fractionation
sorbent, the disruptive influence of such addi-
tives should be checked in each case. The
buffers used should have an ionic strength of at
least 0.05 M to minimize non-specific adsorp-
tion or ion exchange effects between the sam-
®
ple proteins and the sorbent matrix.
Detergents and denaturing agents may be used
as eluants only in restricted conditions: guani-
dine hydrochloride should be used at a maxi-
mum concentration of 2 M. Urea is a denatur-
ing agent comparable to guanidine. It can be
currently used at 2 M. SDS, Triton X-100, DOC,
Rennex and other detergents can be used with-
out significant modifications of the sorbent
properties.
Ultrogel AcA sorbent should be used between
2ºC and 36ºC; a temperature below 0°C is not
®
advised. Ultrogel AcA sorbent cannot be auto-
claved, as this may decompose the agarose.
Applications
The main applications of Ultrogel AcA are:
- Fractionation and purification of biological
molecules by size exclusion,
- Determination of molecular weights,
- Desalting.
Ultrogel AcA sorbents allow the separation of
components of a complex mixture by size
exclusion. The fractionation range is comprised
between 1,000 and 12,000,000 daltons. Each
type of sorbent has a specific molecular
weight/fractionation range.
● Determination of molecular weights
Molecular weights of proteins may be reliably
determined by choosing an Ultrogel AcA sor-
bent which has the required fractionation
2
PRODUCT NOTE
Figure 1. Determination of a selectivity curve for
Ultrogel AcA 54 using a mixture of known proteins.
a
Conc.
b d
Kav
e
c
0.6 a
d 20 40 60
0.4
c
0.2
b
1 2 3 4 5 6 7 8
MW (x104)
Column: 1.6 x 40 cm; Buffer: 0.05 M Tris-HCl, pH 7.4
containing 0.17 M sodium chloride: sample constituted of
Blue-Dextran 2000 (a) for the determination of the void
volume; Bovine serum albumin (b) (MW 68,000); ß-lacto-
globulin (c) (MW 35,000); Myoglobin (d) (MW 17,800);
And cytochrome c (e) (MW 12,400) ; Sample volume:
0.6 ml; Flow rate: 4.8 cm/h. The insert represents the elu-
tion curve.
range. The first step in the process consists in
the determination of a selectivity curve with
known standard proteins. The second step con-
sists in the size exclusion of the studied protein
and the comparison of its elution volume or its
Kav with the selectivity curve (see figure 1).
● Desalting
The term is used to describe the separation of
substances present in a solution into 2 groups :
one consisting of the macromolecules which
are totally excluded from the sorbent, and the
other consisting of the low molecular weight
components which diffuse into the sorbent net-
work. Ultrogel AcA 202 sorbent is dedicated to
this application (see figure 2).
1. Separation of salts
If the separation of proteins from salts is opti-
mized, very large volumes may be processed.
The sample volume must theoretically corre-
spond to the difference between the total sor-
bent volume and the void volume (generally
60% of the sorbent volume). For sorbents tra-
ditionally used for desalting, the recommend-
ed sample volume is only 30% of the sorbent
Figure 2. Example of desalting using Ultrogel AcA 202. Since it is a mild process, size exclusion desalting is some-
times the only technique which can be employed for the
UV detection
Salt concentration detection
total removal of salts from highly unstable biological macro-
Conc.

A molecules. It should also be noted that desalting is the only

technique which can be used for rapid buffer exchange of a
protein solution. This is done simply by passing the protein
solution through an Ultrogel AcA 202 column reequilibrated
with the new buffer.
300 600
Conc.

B
● Affinity
Ultrogel AcA also provide excellent supports for the prepara-
tion of derivatives for use in affinity chromatography. The
quality of the agarose used in the manufacture of these sor-
bents results in an almost total absence of the non-specific
300 600
adsorption's which are frequently encountered with compet-
Conc.

C itive sorbents of this type. The regular size distribution of

0 300 600
Column: 5 x 37 cm; volume: 730 ml; Sample: bovine serum albumin
(5 mg/ml) containing NaCl (6.5 mg/ml); Flow rate: 7 cm/h (i.e. 140
ml/h). Sample volumes: A = 36 ml (5 % of sorbent volume); B = 220
ml (30 % of sorbent volume); C = 327 ml (45 % of sorbent volume);
280 nm U.V. detection.
Ultrogel AcA particles, coupled with their mechanical rigidi-
ty, allows their use for extended periods of time with no sig-
nificant decrease in flow rate. The large pore sizes also allow
high coupling capacities to be achieved. The Ultrogel AcA
sorbent most commonly used in affinity chromatography is
Ultrogel AcA 22. The principal activation methods used for
attaching a spacer arm or for immobilizing a ligand directly
onto the sorbent involve the following reagents: glutaralde-
hyde, cyanogen bromide, epichlorohydrin, bis-epoxiranes,
benzoquinone, divinylsulfone or periodate.

volume. Because the peak broadening is limited with Ultro-

gel AcA 202 sorbent, as a result of the regularity of the
References
particles and the pores, the sample volume on AcA 202
sorbent may be as high as 40% of the sorbent volume, or 1. Gomi, K. and Jajiyama, N., J. Biol. Chem. 276/33 (2001) 36508.
even 45% under certain circumstances. Similarly, the con- 2. Sehgal, N. and Goswami, S., Indian J. Biochem. Biophys. 38/4 (2001) 263.
3. Knutson, V.P. et al., J. Immunol. Meth. 145 (1991) 263.
centration of each component in the sample may be as 4. Diesterhaft, M., Biochem. Biophys. Res. Commun. 125/3 (1984) 888.
high as 40 g/L without affecting the desalting quality. 5. Boschetti, E. et al., Biochimie 54 (1972) 439.

2. Removal of various reagents

In addition to the removal of salts, desalting can be extend- Ordering Information
ed to :
- Removal of low molecular weight sugars (e.g. lactose from Product Cat. No. Size
whey).
Ultrogel AcA 22 23013-014 1L
- Removal of small aromatic compounds (e.g. phenol during Ultrogel AcA 22 23013-030 10 L
the purification of nucleic acids).
Ultrogel AcA 34 23015-019 1L
- Removal of fluorescent or radioactive compounds (e.g. flu- Ultrogel AcA 34 23015-035 10 L
orescein, rhodamine and I125 during the general labelling
Ultrogel AcA 44 23022-015 1L
of proteins). Ultrogel AcA 44 23022-031 10 L
- Removal of certain detergents used for the solubilizing
Ultrogel AcA 54 23019-011 1L
proteins (SDS, urea, guanidine salts). Ultrogel AcA 54 23019-045 10 L
In all cases, desalting with Ultrogel AcA 202 sorbent is supe- Ultrogel AcA 202 24892-010 1L
rior to classical dialysis because of the considerable savings Ultrogel AcA 202 24892-036 10 L
in time, the very low degree of dilution, and high recovery.

3

2200 Northern Boulevard
East Hills, New York 11548-1289
+1 800.717.7255 toll free
+1 516.484.5400 phone
+1 516.801.9548 fax
pharmafilter@pall.com
Europa House, Havant Street
Portsmouth PO1 3PD, United Kingdom
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com
BioSepra SA
48 avenue des Genottes
95800 Cergy Saint Christophe, France
+33 (0)1 34 20 78 00 phone
+33 (0)1 34 20 78 78 fax
PRODUCT NOTE
About BioSepra® Products & Collaborative
Services
BioSepra process chromatography sorbents are manu-
factured and marketed by Pall Life Sciences. They great-
ly simplify protein purification development and signifi-
cantly improve biopharmaceutical manufacturing pro-
ductivity.
Over the past 25 years, BioSepra® chromatography
products and services have earned an outstanding
reputation for product innovation and technical support.
Our expanded R&D sorbent program, ISO 9001 manu-
facturing plant and HyperCel™ sorbents represent our
latest commitment to the biopharmaceutical industry.
With the acquisition of BioSepra® products and services,
Pall combines chromatography development expertise
with Ciphergen®'s SELDI-based ProteinChip® technology
to set in motion an entirely new approach to protein
purification development.
This single-step, on-chip approach dramatically acceler-
ates and simplifies purification development and analy-
sis. The future of Process Proteomics begins with Pall.
Pall has the most comprehensive
family of scaleable separation products.
Visit us on the web at www.pall.com/biopharmaceutical
These products are for laboratory research use only and are not intended for human
or animal diagnostic, therapeutic, or other clinical uses, unless otherwise stated. The
information contained in this brochure are subject to change without notice.
Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand,
Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
, Pall, BioSepra, Ultrogel, Hypercel are registered trademarks of Pall Corporation.
Filtration. Separation. Solution. and UpScale are service marks of Pall Corporation.
ProteinChip is a trademark of Ciphergen Biosystems, Inc.
LPN BT200912 - 12/2004
4
 PRODUCT NOTE

MEP HYPERCEL®
Hydrophobic Charge Induction Chromatography (HCIC) Sorbent
• Specially designed for purification of antibodies.
• Direct sample loading without any adjustment of pH or ionic strength.
• High purity achieved in a single step.
• High IgG capacity, independent of subclass or species.
®
BIOSEPRA MEP HYPERCEL

• Easy cleaning with sodium hydroxide.

MEP HYPERCEL is a high capacity, high selec- TABLE 1 : MEP HYPERCEL Main Properties.
tivity sorbent specially designed for the cap-
ture and purification of monoclonal and Particle size 80-100 µm
polyclonal antibodies. Dynamic binding capacity for ≥ 20 mg/ml
MEP HYPERCEL supports efficient capture and hu IgG* (10% breakthrough)
purification of antibodies from a broad Ligand 4-Mercapto-Ethyl-Pyridine
range of sources, such as animal sera, ascites Ligand density 70-125 µmol/ml
fluid and cell culture supernatant. A variety Working pH 3 -12
of cell culture formulations are readily accom- Cleaning pH 3 -14
modated, including protein-free, albumin-
Pressure resistance < 3 bar (44 psi)
supplemented and serum-supplemented
Typical working pressure < 1 bar (14 psi)
media. In contrast to Protein A sorbents, IgG
binding capacity on MEP HYPERCEL is essen-
* Determined using 5 mg/ml human IgG in PBS, flow rate:
tially independent of subclass or species. 60 cm/h.
"Weakly-binding" variants (e.g., murine IgG1)
are well retained.
®

MEP HYPERCEL provides significant benefits at

both laboratory and process-scale :

• Sample preparation is reduced to clarifi-
cation.
- Feedstock may be applied without adjust-
ment. Binding occurs at neutral pH, and is
independent of ionic strength. No need to
add lyotropic or other salts.
- Concentration of dilute samples is not
necessary. Efficient capture is achieved
even with feedstocks as dilute as ~50-100 µg
IgG/ml.
- Gentle elution reduces the risk for antibody
aggregation and eliminates the need for
desalting or diafiltration. A simple lower-
ing of the pH to 4, at low ionic strength,
will elute the antibody.
• Chemically stable to base.
- Easy long term cleaning with 1 M sodium
hydroxide gives this material a significant
advantage over Protein A-based sorbents.

• Rapid and efficient sample processing. MEP HYPERCEL is supplied in 1 M NaCl con-
- Large volumes of sample can be processed taining 20% ethanol and is available in a
rapidly and efficiently. Dynamic binding range of package sizes. Custom packaging
capacities ≥ 30 mg IgG per ml of sorbent to meet specific manufacturing require-
(at 10% breakthrough) are routinely ments is available on request.
achieved.
- High purity in one step. Product purities
of 70-90%, or greater, are typically
achieved.

1
 Hydrophobic Charge Induction
Chromatography Mechanism
Hydrophobic Charge Induction Chromato-
graphy (HCIC) is based on the pH-dependent
behavior of ionizable, dual-mode ligands.
MEP HYPERCEL carries an antibody-selective
ligand, 4-Mercapto-Ethyl-Pyridine (4-MEP).
As shown in figure 1, adsorption is based on
mild hydrophobic interaction, and is
achieved without addition of lyotropic or
®
other salts. Desorption is based on charge
BIOSEPRA MEP HYPERCEL
repulsion. It is performed by reducing the
pH.
In contrast to traditional hydrophobic inter-
action chromatography, HCIC is controlled
on the basis of pH rather than salt concen-
tration. Antibody elution is conducted at
low ionic strength, eliminating the need for
extensive diafiltration in applications where
ion exchange chromatography will follow
capture. Compared to chromatography on
Protein A sorbents, elution from MEP
HYPERCEL is achieved under relatively mild
conditions (pH 4.0). Thus, aggregate forma-
tion is reduced and antibody activity is pre-
served.
BIOSEPRA MEP HYPERCEL is composed of
cellulose matrix to which 4-Mercapto-Ethyl-
Pyridine (4-MEP) is linked. The cellulose
bead confers high porosity, chemical stabili-
ty and low non-specific interaction. Bead
size is 80-100 µm to allow a good compro-
®
mise between capacity and flow property.
4-MEP was chosen for its high selectivity
and capacity for antibodies, and for its pKa
which is 4.8. It contains a hydrophobic tail
and an ionizable headgroup. At physiologi-
cal pH, the aromatic pyridine ring (figure 2)
is uncharged and hydrophobic. Additional
contributions to binding are provided by
the aliphatic spacer arm. Antibody binding
is further enhanced by interaction with the
thioether group. Both ligand structure and
ligand density are designed to provide
effective binding in the absence of lyotropic
or other salts.
When pH of the mobile phase is adjusted to
values below 4.8 (typically pH 4.0), the
ligand takes on a distinct positive charge.
Under such conditions, antibody molecules
also carry a positive charge. Electrostatic
repulsion is induced and antibody is
desorbed.
2
Figure 1. Adsorption elution mechanism.
ADSORPTION HIC
(hydrophobic
association)
DESORPTION
(ionic repulsion)
Figure 2. MEP HYPERCEL head group.
S
N
4-Mercapto-Ethyl-Pyridine
(4-MEP)
pKa = 4.8
Capacity
The binding capacity specification for MEP
HYPERCEL is ≥ 20 mg human IgG/ml sorbent.
As shown below, however, dynamic binding
capacity values ≥ 30 mg/ml are more typical
in practical application.
Compared to Protein A sorbents, MEP
HYPERCEL is remarkably independent of feed-
stock composition. Likewise, binding capaci-
ty for IgG variants is largely independent of
subclass or species.
• Capacity and pH
The influence of pH on binding capacity is
illustrated in figure 3. The relationship is
consistent with the chromatographic mech-
anism described above. At pH values from 7
to 9, the binding capacity for human poly-
clonal IgG ranges from 25 to 33 mg/ml. At
pH 6.5, binding capacity is ~20 mg/ml. As
pH is reduced further toward the pKa of
4-MEP, there is a distinct decline in binding
capacity as the ligand – and antibody – take
on increasing positive charge. At pH 4.0,
antibody is entirely unretained in most
applications.
The data demonstrate that high binding
capacity is achieved at pH values represen-
tative of typical feedstocks. Precipitation,
sometimes observed during adjustment of
feedstock pH, is thus avoided.
During chromatography on Protein A sorbents, elution Preliminary concentration is not required. Indeed, har-
of antibody at pH 3 frequently leads to aggregation and vest and concentration of antibody on MEP HYPERCEL
loss of activity. Elution from MEP HYPERCEL is achieved can be used to replace traditional concentration proce-
under milder conditions. dures. Concentration and initial purification can be
achieved in a single step.
• Capacity and ionic strength
A plot demonstrating the influence of ionic strength on • Capacity for IgG variants
binding capacity is shown in figure 3. Dynamic binding The data in table 2 illustrate that binding capacity for
capacity was determined in the presence of sodium IgG is little influenced by subclass or species. In contrast
chloride, at concentrations ranging from 50 mM to 1 M. with Protein A sorbents, there is no significant difference
Binding capacity is constant over this range. between capacity for murine IgG2a and the IgG1, the
Such behavior is typical at pH values where the ligand later being "weakly bound" by Protein A.
carries little or no charge (e.g., pH 6.5-9.0). The data MEP HYPERCEL is "antibody selective". Nevertheless, its
demonstrate that typical feedstock may be loaded selectivity is sufficiently broad to provide high binding
without adjustment of ionic strength. Neither diafiltra- capacity for a broad range of IgG variants.
tion nor addition of lyotropic salt is required. Viscous
feedstocks such as animal sera or ascites fluids may be
diluted. Purity
Antibodies are eluted using dilute buffer (e.g., 50 mM When antibody is isolated from protein-free cell culture
sodium acetate or sodium citrate, pH 4). supernatant using MEP HYPERCEL, product of >90% puri-
ty (SDS-PAGE) is typically obtained. In the example
• Capacity and antibody concentration shown in table 3, product of 99% purity was recovered
The influence of IgG concentration on dynamic binding
capacity is illustrated in figure 4. Concentration ranges TABLE 2. MEP HYPERCEL Capacities.
from 50 µg/ml to 5 mg/ml. No significant variation in
Binding capacity
capacity is observed. MEP HYPERCEL supports efficient
capture of antibody from highly dilute feedstock. Human polyclonal IgG 32 mg/ml
Murine monoclonal IgG1 (from ascites fluid) 37 mg/ml
Murine monoclonal IgG2a (from cell culture) 34 mg/ml
Figure 3. Influence of pH and ionic strength on the binding
capacity of MEP HYPERCEL.
Figure 4. Influence of human IgG concentration on the binding
A B capacity of MEP HYPERCEL.
DBC at 10% breakthrough
(mg/ml)

35 35
DBC at 10% breakthrough
(mg/ml)

25 25 40

30
15 15

20
5 5
10
4 5 6 7 8 9 10 0 0.2 0.4 0.6 0.8 1

pH NaCl (M) 0 1 2 3 4 5

IgG capacities obtained at 10% breakthrough on MEP HYPERCEL vs. pH (A) and IgG (mg/ml)
ionic strength (B) of the binding buffer. Experimental conditions : Column 1.1 cm
ID x 9 cm ; Sample : IgG (2 mg/ml) ; Flow rate: 90 cm/h. Working buffer : PBS, pH 7 ; Flow rate : 70 cm/h.

TABLE 3. Examples of Purifications on MEP HYPERCEL.

Total proteins IgG content IgG initial Final IgG Recovered Overall IgG Purification
Feedstock (mg) (mg) purity (%) purity (%) IgG (mg) yield (%) factor
CCS* with FBS 1740 30 1.7 69 23 76 40
Protein-free CCS* 330** 17 5** 99 17 99 19**
Bovine serum 440 121 28 75 105 87 3
Ascites fluid 55 9 16 83 7 79 5

* CCS = Cell culture supernatant ** BCA methodology

3
in a single chromatographic step. Isolation included in schemes for antibody purifica-
from crude feedstock – bovine serum and tion, this approach is convenient and
ascites fluid or CCS supplemented with FBS effective.
– is also illustrated, with purity values rang-
ing from 69 to 83%. When antibody is iso-
Stability and Cleaning
lated from albumin-containing feedstock,
albumin is the principal remaining impurity. The physical and chemical properties of
In such applications, product of 70 to >90% MEP HYPERCEL are well suited to both labora-
purity is generally obtained in including an tory and process scale use. MEP HYPERCEL is
additional washing step with water or sodium compatible with systems routinely used for
caprylate to selectively desorb the albumin. low or medium-pressure process chromato-
If a simple anion exchange procedure is graphy. Sorbent-related backpressure is less
used to bind residual albumin, product of than 0.5 bar in practical application at linear
99% purity can be obtained. Since anion velocities up to 200 cm/h. Pressure/flow
exchange chromatography is frequently curves for columns up to 300 mm I.D. are
shown in figure 5. To assure best capture
efficiency, it is recommended that initial
Figure 5. Backpressure as a function of flow rate. loading studies be conducted at 70 cm/h.
----- ----- ID 90 mm column
MEP HYPERCEL is chemically stable from pH 4
to 14. Sodium hydroxide, 0.5-1.0 M, is
Pressure (bar)

---------- ID 300 mm column

0.3 -- -- -- ID 25 mm column
recommended for cleaning. Submitted to a
0.2
series of 200 clean-in-place cycles with 1 M
0.1
sodium hydroxide (1 hour contact/cycle),
0 50 100 150 200
the sorbent maintained its initial properties.
Ligand density was unchanged.
Flow rate (cm/h)
Other useful cleaning agents include 4-6 M
Column height 150 mm ; PBS, pH 7.4.
guanidine, 8 M urea and 50/50 ethylene
glycol/ water.
Figure 6. Monoclonal antibodies purification on MEP
HYPERCEL from cell culture supernatants. Applications
A - MEP HYPERCEL provides excellent selectivity
for a broad range of antibody variants.
A280nm

H Representative applications are summarized

below.
A 280 nm

L
• Direct capture from cell culture super-
1 2
natant.
+ Capture of antibody from both protein-free
ml and serum-supplemented (5% fetal bovine
-
serum) cell culture supernatant (CCS) is
B described. In both cases, clarified samples
A280nm

H
were loaded without concentration or
adjustment of composition. The IgG con-
a
b centration in the protein-free CCS was
L
114 µg/ml. Chromatograms are shown in
1 2 figure 6 and results are summarized in
+
ml table 3.
ml In both applications, the column was equili-
Sample A = 300 ml protein-free cell culture supernatant.
brated with 50 mM Tris-buffer, pH 8.0. After
Sample B = 300 ml cell culture supernatant containing 5% fetal loading, the column was washed with the
bovine serum ; Equilibration : 50 mM Tris-HCl, pH 8 ; Elution : same buffer. PBS, pH 7.4 may also be used.
50 mM acetate, pH 4 ; Flow rate : 70 cm/h. In curve B, (a) and (b)
are respectively water and 25 mM sodium caprylate washings ; During chromatography of serum-supple-
SDS-PAGE (reduced conditions) : (1) = crude sample, (2) = purified mented cell culture supernatant, two
IgG. H = Heavy chain ; L = Light chain.

4
 additional wash steps (figure 6) were added
to promote desorption of albumin.
In both cases, the IgG fraction was eluted
under the influence of 50 mM sodium
acetate, pH 4.0. Product isolated from pro-
tein-free CCS was 99% pure (SDS-PAGE).
Despite the presence of abundant albumin in
the feedstock, product isolated from serum-
supplemented CCS was 69% pure. The lat-
ter could be brought to 99% purity by
®
equilibrated with 25 mM Tris buffer, pH 8.8,
containing sodium chloride sufficient to pro-
vide a conductivity of 10 mS. The IgG
fraction obtained following HCIC is diluted
with two volumes of the same buffer and
applied to the column.
After loading, elution is continued with the
above buffer. Antibody appears as an unre-
tained peak, while albumin is retained. The
latter is desorbed using 25 mM Tris buffer

application of a simple anion exchange pro- containing 0.5-1.0 M sodium chloride, pH 8.8.
BIOSEPRA MEP HYPERCEL

cedure.
• Purification of monoclonal IgG from
ascites fluid.
IgG was isolated from ascites fluid using the
same procedure as described above for use
with serum-supplemented CCS. In order to
reduce viscosity, the sample was diluted
with an equal volume of equilibration buffer
prior to loading. The chromatogram appears
in figure 7. Results are summarized in table
3. Isolated product was 83% pure. Purity of
the IgG fraction could be brought to 98%
using the anion exchange procedure sum-
marized below.
• MEP HYPERCEL followed by Anion
Exchange Chromatography.
Efficient removal of residual albumin present
in the IgG fraction can be accomplished
using DEAE Ceramic HYPERD. The column is
®
• Additional Applications :
MEP HYPERCEL has been studied in a broad
range of applications, including :
- Isolation of antibodies from sweet-whey
and colostrum.
- Isolation of antibodies from transgenic
plant and animal sources.
- Isolation of IgA and selected fusion pro-
teins.
For industrial applications, a validation pack-
age is available and provides necessary
information to assist users in development
of validation procedures.
References

1. Boschetti, E., Jungbauer, Sep. Sci. & Tech. 2 No. 15,

Acad. Press (2000) 535.
Figure 7. Immunoglobulin capture from ascites fluid 2. Manzke, O., et al., J. Immunol Methods 208 (1997)
on MEP HYPERCEL. 65.
3. Burton, S.C., Hardling, D.R.K., J. Chromatogr. 814
- (1998) 71.
4. Scholz, G.H., et al., J. Chromatogr. 709 (1998) 189.
5. Scholz, G.H., et al., J. Immunol. Meth. 219 (1998) 109.
A 280 nm

6. Schwartz, W,. et al., J. Chromatogr. A 908 (2001) 251.

7. Guerrier, L., et al., Bioseparation 9 (2000) 211
8. Guerrier, L., et al., J. Chromatogr. B 755 (2000) 37
H
a b 9. Boschetti, E., J. Biochem. Biophys. Methods 49 (2001)
361.

1 2
Ordering Information
+

Product Cat. No. Size

MEP HYPERCEL 12035-069 5 ml

12035-010 25 ml
12035-028 100 ml
ml
12035-036 1L
(a), (b) = Contaminant elution peaks after the 2 washing steps ; 12035-040 5L
Same conditions as those of figure 6. SDS-PAGE (reduced condi- 12035-044 10 L
tions) analysis : (1) = crude sample ; (2) = purified IgG.

5

2200 Northern Boulevard
East Hills, New York 11548-1289
+1 800.717.7255 toll free
+1 516.484.5400 phone
+1 516.801.9548 fax
pharmafilter@pall.com
Europa House, Havant Street
Portsmouth PO1 3PD, United Kingdom
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com
BioSepra SA
48 avenue des Genottes
95800 Cergy Saint Christophe, France
+33 (0)1 34 20 78 00 phone
+33 (0)1 34 20 78 78 fax
PRODUCT NOTE
About BioSepra® Products & Collaborative
Services
BioSepra process chromatography sorbents are manu-
factured and marketed by Pall Life Sciences. They great-
ly simplify protein purification development and signifi-
cantly improve biopharmaceutical manufacturing pro-
ductivity.
Over the past 25 years, BioSepra® chromatography
products and services have earned an outstanding
reputation for product innovation and technical support.
Our expanded R&D sorbent program, ISO 9001 manu-
facturing plant and HyperCel™ sorbents represent our
latest commitment to the biopharmaceutical industry.
With the acquisition of BioSepra® products and services,
Pall combines chromatography development expertise
with Ciphergen®'s SELDI-based ProteinChip® technology
to set in motion an entirely new approach to protein
purification development.
This single-step, on-chip approach dramatically acceler-
ates and simplifies purification development and analy-
sis. The future of Process Proteomics begins with Pall.
Pall has the most comprehensive
family of scaleable separation products.
Visit us on the web at www.pall.com/biopharmaceutical
These products are for laboratory research use only and are not intended for human
or animal diagnostic, therapeutic, or other clinical uses, unless otherwise stated. The
information contained in this brochure are subject to change without notice.
Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand,
Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
, Pall, BioSepra, Hypercel are registered trademarks of Pall Corporation.
Filtration. Separation. Solution. and UpScale are service marks of Pall Corporation.
ProteinChip is a trademark of Ciphergen Biosystems, Inc.
LPN PN702-002 - 12/2004
6

MBI HYPERCEL ™
Mixed-mode sorbent for direct capture of antibodies.
• Designed for direct capture of monoclonal and polyclonal IgG.
• Alternative to Protein A sorbents.
• Complement to Hydrophobic Charge Induction Chromatography (MEP HyperCel ).
• No albumin contamination if present in the feedstock.
™
BIOSEPRA MBI HYPERCEL
MBI HyperCel™ is a high capacity, high
selectivity, scalable mixed-mode sor-
bent, specially designed for the cap-
ture and purification of monoclonal
and polyclonal antibodies from various
sources. Complementing recently
introduced approaches (HCIC – Hydro-
phobic Charge Induction Chromato-
graphy – on MEP HyperCel™), MBI
mixed-mode sorbent provides alterna-
tive selectivity characteristics and
expands the range of chromatographic
options for proteins of various pI val-
ues or limited pH-stability. MBI
HyperCel™ is particularly suited to sep-
aration of IgG sensitive to acidic elution.
MBI HyperCel™ can be used to sepa-
®
rate antibodies from cell culture super-
natant and from other non conven-
tional sources such as sweet whey,
milk from hyper-immunized animals,
recombinant expression systems or
from human plasma Cohn fractions
(obtained by alcohol precipitation).
Mixed-mode ligand complements
Hydrophobic Charge Induction
Chromatography (MEP HyperCel™).
The MBI HyperCel™ ligand is a comple-
ment to the Hydrophobic Charge
Induction Chromatography (HCIC)
sorbent MEP HyperCel™ (refer to our
Product note LPN PN702-002). MBI
HyperCel™ can be used alone as a
1
PRODUCT NOTE
™
Table I. MBI HyperCel™ Main Properties.
Particle size 80-100 µm
Dynamic binding capacity for 20-40 mg/ml
hu IgG (10% breakthrough)*
Ligand 2-mercapto-5-benzimida-
zole sulfonic acid (MBI)
Working pH Adsorption: pH 5.0-5.5
Elution: pH 8.0-9.5
Cleaning pH 3 -14
Pressure resistance < 3 bar (44 psi)
Typical working pressure** < 1 bar (14 psi)
* Capacity varies according to the IgG type, the concentration and the resi-
dence time, i.e. for human polyclonal IgG (5 mg/ml) in a 50 mM sodium
acetate, pH 5.5, capacity is equal to 25 mg/ml for 5 min residence time.
** With buffer, backpressures of <1 bar are obtained at linear flow rates of 500-
700 cm/h.
direct capture step, or in a sequence, combined to
other standard chromatographic steps (e.g. ion
exchange).
HCIC (MEP) and mixed mode ligands (MBI) repre-
sent cost-effective alternatives to Protein A-based
sorbents for the capture of antibodies. MEP
HyperCel™ binds IgG at neutral pH, and typically
elutes at slightly acidic pH (pH 4.0). MBI adsorbs
antibodies at mildly acidic pH (typically in the pH
range of 5.0 - 5.5), and IgG is eluted at alkaline pH
(8.0 - 9.5). While operating at physiological ionic
strength for IgG capture, MBI HyperCel™ gives the
users more options to explore, according to the pI
and pH-sensitivity of their specific antibody. This
alkaline elution may preserve the biological activity
of acidic-sensitive IgGs, or limit aggregation and
precipitation during the purification process.
 PRODUCT NOTE

MBI HyperCel™ can be used at both Figure 1. Pressure vs. Flow Rate.
laboratory or process-scale : the sor-
psi bar
bent is easy to pack and run, and can 15 1
be operated at low backpressure 12.5 0.8
(<3 bar) in ml to multi-liter packings.

Pressure
10
0.6
See pressure vs flow rate curve in 7.5
0.4
Figure 1. 5
0.2
2.5
0 0
100 200 300 400 500 600 700
Antibody selectivity of MBI HyperCel®
™

Flow rate (cm/h)

and segregation between IgG and
BIOSEPRA MBI HYPERCEL

albumin.
Column: 15.6 cm x 2.5 cm I.D., 50 mM sodium acetate, 0.14 M NaCl, pH 5.5.

2-mercapto-5-benzimidazole sulfonic
acid (MBI) – see Figure 2 – used as a Figure 2. Structure of the MBI ligand.
ligand for the adsorption of immuno-
globulin G was deduced from an
extensive number of synthetic ligands
described in the literature. From this
review, it appeared that heterocycles
were among those molecules repeat-
edly described for the capture of anti-
bodies. The MBI ligand has a sulfonate
group present on the aromatic ring Figure 3. Effect of binding pH on discrimination between
which is negatively charged over the human IgG and albumin.
recommended adsorption pH range
(5.0 - 5.5). Most of the antibodies are 50
Dynamic binding capacity (mg/ml)

positively charged around pH 5.5, 45

whereas albumin is negatively charged 40 HSA

and therefore does not interact by 35

®

30
ionic effect. The separation between
25 IgG
IgG and human albumin as a function
20
of the adsorption pH is shown in
15
Figure 3.
10
Experimental data based on protein 5
binding capacity as a function of tem- 0
perature and competition using 2 3 4 5 6 7
pH
8

inhibitors of hydrophobic associations

(e.g.polyvinyl alcohol) suggests that
hydrophobic associations between the
spacer and albumin do not occur.
Contrary to HCIC sorbents, the spacer
and the ligand head are both hydro-
philic in the MBI HyperCel™ sorbent.
Data using solutions of pure HSA and hu IgG (5 mg/ml) shows that the highest
binding capacity for human albumin is obtained at pH 4.0. HSA is not bound
at pH values above pH 5.0, where the optimal binding capacities for IgG are
found.
Dynamic binding capacity for IgG.
The capacity of MBI HyperCel™ for IgG depends on
multiple parameters: column geometry and flow rate
should be adjusted to allow an average residence
time around 5 min to get an optimum capacity.
Other important parameters include the nature and

2
concentration of the IgG itself as well as the relative 2. Influence of ionic strength.
isoelectric points of the IgG and feedstream proteic MBI HyperCel™ is suited to direct capture of IgG at
contaminants. physiological ionic strength. The optimal capacity is
MBI HyperCel™ has a dynamic capacity of 20-40 mg/ml typically obtained in the presence of 0.14 M NaCl,
with concentrated hu IgG (standard residence times as shown in Figure 4.
around 5 min and adsorption in 50 mM acetate,
0.14 M NaCl, pH 5.5). Higher capacities may be Figure 5. IgG dynamic binding capacity vs. pH.
observed by increasing the residence time.

DBC at 10% BT (mg IgG/ml)

30
Figure 4. IgG dynamic binding capacity vs. ionic strength.
20
Dynamic binding capacity (mg/ml)

80 10
0.14 M NaCl
Conductivity (mS/cm)

30 60

4.5 5.5 6.0 7.5 8.5 pH

20 40
5 mg/ml hu IgG in 50 mM sodium acetate, 0.14 M NaCl, pH 5.5. Conductivity
20
17.5 mS/cm. Flow rate 100 cm/h.
10

0 0.5 1.00 NaCl (M) 3. Influence of IgG concentration.

Hu IgG (5 mg/ml) in 50 mM sodium acetate, pH 5.5 containing 0 - 0.07 - 0.14 MBI HyperCel™ capacity and purity performance
- 0.28 or 1 M NaCl. may vary according to the IgG concentration in the
feedstream. When using human polyclonal IgG at
concentrations from 0.05 to 1 mg/ml, capacity at
1. Influence of pH. pH 5.0 was found higher than at pH 5.5, as shown
The adjustment of the adsorption pH is a critical in Figure 6.
parameter to achieve the optimum purity and When MBI HyperCel™ is used to capture dilute IgG
capacity performance. The MBI ligand does not (<250 µg/ml) from serum-supplemented feedstream,
normally co-adsorb albumin at pH 5.5 (pH usually a binding pH optimization is recommended to find
recommended to start experiments). With pure the best purity/capacity compromise (see Figure 9
concentrated IgG, the capacity of MBI at pH 5.5 is and Table II).
in the range of 30 mg/ml, as shown in Figures 3
and 5.
However, with crude feedstreams, this "standard" Figure 6. Binding capacity as a function of IgG concentration.
recommended adsorption pH of 5.5 may not lead to
30
the best purity/capacity ratio. Therefore, a pH
Dynamic binding capacity (mg/ml)

pH 5.0
adjustment (typically in the pH range of 5-6) is 25
recommended (refer to Table II).
20
pH 5.5

15
Table II. Guidelines for adsorption pH optimization
according to feedstream composition and IgG 10
concentration.
5
Type of feedstream Recommended binding pH

No albumin present pH 5.0 0

0 0.2 0.4 0.6 0.8 1

Albumin present IgG <250 µg/ml pH 5.0 - pH 5.5 IgG concentration (mg/ml)
optimization
Albumin present IgG ≥250 µg/ml pH ≥ 5.5 0.05, 0.25 and 1 mg/ml hu IgG in 50 mM sodium acetate, 0.14 M NaCl, pH
5.0 or 5.5 containing 0.14 M NaCl.

3
 PRODUCT NOTE

Elution : recovery and purity factors APPLICATION EXAMPLES

Purity values of 80-95 % (SDS-PAGE)
are typical with crude feedstreams.
Higher purities (95-98%) can be
obtained in a single step when using
protein-free cell culture supernatants.
Elution is performed with alkaline
buffers, in the pH range of 8.0 - 9.5.
The nature of the elution buffer may
™
Example 1. Purification of Rat monoclonal IgG
from a hybridoma cell culture containing 10%
serum – a comparison with Protein A.
MBI HyperCel™ allows an efficient capture of Rat IgG
in the presence of fetal bovine serum, in contrast
with Protein A: IgG purity was estimated higher than

influence the recovery, typically

BIOSEPRA MBI HYPERCEL

95% by SDS-PAGE. Albumin from serum was not

50 mM sodium bicarbonate, pH 9.0 bound by MBI HyperCel™, no trace of IgG was found
containing 0.14 M NaCl is recom- in the MBI HyperCel™ column flowthrough.
mended.

Figure 7. Separation of Rat IgG on MBI HyperCel™ (A) and on a

Stability, cleaning and regulatory Protein A-based sorbent (B).
support for industrial applications.

MBI HyperCel™ is stable to repeated A

cleaning with 1 M sodium hydroxide. 0.75

50mM bicarbonate
pH9, 0.14 M NaCl
In most cases, 30 to 60 min wash pro-
A280 nm

cedures using 0.5-1 M NaOH are suf- 0.50

ficient for cleaning and column regen- 0.25

eration.
0
Ligand and sorbent toxicity: a study 0 10 20 30 40 ml Non reducing
SDS-PAGE
performed according to ISO 10993-5
(1992) standard showed the absence Load:19 ml sample, adjusted to pH 5.2 by addition of acetic acid.
of toxicity of the MBI HyperCel™ Wash: 50 mM acetate buffer, 0.14 M NaCl, pH 5.2.
Elution: 50 mM bicarbonate buffer, 0.14 M NaCl, pH 9.0.
sorbent. 1 = Crude feesdstock. 2 = Column flowthrough. 3 = Eluate.
®

For industrial applications, a validation

regulatory package is available, please
contact our technical service. B
0.4
A280 nm

0.1M acetic acid

0.3

0.2

0.1

0 30 60 ml Non reducing
SDS-PAGE

Load: Direct sample load on Protein A Ceramic HyperD® F. Wash: PBS. Elution:
0.1 M acetic acid.

4
Example 2. Purification of monoclonal IgG1 from Example 4. Capture of Mouse monoclonal IgG1
ascites fluid. from a low expression hybridoma cell super-
natant – Influence of adsorption pH.
Figure 8. Mouse Monoclonal IgG1 purification on MBI HyperCel™.
Low expression Mouse IgG1 cell culture supernatant
(150 µg/ml) was loaded on MBI HyperCel™ at two
Non-reducing Reducing
IgG

SDS-PAGE SDS-PAGE different adsorption pH (5.0 and 5.2). Figure 9 shows

the RC-SELDI-MS analysis of chromatography frac-
Cleaning 1M NaOH

tions on NP20 ProteinChip® Array.

Elution pH 9

HC The data shows that the capture of this low IgG1 titre
can be performed on MBI HyperCel™ at both pH 5.0
Load

or 5.2, but differences in recoveries exist according

0 5 10
MBI HyperCel™ chromatography resulted in an effi-
cient capture of Mouse IgG from a complex mixture
such as ascites fluid. Purity was higher than that
obtained on Protein A Ceramic HyperD® F and albu-
min was not bound by MBI HyperCel™.
LC
to the binding pH.
15 ml 1 2 3 1 2 3
When adsorption is performed at pH 5.2, some loss
1: Crude feedstream
2: MBI HyperCel™ eluted fraction of IgG is found in the flowthrough (FT) and in the
3: Protein A resin eluted fraction wash (W).
In contrast, when pH 5.0 is used during the adsorp-
tion step, a better capture is observed. IgG is eluted
in one fraction (pH 9.0 elution), and no IgG loss is
found. This data highlights the importance of fine-
tuning the pH in order to achieve the best capture
and recovery efficiencies when using dilute IgG.

Figure 9. Capture of Mouse monoclonal IgG1 from a low expres-

sion feedstream – Influence of adsorption pH (RC-SELDI-MS
analysis of eluted fractions from MBI HyperCel™ column).
Example 3. Use of MBI HyperCel in a three-step
sequence as alternative to Protein A for clinical Adsorption at pH 5.0

grade IgG purification. 120000 140000 160000 IgG

F0
MBI HyperCel™ was evaluated as a potential replace- FT
ment to a conventional Protein A sorbent in a three- FT

step “generic” purification. IgG purity, host cell W

E
impurity removal and Protein A leakage were evalu- MW (Da) 120000 140000 160000

ated. Data suggests that MBI HyperCel™ capture step

is compatible with the needs of preclinical antibody
purification. Adsorption at pH 5.2
IgG
120000 140000 160000

F0
Table III. Use of MBI HyperCel™ in a three-step FT
sequence as alternative to Protein A for clinical FT
grade IgG purification.
W
Process IgG purity HCP Protein A E
MW (Da) 120000 140000 160000
(%) (ng/mg IgG) (ng/mg IgG)
MBI HyperCel 99.3 3.52 NR Sample: 150 µg/ml IgG1 in cell culture supernatant, protein-free medium;
+ IEX1 + IEX2 40 ml of cell culture supernatant (CCS) are filtered and loaded on an MBI
HyperCel™ column (10 cm x 0.3 cm ID). Equilibration buffer: 50 mM sodium
Protein A sorbent 99.9 < 0.64 < 0.15 acetate, 0.14 M NaCl, pH 5.0 or 5.2. Elution buffer: 50 mM sodium bicarbon-
+ IEX1 + IEX2 ate, 0.14 M NaCl, pH 9.0. Column regeneration and cleaning: 1 M NaOH
(10 CV). Linear flow rate : 150 cm/h; Residence time: 4 min. Analysis per-
Data courtesy of Dr. Philippe Marschal, Novartis Pharma AG. formed on normal phase (NP20) ProteinChip® Arrays.
IEX = Ion Exchange step, HCP = Host Cell Proteins, NR = Non Relevant. F0 = load, FT = flowthrough, W= wash, E= elution.

5
 PRODUCT NOTE

Example 5. Purification of polyclon- Figure 10. Purification of polyclonal antibodies from human
al IgG from human plasma Cohn plasma Cohn fraction.
fractions on MBI HyperCel™ and
comparison with a Protein A sorbent A
and MEP HyperCel™. 1.5 MBI HyperCel

A 280 nm
IgG

Figure 10 shows the separation of

polyclonal IgG from human plasma 1.0
Cohn Fraction II+III on MBI HyperCel™
and Protein A Ceramic HyperD® F.
™

Fraction II+III is a protein-rich, 19%

BIOSEPRA MBI HYPERCEL

0.5 50 mM bicarbonate
1 M NaOH
ethanol precipitated fraction, contain- 0.14M NaCl, pH 9.5

ing mainly immunoglobulins, trans-

ferrin and α and β-globulins. IgG are
0
estimated to represent about 40% of 20 40 60 80 ml
total soluble proteins in this fraction.
B
In Figure 10A, IgG was captured on 1.5
Protein A
A 280 nm
MBI HyperCel™ in 50 mM acetate, IgG Ceramic HyperD F

0.14 M NaCl at pH 5.5 and totally

desorbed in 50 mM bicarbonate, 1.0

0.14 M NaCl at pH 9.5. A cleaning

step using 1 M sodium hydroxide
resulted in elution of a large amount 0.5
0.1M acetic acid 1 M NaOH
of non-specifically adsorbed proteins.
Figure 10B shows the same separation
performed on a Protein A Ceramic 0
20 40 60 80 ml
HyperD® F sorbent, where IgG were
adsorbed in PBS and eluted by 0.1 M
acetic acid, pH 3.0.
C
®

Standard pure IgG

Figure 10C shows the SDS-PAGE of Standard pure albumin
Standard pure transferrin
the eluted fractions in non-reducing
Paste II+III
conditions: purity of polyclonal anti- IgG purified on MBI HyperCel
bodies was estimated to be about IgG purified on Protein A

90% in the MBI HyperCel™ eluate,

and about 95% with the Protein A
sorbent.
Gel analysis
of eluted fractions
(non denaturing conditions)

Purification on MBI HyperCel: Equilibration: 50 mM acetate, 0.14 M NaCl,

pH 5.5; Elution: 50 mM bicarbonate buffer, 0.14 M NaCl, pH 9.5
Purification on Protein A Ceramic HyperD F: Equilibration: PBS ; Elution:
100 mM acetic acid, pH 3.0.
Column dimensions: 11 mm ID x 65 mm (6.5 ml sorbent); Protein load inject-
ed around 120 mg, linear flow rate: 50 cm/h.
A column cleaning was performed in each case using 1 M sodium hydroxide.
Sample courtesy of Dr. Andrea Buchacher, Octapharma, Austria.

6
Example 6. Separation of IgG light and heavy Figure 11B. Purification of a monoclonal humanized IgG1a from
chains. a CHO cell line grown in protein-free medium (stirred reactor
tank). Analysis using RC-SELDI-MS of collected fractions during
Figure 11A shows the chromatographic profile corre- chromatography on MBI HyperCel™on an NP 20 ProteinChip®
sponding to the purification of a humanized mono- Array.
clonal IgG1 expressed in CHO cells which were
pH 7.0 pH 7.5 pH 8.0 pH 8.5 pH 9.0
grown in a protein-free cell culture medium. Figures L FT

11B and 11C show RC-SELDI-MS profiles of the frac- Intact 150000
tions collected along the chromatography: heavy IgG

and light chains are collected at pH 7.0 and 7.5,

whereas the intact antibody was primarily eluted at
100000
higher pH (8.0 - 8.5).

Figure 11A. Purification of a monoclonal humanized IgG1a from HC 50000

CHO cells in a protein-free medium on MBI HyperCel™ chro-

LC
matography sorbent. MW
(Da)

1600
Absorbance, mAU

1400
Figure 11C. Separation of light and heavy chains from intact
1200
antibody using pH step elution on MBI HyperCel™.
1000

800
pH 7.5 pH 8.5 80
600
pH 7.0 pH 8.0 pH 9.0
Heavy chain
Relative peak intensity

400 70
Light chain
200 Intact IgG
60
0
0 50 100 150 200 50
Elution (ml)
40

Conditions (Figures 11A, 11B & 11C) : 1 cm ID column; 7 ml of sorbent; Flow 30

rate: 100 cm/h. Equilibration/Wash: 50 mM sodium acetate with 0.14 M NaCl,
pH 5.2. Step elutions using 50 mM Tris buffer at pH 7.0, 7.5, 8.0, 8.5 and 9.0. 20

10

FT pH 7.0 pH 7.5 pH 8.0 pH 8.5 pH 9.0

Load
Collected fractions

Ordering Information

Product Cat. No. Size

MBI HyperCel 20194-069 5 ml

20194-010 25 ml
20194-028 100 ml
20194-036 1L

Bulk quantities available on request.

7

2200 Northern Boulevard
East Hills, New York 11548-1289
+1 800.717.7255 toll free
+1 516.484.5400 phone
+1 516.801.9548 fax
pharmafilter@pall.com
Europa House, Havant Street
Portsmouth PO1 3PD, United Kingdom
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com
BioSepra SA
48 avenue des Genottes
95800 Cergy Saint Christophe, France
+33 (0)1 34 20 78 00 phone
+33 (0)1 34 20 78 78 fax
PRODUCT NOTE
About BioSepra® Products & Collaborative
Services
BioSepra process chromatography sorbents are manu-
factured and marketed by Pall Life Sciences. They great-
ly simplify protein purification development and signifi-
cantly improve biopharmaceutical manufacturing pro-
ductivity.
Over the past 25 years, BioSepra® chromatography
products and services have earned an outstanding
reputation for product innovation and technical support.
Our expanded R&D sorbent program, ISO 9001 manu-
facturing plant and HyperCel™ sorbents represent our
latest commitment to the biopharmaceutical industry.
With the acquisition of BioSepra® products and services,
Pall combines chromatography development expertise
with Ciphergen®'s SELDI-based ProteinChip® technology
to set in motion an entirely new approach to protein
purification development.
This single-step, on-chip approach dramatically acceler-
ates and simplifies purification development and analy-
sis. The future of Process Proteomics begins with Pall.
Pall has the most comprehensive
family of scaleable separation products.
Visit us on the web at www.pall.com/biopharmaceutical
These products are for laboratory research use only and are not intended for human
or animal diagnostic, therapeutic, or other clinical uses, unless otherwise stated. The
information contained in this brochure are subject to change without notice.
Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand,
Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
, Pall, BioSepra, Hypercel are registered trademarks of Pall Corporation.
Filtration. Separation. Solution. and UpScale are service marks of Pall Corporation.
ProteinChip is a trademark of Ciphergen Biosystems, Inc.
LPN PN704-008 - 12/2004
8
 PRODUCT NOTE

Protein A Ceramic HyperD® F

Affinity Chromatography Sorbent
BIOSEPRA Protein A Ceramic HYPERD F

• Ideal for large-scale antibody purification.

®

• High binding capacity for human and murine IgGs.

• High selectivity with no non-specific binding.
• Rigid.
• Low backpressure.
• Easy to pack.

BioSepra® Protein A Ceramic HyperD® F sor- Table 1: Main Properties of Protein A Ceramic
bent available from Pall® is a high capacity HyperD F sorbent.
.
affinity sorbent designed for process-scale
purification of immunoglobulins G. The sor- Particle size 50 µm (av.)
bent combines ease of use with high bind- Dynamic binding capacity for > 30 mg/ml
ing capacity and excellent scalability. Anti- hu IgG* (10% breakthrough,
100 cm/h)
bodies of greater than 95% purity are isolat-
ed from cell culture supernatant or ascites Ligand Recombinant Protein A
fluid in a single chromatographic step. Immobilized Protein A 4 - 5 mg/ml of sorbent
Dilute feedstock (~100 µg IgG/ml) may be Working pH 2 - 11
applied without preliminary concentration. Cleaning pH 2 - 13
BioSepra Protein A Ceramic HyperD F sor- Volume changes due to pH Non compressible
bent is prepared using a rigid proprietary and ionic strength
ceramic bead. Recombinant Protein A is Pressure resistance 70 bar (1,000 psi)
immobilized to a specially formulated hydro- * Determined using 10 mg/ml hu IgG in PBS, pH 7.4; Elution
gel within the porous ceramic bead. with 0.1 M sodium citrate, pH 2.5. Column: 4.6 ID x 100 mm.
The ceramic bead, the hydrogel, and the
linkage used for the Protein A coupling are
chemically stable over a broad range of con- sorbent facilitates operation at high linear
ditions. Cleaning-in-place and sanitization velocity. Similarly, bed depth may be
procedures using sodium hydroxide may be increased to provide increased residence
employed with only limited loss of binding time and enhanced capture efficiency.
capacity. The unique, multi-point coupling The sorbent is ideal for production scale
®

chemistry provides a sorbent that exhibits
very low leakage of recombinant Protein A.
The Protein A ligand is of recombinant ori-
gin and is produced in strict compliance
with cGMP requirements. The rec Protein A
is purified by standard chromatographic
processes and is never in contact with
immunoglobulins.
The rigidity of Protein A Ceramic HyperD F
purification. The dense ceramic material
settles quickly and packs easily, even in large
columns. Equally important, the material
does not shrink or swell in response to
changes in pH, ionic strength or flow rate.
The material is shipped in 1 M NaCl con-
taining 20% ethanol and is available in a
range of package sizes. Special packaging to
meet specific manufacturing requirements is
available on request.

1
 PRODUCT NOTE

• Capacity Figure 2. Dynamic hu IgG binding capacity as a func-

tion of flow rate (hu IgG: 1 mg/ml).
As with all Protein A sorbents, the dynamic
binding capacity is influenced by the com-
BIOSEPRA Protein A Ceramic HYPERD F

position of the sample, the IgG subclass,

Dynamic binding capacity (mg/ml)

®

and the IgG concentration in the feedstock

(figure 1). Nevertheless, Protein A Ceramic
HyperD F sorbent exhibits high binding
capacities with a variety of samples.
Dynamic binding capacity for human IgG
exceeds 30 mg/ml (figure 2) at linear veloci-
ties ranging from 100 to 300 cm/h.
Table 2 shows binding capacity values for dif-
ferent IgG subclasses from ascites or cell cul-
Linear Velocity (cm/h)
ture supernatant. The capacity ranges from
3.6 mg/ml for IgG2a to 19 mg/ml for IgG3.
Figure 3. Capacity vs. linear velocity or residence time
Studies have shown that the best produc- for hu IgG1.
tivity is obtained when the average IgG resi-

DBC at 50% breakthrough

(mg/ml)
dence time in the column is about 3-5 min-
utes (figure 3). A column 15-20 cm deep,
operated at 300 cm/h provides a good
compromise between high capacity and
high linear velocity for process-scale use.

Figure 1. Influence of hu IgG concentration on binding

capacity (flow rate: 75 cm/h). Linear velocity (cm/h)
Dynamic binding capacity (mg/ml)

DBC at 50% breakthrough

(mg/ml)

Residence time (min)

®

hu lgG concentration (mg/ml) Experimental: 2.55 mg/ml hu IgG1; Column: 1.0 x 11.7 cm.

Table 2. Binding Capacities for IgG Subclasses at 300 cm/h.

Source IgG conc. in the Subclass Capacity
sample (mg/ml) (mg/ml)
Cell culture supernatant 0.05 IgG1 13.4
Ascites fluid 6.34 IgG1 12.7
Ascites fluid 2.43 IgG2a 3.6
Ascites fluid 4.00 IgG3 19.0
Ascites fluid 4.10 IgG2b 9.5
Column: 3 mm ID x 100 mm; Volume: 0.7 ml; Loading: 1 M glycine / 2 M NaCl, pH 8.9; Elution:
0.1 M acetic acid, pH 3.

2
• Purity Table 3. Preparative Purification of Monoclonal IgG on Protein A Ceramic HYPERD F.
During studies with various IgG Source Origin IgG Initial IgG Eluted IgG Purity
subclasses and feedstocks, Protein A Subclass conc. (mg/ml) (mg) SDS-PAGE
Ceramic HyperD F sorbent provided Ascites fluid murine IgG1 kappa 6.34 37 > 98%
high purity product, even at high Ascites fluid murine IgG1* 2.26 20 > 98%
column loading. Results are summa- Ascites fluid murine IgG1* 3.86 31 > 98%
rized in table 3. In all cases, the Ascites fluid murine IgG2b** 2.31 6 > 98%
purity was greater than 98% as Ascites fluid murine IgG2a** 2.43 10 > 98%
Ascites fluid murine IgG2a* 2.86 28 > 98%
determined by SDS-PAGE. No albu-
Cell culture supernatant murine IgG1* 0.05 15 > 98%
min was detected in IgG1 isolated
Cell culture supernatant humanized IgG1* 0.20 30 > 98%
from ascites fluid. Isolation of anti-
body from serum-containing cell Column: 6.6 mm ID x 120 mm; Volume: 4 ml, 10-30 mg IgG per run; Loading: 1 M glycine / 2 M NaCl (*), pH
8.9 or PBS (**); Elution: 0.1 M acetic acid.
culture supernatant is illustrated in
figure 4. Analysis by SDS-PAGE is
shown in figure 5. Figure 4. Isolation of IgG1 from serum-con- Figure 5. SDS-PAGE analysis of feedstock (1),
Despite the relatively high selectivi- taining cell culture supernatant on Protein A flowthrough (2), recovered IgG1 (3).
Ceramic HyperD F sorbent.
ty of Protein A, isolation of high 1 2 3
purity product, suitable for thera-
UV
peutic use requires further, ortho-
gonal chromatographic steps.
Cation exchange chromatography
may be conducted using CM or S
Ceramic HyperD F sorbents.
Typically, the cation exchange pro-
cedure is designed to bind IgG
while impurities are selectively des- Time (min)
orbed. Anion exchange chromatog-
The arrow indicates introduction of elution buffer.
raphy on Q or DEAE Ceramic Column: 3 mm ID x 100 mm. Loading and wash: 1 M
HyperD F sorbents may be glycine / 2 M NaCl, pH 8.9. Elution: 100 mM acetate
buffer, pH 4.6. Linear velocity: 300 cm/h. Sample:
employed to bind a variety of rela- 50 ml cell culture supernatant. Figure 6. Pressure vs. number of cycles.
tively acidic impurities while the
antibody passes unretained in the
flowthrough fraction.
Pressure (bar)

• Stability chromatography described in figure

BioSepra Protein A Ceramic HyperD F
sorbent is a dense, rigid, non com-
pressible material. Packing is faster
than for conventional Protein A
Agarose. The sorbent typically set-
tles in a few minutes, i.e. less than
10 min are needed to pack a 10 ml
column.
Protein A Ceramic HyperD F sor-
bent allows the use of flow rates
higher than 300 cm/h at backpres-
sure less than 3 bar. Indeed, the
6 is accomplished at less than 0.4
bar at 300 cm/h. The pressure
remained consistent for more than
30 cycles.
Pressure/flow rate characteristics of
Number of cycles
Protein A Ceramic HyperD F sor-
bent facilitate process-scale applica- hu IgG capacity at 10% breakthrough; Linear flow
rate: 300 cm/h; Bed height: 25 cm; Residence time:
tion. For example, at large scale, 5 min; Loading: 35 mg/ml.
bed heights of 20-50 cm can be
used at flow rates up to 200 cm/h
to maximize capacity of the sorbent
by optimising the residence time.

3
• Cleaning Figure 7. Tentative schematic structure of immobilized
Protein A on Ceramic HyperD.
Recombinant Protein A, rich in carboxylic
side chains, is coupled to the primary-
amine-containing hydrogel via stable sec-
ondary-amide linkages. The procedure has
been tailored to give optimized multi-point
attachment, as illustrated in figure 7.
This unique multi-point coupling chemistry
confers high chemical stability.
Cleaning with sodium hydroxide from 1 to
100 mM can be performed repeatedly.
Modest decreases in binding capacity can
occur over time depending upon the
concentration of sodium hydroxide and the
total contact time. Alternatively, cleaning
may be conducted using 6 M guanidine
hydrochloride for some/all cleaning cycles.
The arrows represent proteolysis sensitive locations of Protein A
• Ligand leakage between sub-units responsible for Fc binding.

As a consequence of the Protein A coupling

chemistry, the ligand leakage is low. An
independent study of Protein A Ceramic
Figure 8. Separation of spiked Protein A from IgG1
HyperD F sorbent showed less than 10 ng using a Q Ceramic HyperD F column.
Protein A per mg of purified hu IgG (aver-
age value).
UV abosrbance

A non-competitive ELISA procedure was

used to determine native Protein A in the
IgG eluate. These findings reflect the high
stability of Protein A Ceramic HyperD F sor-
bent.
In many pharmaceutical applications, an
anion exchange procedure is employed to
assure removal of trace quantities of leached
rec Protein A. Q Ceramic HyperD F sorbent
is well suited to this application. The proce-
dure is conducted under conditions which Time (s)
promote dissociation of the IgG-Protein A
Sample: IgG1 (7.9 mg) purified from a cell culture supernatant
complex. As illustrated in figure 8, IgG is using Protein A Ceramic HyperD F sorbent spiked with 850 µg
unretained, while the relatively acidic Protein A. As required, the mobile phase can contain up to 2 M
urea and 50% ethylene glycol. A sodium chloride gradient up to
Protein A (pI < 5) is bound. The study was 2.6 mS can be employed.
performed using IgG1 spiked with 107 µg of
rec Protein A per mg of IgG1.

4
 Applications References
Optimum binding conditions depend upon
1. Boschetti, E., Jungbauer, A., Separation Science &
the IgG subclass to be purified. In most
BIOSEPRA Protein A Ceramic HYPERD F

Technology, Academic Press Vol. 2 (2000) 535.

applications, binding is conducted under 2. Guerrier, L., et al., J. Chromatogr. B 755 (2000) 37.
®

physiological conditions. For weakly inter- 3. Eliasson, M., et al., J. Biol. Chem. 263 (1988) 4323.
4. Akerstrom, B., J. Biol. Chem. 261 (1986) 10240.
acting immunoglobulins (e.g. murine IgG1), 5. Watanabe, M., et al., Japan J. Exp. Med. 225 (1981) 51.
efficient binding is accomplished at higher 6. Der Balian, G.P., et al., J. Exp. Med. 152 (1980) 209.
pH (~ 8.5 - 9.0) using a mobile phase aug- 7. Ledbetter, J.A., Immunol. Rev. 47 (1979) 63.
8. Medgyesi, G.A., Fust, G., et al., Immunochemistry 15
mented with glycine and sodium chloride.
(1978) 125.
Elution is normally accomplished at acidic 9. Lindmark, R., Movitz, J., Sjoquist, J., Eur. J. Biochem.
pH (2.5 - 3.0). Milder pH can be used for 74 (1977) 623.
10. Sjoquist, J., Movitz, J., et al., Eur. J. Biochem. 30
weakly adsorbed IgGs such as mouse IgG1. (1972) 190.
Once conditions have been optimized, scale 11. Kronvall, G., Seal, U.S., et al., J. Immunol. 104
(1970), 140.
up is accomplished by increasing the col-
umn diameter while maintaining the opti-
mum bed height and linear velocity.
Detailed recommendations for use can be
found in the Product Insert which is sup-
plied with the product.
Protein A Ceramic HyperD F sorbent is well
suited to isolation and purification of IgG
from ascites fluid, cell culture supernatant,
transgenic milk, and various animal sera.
Other applications include :
- Separation of IgG subclasses (e.g. Protein
A does not interact with human IgG3).
- Separation of Fc fragments from a mixture
of Fc and Fab fragments obtained after
enzymatic hydrolysis.
- Purification of humanized or mouse mono-
clonal antibodies.
- Separation of immune complexes.
- Purification of enzyme conjugates.
- Removal of bovine IgG from hybridoma
®

cell culture.

Ordering Information

Product Cat. No. Size

Protein A Ceramic HYPERD F 20078-036 5 ml

20078-028 25 ml
20078-010 100 ml
20078-044 1L
20078-051 5L
20078-069 10 L

5

2200 Northern Boulevard
East Hills, New York 11548-1289
+1 800.717.7255 toll free
+1 516.484.5400 phone
+1 516.801.9548 fax
pharmafilter@pall.com
Europa House, Havant Street
Portsmouth PO1 3PD, United Kingdom
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com
BioSepra SA
48 avenue des Genottes
95800 Cergy Saint Christophe, France
+33 (0)1 34 20 78 00 phone
+33 (0)1 34 20 78 78 fax
PRODUCT NOTE
About BioSepra® Products & Collaborative
Services
BioSepra process chromatography sorbents are manu-
factured and marketed by Pall Life Sciences. They great-
ly simplify protein purification development and signifi-
cantly improve biopharmaceutical manufacturing pro-
ductivity.
Over the past 25 years, BioSepra® chromatography
products and services have earned an outstanding
reputation for product innovation and technical support.
Our expanded R&D sorbent program, ISO 9001 manu-
facturing plant and HyperCel™ sorbents represent our
latest commitment to the biopharmaceutical industry.
With the acquisition of BioSepra® products and services,
Pall combines chromatography development expertise
with Ciphergen®'s SELDI-based ProteinChip® technology
to set in motion an entirely new approach to protein
purification development.
This single-step, on-chip approach dramatically acceler-
ates and simplifies purification development and analy-
sis. The future of Process Proteomics begins with Pall.
Pall has the most comprehensive
family of scaleable separation products.
Visit us on the web at www.pall.com/biopharmaceutical
These products are for laboratory research use only and are not intended for human
or animal diagnostic, therapeutic, or other clinical uses, unless otherwise stated. The
information contained in this brochure are subject to change without notice.
Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand,
Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
, Pall, BioSepra, HyperD, Hypercel are registered trademarks of Pall Corporation.
Filtration. Separation. Solution. and UpScale are service marks of Pall Corporation.
ProteinChip is a trademark of Ciphergen Biosystems, Inc.
LPN PN702-004 - 12/2004
6
 PRODUCT NOTE

Heparin HyperD® M
Affinity Chromatography Sorbent
BIOSEPRA Heparin HyperD M

BioSepra® Heparin HyperD® M Figure 1 : Dynamic binding capacity vs. linear velocity.
®

composite chromatography sor-

bent is the most technologically 40

Hu ATIII dynamic binding capacity

(UI/ml)
advanced high speed, high
capacity affinity preparative sor- 30

bents for the purification of bio-

20
logical molecules that bind to
heparin, such as coagulation
10
factors, growth factors, lipopro-
teins... The sorbent provides
high binding capacity at high 200 300 400 500 600 700 800
flow rates. Linear velocity (cm/h)

Heparin HyperD® M unique

Column dimensions: 0.46 cm I.D. x 10 cm; Sample: hu ATIII at 72.5
composite structure was chosen
UI/ml; Equilibration buffer: 20 mM Tris-HCl containing 0.3 M NaCl, pH
to provide superior dynamic 7.4; Elution buffer: 20 mM Tris-HCl containing 2 M NaCl, pH 7.4.
capacity at high linear velocities.
HyperD® sorbent is comprised
of a porous rigid mineral bead Table 1. Heparin HyperD ® M Main Properties.
containing heparin bound
Particle size ............................................................................ 80 µm (av.)
hydrogel filled pores. BioSepra
holds U.S. patent 5,268,097 Dynamic binding capacity for
(1993) covering the unique hu ATIII (600 cm/h) .................................................... > 25 mg/ml*
properties of HyperD® sorbents Ligand .......................................................................................... Porcine heparin
®

and U.S. patent 5,234,991

Recommended operating pH range ...... 3-13
(1987) on other “supported
gel” or “gel-in-a-shell” sorbents. Volume changes due to pH
and ionic strength ........................................................ Non compressible
Heparin HyperD® M has an
average particle size of 80 µm Pressure resistance ........................................................ 70 bar (1,000 psi)
and is used for preparative scale
* Capacity determined using hu ATIII at 72.5 UI/ml in 20 mM Tris-HCl,
purification of ATIII. The sor-
0.3 M NaCl, pH 7.4. Elution with 20 mM Tris-HCl, 2 M NaCl, pH 7.4 at a
bent can be packed in column flow rate of 600 cm/h, 10 cm bed height.
sizes from ml to more than
hundred liters and operated at
high flow rates with low back-
pressure.

1

The main benefits of Heparin HyperD® M
sorbent are:
● Rapid packing due to the high density of
BIOSEPRA Heparin HyperD M
heparin sorbent which settles in a few minutes.
● HyperD® sorbent is very rigid and allows
the use of high flow rates without pres-
sure increase or shrinking or swelling of the
®
sorbent.
● Heparin leakage is minimized due to the
stable chemical link of the heparin mole-
cule to the sorbent.
Heparin HyperD® M is available as ready-to-
use labpacks suspended in 1 M sodium
chloride with 20 % ethanol as bacteriostat-
ic. Larger bulk quantities are also available
upon request.
Capacity.
Heparin HyperD® M maintains high binding
capacity, even at extremely high linear
velocity. It is commonly used at large scale
for the production of pharmaceutical grade
ATIII. Production scale columns (>100 L) can
be operated at high linear velocities (>200
cm/h) while maintaining capacity with mini-
mal backpressure (Figure 2). Its capacity is
higher than 25 UI/ml even at 600 cm/h
with a 10 cm bed height (Figure 1).
®
Stability.
The non compressible HyperD matrix can
®
withstand very high flow rates without any
risk of bed collapse. As a result, Heparin
HyperD® M can be used with LPLC, MPLC
or HPLC systems. An HPLC purification can
be performed in less than 10 minutes using
a 0.46 I.D. x 5 cm column. Faster purifica-
tion saves user time and preserves the bio-
logical integrity of the purified proteins. The
mechanical properties of Heparin HyperD®
M sorbent remain constant across a wide
range of velocities. Minimum pressure drop,
2
PRODUCT NOTE
Figure 2: Pressure vs. linear flow velocity.
Pressure
psi bar
45
3
30 2
15 1
200 600 1000 1400 1800 2200
Linear velocity (cm/h)
Column: 0.46 cm I.D. x 10 cm; Buffer: 20 mM Tris-HCl
containing 0.3 M NaCl, pH 7.4.
even at high linear velocity, assures direct,
predictable scale up to any volume (see
Figure 2).
Mechanical and chemical stability.
The pH stability is the same as for the free
soluble heparin: between 3 and 13.
Dissociating agents and detergents have
generally no effect on heparin sorbent.
Treatments of Heparin HyperD® M sorbent
with 8 M urea, 6 M guanidine hydrochlo-
ride and 1% Triton X-100 led to no change
when tested with bovine ATIII or Hu ATIII.
Heparin HyperD® M can be cleaned with sodi-
um hydroxide in concentrations of 0.01 to
0.1 M.
Validation.
The heparin used for the production of
Heparin HyperD® M has a North American
origin and is from porcine intestinal
mucosa. The heparin is produced in compli-
ance with the applicable requirements of
the FDA’s Good Laboratory Practices and
Good Manufacturing Practices regulations.
A validation file can be provided to industri-
al customers to support the regulatory
requirements for producing clinical and
approved therapeutics.
Applications. ● Lipoproteins (LDL, VLDL, VLDL apoprotein, HDL)
Heparin is a mucopolysaccharide known for its antico- may form an insoluble complex with heparin in the
agulant and clarifying actions. presence of divalent cations. This property is
exploited in the separation of serum lipoproteins on
Heparin is essentially composed of equimolar quanti-
immobilized heparin (e.g. lipoprotein elimination
ties of glucosamine and glucuronic acid, alternatively
from serum to reduce interference with enzymatic
linked by α-1,4 glycosic bonds.
assays).
A certain number of its hydroxyl groups are esterified
● Growth hormones.
with sulfuric acid, especially those on C-6 of glu-
cosamine. Other groups are also sulfated, including ● Growth factors: FGF, ECGF.
C-3 of glucosamine and C-2 of glucuronic acid. The ● DNA- and RNA-related enzymes as heparin is an
main characteristic of heparin is that it contains a inhibitor of DNA and RNA polymerases, and inter-
large number of amino groups combined with sulfate acts with numerous DNA- and RNA-dependent
groups, the latter being quite labile in acidic medium. enzymes. These properties are used to purify a wide
The molecule contains small quantities of other sugar, variety of enzymes (polymerases, restriction
such as galactose and xylose, and amino acids, e.g. endonucleases,...).
serine, which explains positive ninhydrin reactions. ● Other applications: immobilized heparin has been
As a result of its composition and its biochemical role, used for the purification of various other enzymes
heparin has the property to combine with a number (collagenase, α-L-iduronidase, hyaluronidase and
of proteins, enzymes and in general with polycationic lysozyme), fibronectin, fibronectin fragments and
organic compounds. It is also combined with alka- hormones receptors.
loids, antibiotics, stains and hormones.
There are many fields of applications of Heparin
HyperD® M sorbent which are related to the different
types of interactions of native heparin.These interac-
tions may be specific as with certain coagulation factors Ordering Information
or may be due to a more complex ionic interaction.
Product Cat. No. Size
Seven major groups of proteins can be purified on
Heparin HyperD® M: Heparin HyperD® M 20029-039 25 ml
20029-021 100 ml
● Coagulation factors such as ATIII, Factor IX, Factor 20029-013 1L
VII, Factor XI, Factor XII and XIIa. 20029-054 10 L
● Lipoprotein lipases are enzymes which participate in
lipid metabolism. Forming ionic complexes with
heparin, immobilized heparin provides a suitable
means for their purification. There are numerous
References
reports on the purification of lipoprotein lipases
from serum, mammalian heart, adipose tissue and 1. Lebing, W.R. et al., Vox Sang 67 (1994) 117.
2. Josic, D., Bal, F., Schwinn, H., J. Chromatogr. 632 (1993) 1.
bovine milk. 3. Kisiel, W., Davie, E.W., Biochemistry 14 (1975) 4928.
4. Lindon, J., et al., J. Lab. Clin. Med. 253 (1978) 5946.
5. Augustin, J., Freeze, H., J. Biol., Chem. 253 (1978) 2912.
6. Ashby, P., et al., Biochem. J. 171 (1978) 305.
7. Bengtson, G., Olivecrona, T., J. Biochem. 167 (1977) 109.
8. Pan, Y.T., et al., Arch. Biochem. Biophys. 189 (1978) 231.
9. Huet, J. et al., Meth. Enzymol. 273 Part A, 249.

3

2200 Northern Boulevard
East Hills, New York 11548-1289
+1 800.717.7255 toll free
+1 516.484.5400 phone
+1 516.801.9548 fax
pharmafilter@pall.com
Europa House, Havant Street
Portsmouth PO1 3PD, United Kingdom
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com
BioSepra SA
48 avenue des Genottes
95800 Cergy Saint Christophe, France
+33 (0)1 34 20 78 00 phone
+33 (0)1 34 20 78 78 fax
PRODUCT NOTE
About BioSepra® Products & Collaborative
Services
BioSepra process chromatography sorbents are manu-
factured and marketed by Pall Life Sciences. They great-
ly simplify protein purification development and signifi-
cantly improve biopharmaceutical manufacturing pro-
ductivity.
Over the past 25 years, BioSepra® chromatography
products and services have earned an outstanding
reputation for product innovation and technical support.
Our expanded R&D sorbent program, ISO 9001 manu-
facturing plant and HyperCel™ sorbents represent our
latest commitment to the biopharmaceutical industry.
With the acquisition of BioSepra® products and services,
Pall combines chromatography development expertise
with Ciphergen®'s SELDI-based ProteinChip® technology
to set in motion an entirely new approach to protein
purification development.
This single-step, on-chip approach dramatically acceler-
ates and simplifies purification development and analy-
sis. The future of Process Proteomics begins with Pall.
Pall has the most comprehensive
family of scaleable separation products.
Visit us on the web at www.pall.com/biopharmaceutical
These products are for laboratory research use only and are not intended for human
or animal diagnostic, therapeutic, or other clinical uses, unless otherwise stated. The
information contained in this brochure are subject to change without notice.
Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand,
Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
, Pall, BioSepra, HyperD, Hypercel are registered trademarks of Pall Corporation.
Filtration. Separation. Solution. and UpScale are service marks of Pall Corporation.
ProteinChip is a trademark of Ciphergen Biosystems, Inc.
LPN BT200080 - 12/2004
4
 PRODUCT NOTE

Blue Trisacryl M ®

Affinity Chromatography Sorbent

Introduction Figure 1. Structure of Blue Trisacryl M.

BioSepra Blue Trisacryl® M is an affinity chromato-

O NH2
®

graphic sorbent used for the purification of a wide SO2ONa R2

BioSepra Blue Trisacryl

variety of enzymes and proteins such as kinases,

NH R1
albumin, interferons, and some coagulation factors.
N
The basic matrix is Trisacryl® GF2000, a macroporous O NH NH N
non ionic sorbent on which Cibacron Blue is cova- N
SO2ONa NH
lently immobilized.
The initial matrix is a copolymer of N-acryloyl-2-
amino-2 hydroxymethyl-1,3-propane-diol in bead
form. Its macroporous structure allows a good diffu- Trisacryl M
sion and improves exchange kinetics.
Cibacron blue F3GA dye is strongly bound to the
matrix through a six carbon spacer arm (Figure 1).
The reaction is performed with the EEDQ coupling
agent. This type of coupling prevents any leakage of Table 1. Main Properties of Blue Trisacryl M.
the dye in normal working conditions. Particle size . . . . . . . . . . . . . . . . . 40-80 µm
Exclusion limit . . . . . . . . . . . . . . . 107 dt
Chemical and mechanical stability Capacity for human albumin* . . . . 10-15 mg/ml
Capacity tor bovine albumin* . . . . 5-7 mg/ml
The excellent chemical stability of Blue Trisacryl® M is pH stability . . . . . . . . . . . . . . . . . 1-10
a function of the synthetic nature of Trisacryl sorbent Heat stabibity . . . . . . . . . . . . . . . . –20°C to +121°C
and the enhanced stability of the ligand coupling Pressure stability . . . . . . . . . . . . . . Up to 3 bar (45 psi)
®

mechanism. Stability to detergents and

The sorbent has an excellent mechanical stability.
High flow rates with working pressures up to 3 bar
can be used.
Experimental results have shown that the flow rate
increases linearly with pressure up to about 40 cm
per hour. However, the absolute linear flow rate and
its relation to working pressure will vary according to
the column height.
Due to their extended lifetime, Blue Trisacryl® M
columns do not require frequent repacking, which is
cost- and labour-saving.
Experimental results showed no modification of the
chromatographic properties of the sorbent after
more than 100 cycles of albumin separation from
whole plasma.
On an industrial scale, Blue Trisacryl® M was used
over 700 cycles in the production of human albumin
from IgG depleted plasma.
denaturing agents . . . . . . . . . . . . Excellent
* Capacity determined in PBS buffer using 5 mg/ml.
Capacity
The binding capacity of Blue Trisacryl® M depends
on the protein involved. Additionally, the capacity
for a given protein may differ according to the ani-
mal species. For example, the binding capacity for
bovine albumin is lower than for human albumin.
Binding capacity can also vary according to the
working conditions, especially pH (see Figure 2).
Due to its binding capacity and its outstanding flow
rate, Blue Trisacryl® M is more efficient than any
commonly used sorbent. Its long lifetime and the
absence of non-specific adsorption contribute to
improve yields.

1
 PRODUCT NOTE

Figure 2. Sorption capacity (Calb) and sodium chloride elution On the industrial level, Blue Trisacryl® M is the ideal
molarity (Melu) of human albumin at different pHs. sorbent for human albumin separation in a single
step, for interferon purification and for TPA isolation.
Calb
(mg/ml) [NaCl] Blue Trisacryl® M may be used in any other purifica-
30 2 tion of Cibacron Blue F3GA-affine proteins. Many
other enzymes may be purified on Blue Trisacryl® M,
Melu such as sulfatases, phosphatases, RNA polymerases,
20 mono-oxygenases, and oxydoreductases.
1
®

Calb
BioSepra Blue Trisacryl

10
Application examples
0 Example I. Separation of phytohemagglutinin-
4 5 6 7 8 9 10 11 pH
induced interferon (-IFN) on Blue Trisacryl® M.
Courtesy of S. Stefanos, J. Wietzerbin, published by Mary
Ann Liebert Inc. Publications, NY.

Presentation and storage PB PBS

1.5 M
NaCl EG

-3
3

–– prot. (mg/ml)

--- IFN units/ml x10

Blue Trisacryl M is supplied as ready-to-use labpacks
®
80
suspended in 1 M sodium chloride and 20% ethanol
as bacteriostatic. 60
2
Before the first use, the sorbent can be stored at
room temperature.
40
Once opened, Blue Trisacryl® sorbent or columns
1
must be stored at +4°C in a neutral buffer contain-
20
ing a bacteriostatic agent. They must never be
frozen.
0 20 40 60 Fraction
Applications
––– Protein concentration ---- Interferon activity
®

Blue Trisacryl® M can be used for the purification of PB = 0.02 M phosphate buffer, pH 7.2
PBS = phosphate buffer saline
many proteins. Generally speaking, the Cibacron EG = ethylene-glycol mixed with PBS (50:50)
Blue F3GA chromophore interacts with most
enzymes which need NAD as cofactor (kinases,
dehydrogenases, phosphatases). Other proteins with
a non-enzymatic activity can also be separated: Example II. Analytical separation of human plas-
albumins, lipoproteins, growth factors such as matu- ma proteins on Blue Trisacryl® M.
ration promoting factor and heparin-binding growth
%T
factors, clotting factors, interferons (Example I) and (280 nm) [NaCl]
plasma proteins.
IgG Transferrin Albumin 2
The interaction mechanism between Cibacron Blue
F3GA and proteins involves one or more of the fol-
50
lowing:
- Stereospecific recognition of NAD analogs,
1
- Electrostatic and hydrophobic interaction,
- Electron exchange.
Due to its high selectivity and resolution power, Blue
Trisacryl® M may be used on the laboratory level for 0
rapid analytical and preparative separations of 100
1 2 3
numerous proteins (Example II). The separation Hours
speed allows several chromatographic cycles to be
Column: 1.6 cm I.D. x 10 cm; Buffer: 0 05 M Tris-HCI, pH 8 8; Elution
performed in a single day.
performed by a continuous sodium chloride gradient from 0 to 3 M;
Flow rate: 100 cm/h; Separation time: 180 min; Temperature: 20°C.

2
Example III. Automatic separation of Example IV. Purification of phospho- Example V. Purification of MPF
human albumin from plasma on Blue fructokinase-2/fructose-2,6-bisphos- (Maturation-Promoting Factors) on a
Trisacryl® M by step elution chroma- phatase (PFK 2/FBP) on a Blue Blue Trisacryl® M column from a
tography. Trisacryl® M column from an anion hydroxyapatite fraction obtained
exchange chromatography of a using a x.laevis unfertilized egg
%T
spinach extract. extract.
(280 nm) [NaCl] pH (Courtesy of Y. Larondelle, E. Mertens, E. Van Courtesy of P. Nguyen-Gia, M. Bomsel, J.P.
INJECTION 1 INJECTION 2
Schaftingen & H.G. Hers, Université Labrouase, C.L. Gallien & H. Weintraub,
3 Catholique de Louvain, Eur. J. of Biochem.). CNRS, Unité d'Enseignement et de Recherche
Biomédicale des Saints-Pères, Paris, Eur. J. of
9
PFK2 or
Biochem.
2 FBPase2 Protein
(mU/ml) (µg/ml)
8 C
1.5 A (280 nm)
8 A (280 nm)
PFK2 0.16 0.04
1 7
NaCl 6
1 (2 M) 0.12 0.03
6
4
0
0.08 0.02
0.5
B D
E F 2
Elution volume
A 0.04 0.01

Column: 2.5 cm I.D. x 6 cm; Adsorption buffer:
0.05 M Tris-HCl, 0 5 M NaCI, pH 8; Albumin elution
buffer: 2.5 M NaCl in the same buffer; Regeneration
solution: water-ethylene glycol mixture (50:50).
—— UV absorbance at 280 nm
- — - lonic strength ---- pH
References
0 FBPase
0 10 20 30 40 50
Fraction No.
21 mU ot PFK 2/FBP were injected into a 2 cm I.D. x
0.9 cm Blue Trisacryl M column pre-equilibrated
with 25 mM Tris-acetate buffer, pH 7.8 containing
5 mM magnesium acetate, 5 mM dithiothreitol and
0.2% Triton X-100. Elution was performed by a sodi-
um chloride gradient up to 2 M. For the determina-
tion of proteins (histograms), six pools (A to F) were
prepared and concentrated. The purification factor
from the previous column was 27.6; The recovery
was approximately 44%.
0 A B C
0 0
0 10 20 30 40 50
Fraction No.
7 ml (12 mg/ml) of the MPF extract were applied to
a 10 ml Blue Trisacryl M column pre-equilibrated
with 80 mM sodium glycerol-2-phosphate, 20 mM
EGTA, 15 m M MgCI2, 1 mM dithiothreitol, ATP and
phenylmethylsulfonylfluoride. The MPF activity was
retained and eluted with the same buffer containing
500 mM NaCI.
The horizontal lines show fractions pooled to give
three sets: Inactive peaks A and B (emerging with
the flowthrough and eluted with extraction buffer
containing 100 mM NaCI), and the active MPF
(peak C) eluted with extraction buffer and 500 mM
NaCI.
Left absorbance axis relates to peak A, right axis to
peaks B and C. Purification factor from the previous
column was 12. Recovery was 51%.

1. Travis, J., Pannell, R., Clin. Chim. Acta 49 (1973) 49.

2. Saint-Blancard, J., et al., Proc. Int. Symp. Aff. Chromatogr., Veldhoven (1981) 546.
3. Stefanos, S., et al., J. Interferon Res. 2 (1982) 447.
4. Barot-Ciorbaru, R., et al., Science Tools 29 (1982) 20.
5. Bohme, J.J., et al., J. Chromatogr. 60 (1972) 209.
6. Clonis, Y.D., Biochim. Biophys. Acta 659 (1981) 86.
7. Carne, A., Anal. Biochem. 121 (1982) 227.
8. Travis, J., et al., J. Biochem. 157 (1976) 301.
9. Roschlau, P., Hess, B., Z. Physiol. Chem., Hoppe Seyler's 353 (1972) 441.
10. Lowe, C.R., J. Chromatogr. 216 (1981) 175.
11. Trisacryl GF05 BioSepra Product Note No. BT B202915.
13. Wille, L.E., Clin. Chim. Acta 71 (1976) 355.
Ordering Information
14. Barritault, D., et al., J. Neurosci. Res. 8 (1982) 477.
15. Ahmad, A., et al., Biochim. Biophys. Acta 481 (1977) 542. Product Cat. No. Size
16. Shaw, D.J., et al., Biochem. J. 187 (1980) 181.
17. Bouriotis, V., J. Chromatogr. 206 (1981) 521. Blue Trisacryl® M 25896-010 100 ml
18. Bull, R., et al., Biochim. Biophys. Acta 653 (1981) 368.
25896-028 1L
19. Skotland, T., Biochim. Biophys. Acta, 659 (1981) 312.
20. Carillo, N., Vallejos, R.H., Biochim. Biophys. Acta 742 (1983) 285. 25896-036 10 L
21. Saint-Blancard, J., et al., Sci Tools 32 (1985) 87.
22. Lau, D., et al., Biotechnology 5 (1987) 953.
23. Nguyen-Gia, R, et al., Eur. J. Biochem. 161 (1986) 771.
24. Larondelle, Y., et al., Eur. J. Biochem. 161 (1986) 351.
25. Lobb R.R., et al., Anal. Biochem. 154 (1986) 1.
26. Iberg, N., Fluckiger, R., J. Biol. Chem. 261 (1986) 13542.

3

2200 Northern Boulevard
East Hills, New York 11548-1289
+1 800.717.7255 toll free
+1 516.484.5400 phone
+1 516.801.9548 fax
pharmafilter@pall.com
Europa House, Havant Street
Portsmouth PO1 3PD, United Kingdom
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com
BioSepra SA
48 avenue des Genottes
95800 Cergy Saint Christophe, France
+33 (0)1 34 20 78 00 phone
+33 (0)1 34 20 78 78 fax
PRODUCT NOTE
About BioSepra® Products & Collaborative
Services
BioSepra process chromatography sorbents are manu-
factured and marketed by Pall Life Sciences. They great-
ly simplify protein purification development and signifi-
cantly improve biopharmaceutical manufacturing pro-
ductivity.
Over the past 25 years, BioSepra® chromatography
products and services have earned an outstanding
reputation for product innovation and technical support.
Our expanded R&D sorbent program, ISO 9001 manu-
facturing plant and HyperCel™ sorbents represent our
latest commitment to the biopharmaceutical industry.
With the acquisition of BioSepra® products and services,
Pall combines chromatography development expertise
with Ciphergen®'s SELDI-based ProteinChip® technology
to set in motion an entirely new approach to protein
purification development.
This single-step, on-chip approach dramatically acceler-
ates and simplifies purification development and analy-
sis. The future of Process Proteomics begins with Pall.
Pall has the most comprehensive
family of scaleable separation products.
Visit us on the web at www.pall.com/biopharmaceutical
These products are for laboratory research use only and are not intended for human
or animal diagnostic, therapeutic, or other clinical uses, unless otherwise stated. The
information contained in this brochure are subject to change without notice.
Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand,
Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
, Pall, BioSepra, Trisacryl, Hypercel are registered trademarks of Pall Corporation.
Filtration. Separation. Solution. and UpScale are service marks of Pall Corporation.
ProteinChip is a trademark of Ciphergen Biosystems, Inc.
LPN BT201138 - 12/2004
4
 PRODUCT NOTE

SDR HyperD ®

Solvent-detergent removal chromatography sorbent.

• Binds solvent and detergent molecules used in viral inactivation processes
(TnBP and Triton® X-100).
• High recovery for proteins (exclusion limit 10 kDa).
• High sorption capacity for small hydrophobic molecules.
®

• Stable in acid, polar organic and oxidizing solutions.

BIOSEPRA SDR HYPERD

Plasma preparations may contain viruses Figure 1. Schematic interaction mechanism of

that are effectively removed and inactivated Triton X-100 and TnBP on SDR HyperD® sorbent.
by combining nanofiltration (for size exclu-
sion removal of non-lipid enveloped viruses) TnBP
OH O
and treatment with non-ionic solvents and
OH O
detergents (effective for lipid-coated virus-
es). OH O
O=P
The elimination of solvent and detergent OH O

HYDROPHOBIC POLYMER
from biological fractions is necessary, and OH O
SILICA

can be achieved by various methods includ- OH O O=P

ing sorbent partitioning, size exclusion, OH O
affinity or batch extraction with vegetable
OH O
oils combined to reverse phase on C18.
O=P
OH O
SDR HyperD® is a unique sorbent designed
®

OH O
to eliminate solvent and detergent from bio-
logical fluids. OH O

Triton X-100

Product description and mechanism of

solvent detergent adsorption.
SDR HyperD® is a composite sorbent that
combines a silica-bead moiety filled with a
three-dimensional cross-linked hydrophobic
polymer.
The particle size distribution (40-100 µm),
the small pore size of the silica beads and
the nature of the polymer have been opti-
mized for a retention of solvents and deter-
gents typically used in viral inactivation
processes (i.e. Tri-n-Butyl Phosphate – TnBP
– and Triton® X-100).
Triton X-100 interacts both with the silica surface (for-
mation of hydrogen bonds between the silanols and
the polyoxyethylene chain) and with the hydrophobic
polymer moiety. TnBP interacts only with the
hydrophobic polymer of the sorbent.
The adsorption mechanism involves both
the silica moiety and the hydrophobic poly-
mer. The adsorption of Triton X-100 is pro-
portional to the silica surface area, whereas
the adsorption of TnBP is linked to binding
to the organic polymer moiety. The main
features of SDR HyperD® sorbent are sum-
marized in Table I and the adsorption
mechanism represented in Figure 1.

1
 PRODUCT NOTE

Table I. Main Properties of SDR HyperD® sorbent.

Sorbent structure Spherical silica beads filled with a three-dimensional
hydrophobic polymer.
Average particle size 40-100 µm
Nature of polymer Hydrophobic, long aliphatic chains bind solvents.
10 kDa limit prevents proteins from being retained.
Typical sample load 2-3 times the column volume with residence times of
5 min using IgG or ATIII treated solutions.
®

Recommended residence time 5-15 min

BIOSEPRA SDR HYPERD

Binding capacity for Triton X-100 60-80 mg/ml*

Adsorption buffer PBS
Solvent/detergent elution buffer PBS/Ethanol (50/50) and EtOH or/and isopropanol
Operating pH range 2-12
Sorbent pressure resistance 70 bar (1000 psi)
* Determined using 5 mg/ml Triton X-100 in PBS, pH 7.4, 10% breakthrough, 300 cm/h.

Capacity and solvent- 100 cm/h (initial concentration of Triton X-100 and TnBP in
detergent removal effi- bovine plasma are respectively 10 and 5 mg/ml).
ciency. Examples of removal efficiencies from various feedstreams
are summarized in Table II.
The structure of SDR
HyperD® sorbent has been
engineered to optimize the
®

solvent/detergent retention. Table II. Solvent-Detergent Depletion Example.

Due to the specific degree
of three-dimensional poly- Before After Removal
mer cross-linking, a low depletion depletion efficiency

exclusion limit of 10 kDa IgG TnBP 5,000 ppm < 0.4 ppm 99.9%
allows target proteins to be Triton X-100 10,000 ppm < 10 ppm 99.9%
"excluded" from the sor- ATIII TnBP 5,000 ppm < 0.4 ppm 99.9%
bent, and are found unre- Triton X-100 10,000 ppm < 10 ppm 99.9%
tained in the column void
Bovine serum TnBP 5,000 ppm < 0.4 ppm 99.9%
volume.
Triton X-100 10,000 ppm < 10 ppm 95.5%
On the other hand, the high
specific surface area (200 Sample volume: 3.6 CV, Flow rate: 150 cm/h; Column length: 10 cm;
m2/g) of the porous silica Residence time: 4 min.
NOTE: The removal efficiency is also dependent on flow rate and column load-
allows a high capacity for ing: i.e. when using a 10 cm column at 150 cm/h (2 CV load of bovine serum
Triton X-100 and TnBP. The supplemented with Triton X-100 or TnBP), a removal of 95.5% was observed
dynamic binding capacities for Triton X-100; this removal efficiency was decreased to 80% when 8 CV
currently obtained are 60-80 loads were used.

mg/ml for Triton X-100 and

40-50 mg/ml for TnBP at

2
Guidelines for binding capacity optimization. Cleaning in place and chemical stability.
As for any sorbent, the dynamic binding capacity
SDR HyperD® sorbent is insoluble in water and in
(DBC) of SDR HyperD® sorbent is sensitive to the lin-
organic solvents. It is also very stable to strong
ear flow rate, to the residence time on the column
denaturating agents and chaotropic agents. The sor-
and to the nature of the sample. Therefore, it is
bent can be treated with 0.01 to 0.1 M hydrochloric
recommended to start trials by loading not more
acid or water-miscible organic solvent. SDR HyperD®
than 5 CV of sample on a column with a minimum
sorbent can also be treated with oxidizing agents
height of 15 cm, and a working flow rate not
such as peracetic acid (1500 ppm in sodium acetate,
exceeding 150 cm/h. Adsorption buffer sample load
pH 5.0), which is a well-known bactericide and spo-
and flow rate can be increased according to per-
ricide.
formance. Note that the rigid nature of SDR
HyperD® sorbent allows to use higher flow rates Recommendations for sanitization are shown in
(i.e. > 600 cm/h) for washing and cleaning, with Table III.
moderate backpressure (< 2 bar).

Desorption of retained solvent/detergent. SDR HyperD sorbent is supplied in a storage solution

It is typically achieved by injecting 1-10 CV of containing 20% ethanol.
PBS/Ethanol 95° (50/50), followed by 3-10 CV of For industrial applications, bulk quantities are avail-
ethanol 95°. If necessary, 2-isopropanol can also be able on request.
used (10 CV) in the washing sequence.

Table III. Recommended clean-in-place methods.

Method Procedure

Alcohol/acid treatment Wash with at least 3 CV of a solution of 20% (v/v) ethanol containing 1 M acetic acid.
This solution should be injected after removal of dissolved gas at a flow rate of 10-20 cm/h
(1 hour contact time). After treatment, reequilibrate with normal sterile pyrogen-free buffer.

Diethylpyrocarbonate/ Wash with 2 CV of PBS buffer containing 95% ethanol - 5% diethylpyrocarbonate solution.
ethanol treatment Then wash the column with 3 CV of 3 M pyrogen-free sterile NaCI / 1 M acetic acid to
remove pyrogens. Reequilibrate the column in sterile pyrogen-free buffer.

Reference
● Specific sorbent to remove solvent-detergent mixtures from
virus-inactivated biological fluids.
Guerrier, L., et al., J. Chromatogr. B, 664 (1995) 119.

Ordering Information
Product Cat. No. Size

SDR HyperD® 20033-031 25 ml

20033-023 100 ml
20033-015 1L
20033-056 5L
20033-049 10 L

3

2200 Northern Boulevard
East Hills, New York 11548-1289
+1 800.717.7255 toll free
+1 516.484.5400 phone
+1 516.801.9548 fax
pharmafilter@pall.com
Europa House, Havant Street
Portsmouth PO1 3PD, United Kingdom
+44 (0)23 9230 3303 phone
+44 (0)23 9230 2506 fax
BioPharmUK@europe.pall.com
BioSepra SA
48 avenue des Genottes
95800 Cergy Saint Christophe, France
+33 (0)1 34 20 78 00 phone
+33 (0)1 34 20 78 78 fax
PRODUCT NOTE
About BioSepra® Products & Collaborative
Services
BioSepra process chromatography sorbents are manu-
factured and marketed by Pall Life Sciences. They great-
ly simplify protein purification development and signifi-
cantly improve biopharmaceutical manufacturing pro-
ductivity.
Over the past 25 years, BioSepra® chromatography
products and services have earned an outstanding
reputation for product innovation and technical support.
Our expanded R&D sorbent program, ISO 9001 manu-
facturing plant and HyperCel™ sorbents represent our
latest commitment to the biopharmaceutical industry.
With the acquisition of BioSepra® products and services,
Pall combines chromatography development expertise
with Ciphergen®'s SELDI-based ProteinChip® technology
to set in motion an entirely new approach to protein
purification development.
This single-step, on-chip approach dramatically acceler-
ates and simplifies purification development and analy-
sis. The future of Process Proteomics begins with Pall.
Pall has the most comprehensive
family of scaleable separation products.
Visit us on the web at www.pall.com/biopharmaceutical
These products are for laboratory research use only and are not intended for human
or animal diagnostic, therapeutic, or other clinical uses, unless otherwise stated. The
information contained in this brochure are subject to change without notice.
Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, India,
Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, the Netherlands, New Zealand,
Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden,
Switzerland, Taiwan, Thailand, United Kingdom, United States and Venezuela.
Distributors are located in all major industrial areas of the world.
, Pall, BioSepra, HyperD, Hypercel are registered trademarks of Pall Corporation.
Filtration. Separation. Solution. and UpScale are service marks of Pall Corporation.
ProteinChip is a trademark of Ciphergen Biosystems, Inc.
LPN PN704-009 - 12/2004