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Getinge Worldwide
Getinge is a leading global medical technology group
that provides complete solutions to clients engaged in
the provision of healthcare.
The ‘Infection Control’ business area provides
equipment and services to hospitals, laboratories and
pharmaceutical companies around the world.
As in other business areas, the Getinge Group is the
world market leader in this field, with sales and service
support channels in more than 100 countries on all
5 continents.
The Getinge Group headquarters and primary factory
within the Infection Control business area is located in
the town of Getinge on the West Coast of Sweden. This
state-of-the-art, 16,500 sq.m (178,000 sq.ft) factory is
State-of-the-art production facilities
the world’s largest of it’s type, and produces the
majority of the Group’s pressure vessels, used in
Getinge-Kemiterm and the sterilizers, steam generators and multi-effect water stills.
Getinge Group
Located near Copenhagen, Denmark, Kemiterm A/S has
been manufacturing water treatment equipment for Getinge-Kemiterm
more than 30 years. After many years as a business Products & Services
partner and supplier, Kemiterm joined the Multi-Effect Water Distillation Equipment
Getinge Group in 1998 and became For production of Water For Injection (WFI)
Getinge-Kemiterm A/S.
Now an integral part of the Infection Pharmaceutical Steam Generators
Control business area, Getinge- Clean / Pure Steam* for use in the production of
Kemiterm’s products are pharmaceuticals.
globally distributed and
supported by the Getinge Clean-Steam Generators
Group distribution Clean Steam* for use in laboratories, hospitals and
channels, alongside non-critical production applications.
existing channels.
Water Treatment Equipment ∆
Complete scope including filtration, softening, RO
plant, CEDI plant, for production of purified water.
Distribution Systems ∆
Storage and handling of treated water and steam;
piping & control systems, heat exchangers and
storage tanks.
ISPE Baseline®
Philosophies Guides GAMP
Basics F DA 2 1 C F R
Getinge-Kemiterm understands the importance of Pa r t 1 1
Pharmaceutical Water as the most widely used
ingredient in drug manufacturing and that cGMP
Pharmaceutical Water and Steam are the fundamental
utilities for the manufacturing process.
Quality Assurance / Validation
Getinge-Kemiterm recognize that design, construction
and performance are not the only criteria for selection of
Design & a piece of equipment for pharmaceutical production, but
Manufacture thatURS
quality control and documentation are PQ equally
The guiding Getinge-Kemiterm important, and must be an integral part of a project to
philosophies are: install and validate new equipment. To this end, every
Customer Service / Satisfaction Getinge-Kemiterm water still and pure steam generator
Reliability FS with extensive documentation
is provided OQ covering
Quality Control / Validation design, function, materials and components used,
Regulatory Compliance software programming and test protocols.
Cost-effectiveness
Environmental Considerations Factory Acceptance
DS Testing is also IQ an integral part of
every project. All equipment is tested in a purpose built,
Pressure vessels are produced in our state-of-the-art 600 sq.m (6,500 sq.ft) testing hall after manufacture.
production facility in Getinge, Sweden using automated
welding equipment, according to ISO 9001 procedures This state-of-the-artSystem
hall is equipped
Build with controllable,
and following all appropriate pressure vessel codes. quantifiable utilities and data acquisition / monitoring
Design, Project Management, Assembly and Testing of equipment, used in generation of FAT reports.
the equipment is made at the Getinge-Kemiterm
headquarters & factory in Lynge, near Copenhagen. After installation a Site Acceptance Test may be
performed to verify the FAT results before handover.
Pharmaceutical Steam
Definitions Basis Of Design
Getinge-Kemiterm follow the concepts established in Getinge-Kemiterm CSG and PFS Generators
the ISPE Baseline® Guide for Pharmaceutical Steam. have the same basic construction and
For the purpose of defining our product range we use operating principle. The CSG incorporates
the terms Clean Steam Generator (CSG) and Pure a labyrinth baffle system to remove water
Steam Generator (PFS) as follows: droplets, whereas the PFS uses the 3+
separation system to guarantee pure
CSG: Produces steam by evaporation of ‘clean’ steam quality irrespective of
water. The properties of the steam are generally feedwater quality.
similar to those of the feedwater.
Features
Common Features
316L stainless steel pressure vessel – shell & tube
Unique single port double tube sheet design
Pressure fed ‘falling film’ evaporation system
304 stainless steel frame and electrical enclosure
Electrical or plant steam heating
Standalone or integrated with Getinge™ autoclave
Pure steam pressure control system
GAMP compliant PLC system
Allen Bradley
Siemens
Mitsubishi
CSG Features
Tube in tube external preheater
Labyrinth separation system
PFS Features
Unique Ω internal preheaters
Unique 3+ separation system
Steam generators are available in a variety of capacities
from 100 to 8,000 kg per hour (220 to 17,600 lbs per
hour).
Autoclave Integration
The combination of separation systems and the rapid
response of the falling film technique enable the Getinge-
Kemiterm steam generators to operate under a wider
variety of operational conditions than generators with only
gravity and/or demister separation and ideal for
applications with fluctuating flow and pressure
requirements, such as the supply of steam to autoclaves.
Getinge-Kemiterm steam generators may be supplied
‘stand alone’ or may be integrated with any Getinge steam
sterilizer. A degasser option is available to ensure non-
condensible gas content remains below 3.5%. This together An 8000 kg per/hour
pure steam generator
with the precision control and separation systems ensures installed at Getinge’s
compliance with EN 285 and HTM 2031 irrespective of test facility in Sweden.
feedwater quality.
PFSTM Function
The generator consists of a 316L stainless steel shell and
tube heat exchanger (column). The shell is heated by an
external energy source, such as utility steam or
electricity. As it flows to the evaporation tubes,
feedwater is preheated to boiling point via inverted U
Pharmaceutical Steam
tubes (Ω preheaters) within the column. At the top of the
column the feedwater is distributed uniformly into the
evaporation tubes, creating a thin film on the internal
walls. This ‘falling film’ is rapidly evaporated, creating
clean steam.
PT
CT
Advantages of
All stainless steel piping system Multi-effect Distillation
AISI 316L for all piping and components No Moving Parts
Choice of surface finishes. Low Maintenance
Dead legs less than 3D.
Quiet Operation
Sanitary clamp connections with FDA approved
gasket materials Energy Efficient
Minimal Pretreatment Requirements
Stills are available in a variety of capacities from 100 Steam or Electrical Heating
to 15,000 liters per hour (26 to 4,000 gallons per hour).
Multi-Effect Stills
MS™ Function
Getinge-Kemiterm MS stills are designed to produce Water
For Injection by evaporating, purifying and condensing
feedwater. Due to the unique 3+ separation system, MS stills do not
require high quality water as a precondition to reliably produce WFI
satisfying USP, EP, JP or other pharmacopoeial requirements.
The size and design of each column determines the output capacity of the still,
the number of columns determines the efficiency; the greater the number of
effects, the lower the consumption of utilities. Thus the selection of the number
The WFI produced in each The steam from the final effect
effect and the condenser is provides a slight overpressure
collected in the condenser. to raise the distillate to a
degassing chamber.
In normal production, the still may be operated manually, or remotely according to the level in the downstream storage
tank. In the latter case, on reaching the upper level, the still may either stop, or enter a ‘hot standby’ mode where it
remains heated and available for immediate production. In stop mode, the still will cool and will vent via a built in
0.2µm sterilizing grade filter in a heated stainless steel housing.
Combination Systems
Examples
Typical Laboratory System
Pure Steam Generator with condensing system
(produces WFI on demand or during night-time)
Storage Tank, Distribution Pump, Loop Piping
Point of Use Heat Exchanger and User Point
Getinge GE 66xx autoclave
Getinge 8666 washing machine
Storage Tanks
Distribution Piping
Point of Use Heat Exchangers
User Points
The ‘COMBI’, A Unique
Solution
All Multiple Effect water stills may be used to generate
Pure Steam. However, the quantity is limited to a small
proportion of the capacity of the first effect. Steam may
only be extracted during WFI production and extraction
proportionately reduces the WFI capacity of the still.
Furthermore, the pure steam production cannot respond
to large fluctuations in demand, such as provision of
steam to an autoclave.
The Getinge-Kemiterm COMBI solves these problems,
allowing simultaneous production of Pure Steam and
WFI in specified flow rates. Pure Steam and WFI may
be produced either simultaneously or independently.
Combination Systems
frame reduces equipment cost and space
requirements.
The ‘Combi’: note the larger first effect. Single unit design reduces time and cost of validation
and maintenance
PFS-C Multi-mode control allows use as steam generator or
For small scale production and laboratory use it is not multi-effect still or both
cost effective to use multiple effect distillation plant.
The cost advantages / energy savings that can be made
by the ME principle cannot offset the capital cost.
However, frequently there is a requirement for both
Water for Injection and Pure Steam in such facilities.
In these cases, the PFS-C is a sensible choice. This may
be regarded as Single Effect (SE) distillation.
A PFS generator produces pure steam, for use with an
autoclave and SIP processes. Alternately the pure steam
is condensed in a water cooled condenser to produce
WFI. The controls may be configured according to the
usage pattern – for example, during the day, pure steam PFSc Storage
or &
is constantly available and by night, the pure steam is Combi Distribution
condensed and the collected WFI is stored in a tank for
use during the day. Autoclave Washer
Testing, Commissioning and Qualification
Quality Philosophy
Quality is an intrinsic feature of every Getinge-
Kemiterm product. From the design specification,
through component selection, fabrication, assembly and
factory acceptance testing, every aspect of the
manufacturing process is examined and documented to
ensure and prove that the product is designed, built and
tested according to the customer specification and
performance requirements.
FAT Contents
Layout, dimension and appearance check
Documentation Component identification / verification of design
Our objective is to provide a documentation package Calibration
that may be used as an integral part of the clients’ Capacity and consumption check, confirmation of
qualification support documentation thus saving time performance specification
and cost. Unless otherwise specified the documentation Alarm checks
package comprises: External signal check
Operating mode confirmation & I/O check
Material Certificates
Isometric Weld Identification Drawings
Weld Parameter Reports
Welders Certificates
Passivation Report
Design Qualification
FAT Protocol and Report URS PQ
Component Datasheets
Operation & Maintenance Manual
QA Report
SAT Protocol and Report
FS OQ
PLC Systems
All our PLC systems are designed and programmed
according to current GAMP guidelines. Complete
Commissioning &
Site Services
After delivery factory trained technicians are available
to supervise and assist with start up and Site Acceptance
Testing. System Build
Getinge-Kemiterm A/S
Phone: +45 48 16 33 33
Fax: +45 48 18 91 04
Email: info@kemiterm.com
www.getingeproducts.com/scientific