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REPLIGEN XCell ATF Series User Manual

REPLIGEN XCell ATF Series
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XCell
TM
ATF System with C410:V4B Controller User Guide
106
Only one input loop shall be calibrated at a time. Each loop shall be calibrated in its entirety by
itself, without enabling (or initiating) the calibration of another loop.
The process of calibration is a 2-point linear scaling process, where a technician first confirms all
required utilities, external pressure gauge and loop wiring is connected. The following steps are
performed:
1) An enable bit is momentarily asserted. Controller is enabled in calibration mode for a
particular analog input.
2) Pneumatic devices are set to produce a minimum setting. The pressure in the system
approaches the minimum value commanded. Pressure gauge reading is allowed to
stabilize.
3) The pressure gauge reading is provided to the controller. A minimum capture bit is
momentarily asserted.
4) Pneumatic devices are set to produce a maximum setting. The value on the pressure
gauge is allowed to stabilize.
5) The pressure gauge reading is provided to the controller. A maximum capture bit is
momentarily asserted.
6) Once both minimum and maximum points are captured, the linear scaling calculation
can be performed by the PLC. This calculation is initiated by setting an accept bit
(momentarily asserted). Controller performs the linear scaling calculation and resets
the controller’s internal calibration enable bit.
Calibration Example
Technician calibrates the P2 pressure sensor.
1) Assert enable bit:
a. Set P2_Cal_Enable (input command bit) = 1 until P2_Cal_Enable (output
response bit) is set (= 1) and is received. When true…
b. Reset P2_Cal_Enable = 0.
c. Controller is enabled in calibration mode for P2 analog input.
2) Pneumatic devices are set to produce a minimum setting. (PV2=100%, PRV2=-5.00 PSI,
Solenoid=0 [vacuum])
a. While “SendingDataPage” is still equal to 3…
b. Set PV2_SP (input) = 100 Confirmed by examining DL_PV2 (output)
c. Set PRV2_SP (input) = -5 Confirmed by examining DL_PRV2 (output)
d. Reset Force_Solenoid (input) = 0 Confirmed by examining Solenoid_Forced
(output)
e. The pressure in the system approaches the minimum value commanded.
Pressure gauge reading is allowed to stabilize.
Note: P2_PV andPRV2_PV should be very near the value on the external pressure gauge.
3) Pressure gauge reading is provided to the controller.
a. Programmer provides a data entry location for technician to enter the pressure
value.
b. Set P2_P1_EU = the pressure value from the data entry location.
c. Set P2_P1_Capture = 1 until P2_P1_Captured bit is received. When true…

Table of Contents

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REPLIGEN XCell ATF Series Specifications

General IconGeneral
Filtration MethodTangential Flow Filtration (TFF)
TypeXCell ATF System
ApplicationCell Culture Harvest, Clarification, Concentration, Diafiltration
TechnologyAlternating Tangential Flow (ATF)
ApplicationsCell Therapy, Vaccine Production
Volume Range1 L to 2000 L
Membrane Area0.1 m² to 10 m²
CompatibilityCompatible with various cell types and media
DimensionsVaries by model
WeightVaries by model
Power Requirements100-240 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

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