Thermo Fisher Scientific CTS Rotea User Manual
CTS™ Rotea™ Counterflow Centrifugation
System
USER GUIDE
Catalog Number A44769
Publication Number MAN0018908
Revision B.0
For Research Use or Manufacturing of Cell, Gene, or Tissue- Based
Products.
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 fill and finish
applications. 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
B.0 02 December 2020 Minor change to CTS™ Rotea™ Counterflow Centrifugation System
A.0 20 October 2020 New document. User guide for new workflow.
specific disclaimer statement.
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
™
Rotea™ Counterflow Centrifugation System User Guide
CTS
3
Contents
■
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
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CTS™ 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
Contents
■
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
CTS™ Rotea™ Counterflow Centrifugation System User Guide
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Contents
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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
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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 dierent cell types.
The CTS™ Rotea™ Single-Use Kit is specifically designed for a range of cell processing applications
such as separation, isolation, buer 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.
Product information
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
CTS™ Rotea™ Centrifuge 1 ea
CTS™ Rotea™ Single-Use Kit Available separately
Protocol Development Application 1 ea
Amount
Dell™ 2-in-1 laptop for operation/programming 1 ea
CTS™ Rotea™ Counterflow Centrifugation System User Guide
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2
1
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Chapter 1 Product information
1
System overview
System overview
Instrument description
Figure 1 Instrument – Front View
Instrument Door
1
Pinch Valves (J & K)
2
Kit Location Button
3
2D Barcode Reader
4
CFC Chamber Detector
5
CFC Chamber Carrier
6
Camera
7
Moisture Sensor
8
Pushbutton Controls
9
8
Optical Density Sensor & Pressure Sensor (P1)
10
Peristaltic Pump
11
Pump Clamp Arm
12
Pinch Valve (H)
13
Kit Location Button & Pressure Sensor (P2)
14
Door Latch
15
Pinch Valves (A, B, C, D, E, F, & G)
16
Bubble Sensors
17
Hanger Posts
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CTS™ Rotea™ Counterflow Centrifugation System User Guide
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7
6
5111
1
432
Chapter 1 Product information
System overview
1
Figure 2 Instrument – Rear View
Power Switch
1
Mains Connector
2
CAN bus (2 o)
3
Ethernet (RJ-45)
4
USB-C
5
Bag Hooks
6
Hanger Post
7
Hanger Post Adjustment
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1
Chapter 1
System overview
Product information
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.
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CTS™ Rotea™ Counterflow Centrifugation System User Guide
Instrument properties
Chapter 1 Product information
System overview
1
Category
Electrical
Sound level
Environmental ranges
Property Value
Supply voltage 100–240 V AC ±10%, 50/60 Hz
Phases Single
Maximum Rated Input Current 5 A
Fuses 2 x 5 A
Maximum sound level 70 dBA (measured 1 m from instrument)
Typical sound level 65 dBA (measured 1 m from instrument)
Ambient temperature 15℃ to 30℃
Transport temperature 0℃ to 45℃
Storage temperature 15℃ to 30℃
Maximum relative humidity 80% (non-condensing)
Operating limits
Altitude (max.) 2000 m
Indoor use only —
Not intended for use in a wet
location
Intended for use in Pollution
degree 2 environment
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
—
—
CTS™ Rotea™ Counterflow Centrifugation System User Guide
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Chapter 1 Product information
1
System overview
(continued)
Category
CAN bus connection
Property Value
Minimum concentrate recovery
volume
Centrifuge chamber volume 10 mL chamber containing up to 4 × 109 cells (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 × 106 cells/mL (cell type and operating
parameters dependent)
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
5 mL (subject to protocol optimization)
Pin 4 - GND - Ground
Pin 5 - GND - Shield, optional
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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.
Chapter 1 Product information
System overview
1
Figure 3 Instrument push button controls
Light
Push button
operation
Solid Push button to stop
Flashing Instrument has
STOP START/PAUSE ADVANCE DOOR UNLOCK
the instrument and
the current protocol
stopped due to
an alarm condition.
User intervention is
required.
Push button to start
the Protocol, pause
the current step in
the protocol or re-
start a paused step
Instrument is in a
paused condition.
Pressing allows
the instrument to
continue the current
step of the protocol.
Push button to
advance to the next
step in the protocol
Button can be
pushed, advancing
to the next step of
the protocol
Push button to
unlock the door
N/A
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6
3
5
1
2
4
7
8
9
10
11
12
Chapter 1 Product information
1
System overview
CTS™ Rotea™ Single-Use Kit schematic
The CTS™ Rotea™ Single-Use Kit enables users to configure kits to suit dierent protocols by adding
input and output vessels. Unused fluid lines are simply left sealed o.
Figure 4 CTS™ Rotea™ Single-Use Kit
Valve Hole & Tube ID
1
Carrier Frame
2
Bubble Trap
3
Location Hole
4
CFC Chamber
5
Rotary Coupling
6
14
2D Barcode
7
Pump Tubing
8
Tube Retainer
9
Valve H Hole
10
Location Hole
11
Kit Tubing (Input and Output)
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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
Kit tubing
Chapter 1 Product information
System overview
Pump tube Bioprene
1
CFC ChamberC
Rotary Coupling
Bubble Trap
0.160” OD, 0.116” ID
(4 mm OD, 3 mm ID)
Base Tritan MX711
Cone Tritan MX711
O-Rings EPDM, 70 DURO, FDA compliant
Cannular 316 SS
Cap Tritan MX711
Body Tritan MX711
Bush & Collar Ketron LSG Peek Classix, USP
Base Tritan MX711
Cap Tritan MX711
DEHP-FREE PVC
Class VI
Fittings
Triple Y Connector PVC
Barbed T-Connector Polyproylene
Allowed chemicals for wetted surfaces
Chemical
WFI 100% 5 minutes
Ethanol in water 50% 5 minutes
Culture media 100% 5 minutes
CTS™ Rotea™ Counterflow Centrifugation System User Guide
Concentration Maximum exposure time
15
2
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
Installation and setup
CAUTION! The Rotea
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 sucient 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
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 dicult to disconnect
the power cord from the power inlet.
CAUTION! If using an alternate mains cable, ensure it is rated for at least 10A.
™
instrument should be installed on a stable bench. If a mobile set up is used,
™
instrument weighs 40 lbs (18 kg) excluding hanger bag posts. Use
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1
2
Chapter 2
Note: Suitable means of protective earthing are provided for this device
Installation and setup
Instrument installation
2
Figure 5 Back view of instrument
Mains IEC connector
1
USB-C port
2
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.
CTS™ Rotea™ Counterflow Centrifugation System User Guide
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1
Chapter 2 Installation and setup
2
Power instrument “On”
Power instrument “On”
1.
Switch on using the mains IEC switch at the rear of the instrument.
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.
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CTS™ Rotea™ Counterflow Centrifugation System User Guide
Power instrument “O”
1
Switch o the instrument using the mains IEC switch or mains power.
Chapter 2 Installation and setup
Power instrument “O”
2
CAUTION! There is no automatic recovery procedure. If a loss of power event has occurred see
“Restart after shut down” on page 117.
CTS™ Rotea™ Counterflow Centrifugation System User Guide
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Chapter 2 Installation and setup
2
Installation
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.
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CTS™ Rotea™ Counterflow Centrifugation System User Guide
Chapter 2
2.
Run the Rotea-X.X.X.exe installer. Click Install. The application will be installed in C:\Program
Files (x86)\Rotea\.
Installation and setup
Installation
2
3.
Click Close to finish the app installation.
4.
Power on the Rotea™ instrument (with the switch on the back) and plug it into the laptop.
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Chapter 2 Installation and setup
2
Installation
5.
The next step is to update Windows™ software. Make sure the laptop is connected to the local wifi
network. This can be done by opening the start menu and searching for Check for updates.
6.
Click Check for updates, Install now and restart the laptop as required. This process may need
to be repeated multiple times until Windows™ software is completely up to date.
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CTS™ Rotea™ Counterflow Centrifugation System User Guide
Chapter 2
7.
Check if Windows Update installed the required USB device drivers. Right click on This PC on the
desktop and open Manage.
8.
Ensure the USB devices are detected correctly. Check that the devices highlighted in figure can be
seen:
•
USB Vision Digital Camera
•
USB Serial Port (COM X)
•
SNAPI Imaging Interface
Installation and setup
Installation
2
Note: If these devices are missing ensure the USB cable is plugged in, the Rotea™ instrument is
powered and on, that there are no more Windows™ software updates to complete.
9.
The installation is now complete. Move onto setting up the application for the first time.
CTS™ Rotea™ Counterflow Centrifugation System User Guide
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Chapter 2 Installation and setup
2
First time setup
First time setup
1.
Push the power button on the laptop to start Windows™ software.
2.
Run the Rotea™ application from the desktop or start menu. The application has a single admin
user with Username: admin, Password: admin on a fresh installation.
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CTS™ Rotea™ Counterflow Centrifugation System User Guide
Chapter 2 Installation and setup
First time setup
3.
The main navigation menu in the top right corner is used to get to all areas of the applications.
2
4.
Click the Settings in the navigation menu to set the instrument name. Edit the instrument name if
required.
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2
Chapter 2
First time setup
5.
Installation and setup
Click User Management in the navigation menu to change the admin username/password. This
page shows all the users configured for in the application. Click the admin user to change the
account details. New users can be added with the + button.
6.
Change the admin user account username, password and the default directory for this user to find
protocols. Click Save for any changes.
7.
The configuration is now complete.
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CTS™ Rotea™ Counterflow Centrifugation System User Guide
Download protocols
Create protocols
Protocols comprise a series of individual steps that are to be perfomed by the instrument. Triggers are
used to define when the instrument will move to the next step. A range of existing protocols can be
downloaded from the Thermo Fisher Scientific portal.
Users can also modify existing protocols or create entirely new protocols using the Rotea Protocol
App that can be installed on any Windows™ PC, laptop or tablet.
Protocols can be saved for future retrieval using the GUI.
The Rotea Protocol App can be accessed at any time by clicking on the icon on the desktop.
Chapter 2 Installation and setup
Download protocols
2
Load a protocol
1.
Click on the Select a Protocol button
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Chapter 2 Installation and setup
2
Download protocols
2.
Click Browse or Select a Protocol to browse for a protocol stored locally or on any connected
devices.
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CTS™ Rotea™ Counterflow Centrifugation System User Guide
Chapter 2 Installation and setup
Download protocols
3.
Double click the required protocol to display the filename in the Protocol File text box.
2
4.
Click on Select Protocol.
Note: If an invalid protocol is selected, a warning box will be displayed.
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Chapter 2 Installation and setup
2
Download protocols
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CTS™ Rotea™ Counterflow Centrifugation System User Guide
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