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Systems, Turnkey Solutions and Services for clean media supplyBWT Pharma & Biotech

BWT Pharma & Biotech • Turnkey Solutions for the Pharmaceutical & Biotech Industry | 2

Water – Our Elixir of Life

The UN estimates that by 2050 the current world population will climb from roughly 6.6 billion to 9.2 billion. Yet average water consumption, currently 625 m3 per year, is growing on a per capita basis, meaning that the water consumption will rise disproportionately. More than a billion humans lack clean drinking water worldwide. In 25 years as many as 6 billion humans will suffer from unsafe water supplies.

The demand for improved water quality has been a fundamental need since time immemorial and is also a precondition for optimal results in various aspects of work and life. The technological and legal requirements for optimal water treatment are constantly rising.

The BWT – Best Water Technology Group was formed in 1990 and today is Europe’s leading water technology company. The goal of our 2,800 employees in 70 subsidiaries and associates is to provide private, industrial, business, hotel, hospital and municipality customers with innovative, ecological and efficient technologies that deliver a maximum safety, hygiene and health in their daily contact with the elixir of life, water.

| 3 BWT – For You and Planet Blue.

BWT Pharma & Biotech –Partner for Turnkey Solutions in the Pharma & Biotech Industry

Water is the most widely used material within the Pharma & Biotech Industry. Most processes require water and other clean media which meets legal standards defined in pharmacopoeias. BWT Pharma & Biotech provides systems of pharmaceutical water from the feedwater supply to the point-of-use. Furthermore, we offer complete sterile manufacturing systems including solution preparation, CIP/SIP and wastewater inactivation.

As a leading supplier to this market, BWT Pharma & Bio-tech has many years of experience and possesses a com-prehensive spectrum of technologies for producing all the grades of water required in R&D and production environments as well as handling the waste produced.

Our manufacturing facilities in Europe, Asia and the United States provide equipment, skid mounted systems, tanks and vessels. BWT Pharma & Biotech supplies key components such as vessel manufacture from own pro-duction, orbital welding of pipework for equipment, soft-ware programming and control panel manufacturing. Furthermore, BWT is the only European supplier of EDI modules. The unique, patented EDI spiralwound module SEPTRON® is the core component of many modern water treatment systems.

Understanding Project ExecutionTo achieve a consistent level of solid Project Execution you must first of all understand the customer and project demands at tender stage. Evaluating the information and providing the best solution to meet the project and customer demands encompasses all aspects of the project from

specifications, drawings, programme and budgets to conditions of contract, etc. When all this is evaluated correctly at tender stage, experience dictates that projects are executed harmoniously, on time and within budget. It is our aim to work with our customers as partners.

After all we all want the same thing – a successful project, constructed on time and within budget. As partners we introduce our Key Performance Indicators which are our joint mechanism for monitoring all aspects of the project on a regular basis. This allows senior management of both companies to monitor and influence the success of the pro-ject. We continually work with our customers, ensuring that their requirements and expectations are met in line with the project programme.

Markets and PartnersProjects are carried out in partnership with pharmaceu-tical manufacturers, pharmaceutical plant designers and other specialist leading engineering companies. Among our customers are AstraZeneca, Sanofi-Aventis, Boehringer Ingelheim, Eli Lilly, Glaxo Smith Kline, Novartis, Novo Nordisk, Pfizer, Roche, Bayer Schering and Merck Serono.


BWT Pharma & Biotech turnkey services and products include

Concept Design, Basic Design, consultancy services, case studies

Assistance for User Requirement Specification (URS)

Detail Design

PW, HPW, WFI and pure steam production

Storage and distribution systems

Complete sterile manufacturing systems including solution preparation, CIP/SIP and waste water inactivation

Ozone and heat sanitisation for distribution systems

PLC systems and SCADA (supervisory control and data acquisition) according to 21 CFR Part 11, GAMP

Design, maintenance & consultancy services

Qualification, validation & full documentation packages according to cGMP

Advantages of turnkey projects Uniform high product quality with high-end components

Seamless project execution without interfaces, shorter project cycles, one communication for partners

Single warranty for products and quality

Consistent documentation and validation package

Lean & cost efficient service and recalibration

Simplified spare parts storage

Easier and safer operation due to uniform HMI user interface (e.g. with our AqU@vIEW software)

Uncomplicated acceptance by authorities

Components for Turnkey SystemsValidation and documentation engineers accompany each project through all steps of the V-model, starting with the URS and ending with FAT, SAT, IQ/OQ. BWT can also support the customer in the PQ phase.

Typical limit of supply

System Build – Control System Programming / Code Review

Quality Software Module Design Specifications

Software Design Specification

Mechanical & Electrical Hardware Design Specification

Functional Specification OqSystem Acceptance Test

IqHardware Acceptance Test

Software Integration Test

Software Module Test

Service Contract

Pq

quality & Project Plan

Concept & Basic Design URS Consultancy by BWT Pharma & Biotech

Support by BWT Pharma &

Biotech


Components and Systems, including Qualification and ValidationIn the areas of pharmaceuticals, biotechnology, cosmetics and health care, and in the contributing and accompanying processes, there are requirements for water of many different qualities, such as potable water, process water, Aqua Purificata / Purified Water, Aqua Valde Purificata / Highly Purified Water and Aqua Ad Iniectabilia / Water for Injection.

Knowledge of customer requirements and expectations; understanding of legal requirements such as USP, EP and JP; appreciation of the demands of inspection authorities such as the FDA and various local authorities; compliance with GMP standards and familiarity with state-of-the-art pro-cesses and technologies all combine to characterize BWT Pharma & Biotech as a competent specialist supplier and partner for turnkey process water systems.The worldwide presence of BWT and our growth in the-se markets demonstrate competence and reflect longterm satisfaction of our customers.

Research and development, future-oriented thought pro-cesses and the flexibility and innovative power of the staff ensure that BWT can meet the continually increasing demands with respect to the latest quality standards while complying with responsibility for sustainable actions and for protecting the environment.

BWT Pharma & Biotech is thus certified in accordance with ISO 9001.

Processes and products Single- and double-stage reverse osmosis systems OSMOSTIL®

Electrodeionisation with patented SEPTRON® spiralwound modules

Ultrafiltration systems ULTRASTIL TW for pre-treatment of raw water

Ultrafiltration systems ULTRASTIL for depyrogenation of pure and ultrapure water

Compact water treatment systems OSMOTRON®

Distillation systems MULTITRON

Pure steam generators vAPOTRON

Combined distillation and pure steam generation COMBITRON

Uv systems BEWADES for disinfection, TOC reduction and destruction of ozone

Electrolytic ozone generation systems STERITRON

Storage and distribution systems LOOPO for ultrapure media, made of stainless steel or PvDF

LIPROLINE CIP/SIP and solution preparation systems

LIPROLINE waste water decontamination systems

AqU@vIEW process and point-of-use management software

AqU@vIEW data archiving & remote control software

BWT – For You and Planet Blue.


Potable Water

HPW/PW distribution

Usage

Waste water

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PW production

Pure steam production

Pure steam distribution

HPW production

WFI production

WFI distribution

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Products and Processes

OSmOTROn

Compact water treatment systemsOSMOTRON® is the world‘s most popular skid-mounted water treat-ment system for production of PW and HPW. The new PRO version focuses on ergonomics and energy efficiency.

UlTRASTIl

Ultrafiltration depyrogenation systemsULTRASTIL post-treatment systems are used for HPW production e.g. with existing ion-exchanger systems

Lower operation costs & invest-ment than for distillation units

Safe operation guaranteed Integrity test applicable

COmBITROnCombined pure steam generation / distillationCOMBITRON reduces investment costs and footprint by up to 30 % in comparison with individual WFI and PSG systems.

VAPOTROnPure steam generatorsvAPOTRON pure steam generators are available from 50 to 5.000 kg/h. An integrated degassing stage allows for compliance with NCG applications.

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lOOPO

Storage and distribution systems for cold and hot mediaLOOPO skids contain all compo-nents which are necessary for the distribution of PW, HPW and WFI. Ozone and hot water versions are available.

mUlTITROn

Distillation systemsMULTITRON distillation systems are available for capacities from 100 to 17.000 l/h. Highest ener-gy efficiency can be achieved with output control ranging from 20 to 100 %.

SePTROn

Patented spiral-wound EDI modulesSEPTRON® is the only EDI module manufactured in Europe and is a product of genuine Swiss quality. Each module is tested in the fac-tory and delivered with a factory and test certificate.

STeRITROnElectrolytic ozone generation systemsSTERITRON produces ozone from high-purity water and guarantees automatic and cost-effective micro biological protection of the distribution loop.

OSmOSTIlSingle- and double-stage reverse osmosis systemsOSMOSTIL units are available for pre-treatment, post-treatment and PW/HPW applications. OSMO-STIL can either be sanitized with hot water or with chemical agents.

lIPROlIneCIP / SIP and solution preparation systemsLIPROLINE process solutions meet a wide range of pharmaceutical applications such as WIP/CIP and SIP as well as solution preparation systems, storage tanks and process equipment.

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Comprehensive Services for Successful Projects

Concept studies

International experience and practically-oriented construction of standard and customer-specific systems form the basis for good overall concepts.

Staff members who are familiar with the latest regulations and directives of all applicable authorities ensure that the current FDA and GMP requirements are implemented.

Planning and dimensioning

The spectrum of available services includes mass balance consi-derations with the aid of the most modern tools, pressure drop calculations in distribution systems, 3D design, P+I diagrams with the generation of the corresponding parts lists, on-site inspection of the planned site and the inclusion of specific requirements.

BWT Pharma & Biotech also has novel approaches to reducing the quantity of water wasted from a system and the power con-sumption, thus increasing the economy of clean media generati-on and distribution.

Validation and documentation

In the beginning of a project a quality & Project Plan is set up to show the quality Control in the project, together with scope, responsibilities, communication routes, submittals etc. This docu-ment is given to the customer for approval.

The water treatment systems are validated according to FDA, cGMP, GAMP, USP and Ph. Eur. requirements. BWT Pharma & Biotech also follows the ISPE Engineering Baselines for Water and Steam Systems, and Commissioning and Qualification. The systems are CE-marked.

Skid-mounted systems leave the factory after a successfully exe-cuted FAT in order to shorten commissioning and validation on site. The FAT is carried out together with the customer under real conditions. For turnkey projects, the required equipment skids are installed as a complete system. Commissioning and qualification are then performed before the final handover to the customer.


Automation technology

The critical area of automation is handled using only in-house resources. Unlike many suppliers BWT Pharma & Biotech employs own specialist departments for the design and construction of the control cabinets and for the development and programming of software. Pre-validated software modules are used for fail-safe operation in accordance with GAMP guidelines.

HMI visualisation with modern touch-screen panels at the unit level, process visualisation via networked PLC structures and PC visualisation of the entire turnkey project are implemented on a wide range of platforms. Where customised software is required the end-users control personnel can work directly with BWT per-sonnel to prepare this software on a project specific basis.

Assembly and full production facilities

All BWT factories use the latest technology for the production of the systems.

Most of the water treatment systems are manufactured with the aid of orbital welding machines (for stainless steel (316 L) appli-cations) and BCF machines (for PVDF applications), if necessary under cleanroom conditions.

The final assembly of the systems in the factory, including com-missioning and the FAT (carried out together with the customer) results in pre-qualified complete systems.

IQ, OQ, SAT and training

After erection of the systems the IQ (Installation Qualification) verifies the installation, the OQ (Operational Qualification) the correct functionality. After completion of IQ/OQ the SAT (Site Acceptance) is carried out together with the customer.

Training of the operating personnel in the individual system func-tions and more complex applications makes it easier to handle the system and to ensure reliable and trouble-free operation.


Scope of ServicesBy the integration of all process steps, BWT Pharma & Biotech offers its customers a complete concept extending from pro-ject identification, validation and production up to commissioning and start-up, training, customer services and operation of plants.

quality & Project Plan / validation Plan

validation strategy

Traceability matrix, design verification

validation protocols

Execution of tests such as FAT, SAT

Iq, Oq, validation

Pq support

SOP preparation

Review of certificates, technical documentation, executed tests, etc.

Change control documentation

Services during the entire project cycle


Scope of our customer services

Service upon request with cGMP trained staff

Short, medium or long term maintenance agreements

Calibration agreements for measuring devices (such as for conducitivity, pressure, flow, temperature, TOC, ozone)

Service hotline (24 hours, 365 days a year)

Spare parts service

Plant operation supervisor agreements

Plant remote maintenance & control (AQU@VIEW)

Operating personnel training

Plant operation and maintenance agreements

Laboratory analyses

Plant audits (plant and process optimisation)

Modernisation, upgrade and refurbishment services

Change control documentation

validation services incl. retrospective validation

To support our customers in maintaining highest system reliability and availability, BWT Pharma & Biotech offers full customer service capabilities.

Project Developement and Financing

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ProjectPresentation

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ProjectManagement

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ProjectPlanning

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Manufacturing

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Installation

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Commissioning,Validation

and Training

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Customer Service and Operation

9. ProjectIdentification

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GLOBALSERVICE CENTER

CUSTOMER

Contact:

BWT

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The Best Water Technology Group was formed in 1990 and is today Europe’s leading water technology company. More than 2,700 employees in over 70 subsidiaries and associates together with thousands of service employees, plumbers, planners, architects and hygiene experts constitute the BWT water partner network. Employees in Research & Development work on new processes and materials using state-of-the-art methods to target the development of ecological and at the same time economical products. Thereby the reduction of energy consumption of products and the consequent minimisation of CO2 emissions is a key issue.

When it comes to water, almost everywhere, whether at the entrance of the water pipe into a building – the Point of Entry – or at the tapping point – the Point of Use, the trend-setting products by BWT are in use and have proved their quality millions of times. For the treatment of drinking water, mineral water and ultrapure water for the pharma-ceutical industry as well as in swimming pools, heating and process water, boiler and cooling water as well as for water for air-conditioning. Extensive innovations

guarantee our customers maximum security, hygiene and health in the daily use of water, the precious elixir of life. These innovations, among others, include SEPTRON®, the worldwide first electrode deionisation module (EDI) with spiral wrap, the MDA (manganese oxide activation) – method for effective manganese removal, the bipolar technology AqA total for chemical-free lime protection, SANISAL – the worldwide first

regeneration salt for softening systems, which at the same time works as a disinfectant as

well as the new, revolutionary Mg2+-technology for better taste of

filtered water, coffee and tea. With unique high efficiency

membranes for fuel cells and batteries, BWT is bringing about a cleaner and sustainable energy supply in the 21st century.

BWT – For You and Planet Blue is our mission to take eco logical, economical and social responsi-bility, to provide our customers

and partners with the best products, systems, technologies and

services in all areas of water treat-ment and simultaneously contribute

valuably to preserve the global resources of our blue planet.

BWT – The Company

EUROPE: BWT Pharma & Biotech GmbH Steinbeisstraße 41 – 43D-71665 Vaihingen / Enz, GermanyPhone: +49/7042/910-0E-Mail: [email protected]

ASIA: BWT Water Technology (Shanghai) Co., Ltd.No. 248 Xintuan Road, 12# Workshop,qingpu Industry Zone, Shanghai,201707 Shanghai, P. R. ChinaPhone: +86/21/5986-7100E-Mail: [email protected]

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