REPLIGEN XCell ATF6 User Manual
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REPLIGEN XCell ATF6 User Manual

With c410:v4b controller
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TM
XCell
ATF System
With C410:V4B Controller
USER GUIDE
XCell ™ ATF4 | XCell ™ ATF6 | XCell ™ ATF10

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Summarization of Contents

1.0 Description of the XCell™ ATF System and Process
Controller
Dedicated controller for XCell ATF System activity, managing pressure and vacuum.
Filtration Assembly
Assembly of two elements: stainless steel filter housing and silicone diaphragm pump.
A2B Connection Assembly
Tubing assembly connecting Filtration Assembly to bioreactor or process vessel.
Bioreactor Adaptor
Adaptor between Connection Assembly and bioreactor port.
1.1 XCell™ ATF System Pump Cycle
1.2 XCell™ ATF System Control Scope and Objectives
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 controller components: P-Box, E-Box, and Power-Box.
5.2 Filtration Assembly (Stainless Steel)
5.3 Pneumatics Box (P-Box) Components
5.4 Electrical Box (E-Box)
5.5 Power Box (Power Separation) Components
5.6 Primary Pneumatic Services
5.7 Primary Electric Services
5.8 Signal
6.0 C410v4B Controller Process and Control
6.1 Control Overview
Explains the diaphragm pump cycle, driving pressure, and control rules for optimum results.
6.2 Control Functional Algorithms
6.3 Interface and Screens
A. INITIAL Screen
B. MAIN Screen
C. SET UP Section
C.1 BASIC SET UP
Details entries and actions for the basic setup screen.
C.2 ADVANCED SET UP
C.3 START-UP GUIDE
C.4 CALIBRATION Section
D. TRENDING Section
D.1 PROCESS TREND
Monitors real-time flow and exhaust set points and process values.
D.2 PV, PRV, P2, P3, P4, P5, W1 TREND
Weight TREND
E. ALARMS Section
F. ADMIN. Section
F.1 USERS
Details user ID creation, amendment, and security levels.
F.2 BASIC Administration Screen
G. BATCH INFO. Section
G.1 OVERVIEW
Displays current batch information like elapsed time and cycle count.
G.2 ALGORITHM Section
H. LOGOFF.
Startup Procedure
Examples
7.0 XCell™ ATF Hollow Fiber Module and Diaphragm Replacement
7.1 Separating the Filtration Assembly from the bioreactor
Steps to disconnect the Filtration Assembly from the bioreactor.
7.2 HFM removal
Procedure for removing the Hollow Fiber Module from the housing.
7.3 HFM insertion
7.4 Screen Module replacement
7.5 Diaphragm replacement
8.0 Sterilization
8.1 Preparation of Filtration Assembly for Autoclaving
Steps for preparing the assembly for autoclaving.
8.2 Autoclave Cycle
8.3 Sterilization of Filtrate / Harvest line
9.0 Connection to Bioreactor (ATF-to-Bioreactor)
9.1 Hard Connection
Details the procedure for making a hard connection, including SIP.
10.0 Maintenance
10.1 Diaphragm
Recommendations for diaphragm use and lifespan.
10.2 Pump Air Inlet Filter
Guidelines for replacing the pump air inlet filter.
10.3 “O” Rings, gaskets and Quick Connects
Recommendations for replacing O-rings, gaskets, and quick connects.
Appendix 1: Cycle time vs. Flow rate
Appendix 2: Access levels to the C410v4B controller
Appendix 3: Controller Lists: Alarm, Warning, Inputs & Outputs
Appendix 4: Profinet Communication
Profinet® Infrastructure
Explains the Profinet infrastructure and its components.
Configuration
Lists the factory default IP settings for HMI and PLC.
Set/Change IP Address of HMI
Appendix 5: Profibus Communication
1.1 Remote Control Mode
How to set the ATF controller to Remote Control Mode.
1.2 Input Signals (from Master to XCell™ ATF)
Describes input signals sent from the Profibus master to the ATF controller.
1.3 Output Signals (to Master from XCell™ ATF)
Describes output signals sent from the ATF controller to the Profibus master.
Black-Box Configuration
How black-box configuration differs from remote control mode.
Prerequisites
Requirements before setting up Profibus communication.
Profibus Configuration for DCS Integration
Remote Set-up
Remote Start
Remote Stop
Remote running
System-stop
Calibration Process
Calibration Example
OPC Inputs
Appendix 6: Delta V Example configuration
1.1 Install the GSD File in Delta V Explorer
Steps to install the GSD file in Delta V Explorer.
1.2 Add new Profibus Device
1.3 Select Profibus Device Type
1.4 Address Setting
1.5 Confirm and Select “OK” button
1.6 Verify “Enabled”
1.7 Create Slot
1.8 Set Slot Size
1.9 Verify Communications are functioning
1.10 Create Signals
1.11 Create a Real datatype tag
Appendix 7: OPC Communication
1.1 Remote Control Mode (OPC)
1.2 Input Signals (from Master to XCell™ ATF) (OPC)
1.3 Output Signals (to Master from XCell™ ATF) (OPC)
OPC Configuration for DCS Integration
Black-Box Configuration (OPC)
Prerequisites (OPC)
Remote Set-up (OPC)
Remote Start (OPC)
Remote Stop (OPC)
Remote running (OPC)
System-stop (OPC)
Calibration Process (OPC)
Calibration Example (OPC)
Appendix 9: Example EU Declaration of Conformity
Sample Nameplate
General Information and handling Instructions
Handling Instructions
Appendix 10: UL Listing
Appendix 11: Spare Parts List
XCell™ ATF Electronics Spares
List of spare electronic parts for the XCell ATF system.
XCell™ ATF 6 Pneumatics Spares
List of spare pneumatic parts for XCell ATF 6 system.
XCell™ ATF 6 Pump Housing Spares
XCell™ ATF 10 Pump Housing Spares

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