fill-it Automated GMP Cell and Strain Banking System

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Dominic Barrett
7 years ago
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1 fill-it Automated GMP Cell and Strain Banking System

2 An Automated Benchtop System for Filling Screw-Cap Cryovials in GMP Laboratories fill-it decaps cryovials held in racks and then dispenses cell suspensions or other liquids before recapping. It is suitable for suspensions of mammalian, insect and microbial cells as well as other biological and non-biological liquids from bulk stocks. fill-it fits inside a standard biosafety cabinet and is ideal for automated preparation for cell banks, reference standards and other applications requiring aseptic performance and GMP compliance. fill-it creates cell banks of higher quality, consistency and viability - Maintains sample integrity by handling cells as gently but with lowered risk of contamination when compared to manual processing. - Creates higher quality cell stocks by minimizing the time cells are in contact with cryopreservative before freezing. - Increases sample consistency by filling the vials quickly, to a specified volume and tightening caps evenly to create an air lock. - Enables larger batches by mechanically creating consistent batches of cryovials, only one QC test is necessary per run further reducing processing cost per vial. - Improves lab productivity by reducing the possibility of human error and enabling an improved efficiency in the way lab staff work with screw-cap cryovials. - Reduces operator risk by removing the risk of injuries due to the repetitive manipulations needed to manually process large batches of screw-cap cryovials. 2

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4 fill-it System Combines Proven Decap Recap Modules with Aseptic Liquid Handling Single-use disposable tube sets fill-it uses a disposable, single-use, sterile tube set for all the product contact areas. Different tube set configurations are available for the three rack formats. 4-way for the 24 tube racks, V 8 way for the 48 tube racks and 8-way for the 96 tube racks. Rack transfer unit Moves the rack of screw-cap cryovials between the dispensing module and the decap recap module allowing the system to fulfill both functions in quick succession. Dispense module Automated carriage to move the racks of tubes between the decapping recapping unit and the peristaltic pump. 4

5 User interface Simple 3 button user interface controls all system parameters and set-up menus. Fits within biological safety cabinet System fits within standard biological safety cabinet which allows aseptic cryovial processing to take place easily and in accordance with GMP protocols. Decap recap module Removes and retains the screw-caps from the cryovials. After fiilling, recaps the vials to recommended torque setting to ensure precise sealing. Tube racks spacers Hold tubes in place at the correct height to allow processing of a range of different brands and sizes pre-racked; or loose - in dedicated 24-way stainless steel racks. 5

6 Functions fill-it removes all caps simultaneously and dispenses into multiple cryovials in parallel. fill-it operation The simple 3 button interface enables users to control the dispense volume and dispense speed, plus specific functions such as: - System prime and deprime - Decap dispense recap - Dispense only - Decap only or recap only (ie for manual processing offline). fill-it compatible tube types fill-it has the flexibility to work with a large range of branded screw-cap cryovials from leading suppliers such as: - Corning - Greiner - Matrix - Nalgene - Nunc fill-it accessories fill-it comes with accessories including tube racks and spacers to fit the tube types you select. Optional accessories include dispensing pots and priming tubs to further tailor it to your lab requirements. fill-it tube set Dispenses cell suspensions and liquids through a single-use sterile disposable tube set. This allows the system to transfer them aseptically form reservoir to tubes without risk of cross contamination. See fill-it Consumables, Accessories and Tube Compatibility Guide for further information including a complete list of current compatible types and sizes. 6

7 Applications fill-it is a valuable tool for a variety of biologics applications - Preparation of master and working cell banks for GMP applications - Preparation of reference standards monoclonal antibodies, other protein therapeutics and vaccines - Cell banks for drug discovery research assay development, screening, lead optimization, and basic research - Strain banks for biopharma process development and R&D - Strain banks for food industry, industrial biotech, and biofuels. 7

8 Sales and Service Contacts For further contacts, visit Europe America Germany Sartorius Stedim Biotech GmbH August-Spindler-Strasse Goettingen Phone Fax Sartorius Stedim Systems GmbH Robert-Bosch-Strasse Guxhagen Phone Fax France Sartorius Stedim FMT S.A.S. ZI des Paluds Avenue de Jouques CS Aubagne Cedex Phone Fax Sartorius Stedim France SAS ZI des Paluds Avenue de Jouques CS Aubagne Cedex Phone Fax Austria Sartorius Stedim Austria GmbH Franzosengraben Vienna Phone Fax Belgium Sartorius Stedim Belgium N.V. Leuvensesteenweg, 248/B 1800 Vilvoorde Phone Fax Hungary Sartorius Stedim Hungária Kft. Kagyló u Budakeszi 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. Phone Fax filtratie.nederland@sartorius-stedim.com Poland Sartorius Stedim Poland Sp. z o.o. ul. Wrzesinska Kostrzyn Phone Fax Russian Federation LLC Sartorius ICR and LLC Biohit Uralskaya str. 4, Lit. B , Saint-Petersburg Phone Fax Spain Sartorius Stedim Spain, S.A.U. Avda. de la Industria, 32 Edificio PAYMA Alcobendas (Madrid) Phone Fax Switzerland Sartorius Stedim Switzerland AG Ringstrasse 24 a 8317 Tagelswangen Phone Fax U.K. Sartorius Stedim UK Ltd. Longmead Business Centre Blenheim Road, Epsom Surrey KT19 9 QQ Phone Fax Sartorius Stedim Biotech UK formerly TAP Biosystems York Way, Royston, Herts, SG8 5WY Phone Fax Ukraine LLC Biohit Post Box 440 B Kiev, Ukraine Phone Fax USA Sartorius Stedim North America Inc. 5 Orville Drive, Suite 200 Bohemia, NY Toll-Free Fax Argentina Sartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires Phone Fax Brazil Sartorius do Brasil Ltda Avenida Senador Vergueiro 2962 São Bernardo do Campo CEP SP- Brasil Phone Fax Mexico Sartorius de México S.A. de C.V. Circuito Circunvalación Poniente No. 149 Ciudad Satélite 53100, Estado de México México Phone Fax Asia Pacific Australia Sartorius Stedim Australia Pty. Ltd. Unit 5, 7-11 Rodeo Drive Dandenong South Vic 3175 Phone Fax China Sartorius Stedim Biotech (Beijing) Co. Ltd. No. 33 Yu an Road Airport Industrial Park Zone B Shunyi District, Beijing Phone Fax Sartorius Stedim Biotech (Beijing) Co. Ltd. Shanghai Branch Office 3rd Floor, North Wing, Tower 1 No Jin Ke Road Pudong District, Shanghai Phone Fax Sartorius Stedim Biotech (Beijing) Co. Ltd. Guangzhou Representative Office Unit K, Building 23 Huihua Commerce & Trade Building No. 80 Xianlie Middle Road Guangzhou Phone Fax India Sartorius Stedim India Pvt. Ltd. #69/2-69/3, NH 48, Jakkasandra Nelamangala Tq Bangalore, India Phone Fax Japan Sartorius Stedim Japan K.K. 4th Fl., Daiwa Shinagawa North Bldg. 8-11, Kita-Shinagawa 1-chome Shinagawa-ku, Tokyo, Japan Phone Fax Malaysia Sartorius Stedim Malaysia Sdn. Bhd. Lot L3-E-3B, Enterprise 4 Technology Park Malaysia Bukit Jalil Kuala Lumpur, Malaysia Phone Fax Singapore Sartorius Stedim Singapore Pte. Ltd. 1 Science Park Road, The Capricorn, #05-08A, Singapore Science Park II Singapore Phone Fax South Korea Sartorius Korea Biotech Co. Ltd. 8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-Gu SeongNam-Si, GyeongGi-Do, Phone Fax TAP Biosystems is now part of the Sartorius Stedim Biotech Group Specifications subject to change without notice. Publication No.: SBI1524-e Order No.: Ver

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