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Summary of Contents for REPLIGEN XCell ATF 2
- Page 1 XCell® ATF 2 and 4 Stainless Steel Housings User Guide For Use with: • XCell® ATF 2 Stainless Steel Housing • XCell® ATF 4 Stainless Steel Housing SG-SSATF24 rev 1...
- Page 2 Customer shall refer to the terms and conditions of sale governing the transaction for any and all warranties for the product. Repligen Corporation shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material.
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Page 3: Table Of Contents
User Guide XCell® ATF 2 and 4 Stainless Steel Housings User Guide KrosFlo® TFDF™ Lab System Contents 6.1.1 Installing the diaphragm ..................... 10 6.2.1 XCell® ATF 2 Stainless Steel Housing hollow fiber filter installation......11 6.3.1 Filter wetting ....................... 12 6.3.2 Integrity testing pre-autoclaving ................ - Page 4 User Guide XCell® ATF 2 and 4 Stainless Steel Housings User Guide KrosFlo® TFDF™ Lab System List of tables Table 1. Explanation of user attention phrases ..................8 Table 2. Explanation of symbols ......................8 Table 3. Dimensions ..........................9 Table 4.
- Page 5 User Guide XCell® ATF 2 and 4 Stainless Steel Housings User Guide KrosFlo® TFDF™ Lab System Abbreviations ATF device to bioreactor ATF device to controller Alternating tangential flow Disposable aseptic connectors Driving force Driving pressure Exhaust Field Applications Specialist Hollow fiber filter Hollow fiber module Hour kilodalton...
- Page 6 XCell® ATF 2 and 4 Housings and hollow fiber filters. Users should possess a basic level of skill in the areas of aseptic technique and fluid handling. For further support in optimizing or troubleshooting, please contact your local Repligen Field Applications Specialist (FAS).
- Page 7 User Guide XCell® ATF 2 and 4 Stainless Steel Housings 2. Description of XCell® ATF Stainless Steel Housings XCell® ATF Technology includes two sizes of housings to support a fully scalable process. An integrated diaphragm pump provides alternating tangential flow through a hollow fiber filter which retains large components (i.e., cells) and removes waste or product components (permeate/filtrate).
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Page 8: Table 1. Explanation Of User Attention Phrases
User Guide XCell® ATF 2 and 4 Stainless Steel Housings Figure 1. Pressure and exhaust strokes To bioreactor From bioreactor Filtered harvest Filtered harvest Diaphragm Diaphragm Positive air pressure Negative air pressure Note: XCell® ATF Stainless Steel Housings require a vacuum (negative pressure) to move the diaphragm to its lowest position. -
Page 9: Table 3. Dimensions
User Guide XCell® ATF 2 and 4 Stainless Steel Housings 5. Specifications 5.1 Utility requirements Utility requirements for the XCell® ATF 2 and 4 Systems can be found in the XCell® Lab Controller User Guide. Table 3. Dimensions Filtration Assembly Dimensions H, W Nominal footprint (m... -
Page 10: Installing The Diaphragm
Use with aqueous liquids only. For use with other fluids contact Repligen for a technical discussion. When used as instructed, the diaphragm is designed to last over one million pressure/exhaust cycles. -
Page 11: Xcell® Atf 2 Stainless Steel Housing Hollow Fiber Filter Installation
6.2.1 XCell® ATF 2 Stainless Steel Housing hollow fiber filter installation XCell® ATF 2 Stainless Steel Housing accommodates a variety of hollow fiber modules. For selection support, please contact your local Repligen Field Applications Specialist (FAS). Figure 4. XCell® ATF 2 Stainless Steel Housing Installation of HFM 1. -
Page 12: Filter Wetting
Refer to the XCell® ATF Technology Filter Preparation and Autoclaving User Guide for instructions. 6.3.2 Integrity testing pre-autoclaving Note: Repligen strongly recommends the practice of pre-autoclaving integrity testing to ensure a proper assembly prior to autoclaving. Refer to the XCell® ATF Technology Filter Preparation and Autoclaving User Guide for configurations for both glass and single-use bioreactor integrity tests and testing instructions and criteria. -
Page 13: Xcell® Atf 2 Stainless Steel Tubing Set Kits And Accessories
User Guide XCell® ATF 2 and 4 Stainless Steel Housings Table 5. Headplate fitting part numbers Head plate fitting Bioreactor HP:MPP-19 3 L Applikon HP:MPP-M26 5 - 10 L Applikon HP:BBI-M26 Sartorius/BBI HP-PG13.5L Millipore Mobius® CellReady PG13.5 Generic 6.4.1 XCell® ATF 2 Stainless Steel tubing set kits and accessories Several components are required to connect the XCell®... -
Page 14: Tubing Set Kit For Xcell® Atf 2 Stainless Steel Housing Connected To Glass Bioreactor
User Guide XCell® ATF 2 and 4 Stainless Steel Housings 6.4.2 Tubing set kit for XCell® ATF 2 Stainless Steel Housing connected to glass bioreactor Assembly of the housing, tubing set, and accessories is completed prior to autoclaving. Figure 5. XCell® ATF 2 Stainless Steel Housing connection to glass bioreactor (tri-clamp) A. -
Page 15: Removing The Housing From The Bioreactor
User Guide XCell® ATF 2 and 4 Stainless Steel Housings 4. Attach bottom permeate (C2) to hose barb. 5. Attach drain (C3) to hose barb. Autoclave. 6.5 Disassembly and maintenance 6.5.1 Removing the housing from the bioreactor 1. Stop the permeate/harvest pump and disconnect the harvest bag from the housing. 2. -
Page 16: Installing The Diaphragm
Use with aqueous liquids only. For use with other fluids contact Repligen for a technical discussion. When used as instructed, the diaphragm is designed to last over one million pressure/exhaust cycles. -
Page 17: Xcell® Atf 4 Stainless Steel Housing Hollow Fiber Filter Installation
7.1.2 XCell® ATF 4 Stainless Steel Housing hollow fiber filter installation XCell® ATF 4 Stainless Steel Housing accommodates a variety of hollow fiber filters. For support in selecting hollow fiber filters, please contact your local Repligen Field Applications Specialist (FAS). 1. Stand the filter housing vertically, with harvest port up. -
Page 18: Filter Wetting
Refer to the XCell® ATF Technology Filter Preparation and Autoclaving User Guide for instructions. 7.2.3 Integrity testing pre-autoclaving Note: Repligen strongly recommends the practice of pre-autoclaving integrity testing to ensure a proper assembly prior to autoclaving. Refer to the XCell® ATF Technology Filter Preparation and Autoclave User Guide for configurations for both glass and single-use bioreactor integrity tests and testing instructions and criteria. -
Page 19: Xcell® Atf 4 Stainless Steel Housing Tubing Set Kits And Accessories
User Guide XCell® ATF 2 and 4 Stainless Steel Housings Table 8. Headplate fitting part numbers Head plate fitting Bioreactor HP:MPP-19 3 L Applikon HP:MPP-M26 5 -10 L Applikon HP:BBI-M26 Sartorius/BBI HP-PG13.5L Millipore Mobius® CellReady PG13.5 Generic 7.3.1 XCell® ATF 4 Stainless Steel Housing tubing set kits and accessories Several components are required to connect the XCell®... -
Page 20: Tubing Set Kit For Xcell® Atf 4 Stainless Steel Housing Connected To Glass Bioreactor
User Guide XCell® ATF 2 and 4 Stainless Steel Housings 7.3.2 Tubing set kit for XCell® ATF 4 Stainless Steel Housing connected to glass bioreactor Assembly of the housing, tubing set, and accessories is completed prior to autoclaving. Figure 9. XCell® ATF 4 Stainless Steel Housing connection to glass bioreactor (tri-clamp) A. -
Page 21: Removing The Housing From The Bioreactor
User Guide XCell® ATF 2 and 4 Stainless Steel Housings 7.4.1 Removing the housing from the bioreactor 1. Stop the permeate/harvest pump and disconnect the harvest bag from the housing. 2. Stop and disconnect the A2C line from the diaphragm pump. 3. -
Page 22: Eu Declaration Of Conformity
XCell® ATF 2 and 4 Stainless Steel Housings 8. Appendix 3: Safety, Handling, and Conformity Information 8.1 Safety Repligen XCell® ATF System is rated for acceptable sound levels (60 dBA). • • Complete system visual inspection for damage or potential risk to the operator, surrounding personnel, or equipment on a semi-annual basis. -
Page 23: Tube Set Kits
XCell® ATF 2 and 4 Stainless Steel Housings 8.3.2 Tube set kits Tube set kits are manufactured under the Repligen Quality Management System certified under current revision of ISO 9001:2015. All product-contact components are USP Class VI, (USP<88>) and/or ISO 10993 tested and free of animal derivatives or are compliant with EMA/410/01 guidelines. -
Page 24: Table 12. Xcell® Atf 4 Spare Parts
User Guide XCell® ATF 2 and 4 Stainless Steel Housings Table 12. XCell® ATF 4 spare parts Part Number Description SC-4.0 Sanitary, 4" TC AISI Type 316L stainless steel 1 SG-2.5-E Sanitary Gasket, 2 1/2" TC EPDM 2 RM-10266 Hollow Fiber Module PC/PS w/ Hollow Fibers 1 A4H1 Housing Assembly, ATF4 AISI Type 316L stainless steel O-224-S-GMP... - Page 25 User Guide XCell® ATF 2 and 4 Stainless Steel Housings 10. Index Autoclaving ..........12, 18 Installing the diaphragm ......10, 16 Connecting housing to a bioreactor.. 12, 14, 18 Integrity testing ........12, 18 Danger ............8, 22 Precautions ............. 8 Disassembly..........
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