cytiva AKTA readyflux User manual

ÄKTA readyflux™
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1 Introduction ........................................................................................................ 5
1.1 Important user information ....................................................................................................................... 6
1.2 About this manual ......................................................................................................................................... 7
1.3 Associated documentation ....................................................................................................................... 8
1.4 Abbreviations .................................................................................................................................................. 10
2 Safety instructions ............................................................................................. 11
2.1 Safety precautions ........................................................................................................................................ 12
2.2 Labels and symbols ....................................................................................................................................... 16
2.3 Emergency procedures ............................................................................................................................... 18
3 System description ............................................................................................ 21
3.1 System overview ............................................................................................................................................ 22
3.2 Illustrations ...................................................................................................................................................... 24
3.3 Components .................................................................................................................................................... 34
3.3.1 Flow kits ............................................................................................................................................................ 35
3.3.2 Pumps and valves ......................................................................................................................................... 38
3.3.3 Meters and sensors ..................................................................................................................................... 43
3.3.4 CUSTOMER I/O connectors ................................................................................................................... 45
3.4 Flow path ........................................................................................................................................................... 47
3.4.1 Flowchart and description for CFF ........................................................................................................ 48
3.4.2 Flowchart and description for NFF ........................................................................................................ 52
3.5 Filters .................................................................................................................................................................. 54
3.5.1 Flat sheet filters ............................................................................................................................................. 55
3.5.2 Hollow fiber filters ......................................................................................................................................... 56
3.6 UNICORN control system ........................................................................................................................... 58
3.6.1 Introduction .................................................................................................................................................... 59
3.6.2 Description of UNICORN .......................................................................................................................... 60
3.6.3 The System Control module ................................................................................................................. 61
3.6.4 Process picture .............................................................................................................................................. 63
3.6.5 Warnings and alarms ................................................................................................................................. 75
4 Installation .......................................................................................................... 76
4.1 Safety precautions ........................................................................................................................................ 77
4.2 Site preparation .............................................................................................................................................. 81
4.2.1 Room requirements .................................................................................................................................... 82
4.2.2 Site environmental requirements ......................................................................................................... 84
4.2.3 Electrical power requirements ............................................................................................................... 85
4.2.4 Media supply .................................................................................................................................................. 86
4.2.5 Computer requirements ........................................................................................................................... 87
4.3 Transport .......................................................................................................................................................... 88
4.4 Unpack the system ........................................................................................................................................ 91
4.5 Setup ................................................................................................................................................................... 92
4.5.1 Position the system ..................................................................................................................................... 93
4.5.2 Setup of control system and network .................................................................................................. 94
4.5.3 Start UNICORN and connect to system .............................................................................................. 96
4.5.4 Connect compressed air supply ............................................................................................................. 105
4.5.5 Bag and filter tubing connections ......................................................................................................... 106
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ÄKTA readyflux Operating Instructions 29175550 AG 2

4.6 Power supply .................................................................................................................................................... 108
4.7 Install the pump upgrade kit ...................................................................................................................... 112
5 Operation ............................................................................................................ 118
5.1 Safety precautions ........................................................................................................................................ 119
5.2 Flow kit installation ....................................................................................................................................... 124
5.2.1 Preparations ................................................................................................................................................... 126
5.2.2 Flow kit package ........................................................................................................................................... 127
5.2.3 Install the CFF flow kit ................................................................................................................................. 128
5.2.4 Install the NFF flow kit ................................................................................................................................. 152
5.2.5 Flow kit installation test ............................................................................................................................. 167
5.3 Bag installation ............................................................................................................................................... 174
5.3.1 2D hanging bag (Bagkart) ......................................................................................................................... 175
5.3.2 3D bag (XDUO or XDM S UF mixer) ....................................................................................................... 178
5.4 Filter installation ............................................................................................................................................ 182
5.4.1 Membrane filter cassettes ....................................................................................................................... 183
5.4.2 Hollow fiber cartridges ............................................................................................................................... 185
5.5 System installation test ............................................................................................................................... 188
5.5.1 About the system installation test ........................................................................................................ 189
5.5.2 Run a system installation test ................................................................................................................. 191
5.5.3 The installation test report ....................................................................................................................... 193
5.6 Calibration ........................................................................................................................................................ 195
5.7 Perform a run ................................................................................................................................................... 198
5.7.1 Before you start ............................................................................................................................................. 199
5.7.2 Start and monitor a method run ............................................................................................................ 201
5.8 Procedures after a run ................................................................................................................................. 204
6 Maintenance ....................................................................................................... 207
6.1 Safety precautions ........................................................................................................................................ 208
6.2 Cleaning before planned service ............................................................................................................. 210
6.3 Daily maintenance ........................................................................................................................................ 211
6.4 Yearly maintenance ..................................................................................................................................... 213
6.5 Spare parts ...................................................................................................................................................... 214
6.6 Storage .............................................................................................................................................................. 215
7 Troubleshooting ................................................................................................. 216
8 Reference information ....................................................................................... 224
8.1 Specifications .................................................................................................................................................. 225
8.2 Process wetted materials ........................................................................................................................... 231
8.3 Chemical resistance ..................................................................................................................................... 232
8.4 Ordering information ................................................................................................................................... 235
8.5 Recycling information .................................................................................................................................. 238
8.6 Regulatory information ............................................................................................................................... 240
8.6.1 Contact information .................................................................................................................................... 241
8.6.2 European Union and European Economic Area .............................................................................. 242
8.6.3 Great Britain ................................................................................................................................................... 243
8.6.4 Eurasian Economic Union (Евразийский экономический союз) .......................................... 244
8.6.5 North America ............................................................................................................................................... 246
8.6.6 General regulatory statements .............................................................................................................. 247
8.6.7 Other regulations and standards .......................................................................................................... 248
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ÄKTA readyflux Operating Instructions 29175550 AG 3

8.6.8 Declaration of Hazardous Substances (DoHS) ................................................................................ 249
8.7 Health and Safety Declaration Form ...................................................................................................... 253
8.8 More information ........................................................................................................................................... 255
Index ........................................................................................................................... 256
Table of Contents
ÄKTA readyflux Operating Instructions 29175550 AG 4

1 Introduction
About this chapter
This chapter contains information about this manual and associated user documenta-
tion, important user information and intended use of the ÄKTA readyflux™ system.
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 Abbreviations 10
1 Introduction
ÄKTA readyflux Operating Instructions 29175550 AG 5

1.1 Important user information
Introduction
This section contains important user information about the product and this manual.
Read this before operating the
product
All users must read the entire Operating Instructions before installing, oper-
ating, or maintaining the product.
Always keep the Operating Instructions at hand when operating the product.
Do not install, operate, or perform maintenance on the product in any other way than
described in the user documentation. If you do, you may be exposed or expose others
to hazards that can lead to personal injury and you may cause damage to the equip-
ment.
Intended use of the product
ÄKTA readyflux is intended to be used as development and manufacturing equipment
for processing of biomolecules, both upstream and downstream. The system must not
be used in any clinical procedures, or for diagnostic purposes.
Prerequisites
•The user should be acquainted with the use of bioprocessing equipment and with
the handling of biological materials.
•The user 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 76.
•The user must have a working knowledge of the UNICORN™ software. See the
UNICORN manuals for instructions on the software structure and the work flow.
•The user must have a working knowledge of Microsoft Windows.
1 Introduction
1.1 Important user information
ÄKTA readyflux Operating Instructions 29175550 AG 6

1.2 About this manual
Purpose of this manual
The Operating Instructions provide the information needed to install, operate and
maintain the product in a safe way.
Scope of this manual
The Operating Instructions manual covers the ÄKTA readyflux system including the
optional Bagkart™ 2D bag trolley and the optional Fluxkart™ flat sheet filter trolley. The
Operating Instructions describes instrument configuration 2.0.0.1 compatible with
UNICORN 7.6 or later versions. The examples in this manual are from UNICORN 7.7. 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.
Tip: The text can include clickable hyperlinks to reference information.
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 readyflux Operating Instructions 29175550 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
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
(29175550)
Instructions needed to install, operate
and maintain the system in a safe way.
ÄKTA readyflux Site Preparation Guide
(29178995)
Information needed to prepare the site
for installation and use of the system.
Contains a checklist as a feedback tool
to the Cytiva personnel prior to installa-
tion of the system.
ÄKTA readyflux Unpacking Instructions
(29178997)
Instructions on how to unpack the
system upon arrival.
Hardware Product Documentation
binders
Documents that include hardware
specifications.
UNICORN 7.6 (or later version) docu-
mentation 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.
ÄKTA readyflux Software Guide
(29296551)
Instructions on how to use the software.
ÄKTA readyflux Workflow Phases Binder
(29253906)
Schematic representations of the
different workflow phases available for
ÄKTA readyflux.
Pump Upgrade Kit for ÄKTA readyflux
Instructions for Use (29723633)
Instructions on how to install the pump
upgrade kit for the feed pump, to enable
the use of the ÄKTA readyflux system
with ¼ inch flow kits for low flow rate
applications.
1 Introduction
1.3 Associated documentation
ÄKTA readyflux Operating Instructions 29175550 AG 8

Documentation Main contents
Pump Upgrade Kit Cue Cards
(29726810)
Brief instructions on how to set up the
system and software, install the pump
upgrade kit, as well as considerations
regarding ¼ inch flow kit usage and
system operation.
ÄKTA readyflux Flow kit Product Docu-
mentation (29710614, 29209885,
29733825)
General specifications for ¼ inch, ½
inch, and ⅜ inch flow kits and list of
materials in the flow path.
Help in the software
The following help information is available on the workstation software.
Documentation Main contents
UNICORN 7.6 (or later version) software
help
Overview and detailed descriptions of
menus and functions in UNICORN 7.6 or
later versions.
To access the software help, select
Help from the menu bar or press the F1
key.
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 AG 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 Practice Good Manufacturing Practice
HF Hollow fiber Hollow fiber
IC Instrument configuration Instrument configuration
LPM Liter per minute Liter per minute
MAbs Monoclonal antibodies Monoclonal antibodies
NFF Normal flow filtration Normal flow filtration
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
ÄKTA readyflux Operating Instructions 29175550 AG 10

2 Safety instructions
About this chapter
This chapter describes safety precautions, labels and symbols that are attached to the
equipment. In addition, the chapter describes emergency and recovery procedures.
In this chapter
Section See page
2.1 Safety precautions 12
2.2 Labels and symbols 16
2.3 Emergency procedures 18
2 Safety instructions
ÄKTA readyflux Operating Instructions 29175550 AG 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, the user must be aware of the
hazards described in this manual.
Definitions
This user documentation contains safety notices (WARNING, CAUTION, and NOTICE)
concerning the safe use of the product. It also contains important notices for critical
software or application information. 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.
IMPORTANT
IMPORTANT indicates instructions that are essential for the soft-
ware or application to function.
General precautions
The following general precautions must be considered at all times. There are also
context related precautions, which are written in their respective chapters.
2 Safety instructions
2.1 Safety precautions
ÄKTA readyflux Operating Instructions 29175550 AG 12

WARNING
Risk assessment. Perform a risk assessment for the process or
process environment. Evaluate the effects the use of the product
and the operational processes may have on the classification of the
hazardous area. The process can cause the hazardous 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 according to local regula-
tions by adequately trained personnel.
WARNING
Only properly trained personnel are allowed to operate and main-
tain the product.
WARNING
Electrical shock hazard. All installation, service and maintenance
of components inside the electrical cabinet must be done by
personnel authorized by Cytiva.
WARNING
Accessories. Use only accessories supplied or recommended by
Cytiva.
2 Safety instructions
2.1 Safety precautions
ÄKTA readyflux Operating Instructions 29175550 AG 13

WARNING
Do not use the product if it is not working properly, or if it has
suffered any damage including:
•damage to the power cord or its plug,
•damage caused by dropping the product,
•damage caused by splashing liquid onto the product.
WARNING
Pressurized flow path. During a power failure or emergency stop,
the equipment can remain pressurized. Make sure all lines and
vessels are depressurized before opening a line or vessel.
Personal protection
WARNING
Personal Protective Equipment (PPE). When packing,
unpacking, transporting or moving the product, wear the following.
•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 or biological agents, take all suitable protec-
tive measures, such as wearing protective clothing, glasses and
gloves resistant to the substances used. Follow local and national
regulations for safe operation and maintenance of this product.
2 Safety instructions
2.1 Safety precautions
ÄKTA readyflux Operating Instructions 29175550 AG 14

Flammable liquids and explosive
environment
WARNING
Flammable liquids. This product is not approved for handling
liquids under conditions when they can be flammable.
WARNING
Explosion hazard: The product is not approved for use in a
potentially explosive atmosphere. The product does not fulfill the
requirements of the ATEX Directive.
2 Safety instructions
2.1 Safety precautions
ÄKTA readyflux Operating Instructions 29175550 AG 15

2.2 Labels and symbols
Introduction
This section describes the system label and other safety or regulatory labels that are
attached to the product.
Nameplate
The system nameplate is located on the back of the equipment. The nameplate identi-
fies the equipment and shows electrical data, regulatory compliance, and warning
symbols.
The following symbols and text may be present on the nameplate:
Label text Description
Warning! Read the user documentation before using the
system. Do not open any covers or replace parts unless
specifically stated in the user documentation.
Code Number Ordering number for ÄKTA readyflux
Serial Number System serial number
Manufacturing
Month/Year
Month (MM) and Year (YYYY) of manufacture
Supply Voltage Supply voltage
Frequency Supply voltage frequency
Max Power
Consumption
Maximum power consumption
Pneumatic Supply Pneumatic supply pressure requirement
Protection Class Protection class. Ingress protection according to IEC
60529. This covers the electric cabinet only.
Safety labels
The table below describes the various safety labels that may be found on the product.
2 Safety instructions
2.2 Labels and symbols
ÄKTA readyflux Operating Instructions 29175550 AG 16

Symbol/text Description
Warning! Hazardous Voltage. Always make sure that
the system is disconnected from electric power before
opening the cabinet doors or disconnecting any electric
device.
Warning! Pinch hazard. This sign is located next to
pinch valves. Never put your fingers or any objects other
than the intended tubing into the pinch valve openings.
Ensure that clothing or other equipment cannot get
caught in the pinch valves.
Warning! Pinch hazard because of rotating parts.
This sign is located next to the pumps. Turn off the pump
motor before opening the pump. Keep your hands out of
the pump openings.
2 Safety instructions
2.2 Labels and symbols
ÄKTA readyflux Operating Instructions 29175550 AG 17

2.3 Emergency procedures
Introduction
This section describes how to do an emergency shutdown of the ÄKTA readyflux
system, and the procedure for restarting the system.
The section also describes the result in the event of power failure.
Precautions
WARNING
Pressurized flow path. During a power failure or emergency stop,
the equipment can remain pressurized. Make sure all lines and
vessels are depressurized before opening a line or vessel.
WARNING
Emergency stop. Pressing the EMERGENCY STOP will not shut
off mains power to the electrical cabinet.
Emergency stop button and main
power switch
1
2
Part Function
1 Emergency stop button EMERGENCY STOP
2 Main power switch MAIN POWER
2 Safety instructions
2.3 Emergency procedures
ÄKTA readyflux Operating Instructions 29175550 AG 18

Emergency shutdown
In an emergency situation, follow the steps below to stop the run:
Intended action Procedure
Stop the run •Press the EMERGENCY STOP button.
or
•To stop the run from UNICORN, click the End button
in the System Control module.
Result: All pumps in the instrument are stopped immedi-
ately. The valves are reset to their default positions.
Switch off the instru-
ment •Turn the MAIN POWER switch to the O position.
or
•Disconnect the power cord from the wall socket.
Result: The run is interrupted immediately.
Note:
The sample and data may be lost as a result of switching
off the power.
Power failure
The following table describes the consequences of a power failure.
Power failure of unit Result
ÄKTA readyflux system •The run is interrupted immediately.
•The data collected up to the time of the power
failure is available in UNICORN.
2 Safety instructions
2.3 Emergency procedures
ÄKTA readyflux Operating Instructions 29175550 AG 19

Power failure of unit Result
Computer •The UNICORN computer shuts down.
•The Power/Communication indicator
(white) on the Instrument control panel
displays a slowly flashing light.
•The run is interrupted immediately.
•Data generated up to 10 seconds before the
power failure can be recovered.
Note:
The UNICORN client may lose connection to
the instrument during a temporary overload
of the processor and display an error
message. This may appear as a computer
failure. The run continues and you can restart
the UNICORN client to regain control. No data
will be lost.
Restart after emergency shutdown or
power failure
Follow the instructions to restart the instrument after an emergency shutdown or
power failure.
Step Action
1Make sure that the condition that caused the emergency shutdown or
power failure is corrected.
2If power to the instrument has been lost, restart the instrument.
3Click the Continue button in the System Control module.
2 Safety instructions
2.3 Emergency procedures
ÄKTA readyflux Operating Instructions 29175550 AG 20