cytiva AKTA flux 6 User manual

ÄKTA flux 6
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1Introduction ........................................................................................................ 4
1.1 About this manual ......................................................................................................................................... 5
1.2 Important user information ....................................................................................................................... 6
1.3 Associated documentation ....................................................................................................................... 8
2 Safety instructions ............................................................................................. 9
2.1 Safety precautions ........................................................................................................................................ 10
2.2 Labels ................................................................................................................................................................. 20
2.3 Emergency procedures ............................................................................................................................... 22
3 System description ............................................................................................ 24
3.1 Illustrations of ÄKTA flux 6 ........................................................................................................................ 25
3.2 System control ................................................................................................................................................ 28
3.3 Standard equipment ..................................................................................................................................... 37
3.3.1 Feed pump, pressure sensors and pressure control valve .......................................................... 38
3.3.2 Tank .................................................................................................................................................................... 40
3.3.3 Communication connection .................................................................................................................... 42
3.4 Optional equipment ...................................................................................................................................... 43
3.5 Filter devices .................................................................................................................................................... 44
3.5.1 Hollow fiber cartridges ............................................................................................................................... 45
3.5.2 Kvick Lab Cassette Holder II .................................................................................................................... 46
3.6 Flowchart .......................................................................................................................................................... 48
4 Flow lines ............................................................................................................. 51
4.1 Recirculation loop .......................................................................................................................................... 52
4.2 Permeate line .................................................................................................................................................. 54
4.3 Transfer line ..................................................................................................................................................... 56
5 Installation .......................................................................................................... 57
5.1 Site requirements .......................................................................................................................................... 58
5.2 Unpack the ÄKTA flux 6 .............................................................................................................................. 59
5.3 Transport .......................................................................................................................................................... 61
5.4 Set up the ÄKTA flux 6 ................................................................................................................................. 62
5.4.1 Power supply and USB connection ....................................................................................................... 63
5.4.2 Install and remove the tank ...................................................................................................................... 66
5.4.3 Tubing ................................................................................................................................................................ 67
5.4.4 Install the transfer pump ........................................................................................................................... 72
5.4.5 Install the permeate pump ....................................................................................................................... 76
5.4.6 Install the permeate pressure sensor .................................................................................................. 80
5.4.7 Pump tubing ................................................................................................................................................... 83
5.5 Installation test ............................................................................................................................................... 85
6 Run preparations ................................................................................................ 86
6.1 Filter installation ............................................................................................................................................ 87
6.1.1 Filtration tubing ............................................................................................................................................. 89
6.1.2 Install hollow fiber cartridges .................................................................................................................. 90
6.1.3 Install Kvick Lab cassettes ........................................................................................................................ 96
6.2 Testing filters ................................................................................................................................................... 99
6.3 Calibration ........................................................................................................................................................ 100
Table of Contents
2 ÄKTA flux 6 Operating Instructions 29046896 AE

6.3.1 Calibration of the feed pump ................................................................................................................... 101
6.3.2 Calibration of the transfer pump ........................................................................................................... 107
6.3.3 Calibration of the permeate pump ........................................................................................................ 113
6.3.4 Calibration of the pressure sensors ...................................................................................................... 119
6.3.5 Motor control .................................................................................................................................................. 121
6.3.6 Tank level ......................................................................................................................................................... 122
7 Operation ............................................................................................................ 124
7.1 Start the system ............................................................................................................................................. 125
7.2 Perform a run ................................................................................................................................................... 127
7.2.1 Basic filtration ................................................................................................................................................ 129
7.2.2 Automated features .................................................................................................................................... 130
7.2.3 Data logging ................................................................................................................................................... 134
7.2.4 Shutdown ÄKTA flux 6 ............................................................................................................................... 136
7.3 Procedures after the run ............................................................................................................................. 137
8 Settings ............................................................................................................... 139
8.1 USB Device Management screen and software update ............................................................. 140
8.2 Configure Alarms screen ......................................................................................................................... 143
8.3 Configure System screen ........................................................................................................................ 148
8.4 Calibration Settings screen ................................................................................................................... 152
8.5 System Information screen ................................................................................................................... 153
8.6 Set-points ......................................................................................................................................................... 156
9 Maintenance ....................................................................................................... 159
9.1 User maintenance schedule ...................................................................................................................... 161
9.2 Sanitization and cleaning ........................................................................................................................... 163
9.3 Storage .............................................................................................................................................................. 167
9.4 Repair and calibration .................................................................................................................................. 169
9.5 Replace mains fuse ....................................................................................................................................... 170
10 Troubleshooting ................................................................................................. 174
11 Reference information ....................................................................................... 176
11.1 Specifications .................................................................................................................................................. 177
11.2 Filter specifications ....................................................................................................................................... 180
11.3 Wetted materials ........................................................................................................................................... 181
11.4 Chemical resistance ..................................................................................................................................... 189
11.5 Recycling information .................................................................................................................................. 192
11.6 Regulatory information ............................................................................................................................... 193
11.6.1 Contact information .................................................................................................................................... 194
11.6.2 European Union and European Economic Area .............................................................................. 195
11.6.3 Eurasian Economic Union
Евразийский экономический союз .................................................................................................. 196
11.6.4 Regulations for North America ............................................................................................................... 198
11.6.5 Regulatory statements .............................................................................................................................. 199
11.6.6 Declaration of Hazardous Substances (DoHS) ................................................................................ 200
11.6.7 Other regulations and standards .......................................................................................................... 202
11.7 Ordering information ................................................................................................................................... 203
11.8 Health and Safety Declaration Form ...................................................................................................... 204
Index ........................................................................................................................... 206
Table of Contents
ÄKTA flux 6 Operating Instructions 29046896 AE 3

1 Introduction
About this chapter
This chapter contains important user information, descriptions of safety notices, and
intended use of ÄKTA™ flux 6.
In this chapter
Section See page
1.1 About this manual 5
1.2 Important user information 6
1.3 Associated documentation 8
1 Introduction
4 ÄKTA flux 6 Operating Instructions 29046896 AE

1.1 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.
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 About this manual
ÄKTA flux 6 Operating Instructions 29046896 AE 5

1.2 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 6
ÄKTA flux 6 is intended for research and process development use, as well as small
scale pharmaceutical production.
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 6 is not intended for diagnostic purposes.
Prerequisites
In order to operate ÄKTA flux 6 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 57.
Safety notices
This user documentation contains safety notices (WARNING, CAUTION, and NOTICE)
concerning the safe use of the product. See definitions below.
1 Introduction
1.2 Important user information
6 ÄKTA flux 6 Operating Instructions 29046896 AE

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.
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 Important user information
ÄKTA flux 6 Operating Instructions 29046896 AE 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.
Data files, application notes and user
documentation on the web
To order or download data files, application notes or user documentation, see the
instruction below.
Step Action
1Go to cytiva.com/aktaflux..
2Select ÄKTA flux 6 from the list.
3Click Related Documents.
4Select to download the chosen literature.
1 Introduction
1.3 Associated documentation
8 ÄKTA flux 6 Operating Instructions 29046896 AE

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.
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 10
2.2 Labels 20
2.3 Emergency procedures 22
2 Safety instructions
ÄKTA flux 6 Operating Instructions 29046896 AE 9

2.1 Safety precautions
Introduction
ÄKTA flux 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 10
•Personal protection, on page 11
•Flammable liquids and explosive environment, on page 12
•Installing and moving the system, on page 12
•Power supply, on page 14
•Operation, on page 15
•Maintenance, on page 17
General precautions
WARNING
Operation and user maintenance of ÄKTA flux 6 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 6 is designed for indoor use only.
2 Safety instructions
2.1 Safety precautions
10 ÄKTA flux 6 Operating Instructions 29046896 AE

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 ÄKTA flux 6.
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 6.
WARNING
Use fume mask during tank opening when processing hazardous
liquids, to avoid possible exposure to aerosols.
WARNING
Hot circulating fluids in ÄKTA flux 6 can cause hot fluidic lines, hot
tank and hot chassis components.
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 6 is powered.
2 Safety instructions
2.1 Safety precautions
ÄKTA flux 6 Operating Instructions 29046896 AE 11

Flammable liquids and explosive
environment
WARNING
ÄKTA flux 6 is not approved to handle flammable liquids.
WARNING
ÄKTA flux 6 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 6 does not fulfill the requirements of
the ATEX Directive.
WARNING
Some of the chemicals used with ÄKTA flux 6 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 6 the following must be done:
1. Empty ÄKTA flux 6.
2. Shut down ÄKTA flux 6 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.
2 Safety instructions
2.1 Safety precautions
12 ÄKTA flux 6 Operating Instructions 29046896 AE

WARNING
Before connecting the filter to ÄKTA flux 6, 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.
CAUTION
Whenever packing, unpacking, transporting or moving ÄKTA flux 6,
wear:
•Protective footwear, preferably with steel lining.
•Working gloves, protecting against sharp edges.
•Protective glasses.
CAUTION
Do not transport, handle and store ÄKTA flux 6 in any other way
than described in this manual.
CAUTION
Two persons are required to lift ÄKTA flux 6. 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 6 when the
instrument is placed onto a bench.
2 Safety instructions
2.1 Safety precautions
ÄKTA flux 6 Operating Instructions 29046896 AE 13

CAUTION
Use only tubing supplied by Cytiva.
CAUTION
Take care not to drop the optional pump assembly during installa-
tion as it can result in damage to the unit or injury to yourself.
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.
CAUTION
Because of the weight of the KvickLab Cassette Holder ll, great care
must be taken not to cause squeezing or crushing injuries during
movement. To prevent injury from dropping a cassette holder on
your feet or hands, make sure you have a secure, controlled grip, or
the proper equipment to move the cassette holder.
Wear safety shoes.
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.
2 Safety instructions
2.1 Safety precautions
14 ÄKTA flux 6 Operating Instructions 29046896 AE

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 6 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 6 before replacing fuses.
Operation
WARNING
Do not use ÄKTA flux 6 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.
2 Safety instructions
2.1 Safety precautions
ÄKTA flux 6 Operating Instructions 29046896 AE 15

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 6, 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.
WARNING
Never block the outlet tubing and/or the check valves outlet with,
for example, stop plugs, since this will create overpressure or hard-
ware failure and can result in injury.
WARNING
Make sure integrity of flowpath through pre-run with harmless
liquids before use and sanitization.
CAUTION
Let the ÄKTA flux 6 cool down after use as the components and
internal compartments can become hot during use.
2 Safety instructions
2.1 Safety precautions
16 ÄKTA flux 6 Operating Instructions 29046896 AE

CAUTION
Handle fluids with care when adding fluid to the system or
collecting fluid from drain valves. Always use appropriate Personal
Protective Equipment (PPE) when operating and interacting with
ÄKTA flux 6.
CAUTION
Make sure the control valve is released when there is no active
filtration.
Maintenance
WARNING
All repairs should be done by service personnel authorized by
Cytiva. Do not open any covers or replace parts unless specifically
stated in this operating instruction.
WARNING
Disconnect the power supply to the system before performing any
form of maintenance on ÄKTA flux 6. Only personnel authorized by
Cytiva may perform maintenance other than maintenance proce-
dures described in ÄKTA flux user documentation. The power
supply unit contains high voltage that may cause injury or death.
WARNING
Maintenance should be scheduled regularly with Cytiva to assure a
proper function of the system.
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
ÄKTA flux 6 Operating Instructions 29046896 AE 17

WARNING
When using hazardous chemicals, run System CIP and
Membrane CIP to flush the entire system, including filters, with
distilled water until a pH of approximately pH 7.0 is reached, before
performing service or maintenance.
WARNING
Corrosive substance. NaOH is corrosive and therefore dangerous
to health. When using hazardous chemicals, avoid spillage and
wear protective glasses and other suitable Personal Protective
Equipment (PPE).
WARNING
Periodically inspect the system’s tubing, gaskets, seals, and
connections for wear and damage to prevent leaks and the release
of potentially hazardous fluids.
WARNING
Before maintenance/service is performed, the system owner must
first clean the system and complete a Health & Safety Declaration
Form. Contact Cytiva for further information.
WARNING
To avoid personnel being exposed to potentially hazardous
substances, make sure that the column is properly decontami-
nated and sanitized before maintenance or service.
WARNING
Decontaminate the equipment before decommissioning to make
sure that hazardous residues are removed.
2 Safety instructions
2.1 Safety precautions
18 ÄKTA flux 6 Operating Instructions 29046896 AE

CAUTION
To prevent exposure to leaking hot fluids:
•Do not use non-approved tubing and components together with
or inside the system.
•Maintenance and pump tubing replacement of the ÄKTA flux 6
must be scheduled on regular basis with a Cytiva representative
and performed by properly trained personnel only.
•Always use appropriate Personal Protective Equipment (PPE)
when operating and interacting with ÄKTA flux 6.
CAUTION
Changing of tubing exposes operator to residual fluid that might
cause contamination of skin and clothing. Always use appropriate
Personal Protective Equipment (PPE) when operating and inter-
acting with ÄKTA flux 6.
2 Safety instructions
2.1 Safety precautions
ÄKTA flux 6 Operating Instructions 29046896 AE 19

2.2 Labels
Introduction
This section describes the system label and other safety or regulatory labels that are
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.
The system label information is explained in the table below.
Label text Description
Code no System code number
Serial no System serial number
Mfg Year Manufacturing year and month
Voltage Supply voltage
Frequency Supply voltage frequency
Max power Max power consumption
Fuse System fuse
Protection class Protection class, ingress protection according to IEC
60529. This covers the electric cabinet only.
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
20 ÄKTA flux 6 Operating Instructions 29046896 AE