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
For descriptions of symbols on product labels or product documents, go to thermofisher.com/symbols-definition.
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

■APPENDIX A Safety .............................................................. 121
Symbols on this instrument .................................................... 121
Standard safety symbols .................................................. 122
Control and connection symbols ........................................... 122
Conformity symbols ...................................................... 122
Safety information for instruments not manufactured by Thermo Fisher Scientific ..... 124
Instrument safety ............................................................. 124
General ................................................................. 124
Physical injury ............................................................ 125
Electrical safety .......................................................... 125
Cleaning and decontamination ............................................. 126
Safety and electromagnetic compatibility (EMC) standards ......................... 126
Safety standards ......................................................... 126
EMC standards ........................................................... 127
Environmental design standards ............................................ 127
Chemical safety .............................................................. 128
Biological hazard safety ....................................................... 129
■APPENDIX B Documentation and support .................................... 130
Customer and technical support ................................................ 130
Limited product warranty ...................................................... 130
Contents
6CTS™Rotea™Counterflow Centrifugation System User Guide

Product information
IMPORTANT! Before using this product, read and understand the information in the “Safety” appendix
in this document.
Product description
The CTS™Rotea™Counterflow Centrifugation System is an automated, closed-flow benchtop
instrument that can perform a wide variety of cell processing steps across dierent cell types.
The CTS™Rotea™Single-Use Kit is specifically designed for a range of cell processing applications
such as separation, isolation, buer exchange, wash and concentrate. Each kit has 8 input/output
sterile weldable tubes, counterflow centrifuge and Carrier Frame for unparalleled setup flexibility.
The CTS™Rotea™Software is user-programmable and allows users to save, create, and modify
protocols depending on the application. The system's open design and integrated camera allows users
to visualize cells in real-time to more easily optimize protocols.
Features
CTS™Rotea™Counterflow Centrifugation System easily fits into existing workflows, from research to
commercial manufacturing.
•Integrated camera provides real-time sample visualization
•Patented technology that can process up to 20 L of starting volume to as little as 5 mL of output
volume
•Gentle fluidized bed results in unmatched cell recovery and viability
•Seamlessly transition from process development to GMP manufacturing on the same system.
Contents
Table 1 CTS™Rotea™Counterflow Centrifugation System (Cat. No. A44769)
Contents Amount
CTS™Rotea™Centrifuge 1 ea
CTS™Rotea™Single-Use Kit Available separately
Protocol Development Application 1 ea
Dell™2-in-1 laptop for operation/programming 1 ea
1
CTS™Rotea™Counterflow Centrifugation System User Guide 7

System overview
Instrument description
2
1
3
4
5
6
7
8
9
10
11
12
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14
15
16
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Figure 1 Instrument – Front View
1Instrument Door
2Pinch Valves (J & K)
3Kit Location Button
42D Barcode Reader
5CFC Chamber Detector
6CFC Chamber Carrier
7Camera
8Moisture Sensor
9Pushbutton Controls
10 Optical Density Sensor & Pressure Sensor (P1)
11 Peristaltic Pump
12 Pump Clamp Arm
13 Pinch Valve (H)
14 Kit Location Button & Pressure Sensor (P2)
15 Door Latch
16 Pinch Valves (A, B, C, D, E, F, & G)
17 Bubble Sensors
18 Hanger Posts
Chapter 1 Product information
System overview
1
8CTS™Rotea™Counterflow Centrifugation System User Guide

8
7
6
5111
1432
Figure 2 Instrument – Rear View
1Power Switch
2Mains Connector
3CAN bus (2 o)
4Ethernet (RJ-45)
5USB-C
6Bag Hooks
7Hanger Post
8Hanger Post Adjustment
Chapter 1 Product information
System overview 1
CTS™Rotea™Counterflow Centrifugation System User Guide 9

Instrument dimensions
Working space
The Rotea™instrument is designed for bench top use and requires a working space of approximately
Height: 30” (76 cm), Width: 25” (63.5 cm), Depth: 20” (50.8 cm).
Note: The 2‑in‑1 laptop is connected via a USB-C cable and hence can be located in a range of
positions. The width dimension of 25” assumes that the laptop is located on the bench beside the
instrument.
Instrument weight
The Rotea™instrument weighs 44 lbs (20 kg) with hanger posts installed.
Chapter 1 Product information
System overview
1
10 CTS™Rotea™Counterflow Centrifugation System User Guide