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Thermo Fisher Scientific CTS DynaCellect Magnetic Separation System User guide

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For Research Use or Manufacturing of Cell, Gene, or Tissue- Based
Products. CAUTION: Not intended for direct administration into
humans or animals.
CTS™ DynaCellect™ Magnetic Separation
System
USER GUIDE
Catalog NumberA55867
Publication Number MAN0026480
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.
Revision history:Pub.No. MAN0026480
Revision Date Description
A.0 13 October 2022 New document for CTS™ DynaCellect™ Magnetic Separation System.
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.
Important Licensing Information: These products may be covered by one or more Limited Use Label Licenses. By use of these
products, 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.
©2022 Thermo Fisher Scientific Inc. All rights reserved.
Contents
■CHAPTER1Productinformation .................................................. 8
Productdescription ............................................................. 8
Single-UseKits ............................................................. 9
Storage .................................................................... 9
Instrument features .............................................................. 9
Contents ...................................................................... 10
Required materials notsupplied ................................................. 10
Embedded Graphical User Interface (eGUI) features ................................ 10
Process developmentmode ................................................ 10
Clinical manufacturingmode ................................................ 11
System overview ............................................................... 11
Instrumentdimensions ..................................................... 14
Workingspace ............................................................ 14
Instrumentweight ......................................................... 14
Productspecifications ...................................................... 15
CTS™ DynaCellect™ Single-Use Kitschematic ................................. 17
Tube sets volume overview ................................................. 18
Single-Use Kitpackaging ................................................... 21
Wettedcomponents ....................................................... 22
■CHAPTER2Installation andsetup ............................................... 23
Packaging contents ............................................................ 23
Upon receiving theinstrument ................................................... 23
Unpack theinstrument ......................................................... 24
Installing theinstrument ......................................................... 28
Installation ................................................................ 28
Power instrument"On" ......................................................... 32
Power instrument"O" ......................................................... 32
CTS™ DynaCellect™ Magnetic Separation System User Guide 3
■CHAPTER3Embedded graphical user interface (eGUI) userinstructions ... 33
Home screen .................................................................. 33
User interface overview ......................................................... 34
Touch screen controls .......................................................... 35
Status indicators .......................................................... 35
Enter text ................................................................. 36
Enternumbers ............................................................ 37
Connect the instrument to the internet ............................................ 37
Set up a wiredconnection .................................................. 38
Create a user profile on theinstrument ............................................ 41
Manage userprofiles ........................................................... 42
Change a userPIN ......................................................... 42
Delete a userPIN .......................................................... 42
Add a userprofile .......................................................... 42
Delete a userprofile ........................................................ 43
Assign or remove administratorprivileges ..................................... 43
Manualmode .................................................................. 43
Manage protocols .............................................................. 44
Protocol parameters ....................................................... 45
Create protocols ........................................................... 45
Create protocol steps ...................................................... 54
Prompts .................................................................. 66
Run protocol .................................................................. 68
Pause protocol ................................................................ 78
Skip step ..................................................................... 79
Stop protocol .................................................................. 80
Import a protocol .............................................................. 81
Export a protocol .............................................................. 83
Edit protocols ................................................................. 87
Systemsettings ................................................................ 93
Software updates .......................................................... 93
OPC-UA ...................................................................... 96
■CHAPTER4OPC-UA interface ................................................... 97
Introduction ................................................................... 97
Definitions .................................................................... 97
MES Interface ................................................................. 98
Background ............................................................... 98
Architecture ............................................................... 99
Initial OPC-UASetup .......................................................... 100
AccessMethods ......................................................... 101
Contents
4CTS™ DynaCellect™ Magnetic Separation System User Guide
Enable OPC-UA .............................................................. 108
Import protocol for OPC-UA .................................................... 110
OPC-UA interface ............................................................. 114
Informationmodel ........................................................ 114
Monitoring ............................................................... 115
Controlling ............................................................... 118
■CHAPTER5Maintenance ....................................................... 119
Cleaning and maintenance ..................................................... 119
Power andfuses .............................................................. 120
Powersupply ............................................................ 120
Fuses ................................................................... 120
Restore factory settings (Administrator profileonly) ................................ 123
Repackaging theinstrument .................................................... 123
Repackaging and storageinstructions ....................................... 124
■CHAPTER6Basic instrument operation ....................................... 125
Unpack Single-UseKits ....................................................... 125
Connecting vessels, bags and reagents .......................................... 127
Prepare consumables for arun ................................................. 128
Example consumableconfiguration ......................................... 128
Bags and connectors ..................................................... 130
Prepare bags (for DPBS/1% HSA, waste, output,cells) ........................ 131
Prepare conical bag (for beadinput) ........................................ 134
Transfer the beads to bag with a vial adapter ................................. 135
Welding transfer bags tokit ................................................ 137
Install CTS™ DynaCellect™ Cell Isolation Kit on theinstrument ...................... 139
Install CTS™ DynaCellect™ Bead Removal Kit on theinstrument .................... 148
Initiate a protocol ......................................................... 150
Isolation protocol overview ..................................................... 151
Bead removal protocol overview ................................................ 151
Remove Single-UseKit ........................................................ 152
Aseptic disconnection of the kitcomponents ................................. 154
Contents
CTS™ DynaCellect™ Magnetic Separation System User Guide 5
■CHAPTER7Safetyinstructions ................................................ 155
Labels ....................................................................... 155
Emergency procedures ........................................................ 155
Instrument emergency stopevent .......................................... 155
Emergency shutdown .................................................... 156
Restart after shutdown ................................................... 156
Protocol recovery process ................................................. 157
Warnings and precautions ..................................................... 158
Warnings ................................................................ 158
Cautions ................................................................ 159
■APPENDIXATroubleshooting .................................................. 160
■APPENDIXBErrorlists .......................................................... 162
Definitions/Acronyms .......................................................... 162
System errorlist .............................................................. 163
BLDC errorlist ................................................................ 166
VCB errorlist ................................................................. 167
MCB errorlist ................................................................ 171
■APPENDIXCRecommended instrumentsettings ............................ 173
Aboutinstrument ............................................................. 173
Recommended instrumentsettings ............................................. 173
Instrument settings (administratoronly) .......................................... 174
Maintenance and service ...................................................... 176
Run history ................................................................... 177
■APPENDIXDRelated products ................................................. 178
Additional products ........................................................... 178
■APPENDIXESafety .............................................................. 180
Symbols on thisinstrument .................................................... 180
Safetylabels ............................................................. 181
Location of safetylabels ................................................... 182
Safetycompliance ........................................................ 183
Contents
6CTS™ DynaCellect™ Magnetic Separation System User Guide
Informationalsymbols ..................................................... 183
Symbolesd’information ................................................... 184
Instrumentsafety ............................................................. 185
General ................................................................. 185
Physical injury ............................................................ 186
Electricalsafety .......................................................... 187
Cleaning anddecontamination ............................................. 187
Instrument component and accessorydisposal .............................. 188
Environmental requirements .................................................... 188
Electromagnetic compatibility (EMC) standards ................................... 188
Class Anotice ............................................................ 188
EMCcompliance ......................................................... 189
Environmental design standards ................................................ 190
Electricalsafety ............................................................... 190
MagnetSafety ................................................................ 191
Chemicalsafety .............................................................. 192
Biological hazardsafety ....................................................... 193
Servicepersonnel ............................................................. 193
Safety precautions ........................................................ 194
Return touse ............................................................ 195
■APPENDIXFDocumentation and support ..................................... 196
Customer and technical support ................................................ 196
Limited product warranty ...................................................... 196
Contents
CTS™ DynaCellect™ Magnetic Separation System User Guide 7
Product information
IMPORTANT! Before using this product, read and understand the information in the “Safety” appendix
in this document.
Product description
The Gibco™ CTS™ DynaCellect™ Magnetic Separation System is an instrument for automated, magnetic
cell separation and bead removal. The instrument is accommodated by single-use fit-for-purpose kits
for cell isolation and bead removal. The key feature of the instrument is an automated magnet. The
magnet is situated on a rocker, which enables mixing of cells and beads during cell-bead incubation.
Automated fluid management is achieved by a peristaltic pump and pinch valves allowing transfer
of fluid between bags. Fluid movement and pressure is monitored by bubble sensors and pressure
occlusion sensors, respectively. Customizable software enables flexibility from process development to
commercial manufacturing. The closed and automated configuration minimize failures in manufacturing,
oering operator independent results and reduced contamination, while providing increased precision
and scalability.
1
8CTS™ DynaCellect™ Magnetic Separation System User Guide
Single-Use Kits
The CTS™ DynaCellect™ Cell Isolation Kit and the CTS™ DynaCellect™ Bead Removal Kit are specifically
designed Single-Use Kits for a range of cell processing applications such as isolation, depletion and
bead removal. Each kit has input/output sterile weldable tubes for flexible setup configurations. See
“CTS™ DynaCellect™ Single-Use Kit schematic” on page17.
Storage
Store at ambient temperature. Storage at this temperature does not lead to decrease in magnetism.
Protect the CTS™ DynaCellect™ Magnetic Separation System from vibration and keep out of direct
sunlight.
Instrument features
•Automated magnet
•Rocker
•Embedded Graphical User Interface (eGUI) with 8” touch screen display (800px × 600px)
•8 GB storage capacity for protocols
•Fluidics panel:
–11 pinch valves, 2 pressure occlusion sensors, 2bubble sensors, peristaltic pump, peristaltic
pump cover
•Overfill detector
•Leakage sensor
•Lid sensor
•HEPA filter
•2Bag hangers
•2 Pole extensions
•2 Pole adaptors
•3 USB ports
–USB port ready for barcode scanner
•Ethernet port
•Power inlet
•Power switch
Chapter1Product information
Instrument features 1
CTS™ DynaCellect™ Magnetic Separation System User Guide 9
Contents
Table1CTS™ DynaCellect™ Magnetic Separation System (Cat.No.A55867)
Component Quantity
CTS™ DynaCellect™ Magnetic Separation System 1
Power cord 1
Ethernet cable 1
Pole extension 2
Bag hanger 2
Pole adaptor 2
Quick reference guide 1
Installation guide 1
Required materials not supplied
Unless otherwise indicated, all materials are available through thermofisher.com.
Catalog numbers that appear as links open the web pages for those products.
Item Source
CTS™ DynaCellect™ Cell Isolation Kit A52300
CTS™ DynaCellect™ Bead Removal Kit A52301
Embedded Graphical User Interface (eGUI) features
The embedded graphical user interface (eGUI) is where you control the instrument and user access.
See Chapter 3, “Embedded graphical user interface (eGUI) user instructions”.
Process development mode
•Parameters
–Magnet: engaged/disengaged
–Pinch valves: open/closed
–Pump speed: 10–150mL/min
–Pump: specified volume or duration
Chapter1Product information
Contents
1
10 CTS™ DynaCellect™ Magnetic Separation System User Guide
–Rocker angle: -30° to 30°
–Rocker speed: 1–30 CPM (cycles per minute)
•Export summary reports (sample ID, run ID, Single-Use Kit lot, bead lot, operator, date)
•DeltaV™ system communication via OPC UA (under development)
Clinical manufacturing mode
•Locked, standardized cell processing protocols
–Cell isolation
–Cell depletion
–Bead removal
•eBatch Records
–Enable 21 CFR part 11 compliance with SAE Administrator Console Software2.1
System overview
CAUTION! This device contains extremely powerful permanent magnets. Keep ferromagnetic and
ferromagnetically-sensitive material away from the magnetic surfaces and associated fields. Do not
bring tools, equipment or personal items containing steel, iron or other magnetic materials close to
the magnets. The strong magnetic field can erase magnetic media such as hard disc drive (HDD)
memory devices, disable ATM and credit cards, and can damage some watches. Strong magnetic
fields can also cause serious injury to persons with implanted or attached medical devices, such as
pacemakers and prosthetic parts.
The Health and Safety Ocer should take all necessary steps and full responsibility to ensure that
the precautions and statements are followed and adhered to. IN NO EVENT SHALL Thermo Fisher
Scientific BE LIABLE FOR ANY SPECIAL, INCIDENTIAL OR CONSEQUENTIAL DAMAGES.
Chapter1Product information
System overview 1
CTS™ DynaCellect™ Magnetic Separation System User Guide 11
6
10
18
32
1
16
17
15
14
12
98
13
11 7
5
4
Figure1Front view
1Lid
2Pole extension
3Pole adaptor
4Bag hanger
5Pinch valve
6Fluidic panel
7Pressure occlusion sensor
8Peristaltic pump
9Bubble sensor
10 USB port
11 Emergency stop button
12 Embedded Graphical User Interface (eGUI)
13 Tube guide for upstream or downstream connection
14 Rocker guard
15 Rocker with integrated magnet
16 Leakage detection sensor and overfill detector
17 Tube guide
18 Nest
Chapter1Product information
System overview
1
12 CTS™ DynaCellect™ Magnetic Separation System User Guide
2
3
4
6
5
1
Figure2Rear view
1Exhaust filter
2USB 2.0 port
3USB wireless adaptor port
4Ethernet
5Power switch
6Power cable inlet
Chapter1Product information
System overview 1
CTS™ DynaCellect™ Magnetic Separation System User Guide 13
Instrument dimensions
The dimensions for the CTS™ DynaCellect™ Magnetic Separation System are:
•Height: 19" (495mm with pole base), 17" (434mm without pole base)
•Width: 29.5" (749.5mm)
•Depth: 22.12" (562mm)
Working space
The CTS™ DynaCellect™ Magnetic Separation System is designed for benchtop use and requires a
working space of approximately height 495mm (19") with pole base and 434mm (17") without pole
base, width 749.5 mm (29.5"), depth 562 mm (22.12"). The system can also be placed on a cart.
Instrument weight
The CTS™ DynaCellect™ Magnetic Separation System weighs 49.75kg (109.7lbs) (50.6kg/111.6lbs
with poles and bag hangers).
Chapter1Product information
System overview
1
14 CTS™ DynaCellect™ Magnetic Separation System User Guide
Product specifications
Category Property Value
Electrical
Supply voltage 100–240 VAC ±10%, 50/60Hz,
600W
Phases Single
Maximum rated input current 6A
Fuses 2×10A
Instrument
Regulatory requirements HEPA filter meets ISO 14644-14
Installation category II
Instrument type Benchtop/cart unit
Instrument dimensions 495mm (19") with pole base/
434mm (17") without pole
base (H)×749.5mm (29.5")
(W)×562mm (22.12") (D)
Instrument weight 49.75kg (109.7lbs)
(50.6kg/111.6lbs with poles and
bag hangers)
Built-in features 8” touch screen display
(800×600px)
Sound level
Operating sound level 73 dBA (measured 1 m from
instrument)
Non-operating sound level 63 dBA (measured 1 m from
instrument)
Environmental ranges
Ambient temp 15°C to 30°C
Transport temperature -30°C to 60°C (extreme end
temperatures at maxium 72hours)
Storage temperature 15°C to 30°C
Relative humidity 15%–80% (non-condensing)
Operating limits
Magnet Engaged/Disengaged
Chapter1Product information
System overview 1
CTS™ DynaCellect™ Magnetic Separation System User Guide 15
(continued)
Category Property Value
Pinch valves Open/Closed
Pump speed 10–150mL/min
Rocker angle -30° to 30°
Rocker speed 1-30 CPM (cycles per minute)
Pressure occlusion sensor Max 2 Bar. Only detect liquid
pressure (not pressure build up by
air).
Following lines are not covered:
•CTS™ DynaCellect™ Cell
Isolation Kit – Ports B and K
•CTS™ DynaCellect™ Bead
Removal Kit – Ports B, D and
E
Height rocker lid (isolation) 35mm (1.4")
Height rocker lid (bead removal) 5mm (0.2")
Overfilled detection 1120 mL (static and rocking)
Magnet
Magnet dimensions 265×205mm (10.4"×8.07")
Magnetic strength ≥6000G
Pole
Max height 1070 mm (42.13") from the
bottom of the rubber foot of the
instrument to the tip of the bag
hanger hook point
Pole adaptor
Max weight 3kg (6.6lbs) per hook on bag
hanger. Total 15kg (33lbs) per
bag hanger
Use
Indoor use only
Not intended for use in a wet
environment
Intended for use in Pollution
degree 2 environment
Chapter1Product information
System overview
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16 CTS™ DynaCellect™ Magnetic Separation System User Guide
CTS™ DynaCellect™ Single-Use Kit schematic
8
6
5
4
3
2
1
7
1PVC tubing
2Tube holder
3Silicone tubing
4Sterile air filter
5Oetiker clamps
6Cassette
7Bioprene tubing
8Isolation bag
Figure3CTS™ DynaCellect™ Cell Isolation Kit (Cat. No. A52300)
•8 weldable PVC lines [150 mm (5.91") (length), 2.4 mm (0.094") ID, 4.0mm (0.157") OD]
•Sterile air filter: 0.20 micron
•Max capacity of isolation bag: 1000mL
•Ease of use cassette and tube holder for loading of tubing set
Chapter1Product information
System overview 1
CTS™ DynaCellect™ Magnetic Separation System User Guide 17
8
6
5
4
3
2
1
7
1PVC tubing
2Tube holder
3Silicone tubing
4Sterile air filter
5Oetiker clamps
6Cassette
7Bioprene tubing
8Bead removal bag
Figure4CTS™ DynaCellect™ Bead Removal Kit (Cat. No. A52301)
•4 weldable PVC lines [150 mm (5.91") (length), 2.4 mm (0.094") ID, 4.0mm (0.157") OD]
•Sterile air filter: 0.20 micron
•Continuous processing
•Ease of use cassette and tube holder of tubing set
IMPORTANT! Store the CTS™ DynaCellect™ Single-Use Kit at 15–30°C.
CAUTION! The CTS™ DynaCellect™ Single-Use Kit (Cat. Nos. A52300 and A52301) have been
validated for one-time use by customers. Single-Use Kits are not recommended to be washed,
re-sterilized, or reused as sterility and quality of these kits have not been validated for multiple uses.
Tube sets volume overview
The Single-Use Kits consist of three dierent tubing: silicone, bioprene, and PVC. The tube types and
dimensions are indicated, see Figure5. In Figure6, the “dead volume” for the dierent tube lines is
indicated.
Chapter1Product information
System overview
1
18 CTS™ DynaCellect™ Magnetic Separation System User Guide
1
2
3
1
Figure5Tube types and thickness
Cell isolation kit (left) and Bead removal kit (right)
1PVC: 0.094in ID 0.157in OD; 2.4mm ID 4.0mmOD
2Silicone: 0.125in ID 0.25in OD; 3.2mm ID 6.4mmOD
3Bioprene: 0.125in ID 0.25in OD; 3.2mm ID 6.4mmOD
The dead volume is calculated based on tube diameter and length, using the following formula:
V = A h
Since the area of a circle = π r2, then the formula for the volume of a cylinder is:
V = π r2 h
Note: The volume in mL for each tube is indicated in Figure6. This enables you to adjust for
modifications to the input/output line, by e.g. welding particularly short or long tube lines. While
it is recommended to keep the welding distance from the Single-Use Kits to cell/bead/buer bags
consistent between runs using the same protocol, note that the dead volume per inch/cm is relatively
low. Millimeter precision is therefore not necessary when welding bags onto the Single-Use Kits from
run to run.
Chapter1Product information
System overview 1
CTS™ DynaCellect™ Magnetic Separation System User Guide 19
1
2
3
1
BCD E F GH I
A
0.7 0.7 0.7 0.7 0.7 0.70.7 0.7 0.7 0.7 0.70.7
D E F GH
A B
0.8
0.8 4.10.8
3.1
3.4 3.6 4.04.5
9.3 10.4
3.6 3.1 3.2 2.9 2.9 3.13.3
8.0
0.4
0.5
1..3
3.7
2..3 0.8
Figure6Dead volume in Single-Use Kits
Cell isolation kit (left) and Bead removal kit (right). The numbers show the volume (mL) for each tube.
1PVC: mL per in: 0.11; mL per cm: 0.05
2Silicone: mL per in: 0.2; mL per cm: 0.08
3Bioprene: mL per in: 0.2; mL per cm: 0.08
Chapter1Product information
System overview
1
20 CTS™ DynaCellect™ Magnetic Separation System User Guide
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