REPLIGEN XCell Lab XC-LAB-S User manual

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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

KrosFlo® TFDF™ Lab System
User Guide
XCell™ Lab Controller
User Guide
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XC-LAB-UG-V4
The information contained in this document is subject to change without notice.
With respect to documentation accompanying Product, Repligen makes no warranty, express or
implied. Any and all warranties related to the documentation accompanying 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.
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 Corporation at www.repligen.com.
©2022 Repligen Corporation. All rights reserved. The trademarks mentioned herein are the property
of Repligen Corporation and/or its affiliate(s) or their respective owners.
Customer Support
[e-mail]
[phone] (Option 1)
Repligen Corporation
41 Seyon Street
Building 1 Suite 100
Waltham, Massachusetts 02453
www.repligen.com

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User Guide
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Contents
6.5.1 A2B and A2C tubing sets.............................................................................................18
6.9.1 Windows environment ...............................................................................................20
6.9.2 Repligen XCell™ Lab Software ....................................................................................20
6.9.3 Modbus/ethernet remote monitoring .......................................................................20
7.6.1 Menu bar ....................................................................................................................24
7.8.1 Changing ATF Flow set points .....................................................................................28
7.8.2 Starting, pausing 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 required - security on/off.................................................................................36
7.8.14 Algorithm pop-ups ......................................................................................................37
7.9.1 XCell™ Lab Trend screen.............................................................................................38
7.11.1 Alarm Configuration....................................................................................................40

KrosFlo® TFDF™ Lab System
User Guide
XCell™ Lab Controller
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7.11.2 ATF Flow alarm 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

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List of tables
Table 1. Explanation of user attention phrases................................................................................10
Table 2. Safety precautions examples..............................................................................................10
Table 3. Safety warnings...................................................................................................................11
Table 4. XCell™ Lab Controller model comparison ..........................................................................16
Table 5. Controller ports...................................................................................................................18
Table 6. A2B Tubing ID/OD...............................................................................................................19
Table 7. SAPA components...............................................................................................................19
Table 8. Preset usernames and passwords ......................................................................................22
Table 9. Starting, pausing and stopping an XCell ATF® Device instructions.....................................28
Table 10. Pump status messages examples .......................................................................................29
Table 11. ATF modes - independent and dual ...................................................................................30
Table 12. Starting, pausing and stopping XCell ATF® Device(s) in Dual Mode...................................31
Table 13. ATF service parameters ......................................................................................................36
Table 14. Alarm status........................................................................................................................40
Table 15. Recommended ATF rate to Filtration rate ratios ...............................................................48
Table 16. XCell™ Lab System Price and Parts List - for Sales..............................................................51
Table 17. Windows usernames and passwords .................................................................................60
Table 18. XCell™ Lab users and roles .................................................................................................60
List of figures
Figure 1. XCell™ Lab Controller and accessories ................................................................................9
Figure 2. ATF pressure and exhaust strokes.....................................................................................14
Figure 3. Backflush example.............................................................................................................14
Figure 4. Configuration - bioreactor, controller, and 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 synchronized XCell ATF® Devices attached to the same bioreactor .............26
Figure 15. Example - 2 XCell ATF® Devices attached to two bioreactors...........................................26
Figure 16. Example - Dual controller and single XCell ATF® Device ...................................................27
Figure 17. ATF Flow pop-up example.................................................................................................27
Figure 18. XCell ATF® Device status - running, paused or stopped....................................................28
Figure 19. ATF DUAL Pop-up example................................................................................................30
Figure 20. ATF displacement volume pop-up example......................................................................32
Figure 21. ATF pressure pop-up screen example...............................................................................32
Figure 22. Settings sub-menu example ..............................................................................................33
Figure 23. XCell ATF® Device configuration example.........................................................................33
Figure 24. Bioreactor configuration example.....................................................................................34
Figure 25. ATF pump settings example ..............................................................................................34
Figure 26. General configuration example.........................................................................................35
Figure 27. Service/performance example..........................................................................................36
Figure 28. ATF-A Algorithm pop-up example.....................................................................................37
Figure 29. ATF-A and ATF-B algorithm pop-ups .................................................................................37
Figure 30. XCell™ Lab Trend screen example.....................................................................................38
Figure 31. Alarm condition example ..................................................................................................39

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Figure 32. Alarm status ......................................................................................................................39
Figure 33. Alarm Configuration example ...........................................................................................40
Figure 34. Displacement volume alarm example...............................................................................41
Figure 35. System alarms example.....................................................................................................41
Figure 36. P3 permeate pressure alarm example ..............................................................................42
Figure 37. Accessing Trend and Query example ................................................................................43
Figure 38. Trend screen example.......................................................................................................43
Figure 39. Query example ..................................................................................................................44
Figure 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 values for ATF Flow Alarms ..................................................................................66
Figure 49. Default values for Displacement Volume alarms..............................................................67
Figure 50. Default values for System Alarms .....................................................................................67
Figure 51. Default values for P3 Permeate Pressure Alarms .............................................................68

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User Guide
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Abbreviations
A-B Allen-Bradley
AC Alternating current
Amp Ampere
ATF Alternating tangential flow
ATF-A XCell ATF® Device A
ATF-B XCell ATF® Device B
AUX Auxiliary
A2B XCell ATF® Device to Bioreactor connection
A2C XCell ATF® Device to Controller connection
CFM Cubic feet per meter
CSPR Cell specific perfusion rate
dB Decibels
DC Direct current
DO Dissolved oxygen
DPv1 PROFIBUS Decentralized Peripherals version 1
FAS Field Applications Scientist
FC Flow control
FS Flow sensor
FSE Field Service 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
PRV Pressure regulating valve
PV Process value
P2 PCV outlet pressure (Commanded pressure)
P3 Permeate pressure
PPE Personal protective equipment
psi Pounds per square inch
psig Pounds per square inch gauge
QC Quick Connect
SAPA Supply Air Protection Assembly
SCADA Supervisory Control and Data Acquisition
SP Set point
SUB Single-use Bioreactor
TC Tri-clamp
TCD Total cell density

KrosFlo® TFDF™ Lab System
User Guide
XCell™ Lab Controller
User Guide
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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

XCell™ Lab Controller
User Guide
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repligen.com XC-LAB-UG-V4
1. Introduction
The XCell ATF® Technology provides a complete solution for the retention of cells, removal of media
and, ultimately, the intensification of upstream cell culture processes. It is the most widely used and
proven cell retention solution in the world, having been specified in dozens of commercial
processes. Thousands of XCell ATF® systems are currently utilized in process development and
clinical manufacturing processes. As the gold standard for upstream process intensification, XCell
ATF® often delivers at least 10 times higher cell concentrations or product throughput than typical
batch and fed-batch processes.
The XCell ATF® System includes several components: a controller (with air and vacuum accessories),
software, sensors and XCell ATF® Device.
This User Guide serves as a reference document for your XCell™ Lab Controller 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 performance on an
industrial automation platform. The XCell™ Lab Controller combines performance intensification and
ease of use into a single solution. Key components include an easy-to-use software, flow sensors,
and air and vacuum accessories (Figure 1). The XCell™ Lab Controller is designed to meet the
challenges of the next wave of high-density intensification processes, which are expected to exceed
250 x 106 cells/mL.
Figure 1. XCell™ Lab Controller and accessories
1. XCell™ Lab Controller
2. XCell™ Lab Software and HMI
3. Flow sensor
4. Supply air protection assembly
5. Vacuum manifold
6. Vacuum pump
Existing XCell ATF® users may jump to Section 5for an abbreviated setup description.
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3. About this document
This manual uses several user attention 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.
PRECAUTION
Cautions users of potential physical injury or instrument damage if the information is not
heeded.
WARNING! Warns users of potential serious physical injury if warnings are not heeded.
4. Safety precautions
Table 2. Safety precautions examples
Description of precautions
Use of safety glasses is recommended during installation, set up, operation and while any service
or testing is being performed on the system.
You 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 exhaust from the vessel. This will ensure that no
significant pressure or vacuum occurs in the bioreactor. In the case of a diaphragm failure, for
example, air will penetrate the XCell ATF® Device, through the filter and into the vessel. A free
exhaust from the vessel will minimize the build-up of pressure in the vessel.
You must replace the air filter on Stainless Steel XCell ATF® Devices (ATF2 and ATF4) prior to
operation.
When not in use, you should ensure all the tubing is capped or blocked using the provided caps
and valves. It is recommended to keep unused tubing in the original sealed bag.