Thermo Fisher Scientific CTS Cellmation Software User guide

Type
User guide
For Research Use or Manufacturing of Cell, Gene, or Tissue- Based
Products.
CTS Cellmation Software for DeltaV
System
SITE PREPARATION GUIDE
Catalog NumbersA59196, A59197, A59198
Publication Number MAN0029206
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:MAN0029206 A.0 (English)
Revision Date Description
A.0 29 August 2023 New document. CTS Cellmation Software for DeltaV System Site Preparation Guide.
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.
NOTICE TO PURCHASER: DISCLAIMER OF LICENSE: Purchase of this software product alone does not imply any license under any
process, instrument or other apparatus, system, composition, reagent or kit rights under patent claims owned or otherwise controlled by
Thermo Fisher Scientific, either expressly, or by estoppel.
TRADEMARKS: All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. DeltaV is a
trademark of Emerson Process Management.
©2023 Thermo Fisher Scientific Inc. All rights reserved.
Contents
CHAPTER1Productinformation .................................................. 5
Productiondescription ........................................................... 5
Site preparation requirements as per customer categories ............................ 6
CHAPTER2Software and hardwaresetup ....................................... 8
Minimum DeltaV System Architecture for CTS Cellmation softwaresetup ........... 9
Summary of minimum hardware and software items required for CTS
Cellmation softwaresetup ................................................... 11
Hardwarecomponents ..................................................... 11
Software licenses (refer to License Calculator) ................................. 11
Notes for Emerson Solutions Architects ........................................... 13
Requirements for CTS Cellmation software ................................. 13
Thermo Fisher Scientificinstruments ......................................... 13
Version Control and Historian ............................................... 13
DeltaV hardware and software required items – New DeltaV system ................ 14
CHAPTER3Preinstallation qualifier information ............................... 20
Site Preparation CheckQualifier ................................................. 20
Preinstallation information for Thermo Fisher Scientific representatives ............... 21
CHAPTER4Instrumentinformation ............................................. 22
Rotea, Xenon, and DynaCellectinstruments ................................... 23
CryoMed Controlled Rate Freezer with OPC UA .................................. 24
HeraCell VIOS 160i CR Incubator .............................................. 25
HeraCell VIOS 250i CR Incubator .............................................. 26
HeraCell VIOS CR incubatorstacking .......................................... 27
CHAPTER5Test OPC UA connection using ProSys OPC UA
Simulation Server .................................................................. 28
Install ProSys OPC UA Stimulation Server ......................................... 28
CTS Cellmation Software for DeltaV System Site Preparation Guide 3
APPENDIXADeltaV Architecture .............................................. 38
DeltaV Architecture1 .......................................................... 39
DeltaV Architecture2 .......................................................... 41
DeltaV Architecture3 .......................................................... 43
DeltaV Architecture4 .......................................................... 45
DeltaV Architecture ........................................................... 47
APPENDIXBDocumentation and support ...................................... 48
Customer and technical support ................................................. 48
Limited product warranty ........................................................ 48
Contents
4CTS Cellmation Software for DeltaV System Site Preparation Guide
Product information
Production description
The Gibco CTS Cellmation software (based on the Emerson DeltaV platform) is an open, fully-
configurable software solution designed to provide a flexible system for the control of Thermo Fisher
Scientific cell therapy manufacturing instruments. CTS Cellmation software is powered by the
DeltaV system from Emerson Process Management and is fully compatible with DeltaV system
version 14.LTS.
The software has been developed according to GAMP5 methods. It ensures traceable, reproducible,
and secure data storage with DeltaV Continuous Historian, meeting the requirements of 21CFR
Part 11/Annex 1 for current good manufacturing practice (cGMP) compliance. It is optimized to allow
easy scaling to accommodate R&D, process development, and manufacturing.
The software must be installed on the DeltaV workstation controlling/viewing cell therapy
manufacturing operations. The exceptions are the application stations that may be used for purposes
other than control (e.g., continuous history storage, batch history storage and install batch executive).
The CTS Cellmation software requires a DeltaV MQ, MX or PK controller and an OPC UA Client
interface. The OPC UA Client can reside on an Ethernet Input Output Card (EIOC) or an Application
Station.
1
CTS Cellmation Software for DeltaV System Site Preparation Guide 5
Site preparation requirements as per customer categories
Table1Site preparation requirements as per customer categories
No. Requirements to check
Customer site category
Expansion to existing DeltaV
system with IT support
No DeltaV system and IT
support
No DeltaV system and IT
support
1 DeltaV system version:
Recommended DeltaVsystem
v14.LTS for Cellmation
software setup
Make sure the existing DeltaV
system have the DeltaV
system Version 14.LTS.
Make sure to purchase
DeltaV system Version 14.LTS.
Recommended DeltaV system
v14.LTS English.
Make sure to purchase DeltaV
system Version 14.LTS.
Recommended DeltaV system
v14.LTS English
2 DeltaV System Hardware and
Software: Refer to Minimum
DeltaV System Architecture
for Cellmation software setup
Make sure the existing DeltaV
system have enough hardware
and software required for
Cellmation software setup as
per System Architecture.
Make sure to purchase all
the required DeltaV system
hardware and software required
for Cellmation software setup as
per System Architecture.
Make sure to purchase all
the required DeltaV system
hardware and software required for
Cellmation software setup as per
System Architecture.
3 DeltaV Basic Training: For
basic DeltaV Live operation,
Emerson course 7409 is
recommended. For working
with Batch Applications,
Emerson course 7016 is
recommended.
Make sure the operators have
basic knowledge of the DeltaV
system to operate the DeltaV
system.
Make sure the operators have
basic knowledge of DeltaV
system to operate the DeltaV
system.
The operators should seek DeltaV
basic training to gain the
knowledge of DeltaV system to
operate the DeltaV system.
4 Guardian Support to seek
Emerson support in latest
hotfix installation and/or local
Impact Partner support.
Make sure the existing DeltaV
system has the Guardian
Support license.
Make sure to purchase the
Guardian Support license.
Make sure to purchase the
Guardian Support license.
Chapter1Product information
Site preparation requirements as per customer categories
1
6CTS Cellmation Software for DeltaV System Site Preparation Guide
Table 1 Site preparation requirements as per customer categories(continued)
No. Requirements to check
Customer site category
Expansion to existing DeltaV
system with IT support
No DeltaV system and IT
support
No DeltaV system and IT
support
5 Latest hotfix installed Make sure existing site DeltaV
system has the latest Hotfix
installed to support Cellmation
software setup.
Make sure to purchase latest
DeltaV system version to have
the latest Hotfix installed to
support Cellmation software
setup.
Make sure to purchase latest
DeltaV system version to have the
latest Hotfix installed to support
Cellmation software setup.
6 Applicable Cellmation
software user guide
Make sure to go through the
applicable Cellmation software
user guide.
Make sure to go through the
applicable Cellmation software
user guide user guide.
Make sure to go through the
applicable Cellmation software
user guide.
Chapter1Product information
Site preparation requirements as per customer categories 1
CTS Cellmation Software for DeltaV System Site Preparation Guide 7
Software and hardware setup
Minimum DeltaV System Architecture for CTS Cellmation softwaresetup ................ 9
Summary of minimum hardware and software items required for CTS Cellmation
softwaresetup ....................................................................... 11
Notes for Emerson Solutions Architects ................................................. 13
DeltaV hardware and software required items – New DeltaV system ..................... 14
2
8CTS Cellmation Software for DeltaV System Site Preparation Guide
Minimum DeltaV System Architecture for CTS
Cellmation software setup
The CTS Cellmation software is imported into a DeltaV system and comprises graphics and
controller software modules. The method of communication between the DeltaV system and an
instrument is OPC UA, with the instrument acting as the server and the DeltaV system acting as the
client. The CTS Cellmation software has been developed to reside on a typical system architecture
as shown with the OPC UA client residing on the EIOC or Application Station.
A
13 2
B
5
6
4
CD
7
8 9 10 11 12
Figure1DeltaV system architecture
A: Oce/plant network
B: DeltaV system Area Control Network (ACN)
C: OPC Network
D: Other OPC Instruments
1ProfessionalPLUS Server with Alarm/Event Chronicle, Batch Executive, Continuous Historian, DeltaV Live
2Operator Station (Optional)
3Application Station (OPC UA Client)– Optional if EIOC utilizing the OPC UA client protocol.
Chapter2Software and hardware setup
Minimum DeltaV System Architecture for CTS Cellmation software setup 2
CTS Cellmation Software for DeltaV System Site Preparation Guide 9
Note: Cellmation software was validated with EIOC and the Application Station is only suitable for test
environments.
4Ethernet I/O Card (EIOC) using the OPC UA Client (Optional if Application Station is utilizing the OPC UA client
protocol)
5DeltaV Primary Network Switch
6PK Controller (M or S-series can be used also but PK is preferred)
7OPC UA Network Switch
8CTS DynaCellect Magnetic Separation System
9CTS Rotea Counterflow Centrifugation System
10 CTS Xenon Electroporation System
11 HeraCell VIOS CR CO2 Incubator
12 CryoMed Controlled Rate Freezer with OPC UA
Chapter2Software and hardware setup
Minimum DeltaV System Architecture for CTS Cellmation software setup
2
10 CTS Cellmation Software for DeltaV System Site Preparation Guide
Summary of minimum hardware and software items
required for CTS Cellmation software setup
Hardware components
1. ProfessionalPLUS Station Server
2. Optional: Application Station Server, a server to host Batch Executive or as an OPC UA client
(depending on the workload on existing ProfessionalPLUS Station Server and if using EIOC Client
for OPC Communication)
Note: Application Station is suitable for test or development environments for initial testing. For
production, EIOC is recommended.
3. Operator/Professional Workstation – Operator UI
4. Two network switches, with a minimum of 8 ports each, for the DeltaV network (primary and
secondary) and a third switch for the OPC UA instrument network.
5. PK (recommended for optimal communication with CTS instruments) or MX Controller
(Simplex/Redundant)
6. Ethernet I/O Card (EIOC) (Simplex/Redundant)
7. Network cables for the Oce Network, DeltaV Control Network and OPC Network
8. One cable for each instrument connected to DeltaV (ethernet cables supporting Cat6 / Cat5e /
Cat5 Standards)
Note:
·Case 1: If Using EIOC Client for OPC Communication:
·Hardware item2 is optional if using EIOC for the OPC Communication
·Case 2: If using Application Station Client for OPC Communication (for test or development
environments):
·Hardware item 6 is optional if using Application Station for the OPC Communication
·Case 3: Batch Historian and Batch Executive Installation on Production Sites:
·For smaller systems (less than 10 instruments connected), the Batch Historian and Batch
Executive can reside on the ProfessionalPLUS Station Server.
For larger systems (more than 10 instruments connected), use an Application Station.
Software licenses (refer to License Calculator)
1. ProfessionalPLUS Premium Workstation Software; 500 DST
2. DeltaV Version 14.LTS
3. Optionally Application Station 250 DV (If using EIOC Client for OPC Communication)
4. Batch Executive licenses
Advanced Batch Unit, 5 Units (1 for each instrument, includes Batch Historian)
Advanced Batch Unit Management, 5Units (1 for each instrument)
5. Operator/Professional Station, full span of control. DeltaV Live - DeltaV Live Operations
Premium Performance Pack (Optional)
Chapter2Software and hardware setup
Summary of minimum hardware and software items required for CTS Cellmation software setup 2
CTS Cellmation Software for DeltaV System Site Preparation Guide 11
6. OPC UA related licenses
OPC UA Activation License (systemwide)
OPC UA client for Ethernet connected I/O (EIOC) – Optional if using the Application Station for
OPC Communication
OPC UA Client Signal License, 500 Signals (100 per Instrument) – Optional if using the
Application Station for OPC Communication
7. DST License
Analog Monitor Input 25 DSTs and
Analog Control Output 25 DSTs
Discrete Monitor Input 25 DSTs
Chapter2Software and hardware setup
Summary of minimum hardware and software items required for CTS Cellmation software setup
2
12 CTS Cellmation Software for DeltaV System Site Preparation Guide
Notes for Emerson Solutions Architects
Requirements for CTS Cellmation software
The DeltaV system must be at least v14.LTS with the latest hotfixes as a minimum. It is also
important to consider where to locate the OPC UA client.
One of the following options:
EIOC with any controller type (PK controller preferred)
Application Station with any controller type (PK controller preferred)
The controller runs the equipment/control modules and batch phases, and the EIOC/Application
Station runs the OPC UA data and landing module.
PK Controller selection is based on speed and its potential to support OPC UA clients in the future.
Currently, we are only able to use it to support OPC UA Server functionality.
EIOC selection is important for:
Housing the OPC UA client, as opposed to an Application Station.
More robust and fault-tolerant piece of hardware when compared to a Dell server.
Made redundant for power and OPC UA communications.
Processing software modules within an EIOC is more predictable and not susceptible to
background Microsoft Windows functions.
Network setup of an EIOC is simpler as no MS Windows knowledge is required.
Thermo Fisher Scientific instruments
All Thermo Fisher Scientific instruments used with CTS Cellmation software are standalone,
modular instruments. For space requirements for each instrument model, see Chapter4, “Instrument
information”.
Version Control and Historian
Configuration Audit Trail (http://emerson.com)
Configuration Audit Trail is needed to enable change tracking and manage revision information for
the DeltaV configuration database.
CTS Cellmation software is a validated product by Thermo Fisher Scientific, and changes to the
code will invalidate the customer’s setup.
The following configurations should be enabled:
Continuous Historian
Batch Historian
Alarms and Events
Chapter2Software and hardware setup
Notes for Emerson Solutions Architects 2
CTS Cellmation Software for DeltaV System Site Preparation Guide 13
DeltaV hardware and software required items – New DeltaV system
Table2DeltaV hardware and software required items – New DeltaV system
No. Part No. Description Qty Requirement Purpose/Server
assignment Remarks/ notes
ProfessionalPLUS Server
1 SE2712C0
DeltaV Rack Mtd Server; Win
Server 2016 Std Emb; 2x Xeon
4112 2.6G CPUs;16GB RAM; Six
600GB Drives; RAID 10; DVD;
4 Ethernet Ports; Red. Pwr; No
Monitor; 5 year warranty
1 Required
Alarms and Events
Batch Executive and
Continuous Historian
For smaller systems (less than
10 instruments connected),
the Batch Historian and Batch
Executive can reside on
the ProfessionalPLUS Station
Server
For larger systems (more than
10 instruments connected),
use an Application Station.
2 SE2812
24-inch LED widescreen monitor;
16:10 aspect ratio; HDMI/ VGA /
DVI / DP; 3 year warranty
1 Required
3 VE2101PS0500 ProfessionalPLUS Premium
Workstation Software; 500 DST 1 Required
4 VE21UPS042 Configuration Audit Trail 1 Option Change monitoring will
be performed to ensure
Cellmation software is not
invalidated by unauthorized
modifications.
Operator Station (Optional)
5 SE2608C01
DeltaV Workstation Hardware;
Pre-installed OS software; Win
Server 2016
1 Optional
Terminal Node
6 SE2812
24-inch LED widescreen monitor;
16:10 aspect ratio; HDMI/ VGA /
DVI / DP; 3 year warranty
1 Optional
Chapter2Software and hardware setup
DeltaV hardware and software required items – New DeltaV system
2
14 CTS Cellmation Software for DeltaV System Site Preparation Guide
Table 2 DeltaV hardware and software required items – New DeltaV system(continued)
No. Part No. Description Qty Requirement Purpose/Server
assignment Remarks/ notes
7 VE2104 Operator Station, Full Span of
Control 1
Required, Base
Station with 2
OP & 2 eng
Terminal Node
EIOC
8 SE4100
Simplex Ethernet I/O Card (EIOC)
Assembly (Includes EIOC, Dual
Universal Carrier, Universal Carrier
Protection Cover, 2 Ethernet
Isolation Ports for Twisted Copper,
2 Power Plugs)
1 Required
OPC Communication
Suitable for Development
System
9 VE4109S005 Ethernet connected I/O (EIOC and
PK): 5 Physical Devices 1 Required
10 SE4101 Redundant Ethernet I/O Card
(EIOC) Assembly, (Includes 2
EIOC, Dual Horizontal Carrier, 2
Ethernet Isolation Ports for twisted
copper, 2 Power Plugs)
1 Optional if
redundancy is
required
Suitable for Production
System
Optional: Application Server
11 SE2712C09
DeltaV Rack Mtd Server; Win
Server 2016 Std Emb; 2x Xeon
4112 2.6G CPUs;16GB RAM; Six
600GB Drives; RAID 10; DVD;
4 Ethernet Ports; Red. Pwr; No
Monitor; 5 year warranty
1 Optional
Batch Historian
OPC
Communication
(Optional if using
EIOC)
This Separate Application
Station is required for
Batch Historian installation,
but optional if Batch
Historian/Reporting not
required and using EIOC for
OPC Communication.
Note: Application Station
is suitable for test or
development environments for
initial testing. For production,
EIOC is recommended.
12 SE2812
24-inch LED widescreen monitor;
16:10 Aspect Ratio; HDMI/ VGA /
DVI / DP; 3 yr warranty
1 Optional
13 VE2201S00250 Application Station 250 DV 1 Optional
Chapter2Software and hardware setup
DeltaV hardware and software required items – New DeltaV system 2
CTS Cellmation Software for DeltaV System Site Preparation Guide 15
Table 2 DeltaV hardware and software required items – New DeltaV system(continued)
No. Part No. Description Qty Requirement Purpose/Server
assignment Remarks/ notes
PK Controller
14 PK0300S
Simplex PK300 Controller
Assembly (includes 1 PK300
Controller, 1 Carrier, 2 IOPs, 1
Power Module, 1 PK Controller
Protection Cover, and 1 Power
Module Protection Cover)
1 Required Logic Execution Suitable for Development
System
15 PK0300R
Redundant PK300 Controller
Assembly (includes 2 PK300
Controllers, 1 Carrier, 2 IOPs, and
2 Power Modules)
1 Required Logic Execution Suitable for Production
System
Power Supply
16 VE5126
DeltaV Bulk Power Supply
100-240 VAC to 24 VDC, 20A.
SDN 20-24-100C
1 Required Power Supply
DeltaV Network Switch Primary, Secondary
17 VE6047P2
Smart 8-Port Switch; 19-Inch
Rack Mount; Each port is
10/100BASE-TX Copper RJ45;
Includes two RJ45 Uplink ports
and two slots for VE6050-
series Transceiver Modules;
United Kingdom Power Cord
(RM100-8TX)
2 Required Network Switch
Chapter2Software and hardware setup
DeltaV hardware and software required items – New DeltaV system
2
16 CTS Cellmation Software for DeltaV System Site Preparation Guide
Table 2 DeltaV hardware and software required items – New DeltaV system(continued)
No. Part No. Description Qty Requirement Purpose/Server
assignment Remarks/ notes
OPC UA Network Switch
18 SE6049V1
DeltaV Network Switch for
Host Access and Thin
Client Networks General
Specifications [Hirschmann
Greyhound GRS105-24TX/6SFP]
1 Required Network Switch
DeltaV Software
19 VE2301R14LTSL39 DeltaV Software Media Pack;
v14.LTS; English 1 Required DeltaV Software Media
Pack Should be 14.LTS and above
DeltaV Live Software (Optional if using Operator Station)
20 VE2104P01 DeltaV Live Operations Premium
Performance Pack 1 Required DeltaV Live 1 for each operator station
DeltaV Batch Executive Software
21 VE2248S00005 Advanced Batch Units, 5 Units 1 Required Batch Executive and
Batch Historian 1 Unit for each instrument
22 VE3122S00005 Advanced Unit Management, 5
Units 1 Required Batch Function: Unit
Aliasing 1 Unit for each Instrument
23 VE2249Syyyyy DeltaV Professional Batch 1
Optional if using
Application
Station
Stores data from Units Provides PDF formats for unit
OPC UA
24 VE2200 OPC UA Activation License
(systemwide) 1 Required OPC Communication
25 VE4106 OPC UA client for Ethernet
connected I/O (EIOC) 1 Required OPC Communication
Optional if using
Application Station for OPC
Communication
Chapter2Software and hardware setup
DeltaV hardware and software required items – New DeltaV system 2
CTS Cellmation Software for DeltaV System Site Preparation Guide 17
Table 2 DeltaV hardware and software required items – New DeltaV system(continued)
No. Part No. Description Qty Requirement Purpose/Server
assignment Remarks/ notes
26 VE2201S00500 OPC UA Client Signal License,
500 Signals 1
Required if using
Application
Station
OPC Communication 100 Signals per Instrument
DST Licenses
27 VE3113S00025 Analog Monitor Input 25 DSTs 1 Required DST For Analog Input LDT's
28 VE3114S00025 Analog Control Output 25 DSTs 1 Required DST For Analog Output LDT's
29 VE3111S00025 Discrete Monitor Input 25 DSTs 1 Required DST For Digital Input LDT's
Support/Antivirus
30 VE9041S0100 1-Year Guardian Support for One
System up to 100 DST 1 Required
This is needed to seek
help from Emerson Process
Management for latest Hotfix
installation and other support
31 VE9126WYUM
1st-year Endpoint Security
Unmanaged for DeltaV Systems,
for DeltaV workstation or server
with Guardian Support contracts,
License pack
2 Optional
32 VE9126UM
Endpoint Security, Unmanaged,
for DeltaV Systems, v2.3 Media
Pack only. Not compatible with
32-Bit Operating Systems
1 Optional
Continous Historian
33 VE22UPS042OP1
DeltaV Continuous Historian on
Non-Application Station, Enable
1250 Parameters
1 Optional Continuous Historian
Needed if existing servers do
not have enough Historian
Licenses.
Chapter2Software and hardware setup
DeltaV hardware and software required items – New DeltaV system
2
18 CTS Cellmation Software for DeltaV System Site Preparation Guide
Table 2 DeltaV hardware and software required items – New DeltaV system(continued)
No. Part No. Description Qty Requirement Purpose/Server
assignment Remarks/ notes
Others
34 Back UPS Required Emergency power supply
Chapter2Software and hardware setup
DeltaV hardware and software required items – New DeltaV system 2
CTS Cellmation Software for DeltaV System Site Preparation Guide 19
Preinstallation qualifier information
Site Preparation CheckQualifier ........................................................ 20
Preinstallation information for Thermo Fisher Scientific representatives ...................... 21
Site Preparation Check Qualifier
Use OPC UA Simulation Server to test end-to end OPC UA connectivity to DeltaV system
As part of the site preparation for Cellmation software installation, an end-to-end connection test
is recommended be performed. Use any computer or laptop to simulate an OPC UA server for this
test. During Cellmation software installation by a Thermo Fisher Scientific representative, end-to-end
communication testing may be performed if troubleshooting is needed. Additional service visits will
be at the cost of the customer if end-to-end communication testing indicates that the network is not
properly configured.
3
20 CTS Cellmation Software for DeltaV System Site Preparation Guide
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Thermo Fisher Scientific CTS Cellmation Software User guide

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