MULTITRON VAPOTRON COMBITRON

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1 MULTITRON VAPOTRON COMBITRON WFI & Pure Steam Production MULTITRON multiple-effect distillation units VAPOTRON pure steam generators for the pharmaceutical industry COMBITRON combined pure steam and WFI production

2 2 Multitron Vapotron Combitron BWT Pharma & Biotech offers reliable and most energy efficient multi-effect equipment for the production of Water for Injection (WFI) and Pure Steam. Our systems comply with the latest cgmp requirements and include features to integrate it into an overall system. The state-of-the-art control package complies with GAMP requirements (option) as well as with an intuitive operation via touch-screen panel. Each system is fully equipped to be hooked up to an overall building management or 21 CFR Part 11 data storage system. MULTITRON Multiple-Effect Distillation Units WFI from the pharmaceutical water specialist MULTITRON is a unique designed multi-effect distillation unit with a superior energy efficient performance and most reliable WFI water quality. Employment of the best technologies in multiple-effect distillation, an energy-saving design with 1 up to 8 effects, plus years of experience and specialist know-how are guaranteed. BWT Pharma & Biotech designed a unique double-tube-sheet evaporator, which is integrated into each of the columns without any fixed points. The entire heat exchanger is submersed below the preheated feed water, thus eliminating the chance of scaling or rouging and using all energy which is led into the shell-side of the evaporator. Economic and efficient Latest control paired with proven BWT engineering gives decisive advantages: Our MULTITRON distillation units meet all special pharmacopoeia specifications such as European and the USP regulations. Highest efficiency by optimized design according to cgmp Highest reliability by proven distillation technique Lowest consumption of heating steam and cooling water guarantee High quality of fabrication by orbital welding as well as smooth surface polishing Optimum operational reliability and easy operation using PLC control with touch-screen operator interface Plant steam, hot water or electrical heated systems available Performance can be set between 20 and 100 % as an option for optimised energy-efficient operation

3 BWT For You and Planet Blue. 3 High standards with optional features MULTITRON distillation units consist of 1 up to 8 columns. Continuous monitoring and documentation of the distillate via control system guarantees automatic rejection of, for example, distillate with excessively high conductivity or unacceptable temperature. MULTITRON distillation units are characterized by customeroriented performance features: Compact design. All parts are mounted in a stainlesssteel frame No moving parts, thus minimal maintenance All parts in acid-resistant stainless steel Feed water pump and feed water pre-heater integrated in the frame Low steam velocity Pure steam can be taken from the first column either when producing WFI or independently (COMBITRON version) Unique three phase droplet separation system Automatic sterilisation optionally available Standard control components Standard fittings, measuring and control engineering User-friendly control panel with easy-to-read display and continuous indication of the process status. Standard in all BWT units and skid mounted systems All parts in contact with the product are made of high-quality stainless steel (AISI 316 L) / and all joints have an aseptic TC connection. Calculation, design and production of the pressure vessels are based on the manufacturing and inspection guidelines of PED or ASME rules.

4 4 Multitron Vapotron Combitron VAPOTRON for Efficient Pure Steam Production BWT Pharma & Biotech offers both separate pure steam generators (VAPOTRON) for the production of sterile, pyrogenfree steam as well as combined systems (COMBITRON) for pure steam and WFI in a single unit. VAPOTRON meets the strict requirements for dry, pyrogenfree pure steam for applications, such as: Sterilization in place (SIP) of equipment Sterilization of piping systems Operational heating source for GMP sterilizers Sealing of GMP gaskets such as Biotech fermenters Air humidification of clean-rooms For all these purposes BWT Pharma & Biotech offers the fully cgmp complying pure steam generators VAPOTRON. Pure steam for steam sterilizers/autoclaves which must comply to EN 285 requirements can be equipped with a degasifyer mounted in the same skid. Higher capacity fully automatic The basic principle of a VAPOTRON pure steam generator is the same as the 1 st column of a multiple-effect distillation unit, using the same technology to have the most efficient production and also the most reliable pure steam pressure into the pure steam network as possible.

5 BWT For You and Planet Blue. 5 COMBITRON The Perfect Combination A combined pure steam and distillation unit simplifies the provision of ultra-pure media: instead of using two units, pure steam and Water for Injection (WFI) can be generated with COMBITRON in a single unit. This is made possible by the use of a specially designed first column with a larger diameter and of the natural circulation principle. The media can be produced simultaneously or separately with an output of about 1,000 kg of pure steam and up to 4,000 litres of WFI per hour. The ratio of pure steam to WFI can be adjusted in the range 2:1 to 1:4 to match individual project requirements. Customer-specific versions with higher outputs and with individual configurations are available. Reduced investment costs less footprint Since the COMBITRON produces two ultra-pure media from a single unit, the investment costs for the system and its periphery are reduced by up to 30 per cent, and the combined unit requires considerably less space than two separate units.

6 6 Multitron Vapotron Combitron The Right Solution for Every Need User-friendly and Individually Programmable MULTITRON distillation units, VAPOTRON pure steam generators and COMBITRON skids, equipped with a Siemens or similar control, can be individually programmed for specific requirements. An additional Touch-Screen Panel allows simultaneous operation and process monitoring of the whole distillation unit. Production and process data can be scanned, documented and updated at any time. Fully automatic production of the distillate guarantees, as recommended by the FDA, rejection of the first product after re-start-up. Quality control is then performed at all project steps. Design review Receiving inspections Software review Pre-inspections of control cabinet Manufacturing inspections according to ISO 9001 procedures Factory Acceptance Testing (FAT) Site Acceptance Testing (SAT) Validation, quality control 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 etc. This document is given to the customer for approval and ensures a well working project. MULTITRON, VAPOTRON and COMBITRON 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 according to applicable directives, such as PED, EMC, LV and the Machinery Directive. The validation engineers accompany each project through all steps of the V-model, starting with the URS and ending with FAT/SAT before hand-over of the unit. Our skid-mounted distillation units and pure steam generators leave the manufacturing site after a successfully executed FAT with test run checking capacities. The units can be commissioned easily and quickly and are finally validated on site to start producing WFI and/or pure steam.

7 BWT For You and Planet Blue. 7 Highest Level of Reliability BWT Heat Exchanger Designs Repeatedly Proven through Effective Advantages Stress-free heat exchangers The heat exchangers are immersed completely in feed water and the heating steam at constant temperature in the entire column allows free and uniform expansion of the heat exchanger tubes and of the outer jacket. Your advantage: minimal stress within the heat exchanger and weldings. The risk of corrosion is reduced to a minimum allowing a much extended lifetime. Optimal process engineering is understood in order to avoid vibrations and thermal stress for heat exchangers and installed equipment. Thorough testing Dye penetration testing of tube/tube end plate welds Hydrostatic testing and final inspection according PED Radiography of the main welds according to German rules No tendency to scaling Scaling is kept to an ideal minimum, particularly in the case of feed water containing silicates, as the heat exchangers are immersed completely in feed water and the tubes are continuously in the wet area. Drainability The BWT design allows full drainability of each column and all heat exchangers. Large expansion area for the steam Half the column height is available for expansion of the steam and for droplets precipitation in the upper column area. FDA-approved double-plate tubular heat exchangers with seamless tubes The double-plate tubular heat exchangers are supplied with seamless tubes. The FDA recommends their use wherever a medium of lower purity is at a higher pressure. For example, the 1 st column, the condenser, the cooler and the pre-heater in our distillation units. The heat exchanger tubes are then rolled into the inner tube plate and welded into the outer tube plate. Our heat exchanger design is characterized by longer service intervals, less spare parts (no gaskets) and thus, a much extended lifetime. BWT Pharma & Biotech Your Partner for Sterile Technologies Skilled employees All BWT Pharma & Biotech systems are manufactured by highly qualified fitters and welders. Development, production and pressure tests take place in accordance with the strictest regulations and under official supervision. Before commissioning the plants are completely tested during the FAT (Factory Acceptance Test) and pre-validated. In this way all BWT Pharma & Biotech employees work on the basis of ISO 9001 and and guarantee the highest quality to our customers. Every BWT system is delivered with declaration of conformity and CE mark.

8 BWT The Company 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 CO 2 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 pharmaceutical 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 Mg 2+ - 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 21 st century. BWT For You and Planet Blue is our mission to take eco logical, economical and social responsibility, to provide our customers and partners with the best products, systems, technologies and services in all areas of water treatment and simultaneously contribute valuably to preserve the global resources of our blue planet. BWT Druck: DK Contact: BHF Technologies The Filtration Specialists +61 (03)