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Water System Design

Planning and Practices


John Postiglione
908-575-2141
Agenda
Needs Assessment
Usage Matrix

Loop Layout and Design

System Design Overview

Component Selection

Documentation

Installation and Start-up


Needs Assessment
QQTSM
Quality
What type of water will be used and where
Quantity
How much water will be used
Flow rate
Min and MAX pressure
Time
Usage profile: 8 hours a day five days a week or 24/7
How soon do they need water
Space
Where is the water system being placed, Utilities, egress
Where is the loop run
Money
Overall budget
Needs Assessment
Physical Layout
Create a usage Layout
Start with a drawing of the building and mark use points.
Color code the use points to indicate usage needs
Flow
Daily Usage
Quality
Ergonomics

Complete a Usage Matrix


Use a program like Access for a 3D matrix or Excel for a 2D
Loop Layout and Design
Building Layout In Process
ABC Drug Company Plant Layout Raw Mat QC Sample QC

Utilities Area Receiving

Blending

Office Manufacturing R+D Lab 1

Press
Storage Office
Manufacturing R+D Lab 2

Bathroom

Bathroom Manufacturing R+D Lab 3

Packaging

Shipping Office Cafeteria


Loop Layout and Design
Add Points of Use In Process
ABC Drug Company Plant Layout Raw Mat QC Sample QC

Utilities Area Receiving

Blending
V001
V011 V010 V009 V008

Office Manufacturing R+D Lab 1

V007
V002
Press
Storage Office
Manufacturing R+D Lab 2

Bathroom
V006

V003 Bathroom Manufacturing R+D Lab 3

Packaging V005

Shipping Office Cafeteria


V004

USP 15 GPM UPS+ 1 GPM <10 TOC


USP 15 gpm USP 1gpm <10 TOC
UPS 2 GPM USP 1 GPM
USP 2 gpm USP 1 gpm
2D Usage Matrix
Maximum Hourly Usage

Min Flow Min Max Total


POU #

10:00

11:00

12:00

13:00

14:00

15:00

16:00

17:00
Rate Pressure Press Daily

8:00

9:00
GPM PSI PSI Quality Usage
V001 15 30 99 USP 1200 500 0 0 100 500 0 0 0 100 0
V002 15 20 99 USP 500 100 0 100 0 100 0 100 0 100 0
V003 2 50 40 USP 200 20 20 20 20 20 20 20 20 20 20
V004 2 50 99 USP 200 20 20 20 20 20 20 20 20 20 20
V005 1 20 40 USP 27 3 3 3 3 3 3 3 3 3 0
V006 1 20 40 USP 27 3 3 3 3 3 3 3 3 3 0
V007 1 20 40 USP 27 3 3 3 3 3 3 3 3 3 0
V008 1 20 40 USP+ 27 3 3 3 3 3 3 3 3 3 0
V009 1 20 50 USP 50 5 5 5 5 5 5 5 5 5 5
V010 1 20 40 USP+ 27 3 3 3 3 3 3 3 3 3 0
V011 1 20 40 USP+ 27 3 3 3 3 3 3 3 3 3 0

Totals 41 50 40 2312 663 63 163 163 663 63 163 63 263 45


Usage Profile
Usage Profile

Gallons Per Hour Gallon Per Minute

700 45
600 40

Gallons Per Minute


35
Gallon Per Hour

500
30
400 25
300 20
15
200
10
100 5
0 0
8:00 9:00 10:00 11:00 12:00 13:00 14:00 15:00 16:00 17:00
Time
Loop Layout and Design
Loop Layout
Design the layout of the loop or loops
Decide the placement of the make-up system(s)
Decide on flow rates to size the pipe and pump
Loop Layout Options
One Loop and One Make-Up System
In Process
ABC Drug Company Plant Layout Raw Mat QC Sample QC

Utilities Area Receiving

Blending
V001
V011 V010 V009 V008

Office Manufacturing R+D Lab 1

V007
V002
Press
Storage Office
Manufacturing R+D Lab 2

Bathroom
V006

V003 Bathroom Manufacturing R+D Lab 3

Packaging V005

Shipping Office Cafeteria


V004

USP UPS+ 1 GPM <10 TOC


USP 1515 GPM USP
gpm 1gpm <10 TOC
UPS 2 GPM USP 1 GPM
USP 2 gpm USP 1 gpm
Loop Layout Options Two Loops
and Two Make-Up Systems In Process
ABC Drug Company Plant Layout Raw Mat QC Sample QC

Utilities Area Receiving

Blending
V001
V011 V010 V009 V008

Office Manufacturing R+D Lab 1

V007
V002
Press
Storage Office
Manufacturing R+D Lab 2

Bathroom
V006

V003 Bathroom Manufacturing R+D Lab 3

Packaging V005

Shipping Office Cafeteria


V004

USP15
USP 15GPM
gpm USP 1gpm
UPS+ 1 GPM<10 TOC
<10 TOC
USP22GPM
UPS gpm USP11GPM
USP gpm
Loop Layout Options
Two Loops With POU RO/DI In Process
ABC Drug Company Plant Layout Raw Mat QC Sample QC

Utilities Area Receiving

RO/DI RO/DI RO/DI


Blending
V001
V011 V010 V009 V008

Office Manufacturing R+D Lab 1

V007
V002
Press
Storage Office
Manufacturing R+D Lab 2

Bathroom
V006

V003 Bathroom Manufacturing R+D Lab 3

Packaging V005

Shipping Office Cafeteria


V004

USP
USP15 gpm UPS+
15GPM 1 GPM <10 TOC
USP 1gpm <10 TOC
UPS 2 GPM USP 1 GPM
USP 2 gpm USP 1 gpm
System Design Overview
Review Needs Assessment
Quantity Needs:
Total daily usage Time
Usage profile Usage Profile
Max and Min flow rate
Max and Min Pressure
Space
Loop Layout and Equipment
Quality Needs placement

Does it need to meet any Money


specifications Round number estimates for
USP design from supplier
NCCLS/CAP
ASTM
AAMI Hemo dialysis
Semiconductor Grade Water

Additional water quality needs


TOC
Bacteria Pyrogens
Chemical
System Design Overview
FinalizeLoop Design
Determine Minimum and Maximum
Water Quality
Flow Rate and Velocity Calculations

Size the tank, Tank and Material

Size the Make-up System


Configuration
System Design Overview
Finalize Loop Design
Choose the layout
For the following discussion we have selected a single
loop feeding the entire plant
Calculate loop effective length of pipe
Linear feet + Fittings adjustment
Example - 90 deg elbow is equivalent to 2 of pipe

Qty Equivalent Total


Length Pipe 400 1 400
Elbows 72 2 144
Tee Valves 13 5 65
Valves 4 5 20
Total 629
Choose material and finish
System Design Overview
Determine Min/Max Water
Quality
Starting with your Minimum quality, in most
cases it will be USP Purified
Look for special chemical requirements, TOC
levels, Microbial
Consider polishers in QC lab
Check equipment specifications for min and max
quality
System Design Overview
Flow Rate
Calculations
From Usage Matrix we determined a
maximum draw of 40 gpm and a minimum
velocity of 4 feet per second. We added
10 gpm to maintain some return flow.
Pressure Total
Diameter Velocity Drop per Pressure
100" Drop
1" 17.8 27.8 174.9
1.5" 6.8 4.1 26.0
2" 4.1 1.2 7.4
System Design Overview
Size the Tank and Choose
Material
Design Considerations
Sized with Make-Up system
Store water protected from bacterial growth
Vent filter
Sanitary Overflow
Tank UV light or Spray Ball
Conical bottom
Steam or Ozone sterilization
Rupture Disk should always have Monitor
Smaller the better
Consider varying the tank level for off hours
Stainless Steel
System Design Overview
Size the tank Tank and Choose
Material
The tank need to be at least 700 since our
maximum hourly draw is 700 gallons.

A larger tank can be Usage Profile


used but a smaller Gallons Per Hour Gallon Per Minute
tank will increase
700 45
turnover and 40
600

Gallons Per Minute


maintain a more 35
Gallon Per Hour

500
consistent water 400
30
25
quality. 300 20
15
200
10
100 5
0 0
8:00 9:00 10:00 11:00 12:00 13:00 14:00 15:00 16:00 17:00
Time
System Design Overview
Size the Make-up System
Configuration

We sized the tank first with demand and quality


needs as part of the design goals
Size the make-up system keeping in mind the
quality needs and the rate to meet the quantity
demands
More capacity may be needed if the tank
selected does meet the days or instantaneous
demands
Many different system configurations. Your
usage profile and tank size may effect your
decision
System Design Overview
System selection
ABC Drug company needs water to clean their blending
vessels at the end of the day. They require 2000 gallons of
USP Purified in one hour.
100 gph RO, 2500 Gallon Tank, DI in Loop

XYZ Ointments Company needs 200 gallons per hour to


feed a mixer. They run for 10 hours per day.
200 gph RO with a 200 Gallon Tank
Component Selection

Electrodeionization
Multi-Media
Storage Tank
Carbon Filter
Distribution loop
Sodium Bisulphate
Distribution Pumps
Softener Ultra Violet
Prefilters Postfilter
Reverse Osmosis Loop Monitoring
Raw Water Properties

12 months of historical data Hardness


if available Ph
Facility test reports Turbidity
Local equipment vendors Bacteria count
Water utilities Organic & inorganics
Temperature Sanitization agent
Particulate
Multi-Media Filter
Multi-Media Filter
Design Considerations:
Try to size the multi-media filter to minimize the pressure drop
through the system.
Use the manufacturers recommendation for sizing system.
Special considerations should be made for highly turbid water.
Any system over 1000 lpd should have a multi media filter
Removal of Suspended Particles
ADVANTAGES DISADVANTAGES
Low operating cost High backwash rates
Low maintenance Can grow bacteria
Media is durable Only removes rough
particles
Carbon
Filter
Design Considerations:
Try to size the Carbon filter to minimize the
pressure drop through the system.
Use the manufacturers recommendation for
sizing system.
Special considerations should be made for highly
turbid water.
Sodium Bi-sulfite is being used more frequently
than carbon for chlorine removal.
Removal Dissolved Organics and
Chlorine
ADVANTAGES DISADTVANTAGES
Safe chlorine removal Generates fines
Remove organics Bacteria growth
Some particulate removal Must be sanitized
Softener

Design Considerations:
Size softener to minimize pressure drop.
Size softener to ensure grain capacity will not force
regenerations more than once a day.
Softeners improve the performance of RO systems.
Duplex Softeners extend regeneration period and
eliminate down time.

Does Not Remove, Exchange only


ADVANTAGES DISADVANTAGES
Removes scaling Can grow bacteria
Sanitizable Salt handling
Sodium
Bisulfite

Design Considerations:
Sodium Bisulfite (NaHSO3) is a reducing agent capable of dechlorinating the
feed water to a reverse osmosis system.
Dechlorination reactions
NaHSO3 + CL2 + H2O NaHSO4 + 2 HCL
1 ppm of chlorine (CL2) requires 1.46 ppm of NaHSO3
To ensure complete dechlorination add 10%
excess of sodium bisulphate.
Removal of Free chlorine
ADVANTAGES DISADVANTAGES
Low capital cost High maintenance for mixing solution
Minimal bacterial Chemical handling
growth issues Requires monitoring of chlorine
levels with alarm
Prefilters

Design Considerations:
Size Prefilters to minimize pressure
Absolute filters should be used.
Multiple Prefilters with different micron ratings in series can
length filter life
Final micron size determined by RO membrane requirements
Removal of Suspended particles and
Microorganisms
ADVANTAGES DISADVANTAGES
Absolute filters remove all Potential high expendable costs
particles greater than the pore Non regenerable
size
Does not remove endotoxins and
Minimal maintenance dissolved inorganics
Sterilizable
Reverse Osmosis

Design Considerations:
The most economical means of removing a variety of
contaminants in a water system.
There are many different types of reverse osmosis
membranes to fit different application
Sized together with Tank

Removal of Suspended particles,


Dissolved organics, Dissolved,
inorganics and Microorganisms
ADVANTAGES DISADVANTAGES
Efficiently and economically removes Consumes electricity and heat
particles, microorganisms, dissolved Low flow rate/square foot of surface
inorganics and dissolved organics Can support bacteria growth
Minimal maintenance Permeate will concentrate CO2 from feed
Can eliminate ion exchange water
Electrodeionization

Design Considerations
Electrodeionization is a process which deionizes water by
means of an applied electrical current.
Sized by flow rate

Removal of Dissolved inorganic


ADVANTAGES
DISADVANTAGES
Effectively removes dissolved inorganic
Needs RO or DI pretreatment
No chemical regeneration
Low operating cost Relatively high capital cost
Sanitizable
Storage Tank

Design Considerations
Sized with Make-Up system
Store water protected from bacterial growth
Vent filter
Sanitary Overflow
Tank UV light or Spray Ball
Conical bottom
Steam or Ozone sterilization
Rupture Disk should always have monitor
Smaller the better
Distribution Pumps
Design Considerations
Duplex pumps to improve reliability
Pressure sensor tied to alarm and duplex switch
Material compatibility with sanitization method
Ultraviolet

Design Considerations
Sized by flow rate
Ultraviolet sterilizers emitting:
185NM UV light with the proper contact time can reduce TOC levels
in water.
254NM UV light with proper contact time will Sterilize the water
Ultraviolet sterilizers for pharmaceutical waters must be
equipped with a monitor that measures the UV irradiance and
they should be of sanitary design.

Removal of Microorganisms and


Dissolved Organics
ADVANTAGES DISADVANTAGES
Effective bacterial, ozone Can decrease resistivity
and chlorine reduction Can generate endotoxins
Low operating cost Needs particulate registration
Post Filter

Design Considerations:
Size postfilters to minimize pressure
Absolute filters should be used
Material compatibility with sanitization method

Removal of Suspended Particles


and Microorganisms
ADVANTAGES DISADVANTAGES
Absolute filters remove all Potential high expendable costs
particles greater than the pore Non regenerable
size
Does not remove endotoxins and
Minimal maintenance dissolved inorganics
Sterilizable
Distribution - Hot Loops

Design Considerations
Effective control of bacteria.
Most microorganisms are destroyed at 80C which is a typical
hot loop temperature.
WFI systems will incorporate heat exchangers and monitoring
in the distribution loop to maintain 80C.
Some purified water systems will use heat at 80C to perform
periodic sanitizations.
ADVANTAGES DISADVANTAGES

Widely accepted means of control Energy intensive


for bacteria in pharmaceutical Expensive materials of construction
water Requires insulated piping
Requires no chemical to sanitize Safety hazard
Distribution Loops

FDAComments Water and Steam


Guide
Loop Velocity
Common industry practice is to design circulating
loops for a minimum return velocity of 3 feet/second
or higher
Return velocities less than 3 feet/second are
acceptable for short periods of time or in systems
that do not favor microbial growth such as hot,
chilled or ozonated loops
Distribution Loops

FDA Position on Dead legs


FDA Guide to Inspections of High Purity Water Systems
One common problem with piping is that of dead-legs.
The proposed LVP regulations defined dead-legs as not
having an unused portion greater in length than six
diameters of the unused pipe measured from the axis of
the pipe in use. It should be pointed out that this was
developed for hot 75-80C circulating systems. With
colder systems (65-75C), any drops or unused portion
of any length of piping has the potential for the
formation of a biofilm and should be eliminated if
possible or have special sanitizing Procedures.
Therefore, the firms procedures for sanitization, as well
as the actual piping, should be reviewed and evaluated
during the inspection.
Distribution Loops - 6D Rule

Proposed CFR 212, 1976

1.00"
3.88"
Distribution Loops - 2D Rule

ASME Bioprocess Equipment Guide, 1997

1.00"
1.77"
Loop Monitoring
Documentation
Project engineering drawings and specifications including a
description of the system operation parameters
Specifications of equipment purchased especially material
certification that will come in contact with the finished
product
Equipment supplier shop drawings
Equipment Functional Requirement Specifications
Installation standards and methods including orbital
welding
Materials of construction to assure quality and
compatibility
FAT and SAT test plans and reports
As-Built drawings especially any P&ID as well as isometric
drawings
Cleaning and passivation methods and results
Pressure tests
Piping slope drawings
Instrument documentation
Supply utilities verification with design documents
O& M Manuals
USP 28-NF 23 Standard
Definitions

Water for Injection


Water for Injection is water purified by distillation or a purification
process that is equivalent or superior to distillation in the removal of
chemicals and microorganisms. It is prepared from water complying
with the US EPA NPDWR or comparable regulations of the European
Union or Japan. It contains no added substance.

Purified Water
Purified Water is water obtained by a suitable process. It is prepared
from water complying with the US EPA NPDWR or comparable
regulations of the EU or Japan. It contains no added substance.
Pharma Water Systems

The steps and equipment utilized for the


purification in pharmaceutical water
systems basically consist of different
levels of filtration and ionic contaminant
removal.
Start-Up
Installation Verification,
Punch List
Utility Services Verification
Pressure testing
P&ID walk down, resulting in
an as-built P&ID
Instrument calibration
System Integrity Testing
Initial Operation of System
Initial Testing of Operation
Commissioning
Verification of As-Built Piping and
Instrumentation Diagrams (P & IDs)
Verification of the proper operation of the
unit operations including test sequences,
shutdown & start-up
Alarms and Interlocks Testing
Instrument Calibration
Commissioning Document Execution
Non-conformance Resolution
Thank You

Peter Vishton
Prin. Project Engineer
Wyeth Corp.
Thank You For
Attending
John Postiglione
908-575-2141