cytiva AKTA flux s User manual

ÄKTA flux s
Operating Instructions
Original instructions
ÄKTA flux
cytiva.com

Table of Contents
1Introduction ........................................................................................................ 5
1.1 Important user information ....................................................................................................................... 6
1.2 About this manual ......................................................................................................................................... 7
1.3 Associated documentation ....................................................................................................................... 8
1.4 Additional user documentation - additional/specific documentation ...................................... 10
1.5 Abbreviations .................................................................................................................................................. 11
2 Safety instructions ............................................................................................. 13
2.1 Safety precautions ........................................................................................................................................ 14
2.2 Labels ................................................................................................................................................................. 24
2.3 Emergency procedures ............................................................................................................................... 26
3 System description ............................................................................................ 28
3.1 Illustrations of ÄKTA flux s ......................................................................................................................... 29
3.2 System control ................................................................................................................................................ 32
3.3 Standard equipment ..................................................................................................................................... 41
3.3.1 Feed pump, pressure sensors and pressure control valve .......................................................... 42
3.3.2 Tank .................................................................................................................................................................... 45
3.3.3 Communication connection .................................................................................................................... 46
3.4 Optional equipment ...................................................................................................................................... 47
3.5 Filter devices .................................................................................................................................................... 48
3.5.1 Hollow fiber cartridges ............................................................................................................................... 49
3.5.2 Kvick Lab packet and holder .................................................................................................................... 50
3.6 Flowchart .......................................................................................................................................................... 52
4 Flow lines ............................................................................................................. 54
4.1 Recirculation loop .......................................................................................................................................... 55
4.2 Permeate line .................................................................................................................................................. 58
4.3 Transfer line ..................................................................................................................................................... 60
5 Installation .......................................................................................................... 61
5.1 Site requirements .......................................................................................................................................... 63
5.2 Unpack the ÄKTA flux s ............................................................................................................................... 64
5.3 Transport .......................................................................................................................................................... 66
5.4 Set up the ÄKTA flux s .................................................................................................................................. 67
5.4.1 Power supply and USB connection ....................................................................................................... 68
5.4.2 Install and remove the tank ...................................................................................................................... 71
5.4.3 Tubing ................................................................................................................................................................ 72
5.4.4 Install the transfer pump ........................................................................................................................... 83
5.4.5 Install the permeate pump ....................................................................................................................... 87
5.4.6 Install the permeate pressure sensor .................................................................................................. 91
5.4.7 Pump tubing ................................................................................................................................................... 94
5.5 Installation test ............................................................................................................................................... 97
6 Run preparations ................................................................................................ 98
6.1 Filter installation ........................................................................................................................................... 99
6.1.1 Filter holders and tubing ........................................................................................................................... 100
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2 ÄKTA flux s Operating Instructions 29046893 AG

6.1.2 Install hollow fiber cartridges .................................................................................................................. 102
6.2 Install Kvick Lab packet and holder ......................................................................................................... 106
6.3 Testing filters ................................................................................................................................................... 108
6.4 Calibration ........................................................................................................................................................ 109
6.4.1 Calibration of the feed pump ................................................................................................................... 110
6.4.2 Calibration of the transfer pump ........................................................................................................... 115
6.4.3 Calibration of the permeate pump ........................................................................................................ 120
6.4.4 Calibration of the pressure sensors ...................................................................................................... 125
6.4.5 Motor control .................................................................................................................................................. 126
6.4.6 Tank level ......................................................................................................................................................... 127
7 Operation ............................................................................................................ 129
7.1 Start the system ............................................................................................................................................. 130
7.2 Perform a run ................................................................................................................................................... 133
7.2.1 Basic filtration ................................................................................................................................................ 135
7.2.2 Automated features .................................................................................................................................... 136
7.2.3 Data logging ................................................................................................................................................... 140
7.2.4 Shutdown ÄKTA flux s ................................................................................................................................ 142
7.3 Procedures after the run ............................................................................................................................. 143
8 Settings ............................................................................................................... 145
8.1 USB Device Management screen and software update ................................................................. 146
8.2 Configure Alarms screen ............................................................................................................................ 149
8.3 Configure System screen ............................................................................................................................ 154
8.4 Calibration Settings screen ....................................................................................................................... 157
8.5 System Information screen ........................................................................................................................ 158
8.6 Set-points ......................................................................................................................................................... 161
9 Maintenance ....................................................................................................... 164
9.1 User maintenance schedule ...................................................................................................................... 166
9.2 Sanitization and cleaning ........................................................................................................................... 168
9.3 Storage .............................................................................................................................................................. 174
9.4 Repair and calibration .................................................................................................................................. 176
9.5 Replace mains fuse ....................................................................................................................................... 177
10 Troubleshooting ................................................................................................. 180
11 Reference information ....................................................................................... 182
11.1 Specifications .................................................................................................................................................. 183
11.2 Software license ............................................................................................................................................. 187
11.3 Wetted materials ........................................................................................................................................... 188
11.4 Chemical resistance ..................................................................................................................................... 190
11.5 Recycling information .................................................................................................................................. 193
11.6 Regulatory information ............................................................................................................................... 194
11.6.1 Contact information .................................................................................................................................... 195
11.6.2 European Union and European Economic Area .............................................................................. 196
11.6.3 Eurasian Economic Union
Евразийский экономический союз .................................................................................................. 197
11.6.4 Regulations for North America ............................................................................................................... 199
11.6.5 Regulatory statements .............................................................................................................................. 200
11.6.6 Declaration of Hazardous Substances (DoHS) ................................................................................ 201
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ÄKTA flux s Operating Instructions 29046893 AG 3

11.6.7 Other regulations and standards .......................................................................................................... 203
11.7 Ordering information ................................................................................................................................... 204
11.8 Health and Safety Declaration Form ...................................................................................................... 205
Index ........................................................................................................................... 207
Table of Contents
4 ÄKTA flux s Operating Instructions 29046893 AG

1 Introduction
About this chapter
This chapter contains important user information, descriptions of safety notices, regu-
latory information, and intended use of ÄKTA™ flux s.
In this chapter
Section See page
1.1 Important user information 6
1.2 About this manual 7
1.3 Associated documentation 8
1.4 Additional user documentation - additional/specific docu-
mentation
10
1.5 Abbreviations 11
1 Introduction
ÄKTA flux s Operating Instructions 29046893 AG 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 operate the product in any other way than described in the user documenta-
tion. If you do, you may be exposed to hazards that can lead to personal injury and you
may cause damage to the equipment.
Intended use of ÄKTA flux s
ÄKTA flux s is a cross flow filtration (CFF) system. It is intended for use in a laboratory
environment for research and educational purposes.
The system is configurable for operating hollow fiber cartridges suited for microfiltra-
tion applications, such as cell clarification/harvesting, or cassettes/hollow fibers for
ultrafiltration applications, such as protein concentration and diafiltration in down-
stream unit operations.
ÄKTA flux s is not intended for diagnostic purposes.
Prerequisites
In order to operate ÄKTA flux s safely and according to the intended purpose, the
following prerequisites must be met:
•You should be acquainted with handling of biological materials.
•You must read and understand the Safety instructions chapter of these Operating
Instructions.
•The system must be installed according to the instructions in Chapter 5 Installation,
on page 61.
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
1.1 Important user information
6 ÄKTA flux s Operating Instructions 29046893 AG

1.2 About this manual
Purpose of this manual
The Operating Instructions provide you with the information needed to install, operate,
and maintain the product in a safe way.
Scope of this manual
This Operating Instruction manual is valid for ÄKTA flux s.
ÄKTA flux s is also referred to as the system, or the product in this document.
The instructions do not describe how to use the control software. The user is referred
to the applicable software version instruction manuals provided by the respective soft-
ware supplier.
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
ÄKTA flux s Operating Instructions 29046893 AG 7

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 ÄKTA flux s
The user documentation is listed in the table below.
Translations of the Operating Instructions are provided on the User Documentation CD
(or USB memory stick) together with the User Manual, Product Documentation, and
Unpacking Instructions. Printed copies of the User Manual are available on request
from Cytiva.
Documentation Main contents
ÄKTA flux s Operating Instructions
(this document)
Instructions needed to prepare and
operate the ÄKTA flux s 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.
ÄKTA flux s User Manual Additional information in order to get
the optimal performance from the
system.
Functional description of modules.
Instructions for maintenance and trou-
bleshooting activities.
ÄKTA flux s Site Preparation Guide Information needed to prepare the site
for installation and use of the
ÄKTA flux s system.
ÄKTA flux s Unpacking Instructions Instructions for handling the delivery
package and unpacking the ÄKTA flux s
system.
ÄKTA flux s Product Documentation Specifications and material conformity.
Help in the software
The following help information is available on the Instrument touch screen and the
workstation software.
1 Introduction
1.3 Associated documentation
8 ÄKTA flux s Operating Instructions 29046893 AG

Documentation Main contents
ÄKTA flux s Instrument Display help Brief descriptions of the screens and
functions in the Instrument Display
software.
Tap to access the Instrument
Display help.
ÄKTA flux s Workstation software Help Overview and detailed descriptions of
menus and functions in the Workstation
software.
To access the software help, select
Help from the menu bar or by press the
F1 key.
1 Introduction
1.3 Associated documentation
ÄKTA flux s Operating Instructions 29046893 AG 9

1.4 Additional user documentation - additional/specific
documentation
Introduction
System-specific documentation
In addition to the Operating Instructions manual, the documentation package supplied
with ÄKTA flux s also includes one or more Product Documentation binders containing
detailed specifications and traceability documents.
The most important documents in the documentation package, with regard to tech-
nical aspects of ÄKTA flux s, are listed in the table below.
Document Abbrevia-
tion
Purpose/Contents
Assembly Drawing AD Physical layout. Provides all dimen-
sional data.
Piping and Instrument
Diagram
P&ID Schematic overview of the entire
process flow, all components and
instruments and the control system.
Declaration of
Conformity
DoC Declaration of Conformity for EU and/or
other regions.
General Specification GS Technical data for the system
Equipment Data Sheet EDS Technical data for the system.
Equipment List EQL Description of process-related compo-
nents, including wetted materials and
specifications.
Spare Part List SPL List of spare parts available from Cytiva.
Functional Specification FS Software function description.
Component documentation
Documentation for components produced both by Cytiva and by a third-party are, if
existent, also included in the Product Documentation.
1 Introduction
1.4 Additional user documentation - additional/specific documentation
10 ÄKTA flux s Operating Instructions 29046893 AG

1.5 Abbreviations
Introduction
This section explains abbreviations that appear in the user documentation for ÄKTA™
flux s ÄKTA flux s.
Abbreviations
Abbreviation Definition (English) Translation (local language)
ACD aseptic connection device aseptic connection device
CEM controlled environment module controlled environment module
CV controlled variable
The output from the PID controller, or
a manually set value that controls the
process variable.
controlled variable
The output from the PID controller, or
a manually set value that controls the
process variable.
CVHL controlled variable high limit controlled variable high limit
CVLL controlled variable low limit controlled variable low limit
DP differential pressure differential pressure
EPDM ethylene propylene diene monomer ethylene propylene diene monomer
HEPA high efficiency particulate air controlled variable low limit
PID proportional integral derivative
A PID controller calculates an error
value as the difference between a
measured process variable (PV) and a
desired setpoint (SP). The PID
controller attempts to minimize the
error by adjusting the process control
inputs (CV).
proportional integral derivative
A PID controller calculates an error
value as the difference between a
measured process variable (PV) and a
desired setpoint (SP). The PID
controller attempts to minimize the
error by adjusting the process control
inputs (CV).
PLC programmable logic controller programmable logic controller
PV process variable, measured process variable, measured
SAT site acceptance testing site acceptance testing
SCADA supervisory control and data acquisi-
tion
supervisory control and data acquisi-
tion
1 Introduction
1.5 Abbreviations
ÄKTA flux s Operating Instructions 29046893 AG 11

Abbreviation Definition (English) Translation (local language)
SP setpoint
The target value that an automatic
control system, for example PID
controller, will attempt to reach by
adjusting the process control inputs.
setpoint
The target value that an automatic
control system, for example PID
controller, will attempt to reach by
adjusting the process control inputs.
SPHL setpoint high limit setpoint high limit
SPLL setpoint low limit setpoint low limit
UPS uninterruptible power supply uninterruptible power supply
1 Introduction
1.5 Abbreviations
12 ÄKTA flux s Operating Instructions 29046893 AG

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,
and provides recycling information.
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.
In this chapter
Section See page
2.1 Safety precautions 14
2.2 Labels 24
2.3 Emergency procedures 26
2 Safety instructions
ÄKTA flux s Operating Instructions 29046893 AG 13

2.1 Safety precautions
Introduction
ÄKTA flux s is powered by mains voltage and handles materials that might be
hazardous. Before installing, operating or maintaining the system, you must be aware
of the hazards described in this manual.
The safety precautions in this section are grouped into the following categories:
•General precautions, on page 15
•Personal protection, on page 15
•Flammable liquids and explosive environment, on page 16
•Installing and moving the system, on page 17
•Power supply, on page 19
•Operation, on page 20
•Maintenance, on page 21
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.
2 Safety instructions
2.1 Safety precautions
14 ÄKTA flux s Operating Instructions 29046893 AG

General precautions
WARNING
Operation and user maintenance of ÄKTA flux s must be performed
by properly trained personnel only.
WARNING
Do not operate the product in any other way than described in the
user documentation.
WARNING
Risk assessment. Perform a risk assessment for any risks due to
the process or process environment. Evaluate the effects the use of
the product and the operational processes may have on the classi-
fication of the hazardous area. The process might cause the area to
increase or the zone classification to change. Implement the risk
reduction measures needed, including use of personal protective
equipment.
CAUTION
ÄKTA flux s is designed for indoor use only.
CAUTION
Always use appropriate personal protective equipment when
decommissioning the equipment.
Personal protection
WARNING
Always use appropriate Personal Protective Equipment (PPE)
during operation and maintenance of the product.
2 Safety instructions
2.1 Safety precautions
ÄKTA flux s Operating Instructions 29046893 AG 15

WARNING
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
ÄKTA flux s.
WARNING
In ÄKTA flux s, prevent fluid leakage by tighten the Luer connection
firmly. Do not open the Luer connection by twisting, bending or
vibration. Do not open connectors when pressurized or during on-
going process.
WARNING
Use fume mask during tank opening when processing hazardous
liquids, to avoid possible exposure to aerosols.
CAUTION
Risk of pinching by moving parts inside the tank or inside the
pumps. Do not insert your fingers or other objects into the tank or
other moving parts while ÄKTA flux s is powered.
Flammable liquids and explosive
environment
WARNING
ÄKTA flux s is not approved to handle flammable liquids.
WARNING
ÄKTA flux s is not approved for work in a potentially explosive
atmosphere, in areas classified as Zone 0 to Zone 2 according to
IEC 60079-10 2002. ÄKTA flux s does not fulfill the requirements of
the ATEX Directive.
2 Safety instructions
2.1 Safety precautions
16 ÄKTA flux s Operating Instructions 29046893 AG

WARNING
Some of the chemicals used with the columns may be flammable
under certain conditions. Make sure to use chemicals only under
conditions where they are not flammable. Refer to local and/or
national classifications of flammable liquids.
Installing and moving the system
CAUTION
Before moving ÄKTA flux s the following must be done:
1. Empty ÄKTA flux s.
2. Shut down ÄKTA flux s and disconnect the power cord.
WARNING
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 to the product before installation of the optional
pump.
WARNING
Before connecting the filter to ÄKTA flux s, read the instructions for
use of the filter. To avoid exposing the filter to excessive pressure,
make sure that the pressure limit is set to the specified maximum
pressure of the filter.
CAUTION
Handle tank with care.
•Make sure the tank is not damaged or dropped during handling.
•Do not install or remove the tank in any other way than
described in this manual.
2 Safety instructions
2.1 Safety precautions
ÄKTA flux s Operating Instructions 29046893 AG 17

CAUTION
Whenever packing, unpacking, transporting or moving ÄKTA flux s,
wear:
•Protective footwear, preferably with steel lining.
•Working gloves, protecting against sharp edges.
•Protective glasses.
CAUTION
Do not transport, handle and store ÄKTA flux s in any other way
than described in this manual.
CAUTION
Two persons are required to lift ÄKTA flux s. Lift only in the bottom
part of the system.
CAUTION
Make sure that the system is placed on a stable, level bench with
adequate space for ventilation.
CAUTION
Make sure your fingers not are pinched under ÄKTA flux s when the
instrument is placed onto a bench.
CAUTION
Use only tubing supplied by Cytiva.
CAUTION
Avoid that the filter falls when installing filters.
•Handle filter with care.
•Do not install or remove the filter in any other way than
described in this manual.
2 Safety instructions
2.1 Safety precautions
18 ÄKTA flux s Operating Instructions 29046893 AG

CAUTION
Make sure that the USB port is protected from moisture and liquid
by always having a protective cap on.
Power supply
WARNING
National Codes and standards (NEC, VDE, BSI, IEC, UL etc.) and local
codes outline provisions for safely installing electrical equipment.
Installation must comply with specifications regarding wire types,
conductor sizes, plugs, branch circuit protection and disconnect
devices. Non-compliance may result in personal injury and/or
equipment damage.
WARNING
All electrical installations must be performed by authorized
personnel only unless stated in this manual.
WARNING
The supply voltage must correspond to the markings on the
system.
WARNING
ÄKTA flux s must always be connected to a grounded power outlet.
WARNING
Only use grounded power cords delivered or approved by Cytiva.
WARNING
Always disconnect power to ÄKTA flux s before replacing fuses.
2 Safety instructions
2.1 Safety precautions
ÄKTA flux s Operating Instructions 29046893 AG 19

Operation
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
WARNING
All alarm signals must be set within the limits specified in the
system documentation. Pressure and temperature control must be
activated while the system is in use to prevent the tubing system to
leak or break.
WARNING
Never exceed the operating limits stated in this document and on
the system label. Operation of the product outside these limits can
damage equipment and cause personal injury or death.
WARNING
Disconnect power to the product before installing the pump
tubing.
WARNING
Before connecting the filter to ÄKTA flux s, read the instructions for
use of the filter. To avoid exposing the filter to excessive pressure,
make sure that the pressure limit is set to the specified maximum
pressure of the filter.
WARNING
Make sure that the filter is installed according to instructions for
use of the filter.
2 Safety instructions
2.1 Safety precautions
20 ÄKTA flux s Operating Instructions 29046893 AG