Sartorius Prefilter Elements Designed for Biotech and Pharmaceutical Applications

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1 Sartorius Prefilter Elements Designed for Biotech and Pharmaceutical Applications

2 Prefiltration solutions: Extended filter performance and increased yields The Need for Prefiltration Sartorius offers a broad choice of prefilters for biotech and pharmaceutical applications. Liquids contain contaminants such as bioburden, particles, colloids or lipids. They have to be reduced to extend the service life of the downstream membrane filter and to enhance the production yield. Sartorius prefilters are specifically optimized for individual requirements in biotech and pharmaceutical applications. These major requirements are: Effective clarification for optimal protection of the final membrane filter Highest total throughput performance for the lowest filtration costs Defined particle retention for reliable process conditions Saving Filtration Costs Prefiltration is absolutely necessary for economic reasons. The right choice of the prefilter extends the service life for the following final membrane filter up to several times. The filtration costs will be reduced to a minimum. A higher process reliability is assured and process interruptions avoided. Biotech Applications In biotech applications, prefilters are used in upstream processing for media and for buffer filtration. They protect the final membrane filter, reducing filtration costs as a result. In downstream processing, prefilters are used for the clarification step after fermentation and for protection of the downstream processing equipment. Their key task is to remove contaminants in order to assure optimal downstream processing that uses as few steps as possible and provides the highest production yields. Scale-up with Filter Elements Sartorius prefilters are available in a choice of flat filter material and MidiCaps (filtration area from 150 cm 2 to 4,500 cm 2 ) for R&D laboratory tests and for process development plants. MaxiCaps and standard filter cartridges (filtration area up to 24,000 cm 2 ) are available for production processes. This product portfolio enables users to easily scale up the filter area under process conditions. The aim is to find out the best filter combination in terms of total throughput performance and flow rate. Filter Media Selection Sartorius prefilters are available in a broad choice of filter media to suit the requirements for biotech and pharmaceutical applications: - Cellulose Acetate These membranes provide the lowest unspecific protein adsorption for highvalue product filtration. Polypropylene This low adsorptive material can be used when the highest dirt-holding capacity is needed. The material can be used in the complete ph range (1 14) for filtration of liquids. Glass Fiber High adsorptive fleece is used in selected prefilter types. This glass fiber material delivers exceptionally powerful clarification performance along with defined particle retention. Pharmaceutical Applications For pharmaceutical applications, filtration of plasma, serum or LVP, prefiltration is required to protect the final membrane filter. The right choice of the filter combination (prefilter and final membrane filter) ensures optimum filtration conditions and the lowest filtration costs.

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4 Sartopure PP2 Prefilter Element Featuring Fast Flow Rates and High Total Throughputs Sartopure PP2 filter elements combine multiple layers of progressively finer pleated polypropylene depth filter material. Their defined fractionated depth filtration capabilities ensure reliable retention of particles and reduction of the bioburden in a broad range of liquids. All parts of Sartopure PP2 are made of highly chemically resistant polypropylene. The non-woven pleated polypropylene layers provide excellent flow rates in combination with an extremely high total throughput performance. Typical applications for Sartopure PP2 filter elements are particle removal from various media such as: Plasma fractions Vaccines Diagnostics Ophthalmics WFI

5 Sartopure GF Plus Prefilter Element for Enhanced Adsorptive Power and Extended Flow Rate Performance Sartopure GF Plus adsorptive depth filter elements feature highly charged glass fiber layers for effective clarification of liquids based on the combination of adsorptive and mechanical retention. Sartopure GF Plus filters are designed for the removal of contaminants such as colloids, lipids, protein aggregates (host cell proteins) from biopharmaceuticals. They are the ideal choice for prefiltration and clarification of: Cell culture liquids after cell harvesting Fermentation broth Serum-free or serum-containing cell culture media Serum Highly viscous ophthalmic and LVP solutions

6 Sartoclean CA Cellulose Acetate Prefilter Element Featuring Low Adsorption Sartoclean GF Adsorptive Prefilter for Colloids, Lipids and Bioburden Reduction Sartoclean CA filter elements offers the advantage of defined particle and bioburden reduction. The low adsorptive cellulose acetate membrane reduces product losses and enhances production yields. Sartoclean CA filter element are primarily used in the filtration of: Vaccines MAB S Diagnostics Blood fractions Ophthalmics Sartoclean GF filter elements combine adsorptive glass fiber layers in combination with a cellulose acetate membrane. This combination assures the removal of colloids and lipids and the reduction of bioburden for optimal protection of the final membrane filter. Sartoclean GF filter elements are ideal for integration into processes for filtration of: Serum Plasma Culture media Colloid-containing solutions

7 Sartofine PP Multi-layered Prefilter Element for Fractionated Particle Retention Sartofine PP filter elements contain a multi-layer filter matrix, consisting of 4 to 7 different filter zones. The number of zones depends on the type of filter cartridge. Each zone, made up of polypropylene filter layer, is a heterogeneous depth filter itself. The nominal retention rating of the successive zones becomes progressively finer in the direction of filtration. Sartofine PP filter elements are the ideal choice for the filtration of: Cell Harvest solutions Pharmaceutical water Colloid-containing solutions Bulk chemicals

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 Vivascience AG Feodor-Lynen-Str Hannover 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. 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 Vivascience Ltd. Unit 6 Oldends Lane, Stonedale Road Stonehouse, Glos GI10 3RQ 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 Vivascience Inc. 131 Heartland Blvd. Edgewood, New York Phone Fax Argentinien Sartorius Argentina S.A. Calle Avalos 4251 (B1605ECS) Munro Buenos Aires Phone: Fax: Brazil Sartorius do Brasil Ltda. Av. Jabaquara No. 2940, cjtos. 46, 47 CEP Jabaquara/ Mirandopolis Sao Paulo, SP. 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. 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. Blk. 4010, Ang Mo Kio Ave 10 #04-01B, Techplace 1 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.: SL-1517-e05081 Order No.: