REPLIGEN TangenX SC Series User Manual
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REPLIGEN TangenX SC Series User Manual

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TangenX® SC
TFF Device
User Guide
repligen.com
© 2023 Repligen Corporation. All rights reserved. The trademarks mentioned herein
are the property of Repligen Corporation and/or its affiliate(s) or their respective owners.
Document Number:UG-4457 Revision: 1
Effective Date: 9/27/2023
Page 1 of 31
Legacy Document #: N/A

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Summary of Contents for REPLIGEN TangenX SC Series

  • Page 1 TFF Device User Guide repligen.com © 2023 Repligen Corporation. All rights reserved. The trademarks mentioned herein are the property of Repligen Corporation and/or its affiliate(s) or their respective owners. Document Number:UG-4457 Revision: 1 Effective Date: 9/27/2023 Legacy Document #: N/A...
  • Page 2 Product are expressly disclaimed. 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.

  • Page 3: Table Of Contents

    TangenX® SC TFF Device User Guide Contents 1. About this document .................................5 2. Introduction ....................................6 2.1 Additional references ................................6 3. Device components ..................................8 3.1 Recommended device storage conditions ..........................9 4. Pump requirements ...................................9 5. Preparing to use the TangenX SC TFF Device ..........................9 5.1 Required tools and components ...............................9 5.2 Unpackaging the device ................................10 6.
  • Page 4 TangenX® SC TFF Device User Guide List of figures Figure 1. TangenX SC TFF Device (side view and top view) ........................8 Figure 2. How to pick up the device .................................10 Figure 3. Using AseptiQuik Genderless Connectors ..........................11 Figure 4. System configuration without TangenX SC TFF Device ......................12 Figure 5.

  • Page 5: About This Document

    TangenX® SC TFF Device User Guide 1. About this document This manual uses several different phrases. Each phrase should draw the following level of attention: Table 1. Explanation of user attention phrases Phrase Description Note: Points out useful information. IMPORTANT Indicates information necessary for proper instrument operation.

  • Page 6: Introduction

    TangenX® SC TFF Device User Guide 2. Introduction The TangenX® SC TFF Device from Repligen is a holderless, flat sheet, gamma-irradiated, closed, single-use device for tangential flow filtration (TFF). TangenX SC TFF Devices include:  A fully assembled, capsule-style, closed device with aseptic connectors.
  • Page 7 TangenX® SC TFF Device User Guide Table 3. Symbols used in flow diagrams Symbol Description Vessel Pinch clamp CPC AseptiQuik® aseptic genderless connector Pump - Diafiltration - Feed Pressure sensor - Retentate - Feed - Permeate Flow meter (optimization only) Inactive/Standby flow path On/Open flow path Off/Closed flow path...

  • Page 8: Device Components

    TangenX® SC TFF Device User Guide 3. Device components TangenX SC TFF Device consists of a flat sheet filter within a cylinder, connectors for feed, retentate, and permeate (filtrate), and pinch clamps. The 10 m device includes a handle for lifting and transport. Figure 1.

  • Page 9: Recommended Device Storage Conditions

    TangenX® SC TFF Device User Guide Minimum Working Volume Minimum working volume is influenced by the reservoir used in the TFF process. The user can calculate the minimum working volume as the TangenX SC TFF device holdup volume plus the lowest volume achievable in the reservoir and system plumbing without pulling air into the recirculation pump.

  • Page 10: Unpackaging The Device

    6.1 Installing the TangenX SC TFF Device When integrating the TangenX SC TFF Device with a closed TFF system, several flow path options are available.  A custom ProConnex® Flow Path from the Repligen library of over 400 components  A pre-built, off-the-shelf ProConnex Flow Path ...

  • Page 11: Using Aseptiquik Genderless Connectors

    TangenX® SC TFF Device User Guide 6.1.1 Using AseptiQuik Genderless Connectors Aseptically connect the TangenX SC TFF Device to the TFF system using the genderless AseptiQuik® connectors from Colder Products Company (Figure CPC Worldwide Video). Figure 3. Using AseptiQuik Genderless Connectors Flip the blue pull-tab coxver down towards the hinge to expose the membrane that acts as an aseptic barrier.

  • Page 12: Figure 4. System Configuration Without Tangenx Sc Tff Device

    TangenX® SC TFF Device User Guide Figure 4. System configuration without TangenX SC TFF Device Legend: Vessel Pump Pinch clamp Pressure sensor Genderless connector Flow meter For full list of symbols and descriptions, see Table Document Number:UG-4457 Revision: 1 Effective Date: 9/27/2023 Legacy Document #: N/A Page 12 of 31...

  • Page 13: Connecting The Tangenx Sc Tff Device

    TangenX® SC TFF Device User Guide 6.3 Connecting the TangenX SC TFF Device Aseptically connect the TangenX SC TFF Device to the extended tube set (Figure Figure 5. Connecting TangenX SC TFF Device to tube sets Legend: Vessel Pump Open valve action Pinch clamp Pressure sensor Genderless connector...

  • Page 14: Estimate Hold-Up Volume

    TangenX® SC TFF Device User Guide Figure 6. System configuration with all pinch clamps closed Legend: Vessel Pump Off; Closed flow path Pinch clamp Pressure sensor Genderless connector Flow meter For full list of symbols and descriptions see Table 6.4 Estimate hold-up volume Estimate the hold-up volume of the system based on user engineering diagrams.

  • Page 15: Device Flush

    TangenX® SC TFF Device User Guide Figure 7. System configuration showing flow path for hold-up volume Legend: Vessel Pump Off; Closed flow path Pinch clamp Pressure sensor Hold-up volume Genderless connector Flow meter For a full list of symbols and descriptions see Table 6.5 Device flush Flushing the TangenX SC TFF Device with water for injection (WFI) or reverse osmosis/deionized water (RODI) removes 0.2 M NaOH...

  • Page 16: Figure 8. System Configuration For Retentate Port Wfi Flush

    TangenX® SC TFF Device User Guide Figure 8. System configuration for retentate port WFI flush Legend Vessel Pump Configuration change Pinch clamp Pressure sensor On; Open flow path Genderless connector Flow meter Off; Closed flow path Scale For full list of symbols and descriptions, see Table 4.

  • Page 17: Flush The Tangenx Sc Tff Device Permeate Flow Path

    TangenX® SC TFF Device User Guide Table 7. Normalized TangenX SC TFF Device flush volumes TFF filter surface area Retentate to waste Permeate to waste 0.5 m 2.5 L 1.5 m 7.5 L 15 L 2.5 m 12.5 L 25 L 25 L 50 L 10 m...

  • Page 18: Air Integrity Test

    Therefore, Repligen recommends executing an integrity test immediately prior to running the process. A detailed procedure (UG- 3118 TangenX TFF Cassette Air Integrity Testing) for the measurement of air integrity can be obtained at repligen.com...

  • Page 19: Equilibrate The Tangenx Sc Tff Device Permeate Flow Path

    TangenX® SC TFF Device User Guide Figure 10. System configuration for retentate outlet port buffer equilibration Legend Vessel Pump Configuration change Pinch clamp Pressure sensor On; Open flow path Genderless connector Flow meter Off; Closed flow path Scale For full list of symbols and descriptions, see Table 3.

  • Page 20: Product Introduction

    TangenX® SC TFF Device User Guide Figure 11. System configuration for filtration device permeate outlet port buffer equilibration Legend Vessel Pump Configuration change Pinch clamp Pressure sensor On; Open flow path Genderless connector Flow meter Off; Closed flow path Scale For full list of symbols and descriptions, see Table 3.

  • Page 21: Figure 12. System Configuration For Product Introduction

    TangenX® SC TFF Device User Guide Figure 12. System configuration for product introduction Legend Vessel Pump Configuration change Pinch clamp Pressure sensor On; Open flow path Genderless connector Flow meter Off; Closed flow path Scale For full list of symbols and descriptions, see Table 3.

  • Page 22: Optimization

    TangenX® SC TFF Device User Guide Figure 13. System configuration for recirculation mode Legend Vessel Pump Configuration change Pinch clamp Pressure sensor On; Open flow path Genderless connector Flow meter Off; Closed flow path Scale For full list of symbols and descriptions, see Table 8.

  • Page 23: Figure 14. System Configuration For Optimization Studies

    TangenX® SC TFF Device User Guide Figure 14. System configuration for optimization studies Legend Vessel Pump Configuration change Pinch clamp Pressure sensor On; Open flow path Genderless connector Flow meter Off; Closed flow path Scale For full list of symbols and descriptions, see Table 1.

  • Page 24: Process Optimization Data Plotting And Analysis

    TangenX® SC TFF Device User Guide Allow product to recirculate at a low crossflow rate b. If processing is complete, proceed to product recovery (Section 7.6). 7.3.2 Process optimization data plotting and analysis 1. Graph the TMP vs the permeate flux for each crossflow rate (Figure 15).

  • Page 25: Executing Concentration Step

    TangenX® SC TFF Device User Guide Note: Final retentate volume includes hold-up volume in the filter and tubing, as well as the retentate vessel volume (Section 6.4). To compensate for dilution that occurs during product recovery (Section 7.6), you may elect to over-concentrate the material by a proportional amount during the concentration step.

  • Page 26: Diafiltration

    TangenX® SC TFF Device User Guide 7.5 Diafiltration During constant-volume diafiltration, buffer is added to the retentate vessel as material is circulated from the retentate vessel through the filtration device and back to the retentate vessel. Product is retained on the retentate side of the membrane while salts and buffers pass through the membrane to the permeate.

  • Page 27: Stop The Diafiltration Process

    TangenX® SC TFF Device User Guide Figure 18. System configuration for diafiltration Legend Vessel Pump Configuration change Pinch clamp Pressure sensor On; Open flow path Genderless connector Flow meter Off; Closed flow path Scale For full list of symbols and descriptions, see Table 4.

  • Page 28: Product Recovery

    TangenX® SC TFF Device User Guide Figure 19. System configuration for stopping diafiltration Legend Vessel Pump Configuration change Pinch clamp Pressure sensor On; Open flow path Genderless connector Flow meter Off; Closed flow path Scale For full list of symbols and descriptions, see Table 3.

  • Page 29: Figure 20. System Configuration For Product Recovery, Step 2

    TangenX® SC TFF Device User Guide Figure 20. System configuration for product recovery, Step 2 Legend Vessel Pump Configuration change Pinch clamp Pressure sensor On; Open flow path Genderless connector Flow meter Off; Closed flow path Scale For full list of symbols and descriptions, see Table 3.

  • Page 30: Inactivation And Disposal

    TangenX® SC TFF Device User Guide Figure 21. System configuration for product recovery, Step 3 Legend Vessel Pump Configuration change Pinch clamp Pressure sensor On; Open flow path Genderless connector Flow meter Off; Closed flow path Scale For full list of symbols and descriptions, see Table 7.7 Inactivation and disposal The system remains closed if the product outlet clamp is closed prior to removing the recovery vessel to the system.

  • Page 31: Index

    (781) 250-0111 repligen.com © 2023 Repligen Corporation. All rights reserved. The trademarks mentioned herein are the property of Repligen Corporation and/or its affiliate(s) or their respective owners. Document Number:UG-4457 Revision: 1 Effective Date: 9/27/2023 Legacy Document #: N/A Page 31 of 31...

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