Thermo Scientific HyClone Single-Use Bioreactor (S.U.B.)

Transcription

1 Thermo Scientific HyClone Single-Use Bioreactor (S.U.B.) Standard BioProcess Containers with Disk Sparge System The Thermo Scientific HyClone Single-Use Bioreactor (S.U.B.) is the leading single-use alternative to conventional stirred tank bioreactors for animal and insect cell culture. The current range includes units with maximum working volumes of 50, 100, 250, 500 and 1000 L. The S.U.B. is now available with new optimized standard BioProcess Containers with improved, dual sparge capability. Open pipe and frit sparging systems are now included to provide a wider range of operating conditions. Data Sheet 062 Rev 1 Overview: The HyClone S.U.B. provides all the advantages of single-use bioprocessing without having to buy a complete new bioreactor system. The critical design parameters of the S.U.B., such as height to diameter ratios, mixer design and location and typical control system interfaces, have been maintained. The S.U.B. BioProcess Container (BPC ) is supplied sterilized by irradiation and therefore does not require any facility hook-ups for sterilization or cleaning. A key element to the single-use design is the plastic (polyethylene) impeller with a bearing/seal assembly linked to an external mixer drive. The S.U.B. consists of the following components: 1. Outer Support Container with a mixer drive complete with control unit and an electrical heater or water jacket. Single-Use Bioreactor BPC complete with agitator assembly, sparger, vent filter inlet and outlet ports, plus ports for integration of sensor probes and line sets. The S.U.B. BPC is supplied sterile and readyto-use. Drive Shaft inserted into the S.U.B. BPC through the mixing drive motor and locked into the disposable agitator assembly. Process Controls temperature (not on water jacket) and agitation control are integrated into the S.U.B., but additional ph or dissolved oxygen (DO) controls must be supplied by the user. The intended use of the Single-Use Bioreactor is as an animal cell culture bioreactor. The HyClone S.U.B. is not suitable for use as a microbial fermenter. This document covers the 50, 100, 250, 500 and 1000 L original standard S.U.B. BPCs with disk sparge system. In addition to the change to the dual sparge system the new standard S.U.B. BPC line sets have been optimized to improve functionality. Details of the new standard S.U.B. BPCs along with full details of the other components of S.U.B. systems can be found in data sheets 026, 028, 029, 030 and 034. It is recommended that all customers transition to use the new dual sparge BPCs. 50 L Water Jacket S.U.B L Water Jacket S.U.B.

2 Standard BPCs with Disk Sparge System Standard BPC Configurations 50, 100 and 250 L For use with tubing welder (CPC Quick Connect or Triclamp End Treatments) 4-5. Addition Media/Inoculum 1. Overlay Gas Inlet Impeller 4-5. Addition Media/Inoculum Front Face 6-9. Probe Ports (4) 11. Bottom Drain Harvest 10. Thermo-Well/Small Volume Sample 3. Inoculum Addition Back Face 13. Direct Gas Sparge 2. Base Addition 12. Exhaust Filter Standard BPC Configurations For use with tubing welder and CPC Quick Connects Line Description Tubing Set (ID X OD X Length) End Treatment With Quick Connects With Triclamps 1 Overlay Gas & Sparge 3/16 (4.8 mm) ID X 3/8 (9.5 mm) OD Silicone X 4 (10 cm) Acro 50 Vent Filter 2 Addition 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 48 (122 cm) splits to 2 lines with: 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 36 (91 cm) reduced to SmartSite Valve Port 3 Inoculum Addition Media/Supplement Addition (2) Connections for ph/ DO probes (4) Thermo-Well/ Small Volume Sample Bottom Drain Harvest 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 60 (152 cm) {for TC: 72 (183 cm)} reduced to 1/2 (12.7 mm) ID X 3/4 (19.1 mm) OD C-Flex X 48 (122 cm) reduced to 3/8 (9.5 mm) ID X 5/8 (15.9 mm) OD C-Flex X 12 (30 cm) reduced to 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 6 (15 cm) splits to 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 3 (8 cm) reduced to and 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 12 (30 cm) 1/2 (12.7 mm) Tube ports Thermo-Well Adapter for 1/4 (6.4 mm) Diameter. 1/2 (12.7 mm) ID X 3/4 (19.1 mm) OD C-Flex X 60 (152 cm) reduced to 3/8 (9.5 mm) ID X 5/8 (15.9 mm) OD C-Flex X 12 (30 cm) reduced to 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 6 (15 cm) splits to 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 3 (8 cm) reduced to 1/8 (3.2 mm) ID X 1/4 (6.4 mm) OD C-Flex X 12 (30 cm) and 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 12 (30 cm) 12 Exhaust Filter 1 1/2 (3.81 cm) Triclamp Port 13 Direct Gas Sparge 3/16 (4.8 mm) ID X 3/8 (9.5 mm) OD Silicone X 6 (15 cm) reduced to Check Valve and 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 48 (122 cm) 1/4 MPC Body SSV 3/4 mini TC SSV 3/4 mini TC Pall Kleenpak Aseptic Connector KPCHT Series (Female) SmartSite Valve Port 1/4 MPC Insert 1 1/2 Molded TC 0.2 Micron Exhaust Vent Filter Acro 50 Vent Filter

3 Standard BPC Configurations 500 and 1000 L For use with tubing welder, CPC Quick Connect (see Page 4 for line details) 1. Overlay Gas Inlet Back Face 5. Base Addition 2. Media/Inoculum 3-4. Antifoam 3-4. Feed 14. Direct Gas Sparge 6. Exhaust Filter Impeller Front Face 13. Bottom Drain Harvest Probe Ports (5) 12. Thermo-Well/Small Volume Sample

4 Standard BPC Configurations For use with tubing welder and CPC Quick Connects Line Description Tubing Set (ID X OD X Length) 1 Overlay Gas Inlet 2 Media/Inoculum Addition 3-4 Feed/Antifoam (2) 5 Base Addition 6 Exhaust Filter Connections for ph/ DO probes (5) Thermo-Well/ Small Volume Sample Bottom Drain Harvest 14 Direct Gas Sparge 3/8 (9.5 mm) ID X 5/8 (15.9 mm) OD C-Flex X 9 (23 cm) with inline disposable pressure transducer 2 lines with: 1/2 (12.7 mm) ID X 3/4 (19.1 mm) OD C-Flex X 120 (305 cm) reduced to 3/8 (9.5 mm) ID X 5/8 (15.9 mm) OD PharMed X 24 (61 cm) split to 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 6 (15 cm) reduced to and 3/8 (9.5 mm) ID X 5/8 (15.9 mm) OD C-Flex X 12 (30 cm) 1/2 (12.7 mm) ID X 3/4 (19.1 mm) OD Silicone X 3 (8 cm) reduced to 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 4 (10 cm) reduced to 1/8 (3.2 mm) ID X 1/4 (6.4 mm) OD C-Flex X 120 (305 cm) to 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD PharMed X 24 (61 cm) splits to 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 6 (15 cm) reduced to and 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 18 (46 cm) Dip Tube: 5 (10 cm) C-Flex 3/8 (9.5 mm) ID X 5/8 (15.9 mm) OD C-Flex X 120 (305 cm) to 3/8 (9.5 mm) ID X 5/8 (15.9 mm) OD PharMed X 24 (61 cm) split to 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 12 (30 cm) reduced to and 3/8 (9.5 mm) ID X 5/8 (15.9 mm) OD C-Flex X 12 (30 cm) Dip Tube: 6 (15 cm) C-Flex 7/8 (22.2 mm) ID X 1 1/8 (28.6 mm) OD Silicone X 3.5 (9cm) reduced to 1/2 (12.7 mm) ID X 3/4 (19.1 mm) OD C-Flex X 6 (15 cm) splits to 2 lines with: 1/2 (12.7 mm) ID X 3/4 (19.1 mm) OD C-Flex X 10 (25 cm) to 1 1/2 (3.81 cm) Triclamp Port 1/2 (12.7 mm) Tube ports Thermo-Well Adapter for 1/4 (6.4 mm) Diameter 1/8 (3.2 mm) ID X 1/4 (6.4 mm) OD C-Flex X 24 (61 cm) 1/2 (12.7 mm) ID X 3/4 (19.1 mm) OD C-Flex X 60 (152 cm) split to 1/2 (12.7 mm) ID X 3/4 (19.1 mm) OD C-Flex X 6 (15 cm) split to 1/2 (12.7 mm) ID X 3/4 (19.1 mm) OD C-Flex X 24 (61 cm) and 3/8 (9.5 mm) ID X 5/8 (15.9 mm) OD C-Flex X 24 (61 cm) and 3/8 (9.5 mm) ID X 5/8 (15.9 mm) OD C-Flex X 24 (61 cm) reduced to 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 6 (15 cm) to Check Valve to 1/4 (6.4 mm) ID X 7/16 (11.1 mm) OD C-Flex X 60 (152 cm) End Treatment With Quick Connects SH30748 Gamma 0.2um SmartSite Valve Port, 3/8 MPC Body 1/4 MPC Body, 3/8 MPC Body Emflon II 0.2 um Aseptic Connector (Female) SmartSite Valve Port Aseptic Connector (Male), 3/8 MPC Insert, Gamma 0.2 um

5 Data Sheet Ordering Information for Standard BPC Products Part Number SH SH SH SH SH SH SH SH Description 50 L S.U.B. bag with disk sparge and Quick Connect treatments 50 L S.U.B. bag with disk sparge and Triclamp treatments 100 L S.U.B. bag with disk sparge and Quick Connect treatments 250 L S.U.B. bag with disk sparge and Quick Connect treatments 250 L S.U.B. bag with disk sparge and Triclamp treatments 500 L S.U.B. bag with disk sparge and Quick Connect treatments 1000 L S.U.B. bag with disk sparge and Quick Connect treatments 1000 L S.U.B. bag with disk sparge and Triclamp treatments Presentation (as dry BPC systems): Outer Packaging Label Sterilization Shipping Container Documentation Supplied flat-packed Two polyethylene outer layers Description Product code Lot number Expiry date on outer packaging and shipping container Irradiation (25 to 38 kgy) inside outer packaging Durable cardboard carton Certificate of Analysis provided with each lot for each delivery Custom Options Custom Hardware Options: For stainless steel capabilities, please contact your sales representative for HyClone products for more information Thermo Fisher Scientific Inc. All rights reserved. SmartSite is a trademark of ALARIS Medical Systems, Inc. C-Flex and PharMed are registered trademarks of Saint-Gobain. PharmaPure is a registered trademark of PharmaPure Tubing. Clave is a registered trademark of ICU Medical. Pall, Kleenpak and Emflon are registered trademarks of Pall Corporation. Lynx is a registered trademark of Millipore. SterilEnz is a registered trademark of PAW Bioscience Products, INC. All other trademarks are the property of Thermo Fisher Scientific Inc. and its subsidiaries. Specifications, terms and pricing are subject to change. Not all products are available in all countries. Please consult your local sales representative for details. HyClone Laboratories, Inc. Logan, UT USA is ISO Certified. HyClone - Media BPC Sera 925 West 1800 South Logan, UT In Americas/Asia fax In Europe fax