Kemiterm Pharmaceutical

Steam Generators and

Water Distillation Systems
The Getinge Group

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.

Consultancy and After Sales Services

Design & Integration Service

Installation Service
Validation Service
Complete After Sales Care

∆ Not included in the scope of this brochure.

Details available separately.
*See ‘Definitions’

Key Design
Philosophies
Basics
Getinge-Kemiterm understands the importance of
Pharmaceutical Water as the most widely used
ingredient in drug manufacturing and that
Pharmaceutical Water and Steam are the fundamental
utilities for the manufacturing process.
Design &
Manufacture
The guiding Getinge-Kemiterm
philosophies are:
Customer Service / Satisfaction
Reliability
Quality Control / Validation
Regulatory Compliance
Cost-effectiveness
Environmental Considerations
Pressure vessels are produced in our state-of-the-art
production facility in Getinge, Sweden using automated
welding equipment, according to ISO 9001 procedures
and following all appropriate pressure vessel codes.
Design, Project Management, Assembly and Testing of
the equipment is made at the Getinge-Kemiterm
headquarters & factory in Lynge, near Copenhagen.
Key Design Philosophy
Regulatory Issues
Getinge-Kemiterm closely follows industry trends,
practices, guidelines and regulatory requirements;
actively participating in working groups and committees
working in the determination of these.
All WFI stills, irrespective of optional features and
functions consistently produce WFI that as a minimum
complies with current USP, EP, JP and other
Pharmacopoeial requirements.
ISPE Baseline®
Guides GAMP
F DA 2 1 C F R
Pa r t 1 1
cGMP
Quality Assurance / Validation
Getinge-Kemiterm recognize that design, construction
and performance are not the only criteria for selection of
a piece of equipment for pharmaceutical production, but
thatURS
quality control and documentation are PQ equally
important, and must be an integral part of a project to
install and validate new equipment. To this end, every
Getinge-Kemiterm water still and pure steam generator
FS with extensive documentation
is provided OQ covering
design, function, materials and components used,
software programming and test protocols.
Factory Acceptance
DS Testing is also IQ an integral part of
every project. All equipment is tested in a purpose built,
600 sq.m (6,500 sq.ft) testing hall after manufacture.
This state-of-the-artSystem
hall is equipped
Build with controllable,
quantifiable utilities and data acquisition / monitoring
equipment, used in generation of FAT reports.
After installation a Site Acceptance Test may be
performed to verify the FAT results before handover.
Pharmaceutical Steam
Definitions
Getinge-Kemiterm follow the concepts established in
the ISPE Baseline® Guide for Pharmaceutical Steam.
For the purpose of defining our product range we use
the terms Clean Steam Generator (CSG) and Pure
Steam Generator (PFS) as follows:
CSG: Produces steam by evaporation of ‘clean’
water. The properties of the steam are generally
similar to those of the feedwater.
Basis Of Design
Getinge-Kemiterm CSG and PFS Generators
have the same basic construction and
operating principle. The CSG incorporates
a labyrinth baffle system to remove water
droplets, whereas the PFS uses the 3+
separation system to guarantee pure
steam quality irrespective of
feedwater quality.

PFS™: Produces pure steam whereof the condensate

meets the pharmacopoeial requirements of Water for
Injection, irrespective of feedwater quality.

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

Unique 3+ Separation System

At the exit of the evaporation tubes the clean steam turns
through 180°. Unevaporated feedwater and large
droplets are separated and fall to the bottom of the
column. This effluent (typ. 5-10%) is continuously
discharged to drain as ‘blowdown’, carrying away
impurities from the separation system. Heat may be
1
recovered by cooling the effluent with incoming
feedwater via a heat exchanger.

The clean steam continues at low velocity upwards

through the central tube within the column. Lower
weight droplets continue to separate under gravity.
1+
The clean steam enters a tangential port to the cyclone
chamber and accelerates at high velocity within the
chamber. This centrifugal action further removes water
droplets and impurities, which drain to the base of the 2
cyclone chamber and from there to the base of the
column via a discharge port.

Finally the steam turns again through 180° and exits as

pure steam from the top of the column. 3
Water For Injection (WFI)
Basis Of Design
Getinge-Kemiterm consider assurance and
maintenance of product quality as the
primary factor in the design, construction
and control of the MS WFI stills.

Principle Equipment Features

Production is controlled according to distillate
conductivity and temperature. These parameters, plus
outlet valve position are continuously monitored and
recorded during production.
Superior and unique 3+ stage separation system for
impurity removal
Combination of separation systems allows use of
lower grade feedwater
6 log10 reduction in endotoxin concentration
Unique Ω internal feedwater preheater system
Eliminates stress cracking
Reduced external piping
Unique single port double tubesheet.

Stainless steel frame and control enclosure – as

standard, not optional extras

Vertical condenser for complete drainability

GAMP Compliant PLC Systems

Allen Bradley
Siemens
Mitsubishi

GAMP Documentation available

21CFR Part 11 capable when combined with
supervisory systems
Modem for remote monitoring/troubleshooting

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 feedwater is sequentially evaporated and condensed in a series of columns,

or effects. The design of each column is fundamentally the same as a Getinge-
Kemiterm Pure Steam Generator. Only the first effect is heated by external
energy. Each subsequent effect uses pure steam from the previous effect as
heating media, and the condensate is collected as WFI. Pure Steam from the
final effect enters the shell of a heat exchanger, which uses cooling water to
condense the steam to WFI.

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

Water for Injection

of effects (min:3, max:8) is a balance between initial capital cost and running
cost, and must be evaluated case-by-case based on local conditions such as
utility costs and environmental concerns.
When required,
distillate flows under
In this uniquely designed gravity from the
feature, the distillate gently degassing chamber.
boils to release dissolved gases.
The temperature,
conductivity
and outlet valve
positions are
recorded.
The temperature and
conductivity is continuously
monitored and if not within
appropriate parameters, the
distillate is discharged to
drain.

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

Getinge-Kemiterm products may be combined with other

Getinge equipment to provide our customers with
complete solutions to their process needs.
Getinge takes complete responsibility for the design and
function of these combinations. We provide the customer
with complete peace of mind, saving the time and cost of
designing, selecting, purchasing and validating discrete
components.

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

Typical Water Treatment and

Distribution System
Multi-media Filter
Water Softener
Activated Carbon Filter
RO Plant
CEDI Plant (PW production)
Multiple Effect Still (WFI Production)

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.

Features and Benefits

Combines features and techniques of PFS and MS
systems and may be configured over the same
capacity ranges
Unique Ω internal preheating for optimum efficiency
and longevity
3+ separation system guarantees Pure Steam and WFI
quality
Pure Steam pressure is precision controlled according
to process requirements, including supply of steam to
autoclaves.
Shared use of components, control system and skid

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.

Our objective is to demonstrate and document that we

adhere to a cohesive quality control regimen in
accordance with Good Engineering Practice. Thus our
documentation package should contribute to the
commissioning and validation of our clients’ system,
saving time and cost in the overall validation
exercise.
.
In-Process Checking
During procurement and production, in-process checks
ensure that only the specified materials and components
are being used. Datasheets and certificates are collected,
verified and stored for later inclusion in the project
documentation.

During assembly, a variety of inspections are performed

to the appropriate systems, including but not limited to:
Pressure and leak testing
Inspection of all welds (NDE)
Videoboroscope report
Surface finish
Piping Slope
Dead Legs

On completion of assembly, the column and piping

system are passivated, rinsed and sealed. We only use
stainless steel in our workshop, so avoiding the risk of
contamination of stainless steel with ferrous materials.
 Factory Acceptance Testing (FAT)
On completion of manufacture, every Getinge-
Kemiterm product is tested in our state-of-the-art, 600
sq.m testing hall. Here the utilities are set to emulate
actual site conditions and are monitored whilst the
equipment undergoes stringent tests and checks. Utility
consumption and equipment output are monitored and
recorded for the FAT report. 24 hour performance testing
with simulated usage patterns is also available.

By default, we perform a ’PRE-VALIDATION’ of the

equipment, carrying out the same test procedures as
defined in the IQ-OQ protocols, which will later be
performed on site as part of the validation exercise. This
exhaustive procedure identifies the inevitable minor
issues with equipment and documentation and ensures a
trouble free start-up and site acceptance testing later on.
Chemical (incl. TOC), Microbiological (incl. LAL) and
particle testing may also be performed on request.

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 &

documentation of all software modules, test procedures

DS IQ
Qualification

and reports are available.

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

Americas: GetingeCastle Inc

Phone:1 716 475 1400
Fax:1 716 272 5116
Email: scientific@getingecastle.com
www.getingecastle.com

U.K: Getinge U.K. Ltd

Phone: 01623 510033
Fax: 01623 440456
Email: sales@secl.co.uk
www.getingeproducts.com/scientific

Japan: Maquet-Getinge K.K.

Phone: 03 3599 8366
Fax: 03 3599 8365
Email: enquiries@getinge.co.jp
www.getinge.co.jp

Getinge International A.B.

Phone: +46 35 15 55 00
Fax: +46 35 16 63 92
Email: info@getinge.com
www.getingeproducts.com/scientific