Celsius -Pak. Single-use Containers for controlled Freeze-Thaw Processes. Benefits. Product Information

Transcription

1 Single-use Containers for controlled Freeze-Thaw Processes Benefits Single-use Scalable Proven robustness at low temperature Facilitated Validation Complete Logistical Solution Pre-sterilized, ready-to-use and 00% integrity testing of bag and immediate connection Product Information combines unique design in disposable container with a protective structural frame. The robustness of the assembly ensures protection, support and ease of handling. provides uniform and reproducible freeze and thaw processes for biopharmaceuticals in manu facturing and process development. are specifically designed for controlled freezing, thawing and long term frozen storage of biopharmaceuticals such as: Process intermediates Bulk drug substances Product in clinical phases (pre, I, II +) Monoclonal antibodies Other recombinant proteins Vaccines Single-Use System for Controlled Freeze and Thaw Operation are specifically designed to be used with the Celsius Freeze-Thaw Modules, the only Controlled Freeze-Thaw System in disposable containers. are constructed from S7 film, a multi-layer co-extruded high gas barrier film containing EVAM (ethylene vinyl acetate copolymer, monomaterial) as fluid contact layer and EVOH (ethylene vinyl alcohol) as gas barrier layer. frames provide protection to the contents during all processes, making the assembly robust and reliable and simplifying the handling, storage and shipping of the disposable containers. Freeze-Thaw Systems

2 Security of Supply Sartorius Stedim Biotech has established multiple manufacturing sites with consistent industrial processes. The expertise of designing Single-use solutions based on collaborative supplier management and customer demand planning assures a state of the art and robust supply chain that can cope with strong market growth. Validation have been qualified applying the most complex and innovative test regimes. Biological, chemical and physical tests combined with extensive extractable testing provide users of with data representing the widest range of process fluids in a variety of processing conditions. Full compliance with ISO37 allows sterility assurance level validation of 0 6 for each Single-use product over its entire shelf life. A type III drug master file (DMF) has been recorded (applicable for all S7 single-use bags) Quality Assurance 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.

3 Technical Data Specifications Inlet Port Outlet Port 30 ml on top with female Luer Lock on top with female Luer Lock 00 ml on top with female Luer Lock on top with female Luer Lock L MPC Quick Coupling or Plug MPC Quick Coupling or Plug L MPC Quick Coupling or Plug MPC Quick Coupling or Plug 0 cm Hydrophobic Sterilizing Vent Filter 8.3 L on top with MPC or OPTA connector and Y splitter with male Luerlock or vent filter on bottom with MPC or Opta connector 0 cm Hydrophobic Sterilizing Vent Filter Vent Filter 0 cm Hydrophobic Sterilizing Vent Filter Film S7 S7 S7 S7 S7 S7 Sterilization Gamma Gamma Gamma Gamma Gamma Irradiation Irradiation Irradiation Irradiation Irradiation 6.6 L on top with MPC or Opta connector and Y splitter with male Luerlock or vent filter on bottom with MPC or Opta connector 0 cm Hydrophobic Sterilizing Vent Filter Gamma Irradiation Materials 30 ml 00 ml L L 8.3 L 6.6 L Product Contact EVAM EVAM EVAM EVAM EVAM EVAM Layer Gas & Moisture EVA EVOH EVA EVA EVOH EVA EVA EVOH EVA EVA EVOH EVA EVA EVOH EVA EVA EVOH EVA Barrier Layout External Robust, EVA EVA EVA EVA EVA EVA Handling Layer Fill & Drain Ports EVA EVA EVA EVA EVA EVA Fill & Drain Transfer Line EVA tubing or C-Flex EVA tubing or C-Flex Platinum-Cured or C-Flex Platinum-Cured or C-Flex Platinum-Cured Thermowell EVA EVA EVA EVA Holder HDPE 3 HDPE Platinum-Cured Frames 8.3 L Frame G 6.6 L Frame G Ends HDPE HDPE Plate & Rods 36 Stainless Steel 36 Stainless Steel Dimensions (H + W + D) 9.5 cm cm cm ( ) 9.5 cm cm cm ( ) Ethylene Vinyl Acetate Monomaterial EVA-Ethylene Vinyl Acetate, EVOH-Ethylene Vinyl Alcohol 3 High Density Polyethylene Specifications and material are subject to change. Freeze-Thaw Systems 3

4 Ordering Information Equipment Part Number Description Qty FTH-CF L Frame G FTH-CF L Frame G FTH-CF Frame G RTD Holder FTH-CF L & L Carrier Disposables 30 ml 30 ml with Thermowell & C-Flex Part Number Description Tubing Port Port Qty./Box FZB4804, 30 ml, EVA (4 ) Thermowell sealed end tube 0 Thermowell Female LL + plug, pinch clamp i cm (4 ) Female LL + plug FZB4866 FDP0653 FZB4839 FZB4908 FDP0667, 30 ml, Thermowell, C-Flex Aluminum Foil Overpouch, 30 ml, 50 ml, 00 ml, Thermowell, 00 ml, Thermowell, C-Flex Aluminum Foil Overpouch, 00 ml, 500 ml Clear C-Flex cm (6 ) + Female LL + plug, pinch clamp Thermowell sealed end tube i cm (4 ) Female LL + plug Alu Foil N A N A 50 EVA cm (4 ) Female LL + plug, pinch clamp Clear C-Flex cm (6 ) + Female LL + plug, pinch clamp Thermowell sealed end tube i cm (4 ) Female LL + plug Thermowell sealed end tube i cm (4 ) Female LL + plug Alu Foil N A N A

5 Disposables I N L or L L or L with MPC Part Number Description Tubing Port Port Qty./Box FZB5358, L, TPE, Midisart BV 8 FZB539, L, MPC connectors, Midisart BV FZB5366, L, TPE, Midisart BV FZB53, L, MPC connectors, Midisart BV EVA cm (.36 ) + C-Flex 4 + a + 30 cm ( ) and Plug a + 5 cm (6 ) and Midisart vent filter (.57 ) a + 0 cm (4 ) a + 0 cm (4 ) a + 0 cm (4 ) and Midisart vent filter a + 0 cm (4 ) and male MPC + sealing cap EVA cm (.36 ) + C-Flex 4 + a + 30 cm ( ) and Plug a + 5 cm (6 ) and Midisart vent filter (.57 ) a + 0 cm (4 ) a + 0 cm (4 ) a + 0 cm (4 ) and Midisart vent filter a + 0 cm (4 ) and male MPC + sealing cap (.57 ) + C-Flex 4 + a + 30 cm ( ) and Plug (.57 ) a + 30 cm ( ) and (.57 ) + C-Flex 4 + a + 50 cm (0 ) and Plug (.57 ) + C-Flex 4 + a + 45 cm (8 ) and Plug Freeze-Thaw Systems 5

6 Disposables and 6.6L 8.3L and 6.6L 8.3L or 6.6L without thermowell 8.3L or 6.6L with thermowell L and 6.6L 8.3L and 6.6L 8.3L or 6.6L with vent filter 8.3L or 6.6L with thermowell, aseptic connection device and vent filter

7 Disposables Part Number Description Tubing Port Port Port 3 Qty./Box FZB03478, 8.3L, without Thermowell EVA a + j + 0 cm (4 ) + a + b + 30 cm ( ) + a + b + 60 cm (3.6 ) a + 0 cm (4 ) and male LL + cap + a + b + 0 cm (4 ) and (.57 ) + a + b + 75 cm (69 ) and FZB035, 8.3L, Thermowell FZB5370, 8.3 L, Thermowell, OPTA, Midisart BV FZB5334, 8.3 L, Thermowell, Midisart BV FZB5373 FZB486, 6.6L, without Thermowell, 6.6L, Thermowell FZB589, 6.6 L, Thermowell, OPTA, Midisart BV FZB5377, 6.6 L, Thermowell, Midisart BV EVA a + j + 0 cm (4 ) + a + b + 30 cm (.57 ) + a + ( ) + a + b + b + 75 cm (69 ) and 60 cm (3.6 ) a + 0 cm (4 ) and male LL + cap + a + b + 0 cm (4 ) and EVA a + j + 0 cm (4 ) + a + b + 75 cm (30 ) + a + b + 5 cm (6 ) and Midisart vent filter + a + b + 5 cm (6 ) and OPTA female (.57 ) + a + b + 8 cm (7 ) and OPTA male EVA a + j + 0 cm (4 ) + a + b + 30 cm ( ) (.57 ) + a + + a + b + 60 cm b + 75 cm (69 ) and (3.6 ) + a + b + 5 cm (6 ) and Midisart vent filter + a + b + 5 cm (6 ) and EVA a + j + 0 cm (4 ) + a + b + 40 cm (5.8 ) + a + b + 50 cm (0 ) a + 0 cm (4 ) and female LL + cap + a + b + 0 cm (4 ) and EVA a + j + 0 cm (4 ) + a + b + 40 cm (5.8 ) + a + b + 50 cm (0 ) a + 0 cm (4 ) and male LL + cap + a + b + 0 cm (4 ) and EVA a + j + 0 cm (4 ) + a + b + 75 cm (30 ) + a + b + 5 cm (6 ) and Midisart vent filter + a + b + 5 cm (6 ) and OPTA female (.57 ) + 3a + b + 00 cm (79 ) and (.57 ) + a + b + 00 cm (79 ) and (.57 ) + a + b + 05 cm (8 ) and OPTA male EVA a + j + 0 cm (4 ) + a + b + 40 cm (5.7 ) (.57 ) + a + + a + b + 50 cm (0 ) b + 00 cm (79 ) and a + 5 cm (6 ) and Midisart vent filter + a + b + 5 cm (6 ) and i cm (7 ) + Female LL + plug (thermo well i cm (7 ) + i cm (7 ) + i cm (7 ) + i cm (7 ) + i cm (7 ) Freeze-Thaw Systems 7

8 Sales and Service Contacts For further contacts, visit Europe Americas 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 Modecenterstrasse 030 Vienna Phone Fax Belgium Sartorius Stedim Belgium N.V. Rue Colonel Bourg Bruxelles Phone Fax Hungary Sartorius Stedim Hungária Kft. Kagyló u Budakeszi Phone Fax Italy Sartorius Stedim Italy S.p.A. Via dell Antella, 76/A 500 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 Stedim RUS Uralskaya str. 4, Lit. B 9955 St. Petersburg Phone Fax Spain Sartorius Stedim Spain, S.A.U. Avda. de la Industria, 3 Edificio PAYMA 808 Alcobendas (Madrid) Phone Fax Switzerland Sartorius Stedim Switzerland AG Ringstrasse 4 a 837 Tagelswangen Phone Fax U.K. Sartorius Stedim UK Ltd. Longmead Business Centre Blenheim Road, Epsom Surrey KT9 9 QQ Phone Fax Ukraine LLC Biohit Post Box 440 B 000 Kiev, Ukraine Phone Fax USA Sartorius Stedim North America Inc. 5 Orville Drive, Suite 00 Bohemia, NY 76 Toll-Free Fax Argentina Sartorius Argentina S.A. Int. A. Ávalos 45 B605ECS Munro Buenos Aires Phone Fax Brazil Sartorius do Brasil Ltda Avenida Senador Vergueiro 96 São Bernardo do Campo CEP SP- Brasil Phone Fax Mexico Sartorius de México S.A. de C.V. Circuito Circunvalación Poniente No. 49 Ciudad Satélite 5300, Estado de México México Phone Fax Asia Pacific Australia Sartorius Stedim Australia Pty. Ltd. Unit 5, 7- Rodeo Drive Dandenong South Vic 375 Phone Fax China Sartorius Stedim Biotech (Beijing) Co. Ltd. No. 33 Yu an Road Airport Industrial Park Zone B Shunyi District, Beijing 0300 Phone Fax Sartorius Stedim (Shanghai) Trading Co., Ltd. 3rd Floor, North Wing, Tower No Jinke Road Zhangjiang Hi-Tech Park Pudong District Shanghai 00, P.R. China Phone Fax Sartorius Stedim Biotech (Beijing) Co. Ltd. Guangzhou Representative Office Unit K, Building 3 Huihua Commerce & Trade Building No. 80 Xianlie Middle Road Guangzhou Phone Fax India Sartorius Stedim India Pvt. Ltd. #69/-69/3, NH 48, Jakkasandra Nelamangala Tq 56 3 Bangalore, India Phone Fax Japan Sartorius Stedim Japan K.K. 4th Fl., Daiwa Shinagawa North Bldg. 8-, Kita-Shinagawa -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. Science Park Road, The Capricorn, #05-08A, Singapore Science Park II Singapore 758 Phone Fax South Korea Sartorius Korea Biotech Co., Ltd. 8th Floor, Solid Space B/D, PanGyoYeok-Ro 0, BunDang-Gu SeongNam-Si, GyeongGi-Do, Phone Fax C-Flex is a registered trademark of Saint-Gobain Performance Plastics Corporation. Specifications subject to change without notice. Copyright Sartorius Stedim Biotech GmbH. Printed in the EU on paper bleached without chlorine. Publication No.: S--054-e504 Order No.: Ver. 05