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
13
14
15
16
17
18
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

Instrument properties
Category Property Value
Electrical
Supply voltage 100–240 V AC ±10%, 50/60 Hz
Phases Single
Maximum Rated Input Current 5 A
Fuses 2 x 5 A
Sound level
Maximum sound level 70 dBA (measured 1 m from instrument)
Typical sound level 65 dBA (measured 1 m from instrument)
Environmental ranges
Ambient temperature 15℃to 30℃
Transport temperature 0℃to 45℃
Storage temperature 15℃to 30℃
Maximum relative humidity 80% (non-condensing)
Altitude (max.) 2000 m
Indoor use only —
Not intended for use in a wet
location
—
Intended for use in Pollution
degree 2 environment
—
Operating limits
Centrifuge speed 0 to 3000 × g(7000 rpm)
Flow rate Standard: 5 to 110 mL/min (LS19)
Hi-Flow: 30 to 160 mL/min (LS16 tube)
System pressure 100 kPa
Liquid temperature 4℃to 38℃
Fluid density 1.0 to 1.1 g/mL
Minimum working volume Approx. 50 mL
Note: Smaller volumes of input material can be
diluted to enable processing
Chapter 1 Product information
System overview 1
CTS™Rotea™Counterflow Centrifugation System User Guide 11

(continued)
Category Property Value
Minimum concentrate recovery
volume
5 mL (subject to protocol optimization)
Centrifuge chamber volume 10 mL chamber containing up to 4 × 109cells (cell
type and operating parameters dependent).
Note: Centrifuge chamber can be filled multiple
times to process larger batches.
Maximum bag weight per pole 4.4 lb (2 kg)
Output concentration Up to 300 × 106cells/mL (cell type and operating
parameters dependent)
CAN bus connection
Purpose For connection and control of external devices
Connector TE Connectivity T4111402051-000 M12 Plug
Connections Pin 1 - VCC CAN - +5V out
Pin 2 - CAN-H - Dominant High
Pin 3 - CAN-L - Dominant Low
Pin 4 - GND - Ground
Pin 5 - GND - Shield, optional
Chapter 1 Product information
System overview
1
12 CTS™Rotea™Counterflow Centrifugation System User Guide

Push button controls
Once a protocol has been loaded and confirmed, the Rotea™instrument can be operated almost
entirely from the push buttons on the front of the instrument.
Figure 3 Instrument push button controls
Light STOP START/PAUSE ADVANCE DOOR UNLOCK
Push button
operation
Solid Push button to stop
the instrument and
the current protocol
Push button to start
the Protocol, pause
the current step in
the protocol or re-
start a paused step
Push button to
advance to the next
step in the protocol
Push button to
unlock the door
Flashing Instrument has
stopped due to
an alarm condition.
User intervention is
required.
Instrument is in a
paused condition.
Pressing allows
the instrument to
continue the current
step of the protocol.
Button can be
pushed, advancing
to the next step of
the protocol
N/A
Chapter 1 Product information
System overview 1
CTS™Rotea™Counterflow Centrifugation System User Guide 13

CTS™Rotea™Single-Use Kit schematic
The CTS™Rotea™Single-Use Kit enables users to configure kits to suit dierent protocols by adding
input and output vessels. Unused fluid lines are simply left sealed o.
6
3
5
1
2
4
78
9
10
11
12
Figure 4 CTS™Rotea™Single-Use Kit
1Valve Hole & Tube ID
2Carrier Frame
3Bubble Trap
4Location Hole
5CFC Chamber
6Rotary Coupling
72D Barcode
8Pump Tubing
9Tube Retainer
10 Valve H Hole
11 Location Hole
12 Kit Tubing (Input and Output)
Chapter 1 Product information
System overview
1
14 CTS™Rotea™Counterflow Centrifugation System User Guide

Wetted components
The materials used in the manufacturing of the CTS™Rotea™Single-Use Kit have been chosen for their
biological and chemical compatibility.
Component Description Material
Pump tubing
Pump tube Bioprene
Kit tubing
0.160” OD, 0.116” ID
(4 mm OD, 3 mm ID)
DEHP-FREE PVC
CFC ChamberC
Base Tritan MX711
Cone Tritan MX711
Rotary Coupling
O-Rings EPDM, 70 DURO, FDA compliant
Cannular 316 SS
Cap Tritan MX711
Body Tritan MX711
Bush & Collar Ketron LSG Peek Classix, USP
Class VI
Bubble Trap
Base Tritan MX711
Cap Tritan MX711
Fittings
Triple Y Connector PVC
Barbed T-Connector Polyproylene
Allowed chemicals for wetted surfaces
Chemical Concentration Maximum exposure time
WFI 100% 5 minutes
Ethanol in water 50% 5 minutes
Culture media 100% 5 minutes
Chapter 1 Product information
System overview 1
CTS™Rotea™Counterflow Centrifugation System User Guide 15

Installation and setup
Packaging contents
•Rotea™instrument
•Hanger posts (2 o)
•Mains plug IEC cables (USA/EUROPE/AUSTRALIA)
•Pre-fitted mains fuses (2 x 5A)
•USB-C (male) to USB-C (female)
•Dell™2‑in‑1 laptop tablet (this will be in a separate carton)
Instrument installation
•Remove outer packaging
•Prepare bench space to receive Rotea™instrument unit (see “Working space” on page 10)ensuring
that there is easy access to the “On/O” switch and mains IEC connector at the rear of the
instrument
CAUTION! The Rotea™instrument should be installed on a stable bench. If a mobile set up is used,
it is the user’s responsibility to ensure all safety hazards and functional risks are addressed including
adequately supporting the weight of the instrument and having sucient wheel span so that both the
trolley and instrument are stable.
•Ensure that the bench is stable and level to within ±0.4" (10 mm)
•Position the instrument on the bench with a minimum of 4" (10 m) between the rubber feet and the
edges of the bench
CAUTION! The Rotea™instrument weighs 40 lbs (18 kg) excluding hanger bag posts. Use
appropriate care and seek assistance if necessary when lifting or moving the instrument. Lift the
instrument, holding between the rubber feet on the bottom of the instrument.
CAUTION! Do not position the instrument is such a way that it would make it dicult to disconnect
the power cord from the power inlet.
CAUTION! If using an alternate mains cable, ensure it is rated for at least 10A.
2
16 CTS™Rotea™Counterflow Centrifugation System User Guide

Note: Suitable means of protective earthing are provided for this device
12
Figure 5 Back view of instrument
1Mains IEC connector
2USB-C port
1. Connect mains IEC connector.
2. Plug mains into power GPO
3. Connect the laptop to USB-C port on the instrument using the USB-C cable.
4. Insert 2 o bag hanger posts, adjust height to suit Kit and turn nut clockwise to secure in place.
5. Adjust the instrument position on the bench where it is required.
Chapter 2 Installation and setup
Instrument installation 2
CTS™Rotea™Counterflow Centrifugation System User Guide 17

Power instrument “On”
1. Switch on using the mains IEC switch at the rear of the instrument.
1
2. The instrument button lights will sequence as the instrument powers up. If the door is closed, the
instrument will automatically check if a Single-Use Kit is installed.
Chapter 2 Installation and setup
Power instrument “On”
2
18 CTS™Rotea™Counterflow Centrifugation System User Guide

Power instrument “O”
Switch o the instrument using the mains IEC switch or mains power.
1
CAUTION! There is no automatic recovery procedure. If a loss of power event has occurred see
“Restart after shut down” on page 117.
Chapter 2 Installation and setup
Power instrument “O” 2
CTS™Rotea™Counterflow Centrifugation System User Guide 19

Installation
The Dell™2‑in‑1 laptop will be pre-installed with Windows™OS. The latest CTS™Rotea™Graphical User
Interface (GUI) software will need to be installed onto the Dell™2‑in‑1 laptop provided. New releases of
the Rotea™GUI software will be available for download from thermofisher.com.
1. Download the Rotea-X.X.X.exe installer.
Chapter 2 Installation and setup
Installation
2
20 CTS™Rotea™Counterflow Centrifugation System User Guide