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Getinge Water Systems

Securing critical utilities for pharmaceutical manufacturing

The modular approach to a complete system

Getinge 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. Complete water and steam systems are built up module by module. Each module is assembled on a skid and delivered fully ready for validation. This design saves time and provides flexibility in the production area. New demands just mean adding a new module.

In addition to delivering assembled equipment, Getinge can also provide complete turn-key systems including: · System sizing, design and integration · Components ­ POU heat exchangers, pumps · Installation on-site / SAT · Documentation · Training · Maintenance Systems can include storage and distribution piping, user points but might extend to sterilizers, closure processors and washing equipment.

Why choose Getinge as your partner?

Getinge is a leading global provider of equipment and systems to customers within the Life Sciences, in both research and production environments. Equipment, services and technologies are supplied to customers throughout the world and supported locally by our extensive service group. The Getinge Group's products and services contribute to quality enhancement and reduction of your costs as a customer.You will benefit from: · Consultation service to assist you in selecting and designing a system to meet your requirements · State of the art solutions for optimal productivity · High quality industry standard components for maximum reliability · High performance for optimum energy efficiency and minimal running costs. · Validation support with clear, extensive documentation to assist the qualification effort and satisfy regulatory agency requirements · Local service support by trained, certified professionals

Saves time, effort and cost

As Getinge supplies virtually everything from concept to compliance, you can optimize the lifecycle economy. Dealing with just one competent company will save you time, effort and cost. As all our equipment is compatible and has common documentation, rapid system integration and equipment that is built to meet the world's highest standards of quality and safety means maximum uptime and a safe working environment.

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Getinge Waters Systems

Water Pre-treatment

Process: Water pre-treatment from fresh drinking water Objective: Filtration of particles, water softening and removal of oxidation agents. Series: Getinge PT Product: Non-compendial filtered soft water.

Process: RO ­ Reverse Osmosis Objective: Demineralization and removal of endotoxin / pyrogen retention. Series: Getinge RO Product: RO-permeate. Non-compendial feed water.

WFI ­ Water For Injection

Process: Multiple Effect Distillation Objective: Evaporation of pre-treated feedwater, purification and condensation of steam. Removal of endotoxins. Series: Getinge MS Product: Compendial Water For Injection, WFI

PW ­ Purified Water

Process: CEDI Continuous Electro-De-Ionization Objective: Total desalination of and CO2 removal from pretreated feedwater. Series: Getinge PW Product: Compendial Purified Water, PW

Pharmaceutical Steam

Process: Evaporation and Separation Objective: Evaporate pre-treated feedwater and purify resultant steam. Series: Getinge CSG & PSG Product: CSG: Pharmaceutical Clean Steam PSG: Pure Steam meeting USP requirements for WFI

Process: Storage for WFI Objective: Hot storage of WFI designed for minimal risk of contamination and corrosion. Series: Getinge ST Product: Maintained Compendial Water for Injection, WFI

Process: Storage for PW Objective: Storage of PW designed for minimal risk of contamination and corrosion. Series: Getinge ST Product: Maintained Compendial Purified Water, PW

Core elements

Process: Distribution for WFI Objective: Provide all user points with water at controlled quality, temperature, pressure and flow in the distribution system. Series: Getinge DS Product: Distributed Compendial Water for Injection, WFI Process: Distribution for PW Objective: Provide all user points with water at controlled quality, temperature, pressure and flow in the distribution system. Series: Getinge DS Product: Distributed Compendial Purified Water, PW Know-how Control systems Documentation Training Service

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The heart of the production facility

Pharmaceutical production relies totally on a stable and consistent supply of quality controlled water, for applications ranging from non critical processes to product formulation. Steam is also an essential utility for ensuring sterility of production equipment, components and / or product.

Getinge can equip the utility area with high quality, reliable water and steam supply systems, backed up with specialist local service and support teams to assure that the lifeblood of production keeps flowing.

Pure Steam Generator integrated with a Getinge GEV Terminal Sterilizer.

Seamless integration

In some circumstances it is too costly or impractical to provide media for process equipment from the utility area, and local installation of steam or water systems is necessary. As a World leader in washing and sterilization systems, Getinge provides seamless integration of media production and process equipment.

Reverse Osmosis Plant Performs the majority of the demineralization / water purification task. Water Pre-treatment Filtration of particles, water softening and removal of oxidation agents. Water For Injection (WFI) Stills. Multiple Effect for optimum efficiency. Produces compendial Water For Injection.

Pharmaceutical Steam Generators deliver clean or pure steam. Falling Film principle. Storage and Distribution Systems for both Purified Water and WFI. The distribution skid contains all the loop functionality, including pump(s), valves, flow, pressure and temperature control.

Purified Water System Produces Compendial Purified Water using Reverse Osmosis in combination with Continuous Electrodeionisation (CEDI).

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Experience to rely on

Our long-term involvement with pharmaceutical utilities, washing and sterilization procedures has made us intimately familiar with pharmaceutical production methods. Therefore we are well aware of the challenges associated with the sterile manufacturing environment and the demands of the regulatory agencies on our clients procedures.

Getinge is a leading global medical technology group that provides complete solutions to hospitals, laboratories and pharmaceutical companies around the world. The Getinge Group is the world market leader in this field, with sales and service support channels in more than 100 countries. The Getinge Group headquarters and primary factory 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 the world's largest of it's type, and produces the majority of the Group's pressure vessels, used in sterilizers, steam generators and multi-effect water stills. Getinge Water Systems, located near Copenhagen, specialises in the production of water and steam generators for the pharmaceutical industry. Our knowledgeable staff can recommend the optimum solution for our clients' present and future needs based on more than 30 years of accumulated experience.

From Concept to Compliance

The earlier we are involved in a project, the more we can add to reduce costs and provide the optimum solution for your new or replacement systems. Getinge's local sales teams, supported by professional engineeers have the knowledge and experience to provide the most appropriate systems for your needs. Getinge's local service and support staff are on-hand to provide practical assistance throughout the life of the equipment ­ from installation through start-up and qualification and on to service support and maintenance. Dealing with a single, competent supplier saves our clients' time, effort and cost.

Truly Global Presence

Like many of our clients, Getinge is multi-national. This gives us the ability to work with our customers and engineering companies wherever and however they choose to operate, while at the same time providing local and personal support to the user at the installation site.

An 8000 kg/hr (17,600 lb/hr) pure steam generator installed at Getinge's test facility in Sweden for the Acceptance Testing of Getinge GMP sterilizers.

GETINGE ­ 5

Safeguarding your investment

A production system represents a large capital investment. Therefore Getinge works hard to ensure that our Water and Steam systems provide true value with regard to design, performance and lifecycle economy.

Getinge continually invests in state-of-the-art factories, production equipment and process development for one purpose ­ to ensure that we continue to provide our clients with the best equipment available. We believe we offer true value for money. This is reflected in our impressive client base ­ the World's leading pharmaceutical companies rely on Getinge. We help you in concept and compliance in order to optimize the lifecycle economy.

Satisfying your needs

Getinge water and steam systems are designed to handle the toughest applications, having been developed over many years of practical experience. We recognize that most applications are unique with regard to the installation site, workload requirements and storage and distribution network. Therefore every project is dealt with individually by an experienced project manager who evaluates the circumstances, works with the client and where appropriate, engineering company, to optimise the design, layout and function of the equipment.

Wide range of capacities

Each series of products ­ pretreatment, PW Systems, WFI Stills, Steam Generators is available in a wide range of capacities to meet the clients needs. Generally, our standard modules will meet most needs, but where necessary, custom designed equipment can be provided. This ensures you buy only what you need.

Regulatory issues

Getinge closely follows industry trends, practices, guidelines and regulatory requirements. Additionally we actively participate in working groups and committees working to refine these requirements.

GAMP | cGMP | BPE2002 | MCA | ISPE BASELINE GUIDES USP | FDA | EN46002 | ISO9000 | 21CFR Part 1 | EN285 1

All water and steam systems are manufactured according to the guidelines or standards relating to the intended applications and the country of installation.

Protecting the environment

Water stills can be configured to minimize water and energising usage in some circumstances to eliminate the use of cooling water. All units can utilize chilled or tower cooling water systems to maximize efficiency.

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Functional diagram of a Getinge WFI still. Key features: simple construction, internal stress free preheaters, unique 3+ separation system, and vertical condenser. Consult Getinge for detailed explanation.

1. Pure steam condensate / WFI flows through a reservoir where conductivity is checked and samples may be withdrawn for analysis. 2. As the Reverse Osmosis plants handles the vast majority of the water purification task, Getinge believes the plant must be built to the same level of quality, must be controlled to the same level of precision and must be validatable in the same way as the WFI and pure

steam generation plant that rely on it. Getinge requires only single pass Reverse Osmosis permeate as feedwater to WFI and pure steam generation plant to guarantee final product quality. 3. Meticulously welded, densely packed tube bundles provide highly efficient heat exchange in the evaporation columns. There can be up to 6km of seamless tubing in a multi-effect WFI still. Unique single port double

tubesheet design used on primary evaporation columns allows simple visual inspection. 4. Functional diagram of the unique 3+ separation system. Allows use of single pass RO permeate as feedwater for lower cost PS and WFI production.

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Water pre-treatment

According to USP the raw water for pharmaceutical process must be of fresh potable water quality. Reverse Osmosis (RO) is the main demineralisation process where the bulk of the impurities are removed. Pre-treatment is performed prior to the RO system to protect the RO membranes from physical and chemical damage and scaling. Substances removed by the pre-treatment system are typically particles, materials with low solubility (i.e. silica) and oxidizing agents.

Pre-Treatment

Getinge offers a validatable stainless steel GMP Reverse Osmosis process. Our RO process is protected against microbial growth by frequent automatic re-circulation and flush..(heat sanitisable version available).

KEY BENEFITS

Pre-Treatment

· Custom designed system based on local water analysis at installation site. · Validatable RO system · Getinge stills and generators require only single pass RO permeate as feedwater.

Successful water systems

From many years of experience we know that building a successful water system starts at the pre-treatment stage. Based on a water analysis we can recommend a complete water system that is based the exact conditions at our client's site. Getinge Steam Generators and Water Distillation equipment require only Reverse Osmosis Permeate (typically <20 µS/cm) as feed water ­ not costly Purified Water.

CAPACITIES

Pre-Treatment

Getinge Pre-treatment systems are custom designed and built according to capacity requirements based on antipated usage patterns.

Pre-Treatment Systems are customised according to incoming feedwater chemistry. Getinge will base the design / system on the clients' feedwater analysis.

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Pharmaceutical steam

Getinge PSG Generators are designed to produce Pharmaceutical Grade, Pyrogen Free Pure Steam for equipment, component and terminal sterilization, humidification, etc. Getinge follows 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 (PSG) as follows: · CSG: Produces steam by evaporation of `clean' water. The properties of the steam are generally similar to those of the feedwater. · PSG: Produces pure steam whereof the condensate meets the pharmacopoeial requirements of Water for Injection, irrespective of feedwater quality.

KEY BENEFITS

Steam Generators

· Unique 3+ seperation system to secure steam quality. · Require only RO permeate as feed water to meet USP requirements. · Falling film evaporation for optimum response to varying load, specially for use with autoclaves.

Principle of the systems

Steam is produced by evaporating and purifying feedwater. PSG generators use the unique Getinge preheating and separation systems (see MS, pg 11) for long life and better performance.

Unique technical features

See MS, page 11. Core features are identical, except that the CSG uses a labrinth separation system and stressfree preheating system.

CAPACITIES

Model PSG / CSG

Steam Generators

Capacity Kg / Hr Model PSG / CSG Capacity Kg / Hr 1200 1540 1925 2280 3050 4000

100 80 1500 200 160 2000 350 280 2500 500 400 3000 750 600 4000 1000 800 5000 1250 1000 Capacities at 3 Bar, Source Steam at 8 Bar

EN 285 / Sterilizer integration

The combination of separation systems and the rapid response of the falling film technique enable Getinge 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 steam generators may be supplied `stand alone' or may be integrated with any Getinge steam sterilizer. A degasser option is available to ensure non-condensable gas content remains below 3.5%. This together with the precision control and separation systems ensures compliance with EN285 and HTM 2031 irrespective of feedwater quality.

GETINGE ­ 9

Purified water (PW)

According to the USP "Purified water is water for the preparation of medicines other than those that are required to be sterile and apyrogenic". Water for Injection, WFI, has to be distilled with a bacterial count below 10 CFU per 100 ml. PW can have a content of 100 CFU per 100 ml and distillation is not required. The Getinge Purified Water series is based on the very reliable combination of Reverse Osmosis, RO, and Continuous Electro De-Ionization, CEDI, technologies to produce purified water of a very high quality at ambient temperature. The system runs fully automatically including flushing of RO membranes, optional hot sanitization of the whole system and continuous polishing of the final product, even when there is no demand for PW.

KEY BENEFITS

Purified Water System

· Intergration of RO and CEDI technologies. · Uniform electrical force field in CEDI stack, eliminating pockets for micro bacterial growth. · Interstage quality control of feed water, RO permeate and the final purified water.

The design philosophy includes:

· All stainless steel construction · Individual solutions for feed water treatment, i.e. - Safety-filtration - Oxidation potential reduction - CO2 control - Anti scalant. · GMP design including no recycling of concentrate · No addition of chemicals/brine in the CEDI process · Uniform electrical force field in CEDI stack, eliminates pockets for micro bacterial growth · PW polishing; to reduce potential contamination of the CEDI stack when there is no demand for PW · Inter Stage Quality Control; Feed water before RO, RO permeate before CEDI cell, Purified Water before the product tank. · GAMP compliant software documentation · Easy access to all components on the system skid · Full validation support documentation

CAPACITIES

Model PW 1000 2000 4000 6000 8000 12000

Purified Water System

Capacity L / Hr 1000 2000 4000 6000 8000 12000 Model PW 16000 20000 24000 28000 32000 Capacity L / Hr 16000 20000 24000 28000 32000

Note: As an option, PW systems can deliver Water Highly Purified by addition of an ultra filtration unit.

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Water for injection (WFI)

Getinge MS distillation units are designed to produce Phamaceutical Grade Water For Injection (WFI). This is used in the preparation of parenteral solutions, CIP processes, and similar applications.

Principle of the system

Water is produced by continuously evaporating, purifying and condensing feedwater. The MS series consistently produce WFI that exceeds all pharmacopoeia requirements, and can do so using only single pass RO permeate (typically <20µS/cm) as feedwater.

KEY BENEFITS

Multi-effect stills

Unique technical features include:

· Stress-free preheaters Preheating of feedwater is performed within each column in seamless stainless steel tubes arranged as an inverted 'U' which is free to expand and contract. This unique design eliminates stress cracking associated with traditional shell and tube preheaters. · 3+ Separation System The final cyclone chamber uses centrifugal action to remove water droplets and impurities, resulting in pure steam / WFI of the highest quality. · Compact, stainless steel construction All framework and piping is constructed from stainless steel. The compact design leaves room for easy inspection resulting in fewer maintenance hours. · Combination systems ­ save cost and space As with any still, Pure Steam may be extracted from the first effect for limited production applications. As an option, an independent Pure Steam Generator may be incorporated in the same frame, sharing components and control system. The resulting system reduces both capital and validation costs as well as installation space.

· Unique 3+ seperation in all columns to secure high WFI quality independent of varying feed water quality. · Stress-free feed water preheating to reduce energy consumptions and increase life time. · Active de-gassing system.

CAPACITIES

Model MS

Multi-effect stills

Capacity L / Hr Model MS Capacity L / Hr 4400 5500 6600 8800 11000 13200

100 220 2000 200 440 2500 350 770 3000 500 1100 4000 750 1650 5000 1000 2200 6000 1500 3300 Capacities With Source Steam at 8 Bar

GETINGE ­ 11

Storage & distribution

Control system and documentation

The DS module can be provided with a stand-alone PLC control system or alternatively, any Getinge water generating unit (WFI or PW) can operate the storage and distribution system. The benefit of this modular design is to have only one control system to validate (and consequently reduce overall cost and time required). All storage and distribution systems are delivered with complete validation support documentation. The purpose of the storage and distribution systems is to maintain the high water quality of the WFI or PW. and deliver it to point of use. According to USP, precautions must be taken to ensure that a pharmaceutical water storage and distribution system can run reliably. A Getinge Distribution System is designed to reliably and consistently provide all points of use around the pharmaceutical facility with Water for Injection (WFI), or Purified Water (PW).

KEY BENEFITS

Storage & distribution

· Complete distribution system on one skid, easy to validate. · Controlled from built-in PLC or from PLC in MS or PW unit. · Fully customized, designed according to cGMP and ISPE guidelines

Storage systems

The insulated stainless steel storage tank is normally custom built and fitted with equipment and instrumentation such as non-impact level transmitter, temperature and pressure sensors, spray ball, heated vent filter, drain valves, man hole etc. Pressure vessel documentation (as appropriate for installation site) is provided.

CAPACITIES

Storage & distribution

Getinge storage & distribution systems are custom designed and built according to capacity requirements based on antipated usage patterns.

Distribution systems

The control of one or more complete loops is performed within the Getinge Distribution System skid. The distribution skid contains all the loop functionality,

including pump(s), valves, flow, pressure and temperature control. Heat exchangers are provided to control the loop temperature. Water quality is monitored by conductivity and optionally TOC measurement.

PW loop only

Cooling water

P

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F I UV PW loop only

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From loop

CW return

Condensate return

L

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P C = Condutivity L = Level F = Flow P = Pressure I = Intencity T = Temperature

To loop

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The modular approach to a complete system

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1. Series: Getinge PT

4. Series: Getinge PSG

2. Series: Getinge RO

5. Series: Getinge ST

3. Series: Getinge MS

6. Series: Getinge DS

GETINGE ­ 13

Testing, commissioning and qualification

Quality is an intrinsic feature of every Getinge 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. Our documentation package is designed to contribute to the commissioning and validation of our clients' system, saving time and cost in the overall validation exercise.

Factory Acceptance Testing (FAT)

On completion of manufacture, all Getinge products are tested in our state-of-the-art test facilities. 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. By default (unless otherwise specified), we perform a 'pre-qualification' 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 and particle testing may also be performed on request.

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. 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.

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Validation support documentation

During the manufacturing process, in process checking is performed to ensure compliance with specifications, and documentation is maintained as confirmation. After manufacture, every unit undergoes comprehensive and rigorous Factory Acceptance Testing (FAT), again accompanied by detailed documentation. After installation, Site Acceptance Testing (SAT) services can be provided to confirm / reproduce the results obtained in FAT, once again, with comprehensive documentation following pre-agreed procedures. A complete package comprising these, together with installation, user and technical manuals, is provided with the equipment. These documents are intended to support the client's subsequent process validation procedures, thus saving considerable time, effort and expense.

Our objective is to save time and costs by providing a documentation package that may be used as an integral part of our clients' qualification and validation support documentation.

GAMP

PLC Systems ­ Our PLC systems are designed and programmed according to GAMP4 guidelines. Complete documentation of all software modules, test procedures and reports are available. Project documentation is provided in accordance with GAMP guidelines. Refer to Getinge GAMP4 procedures datasheet for details.

More detailed information

This brochure provides an overview of Getinge water and steam systems. Separate product specifications present detailed information such as capacities, utility consumption, dimensions, materials of construction, etc. Contact Getinge for more details. Refer to back cover for address.

GETINGE ­ 15

Training ­ The Getinge Academy

The training staff at Getinge Academy have extensive experience of both Getinge products and education. In addition, many work with sales and design within the Getinge Group and are confronted every day with the same issues and situations as the operators and technicians who work with our equipment. Indeed the same facilities are used by Getinge for the training and certification of our own staff, who continuously feed back experiences into our programmes. The Getinge Academy is both a state-of-the-art training facility, equipped with a range of equipment and learning aids, and a function ­ meaning that we can perform training either at our facility or yours, depending on your requirements and circumstances. · Local training at your own premises · On-line training · Training at manufacturing company · Seminars at the Getinge Academy THE GETINGE ACADEMY

At the Getinge Academy we offer an extensive range of training courses covering the safe and efficient handling of our process equipment used in pharmaceutical production. We aim to provide equipment and application know-how spanning pharmaceutical steam and WFI generation, washers and sterilizers, and control and documentation systems. Our courses include theoretical studies, hands-on training and practical exercises. In addition to standard courses, we can tailor courses based on the level of knowledge or other considerations of participants.

Getinge Academy

After sales support

Getinge recognises that routine, planned preventative maintenance is an important requirement of Good Manufacturing Practice. We also recognise however, that external factors can ruin the best made plans, resulting in unplanned and expensive, disruptive downtime. Our local service teams are available to support you for both these eventualities. We offer you a variety of service packages combining preventative maintenance (PM) and corrective maintenance (CM). All our staff are continuously trained (see below) to ensure and maintain a high level of quality service and are certified as such. They are equipped with the tools and parts necessary to keep you in productive operation. Additionally, our technicians are supported by a 24 hour call center to provide factory based assistance whenever required.

Validation & routine monitoring

The After Sales team can also provide Validation Support services to assist in start-up, commissioning, validation and routine monitoring of installed equipment.

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Control systems

Reproducibility of process control is crucial in life science applications, particularly in the manufacture of pharmaceuticals. To achieve this and minimize human error, Getinge supplies the PACS 3000 Control Systems.

Versatile features The major features included in PACS 3000 are: · Extensive documentation · Automatic sensor calibration · Comprehensive alarms/alerts · Process and alarm logging · Multilevel password protection · Multilanguage display Regulatory compliance The entire PACS 3000 system is developed In accordance with the stringent GAMP guidelines of the pharmaceutical industry, and is FDA 21 CFR part 11-capable. Every system is supported with comprehensive system documentation.

Standard PLC Systems The PACS 3000 system is specifically designed to control process equipment for applications in the life sciences. Many thousands of PACS systems are in operation around the world in validated production facilities. However, if a customer prefers, standard PLC systems are available based on Allen-Bradley or Siemens hardware platforms. These PLCs are provided as standard options with similar functionality and documentation to the Getinge PACS 3000.

ALTERNATIVE CONTROL PANELS

GETINGE OPTRAIL Documentation tool & 21CFR Part 11 solutions

OP50 USER INTERFACE · 10.4" color screen for process info: ­ Remaining time, cycle & phase, temperature(s) · Graphical process presentation: ­ Plot graph, bar graph · Parameter settings. · Maintenance & service menus. · System configuration. NETWORK SOLUTIONS Ethernet Industry standard protocols Remote support facility CS 1000

PROCESS DOCUMENTATION

GETINGE ­ 17

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GETINGE PROVIDES

a unique range of products that fit together

with coherent design and functionality. We also offer expert advice, analysis of requirements, interior design support, system installation, after-sales service and training.

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Getinge Infection Control P O Box 69 · SE-310 44 GETINGE · Sweden Tel +46 35 15 55 00 · Fax +46 35 549 52 E-mail: [email protected] · www.getinge.com

1293 ENG 04.12 www.byran1och2.se · Göteborgstryckeriet

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