cytiva AKTA readyflux User manual

ÄKTA readyflux
Operating Instructions
Original instructions
Translation disc included
cytiva.com

Table of Contents
1Introduction ........................................................................................................ 4
1.1 About this manual ......................................................................................................................................... 5
1.2 Important user information ....................................................................................................................... 6
1.3 Associated documentation ....................................................................................................................... 8
1.4 Abbreviations .................................................................................................................................................. 10
2 Safety instructions ............................................................................................. 11
2.1 Safety precautions ........................................................................................................................................ 12
2.2 Labels ................................................................................................................................................................. 23
2.3 Emergency procedures ............................................................................................................................... 25
3 System description ............................................................................................ 28
3.1 System overview ............................................................................................................................................ 29
3.2 Illustrations ...................................................................................................................................................... 31
3.3 Components .................................................................................................................................................... 40
3.3.1 Flow kits ............................................................................................................................................................ 41
3.3.2 Pumps and valves ......................................................................................................................................... 43
3.3.3 Meters and sensors ..................................................................................................................................... 48
3.3.4 CUSTOMER I/O connectors ................................................................................................................... 50
3.4 Flow system ..................................................................................................................................................... 52
3.5 Filters .................................................................................................................................................................. 56
3.5.1 Flat sheet filters ............................................................................................................................................. 57
3.5.2 Hollow fiber (HF) filters ............................................................................................................................... 58
3.6 UNICORN control system ........................................................................................................................... 60
3.6.1 Introduction .................................................................................................................................................... 61
3.6.2 Description of UNICORN .......................................................................................................................... 62
3.6.3 The System Control module ................................................................................................................. 63
3.6.4 Process picture .............................................................................................................................................. 65
3.6.5 Warnings and alarms ................................................................................................................................. 73
4 Installation .......................................................................................................... 74
4.1 Site requirements .......................................................................................................................................... 75
4.2 Transport .......................................................................................................................................................... 79
4.3 Unpack the product ...................................................................................................................................... 82
4.4 Setup ................................................................................................................................................................... 83
4.4.1 Position the system ..................................................................................................................................... 84
4.4.2 Setup of control system and network .................................................................................................. 85
4.4.3 Start UNICORN and connect to system ............................................................................................. 86
4.4.4 Connect compressed air supply ............................................................................................................. 89
4.4.5 Bag and filter tubing connections ......................................................................................................... 90
4.5 Power supply .................................................................................................................................................... 92
5 Operation ............................................................................................................ 95
5.1 Flow kit installation ....................................................................................................................................... 97
5.1.1 Preparations ................................................................................................................................................... 99
5.1.2 Flow kit package ........................................................................................................................................... 100
5.1.3 Install the flow kit .......................................................................................................................................... 101
5.1.4 Flow kit installation test ............................................................................................................................. 124
5.2 Bag installation ............................................................................................................................................... 128
Table of Contents
2 ÄKTA readyflux Operating Instructions 29175550 AE

5.2.1 2D hanging bag (Bagkart) ........................................................................................................................ 129
5.2.2 3D bag (XDUO or XDM) .............................................................................................................................. 132
5.3 Filter installation ............................................................................................................................................ 134
5.3.1 Membrane filter cassettes ....................................................................................................................... 135
5.3.2 Hollow fiber (HF) cartridges ...................................................................................................................... 137
5.4 Installation test ............................................................................................................................................... 139
5.4.1 About the system installation test ........................................................................................................ 140
5.4.2 Running a system installation test ........................................................................................................ 142
5.4.3 The installation test report ....................................................................................................................... 144
5.5 Calibration ........................................................................................................................................................ 146
5.6 Perform a run ................................................................................................................................................... 149
5.6.1 Before you start ............................................................................................................................................. 150
5.6.2 Start and monitor a method run ............................................................................................................ 152
5.7 Procedures after a run ................................................................................................................................. 154
6 Maintenance ....................................................................................................... 157
6.1 Cleaning before planned service ............................................................................................................. 158
6.2 Daily maintenance ........................................................................................................................................ 159
6.3 Yearly maintenance ..................................................................................................................................... 161
6.4 Spare parts ...................................................................................................................................................... 162
6.5 Storage .............................................................................................................................................................. 163
7 Troubleshooting ................................................................................................. 164
8 Reference information ....................................................................................... 171
8.1 Specifications .................................................................................................................................................. 172
8.2 Process wetted materials ........................................................................................................................... 176
8.3 Chemical resistance ..................................................................................................................................... 177
8.4 Ordering information ................................................................................................................................... 180
8.5 Recycling information .................................................................................................................................. 182
8.6 Regulatory information ............................................................................................................................... 184
8.6.1 Contact information .................................................................................................................................... 185
8.6.2 European Union and European Economic Area .............................................................................. 186
8.6.3 Eurasian Economic Union
Евразийский экономический союз .................................................................................................. 187
8.6.4 Regulations for North America ............................................................................................................... 189
8.6.5 Regulatory statements .............................................................................................................................. 190
8.6.6 Other regulations and standards .......................................................................................................... 191
8.6.7 Declaration of Hazardous Substances (DoHS) ................................................................................ 192
8.7 Health and Safety Declaration Form ...................................................................................................... 194
8.8 More information ........................................................................................................................................... 196
Index ........................................................................................................................... 197
Table of Contents
ÄKTA readyflux Operating Instructions 29175550 AE 3

1 Introduction
About this chapter
This chapter contains important user information, descriptions of safety notices, regu-
latory information, intended use of ÄKTA™ readyflux™, and lists of associated docu-
mentation.
In this chapter
Section See page
1.1 About this manual 5
1.2 Important user information 6
1.3 Associated documentation 8
1.4 Abbreviations 10
1 Introduction
4 ÄKTA readyflux Operating Instructions 29175550 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.
Scope of this manual
The Operating Instructions cover the ÄKTA readyflux instrument including the optional
2D bag trolley Bagkart™ and the optional flat sheet filter trolley Fluxkart™, and refer-
ences to UNICORN 7. The illustration below shows the ÄKTA readyflux system.
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 readyflux Operating Instructions 29175550 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 the ÄKTA readyflux
system
ÄKTA readyflux system is intended to be used as development and manufacturing
equipment for processing of biomolecules, both upstream and downstream.
Prerequisites
•You should be acquainted with the use of bioprocessing equipment and with the
handling of biological materials.
•You must have read and understood Chapter 2 Safety instructions, on page 11 of
these Operating Instructions.
•The system must be installed according to the instructions in Chapter 4 Installation,
on page 74.
•You must have a working knowledge of the UNICORN™ software. See the UNICORN
manuals for instructions on the software structure and the work flow.
•You must have a working knowledge of Microsoft ® Windows ®.
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
1.2 Important user information
6 ÄKTA readyflux Operating Instructions 29175550 AE

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 readyflux Operating Instructions 29175550 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.
User documentation
The user documentation listed in the table below is available in printed, PDF, or elec-
tronic Help format.
Documentation Main contents
ÄKTA readyflux Operating Instructions Instructions needed to install, operate
and maintain ÄKTA readyflux in a safe
way.
Site Preparation Guide Document specifying site require-
ments. Contains a checklist as a feed-
back tool to the Cytiva personnel prior
to installation of the instrument or
system.
Unpacking Instructions Instructions on how to unpack the
instrument upon arrival.
Hardware Product Documentation
binders
Documents including hardware specifi-
cations.
UNICORN 7 documentation package Overview and detailed descriptions of
the system control software for
ÄKTA readyflux. The manuals cover the
process picture map for real time moni-
toring, the method editor, as well as the
evaluation and administration modules.
Software manual Instructions on how to use the software
Help in the software
The following help information is available on the workstation software.
Documentation Main contents
UNICORN 7 software help Overview and detailed descriptions of
menus and functions in UNICORN 7.
To access the software help, select
Help from the menu bar or press the F1
key.
1 Introduction
1.3 Associated documentation
8 ÄKTA readyflux Operating Instructions 29175550 AE

System-specific documentation
In addition to the Operating Instructions manual, the documentation package supplied
with ÄKTA readyflux also includes product documentation binders containing detailed
specifications and traceability documents.
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
1.3 Associated documentation
ÄKTA readyflux Operating Instructions 29175550 AE 9

1.4 Abbreviations
Introduction
This section explains abbreviations that appear in the user documentation for
ÄKTA readyflux.
Abbreviations
Abbrevia-
tion
Definition (English) Translation
CFF Cross-Flow Filtration Cross-Flow Filtration
GMP Good Manufacturing Practices Good Manufacturing Practices
HF Hollow Fiber Hollow Fiber
LPM Liter Per Minute Liter Per Minute
MAbs Monoclonal Antibodies Monoclonal Antibodies
PCV Pressure Control Valve Pressure Control Valve
RPM Revolutions Per Minute Revolutions Per Minute
SOP Standard Operation Proce-
dures
Standard Operation Proce-
dures
TMP Transmembrane Pressure Transmembrane Pressure
UPS Uninterruptible Power Supply Uninterruptible Power Supply
1 Introduction
1.4 Abbreviations
10 ÄKTA readyflux Operating Instructions 29175550 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,
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 12
2.2 Labels 23
2.3 Emergency procedures 25
2 Safety instructions
ÄKTA readyflux Operating Instructions 29175550 AE 11

2.1 Safety precautions
Introduction
ÄKTA readyflux is powered by mains voltage and handles materials that may be
hazardous. Before installing, operating or maintaining the system, you must be aware
of the hazards described in this manual.
Follow the instructions provided to avoid personal injuries, damage to the
equipment, or to other personnel or equipment in the area.
The safety precautions in this section are grouped into the following categories:
•General precautions on page 12
•Personal protection, on page 14
•Flammable liquids and explosive environment on page 14
•Installing and moving the system on page 15
•Power supply, on page 17
•System operation on page 18
•Maintenance on page 22
General precautions
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.
WARNING
Do not operate the product in any other way than described in the
user documentation.
WARNING
The customer must make sure that all installation, maintenance,
operation and inspection is carried out by qualified personnel who
are adequately trained, understand and adhere to local regulations
and the operating instructions, and have a thorough knowledge of
the product and the entire process.
2 Safety instructions
2.1 Safety precautions
12 ÄKTA readyflux Operating Instructions 29175550 AE

WARNING
Only properly trained personnel may operate and maintain the
product.
WARNING
Electrical shock hazard. All installation, service and maintenance
of components inside the electronics cabinet should be done by
service personnel authorized by Cytiva. Do not open any covers or
replace parts unless specifically stated in the Operating Instruc-
tions.
WARNING
Do not use any accessories not supplied or recommended by
Cytiva.
WARNING
Do not use ÄKTA readyflux 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
Power failure - equipment may remain pressurized. During a
power failure, or if the EMERGENCY STOP button is pressed, the
equipment may remain pressurized. Opening a line or vessel at this
point could result in the release of potentially hazardous process or
cleaning fluid, and cause bodily harm.
When recovering from a power failure or emergency shutdown,
make sure all lines and vessels are depressurized before opening.
2 Safety instructions
2.1 Safety precautions
ÄKTA readyflux Operating Instructions 29175550 AE 13

Personal protection
WARNING
Personal Protective Equipment (PPE). Whenever packing,
unpacking, transporting or moving the product, wear:
•Protective footwear, preferably with steel toe-cap.
•Working gloves, protecting against sharp edges.
•Protective glasses.
WARNING
Always use appropriate Personal Protective Equipment (PPE)
during operation and maintenance of this product.
WARNING
Hazardous substances and biological agents. When using
hazardous chemical and biological agents, take all suitable protec-
tive measures, such as wearing protective clothing, glasses and
gloves resistant to the substances used. Follow local and/or
national regulations for safe operation and maintenance of this
product.
Flammable liquids and explosive
environment
WARNING
Flammable liquids. This product is not approved for handling
flammable liquids.
WARNING
Explosive environment. The product is not approved for work in
a potentially explosive atmosphere. The product does not fulfill the
requirements of the ATEX Directive.
2 Safety instructions
2.1 Safety precautions
14 ÄKTA readyflux Operating Instructions 29175550 AE

Installing and moving the system
WARNING
The product must be installed and prepared by Cytiva personnel or
a third party authorized by Cytiva.
WARNING
Move transport crates. Make sure that the lifting equipment has
the capacity to safely lift the crate weight. Make sure that the crate
is properly balanced so that it will not accidentally tip when moved.
WARNING
Tipping risk. When lifting and moving the product, make sure that
the fork is inserted under the center of gravity of the product. The
center of gravity of the product is high and the product may tip over
if the forks are offset too far to either side.
WARNING
Heavy object. Because of the significant weight of the product,
great care must be taken not to cause squeezing or crushing inju-
ries during movement. At least two, but preferably three or more,
people are recommended when moving the unit.
WARNING
Heavy object. When rolling the system down the ramp take great
care to avoid the wheels slipping off the edge of the ramp.
WARNING
Heavy object. The ramp is not reinforced in the center. Do not use
a pallet lifter or forklift on the ramp.
CAUTION
The product is designed for indoor use only.
2 Safety instructions
2.1 Safety precautions
ÄKTA readyflux Operating Instructions 29175550 AE 15

CAUTION
Do not use the product in a dusty atmosphere or close to spraying
water.
CAUTION
Packing crates may have been exposed to pesticides, depending
on the regulations of the country of delivery. Recycle packing
crates according to local recommendations for pesticide-treated
wood.
CAUTION
The wheels of ÄKTA readyflux should be locked during normal use.
The wheels should be unlocked only when moving the unit.
CAUTION
Make sure that the tubing is not bent along sharp edges. Vibration
of bent tubing along sharp edges causes rubbing that may cause
the tubing to break and leak.
CAUTION
Make sure that all tubing, hoses and cables are placed so that the
risk of tripping accidents is minimized.
CAUTION
Make sure that the common waste outlet is:
•Never exposed to back-pressure.
•Connected to piping with at least the same diameter as the
common waste outlet piping.
•Connected to piping that allows maximum waste flow to be
transported away from ÄKTA readyflux without pooling.
2 Safety instructions
2.1 Safety precautions
16 ÄKTA readyflux Operating Instructions 29175550 AE

CAUTION
The maximum weight of the 2D Bag on the Bagkart is 25 kg.
Bagkart must only be tared with an empty bag and empty flow kits.
Incorrect taring will result in overload of the Bagkart trolley or the
bag, which may result in bag burst.
CAUTION
Bagkart must be calibrated with a pre-calibrated weight. If the cali-
bration terminated or cancelled partially, re-calibrate before use.
CAUTION
Read XDUO and XDM instruction safety procedures and user
manual before interfacing and operating with ÄKTA readyflux .
NOTICE
Use the supplied network cable with encased RJ45 connectors to
protect from liquids. Do not replace this cable with an unprotected
cable.
NOTICE
Vents on the ÄKTA readyflux instrument. Do not block the
ventilation inlets or outlets of the instrument.
Power supply
WARNING
Supply voltage. Before connecting the power cord, make sure
that the supply voltage at the wall outlet corresponds to the
marking on the instrument.
WARNING
Protective ground. The product must always be connected to a
grounded power outlet.
2 Safety instructions
2.1 Safety precautions
ÄKTA readyflux Operating Instructions 29175550 AE 17

WARNING
Access to power switch and power cord with plug. Do not
block access to the power switch and power cord. The power switch
must always be easy to access. The power cord with plug must
always be easy to disconnect.
WARNING
Fuse replacement should only be performed by an authorized
service engineer.
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.
System operation
WARNING
Never exceed the operating limits stated in this document and on
the system name plate. Operation of the product outside these
limits can damage equipment and cause personal injury or death.
WARNING
Over-pressure. Never block the outlet tubing with, for instance,
stop plugs, since this will create over-pressure and might result in
injury.
2 Safety instructions
2.1 Safety precautions
18 ÄKTA readyflux Operating Instructions 29175550 AE

WARNING
Do not close valves located downstream of the pump when pump is
running.
WARNING
During operation, the cabinet door must always be closed and
locked.
WARNING
Safe distance. Always maintain a safe distance from the product
during drainage or other activities that may involve splashing.
WARNING
When the system is operated from a remote controlling computer,
the operator must always make sure that no one is present and
exposed when the system is started and that no one enters the risk
area around the system during operation.
WARNING
Shutdown does not automatically result in depressurizing of the
piping system.
WARNING
Emergency stop. Pressing the EMERGENCY STOP will not shut
off mains power to the electrical cabinet.
WARNING
Alarm signals. 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
leakage or damage to the piping system.
2 Safety instructions
2.1 Safety precautions
ÄKTA readyflux Operating Instructions 29175550 AE 19

WARNING
Make sure that a valid flow path exists before running a pump
manually. Running a pump with invalid flow path will create over-
pressure and may result in tube burst or injury.
WARNING
Never leave a flow kit containing aggressive liquids mounted on the
system for longer time periods. Either discard the flow path, or
rinse it with water or suitable solution.
WARNING
Single use. The flow kit is intended for single use only.
WARNING
Never put fingers or any objects other than the intended tubing
into the pinch valve opening.
WARNING
Emergency stop in XDUO and XDM instruments will pause the
system.
WARNING
Emergency stop in the system will not pause XDUO and XDM
systems.
CAUTION
Hot surface. When pumping fluid through feed pump, do not
touch feed pump until you are sure that this can be done without
risk or when the pump has reached a temperature below 40°C. Use
protective gloves to touch the hot surface e.g. feed pump pressure
plate during run.
2 Safety instructions
2.1 Safety precautions
20 ÄKTA readyflux Operating Instructions 29175550 AE