Thermo Scientific Gibco CTS Rotea User manual

For Research Use or Manufacturing of Cell, Gene, or Tissue- Based
Products.
CTS™Rotea™Counterflow Centrifugation
System
USER GUIDE
Catalog Number A44769
Publication Number MAN0018908
Revision A.0

Life Technologies Holdings Pte Ltd | Block 33 | Marsiling Industrial Estate Road 3 | #07-06, Singapore 739256
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The information in this guide is subject to change without notice.
DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL NOT BE
LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR
ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT.
The CTS™Rotea™Counterflow Centrifugation System is for use in further manufacturing applications only and not for final drug product
formulation. Drug manufacturers are responsible for ensuring the purity, potency, safety and identity of finished drug products and for
obtaining the appropriate regulatory approvals.
Revision history: Pub. No. MAN0018908
Revision Date Description
A.0 20 October 2020 New document. User guide for new workflow.
Important Licensing Information: This product may be covered by one or more Limited Use Label Licenses. By use of this product,
you accept the terms and conditions of all applicable Limited Use Label Licenses.
TRADEMARKS: All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.
©2020 Thermo Fisher Scientific Inc. All rights reserved.

Contents
■CHAPTER 1 Product information .................................................. 7
Product description ............................................................. 7
Features ....................................................................... 7
Contents ....................................................................... 7
System overview ................................................................ 8
Instrument description ....................................................... 8
Instrument dimensions ..................................................... 10
Working space ............................................................ 10
Instrument weight ......................................................... 10
Instrument properties ...................................................... 11
Push button controls ....................................................... 13
CTS™Rotea™Single-Use Kit schematic ...................................... 14
Wetted components ....................................................... 15
Allowed chemicals for wetted surfaces ....................................... 15
■CHAPTER 2 Installation and setup ............................................... 16
Packaging contents ............................................................ 16
Instrument installation .......................................................... 16
Power instrument “On” ......................................................... 18
Power instrument “O” ......................................................... 19
Installation .................................................................... 20
First time setup ................................................................ 24
Download protocols ............................................................ 27
Create protocols ........................................................... 27
Load a protocol ........................................................... 27
Rotea™GUI dashboard ..................................................... 31
User Management ......................................................... 32
Uninstall ...................................................................... 37
Logging ....................................................................... 38
CTS™Rotea™Counterflow Centrifugation System User Guide 3

■CHAPTER 3 Basic instrument operation ........................................ 41
Open the door ................................................................. 41
Kit preparation, loading and removal ............................................. 43
Kit configuration ........................................................... 43
Pre-assembly of processing kit .............................................. 45
Connecting vessels, bags and reagents ...................................... 46
Bubble Trap ............................................................... 47
Kit installation ............................................................. 48
Initiate a protocol .......................................................... 54
Run a protocol ................................................................. 61
Rotea™GUI navigation and instrument operation .............................. 61
Error messages ............................................................ 67
Kit removal .................................................................... 69
Aseptic disconnection of the kit components ...................................... 74
System settings ................................................................ 75
Instrument firmware ........................................................ 75
OPC-UA .................................................................. 80
Settings .................................................................. 81
Licenses .................................................................. 82
Calibration .................................................................... 83
■CHAPTER 4 OPC-UA interface ................................................... 87
Introduction ................................................................... 87
Definitions .................................................................... 87
Scope of system ............................................................... 88
Instrument hardware configuration ........................................... 88
Single-Use Kit ............................................................. 88
Protocol file ............................................................... 89
Protocol metadata ......................................................... 89
MES interface ................................................................. 89
Background ............................................................... 89
Electronic communications ................................................. 90
Communications protocol .................................................. 90
MES – Commands and reports overview .......................................... 91
Enable OPC-UA ........................................................... 92
Log in to instrument ........................................................ 92
Load protocol ............................................................. 92
Load kit .................................................................. 93
Transfer metadata ......................................................... 93
Initialize protocol on to instrument ........................................... 93
Start/Stop/Pause/Resume protocol .......................................... 93
Instrument run status ....................................................... 94
Contents
4CTS™Rotea™Counterflow Centrifugation System User Guide

MES batch history data ..................................................... 94
Alarm recovery tools ....................................................... 95
OPC-UA interface .............................................................. 96
Commands OPC-UA to Rotea™application ................................... 96
Reports Rotea™application to OPC-UA ...................................... 97
Use case sequence diagrams .................................................. 104
MES run a protocol ....................................................... 104
Protocol with parametric data .............................................. 105
MES drives Rotea in response to external systems ........................... 106
MES drives steps within protocol ........................................... 106
MES manage error recovery events with admin user .......................... 107
Use list file to load protocol ............................................... 108
■CHAPTER 5 Maintenance ....................................................... 110
User maintenance schedule .................................................... 110
Instrument cleaning ........................................................... 110
Inspect casing ................................................................ 110
Open the door without power .................................................. 111
Power and fuses .............................................................. 112
Power supply ............................................................ 112
Fuses ................................................................... 112
■CHAPTER 6 Troubleshooting ................................................... 113
■CHAPTER 7 Compliance ........................................................ 115
■CHAPTER 8 Safety instructions ................................................ 116
Labels ....................................................................... 116
Emergency procedures ........................................................ 116
Instrument emergency stop events ......................................... 116
Emergency shut down .................................................... 117
Restart after shut down ................................................... 117
Protocol recovery process ................................................. 118
Warnings and precautions ..................................................... 119
Warnings ................................................................ 119
Cautions ................................................................ 120
Contents
CTS™Rotea™Counterflow Centrifugation System User Guide 5