FlexAct. Configurable solutions. Flexible, ready-to-connect unit operations.

Transcription

1 FlexAct. Configurable solutions. Flexible, ready-to-connect unit operations.

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3 FlexAct. The new benchmark for operational flexibility. FlexAct is a new system that enables you to customconfigure single-use solutions for entire biomanufacturing steps. The FlexAct system consists of the central operating module that offers the widest variety of configuration options so you can take complete control of practically any steps in upstream and downstream processing. Sartorius Stedim Biotech presents the FlexAct BP for buffer preparation. Next in line are media preparation (MP), cell harvest (CH), UF DF crossflow (UD), virus removal (Vr), virus inactivation (VI), virus adsorption (VA), polishing (IX), form fill (FF) and form transfer (FT).

4 FlexAct. Operational excellence for all future needs. The core of FlexAct, the central operating module (COM), has been designed to be used in any application. This means you can quickly reconfigure FlexAct in just a few easy steps. For example, take the FlexAct BP for buffer preparation and effortlessly convert it into FlexAct Vr for virus removal. And it goes without saying that the technologies and products used in FlexAct are scalable. This makes FlexAct a future-proof system in every respect; one that gives you the greatest possible flexibility. FlexAct MP Media Prep FlexA UF DF FlexAct BP Buffer Prep

5 ct UD Cross-Flow FlexAct VI Virus Inactivation FlexAct IX Polishing FlexAct FT Form Transfer FlexAct VA Virus Adsorption FlexAct FF Form Fill FlexAct VR Virus Removal FlexAct CH Cell Harvest

6 FlexAct. Incorporating end-user input at its best. Ease of use gives you peace of mind FlexAct ideally combines functional design with user-friendly features. Each FlexAct system is easy and convenient to maneuver, provides optimal access for changing the application-specific components without tedious cleaning needs and thus ensures maximum mobility. The singleuse products, such as bags, tubing, connectors and filter capsules, are pre-assembled to the greatest extent possible. This means you can install an entire unit operation rapidly and securely. In addition, the single-use configuration protects your staff members, handling potentially hazardous fluids. 80 cm A small footprint means big money savings The FlexAct central operating module takes up remarkably little space. Its compact design lets you easily negotiate doors which are only 80 cm or less than 2.5 feet wide. Despite its space-saving dimensions, the central operating module provides ample room for the accommodation of extra equipment, such as a filter integrity test system or tube sealers. 144 cm PAT in implemented action The control unit with touch-screen operation enables accurate control of the pump and monitoring of the ph, temperatur and weight. The user interface is known from our BIOSTAT bioreactors and Sartoflow crossflow systems. Set-up time and resources drastically reduced When it comes to readiness, FlexAct is extremely fast, so you ll be up and running in no time. The reason: All single-use products, such as bags, tubing, connectors and filter capsules, etc., are pre-assembled to the greatest extent possible and delivered as ready-to-connect units for easy installation on the central operating module. This minimizes set-up time. The central operating module itself can be universally used for a wide variety of applications. That means there is no need to make multiple investments when you have applications that change frequently, and this will save you substantial time and effort.

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8 FlexAct. Discover real operational flexibility. The primary driver behind the FlexAct initiative is the development of single-use equipment which meets all process operations improving efficiency and speed. Sartorius Stedim Biotech specialists have analyzed the process environment and the operating procedures thoroughly and developed an operator friendly multifunctional central operating module (COM). The system set-up is performed within minutes and needs substantially less preparation time compared with existing solutions. Once the operation is performed, the system can be as fast rigged-off without the needs of tedious cleaning. Set-up and disassembly ease allow for more efficient and faster equipment utilization adding to the overall process capacities. Mixing FlexAct Central Operating Select: Drive unit (levmixer MagMix) Volume of mixing tank (50 1,000 l) Volume of mixing bag (50 1,000 l) Powder bags load cells for mixing tank Universal trolley equipped with: work platforms DCU Microbox pressure transmitter Equipment for extension weighing platforms for mixing and storage tanks Controller Filter integrity test systems

9 The monitoring on a 10 touch screen of all main process parameter is easily enabled by integrated single-use sensors. Module Storage tube positioning rail and flexible filter holder watson Marlow peristaltic pump, type 720. Select: Volume of Palletanks (50 1,000 l) Volume of storage bags Trays and racks for smaller volumes Tube welding and sealing devices

10 FlexAct. Trust in exceptional expertise. Sartorius Stedim Biotech quality systems for single-use products follow applicable ISO and FDA regulations for medical devices. Design, manufacture and sterilization processes are conducted under conditions that mirror biopharmaceutical operations and meet cgmp requirements. Sartorius Stedim Biotech has established multiple manufacturing sites with consistent industrial processes and state-of-the-art utilities. The expertise of designing single-use solutions based on collaborative supplier management and customer demand planning assures a flexible and robust supply chain that can cope with strong market growth. Fluid Management Technologies FlexAct from Sartorius Stedim Biotech gives you access to the complete portfolio of the market leader in bags and fluid management systems. Filtration Technologies FlexAct draws from probably the widest and most innovative range of filtration technologies offered. Whether you need a configuration for sterile filtration or virus filtration, all products used in FlexAct are scalable. Scalability All technologies and products used in FlexAct can be scaled as required. This means maximum flexibility for selecting volumes to be processed. Extractables Leachables All FlexAct components are supported by our well-known validation documentation. Our core competency of extractable leachable testing are a service benchmark.

11 Environmental impact Utilizing single-use technology can decisively improve the environmental footprint of biomanufacturing processes. FlexAct and single-use equipment from Sartorius Stedim Biotech help lower energy consumption and reduce climatechanging emissions. In particular, single-use technology can dramatically reduce the usage of water, a resource indispensable for life, by more than 80%.* What s more, the core of the system, the FlexAct central operating module, is designed and manufactured to feature exceptionally compact dimensions and to save resources. As FlexAct can be flexibly configured with single-use components and utilized universally, the materials and energy employed once in the making of FlexAct hardware can be recycled unlimitedly often for the most diverse biomanufacturing applications. * reference: Sinclair, A.; Leveen, et al.; The Environmental Impact of Disposable Technologies, The Biopharm International Guide, November 2008

12 Sales and Service Contacts For further contacts, visit Europe America Asia Pacific Germany Sartorius Stedim Biotech GmbH August-Spindler-Strasse Goettingen Phone Fax Sartorius Stedim Systems GmbH Schwarzenberger Weg Melsungen Phone Fax France Sartorius Stedim Biotech S.A. ZI Les Paluds Avenue de Jouques BP Aubagne Cedex Phone Fax Sartorius Stedim France SAS ZI Les Paluds Avenue de Jouques CS Aubagne Cedex Phone Fax Austria Sartorius Stedim Austria GmbH Franzosengraben 12 A-1030 Vienna Phone Fax Belgium Sartorius Stedim Belgium N.V. Leuvensesteenweg, 248/B 1800 Vilvoorde Phone Fax Denmark Sartorius Stedim Nordic A/S Hoerskaetten 6D, 1. DK-2630 Taastrup Phone Fax Italy Sartorius Stedim Italy S.p.A. Via dell Antella, 76/A Antella-Bagno a Ripoli (FI) Phone Fax Netherlands Sartorius Stedim Netherlands B.V. Edisonbaan MN Nieuwegein Phone Fax Spain Sartorius Stedim Spain SA C/Isabel Colbrand 10, Oficina 70 Polígono Industrial de Fuencarral Madrid Phone Fax Switzerland Sartorius Stedim Switzerland GmbH Lerzenstrasse Dietikon Phone Fax U.K. Sartorius Stedim UK Limited Longmead Business Park Blenheim Road, Epsom Surrey KT19 9 QQ Phone Fax USA Sartorius Stedim North America Inc. 5 Orville Drive Bohemia, NY Toll-Free Fax Sartorius Stedim SUS Inc Mark Court Concord, CA Phone Toll Free Fax Sartorius Stedim Systems Inc. 201 South Ingram Mill Road Springfield, MO Phone Fax Argentina Sartorius Argentina S.A. Int. A. Avalos 4251 B1605ECS Munro Buenos Aires Phone Fax Brazil Sartorius do Brasil Ltda Av. Dom Pedro I, 241 Bairro Vila Pires Santo André São Paulo Cep Phone Fax Mexico Sartorius de México S.A. de C.V. Circuito Circunvalación Poniente No. 149 Ciudad Satélite Naucalpan, Estado de México Phone Fax China Sartorius Stedim Beijing Representative Office No. 33, Yu an Road, Airport Industrial Zone B, Shunyi District Beijing Phone Fax Sartorius Stedim Shanghai Represantative Office Room 618, Tower 1, German Centre, Shanghai, PRC., Phone Fax Sartorius Stedim Guangzhou Office Room 704, Broadway Plaza, No Dong Feng West Road Guangzhou Phone Fax India Sartorius Stedim India Pvt. Ltd. 10, 6th Main, 3rd Phase Peenya KIADB Industrial Area Bangalore Phone Fax Japan Sartorius Stedim Japan K.K. KY Building, 8 11 Kita Shinagawa 1-chome Shinagawa-ku Tokyo Phone Fax Malaysia Sartorius Stedim Malaysia Sdn. Bhd. Lot L3-E-3B, Enterprise 4 Technology Park Malaysia Bukit Jalil Kuala Lumpur Phone Fax Singapore Sartorius Stedim Singapore Pte. Ltd. 10, Science Park Road, The Alpha #02-25, Singapore Science Park 2 Singapore Phone Fax Australia Sartorius Stedim Australia Pty. Ltd. Unit 5, 7-11 Rodeo Drive Dandenong South Vic 3175 Phone Fax Specifications subject to change without prior notice. Printed in Germany on paper that has been bleached without any use of chlorine. W8A000 G. Publication No.: S e09111 Order No.: Ver Flexel for LevMixer bag, using ATMI patented mixing technology LevMixer is a trademark or registered trademark of ATMI, Inc. in the United States, other countries or both