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REPLIGEN XCell Lab XC-LAB-D, User Manual

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REPLIGEN XCell Lab XC-LAB-D User Manual Download Page 47

 

  

 

XCell™ Lab Controller 

User Guide 

 

 

47          repligen.com           XC-LAB-UG-V4 

8.

 

Running the system  

This section provides general guidelines for starting up and operating a bioreactor and XCell ATF® 

Device.  

 

8.1

 

Process workflow 

Figure 43. Workflow for a typical ATF start-up process. 

 

 

  

8.2

 

Selection of ATF flow rates 

Generally, higher ATF flow rates increase backflush efficiency and extend filter life. However, the 
optimum ATF rate depends on the cell line requirements. 
 
 

Summary of Contents for XCell Lab XC-LAB-D

Page 1: ...1 XC LAB UG V4 XCell Lab Controller User Guide PLC Software Version 1 00 HMI Software Version 1 11 Surface Pro SP7 Windows Version 10 Pro 20H2 Devices supported XCell ATF 1 2 and 4 ...

Page 2: ...ental or consequential damages in connection with the furnishing performance or use of this material No part of this document may be photocopied reproduced or translated to another language without the prior written consent of Repligen Corporation Products are not intended for diagnostic or therapeutic use or in vivo with humans or animals For further information please contact Repligen Corporatio...

Page 3: ...and stopping an XCell ATF Device 28 7 8 3 Pump status box 28 7 8 4 Dual mode 29 7 8 5 ATF displacement volume pop up window 32 7 8 6 ATF pressure pop up window 32 7 8 7 Settings sub menu 33 7 8 8 XCell ATF Device configuration 33 7 8 9 Bioreactor configuration 34 7 8 10 Default configuration ATF pump settings 34 7 8 11 General configuration 35 7 8 12 Service performance screen 36 7 8 13 Logon requ...

Page 4: ... configuration 40 7 11 3 Displacement volume alarm configuration 41 7 11 4 System alarm configuration 41 7 11 5 Permeate P3 pressure alarm configuration 42 7 12 1 Historian Client Software 43 7 12 2 Trend 43 7 12 3 Query Tool 44 7 12 4 Exporting data to Excel 44 14 2 1 Changing usernames and passwords 61 ...

Page 5: ...utilities 15 Figure 5 Face A of Controller 17 Figure 6 Face B of Controller 17 Figure 7 SAPA components example 19 Figure 8 Touchscreen splash display example 21 Figure 9 Login screen example 22 Figure 10 Overview SCADA screen example 22 Figure 11 Menu bar example 24 Figure 12 User information 24 Figure 13 ATF main screen example two XCell ATF Devices attached to same vessel 25 Figure 14 Example 2...

Page 6: ...e 40 Columns pane subset of the Query window 45 Figure 41 Query set up 45 Figure 42 Help feature 46 Figure 43 Workflow for a typical ATF start up process 47 Figure 44 Control Panel network and sharing center 56 Figure 45 Control Panel s network adapter properties 56 Figure 46 Windows 10 network adapter TCP IPv4 properties 57 Figure 47 Default values for ATF Pump Configuration 66 Figure 48 Default ...

Page 7: ...Engineer HFM Hollow Fiber Module HMI Human Machine Interface Hz Hertz ID Inner diameter I O Input output kg Kilograms L Liter lbs Pounds LPM Liters per minute mA Milliamp mL Milliliter mV Millivolt NPT National pipe thread OD Outer diameter OSI Open systems interconnection PCV Pressure control valve PID Proportional integral and derivative PLC Programmable logic controller POI Product of interest ...

Page 8: ...ide XCell Lab Controller User Guide 8 XC LAB UG V4 TCP IP Transmission control protocol Internet protocol UF Ultrafiltration VCD Viable cell density VDC Volt direct current VT Volumetric throughput VVD Vessel volume exchange per day ...

Page 9: ...ller and software updates are made on a regular basis For the latest version of this document please visit the Repligen website Installation by a trained Repligen Field Service Engineer FSE is highly recommended 2 Welcome Thank you for choosing the XCell Lab Controller for your laboratory and cell culture intensification needs This next generation system provides proven upstream intensification pe...

Page 10: ...u must use the Supply Air Protection Assembly SAPA on your air source to ensure air is brought to a safe pressure and suitably filtered to ensure pump functionality Vessels or bioreactors should not be pressurized unless otherwise specified by the manufacturer Glass and single use bags can explode if pressurized When using any vessel or bioreactor be sure to maintain an unrestricted vent or exhaus...

Page 11: ... electrical pneumatic or signal connections are made when system is moved Wear standard laboratory PPE including lab coat protective eye wear and gloves Air and vacuum XCell Lab Controller requires pneumatic connections of positive air pressure and vacuum using Repligen provided hoses with safety quick connectors Positive air pressure tubing is colored red while vacuum tubing is colored blue The c...

Page 12: ...j To supply power to the controller connect the 24 V adaptor to the wall power source k Turn on the controller and tablet By default no logon credentials are required for the tablet The XCell Lab Software opens with the Supervisor account and displays the Overview screen 5 2 Software set up Please note the following The newly designed software interface allows you to make real time changes to the ...

Page 13: ...of XCell ATF intensified cell culture processes For support or troubleshooting please contact your local FAS A preventative maintenance PM contract ensures continued operation of the system at optimal performance levels The pneumatic parts that are connected to the controller and SAPA should always remain free of dust and particles Refer to Section 4 for additional safety precautions 6 1 Alternati...

Page 14: ...iber filter during each pump stroke The section of the hollow fiber experiencing the negative pressure and the consequential backflush depends on the direction of the pump stroke Backflush effectively reduces or eliminates filter fouling by displacing material from the lumen wall Incorrect ATF operation with insufficient pump displacement and or low ATF flow rates create reduced levels of backflus...

Page 15: ...w rate over the course of each stroke Generally you do not need to consider the Instantaneous Flow Rate except during troubleshooting A well controlled XCell ATF Device will have the following flow rate properties achieves maximum flow quickly switches smoothly between strokes minimal to no delay between strokes referred to as the Dwell Time maximum liquid displacement during strokes referred to a...

Page 16: ...essure P3 Single Use XCell ATF 1 Single Use XCell ATF 2 Autoclavable XCell ATF 2 Autoclavable XCell ATF 4 If monitoring filter fouling and permeate pressure is important to your process then you should consider purchasing the D P model as this feature is not available on the S and D models If you purchase an S model you will not be able to upgrade your controller to a D model The controller is pow...

Page 17: ...XCell Lab Controller User Guide 17 repligen com XC LAB UG V4 Figure 5 Face A of Controller Figure 6 Face B of Controller 1 2 3 4 5 7 8 9 6 ...

Page 18: ... XCell ATF Device Pressure 16 and flow 14 sensor ports carry data from the device mounted sensor to the controller An ethernet port 15 transfers data to a tablet for viewing processing and analysis Like Face A some ports of Face B are not used in the current model The software interface is accessed through a Surface Pro tablet provided in a protective case The tablet may be mounted directly on the...

Page 19: ...e required to operate XCell ATF 1 XCell ATF 2 and XCell ATF 4 do not adjust 4 Pressure relief valve Factory set air supply pressure relief valve set to relieve if inlet pressure exceeds the specification noted above do not adjust 5 Positive pressure supply manifold Pressurized air to XCell Lab Controller s 6 Manifold outlets Distributes air pressure to up to four XCell Lab Controllers The SAPA nor...

Page 20: ...ration of the tablet into a network in any way Please see Appendix B for further details 6 9 1 Windows environment The Surface Pro comes with Windows 10 Pro installed The user bears full responsibility for modifications to the software system These software changes include but are not limited to Windows software updates anti virus applications and Microsoft Office products While we do not expect a...

Page 21: ...input and easy navigation between different screens A touchpad is also provided for use with the Query and Trend Tools for executing more complicated and advanced selections 7 2 Initial startup The tablet will boot directly into the XCell Lab Software program and display the splash screen below Figure 8 when switched on Login to Windows is not required To add a Windows login please see Appendix B ...

Page 22: ...e and password Default usernames and passwords are in listed in Table 8 Table 8 Preset usernames and passwords Username Password Opr 1234 Eng 1234 Super 1234 7 4 Overview SCADA screen Figure 10 Overview SCADA screen example The Overview screen displays the connectivity of several controllers and devices Figure 10 Currently the XCell Lab Software manages one controller up to two devices per tablet ...

Page 23: ...ave a colored background such as some Process Values or a grey background such as fixed dimensions of a filter shear rate or values for informational purposes only Close pop ups by selecting X in the top right corner of the screen Device start pause and stop features are highlighted green yellow and red respectively when active Note Some options may be greyed out or missing from your software vers...

Page 24: ...ll ATF Devices This screen enables access and modification of ATF size and type bioreactor settings engineering units run time and service information 4 Trends Button Displays data trends and plots 5 Alarms Button Displays historical alarms and settings for alarm set up 6 Logon User Button If security is enabled the logon sub menu displays username and role If security is disabled then Logon Not R...

Page 25: ...specified in Settings Note The ATF DUAL box is only displayed when it is possible to run in dual mode i e two same sized XCell ATF Devices on one bioreactor and includes the synchronization mode of the pumps In independent mode grey dotted lines appear from the ATF Flow box to the Pump Status box Figure 13 In synchronized mode grey dotted lines appear from the ATF DUAL box to the Pump Status box F...

Page 26: ...ple 2 synchronized XCell ATF Devices attached to the same bioreactor Note When an XCell ATF Device is not running the ATF Flow displays a zero value and the corresponding All Pause button is greyed out Figure 15 Figure 15 Example 2 XCell ATF Devices attached to two bioreactors ...

Page 27: ...ATF Device will display one XCell ATF Device and one bioreactor Figure 16 7 8 Pop ups Figure 17 ATF Flow pop up example A dedicated Pop up that contains more detailed information exists for each process variable colored boxes For example the ATF Flow Pop Up displays the ATF Flow Rate PV and SP the Instantaneous Flow Rate Shear rate SP and a chart Figure 17 When two devices are connected to the con...

Page 28: ...Pause button on ATF Main screen Each All Pause button pauses one ATF in independent mode and both ATFs in dual mode 3 Press the appropriate Device PAUSE button on the controller The buttons on the hardware match the functionality of those on the software A Pause is typically used mid run for instance to change out an XCell ATF Device or to adjust something momentarily before continuing as before I...

Page 29: ... button has been pressed either on the HMI or on the side of the controller Pressurizing The controller is performing the P stroke i e pressurizing the diaphragm and moving it up displacing liquid into the vessel Exhausting The controller is performing the E stroke i e exhausting the diaphragm and moving it down displacing liquid into the ATF pump 7 8 4 Dual mode XCell ATF D and D P controller mod...

Page 30: ...ssure and exhaust strokes of both XCellATF Devices occure in an altenating fashion This is useful to keep a bioreactor volume constant when running two XCell ATF Devices on one bioreactor and is used most frequently Note When two ATFs run independently the set points can be adjusted in their respective ATF Flow A or ATF Flow B pop ups When the two ATFs are run In Phase or Out of Phase ATF Flow set...

Page 31: ...ress Pause 5 Software Press the All Pause buttons on ATF Main screenn to pause the respective ATF unit A or B to pause For example if the all pause was pressed for ATF B while running in independent mode then ATF B is paused and ATF A continues to run Hardware Press either Pause button on controller Face B Figure 6 Stop Press Stop on the ATF Flow pop up Upon re start the controller starts without ...

Page 32: ...P2 and the PCV Set point for P2 PCV commanded value You may change the units of the values displayed on the ATF Pressure pop up and the ATF Main Screen in the Settings menu but the values logged into the Historian are always mbar which is shown at the top of the pop up P3 pressure is typically either zero or negative As permeate flow increases the pressure P3 drops If the filter starts to foul P3 ...

Page 33: ...ensor The XCell ATF Device configuration sub menu Figure 23 allows selection of the XCell ATF Device s with a single click Selection of a device opens default values and displays an image of the chosen device To run only one device with the D or D P controller models select NONE for the other device and the graphic will be removed from the device image appears blank The ATF Main screen will be upd...

Page 34: ...ump settings example The Default Configuration menu Figure 25 displays the ATF pump settings which includes expected pump displacement minimum flow maximum flow and default flow These settings can be changed by clicking the relevant box and entering in a new value Default flow represents the most frequently edited parameter and is typically set to the flow rate used in most of your processes A Sup...

Page 35: ...he displayed units can be changed by the user but the permanent logged data cannot Auto logout is turned off by default It is the preferred default setting for a Lab environment If you have multiple users in the facility and are concerned about accidental changes we would advise you to turn on this security feature by choosing 1 Minute or 10 Minutes Enabling auto logout requires the use of a passw...

Page 36: ...rvice Number of cycles completed since the last preventative maintenance or service or calibration Yes only by Repligen FSE Lifetime Number of cycles performed by the controller during its lifetime No 7 8 13 Logon required security on off If the Logon Required box Figure 27 is left unchecked no password is required and each user has equal and full access equivalent to a Supervisor level to the XCe...

Page 37: ...orking satisfactorily Note for control engineers A suitable comparison would be to consider the algorithm to be a series or matrix of PID algorithms combined in some interrelated relationship throughout the pump cycle with the calculations or conclusions from these interactions displayed here Tuning the algorithm is non trivial You can display one or both algorithm pop ups at the same time and eas...

Page 38: ...re predetermined and cannot be modified Data can be displayed and analyzed by going back in time for a selected time interval To explore a variety of time intervals click SHOW OPTIONS All available time intervals are displayed at the bottom of the screen and can be selected by clicking the appropriate button which then appears blue when active As an example Figure 30 displays data in a window of t...

Page 39: ...wed by the user at their convenience when this icon is displayed If an alarm is active a red box will surround the displayed variable As an example an alarm for Displacement Volume on ATF A is shown in Figure 31 Figure 32 Alarm status Pressing the Alarm menu opens the Alarm screen Figure 32 Alarms are displayed until acknowledged by the user Table 14 explains the alarm status messages you may enco...

Page 40: ...he time the alarm is set Flow alarms are compared to the flow set point Alarms are triggered when the flow set point is exceeded or reduced by the specified limits For example Figure 33 if the ATF Flow has a Setpoint of 0 7 LPM then the Hi 10 and HiHi 25 alarms would be triggered when the ATF Flow PV is 0 77 LPM and 0 875 LPM respectively The Hi and Lo triggers are set at 10 in this example If the...

Page 41: ...imilar to ATF Flow Like ATF Flow the values on the selections apply to all ATF sizes and formats the controller can operate Figure 34 Displacement volume alarm example 7 11 4 System alarm configuration Figure 35 System alarms example Two System Alarms are available in the Systems Alarms tab Figure 35 vacuum and flow sensor Neither the system alarm itself nor the triggered action may be disabled by...

Page 42: ...s used Our recommendation is to set the Lo at a point where for one specific process it would trigger a Light and or a Horn warning at the first indication of filter fouling Indications of fouling can be documented during development runs by sampling between the retentate and the permeate streams The P3 alarm indicates the point where swapping should be considered The LoLo alarm may then be set to...

Page 43: ... time and historical data Historian combines the power and flexibility of a Microsoft SQL Server with the high speed acquisition and efficient data compression characteristics of a real time system The Historian enables queries that can retrieve relevant data more efficiently from the database Historian is stored locally no remote access is allowed 7 12 2 Trend Figure 38 Trend screen example Statu...

Page 44: ...r you For example the tags are pre loaded and the screen layout has been optimized for viewing Trend supports two different chart types a regular trend curve and an XY scatter plot Multiple plot configuration and display options are available Figure 38 and it is easy to save preferred layouts for future use For more information on using tag picker and time picker tools please see Section 7 12 7 12...

Page 45: ... or by manually entering it Figure 41 Figure 41 Query set up Loading each new tag takes time To speed up the process set up a quick query by selecting a short time interval say 5 minutes followed by selection of multiple tags and then increasing the time interval to the desired duration Press the Save button select a filename and specify the storage location for your data Copy data from the Surfac...

Page 46: ...he Help Contents section Figure 42 offers a good resource to learn more about Trend Query and Historian applications For information on using the tag picker and the time picker tools please see Common Client Components To show or hide toolbars or components use the corresponding commands in the View menu ...

Page 47: ... for starting up and operating a bioreactor and XCell ATF Device 8 1 Process workflow Figure 43 Workflow for a typical ATF start up process 8 2 Selection of ATF flow rates Generally higher ATF flow rates increase backflush efficiency and extend filter life However the optimum ATF rate depends on the cell line requirements ...

Page 48: ...1 High Productivity Harvest 50 150 1 N 1 Perfusion or Cell Expansion 50 100 1 Short Duration Diafiltration 10 50 1 Rapid Media Exchange Clarification or Cell Concentration 10 50 1 Note Many factors influence the optimum ATF Rate as well as the ratio The default settings work for most applications but please feel free to contact your local FAS to discuss your unique process needs 9 Troubleshooting ...

Page 49: ...Device can be lowered slightly and the ATF Flow can be increased for several minutes before returning values to their baseline levels To avoid large air bubbles place the dip tube or entry point for the A2B line as far away from the sparger as possible Small bubbles even if numerous should not impact sensor or controller performance Permeate flow too low or negligible Upon first starting the perme...

Page 50: ...ual preventative maintenance is strongly advised to ensure equipment stays in prime condition and that performance is not affected Failure to do so could lead to detrimental cell culture results 10 1 Ongoing service and support Repligen provides a range of service and support options to ensure your system is reliable and performs optimally Preventative Maintenance PM Comprehensive Service Contract...

Page 51: ...1 barbed 3mm OD 200mm length B DIP 3 200 Dip tube for XCell ATF 2 TC 1 4 ID 250mm length TC DIP LAB 25 5 250 Dip tube for XCell ATF 4 250mm L Tri clamp Top TC DIP 10 250 Dip tube for XCell ATF 4 450mm L Tri clamp Top TC DIP 10 450 HP for XCell ATF 2 M10 fitting HP M10 25 HP for XCell ATF 2 PG13 5 fitting HP PG13 5 25 Flow Sensor for XCell ATF 1 FS 1 Flow Sensor for XCell ATF 2 FS 2 Flow Sensor for...

Page 52: ... ATF 2 A2C line F AIR2 Air Filter ATF4 6 A2C line F AIR1 Pressure sensor kit for steel XCell ATF 2 SSATF2 PSK V2 Pressure sensor kit for steel XCell ATF 4 SSATF4 PSK V2 Autoclavable A2B tubing kit for XCell ATF 4 TCs ATF4 A2B TC Autoclavable A2B tubing kit for XCell ATF 4 TC AseptiQuik ATF4 A2B TCAQ Half SIP A2B valving kit for XCell ATF 4 GMP ATF4 CHV2 GMP Full SIP A2B valving kit for XCell ATF 4...

Page 53: ...ent internal SAPA filter XC LAB SAPA FLTR A2C tubeset kit 1x XCell ATF 1 2 4 XC LAB A2C TK XCell Lab utility tubeset XC LAB UTILITY TK Power supply kit for XCell Lab Controller XC LAB PWR RJ45 to USB Converter XC LAB HMI USB RJ45 RJ45 to M12 Ethernet cable CA ETH RJ45 M12 Kit spare parts for XCell ATF 2 KIT A2 SVC1 Kit spare parts for XCell ATF 4 KIT A4 SVC1 Assy Air Inlet XCell ATF 2 ATF2 AIR ASS...

Page 54: ...q ft Filtration Area SV SPR 3000995 Microprocessor Board IO C110M SV SPR CS 10748 CA 24VDC to Compactlogix L19 V terminal SV SPR CS 11055 CA 24VDC to Compactlogix L19 FP terminal SV SPR CS 11056 CA PLC to Sonalert Buzzer SV SPR CS 11058 CA PLC 1 to Modbus Terminals SV SPR CS 11104 CA PLC 2 to Modbus Terminals SV SPR CS 11105 CA Enfield PRV01 to IO Bd Port PRV1 SV SPR CS 11106 CA Enfield PRV01 to I...

Page 55: ...bility built in but is not used by the XCell Lab software Connection to a corporate network a remote DCS supervisory monitoring and control system or domain management of tablet or mapped drives is not recommended or supported Note At shipping the controller and Surface Pro are issued with the IP addresses 192 168 1 101 and 192 168 1 167 respectively The HMI is configured to look for these address...

Page 56: ...rnet Protocol Version 6 TCP IPv6 if it is checked 7 Select Highlight the Internet Protocol Version 4 TCP IPv4 option 8 Click the Properties button Figure 45 Control Panel s network adapter properties 9 Select the Use the following IP address option 10 Set the IP address 192 168 1 167 11 Press the Tab key 12 Set the Subnet mask Confirm the subnet mask is 255 255 255 0 13 Leave the Default gateway a...

Page 57: ...n com XC LAB UG V4 Figure 46 Windows 10 network adapter TCP IPv4 properties 16 Click the Close button again Once you complete the steps you can navigate back to the XCell Lab Software and test the new configuration to see if it works correctly ...

Page 58: ...hragm displacement volume System adjusts the pressure curve to try to attain the setpoint A2B Flow Sensor Communication Error One of the A2B flow sensors are not communicating usually due to a disconnected cable If the system is not running it will not be able to start process if the system is running when this alarm occurs the system maintains running at current setpoint with no feedback changes ...

Page 59: ... will be locked and not allowed to increase Initialization Error The initialization process does not complete successfully Cannot start process when caused by inadequate pressure supply when caused by flow sensors the default flow values will be used Filter B Flow not Meeting Setpoint The average flow after 40 consecutive cycles is less than 90 of the setpoint System adjusts the pressure curve to ...

Page 60: ...change any Windows administrator settings you would never need to manually log in to Windows Login 0Admin Operating System Admin is required to modify existing XCell Lab Software usernames or passwords or add new ones It is recommended that a qualified IT or Repligen engineer carries out these tasks 0Admin does not have the same functionality within the XCell Lab Software as Users The two Windows ...

Page 61: ... how to create a user account also applies to deleting and managing accounts You may prefer to use the supplied touchpad for these set of actions 1 Press Start and prepare to log in as the Windows Administrator If the start button the windows icon is not visible you should press the Windows Start button on the tablet or swipe right 2 Click the circular user icon and Select the Admin user see image...

Page 62: ...XCell Lab Controller User Guide 62 repligen com XC LAB UG V4 6 Select Manage The Manager opens 7 Navigate to Local Users and Groups ...

Page 63: ...n com XC LAB UG V4 8 Right click on Users and select New User 9 Enter user information Description and Full names are optional 10 Important Be sure to deselect User must change password at next logon 11 Press the Create button The user is added ...

Page 64: ...ess the Add button Another window appears 14 Press the Advanced Button Another window appears Press the Find Now button 15 Scroll to the bottom and select one of the XCell groups XCell Supervisors is selected 16 Press the OK button The window closes 17 Press the OK button The user is assigned 18 Select the Users group and press the Remove button then Press the OK button ...

Page 65: ...ged in 21 When complete sign out of the admin account and best to restart the Surface Pro 22 Press Start click the circular user icon and select sign out 23 Enter password User123 to return to the XCell windows user account 24 If not already running you can check by swiping right to show all active programs restart the Wonderware View XCell Lab software application ...

Page 66: ...XCell Lab Controller User Guide 66 repligen com XC LAB UG V4 15 Appendix E Default values on HMI Figure 47 Default values for ATF Pump Configuration Figure 48 Default values for ATF Flow Alarms ...

Page 67: ...XCell Lab Controller User Guide 67 repligen com XC LAB UG V4 Figure 49 Default values for Displacement Volume alarms Figure 50 Default values for System Alarms ...

Page 68: ...XCell Lab Controller User Guide 68 repligen com XC LAB UG V4 Figure 51 Default values for P3 Permeate Pressure Alarms ...

Page 69: ...gential flow 13 Backflush 14 47 Components 9 12 19 46 50 Connections 11 18 49 Diafiltration 48 High Productivity Harvest 13 48 Historian 20 32 42 43 44 46 Installation 9 19 53 Mode 23 25 28 29 31 44 58 Precautions 10 11 13 Pressure sensor 12 16 18 58 59 Pump status 28 29 Query 44 45 Shear 13 23 48 TMP 59 Trend 20 21 38 42 43 44 46 ...

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