Table of Contents
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User Guide
Cellicon
Perfusion Solution for Process
TM
Development
The life science business of Merck KGaA, Darmstadt,
Germany operates as MilliporeSigma in the U.S. and Canada.
Contents
Introduction ............................................2
System Components ................................2
Setting Up the System .............................3
Starting the System .................................4
User Interface .........................................4
Settings .................................................7
Running the Pump ...................................7
Alerts .....................................................9
Settings ............................................... 12
Shutdown ............................................. 16
Planning for a Run ................................. 16
Preparation ........................................... 16
Starting a Run....................................... 18
Run Maintenance ................................... 19
Troubleshooting ..................................... 21
Ending the Run ..................................... 22
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Summary of Contents for Merck Milipore Cellicon Perfusion Solution for Process Development
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Page 1: Table Of Contents
Preparation ........... 16 Starting a Run........18 Cellicon Perfusion Solution for Process Run Maintenance ........19 Development Troubleshooting ........21 Ending the Run ........22 The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. and Canada. -
Page 2: Introduction
Cellicon Perfusion Solution for Process Development User Guide Introduction System Components The Cellicon Perfusion Solution for Process The Cellicon Perfusion Solution for Process Development includes a single-use filter and Development includes scalable, single- assembly, a holder for the assembly, a controller, a low-shear centrifugal pump, flowmeter and use filters and controllers that enable seed feed pressure sensor. -
Page 3: Setting Up The System
Cellicon Perfusion Solution for Process Development User Guide Setting Up the System Installing the Filter Refer to System Components image for The system should be set up close to the bioreactor, with cords behind the holder. The reference. controller screen should be easily accessible to the user. Prior to installation, there may be a slight Connecting the Component Cables kink in the feed tubing line between the filter... -
Page 4: Starting The System
Cellicon Perfusion Solution for Process Development User Guide Starting the System User Interface The system must be fully assembled prior to operation, as described The main screen of the system has four regions: Setting Up the System. The filter assembly must be installed and •... - Page 5 Cellicon Perfusion Solution for Process Development User Guide Menu P&ID The P&ID screen displays the components of the system connected Alert Button M Logo User Icon to the bioreactor and the Cellicon Perfusion Solution for Process Development. P2 Retentate Bioreactor Pressure Sensor Filter Control...
- Page 6 Cellicon Perfusion Solution for Process Development User Guide Status Tapping the icons listed in the following table displays the sensor output: The current values, state of the system components and data logging Icon Display switch are displayed here. Pump Speed in RPM Feed flow rate in mL/min Component Indicators Data Logging...
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Page 7: Settings
Cellicon Perfusion Solution for Process Development User Guide Settings Running the Prime System The pump needs to be primed to reduce Pump Selecting an element in the settings menu damage to cells because the design is not will open the screen for that element, positive displacement. - Page 8 Cellicon Perfusion Solution for Process Development User Guide Zero Adjust Control Modes Select from the control region of The pump can be run in either Zero adjust Flow setpoint the main screen. A popup containing options setpoint. Choose the mode using Speed for zero adjustment will appear.
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Page 9: Alerts
Cellicon Perfusion Solution for Process Development User Guide Alerts Alert Bar Selecting the alert bar will display the alert log, where details about previous alerts can be viewed. When an alert is activated, it will appear in the alert bar on the main screen and in the alert log. - Page 10 Cellicon Perfusion Solution for Process Development User Guide Alert Types Alert types indicate the severity of an alert. There are three alert types: Type Color Alarm Type Critical Yellow Warning Blue Notification Alerts The list on the next page shows possible alerts.
- Page 11 Cellicon Perfusion Solution for Process Development User Guide Table of Alerts Alert Full- Alert Alert Full- Alert Alert Description Alert Description Category screen Type Category screen Type Pump not connected TMP: Critical Alarm Low Optional No pump head detected TMP: Warning Alarm Low Never TMP Alarms Pump impellor stabilization...
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Page 12: Settings
Cellicon Perfusion Solution for Process Development User Guide Settings In standby mode, the screensaver shows the A USB drive must be inserted into the controller to start the data logging. Data will be lost if the USB following information: drive is removed prior to ending the data logging. System Settings The logfile is stored as a csv-file to the subfolder/ logs on the USB drive. - Page 13 Cellicon Perfusion Solution for Process Development User Guide Alerts Settings Software Update the Cellicon filter, select Advantaflex, 37 Loading a software package (.levi-file) The low cutoff setting can be specified by This section allows a user to configure how via the USB drive allows the customer to the user.
- Page 14 Cellicon Perfusion Solution for Process Development User Guide Controls Settings Flowmeter Alerts Pressure and TMP Alerts When alerts for Flowmeter 1 are activated, Pressure and TMP alarms can be configured Flow Control the system will take the selected pump to provide an alert when the actual value behavior on flow error (Settings...
- Page 15 Cellicon Perfusion Solution for Process Development User Guide User Accounts Settings Set Permissions for New User The administrator can generate, delete The active user can be changed by selecting and edit user accounts, including password the user account icon in the top right region protection capabilities and rescrict access of the screen and selecting permissions.
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Page 16: Shutdown
Cellicon Perfusion Solution for Process Development User Guide Shutdown Planning for a Preparation Equipment Needs When the power button is pressed a confirmation pop-up will appear. After The following user supplied items may be confirmation, the controller software initiates If possible, the Cellicon Perfusion filter required to execute a perfusion process: the shutdown. - Page 17 Cellicon Perfusion Solution for Process Development User Guide Preparing the Bioreactor Connect the filter to the bioreactor by welding Advantaflex tubing on the assembly. To optimize process efficiency, reduce the holdup of cell culture volume in the recirculation loop outside of the bioreactor by shortening the tubing length between the Cellicon bioreactor and the filter assembly.
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Page 18: Starting A Run
Cellicon Perfusion Solution for Process Development User Guide Starting a Run Operating Parameters angle to remove all bubbles. The bench scale N-1 perfusion filter was 5. Stop external peristaltic pump but leave it designed for N-1 perfusion processes Priming clamped so bubbles do not return to the targeting: feed line. -
Page 19: Run Maintenance
Cellicon Perfusion Solution for Process Development User Guide Run Maintenance 3. Start the perfusate (permeate) pump User inputs a desired flow rate Flow and fill sampling container until the and system will maintain that setpoint appropriate volume is collected. flow rate by adjusting pump RPM. Data Logging User inputs a desired speed in 4. -
Page 20: Troubleshooting
Cellicon Perfusion Solution for Process Development User Guide Troubleshooting 5. Locate a new filter and place it in the holder. System Troubleshooting 6. Use a tubing welder to connect the new filter to the tubing lines that were The following chart can be used to help identify issues related to system operation. designated for feed, retentate, and permeate. - Page 21 Cellicon Perfusion Solution for Process Development User Guide Symptom Corrective Action Symptom Corrective Action Check for cuts, cracks, or damage to assembly Check that crossflow rate is at setpoint Ensure system pressure is less than 5 psi Check system mode, “flow control” vs “speed System leak control”...
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Page 22: Ending The Run
Cellicon Perfusion Solution for Process Development User Guide Ending the Run Disposing of the Filter The filter is completely single use and should be disposed of after use. Follow company procedure for waste disposal. Cleaning the Hardware All parts of the system should be wiped down with a cloth dampened with a 70% ethanol or isopropyl alcohol solution. - Page 23 Phone: 1-800-645-5476 www.sigmaaldrich.com Millipore and Cellicon are trademarks of Merck KGaA, Darmstadt, Germany or its affiliates. All other trademarks are the property of their respective owners. Detailed information on trademarks is available via publicly accessible resources. MK_UG5285EN, Rev 1, 06/2020. © 2020 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.
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