cytiva Xuri W25 User manual

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

2 Safety instructions
About this chapter
This chapter describes safety precautions, labels and symbols that are attached to the
equipment. In addition, the chapter describes emergency and recovery procedures.
In this chapter
Section See page
2.1 Safety precautions 12
2.2 Symbols and abbreviations 19
2.3 Emergency procedures 24
Important
WARNING
Before installing, operating or maintaining the product, all
users must read and understand the entire contents of this
chapter to become aware of the hazards involved.
2 Safety instructions
Xuri Cell Expansion System W25 Operating Instructions 29064612 AD 11

2.1 Safety precautions
Introduction
Xuri Cell Expansion System W25 is powered by mains voltage and handles materials
that can be hazardous.
Before installing, operating or maintaining the system, you must be aware of the
hazards described in this manual.
Definitions
This user documentation contains safety notices (WARNING, CAUTION, and NOTICE)
concerning the safe use of the product. See definitions below.
WARNING
WARNING indicates a hazardous situation which, if not avoided,
could result in death or serious injury. It is important not to proceed
until all stated conditions are met and clearly understood.
CAUTION
CAUTION indicates a hazardous situation which, if not avoided,
could result in minor or moderate injury. It is important not to
proceed until all stated conditions are met and clearly understood.
NOTICE
NOTICE indicates instructions that must be followed to avoid
damage to the product or other equipment.
General precautions
WARNING
Do not operate the product in any other way than described in the
user documentation.
WARNING
Only properly trained personnel may operate and maintain the
product.
2 Safety instructions
2.1 Safety precautions
12 Xuri Cell Expansion System W25 Operating Instructions 29064612 AD

WARNING
Accessories. Use only accessories supplied or recommended by
Cytiva.
WARNING
Do not use the product if it is not working properly, or if it has
suffered any damage, for example:
•damage to the power cord or its plug
•damage caused by dropping the equipment
•damage caused by splashing liquid onto it
NOTICE
Any computer used with the equipment must comply with EN/IEC
60950-1, and be installed and used according to the manufactur-
er's instructions.
Personal protection
WARNING
Always use appropriate Personal Protective Equipment (PPE)
during operation and maintenance of this product.
WARNING
Hazardous substances. When using hazardous chemical and
biological agents, take all suitable protective measures, such as
wearing protective glasses and gloves resistant to the substances
used. Follow local and/or national regulations for safe operation,
maintenance and decommissioning of the system.
WARNING
Spread of biological agents. The operator must take all neces-
sary actions to avoid spreading hazardous biological agents. The
facility must comply with the national code of practice for
biosafety.
2 Safety instructions
2.1 Safety precautions
Xuri Cell Expansion System W25 Operating Instructions 29064612 AD 13

Installing and moving the equipment
CAUTION
Heavy object. Because of the significant weight of Xuri Cell
Expansion System W25 rocker, assistance from another person is
highly recommended when lifting or moving the equipment. Use
the handles on the sides of the rocker when possible. Do not lift
Xuri Cell Expansion System W25 rocker with tray attached.
CAUTION
Due to the size and weight of Tray 50, at least two persons are
recommended for installing the tray.
CAUTION
Falling equipment. Do not stack more than one Xuri Cell
Expansion W25 CBCU and/or Xuri Cell Expansion W25 Pump unit
on top of each other.
Power supply
WARNING
Supply voltage. Before connecting the power cord, make sure
that the supply voltage at the wall outlet corresponds to the
marking on the instrument.
WARNING
Protective ground. The stand-alone products must always be
connected to a grounded power outlet.
WARNING
Only use grounded power cords delivered or approved by Cytiva.
2 Safety instructions
2.1 Safety precautions
14 Xuri Cell Expansion System W25 Operating Instructions 29064612 AD

WARNING
Access to power switch and power cord with plug. Do not
block access to the power switch and power cord. The power switch
must always be easy to access. The power cord with plug must
always be easy to disconnect.
WARNING
Disconnect power. Always disconnect power from the equip-
ment before connecting the product units to any other instrument.
System operation
WARNING
Suffocation hazard. The product must only be used in locations
with forced ventilation. When N2 and/or CO2 are connected, make
sure that:
•the pressure over the gas connections does not exceed 1.5 bar.
•the gas connections are tightly secured.
•Inlet tubing and connections are subject to regular visual
inspection.
Exceeding pressure or loose connections may cause the gas tubing
to disconnect, resulting in dangerous leakages.
WARNING
Prevent gas leakage. To prevent any gas leakage, always switch
off all gas supplies when the system is not in use.
WARNING
Fire hazard. O2 leakage in combination with heat may cause igni-
tion. To avoid O2 leakages, make sure that:
•the pressure over the gas connections does not exceed 1.5 bar.
•the gas connections are tightly secured. Visually inspect the
inlet tubing regularly.
2 Safety instructions
2.1 Safety precautions
Xuri Cell Expansion System W25 Operating Instructions 29064612 AD 15

CAUTION
Only Cellbag bioreactors approved by Cytiva for the product may
be used together with the equipment.
CAUTION
Heavy object. The filled Cellbag bioreactor is heavy and must be
lifted with care. This also applies to optional equipment such as
calibration weights.
CAUTION
Leakage risk of biological substances. Before every use, check
the integrity of all tubing and connections.
CAUTION
Leakage risk of biological substances. Always enter the correct
Cellbag bioreactor size in the system software settings. Failure to
do this may cause overpressure and subsequent rupture of the
Cellbag bioreactor.
CAUTION
Pinch hazard. Body parts may be caught between the rocker base
and tray.
CAUTION
Pinch hazard. Be careful not to trap any fingers between the
rocker platform and tray when repositioning Tray 10 from tilt posi-
tion. Move the tray by firmly gripping both sides of the tray.
CAUTION
Pinch hazard. Moving parts in Xuri Cell Expansion System W25.
Do not open any pump head flip tops during operation.
2 Safety instructions
2.1 Safety precautions
16 Xuri Cell Expansion System W25 Operating Instructions 29064612 AD

CAUTION
Falling equipment. To prevent the bioreactor system units from
accidentally being pulled from the bench, make sure that all tubing
is kept inside the bench area.
NOTICE
If UniNet cables are disconnected during a run, the run will be inter-
rupted and must be restarted. Make sure that cables are properly
secured before starting a run and avoid moving system units
during a run.
Maintenance
WARNING
Electrical shock hazard. All repairs should be done by service
personnel authorized by Cytiva. Do not open any covers or replace
parts unless specifically stated in the user documentation.
WARNING
Disconnect power. Always disconnect power from the instru-
ment before performing any maintenance task.
WARNING
Always clean the equipment in a well ventilated area. Never
immerse any part of the equipment in liquid or spray liquid on the
equipment. Always make sure that the equipment is completely
dry before connecting to a mains power source. Make sure to follow
all environmental, health, and safety guidelines pertaining to the
materials used.
WARNING
Use only approved parts. Only spare parts and accessories that
are approved or supplied by Cytiva may be used for maintaining or
servicing the product.
2 Safety instructions
2.1 Safety precautions
Xuri Cell Expansion System W25 Operating Instructions 29064612 AD 17

CAUTION
Falling equipment. Due to pinch and crush hazards, calibration
weights should not be stacked on top of each other. Remove cali-
bration weights before the power is turned off.
CAUTION
Hazardous substances. Before maintenance, service and
decommissioning, clean the product with an appropriate cleaning
agent to remove any hazardous substances.
2 Safety instructions
2.1 Safety precautions
18 Xuri Cell Expansion System W25 Operating Instructions 29064612 AD

2.2 Symbols and abbreviations
About this section
This section describes the information on the system label and other safety or regula-
tory labels that are attached to the product.
In this section
Section See page
2.2.1 Instrument labels 20
2.2.2 Safety labels 21
2.2.3 Additional labels 23
2 Safety instructions
2.2 Symbols and abbreviations
Xuri Cell Expansion System W25 Operating Instructions 29064612 AD 19

2.2.1 Instrument labels
Instrument labels
The table below describes the different instrument labels and their positions on the
different equipment. The instrument label identifies the equipment and shows elec-
trical data, regulatory compliance, and warning symbols.
Label Position on instrument
Xuri Cell Expansion System
W25 rocker label
Attached on the back of the rocker and underneath
the rocker platform.
Filter heater label Attached to the filter heater.
Tray label Attached to the trays.
Lid label Attached to the lids.
Xuri Cell Expansion W25
CBCU label
Attached on the underside of the unit.
The labels on the CBCU units may have different
looks depending on the CBCU unit configuration.
Xuri Cell Expansion W25
Pump label
Attached on the rear panel of the pump.
Symbol description
The following symbols are used in the labels.
Label Description
Warning! Read the user documentation before using the
system. Do not open any covers or replace parts unless
specifically stated in the user documentation.
Voltage
Frequency
Max. Power
Electrical requirements:
•Voltage (VAC )
•Voltage (VDC )
•Frequency (Hz)
•Max. power (VA)
Protection Class Degree of protection provided by the enclosure.
Mfg. Year Year (YYYY) and month (MM) of manufacture
2 Safety instructions
2.2 Symbols and abbreviations
2.2.1 Instrument labels
20 Xuri Cell Expansion System W25 Operating Instructions 29064612 AD