Christ Aqua

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  • 1. Christ Aqua Pharma & Biotech Turnkey solutions for the pharmaceutical & biotech industry www.christaqua.com
  • 2. 2 | Christ Aqua • Turnkey solutions for the pharmaceutical & biotech industry 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 efficient technologies that deliver a maximum safety, hygiene and health in their daily contact with the elixir of life, water.
  • 3. 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 demands at tender stage. Evaluating the information & Biotech has many years of experience and possesses a and providing the best solution to meet the project and comprehensive spectrum of technologies for producing customer demands encompasses all aspects of the project from all the grades of water required in R&D and production specifications, drawings, programme and budgets to environments as well as handling the waste produced. conditions of contract, etc. When all this is evaluated correctly at tender stage, experience dictates that projects With its integration into the BWT Best Water Technology are executed harmoniously, on time and within budget. It is Group, the newly formed division Christ Aqua Pharma & our aim to work with our customers as partners. Biotech has access to BWT’s international R&D facilities as well as to a comprehensive worldwide R&D partner After all we all want the same thing – a successful project, network. constructed on time and within budget. As partners we introduce our Key Performance Indicators which are our Our manufacturing facilities in Europe, Asia and the joint mechanism for monitoring all aspects of the project United States provide equipment, skid mounted systems, on a regular basis. This allows senior management of both tanks and vessels. Christ Aqua Pharma & Biotech supplies companies to monitor and influence the success of the pro- key components such as vessel manufacture from own ject. We continually work with our customers, ensuring that production, orbital welding of pipework for equipment, their requirements and expectations are met in line with the software programming and control panel manufacturing. project programme. Furthermore, Christ Aqua is the only European supplier of EDI modules. The unique, patented EDI spiralwound Markets and partners module SEPTRON® is the core component of many modern Projects are carried out in partnership with pharmaceu- water treatment systems. tical manufacturers, pharmaceutical plant designers and other specialist leading engineering companies. Among our Understanding Project Execution customers are AstraZeneca, Sanofi-Aventis, Boehringer To achieve a consistent level of solid Project Execution Ingelheim, Eli Lilly, Glaxo Smith Kline, Novartis, Novo you must first of all understand the customer and project Nordisk, Pfizer, Roche, Bayer-Schering and Merck-Serono.
  • 4. 4 | Christ Aqua • Turnkey solutions for the pharmaceutical & biotech industry Components for turnkey systems Validation 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. CHRIST AQUA turnkey services and products include Advantages of turnkey projects æ Concept Design, Basic Design, consultancy services, æ Uniform high product quality with high-end components case studies æ Seamless project execution without interfaces, shorter æ Assistance for User Requirement Specification (URS) project cycles, one communication for partners æ Detail Design æ Single warranty for products and quality æ PW, HPW, WFI and pure steam production æ Consistent documentation and validation package æ Storage and distribution systems æ Lean & cost efficient service and recalibration æ Complete sterile manufacturing systems including æ Simplified spare parts storage solution preparation, CIP/SIP and wastewater æ Easier and safer operation due to uniform HMI user inter- inactivation face (e.g. with our LIPROCONTROL software modules) æ Ozone and heat sanitisation for distribution systems æ Uncomplicated acceptance by authorities æ PLC systems and SCADA (supervisory control and data acquisition) according to 21 CFR Part 11, GAMP æ Design, maintenance & consultancy services æ Qualification, validation & full documentation packagesaccording to cGMP Consultancy by Support by Concept & Basic Design URS PQ CHRIST AQUA CHRIST AQUA Typical limit of supply Quality & Project Plan Service Contract OQ Functional Specification System Acceptance Test Mechanical & Electrical IQ Hardware Design Specification Hardware Acceptance Test Software Design Specification Software Integration Test Quality Software Module Software Module Test Design Specifications System Build – Control System Programming / Code Review
  • 5. BWT – The Water Company | 5 Components and Systems, including Qualification and Validation In 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; Research and development, future-oriented thought proces- understanding of legal requirements such as USP, EP and ses and the flexibility and innovative power of the staff JP; appreciation of the demands of inspection authorities ensure that CHRIST AQUA can meet the continually incre- such as the FDA and various local authorities; compliance asing demands with respect to the latest quality standards with GMP standards and familiarity with state-of-the-art while complying with responsibility for sustainable actions processes and technologies all combine to characterize and for protecting the environment. CHRIST AQUA as a competent specialist supplier and partner for turnkey process water systems. CHRIST AQUA is thus certified in accordance with ISO The worldwide presence of CHRIST AQUA and our growth 9001. in these markets demonstrate competence and reflect long- term satisfaction of our customers. Processes and products æ Single- and double-stage reverse osmosis systems OSMOSTIL® æ Electrodeionisation with patented SEPTRON® spiral wound modules æ Ultrafiltration systems ULTRASTIL TW for pre-treatment of raw water æ Ultrafiltration systems ULTRASTIL for depyrogenation of pure and ultrapure water æ Compact water treatment systems OSMOTRON® æ Distillation systems MULTITRON æ Pure steam generators VAPOTRON æ Combined distillation and pure steam generation COMBITRON æ UV systems BEWADES for disinfection, TOC reduction and destruction of ozone æ Electrolytic ozone generation systems STERITRON æ Storage and distribution systems LOOPO for ultrapure media, made of stainless steel or PVDF æ LIPROLINE CIP/SIP and solution preparation systems æ LIPROLINE wastewater decontamination systems æ LIPROCONTROL process and point-of-use management software æ AQU@VIEW data archiving & remote control software
  • 6. 6 | Christ Aqua • Turnkey solutions for the pharmaceutical & biotech industry Products, Processes and Brands 1 Potable Water 3 2 PW HPW 1 ULTRASTIL 2 3 5 OSMOTRON production production Ultrafiltration depyrogenation Compact water treatment systems systems OSMOTRON® is the world‘s most ULTRASTIL post-treatment systems popular skid-mounted water treat- are used for HPW production e.g. ment system for production of PW 4 with existing ion-exchanger systems and HPW. The new PRO version HPW/PW æ Lower operation costs & invest- focuses on ergonomics and energy distribution ment than for distillation units efficiency. æ Safe operation guaranteed æ Integrity test applicable 7 5 Pure steam WFI production production 6 Pure steam WFI distribution distribution 7 VAPOTRON COMBITRON Pure steam generators Combined pure steam 8 VAPOTRON pure steam generators generation / distillation Usage are available from 50 to 5.000 COMBITRON reduces investment kg/h. An integrated degassing costs and footprint by up to 30 % stage allows for compliance with in comparison with individual WFI NCG applications. and PSG systems. Waste water
  • 7. BWT – The Water Company | 7 2 3 5 SEPTRON 4 6 LOOPO 5 MULTITRON Patented spiral-wound Storage and distribution systems Distillation systems EDI modules for cold and hot media MULTITRON distillation systems SEPTRON® is the only EDI module LOOPO skids contain all compo- are available for capacities from manufactured in Europe and is a nents which are necessary for the 100 to 17.000 l/h. Highest ener- product of genuine Swiss quality. distribution of PW, HPW and WFI. gy efficiency can be achieved with Each module is tested in the fac- Ozone and hot water versions are output control ranging from 10 to tory and delivered with a factory available. 100 %. and test certificate. 8 LIPROLINE 4 STERITRON OSMOSTIL CIP / SIP and solution Electrolytic ozone generation Single- and double-stage preparation systems systems reverse osmosis systems LIPROLINE process solutions meet a STERITRON produces ozone from OSMOSTIL units are available for wide range of pharmaceutical high-purity water and guarantees pre-treatment, post-treatment and applications such as WIP/CIP and automatic and cost-effective PW/HPW applications. OSMO- SIP as well as solution preparation microbiological protection of the STIL can either be sanitized with systems, storage tanks and process distribution loop. hot water or with chemical agents. equipment.
  • 8. 8 | Christ Aqua • Turnkey solutions for the pharmaceutical industry 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.
  • 9. BWT – The Water Company | 9 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.
  • 10. 10 | Christ Aqua • Turnkey solutions for the pharmaceutical & biotech industry Scope of Services By 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. Services during the entire project cycle æ Quality & Project Plan / Validation Plan æ PQ support æ Validation strategy æ SOP preparation æ Traceability matrix, design verification æ Review of certificates, technical documentation, æ Validation protocols executed tests, etc. æ Execution of tests such as FAT, SAT æ Change control documentation æ IQ, OQ, validation
  • 11. BWT – The Water Company | 11 1. Project 2. 9. Identification Customer Service Project Developement and Operation and Financing 3. 8. Project Commissioning, Validation GLOBAL Presentation and Training SERVICE CENTER CUSTOMER 4. 7. Project Installation Management 5. 6. Project Manufacturing Planning To support our customers in maintaining highest system reliability and availability, CHRIST AQUA offers full customer service capabilities. Scope of our customer services æ Service upon request with cGMP trained staff æ Operating personnel training æ Short, medium or long term maintenance agreements æ Plant operation and maintenance agreements æ Calibration agreements for measuring devices (such æ Laboratory analyses as for conducitivity, pressure, flow, temperature, TOC, æ Plant audits (plant and process optimisation) ozone) æ Modernisation, upgrade and refurbishment services æ Service hotline (24 hours, 365 days a year) æ Change control documentation æ Spare parts service æ Validation services incl. retrospective validation æ Plant operation supervisor agreements æ Plant remote maintenance & control (CHRIST AQU@VIEW)
  • 12. BWT-090924BG BWT – The Water Company The Best Water Technology Group was formed in 1990 and a building (at the “Point of Entry”) or at the tapping point (“Point today is Europe’s leading water technology company. The goal of Use”), BWT products “made in Europe” have proven their of our 2,500 employees in 70 subsidiaries and associates is to quality million times. With new table water filters for preparing provide private, industrial, business, hotel, hospital and tea or coffee, filters for optimizing water for coffee machines, municipality customers with innovative, ecological and efficient water filters for baking and steam ovens and vending machines, technologies that deliver maximum safety, hygiene and health in under-the-sink particle-filters as well as micro-filters, water their daily contact with the elixir of life, water. dispensers, reverse osmosis and UV devices BWT also offers compact and innovative products for end consumers for best BWT offers state-of-the-art water treatment technologies and water quality. services for drinking water, pharma water, process water, heating water, boiler water, cooling water and water for air- Best technologies and permanent product development conditioning systems as well as swimming pool water. For the materially contribute to grow the company and reputation of the technological superiority in all areas of water treatment, the inter- market-leading regional brands BWT, Cillit, HOH, Permo and national BWT innovation centers continuously research, Christ Aqua. develop and optimize processes for filtration, limescale protection, softening, dosing, disinfection (UV, ozone, chlorine With unique high efficiency membranes for the fuel cell, the dioxide, advanced oxidation), membrane technology energy converter of the 21st century, BWT is working for a (microfiltration, ultrafiltration, nanofiltration, reverse osmosis) and cleaner energy supply. special filters for the prevention of legionella. BWT – The Water Company - is our vision to provide our Tens of thousands of service employees, plumbers, planners, customers and partners with the best products, systems and architects and sanitation experts constitute the BWT water technologies and services in all areas of water treatment. Water partner network. Whether at the entrance of the water pipe into is the elixir of life and limited resource. Water is our challenge. BWT – The Leading International Water Technology Group. Contact EUROPE: ASIA: Christ Pharma & Life Science Christ Water Technology GmbH, Germany Shanghai Co.Ltd.,P.R., China +49 7042 910 0 +86 10 8448 3654 office@christaqua.com christ.sh@christ.com.cn www.christaqua.com