REPLIGEN KrosFlo KR2i User Manual

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KrosFlo® KR2i/KMPi
TFF Systems
User Guide
repligen.com
© 2024 Repligen Corporation. All rights reserved. The trademarks mentioned herein
are the property of Repligen Corporation and/or its affiliate(s) or their respective owners.

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Summary of Contents for REPLIGEN KrosFlo KR2i

  • Page 1 KrosFlo® KR2i/KMPi TFF Systems User Guide repligen.com © 2024 Repligen Corporation. All rights reserved. The trademarks mentioned herein are the property of Repligen Corporation and/or its affiliate(s) or their respective owners.
  • 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

    KrosFlo® KR2i/KMPi TFF Systems User Guide Contents 4.3.1 Manual Mode ................................. 12 4.3.2 C Mode ................................... 12 4.3.3 D, C, CD, CDC, CFC Modes .............................. 12 4.3.4 CFC/D/C, CDDC, CDCD modes ............................14 6.1.1 Installation..................................18 6.1.2 KR2i Tubing ..................................20 6.1.3 KR2i Multi-Channel.................................
  • Page 4 KrosFlo® KR2i/KMPi TFF Systems User Guide 12.4.1 KR2i ....................................41 12.4.2 KMPi ....................................42 List of Tables Table 1. Explanation of User Attention Phrases ............................6 Table 2. Safety Precautions ..................................6 Table 3. Instrument Safety Labels ................................7 Table 4. Process Mode Abbreviations ..............................9 Table 5.
  • Page 5 Figure 27. Remote Control Mode ................................30 Figure 28. Internal Control Mode ................................30 Figure 29. KrosFlo KR2i TFF System Cable Connections .......................... 32 Figure 30. KrosFlo KMPi TFF System Cable Connections ........................32 Figure 31. KR2i Auxiliary Component Cable ............................32 Figure 32.
  • Page 6: Table 1. Explanation Of User Attention Phrases

    This User Guide provides detailed instructions for the set up and operation of the KrosFlo® KR2i and KMPi Tangential Flow Filtration (TFF) Systems and auxiliary components. Included are descriptions of potential modes of operation and basic concepts of tangential flow filtration. For questions and further information, please contact your Repligen representative. 2. About This Document This manual uses several different phrases.
  • Page 7: Table 3. Instrument Safety Labels

    KrosFlo® KR2i/KMPi TFF Systems User Guide Table 3. Instrument Safety Labels Symbol Description High voltages exist and are accessible. Use extreme caution when servicing internal components. Danger Remove power from the pump before any cleaning operation is started Warning Remove power from the pump before attempting any maintenance. Tubing breakage may result in fluid being sprayed from pump.
  • Page 8 3. Product Description The KrosFlo KR2i and KMPi TFF Systems enable full automation of both lab-scale (2 mL – 15 L) and large-scale (100 mL – 500 L) ultrafiltration/diafilitration (UF/DF) processes. The menu-driven KF Comm 2 Software monitors and controls runs.
  • Page 9: Table 4. Process Mode Abbreviations

    KrosFlo® KR2i/KMPi TFF Systems User Guide Table 4. Process Mode Abbreviations Abbreviation Description Concentration Concentration/Diafiltration Concentration/Diafiltration/Concentration Constant Feed Concentration CDDC Concentration/Diafiltration/Diafiltration/Concentration CDCD Concentration/Diafiltration/Concentration/Diafiltration Diafiltration Cleaning Flux C Flux concentration Flux CV Flux constant volume Flushing Normalized water permeability Vacuum...
  • Page 10: Table 5. Process Mode Configurations

    UV/Aux and Conductivity/Temp ports 4.3 Process Modes The KrosFlo KR2i and KMPi TFF Systems achieve an unparalleled combination of integration, configurability, and automation through modular, plug-and-play hardware. All components, either directly or indirectly, connect to the main peristaltic pump, which then communicates with the KF Comm 2 Software for control and monitoring.
  • Page 11 KrosFlo® KR2i/KMPi TFF Systems User Guide Figure 1. KR2i Complete System 1. KF Comm 2 Software 6. Automatic Back Pressure Valve (ABV) 2. Base pump 7. Conductivity and/or UV sensor 3. Auxiliary pump 1 8. Hollow fiber filter 4. Feed scale 9.
  • Page 12: Manual Mode

    KrosFlo® KR2i/KMPi TFF Systems User Guide 4.3.1 Manual Mode Manual mode is used to ensure the main pump and auxiliary components are operational and connected or to run the system without automation. From the software, users can start/stop the main pump and auxiliary pump(s), tare scales, calibrate pressure sensors, change tubing sizes, and start/stop manual valve control.
  • Page 13: Table 8. Cdc Mode Example

    KrosFlo® KR2i/KMPi TFF Systems User Guide Table 8. CDC Mode Example Steps Volumes and Factors Concentration 1 (C) Feed weight (kg) Concentration factor 1 (X) Feed weight after concentration 1 (kg) Permeate weight after concentration 1 (kg) Diafiltration (D) Diafiltration volumes (X) 7 (2 kg x 7 = 14 kg total) Feed weight (kg) Permeate weight after diafiltration (kg)
  • Page 14: Cfc/D/C, Cddc, Cdcd Modes

    KrosFlo® KR2i/KMPi TFF Systems User Guide 4. Vacuum feed: Connect to additional feed reservoir. Install a vent on both the additional feed reservoir and buffer reservoir, if performing diafiltration. Ensure that the diafiltration pump head is closed on the tubing between the diafiltration buffer and the feed reservoir. The vacuum feed line will pull the contents of the extra feed reservoir during the concentration function.
  • Page 15: Table 10. Cddc Mode Example

    KrosFlo® KR2i/KMPi TFF Systems User Guide Table 10. CDDC Mode Example Steps Volumes and Factors Concentration 1 (C) Feed weight (kg) Concentration factor 1 (X) Feed weight after Concentration 1 (kg) Permeate weight after Concentration 1 (kg) Diafiltration 1 (D) Diafiltration volumes (kg) 7 (2 kg x 7 = 14 kg total) Feed weight after Diafiltration 1 (kg)
  • Page 16 KrosFlo® KR2i/KMPi TFF Systems User Guide 5. Base Pumps Base pumps are controlled through the KF Comm 2 Software. The LCD screen on the pump face contains arrows and an enter key that are disabled. The alarm acknowledgement button silences audio alarms. The Start/Pause button functions as an emergency stop.
  • Page 17: Table 11. Kr2I Pump Head Specifications

    KrosFlo® KR2i/KMPi TFF Systems User Guide 6. Pump Heads The Easy-Load and High-Performance Pump Heads are designed to be used with the TFF System peristaltic pumps. The pump heads accept several tubing sizes for a wide range of flow rates, and the unique designs and automatic tubing retention allows for quick tubing changes.
  • Page 18: Installation

    KrosFlo® KR2i/KMPi TFF Systems User Guide Typical Flow, Pressure and Vacuum Data—3 RollerPumps Flow Rate Discharge Pressure Vacuum @ Suction lift MasterFlex® L/S® Tubing 600 rpm in @ 600 rpm @ 1 rpm @ 600 rpm Continuous Intermittent (mm) Hg ft (m) H20 mL/Rev mL/min...
  • Page 19 KrosFlo® KR2i/KMPi TFF Systems User Guide Figure 5. Attaching Mounting Plate to Drive Figure 6. Back of Research II Pump Head Figure 7. Position for Engaging Bayonet Feature for Horizontal Mounting...
  • Page 20: Kr2I Tubing

    KrosFlo® KR2i/KMPi TFF Systems User Guide Figure 8. Bayonet Feature Locked in Horizontal Pump Orientation Figure 9. Pump Head in Fully Closed Position Figure 10. Pump Head in Fully Open Position 6.1.2 KR2i Tubing WARNING: Stop the pump drive before installing or removing pump head from the drive. WARNING: Stop the pump drive before installing or removing tubing from the pump head.
  • Page 21: Kr2I Multi-Channel

    KrosFlo® KR2i/KMPi TFF Systems User Guide 1. Insert a loop of tubing into one open tubing retainer, between the occlusion bed and the rollers, and into the other tubing retainer (Figure 11). Position the tubing so that it is firmly centered against the rollers. While holding the tubing ends, move the actuator lever back to the far clockwise (right) position (Figure 9).
  • Page 22: Kr2I Maintenance

    KrosFlo® KR2i/KMPi TFF Systems User Guide Figure 13. Engaging Bayonet of Second Pump Head to Bayonet Tabs on the First Figure 14. Drive With Both Pump Heads Locked in Position CAUTION: Be sure that bayonet features on back of each pump head are fully engaged with bayonet tabs on the mounting plate or adjacent pump head before operating pump drive.
  • Page 23: Table 12. Kmpi Pump Head (A) Specifications

    KrosFlo® KR2i/KMPi TFF Systems User Guide 6.2 KMPi Pump Head Specifications and Installation Table 12. KMPi Pump Head (A) Specifications Number of MasterFlex® I/P® Part Number Roller and Bearing Material Tubing Material Rollers Tubing Norprene, Pharmed, ACM3-H3S-01N Stainless Steel I/P 26, 73, 82 Tygon, Pharmapure Typical Flow, Pressure and Vacuum Data—3 Roller Pumps Flow Rate LPM...
  • Page 24: Installation

    KrosFlo® KR2i/KMPi TFF Systems User Guide Table 13. KMPi Pump Head (B) Specifications MasterFlex® I/P Part Number Roller and Bearing Material Number of Rollers Tubing ACM3-PHP-01N Stainless Steel I/P 70, 88, 89 Typical Flow, Pressure and Vacuum Data—3 Roller Pumps Flow Rate Discharge Pressure Suction...
  • Page 25: Kmpi Tubing

    KrosFlo® KR2i/KMPi TFF Systems User Guide Figure 15. Components of the Easy-Load Pump Head Figure 16. Components of the High-Performance Pump Head 6.2.2 KMPi Tubing 1. Ensure that KMPi is turned off 2. For Easy-Load Pump Head (Figure 17), move KMPi Easy-Load Pump Head lever to the left to open the pump occlusion bed. For High-Performance Pump Head (Figure 18), rotate tubing retainer knob counterclockwise to release retainer, then pull...
  • Page 26: Occlusion Adjustment On Kmpi Easy-Load Pump Head

    KrosFlo® KR2i/KMPi TFF Systems User Guide Figure 18. Loading Tubing into Open Occlusion Bed of High-Performance Pump Head Figure 19. Closing Occlusion Bed of Easy-Load Pump Head Figure 20. Occlusion Knob on Top of Easy-Load Pump Head 6.2.3 Occlusion Adjustment on KMPi Easy-Load Pump Head Use knob on top of KMPi Easy-Load Pump Head to adjust occlusion to suit application (Figure 20).
  • Page 27: Kmpi Multi-Channel

    7.1 Auxiliary Scales The TFF Systems interface with digital scales available in 20, 60, 200, and 600 kg versions. For detailed information on operating scales, refer to product-specific User Guide. Please contact Repligen for additional scale compatibility. 7.1.1 Installation •...
  • Page 28 KrosFlo® KR2i/KMPi TFF Systems User Guide Figure 22. Accessory Pump Tubing Compatibility 7.2.1.1 KR1 Pump (600 RPM) The KR1 remote control setting is found in the KF Comm 2 Software. Tubing sizes and flow rates are identical to KR2i (Table 11).
  • Page 29 KrosFlo® KR2i/KMPi TFF Systems User Guide Figure 24. KR Jr Pump Figure 25. KR Jr Remote Control Mode If the KR Jr is not in remote control mode: Enter Settings Menu Enter Global Options Menu Enter Remote Control Menu Enter Voltage Input Menu :Use up or down arrows to highlight “I”...
  • Page 30 KrosFlo® KR2i/KMPi TFF Systems User Guide Figure 26. KR1 Pump 7.2.1.4 I/P Digital Peristaltic Pump (650 RPM – for KMPi only) The I/P Digital Peristaltic Pump has both internal (Figure 28) and remote (Figure 27) capabilities but should be used in remote control. 1.
  • Page 31: Auxiliary Pump Settings

    KrosFlo® KR2i/KMPi TFF Systems User Guide 7.2.2 Auxiliary Pump Settings The KF Comm 2 Software will control the pumps once the pump type and tubing size are input. Refer to the KF Comm 2 Software User Guide. 7.3 Automatic Backpressure Valve The KrosFlo Automatic Backpressure Valve (ABV) controls a variety of pressure set points during tangential flow filtration processes when used in conjunction with the TFF System.
  • Page 32 KrosFlo® KR2i/KMPi TFF Systems User Guide Figure 29. KrosFlo KR2i TFF System Cable Connections Figure 30. KrosFlo KMPi TFF System Cable Connections Figure 31. KR2i Auxiliary Component Cable Auxiliary Auxiliary Feed scale Permeate Valve Auxiliary Computer...
  • Page 33 KF Comm 2C (21 CFR Part 11 compliance-ready) Ensure that a Super-Admin account has been created and the account holder has received an email from Repligen detailing account information. If email has not been received and needs to be resent, contact Repligen Customer Service (customerserviceus@repligen.com).
  • Page 34 Pumping rate depends on the surface area of the device and molecule shear sensitivity. Recommendations for these flow rates are available in the TFF device User Guides and can also be discussed with the Repligen Field Applications team. Process development experiments will always be recommended to optimize flow rates for your molecule.
  • Page 35: Table 14. Troubleshooting Categories

    KrosFlo® KR2i/KMPi TFF Systems User Guide The TFF System diafiltration function relies upon feedback from both the feed and permeate scales. The TFF System will add buffer to maintain the weight on the feed scale. When the permeate scale reaches the weight required to meet the desired DV, the system will end the diafiltration .
  • Page 36 Auxiliary pump(s) losing Loose/damaged cable connections on pump and connection octopus cable ports. Inspect pins. Contact your Repligen Account Manager, Technical Support Team or Pump not working properly Customer Service for assistance. (other) Refer to pump manufacturer’s manual for additional troubleshooting...
  • Page 37: Kr2I

    All repairs of the system must be performed by a qualified Repligen service engineer. Opening of the system and attempted repair by the user or third party shall void the product warranty.
  • Page 38: Table 17. System Pump Input

    KrosFlo® KR2i/KMPi TFF Systems User Guide Table 17. System Pump Input Description Specifications Supply voltage limits 90 to 260 V @ 50/60 Hz (Universal Input) Current, Maximum 2.2A @ 115 VRMS, or 1.1A @ 230 VRMS Table 18. System Pump Construction Description Weight Dimensions (L ×...
  • Page 39: Kmpi

    KrosFlo® KR2i/KMPi TFF Systems User Guide 12.2.2 KMPi Table 21. KMPi System Pump Output Description Specifications Speed 0.1 to 650 rpm 520 oz-in (37.4 kg•cm) Torque output, Maximum 1560 oz-in Starting Line ±0.1% FS Speed regulation Load ±0.1% FS Drift ±0.1% F.S. Display 128 x 64 LCD w/ LED Backlight Voltage speed...
  • Page 40: Pump Drive, Pump Head, And Integrated Pressure Monitor

    KrosFlo® KR2i/KMPi TFF Systems User Guide Table 24. System Environment Description Specifications Temperature, Operating 0° to 40°C (32° to 104°F) Temperature, Storage –25° to 65°C (–13° to 149°F) Humidity (non-condensing) 10% to 100% Altitude Less than 2000 m Pollution Degree Pollution Degree 3 Noise Level <70dBa @ 1 meter...
  • Page 41: Kr2I

    KrosFlo® KR2i/KMPi TFF Systems User Guide 12.4 System Parts List 12.4.1 KR2i Table 26. KR2i SYR2-U50 Components Component Description Ext Qty Unit of Measure SYR2-U10 KR2i Drive and stand ACPC-U10 0.625” BPCV and dongle ACBT-015-S1N 15 mL Conical bottom reservoir, 3 port ACBT-050-S1N 50 mL Conical bottom reservoir, 4 port ACBT-250-S1N...
  • Page 42: Kmpi

    KrosFlo® KR2i/KMPi TFF Systems User Guide 12.4.2 KMPi Table 28. KMPi SYM3-U30 Components Component Description Ext Qty Unit of Measure SYM3-U10 KMPi DRIVE with octopus cables ACM3-STND KMPi Lab stand 13. List of TangenX Cassette and Device Studies TX1001-POQ-117-R Protein Binding Study 10827-19-3528 SC Gamma Cassette &...
  • Page 43 © 2024 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:[Document::Prefix]-[Document::Number] Revision: [Document::Version] Effective Date: [Document::PublishDate] Legacy Document #: [Metadata::Legacy document number] Page 43 of 43...

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