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