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cytiva Xuri W25 User manual

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Xuri Cell Expansion System
W25
Operating Instructions
Original instructions
cytiva.com
Table of Contents
1Introduction ........................................................................................................ 4
1.1 Important user information ....................................................................................................................... 5
1.2 About this manual ......................................................................................................................................... 6
1.3 Associated documentation ....................................................................................................................... 7
1.4 Abbreviations .................................................................................................................................................. 9
2 Safety instructions ............................................................................................. 11
2.1 Safety precautions ........................................................................................................................................ 12
2.2 Symbols and abbreviations ........................................................................................................................ 19
2.2.1 Instrument labels ......................................................................................................................................... 20
2.2.2 Safety labels .................................................................................................................................................... 21
2.2.3 Additional labels ........................................................................................................................................... 23
2.3 Emergency procedures ............................................................................................................................... 24
3 System description ............................................................................................ 27
3.1 System overview ............................................................................................................................................ 28
3.2 Xuri Cell Expansion System W25 rocker .............................................................................................. 30
3.3 Xuri Cell Expansion W25 CBCU ............................................................................................................... 37
3.4 Xuri Cell Expansion W25 Pump ............................................................................................................... 40
3.5 Cellbag bioreactor ........................................................................................................................................ 42
3.6 UNICORN software overview .................................................................................................................... 45
3.6.1 General UNICORN operation .................................................................................................................. 46
3.6.2 Administration ............................................................................................................................................... 49
3.6.3 System control ............................................................................................................................................... 50
3.6.4 Evaluation ........................................................................................................................................................ 56
4 Installation .......................................................................................................... 57
4.1 Site preparation .............................................................................................................................................. 58
4.1.1 Delivery and storage ................................................................................................................................... 59
4.1.2 Site requirements ......................................................................................................................................... 60
4.1.3 Client computer specifications ............................................................................................................... 64
4.2 Hardware installation ................................................................................................................................... 66
4.2.1 Unpack the system units ........................................................................................................................... 67
4.2.2 Connect the system components ......................................................................................................... 69
4.3 Software installation .................................................................................................................................... 72
5 Operation ............................................................................................................ 73
5.1 Set up the system .......................................................................................................................................... 74
5.1.1 Select the tray and Cellbag bioreactor .............................................................................................. 75
5.1.2 Attach and detach tray .............................................................................................................................. 76
5.1.3 Prepare pH and DO sensors ..................................................................................................................... 80
5.1.4 Attach the Cellbag bioreactor ................................................................................................................ 83
5.1.5 Prepare the pump ........................................................................................................................................ 85
5.1.6 Connect gas to the system ....................................................................................................................... 90
5.1.7 Connect the filter heater to the rocker ................................................................................................ 94
5.2 Start and configure the system ................................................................................................................ 95
5.2.1 Start the system and log on to UNICORN ......................................................................................... 96
5.2.2 Connect to the system ............................................................................................................................... 97
Table of Contents
2 Xuri Cell Expansion System W25 Operating Instructions 29064612 AD
5.2.3 Configure system properties ................................................................................................................... 99
5.2.4 Configure system settings ........................................................................................................................ 101
5.2.5 Start a run ........................................................................................................................................................ 107
5.3 Prepare for cultivation ................................................................................................................................. 112
5.3.1 Inflate the Cellbag bioreactor ................................................................................................................. 113
5.3.2 Adjust pump parameters .......................................................................................................................... 114
5.3.3 Add and equilibrate culture medium ................................................................................................... 115
5.3.4 Prepare the sensors .................................................................................................................................... 118
5.4 Perform cultivation ....................................................................................................................................... 121
5.4.1 Inoculate the culture ................................................................................................................................... 122
5.4.2 Monitor and control the run ..................................................................................................................... 123
5.4.3 End a run ........................................................................................................................................................... 126
6 Maintenance ....................................................................................................... 128
6.1 Calibration ........................................................................................................................................................ 129
6.2 Cleaning ............................................................................................................................................................ 131
6.3 Cleaning before planned service ............................................................................................................. 132
7 Troubleshooting ................................................................................................. 133
7.1 Xuri Cell Expansion System W25 ............................................................................................................. 134
7.2 Xuri Cell Expansion System W25 rocker .............................................................................................. 135
7.3 Xuri Cell Expansion W25 CBCU ............................................................................................................... 139
7.4 Xuri Cell Expansion W25 Pump ............................................................................................................... 140
7.5 UNICORN System Control .......................................................................................................................... 141
8 Reference information ....................................................................................... 143
8.1 Chemical resistance ..................................................................................................................................... 144
8.2 Recycling information .................................................................................................................................. 145
8.3 Regulatory information ............................................................................................................................... 146
8.3.1 Contact information .................................................................................................................................... 147
8.3.2 European Union and European Economic Area .............................................................................. 148
8.3.3 Eurasian Economic Union
Евразийский
экономический
союз
.................................................................................................. 149
8.3.4 Regulations for North America ............................................................................................................... 151
8.3.5 Regulatory statements .............................................................................................................................. 152
8.3.6 Declaration of Hazardous Substances (DoHS) ................................................................................ 153
8.3.7 Other regulations and standards .......................................................................................................... 155
8.4 Health and Safety Declaration Form ...................................................................................................... 156
Index ........................................................................................................................... 158
Table of Contents
Xuri Cell Expansion System W25 Operating Instructions 29064612 AD 3
1 Introduction
About this chapter
This chapter contains important user information, the intended use of Xuri™ Cell
Expansion System W25, description of safety notices, and regulatory information.
In this chapter
Section See page
1.1 Important user information 5
1.2 About this manual 6
1.3 Associated documentation 7
1.4 Abbreviations 9
1 Introduction
4 Xuri Cell Expansion System W25 Operating Instructions 29064612 AD
1.1 Important user information
Read this before operating the
product
All users must read the entire Operating Instructions before installing, oper-
ating or maintaining the product.
Always keep the Operating Instructions at hand when operating the product.
Do not install, operate, or perform maintenance on the product in any other way than
described in the user documentation. If you do, you may be exposed or expose others
to hazards that can lead to personal injury and you may cause damage to the equip-
ment.
Intended use
The Xuri Cell Expansion System W25 system is intended to be used as laboratory and
manufacturing equipment for cell cultivation. The system may not be used for clinical
or diagnostic purposes.
Prerequisites
In order to operate Xuri Cell Expansion System W25 in the way it is intended:
•The user has a general understanding of how the client computer and Microsoft®
Windows® operating systems work.
•The user is acquainted with the use of general laboratory equipment and with
handling of biological materials.
•The user must read and understand the Safety Instructions chapter in the Oper-
ating Instructions.
•Xuri Cell Expansion System W25 must be installed in accordance with the site
requirements and instructions in the Operating Instructions.
•A user account has been created according to UNICORN Administration and Tech-
nical manual.
1 Introduction
1.1 Important user information
Xuri Cell Expansion System W25 Operating Instructions 29064612 AD 5
1.2 About this manual
Purpose of this manual
The Operating Instruction manual provides information needed to install, operate and
maintain the product in a safe way.
Scope of this manual
This manual covers the entire Xuri Cell Expansion System W25, including the main unit
(rocker), CBCU and pump, as well as accessories.
Typographical conventions
Software items are identified in the text by bold italic text.
Hardware items are identified in the text by bold text.
In electronic format, references in italics are clickable hyperlinks.
Notes and tips
Note: A note is used to indicate information that is important for trouble-free and
optimal use of the product.
Tip: A tip contains useful information that can improve or optimize your proce-
dures.
1 Introduction
1.2 About this manual
6 Xuri Cell Expansion System W25 Operating Instructions 29064612 AD
1.3 Associated documentation
Introduction
This section describes the user documentation that is delivered with the product, and
how to find related literature that can be downloaded or ordered from Cytiva.
User documentation for Xuri Cell
Expansion System W25
The table below describes the user documentation for Xuri Cell Expansion System
W25, which is available from the Help menu in UNICORN™ or on the user documenta-
tion CD.
Documentation Main contents
Xuri Cell Expansion System W25 Oper-
ating Instructions (29064612)
(this document)
Instructions needed to install, operate
and maintain the Xuri Cell Expansion
System W25 system in a correct and
safe way.
System overview, site requirements,
and instructions for moving the system
within the same building.
Instructions for basic maintenance and
troubleshooting.
Includes basic UNICORN 7.x system
control functions.
Xuri Cell Expansion System W25User
Manual (29064622)
Additional information in order to get
the optimal performance from the
system.
Functional description of modules.
Instructions for maintenance and trou-
bleshooting activities.
Includes UNICORN 7.x system control
functions, method creation and
handling, together with evaluation and
presentation of data.
Xuri Cell Expansion System W25Cue
Card (29087822)
Brief instructions providing an overview
of how to run the system.
UNICORN Quick Installation Guide
(29414475)
Guide for installation of UNICORN.
1 Introduction
1.3 Associated documentation
Xuri Cell Expansion System W25 Operating Instructions 29064612 AD 7
Documentation Main contents
UNICORNAdministration and Technical
manual
Overview and detailed description of
network setup and complete software
installation. Administration of
UNICORN and the UNICORN database.
UNICORN Online Help Dialog descriptions for UNICORN
User Documentation CD CD containing the listed manuals and
translated versions of Xuri Cell
Expansion System W25 Operating
Instructions.
1 Introduction
1.3 Associated documentation
8 Xuri Cell Expansion System W25 Operating Instructions 29064612 AD
1.4 Abbreviations
Concepts and abbreviations used in this manual are explained in the table below.
Concept/
abbreviation
Explanation Translation
Cellbag™
bioreactors
The disposable container in
which the cells are cultured.
The disposable container in
which the cells are cultured.
DO Dissolved oxygen. Dissolved oxygen.
DO sensor Optical sensor for measure-
ment of dissolved oxygen.
Attached to DO configured
Cellbag bioreactors.
Optical sensor for measure-
ment of dissolved oxygen.
Attached to DO configured
Cellbag bioreactors.
Single mode Operating mode with one
Cellbag bioreactors on the
rocker.
Operating mode with one
Cellbag bioreactors on the
rocker.
Dual mode Operating mode with two
Cellbag bioreactors on the
same rocker. Cultivation is
monitored and controlled
independently in the two
bioreactors.
Operating mode with two
Cellbag bioreactors on the
same rocker. Cultivation is
monitored and controlled
independently in the two
bioreactors.
pH sensor Optical sensor for pH meas-
urement. Attached to pH
configured Cellbag bioreac-
tors.
Optical sensor for pH meas-
urement. Attached to pH
configured Cellbag bioreac-
tors.
Xuri Cell
Expansion W25
CBCU
Control unit for gas mixing, pH
and DO control.
Control unit for gas mixing, pH
and DO control.
Xuri Cell
Expansion W25
Pump
The pump unit. The pump unit.
Xuri Cell
Expansion
System W25
rocker
The rocker. The rocker.
Tray Tray for Cellbag, mounted on
the rocker. Different tray sizes
are available for different
culture capacities.
Tray for Cellbag, mounted on
the rocker. Different tray sizes
are available for different
culture capacities.
1 Introduction
1.4 Abbreviations
Xuri Cell Expansion System W25 Operating Instructions 29064612 AD 9
Concept/
abbreviation
Explanation Translation
The bioreactor
system
The entire system, including
rocker, CBCU, and pump,
together with Cellbag
bioreactor and filter heater.
The entire system, including
rocker, CBCU, and pump,
together with Cellbag
bioreactor and filter heater.
UNICORN The software used for control-
ling and monitoring the
system.
The software used for control-
ling and monitoring the
system.
1 Introduction
1.4 Abbreviations
10 Xuri Cell Expansion System W25 Operating Instructions 29064612 AD