REPLIGEN XCell ATF Series User Manual

XCell
TM
ATF System with C410:V4B Controller User Guide
107
d. Reset P2_P1_Capture = 0; the minimum capture bit is momentarily asserted.
4) Pneumatic devices are set to produce a maximum setting. (PV1=100%, PRV1=20.00 PSI,
Solenoid=1 [pressure or air])
a. Set PV1_SP = 100 Confirmed by examining DL_PV1
b. Set PRV1_SP = 20 Confirmed by examining DL_PRV1
c. Set Force_Solenoid = 1 Confirmed by examining Solenoid_Forced
d. The pressure in the system approaches the maximum value commanded.
Pressure gauge reading is allowed to stabilize.
Note: P2_PV and PRV1_PV should be very near the value on the external pressure gauge.
5) Pressure gauge reading is provided to the controller.
a. Programmer provides another data entry location for technician to enter the
pressure value.
b. Set P2_P2_EU = the pressure value from the data entry location.
c. Set P2_P2_Capture = 1 until the P2_Cal_Enable bit is received. When true…
d. Reset P2_P2_Capture = 0; the maximum capture bit is momentarily asserted.
6) Assert accept bit:
a. Set P2_Accept (input) = 1 until the P2_Accept (output) bit is received. When
true…
b. ResetP2_Accept = 0.
c. Controller performs the linear scaling calculation and resets the controller’s
internal calibration enable bit.
7) Clean up: After all calibration activities are complete, be sure to reset parameters that
were set during the calibration process.

REPLIGEN XCell ATF Series Specifications

General

Filtration Method	Tangential Flow Filtration (TFF)
Type	XCell ATF System
Application	Cell Culture Harvest, Clarification, Concentration, Diafiltration
Technology	Alternating Tangential Flow (ATF)
Applications	Cell Therapy, Vaccine Production
Volume Range	1 L to 2000 L
Membrane Area	0.1 m² to 10 m²
Compatibility	Compatible with various cell types and media
Dimensions	Varies by model
Weight	Varies by model
Power Requirements	100-240 VAC, 50/60 Hz

Summary

1.0 Description of the XCell™ ATF System and Process

1.1 XCell™ ATF System Pump Cycle

Explains the alternating tangential flow generated by the diaphragm pump.

1.2 XCell™ ATF System Control Scope and Objectives

Outlines the functionalities and goals of the C410v4B controller.

2.0 Utility Requirements

3.0 Dimensions and Weight

4.0 XCell™ ATF Pump Housing Assemblies

5.0 XCell™ C410v4B Controller Layout

5.1 General Layout

Describes the three main components of the controller system.

5.2 Filtration Assembly (Stainless Steel)

Details the stainless steel filtration assembly components.

5.3 Pneumatics Box (P-Box) Components

Lists the components and connections within the Pneumatics Box.

5.4 Electrical Box (E-Box)

Details the HMI and PLC components within the Electrical Box.

5.5 Power Box (Power Separation) Components

Lists the components found in the Power Box.

5.6 Primary Pneumatic Services

Explains the air inlet and exhaust/vacuum line connections.

5.7 Primary Electric Services

Details power connection, switch, and stop button.

5.8 Signal

Describes sensor inputs, Ethernet/Profibus, and relays.

6.0 C410v4B Controller Process and Control

6.1 Control Overview

Explains how the controller manages diaphragm pump operation and flow.

6.2 Control Functional Algorithms

Details the algorithms used for diaphragm pump cycle control.

6.3 Interface and Screens

Describes the HMI interface, primary screens, and their functions.

6.4 Startup

Provides a step-by-step guide for initial system setup and operation.

6.5 Examples

Offers guidelines for optimizing operating conditions with practical examples.

7.0 XCell™ ATF Hollow Fiber Module and Diaphragm Replacement

7.1 Separating the Filtration Assembly from the bioreactor

Details the procedure for disconnecting the assembly from the bioreactor.

7.2 HFM removal

Describes the steps for removing the Hollow Fiber Module.

7.3 HFM insertion

Explains the process for inserting a new Hollow Fiber Module.

7.4 Screen Module replacement

Provides instructions for replacing a screen module.

7.5 Diaphragm replacement

Outlines the procedure for replacing the diaphragm in the pump.

8.0 Sterilization

8.1 Preparation of Filtration Assembly for Autoclaving

Details pre-autoclaving checks and assembly preparation.

8.2 Autoclave Cycle

Describes recommended autoclave cycle parameters and procedures.

8.3 Sterilization of Filtrate / Harvest line

Explains the sterilization process for the filtrate/harvest line.

9.0 Connection to Bioreactor (ATF-to-Bioreactor)

9.1 Hard Connection

Provides the procedure for making a hard, steam-sterilizable connection.

10.0 Maintenance

10.1 Diaphragm

Recommends diaphragm replacement and proper seating.

10.2 Pump Air Inlet Filter

Advises on the replacement schedule for the air inlet filter.

10.3 “O” Rings, gaskets and Quick Connects

Specifies replacement intervals for O-rings and gaskets.

Appendix 1: Cycle time vs. Flow rate

Appendix 2: Access levels to the C410v4B controller

Appendix 4: Profinet Communication

Appendix 5: Profibus Communication

Appendix 6: Delta V Example configuration

Appendix 7: OPC Communication

Appendix 9: Example EU Declaration of Conformity

Appendix 10: UL Listing

Appendix 11: Spare Parts List