REPLIGEN XCell C410:V3 User manual

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UG-C410v3-06
XCell™ C410:V3 Controller
User Guide
For use with:
•XCell ATF® 4 Device
•XCell ATF® 6 Device
•
XCell ATF® 10 Device

KrosFlo® TFDF™ Lab System
User Guide
XCell™ C410:V3 Controller
User Guide
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UG-C410v3-06
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 for use in vivo with humans or
animals.
For further information, please contact Repligen Corporation at www.repligen.com.
©2021 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
customerserv[email protected]om
[phone] (Option 1)
Repligen Corporation
111 Locke Drive
Marlborough, Massachusetts 01752
www.repligen.com

KrosFlo® TFDF™ Lab System
User Guide
XCell™ C410:V3 Controller
User Guide
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Contents
2.1.1 Filtration assembly......................................................................................................14
4.3.1 S-Line HFM insertion...................................................................................................43
4.3.2 I-Line HFM insertion....................................................................................................43
7.4.1 Bi-annual maintenance...............................................................................................48
7.4.2 Every four years ..........................................................................................................49

KrosFlo® TFDF™ Lab System
User Guide
XCell™ C410:V3 Controller
User Guide
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KrosFlo® TFDF™ Lab System
User Guide
XCell™ C410:V3 Controller
User Guide
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List of tables
Table 1. XCell ATF® pump housing and controller pairings..............................................................10
Table 2. Utility requirements............................................................................................................12
Table 3. Size and weight ...................................................................................................................13
Table 4. Primary screen information................................................................................................18
Table 5. Main screen display parameters.........................................................................................21
Table 6. The Basic Set-up screen display parameters ......................................................................24
Table 7. Advanced Set-up screen display parameters .....................................................................25
Table 8. The Start-up Guide screen display parameters ..................................................................26
Table 9. Calibration screen display parameters ...............................................................................27
Table 10. LPM min/max .....................................................................................................................29
Table 11. Trend screen controls.........................................................................................................29
Table 12. The Alarm screen display parameters ................................................................................32
Table 13. Two (2) Pump controller status relay states ......................................................................32
Table 14. Two (2) Pump interlock relay states...................................................................................32
Table 15. Administration screen display parameters ........................................................................34
Table 16. Batch Information overview screen display parameters ...................................................35
Table 17. Batch Info Algorithm display parameters...........................................................................36
Table 18. Batch Set-up screen values.................................................................................................39
Table 19. Advanced Set Up screen values..........................................................................................39
Table 20. Field: P-Flow and E-Flow values .........................................................................................40
Table 21. Cycle time vs. Flow rate......................................................................................................49
Table 22. Access levels to the XCell™ C410:V3 Controller .................................................................50
Table 23. Monitor points list ..............................................................................................................62
Table 24. Input/Output list.................................................................................................................64
Table 25. Alarm list.............................................................................................................................66
Table 26. Spare parts..........................................................................................................................67
List of figures
Figure 1. Filtration assembly connection to C410:V3 Controller and a bioreactor side port ............8
Figure 2. XCell ATF® Device pump cycles ...........................................................................................9
Figure 3. XCell™ C410:V3 Controller, XCell ATF® 10 SS pump housing and pressure relief valve....11
Figure 4. Pneumatic Enclosure .........................................................................................................14
Figure 5. Electric Box (E-Box) connections .......................................................................................15
Figure 6. Log on screen.....................................................................................................................19
Figure 7. Log on screen and password .............................................................................................19
Figure 8. Main screen .......................................................................................................................20
Figure 9. Basic Set-up screen............................................................................................................23
Figure 10. Advanced Set-up screen....................................................................................................25
Figure 11. Start-up Guide screen .......................................................................................................26
Figure 12. Calibration screen..............................................................................................................27
Figure 13. Trending screen.................................................................................................................28
Figure 14. Process Trend screen ........................................................................................................29
Figure 15. PV, PRV, P2, P3, P4, P5, W1 Trend screens .......................................................................30
Figure 16. Alarm screen .....................................................................................................................31
Figure 17. Users screen ......................................................................................................................33
Figure 18. Basic Administration screen..............................................................................................34
Figure 19. Batch Info overview screen...............................................................................................35
Figure 20. Algorithm screen ...............................................................................................................36
Figure 21. Instrument flow control schematic of XCell™ C410:V3 Controller ...................................38
Figure 22. Types of filter housings .....................................................................................................43
Figure 23. Filtration assembly prepared for autoclaving ...................................................................46

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Abbreviations
ATF Alternating tangential flow
DF Driving force
DP Driving pressure
HFM Hollow fiber filter module
HMI Human machine interface
PA Pump air
PL Pump liquid
PRV Pressure regulator valve
SM Screen module
SUBs Single-use bioreactors
TFDF® Tangential flow depth filtration
California Proposition 65 Warning
WARNING
This product can expose you to chemicals including Cadmium, which is
known to the State of California to cause cancer and birth defects or other
reproductive harm. For more information go to www.P65Warnings.ca.gov.

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User Guide
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1. Description of XCell ATF® Device and process
The XCell ATF® Device provides an efficient means for fractionation of various mixtures. It may
include separation of large particles such as microcarriers (~ 200 microns in size) from a suspending
medium. It may include separation of mammalian cells (~ 10 microns in size) from culture medium;
or it may include separation of some molecules from other molecules or from a suspending solvent.
The focus in this manual will be on the use of the XCell ATF® Device and process for separation of
these constituents by filtration, based primarily on size.
The XCell ATF® Device consists of the following primary components (see also Figure 1):
•Controller: a dedicated controller used to control and monitor XCell ATF® Device activity. It
also provides the means for connecting to and controlling utility services.
•Filtration assembly: a stainless-steel assembly of two major elements, a filter housing and a
diaphragm pump:
oFilter Housing: steel housing containing the filtration element, either a hollow fiber
module (HFM) or screen module (SM).
oDiaphragm pump : steel spherical housing in which a diaphragm membrane is
moved up and down by pressurized air or vacuum, creating alternating flow.
•The filtration assembly includes the following components for each process application:
oConnection Assembly: tubing assembly connecting the filtration assembly to a
bioreactor or process vessel
oBioreactor Adaptor: adaptor between the Connection Assembly and bioreactor
port. Typical ports/connectors/adaptors for stainless steel bioreactors include an
Ingold-type port or, if a single use bioreactor (SUB), then, a disposable aseptic
connector (DAC) or equivalent.
A typical configuration of the XCell ATF® Device is shown in Figure 1. The filter housing accepts
either a HFM, with pore sizes from 30 kD to ~0.5 micron, or a SM for fractionation of larger particles,
> 70 microns. The separating element, the HFM or SM, is positioned between a process vessel or a
bioreactor at one end and the diaphragm pump at the other end. The vessel serves as a storage
container for the content to be filtered. The diaphragm pump provides the means for generating
alternating tangential flow, back and forth, between the vessel and pump, through the hollow fibers
of the HFM or through the SM. The XCell ATF® process provides the means for generating rapid, low
shear, tangential flow. A filtrate pump as shown in Figure 1 is used for controlled removal of a
filtered stream. The unfiltered material remains in the system. The XCell ATF® Device provides the
means for confining the process. The entire process is enclosed. Only a single connection is required
between the XCell ATF® Device and the vessel. As shown in Figure 1, that connection can be either
through a head plate of the vessel or through a side or bottom port. Placing the filtration assembly
next to the vessel requires only a short tubing to complete the connection between the two. That
connection can be hard piped or soft piped. Either one may be used to make a sterile connection
between vessel and the filtration assembly, as will be discussed further on.

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Figure 1. Filtration assembly connection to C410:V3 Controller and a bioreactor side port
1.1 XCell ATF® Device pump cycle
The diaphragm pump is the heart of the XCell ATF® Device process. It produces an alternating flow
through the HFM (lumen side) or SM. The XCell ATF® Device provides a pulsating, reversible, flow of
liquid, back and forth, between the process vessel and the diaphragm pump. The following is a
description of that process:
The diaphragm pump is partitioned into two chambers with a flexible diaphragm, Figure 2. One of
the pump chambers, the pump liquid (PL) chamber is connected to the Filter Housing, which, in
turn, is connected to the process vessel. Therefore, any flow between the diaphragm pump and
process vessel will be through the filtration device. The second pump chamber, the pump air (PA)
chamber, is connected to the pump flow control system. Typically, controlled addition of
compressed air into the PA chamber increases the pressure in the chamber relative to the process
vessel, forcing the flexible diaphragm partitioning the two chambers to move into the PL chamber
and towards the vessel. Liquid in the PL chamber is forced through the filter to the process vessel.
The flow through the HFM (lumen side) generates tangential flow in one direction. This pumping
phase (or cycle) is called the pressure cycle. Inversely, with a pressurized process vessel relative to
PA or PL, or with an external vacuum supply, liquid will flow in the reverse direction, from process
vessel, through the HFM (lumen side), to the PL chamber, generating tangential flow in the other
direction. This pumping phase (or cycle) is called the exhaust cycle. These alternating pump cycles
are then repeated continuously. See also Figure 2.

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Figure 2. XCell ATF® Device pump cycles
Note on the exhaust cycle:
Therefore, to increase the pressure in the vessel relative to the diaphragm pump, a vacuum service
is required. The PA chamber can then be alternately pressurized and evacuated to produce XCell
ATF® Device flow while maintaining the process vessel at atmospheric pressure. On the other hand,
when using a vessel that can be pressurized, vessel pressure can be used to drive the liquid from the
vessel to the PL chamber. When vessel pressure is limited, it may be supplemented with vacuum. In
either of the above schemes, one is driving the liquid from the vessel to the diaphragm pump by
increasing the pressure in the vessel relative to the diaphragm pump.
WARNING: Glass bioreactors or single-use bioreactors (SUBs), unless
otherwise specified by the manufacturer of the vessel, should
not be pressurized. Such vessels can explode if pressurized.
WARNING: When using a glass vessel or SUB, be sure to maintain an
unrestricted vent from the vessel. In the case a diaphragm fails,
the air flow into the diaphragm pump will proceed through the
HFM or SM into the vessel. A free exhaust from the vessel will
minimize the buildup of pressure in the vessel.

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1.2 XCell ATF® Device control scope and objectives:
The XCell™ C410:V3 Controller provides the process control functionality of the XCell ATF® 4, XCell
ATF® 6, and XCell ATF® 10 Devices.
XCell™ C410:V3 Controller is designed to:
1. Control ATF flow rates in both pressure and exhaust phases.
2. Provide a user interface capability for XCell ATF® Device control and monitoring.
3. Set-up and select operation parameters.
4. Display real-time process data.
5. Alarm for error conditions.
6. Provide batch control and user hierarchy.
7. Have PLC software upgrades in the field by replacing memory modules.
8. Have two major components, an Electronics Box (E-Box) and a Pneumatics Box (P-Box).
9. Allow the E-Box to operate an XCell ATF® 4, XCell ATF® 6, or XCell ATF® 10 Device using
specific software and modules.
10. Allow the P-Box hardware and process parameters to be specific to the size of the particular
XCell ATF® Device being controlled.
Table 1. XCell ATF® pump housing and controller pairings
XCell ATF®
pump housing
XCell™ Controller Description
XCell ATF® 4 Stainless
Steel
XCell™ C410:4V3
XCell™ C410:V3 C410 Controller for XCell ATF® 4
Device with air tubing.
XCell™ C410:4V3-GMP
XCell™ C410:V3 C410 controller for XCell ATF® 4 Device
with air tubing and standard GMP documentation and
FAT.
XCell™ C410:4V4B-GMP
Profibus configured XCell™ C410-V4B Controller with
power separation for XCell ATF® 4 Device with air
tubing, standard GMP documents and FAT.
XCell ATF® 6 Stainless
Steel and Single-use
XCell™ C410:6V3
XCell™ C410:V3 C410 Controller for XCell ATF® 6
Device with air tubing.
XCell™ C410:6V3-GMP
XCell™ C410:V3 C410 Controller for XCell ATF® 6
Device with air tubing, standard GMP documents and
FAT.
XCell™ C410:6V4B-GMP
Profibus configured XCell™ C410-V4B Controller with
power separation for XCell ATF® 4 Device with air
tubing, standard GMP documents and FAT.
XCell ATF® 10
Stainless Steel and
Single-use
XCell™ C410:10V3
XCell™ C410:V3 C410 Controller for XCell ATF® 6
Device with air tubing.
XCell™ C410:10V3-GMP
XCell™ C410:V3 C410 Controller for XCell ATF® 10
Device with air tubing, standard GMP documents and
FAT.
XCell™ C410:10V4B-GMP
Profibus configured XCell™ C410-V4B Controller with
power separation for XCell ATF® 10 Device with air
tubing and standard GMP documentation and FAT.