cytiva WAVE Bioreactor 2/10 User manual

Stand-alone instruments for
WAVE Bioreactor 2/10 and
20/50
Operating Instructions
cytiva.com

Table of Contents
1 Introduction ........................................................................................................ 5
1.1 Important user information ....................................................................................................................... 6
1.2 WAVE system configurations ................................................................................................................... 8
1.3 Stand-alone instruments ............................................................................................................................ 10
1.4 Control software ............................................................................................................................................ 11
1.5 Literature .......................................................................................................................................................... 12
2 Safety instructions ............................................................................................. 13
2.1 Safety precautions ........................................................................................................................................ 14
2.2 Labels and symbols ....................................................................................................................................... 17
2.3 Emergency procedures ............................................................................................................................... 18
3 Common process controllers ............................................................................ 19
3.1 Functions .......................................................................................................................................................... 20
3.2 Process controller on stand-alone instruments ................................................................................ 22
3.3 Changing Process controller parameters ............................................................................................ 23
3.3.1 Large Process controller ............................................................................................................................ 24
3.3.2 Small Process controller ............................................................................................................................ 26
4 DOOPT20 dissolved oxygen monitor ................................................................ 27
4.1 Introduction/view .......................................................................................................................................... 28
4.2 Installation ........................................................................................................................................................ 30
4.2.1 Site requirements ......................................................................................................................................... 31
4.2.2 Unpacking ....................................................................................................................................................... 32
4.2.3 Installation ....................................................................................................................................................... 33
4.2.4 Spare parts and accessories .................................................................................................................... 34
4.3 Operation .......................................................................................................................................................... 35
4.4 Maintenance .................................................................................................................................................... 37
4.4.1 Maintenance frequency ............................................................................................................................ 38
4.4.2 Cleaning ........................................................................................................................................................... 39
4.4.3 Calibration ....................................................................................................................................................... 40
4.4.4 DOOPT probe maintenance and storage ........................................................................................... 43
4.4.5 Instrument repair ......................................................................................................................................... 45
4.5 Troubleshooting ............................................................................................................................................. 46
5 CO2MIX20 CO2/air controller ........................................................................... 48
5.1 Introduction/view ......................................................................................................................................... 49
5.1.1 CO2 leakage .................................................................................................................................................... 51
5.2 Installation ........................................................................................................................................................ 52
5.2.1 Site requirements ......................................................................................................................................... 53
5.2.2 Unpacking ....................................................................................................................................................... 54
5.2.3 Installation ....................................................................................................................................................... 55
5.2.4 Spare parts and accessories .................................................................................................................... 56
5.3 Operation .......................................................................................................................................................... 57
5.4 Maintenance .................................................................................................................................................... 59
5.4.1 Maintenance frequency ............................................................................................................................ 60
5.4.2 Cleaning ........................................................................................................................................................... 61
5.4.3 Calibration ....................................................................................................................................................... 62
Table of Contents
2 Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD

5.4.4 Instrument repair ......................................................................................................................................... 63
5.5 Troubleshooting ............................................................................................................................................. 64
6 CO2MIX20-R CO2/air controller ........................................................................ 66
6.1 Introduction/view .......................................................................................................................................... 67
6.1.1 CO2 leakage .................................................................................................................................................... 69
6.2 Installation ........................................................................................................................................................ 70
6.2.1 Site requirements ......................................................................................................................................... 71
6.2.2 Unpacking ....................................................................................................................................................... 72
6.2.3 Installation ....................................................................................................................................................... 73
6.2.4 Spare parts and accessories .................................................................................................................... 74
6.3 Operation .......................................................................................................................................................... 75
6.4 Maintenance .................................................................................................................................................... 76
6.4.1 Maintenance frequency ............................................................................................................................ 77
6.4.2 Cleaning ........................................................................................................................................................... 78
6.4.3 Calibration ....................................................................................................................................................... 79
6.4.4 Instrument repair ......................................................................................................................................... 80
6.5 Troubleshooting ............................................................................................................................................. 81
7 O2MIX20 O2/air controller ................................................................................ 83
7.1 Introduction/view .......................................................................................................................................... 84
7.2 Installation ........................................................................................................................................................ 85
7.2.1 Site requirements ......................................................................................................................................... 86
7.2.2 Unpacking ....................................................................................................................................................... 87
7.2.3 Installation ....................................................................................................................................................... 88
7.2.4 Spare parts and accessories .................................................................................................................... 89
7.3 Operation .......................................................................................................................................................... 90
7.4 Maintenance .................................................................................................................................................... 92
7.4.1 Maintenance frequency ............................................................................................................................ 93
7.4.2 Cleaning ........................................................................................................................................................... 94
7.4.3 Calibration ....................................................................................................................................................... 95
7.4.4 Instrument repair ......................................................................................................................................... 96
7.5 Troubleshooting ............................................................................................................................................. 97
8 O2MIX20-R O₂/air controller ............................................................................. 98
8.1 Introduction/view .......................................................................................................................................... 99
8.2 Installation ........................................................................................................................................................ 100
8.2.1 Site requirements ......................................................................................................................................... 101
8.2.2 Unpacking ....................................................................................................................................................... 102
8.2.3 Installation ....................................................................................................................................................... 103
8.2.4 Spare parts and accessories .................................................................................................................... 104
8.3 Operation .......................................................................................................................................................... 105
8.4 Maintenance .................................................................................................................................................... 106
8.4.1 Maintenance frequency ............................................................................................................................ 107
8.4.2 Cleaning ........................................................................................................................................................... 108
8.4.3 Calibration ....................................................................................................................................................... 109
8.4.4 Instrument repair ......................................................................................................................................... 110
8.5 Troubleshooting ............................................................................................................................................. 111
9 PUMP20 peristaltic feed/harvest or acid/base pump ..................................... 112
9.1 Introduction/view .......................................................................................................................................... 113
9.2 Installation ........................................................................................................................................................ 114
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Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD 3

9.2.1 Site requirements ......................................................................................................................................... 115
9.2.2 Unpacking ....................................................................................................................................................... 116
9.2.3 Installation ....................................................................................................................................................... 117
9.2.4 Spare parts and accessories .................................................................................................................... 119
9.3 Operation .......................................................................................................................................................... 120
9.4 Maintenance .................................................................................................................................................... 121
9.4.1 Maintenance frequency ............................................................................................................................ 122
9.4.2 Cleaning ........................................................................................................................................................... 123
9.4.3 Pumphead tensioning ................................................................................................................................ 124
9.4.4 Instrument repair ......................................................................................................................................... 125
9.5 Troubleshooting ............................................................................................................................................. 126
10 Reference information ....................................................................................... 127
10.1 Specifications .................................................................................................................................................. 128
10.2 Recycling information .................................................................................................................................. 130
10.3 Regulatory information ............................................................................................................................... 131
10.3.1 Contact information .................................................................................................................................... 132
10.3.2 European Union and European Economic Area .............................................................................. 133
10.3.3 Regulations for North America ............................................................................................................... 134
10.3.4 Regulatory statements .............................................................................................................................. 135
10.4 Ordering information ................................................................................................................................... 136
Appendix A: Communications and data acquisition .............................................. 137
A.1 Overview ............................................................................................................................................................ 138
A.2 Analog/Alarm port ......................................................................................................................................... 139
A.3 Analog signals ................................................................................................................................................. 140
A.4 Alarm contact .................................................................................................................................................. 141
A.5 Digital communication protocol .............................................................................................................. 142
A.6 Communication wiring ................................................................................................................................ 143
A.7 Digital instrument addressing .................................................................................................................. 145
Appendix B: DOOPT20 measurement theory .......................................................... 146
B.1 Introduction ..................................................................................................................................................... 147
B.2 Measurement theory ................................................................................................................................... 148
B.3 Effect of temperature ................................................................................................................................... 150
B.4 Measurement range ..................................................................................................................................... 151
B.5 Cross-sensitivity ............................................................................................................................................ 152
B.6 Response time ................................................................................................................................................ 153
B.6.1 Bare probe ....................................................................................................................................................... 154
B.6.2 Wet Oxywell2 ................................................................................................................................................. 155
B.6.3 Dry Oxywell2 .................................................................................................................................................. 156
B.7 Stability .............................................................................................................................................................. 157
Table of Contents
4 Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD

1 Introduction
Purpose of the manual
This manual provide you with the instructions needed to handle WAVE Bioreactor™
system optional stand-alone instruments. For further information regarding the use of
WAVE Bioreactor 2/10, WAVE Bioreactor 20/50 and WAVEPOD II1, refer to WAVE
Bioreactor System BASE 2/10 EH Operating Instructions and WAVE Bioreactor 20/50
and WAVEPOD II User Manual, respectively.
Prerequisites
In order to operate WAVE Bioreactor stand-alone instruments safely and according to
the intended purpose the following prerequisites must be met:
•You should be acquainted with the use of general laboratory equipment and with
handling of biological materials.
•You must read the Safety Instructions in Chapter 2 Safety instructions, on page 13.
•The system should be installed according to the Installation sections in Chapter 4
DOOPT20 dissolved oxygen monitor, on page 27 to Chapter 9 PUMP20 peristaltic
feed/harvest or acid/base pump, on page 112.
In this chapter
This chapter contains important user information and a general description of WAVE
Bioreactor stand-alone instruments, and their intended use.
In this chapter
Section See page
1.1 Important user information 6
1.2 WAVE system configurations 8
1.3 Stand-alone instruments 10
1.4 Control software 11
1.5 Literature 12
1The optional WAVEPOD II controller integrates instrumentation associated with WAVE
Bioreactor units. This includes pH, dissolved oxygen, and CO2/O2 gas mixing controls.
1 Introduction
Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD 5

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 WAVE Bioreactor system is intended to be used as development and manufac-
turing equipment for expansion of cells. Cultivation is performed in a single use,
gamma irradiated bag, known as a Cellbag™, which is placed on the WAVE Bioreactor
instrument.
Note: When used for cell therapy applications outside the European Union and
Australia, the WAVE Bioreactor system shall be used for research only.
Control of various parameters can be made in different ways depending on WAVE
Bioreactor system configuration. Optional stand-alone instruments can be used to
control, for example, O2 concentration and CO2 concentration.
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.
1 Introduction
1.1 Important user information
6 Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD

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.
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.
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.
1 Introduction
1.1 Important user information
Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD 7

1.2 WAVE system configurations
There are several different sizes of WAVE™ systems available that provide scalable cell
culturing possibilities and several different configurations available for control of key
culture parameters:
•WAVE Bioreactor instrument options with different internal control modules.
•WAVEPOD II options with different internal control modules (available for WAVE
Bioreactor 20/50 instrument).
•Stand-alone instruments for control of specific parameters (described in this
manual).
For examples of how control of different parameters can be achieved, see Table 1.1, on
page 9. Note that more than one stand-alone instrument can be used with a WAVE
Bioreactor instrument to get access to more control functions.
For some parameters, several control options are available. For example, pH in the
culture medium can be controlled by:
•On-line control of pH by pH measurement and pH adjustment by acid and base
additions. This requires a WAVEPOD II with pH control module and PUMP20.
•Indirect control of pH by changing the CO2 concentration setpoint. This requires:
-Integrated CO2 control module (as in BASE20/50EHT-CO2), or
-WAVEPOD II with CO2 control module, or
-the stand-alone instrument CO2MIX20 or CO2MIX20-R.
Table 1.1, on page 9 shows example instrument and system configurations. The
stand-alone instrument PERFCONT2E and all WAVEPOD II units are included, but not
described further in this manual. See the respective product manuals for more infor-
mation.
1 Introduction
1.2 WAVE system configurations
8 Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD

Table 1.1: Examples of WAVE Bioreactor 2/10 and 20/50 system configurations using WAVE
Bioreactor instruments alone or in combination with stand-alone instruments. Several other
options are possible. Some configurations of WAVE Bioreactor 20/50 system are available as Dual
system configuration (WAVE Bioreactor instrument 20/50 EHTD), which enables operation of two
Cellbag bioreactors in parallel.
System configuration Control parameters
Bioreactor
base unit
Stand-alone
instrument
Rocking Temperature
Dissolved O2
pH Inlet gas CO2 concentration
Inlet gas O2 concentration
Perfusion culture
WAVE Bioreactor 2/10 system
BASE2/10EH + +
BASE2/10EH DOOPT20 + + +
BASE2/10EH CO2MIX20 + + +
BASE2/10EH O2MIX20 + + +
BASE2/10EH PERFCONT2E + + +
WAVE Bioreactor 20/50 system
BASE20/50EHT + +
BASE20/50EHT-CO2 + + +
BASE20/50EHT-O2 + + +
BASE20/50EHT-L PUMP20 + + +
BASE20/50EHT DOOPT20 + + +
BASE20/50EHT CO2MIX20 + + +
BASE20/50EHT O2MIX20 + + +
BASE20/50EHT WAVEPOD II PHOPT
CO2
+ + + +
BASE20/50EHT WAVEPOD II DOOPT
O2
+ + + +
BASE20/50EHT WAVEPOD II PHOPT
DOOPT CO2 O2
+ + + + + +
BASE20/50EHT-L WAVEPOD II PHOPT
DOOPT CO2 O2
PUMP20
+ + + + + + +
1 Introduction
1.2 WAVE system configurations
Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD 9

1.3 Stand-alone instruments
Overview
Several stand-alone instruments for the WAVE Bioreactor 2/10 and 20/50 systems are
available. The stand-alone instruments are used connected to the WAVE Bioreactor
instrument and designed to fit in racks (SRACK) for single instruments. Racks include a
power supply and a RS485 dataport communicating via the MODBUS RTU protocol for
data acquisition.
The available stand-alone instruments are listed in the table below. See respective
chapter for a description and instruction for use.
Name Function Chapter
DOOPT20 Dissolved oxygen
monitor
Chapter 4 DOOPT20
dissolved oxygen
monitor, on page 27
CO2MIX20 CO2/air controller Chapter 5 CO2MIX20
CO2/air controller, on
page 48
CO2MIX20-R CO2/air controller (rota-
meter model)
Chapter 6 CO2MIX20-R
CO2/air controller, on
page 66
O2MIX20 O2/air controller Chapter 7 O2MIX20
O2/air controller, on page
83
O2MIX20-R O2/air controller (rota-
meter model)
Chapter 8 O2MIX20-R
O₂/air controller, on page
98
PUMP20 Peristaltic feed/harvest
or acid/base pump
Chapter 9 PUMP20 peri-
staltic feed/harvest or
acid/base pump, on page
112
1 Introduction
1.3 Stand-alone instruments
10 Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD

1.4 Control software
The WAVE system stand-alone instruments are equipped with embedded software for
control and supervision. See Chapter 3 Common process controllers, on page 19 for
instruction for use of common process controllers.
1 Introduction
1.4 Control software
Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD 11

1.5 Literature
For further information regarding the use of WAVE Bioreactor 2/10, WAVE Bioreactor
20/50 and WAVEPOD II refer to the following:
•WAVE Bioreactor System BASE 2/10 EH Operating Instructions, article no.
87450023.
•WAVE Bioreactor System 20/50 and WAVEPOD II User Manual, article no.
28984680.
1 Introduction
1.5 Literature
12 Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD

2 Safety instructions
This chapter describes safety compliance, safety labels, general safety precautions,
emergency procedures, power failure and recycling of WAVE stand-alone instruments.
In this chapter
Section See page
2.1 Safety precautions 14
2.2 Labels and symbols 17
2.3 Emergency procedures 18
2 Safety instructions
Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD 13

2.1 Safety precautions
Introduction
Before installing, operating or maintaining stand-alone instruments, you must be
aware of the hazards described in WAVE Bioreactor System BASE 2/10 EH Operating
Instructions and WAVE Bioreactor System 20/50EHT Operating Instructions, as well as
hazards specifically related to WAVE stand-alone instruments, which are described in
this manual. Follow the instructions provided to avoid personal injury or damage to the
equipment.
The safety precautions in this section are grouped into the following categories:
•General precautions
•Personal protection
•Installing
•System operation
•Maintenance
General precautions
WARNING
Do not use any accessories not supplied or recommended by
Cytiva.
Personal protection
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
and maintenance of the system.
2 Safety instructions
2.1 Safety precautions
14 Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD

Installing instrument
WARNING
Place CO2MIX20 and CO2MIX20-R instruments in a well
ventilated environment. Failure to do so can lead to heightened
CO2 concentrations.
Care should be taken to remove pressurized CO2 supply when not
in use.
WARNING
Place O2MIX20 and O2MIX20-R instruments in a well venti-
lated environment. Failure to do so can lead to heightened O2
concentrations.
Care should be taken to remove pressurized O2 supply when not in
use.
WARNING
Protective ground. The WAVE stand-alone instruments must
always be connected to grounded power outlets.
WARNING
Supply voltage. Ensure that the supply voltage at the wall outlet
corresponds to the marking on the instrument before connecting
the power cord.
CAUTION
Ensure that all tubing, hoses and cables are placed so that the risk
or tripping accidents is minimized.
System operation
CAUTION
Remove any spillage on the floor immediately to minimize the risk
for slipping accidents.
2 Safety instructions
2.1 Safety precautions
Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD 15

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
Only spare parts that are approved or supplied by Cytiva may be
used for maintaining or servicing the system.
2 Safety instructions
2.1 Safety precautions
16 Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD

2.2 Labels and symbols
Introduction
This section describes the product nameplate (label) and other safety and regulatory
labels attached to the product.
System label
The system label is located on the back of the equipment. The system label identifies
the equipment and shows electrical data, regulatory compliance, and warning
symbols.
Symbols used in safety 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.
2 Safety instructions
2.2 Labels and symbols
Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD 17

2.3 Emergency procedures
This section describes how to do an emergency shutdown of a WAVE instrument. The
section also describes the result in the event of power failure.
Emergency procedures
In an emergency situation, do as follows to stop the run:
Step Action
1Switch off the power to the instrument by pressing the power switch to the O
position.
2Disconnect the power cord from the power outlet.
2 Safety instructions
2.3 Emergency procedures
18 Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD

3 Common process controllers
In this chapter
Section See page
3.1 Functions 20
3.2 Process controller on stand-alone instruments 22
3.3 Changing Process controller parameters 23
3 Common process controllers
Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD 19

3.1 Functions
Most WAVE Bioreactor stand-alone instruments are controlled by use of integrated
Process controllers. In the stand-alone instrument, the Process controller (large or
small type) is integrated in the front of the instrument, see the example figure below.
Figure 3.1: Example of stand-alone instrument (DOOPT20) with a small Process
controller, see arrow.
The Process controllers are used in similar way in different stand-alone instruments
and the main functionality is described in this chapter. Actual and setpoint values can
be viewed and setpoint values can be changed.
Figure 3.2: Large Process controller (left) and small Process controller (right).
3 Common process controllers
3.1 Functions
20 Stand-alone instruments for WAVE Bioreactor 2/10 and 20/50 Operating Instructions 87450009 AD