Christ Aqua

www.christaqua.com

Turnkey solutions for the pharmaceutical & biotech industryChrist Aqua Pharma & Biotech

Christ Aqua • 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 m2 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 2,500 employees in 70 subsidiaries and associates is to provide private, industrial, business, hotel, hospital and municipality customers with innovative, ecological and effi cient technologies that deliver a maximum safety, hygiene and health in their daily contact with the elixir of life, water.

BWT – The Water Company | 3

CHRIST AQUA –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. CHRIST AQUA 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, Christ Aqua Pharma & Biotech has many years of experience and possesses a comprehensive spectrum of technologies for producing all the grades of water required in R&D and production environments as well as handling the waste produced.

With its integration into the BWT Best Water Technology Group, the newly formed division Christ Aqua Pharma & Biotech has access to BWT’s international R&D facilities as well as to a comprehensive worldwide R&D partner network.

Our manufacturing facilities in Europe, Asia and the United States provide equipment, skid mounted systems, tanks and vessels. Christ Aqua Pharma & Biotech supplies key components such as vessel manufacture from own production, orbital welding of pipework for equipment, software programming and control panel manufacturing. Furthermore, Christ Aqua 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.


CHRIST AQUA turnkey services and products includeConcept Design, Basic Design, consultancy services, æ

case studies

Assistance for User Requirement Specifi cation (URS) æ

Detail Design æ

PW, HPW, WFI and pure steam production æ

Storage and distribution systems æ

Complete sterile manufacturing systems including æ

solution preparation, CIP/SIP and wastewater inactivation

Ozone and heat sanitisation for distribution systems æ

PLC systems and SCADA (supervisory control and data æ

acquisition) according to 21 CFR Part 11, GAMP

Design, maintenance & consultancy services æ

Qualifi cation, validation & full documentation æ

packagesaccording to cGMP

Advantages of turnkey projectsUniform high product quality with high-end components æ

Seamless project execution without interfaces, shorter æ

project cycles, one communication for partners

Single warranty for products and quality æ

Consistent documentation and validation package æ

Lean & cost effi cient service and recalibration æ

Simplifi ed spare parts storage æ

Easier and safer operation due to uniform HMI user inter- æ

face (e.g. with our LIPROCONTROL software modules)

Uncomplicated acceptance by authorities æ

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. CHRIST AQUA can also support the customer in the PQ phase.

Typical limit of supply

System Build – Control System Programming / Code Review

Quality Software Module Design Specifi cations

Software Design Specifi cation

Mechanical & Electrical Hardware Design Specifi cation

Functional Specifi cation OQSystem Acceptance Test

IQHardware Acceptance Test

Software Integration Test

Software Module Test

Service Contract

PQ

Quality & Project Plan

Concept & Basic Design URS Consultancy by CHRIST AQUA

Support by CHRIST AQUA


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 processes and technologies all combine to characterize CHRIST AQUA as a competent specialist supplier and partner for turnkey process water systems.The worldwide presence of CHRIST AQUA and our growth in these markets demonstrate competence and reflect long-term satisfaction of our customers.

Research and development, future-oriented thought proces-ses and the flexibility and innovative power of the staff ensure that CHRIST AQUA can meet the continually incre-asing demands with respect to the latest quality standards while complying with responsibility for sustainable actionsand for protecting the environment.

CHRIST AQUA is thus certified in accordance with ISO 9001.

Processes and productsSingle- and double-stage reverse osmosis systems æ

OSMOSTIL®

Electrodeionisation with patented SEPTRON æ ® spiral wound modules

Ultrafiltration systems ULTRASTIL TW for pre-treatment æ

of raw water

Ultrafiltration systems ULTRASTIL for depyrogenation of æ

pure and ultrapure water

Compact water treatment systems OSMOTRON æ ®

Distillation systems MULTITRON æ

Pure steam generators VAPOTRON æ

Combined distillation and pure steam generation æ

COMBITRON

UV systems BEWADES for disinfection, TOC reduction æ

and destruction of ozone

Electrolytic ozone generation systems STERITRON æ

Storage and distribution systems LOOPO for ultrapure æ

media, made of stainless steel or PVDF

LIPROLINE CIP/SIP and solution preparation systems æ

LIPROLINE wastewater decontamination systems æ

LIPROCONTROL process and point-of-use management æ

software

AQU@VIEW data archiving & remote control software æ


Potable Water

HPW/PW distribution

Usage

Waste water

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4

PW production

Pure steam production

Pure steam distribution

HPW production

WFI production

WFI distribution

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5

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Products, Processes and Brands

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 effi ciency.

ULTRASTIL

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

Lo æ wer operation costs & invest-ment than for distillation unitsSafe operation guaranteed æ

Integrity test applicable æ

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 10 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 microbiological 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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Christ Aqua • Turnkey solutions for the pharmaceutical industry | 8

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.

CHRIST AQUA also has novel approaches to reducing the quan-tity of water wasted from a system and the power consumpti-on, thus increasing the economy of clean media generation 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. CHRIST AQUA 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 CHRIST AQUA 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 CHRIST AQUA personnel to prepare this software on a project specific basis.

Assembly and full production facilities

All CHRIST AQUA factories use the latest technology for the pro-duction 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) is verifying 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, CHRIST AQUA offers its customers a complete concept extending from project identi-fication, validation and production up to commissioning and start-up, training, customer services and operation of plants.

Quality & Project Plan / Validation Plan æ

Validation strategy æ

Traceability matrix, design verification æ

Validation protocols æ

Execution of tests such as FAT, SAT æ

IQ, OQ, validation æ

PQ support æ

SOP preparation æ

Review of certificates, technical documentation, æ

executed tests, etc.

Change control documentation æ

Services during the entire project cycle


Scope of our customer services

Service upon request with cGMP trained staff æ

Short, medium or long term maintenance agreements æ

Calibration agreements for measuring devices (such æ

as for conducitivity, pressure, fl ow, temperature, TOC, ozone)

Service hotline (24 hours, 365 days a year) æ

Spare parts service æ

Plant operation supervisor agreements æ

Plant remote maintenance & control æ

(CHRIST AQU@VIEW)

Operating personnel training æ

Plant operation and maintenance agreements æ

Laboratory analyses æ

Plant audits (plant and process optimisation) æ

Modernisation, upgrade and refurbishment services æ

Change control documentation æ

Validation services incl. retrospective validation æ

To support our customers in maintaining highest system reliability and availability, CHRIST AQUA offers full customer service capabilities.

Project Developement and Financing

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ProjectPresentation

3.

ProjectManagement

4.

ProjectPlanning

5.

Manufacturing

6.

Installation

7.

Commissioning,Validation

and Training

8.

Customer Service and Operation

9. ProjectIdentification

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GLOBALSERVICE CENTER

CUSTOMER

Contact

www.christaqua.com

BWT – The Water Company

BWT – The Leading International Water Technology Group.

The Best Water Technology Group was formed in 1990 and today is Europe’s leading water technology company. The goal of our 2,500 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 maximum safety, hygiene and health in their daily contact with the elixir of life, water.

BWT offers state-of-the-art water treatment technologies and services for drinking water, pharma water, process water, heating water, boiler water, cooling water and water for air-conditioning systems as well as swimming pool water. For the technological superiority in all areas of water treatment, the inter-national BWT innovation centers continuously research, develop and optimize processes for filtration, limescale protection, softening, dosing, disinfection (UV, ozone, chlorine dioxide, advanced oxidation), membrane technology (microfiltration, ultrafiltration, nanofiltration, reverse osmosis) and special filters for the prevention of legionella.

Tens of thousands of service employees, plumbers, planners, architects and sanitation experts constitute the BWT water partner network. Whether at the entrance of the water pipe into

a building (at the “Point of Entry”) or at the tapping point (“Point of Use”), BWT products “made in Europe” have proven their quality million times. With new table water filters for preparing tea or coffee, filters for optimizing water for coffee machines, water filters for baking and steam ovens and vending machines, under-the-sink particle-filters as well as micro-filters, water dispensers, reverse osmosis and UV devices BWT also offers compact and innovative products for end consumers for best water quality.

Best technologies and permanent product development materially contribute to grow the company and reputation of the market-leading regional brands BWT, Cillit, HOH, Permo and Christ Aqua.

With unique high efficiency membranes for the fuel cell, the energy converter of the 21st century, BWT is working for a cleaner energy supply. BWT – The Water Company - is our vision to provide our customers and partners with the best products, systems and technologies and services in all areas of water treatment. Water is the elixir of life and limited resource. Water is our challenge.

EUROPE:

Christ Pharma & Life Science GmbH, Germany+49 7042 910 [email protected]

ASIA:

Christ Water Technology Shanghai Co.Ltd.,P.R., China+86 10 8448 [email protected]

BWT-

0909

24BG

Christ Aqua

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