Filter Cartridge Housings for the Pharmaceutical Industry Modular, Individual, Flexible

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1 Filter Cartridge Housings for the Pharmaceutical Industry Modular, Individual, Flexible

2 The Sartorius Group is an internationally leading laboratory and process technology provider covering the segments of biotechnology and mechatronics. In 2005, the technology group earned sales revenue of million euros. The Goettingen-based company founded in 1870 currently employs approximately 3,600 persons. Its biotechnology segment focuses on filtration and separation products as well as fermenters and bioreactors. The mechatronics segment manufactures, in particular, equipment and systems, which feature weighing, measurement and automation technology for laboratory and industrial applications, as well as hydrodynamic bearings. Key Sartorius customers are from the pharmaceutical, chemical and food and beverage industries and from numerous research and educational institutes of the public sector. Sartorius has its own production facilities in Europe, Asia and America as well as sales subsidiaries and local commercial agencies in more than 110 countries.

3 Sartorius Filter Cartridge Housings Sartorius standard filter housings meet the highest requirements of the pharmaceutical industry. Benchmark production engineering is a guarantee for outstanding quality in processing and operational safety. All pressurized filter cartridge housings comply with Pressure Equipment Directive PED 97/23/EC. Our housings additionally feature GMP-compliant designs and FDA/USP Class VI approved gasket materials. Meticulously processed surfaces ensure operational safety wherever sterility and cleanability are concerned. Customer-specific documents are available for every filter cartridge housing. If requested, we can supply housing designs customized to meet your specific application. Features of Sartorius Filter Housings Hygienic, dead space-free design All product-contact surfaces are electropolished with a surface finish of Ra < 0.5 µm Clamps, flanges and threaded couplings are TÜV-tested (German Association for Technical Inspection and Safety) Minimal pressure losses thanks to optimized flow technology High-grade stainless steel 316 L construction Options for connecting test and measuring instruments Condensate run-off valves on compressed gas housings Approved according to Atex EX II 2 G D c

4 The M.D.S. Software (Modularly Designed System Software) was developed by Sartorius for configuring filter housings. The wide variety of components lets you combine and configure your own filter cartridge housing according to your specific requirements. After you have drafted your configuration, M.D.S. generates a dimensional sheet with following data: Drawing with installation dimensions Detailed components description Technical information (certificates, surface properties, materials used, delivery periods, etc.) Every Sartorius filter housing consists of the following basic components: Top part of the housing with vent Housing bell (of the appropriate height) Clamp for filter housing lock (Tri-clamp) Gaskets (made of various materials) Housing base: a) without condensate run-off valves b) with condensate run-off valves (connecting pipes available in types compliant with DIN, ISO, BSOD) Fittings Extra drain options All filter housings are available in a choice of the following designs: T type, in-line type or L type. Brief Example: Housing for Liquids Drawing Code Technical Description BA001 Bell height BB0H0 BB0H1 BB0H2 BB0H3 BB0H4 Fittings, general: Clamp 50.5 mm Pipe 38.1 mm mm Side fittings: New pharmaceutical-grade valve (PTFE tip, silicone O-ring) Pipe: mm mm TC mm Housing bell for: 5" filter cartridges 10" filter cartridges 20" filter cartridges 30" filter cartridges 40" filter cartridges BC0K2 2-piece joint clamp with 2 hexagonal nuts mm Temp.: C Pressure: +10 bar (~145 psi) (limited by housing) BDE01 EPDM Clamp gasket ISO 2852, BSOD 4" BDS01 Silicone USP Class VI FDA BDV01 Viton (Title 21, Chapter 1, Part ) BDW01 FEP (Viton core with PTFE coating) Base plate adapter 25 with removable legs with vent valve Pipe dimensions: BE004 BSOD 1 : 25.4 mm mm BE005 DIN DN 25: 29.0 mm mm BE006 ISO DN 25: 33.7 mm mm ZAA001 Clamp acc. to ISO 2852 BSOD 1 : clamp 50.5 mm ZAB001 Flange, DIN EN (DIN 2633) DN 25 ZAD002 Beverage thread connector DIN Inlet: threaded fittings, DN 25 Outlet: Conical fittings with threaded nut, DN 25

5 Modularly Designed Software (M.D.S) Selecting Your Specifications Using our M.D.S. software according to your specifications, the final drawing of a modular, custom-configured housing can be produced within minutes as a dimensional sheet and printed out or sent as an Acrobat Reader (PDF) file. This drawing will also be used to prepare the cost estimate and for customer release. Your Added Benefits Customized configuration of the filter housing on-site Fast drafting of the dimensional sheet Technical modifications can be made right away Simplified order processing Prompt delivery Better prices Customized Versions, Such as Housing materials e.g.: AISI 904 L (1.4539), alloy 59 (2.4605), etc. Clamp gasket material e.g.: Kalrez, Isolat, etc. Operating pressure e.g.: 6 bar, 16 bar, etc. Surfaces e.g.: interior Ra < 0.4 µm Connections e.g.: BioConnect, Ingold, etc. Delta ferrite content e.g. < 1%, <0.5%, etc., can be ordered as customized designs Add New Project: Display Dimensional Sheet You can choose from the following modular programs: Mini-filter cartridge housing Standard 1-round (single cartridge) housing Standard 3-round housing Standard 5-round housing Standard 7-round housing Standard 8-round housing Page 1 (Dimensional sheet) Page 2 (Bill of materials) Page 3 (Technical Information) New Accessories and Spare Parts Project: Display Order Form Spare Parts and Accessories in M.D.S Replacement parts and accessories can be easily selected and ordered in M.D.S. Ordering information (spare parts)

6 The widest variety of configurations is possible when designing filter housings that meet the needs of the pharmaceutical industry. That is why we have broken down the housing into its individual components. You select the components according to your needs and custom-design your own housing. Then, we manufacture your housing in compliance with certified quality standards. Your Choice: Various vent valves Pipes according to DIN, ISO or BSOD Connectors and clamps such as Tri-clamps, flanges, and threaded fittings according to all conventional standards Sartorius Standard Housing Material AISI 316 L (1.4404/1.4432/1.4435) Surfaces Interior: Ra < 0.5 µm; Exterior: Ra< 1.6 µm Temperature range C Pressure range bar Adapters Mini: 15; Standard (Single Multiple): Housing closure Clamp Clamp gasket Silicone (FDA); EPDM (FDA) Certified Quality Standards Our standard documentation supplied with every filter housing includes: CE Declaration of Conformity (PED 97/23/EC and ATEX 94/9/EC) Pressure and leakage test Material inspection certificates for pressurized components (restamping certificate) FDA Declaration of Conformity Dimensional sheet Stock We stock a sufficient number of all the individual components for the modular system. This guarantees that delivery will be prompt and that high quality standards are maintained.

7 Electric Trace Heating in M.D.S When selecting standard 1-round (single cartridge) housings, you can optionally equip your Sartorius filter housing with electric trace heating. Easy operation and reliability are the stellar features of these devices. The temperature range set can be read off at any time from the digital display. Acoustic and visual warnings go off whenever the temperature is out of the pre-set tolerance. Sartorius uses bracket-style locking clamps that guarantee simple, quick and safe assembly. The open-bracket design is exceptionally easy to clean and there are hardly any surfaces where contamination can adhere. The angled clamp position securely locks the filter cartridges in place. The housing bases for multiround housings are manufactured in one piece. Drill holes beveled towards the center allow for optimal flow dynamics and excellent cleanability. The patented Sartorius pharmaceutical-grade valve offers tubing connections and an alternative plug-in nipple for RBEO3 coupling. One important feature of this valve is that the tubing or coupling cannot be twisted when the valve is opened or closed. The flat-front gasket is shaped so that it is securely embedded after snapping into the plug and can only be removed by extreme force. This construction ensures that the gasket does not rotate when the valve is opened or closed. C h C hii2gdc All Sartorius filter cartridge housings and pressure tanks are designed and manufactured according to the Pressure Equipment Directive 97/23/EC (PED). Production meets the highest standards and is subject to continuous quality control tests performed by independent notified bodies and Sartorius AG. As of July 1, 2003, equipment and protective systems intended for use in potentially explosive atmospheres must comply with the new EC Directive 94/9/EC (ATEX 95). With this Directive, the European Community has created the basis for mandatory and harmonized requirements governing the composition, installation and maintenance of explosion prevention and protection systems, equipment and components. Sartorius filter housings meet the requirements of this Directive and can be used in Category II (2) GD hazardous areas governed by ATEX Directive 94/9/EC. Atex marking with Sartorius ID number.

8 Sales and Service Contacts For further contacts, visit Europe America Asia Pacific Germany Sartorius AG Weender Landstrasse Goettingen Phone Fax Sartorius BBI Systems GmbH Schwarzenberger Weg Melsungen Phone Fax Austria Sartorius Ges.m.b.H. Wien Franzosengraben 12 A-1030 Wien Phone Fax Belgium Sartorius Technologies N.V. Luchthavenlaan Vilvoorde Phone Fax Denmark Sartorius A/S Himmelev Bygade Roskilde Phone Fax France Sartorius S.A.S. 4, rue Emile Baudot Palaiseau Cedex Phone Fax Italy Sartorius S.p.A. Via dell Antella, 76/A Antella-Bagno a Ripoli (FI) Phone Fax Netherlands Sartorius Filtratie B.V. Edisonbaan MN Nieuwegein Phone Fax Spain Sartorius, S.A. C/Isabel Colbrand 10 12, Planta 4, Oficina 121 Polígono Industrial de Fuencarral Madrid Phone Fax Switzerland Sartorius Schweiz AG Lerzenstrasse Dietikon Phone Fax U.K. Sartorius Ltd. Longmead Business Park Blenheim Road, Epsom Surrey KT19 9 QQ Phone Fax USA Sartorius North America Inc. 131 Heartland Blvd. Edgewood, New York Phone Toll-Free Fax Sartorius BBI Systems, Inc Baglyos Circle Bethlehem, PA Phone Fax Argentinien Sartorius Argentina S.A. Calle Avalos 4251 (B1605ECS) Munro Buenos Aires Phone Fax Brazil Sartorius do Brasil Ltda. Rua Santo André, Santo André São Paulo Phone Fax Mexico Sartorius de Mexico S.A. de C.V. Circuito Arquitectos No. 11 Despacho 201 Ciudad Satelite Naucalpan, Estado de Mexico Phone Fax China Beijing Sartorius Instrument & System Engineering Co., Ltd. Beijing Rep. Office Dong Hu Qu, Wang Jing Industrial Zone Chao Yang District Beijing, P.R.C. P.O. Box 8516 Phone Fax Sartorius Ltd. Unit , Lu Plaza, 2 Wing Yip Street Kwun Tong, Kowloon, Hong Kong Phone Fax India Sartorius India Private Ltd. 10, 6th Main, 3rd Phase Peenya KIADB Industrial Area Bangalore Phone Fax Japan Sartorius K.K. KY Building., 8-11 Kita Shinagawa 1-chome Shinagawa-ku Tokyo Phone Fax Korea Sartorius Korea 17-2 Jungja-Dong, Bundang-Gu Sungnam, Gyunggi-Do B-1023, Paragon , Korea Phone Fax Malaysia Sartorius (Malaysia) Sdn. Bhd. Lot L3-E-3B, Enterprise 4 Technology Park Malaysia Bukit Jalil Kuala Lumpur Phone Fax Singapore Sartorius Singapore Pte. Ltd. 10, Science Park Road, The Alpha #02-25, Singapore Science Park 2 Singapore Phone Fax Australia Sartorius Australia Pty. Ltd. Unit 17/104 Ferntree Gully Road Waverley Business Park East Oakleigh, Victoria 3166 Phone Fax Specifications subject to change without notice. Printed in Germany on paper that has been bleached without any use of chlorine. W/sart-000 G. Publication No.: SPG1501-e06033 Order No.: