REPLIGEN KrosFlo FS-15 User Manual

Rpm real-time process management system
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KrosFlo
RPM
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User Guide
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© 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.
FS-15
®
DOC0331 eRev. 1.0 8/29/2024

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Summary of Contents for REPLIGEN KrosFlo FS-15

  • Page 1 KrosFlo FS-15 ® System ™ User Guide DOC0331 eRev. 1.0 8/29/2024 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® FS-15 Real-Time Process Management (RPM™) System User Guide Contents 7.8.1 Pump Calibration ................................24 7.8.2 Pressure Sensor Calibration ............................. 24 8.1.1 Installation ..................................26 8.2.1 Installation ..................................26 8.2.2 Auxiliary Pump Settings ..............................26 8.3.1 ABV Installation ................................27 8.3.2 ABV Settings ..................................
  • Page 4 KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide List of tables Table 1. Explanation of user attention phrases............................7 Table 2. Safety precautions ..................................8 Table 3. Performance Specifications ................................9 Table 4. Electrical Input Specifications ..............................10 Table 5. Physical Specifications ................................. 10 Table 6.
  • Page 5 KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide Figure 33. FlowVPX I/O cable connections ..............................37 Figure 34. USB Cable (EC0207) to FlowVPX Head ............................. 38 Figure 35. FlowVPX USB cable (EC0207) to computer ..........................38 Figure 36. VPT OPC Server desktop icon ..............................38 Figure 37.
  • Page 6 Repligen representative. The KrosFlo FS-15 RPM System integrates the functionality of the FS-15 tangential flow filtration (TFF) system and the CTech™ FlowVPX® in-line spectrophotometer, which provides real-time concentration monitoring and control. The TFF system is designed for flat sheet membrane and hollow fiber, single-use applications.
  • Page 7: About This Document

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide 2. 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 WARNING! Warns users that serious physical injury can result if warning precautions are not heeded. PRECAUTION Cautions users of potential physical injury or equipment damage if the information is not heeded.
  • Page 8: Table 2. Safety Precautions

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide 3. Safety precautions Table 2. Safety precautions Symbol Description High voltages exist and are accessible. Use extreme caution when servicing internal components. Remove power Danger from the pump before any cleaning operation is started. To avoid electrical shock, the power cord protective grounding conductor must be Warning connected to the ground.
  • Page 9: System Specifications

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide 4. System Specifications The tables below outline the performance specifications, electrical requirements, physical attributes, environmental considerations, and compliance information of the major system components. Tubing specifications can be found in section 8. Table 3.
  • Page 10: Table 4. Electrical Input Specifications

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide UV Sensor Maximum Zero Shift <2% of full scale (<0.040 AU) UV Sensor Long-term Output Drift <5% per month of full scale (<0.100 AU) Table 4. Electrical Input Specifications Specification Value FS-15 TFF System Input Power 250 W...
  • Page 11: Table 6. Environmental Specifications

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide Weight 1.6 kg Housing Materials Powder-coated aluminum, urethane Table 6. Environmental Specifications Specification Value FS-15 TFF System Enclosure Rating IP33 Operating Temperature 4 to 40°C (39 to 104°F) Storage Temperature -25 to 65°C (-13 to 149°F) Humidity (non-condensing) 10%–85% Altitude...
  • Page 12: Table 8. Computer Specifications: Included Tablet

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide Conforms to ANSI/UL Std 61010-1 Certified to CAN/CSA Std C22.2 No. 61010-1 This product has been tested to the requirements of CAN/CSA-C22.2 No. 61010-1 second edition, including Amendment 1, or a later version of the same standard incorporating the same level of testing requirements.
  • Page 13: System Configuration And Major Components

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide 5. System Configuration and Major Components See the following page for illustrations of the system components. Table 9. System Parts List Item Quantity TFF System Components Base pump with QF150SU EZ head Component communication cable, 31 pin (octopus cable 1 of 2) –...
  • Page 14 KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide FlowVPX System Suitability Adapter (XSA) FlowVPX XSA Fibrette VPT Quick Check Tools Detector Validation Adapter (DVA) Transmission Tool (Cary 60) Shortened Fused Silica Sample Vessel, 13 mm ID 16 mm OD 15 mm Tall Sample Vessel Holder, Large Cables (left to right, top to bottom) FlowVPX Extender Power Cable...
  • Page 15 KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide DOC0331 eRev. 1.0 8/29/2024...
  • Page 16 KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide DOC0331 eRev. 1.0 8/29/2024...
  • Page 17 KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide DOC0331 eRev. 1.0 8/29/2024...
  • Page 18: Table 10. Materials Of Construction

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide 6. Materials of Construction Table 10. Materials of Construction Contact Surface Material KR2i TFF System Process Contact Surfaces Tubing / Reservoir Closures C-Flex® / Pharmapure® Reservoirs Polypropylene Disposable Pressure Transducers Polysulfone Plastic Fittings Polypropylene / Polysulfone FlowVPX System Process Contact Surfaces...
  • Page 19: Setup And Operation

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide 7. Setup and Operation Basic Setup Note: See sections 7.2 through 7.7 for example configurations. Figure 1. System space requirements 1. Mount the FS-15 main pump on a flat, horizontal surface with the pump head attached (see chapter 8 for pump head installation details).
  • Page 20: Figure 2. Fs-15 Main Pump Electrical Connections

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide Figure 2. FS-15 Main Pump Electrical Connections Component Communication Cable Pressure Sensors Communication Cable Power Cable Note: Valves, cables, and the computer are intentionally left out of the diagrams below for visual clarity. Manual Mode Setup Figure 3.
  • Page 21: Figure 4. Concentration Mode (C Mode) Setup Configuration

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide Concentration Mode (C Mode) Setup Figure 4. Concentration Mode (C Mode) setup configuration. Cassette Filter Permeate Module Reservoir Feed Reservoir VPT Device FS-15 Pump Permeate Scale (FlowVPX) 1. Auxiliary Scales Connect scale to the Auxiliary Component Cable’s “Permeate Scale”. C/D and C/D/C Mode Setup Note: Permeate Pump is optional and shown in the diagram as an example for applications that require permeate control.
  • Page 22: Figure 6. C/D/D/C Mode Setup Configuration

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide b. Connect Auxiliary pump power cables(s). 2. Auxiliary Scales Connect first scale to the Auxiliary Component Cable’s “Feed Scale” port and second scale to the Auxiliary Component Cable’s “Permeate Scale” port. C/D/D/C Mode Setup Figure 6.
  • Page 23: Figure 7. Cfc Mode Setup Configuration

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide Figure 7. CFC Mode setup configuration Extra Feed Reservoir Cassette Filter Module Permeate Reservoir Feed Reservoir Extra Feed Pump Feed VPT Device Permeate Pump Permeate FS-15 Pump (Auxiliary Pump 1) Scale (FlowVPX) (Auxiliary Pump 2) Scale...
  • Page 24: Pump Calibration

    Note: Pressure sensor calibration requires an additional tool to independently maintain and measure pressure. Pressure sensor calibration should only be performed by a Repligen representative during system qualification and maintenance services. 1. Connect a hand pump manifold with calibrated pressure gauge in line with the Feed pressure sensor.
  • Page 25 12. Set the pressure to 15 psi again, followed by 45 psi, and lastly 60 psi. Confirm that the gauge reading and the FS-15 system reading are within the allowed tolerance. If not, repeat this process starting from step 6. If the calibration process fails a second time, contact Repligen support. 13. Repeat this entire process for all three pressure sensors.
  • Page 26: Auxiliary Component Setup And Operation

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide 8. Auxiliary Component Setup and Operation Auxiliary Scales The TFF systems interface with digital load cell auxiliary scales. These scales are dynamic instruments suitable for various TFF processes. For detailed information on the scales, refer to the scale manufacturer's user manual. 8.1.1 Installation 1.
  • Page 27: Abv Installation

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide In order for the TFF system to control the Auxiliary Pumps properly, enter the Auxiliary Pump type and the tubing size in the RPM software. For further information on Auxiliary Pump functionality, including operation outside of remote control mode, please refer to the manufacturer's manual.
  • Page 28: Basic Setup

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide Single-use Conductivity/Temperature Flow Path Components Combination Conductivity and Temperature in-line flow path sensors; made of Polysulfone and in assorted hose barb sizes. Optional: UV Photometer Available in either 260 nm or 280 nm models; consists of 2 fiber optic cables, 2 optical couplers to connect to flow cell, and power supply.
  • Page 29: Maintenance

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide When a conductivity set-point is entered, the system will stop the sequence when the value is reached. The system will only track in the linear range either positive or negative from the starting conductivity. UV Sensor For UV alarms, the sensors are usually placed on the permeate line to detect sample breakthrough.
  • Page 30: Pump Head Replacement

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide 9. Pump Head Replacement The FS-15 pump head must be replaced periodically depending on the user’s application and requirements. Follow the steps below to remove the old pump head and install a new one. 1.
  • Page 31: Figure 16. Attach The New Pump Head

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide 5. Take the new pump head and align the guide pins with the appropriate holes. Slide the pump head along the pins and push it firmly against the pump head mount. Figure 16.
  • Page 32: Connecting The Flowvpx Head To The Flowvpx Standard Mount

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide 10. FlowVPX Instrument Setup Figure 18. CTech FlowVPX instrument 10.1 Installation and Basic Setup 10.1.1 Connecting the FlowVPX Head to the FlowVPX Standard Mount 1. Turn the FlowVPX Head on its face (logo side down) so that the two mounting holes are facing up (see Figure 19). Figure 19.
  • Page 33: Figure 21. 5 Mm Ball End Driver

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide 3. Insert the mount clamp screws. Tighten with the provided 5 mm ball end driver (Figure 21). Figure 21. 5 mm Ball End Driver 4. Install the Clamp Handle from the right side of the Standard Mount Clamp (Figure 22). Figure 22.
  • Page 34: Figure 25. Install Flowvpx Head On Mounting Post

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide 7. Pick up the FlowVPX Head and align the hole in the clamp with the mounting post. Ensure the flattened location on the post aligns with the flattened area on the clamp (Figure 25). Figure 25.
  • Page 35: Connecting The Flowvpx Instrument To The Cary 60 Spectrophotometer And Computer

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide 10.1.2 Connecting the FlowVPX Instrument to the Cary 60 Spectrophotometer and Computer 1. Pass the Detector Cable (EC0196) and the Delivery Fiber (SMA/hex-nut end) through the open accessory port at the back of the Cary 60 spectrophotometer into the sample compartment (Figure 28).
  • Page 36: Figure 30. Cary 60 Power Cable And Usb Cable, Back Panel

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide Figure 30. Cary 60 power cable and USB cable, back panel 5. Connect the SMA end of the Delivery Fiber to the threaded splice bushing at the back of the Fiber Optic Coupler (Figure 31). Use the hex nut to securely tighten the connection.
  • Page 37: Table 12. I/O External Cable Pin Assignments

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide Figure 33. FlowVPX I/O cable connections WARNING: Explosion hazard for hazardous locations. Do not connect or disconnect any cabling while energized. 8. If using I/O connections, connect the I/O External Cable (EC0214) to the DAQ device. Pin assignments are given in Table 12. Table 12.
  • Page 38: Loading The Flow Cell

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide Figure 34. USB Cable (EC0207) to FlowVPX Head 9. Connect the USB cable (EC0207) to the USB communications connector on top of the FlowVPX® Head (Figure 34). 10. Connect the FlowVPX USB cable (EC0207) to a USB port on the computer (Figure 35). Make sure the computer is turned on. Figure 35.
  • Page 39: Figure 37. Vpt Opc Server

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide Figure 37. VPT OPC Server 2. Once diagnostics have been completed, open KrosFlo RPM Software and login using proper credentials. 3. Within the software, navigate to the blue-ribbon menu and open the Analytics drop-down menu. Click VPT Device. Figure 38.
  • Page 40: Figure 40. Vpt Device Serial Number

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide 5. After clicking Connect, ensure that the serial number from the VPT device matches the serial number found by KrosFlo RPM Software (Figure 40). Figure 40. VPT Device Serial Number 6. Scroll to Flow Cell and click Load Flow Cell. Figure 41.
  • Page 41: Unloading The Flow Cell

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide Figure 43. Loading Flow Cell instructions 9. Upon completing the loading of the flow cell, the pop-up window will automatically close and return to the previous VPT Device menu. The serial number and flow cell name will automatically populate under the Loaded Flow Cell Serial Number and Loaded Flow Cell Name fields, respectively.
  • Page 42: Figure 46. Unloading Flow Cell Instructions

    KrosFlo® FS-15 Real-Time Process Management (RPM™) System User Guide Figure 46. Unloading Flow Cell instructions 4. Upon completion of unloading the flow cell, the pop-up window will automatically close and return to the previous VPT Device menu. The serial number and flow cell name will be removed automatically. DOC0331 eRev.
  • Page 43: Figure 47. Vpt Opc Server Desktop Icon

    User Guide 11. Software The KrosFlo FS-15 RPM System is controlled using software that can be installed either on the provided tablet or on a computer provided by the customer. The provided tablet is fully unlocked to the end user.
  • Page 44: Figure 49. Fs-15 Tube Set

    12.1 Tubing Guidelines The KrosFlo FS-15 System is designed to accommodate high-pressure applications up to pressures of 4 bar (58 PSI) with use of the specified ProConnex flow paths. To ensure safe operation, it is important to adhere to the following guidelines: •...
  • Page 45 12.4 Reinforced Feed Tube Set This tube set is one of two reinforced flow path sections required for high-pressure operation. Repligen recommends that the pressure transducers be located nearest the cassette filter holder for the most accurate representation of cassette pressure profile.
  • Page 46 Filter membranes differentiate components based on size: components larger than the membrane pore are held back by the membrane, while smaller components pass through the membrane structure along with the permeate. Repligen’s hollow fiber TFF modules are designed for pressure-driven applications, though there are other methods for driving the separation process.
  • Page 47: Table 13. Troubleshooting

    Ensure concentration vessel is properly mixed; consistent with off-line Process fluid not homogenic recommendation is using a magnetic mixer or stir bar in the measurements feed tank when possible. For further Technical Assistance, please contact Repligen at analytics-support@repligen.com or (908) 707-1009. DOC0331 eRev. 1.0 8/29/2024...
  • Page 48: Customer Service

    Repligen Corporation 685 Route 202/206 Bridgewater, NJ 08807 analytics-support@repligen.com (908) 707-1009 DOC0331 eRev. 1.0 8/29/2024 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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