GE AKTA ready XL User manual

ÄKTA™ ready XL
Operating Instructions
Original instructions
gelifesciences.com
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185018004599

Table of Contents
1Introduction .............................................................................................................. 4
1.1 About this manual ..................................................................................................................................... 5
1.2 Important user information ................................................................................................................... 6
1.3 Associated documentation ................................................................................................................... 9
1.4 Abbreviations .............................................................................................................................................. 11
2 Safety instructions .................................................................................................. 12
2.1 Safety precautions .................................................................................................................................... 13
2.2 Labels ............................................................................................................................................................. 21
2.3 Emergency procedures ........................................................................................................................... 24
3 System description ................................................................................................. 30
3.1 Overview ....................................................................................................................................................... 31
3.2 Illustrations .................................................................................................................................................. 33
3.3 Flowchart ...................................................................................................................................................... 43
3.4 System components ................................................................................................................................. 47
3.4.1 Skid and electrical cabinet ................................................................................................................. 48
3.4.2 Control system components ............................................................................................................ 49
3.4.3 System pumps ...................................................................................................................................... 51
3.4.4 Valves ....................................................................................................................................................... 55
3.4.5 Transmitters and sensors ................................................................................................................. 60
3.5 Flow kits ......................................................................................................................................................... 62
3.5.1 Flow kit description ............................................................................................................................. 63
3.5.2 Flow kit parts and components ....................................................................................................... 65
3.5.3 Gradient section and components ................................................................................................. 71
3.6 Process control software ........................................................................................................................ 72
4 Installation ................................................................................................................ 76
4.1 Site requirements ...................................................................................................................................... 77
4.2 Transport and moving of the system .................................................................................................. 78
4.3 Setup ............................................................................................................................................................... 86
4.3.1 Assembly ................................................................................................................................................ 87
4.3.2 Setup of control system and network ........................................................................................... 90
4.3.3 Connect compressed air supply ...................................................................................................... 91
4.3.4 Guidelines for connections ................................................................................................................ 92
4.4 Power supply ............................................................................................................................................... 93
5 Preparation ............................................................................................................... 94
5.1 Start the system and log on to control software ........................................................................... 96
5.2 Install disposable flow kits ..................................................................................................................... 97
5.3 Perform flow kit installation test ......................................................................................................... 123
5.4 Prime to remove air from the pump and flow path ....................................................................... 126
5.5 Install filter (optional) ............................................................................................................................... 129
6 Operation .................................................................................................................. 130
6.1 Connect a column ...................................................................................................................................... 131
6.2 Run a method .............................................................................................................................................. 134
Table of Contents
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6.3 Controlled shutdown and removal of flow kit ................................................................................. 139
7Maintenance ............................................................................................................. 143
8 Troubleshooting ...................................................................................................... 146
9 Reference information ........................................................................................... 149
9.1 Specifications .............................................................................................................................................. 150
9.2 Flow kit ordering information ................................................................................................................ 152
9.3 Chemical resistance ................................................................................................................................. 153
9.4 Recycling information .............................................................................................................................. 156
9.5 Regulatory information ........................................................................................................................... 157
9.5.1 Contact information ........................................................................................................................... 158
9.5.2 European Union and European Economic Area ......................................................................... 159
9.5.3 Eurasian Economic Union
Евразийский экономический союз ........................................................................................ 160
9.5.4 Regulations for USA ............................................................................................................................ 162
9.5.5 Regulatory statements ...................................................................................................................... 163
9.5.6 Declaration of Hazardous Substances (DoHS) .......................................................................... 164
9.5.7 Additional regulations and standards .......................................................................................... 166
9.6 Health and Safety Declaration Forms ................................................................................................ 167
9.7 More information ....................................................................................................................................... 169
Index ................................................................................................................................... 170
Table of Contents
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1 Introduction
About this chapter
This chapter contains important user information, descriptions of safety notices, reg-
ulatory information, intended use of ÄKTA ready XL, 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 9
1.4 Abbreviations 11
1 Introduction
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1.1 About this manual
Purpose of this manual
The Operating Instructions provide you with the information needed to install, oper-
ate, and maintain the product in a safe way.
Scope of this manual
This manual is specific for ÄKTA ready XL and describes the safety instructions and
procedures required to operate ÄKTA ready XL together with either the ¾ inch or 1
inch disposable ÄKTA ready XL Flow kit, as well as technical information and instruc-
tions for troubleshooting and maintenance.
Only UNICORN™ software instructions are provided as examples. For other control
software instructions, refer to the software documentation.
Detailed information regarding columns, resin and buffer tanks is not covered.
Illustrations
The illustrations provided in this manual are for illustrative purposes and may not al-
ways be representative for ÄKTA ready XL.
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 ready XL Operating Instructions 29281616 AE 5
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1.2 Important user information
Read this before operating the
product
All users must read the entire Operating Instructions before installing, operat-
ing 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 ready XL
ÄKTA ready XL is intended to be operated as an isocratic or gradient, low pressure,
automated liquid chromatography system using corresponding single-use isocratic
or gradient ÄKTA ready XL flow kits and columns (for example ReadyToProcess™ col-
umns).
ÄKTA ready XL can be controlled by UNICORN software or other control softwares
such as DeltaV™.
The system design is based on proven liquid chromatography techniques, such as ion
exchange, affinity chromatography, and hydrophobic interaction.
ÄKTA ready XL is biocompatible, hygienic, and meets all GLP and cGMP demands for
clinical phases I–III and commercial production.
ÄKTA ready XL is not approved for use in a potentially explosive atmosphere or for
handling liquids under conditions at which they could be flammable.
Disposable flow kits and columns for use with ÄKTA ready XL are not included with
the system and are ordered separately. See Flow kit options, on page 152 for ordering
information and lists of available flow kits.
WARNING
Do not operate the ÄKTA ready XL instrument in any other way
than described in the ÄKTA ready XL Operating Instructions and
control software manuals.
1 Introduction
1.2 Important user information
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Prerequisites
In order to operate ÄKTA ready XL in the way it is intended, the following prerequi-
sites must be fulfilled:
•The user must be acquainted with the use of general bioprocessing equipment
and with handling of biological materials.
•The user must have a general understanding of how a PC and Microsoft® Win-
dows® work.
•The user must have a working knowledge of the control software.
•The user must read and understand Chapter 2 Safety instructions, on page 12.
•ÄKTA ready XL must be installed in accordance with the site requirements and
instructions in the Operating instructions.
Safety notices
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 pro-
ceed 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 pro-
ceed 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.
1 Introduction
1.2 Important user information
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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
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1.3 Associated documentation
Introduction
Together with each system, the following documents are supplied providing informa-
tion that applies to ÄKTA ready XL.
System documentation
In addition to the Operating Instructions, the documentation package supplied with
ÄKTA ready XL also includes detailed specifications and traceability documents.
The following table provides examples of technical specification documents that can
be found in the documentation package delivered with the product.
Document Abbrevi-
ation
Purpose/Contents
Piping and Instrumenta-
tion Diagram
P&ID Schematic overview of the process
flow, components and instruments
and the control system.
General specification GS Technical data for the system.
Assembly Drawing AD Physical layout. Provides dimensional
data.
Bill of Material BOM Description of process-related compo-
nents.
Spare Part List SPL List of spare parts available from GE
Healthcare.
Third-party component
documentation
Documentation for components produced by a third-party are, if existent, also inclu-
ded in the document package.
1 Introduction
1.3 Associated documentation
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Related literature
This list describes related literature that may be useful.
Contact your GE Healthcare representative for more details.
Document Product Product code
ÄKTA ready XL chromatography system Data file KA1755181217DF
ReadyToProcess columns User Manual User Manual 28925644
ReadyToProcess columns Data file 28915987
Process chromatography: A guide to op-
timization, scale-up and validation
Handbook 18112156
Efficiency test of ReadyToProcess col-
umns
Application
note
28919821
Purification of a monoclonal antibody
using ReadyToProcess columns
Application
note
28919856
1 Introduction
1.3 Associated documentation
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1.4 Abbreviations
Introduction
This section explains abbreviations that appear in the user documentation for ÄKTA
ready XL.
Terminology
Term Definition
CU Control unit
PBS Phosphate-buffered saline
PTFE Polytetrafluoroethylene
TC Hygienic tubing connection
UPS Uninterruptible power supply
XV Pneumatically actuated valve (automatic valve)
1 Introduction
1.4 Abbreviations
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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 proce-
dures, and provides recycling information.
In this chapter
Section See page
2.1 Safety precautions 13
2.2 Labels 21
2.3 Emergency procedures 24
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.
2 Safety instructions
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2.1 Safety precautions
Introduction
ÄKTA ready XL is powered by mains voltage and handles materials that may be haz-
ardous. 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 13
•Personal protection, on page 15
•Flammable liquids and explosive environment, on page 14
•Installing and moving, on page 15
•Operation, on page 18
•Maintenance, on page 20
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
classification 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
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 regu-
lations and the operating instructions, and have a thorough
knowledge of the product and the entire process.
2 Safety instructions
2.1 Safety precautions
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WARNING
Do not operate the product in any other way than described in the
user documentation.
WARNING
Do not use the product if it is not working properly, or if it has suf-
fered 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
The electrical cabinet doors may only be opened when the prod-
uct is taken out of operation and subject to LOCK OUT / TAG
OUT (LOTO) (lockout-tagout).
WARNING
Only authorized personnel may open the electrical cabinet doors.
There is high voltage inside the electrical cabinet that can cause
human injury or death.
WARNING
Emergency stop. Pressing the EMERGENCY STOP will not shut
off mains power to the electrical cabinet.
Flammable liquids and explosive
environment
WARNING
Flammable liquids. This product is not approved for handling
liquids under conditions at which they could be flammable.
2 Safety instructions
2.1 Safety precautions
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WARNING
Explosive environment. The product is not approved for work
in a potentially explosive atmosphere.
Personal protection
WARNING
Hazardous substances and biological agents. When using
hazardous chemical and biological agents, take all suitable pro-
tective 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.
WARNING
Personal Protective Equipment (PPE). Whenever packing, un-
packing, transporting or moving the system, wear protective foot-
wear, preferably with steel toe caps.
Installing and moving
WARNING
The product must be installed and prepared by GE Healthcare
personnel or a third party authorized by GE Healthcare.
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.
2 Safety instructions
2.1 Safety precautions
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CAUTION
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 three people are needed when rolling the system out
of the transport crate.
•At least two, but preferably three or more, people are recom-
mended when moving the unit on flat and even surfaces.
CAUTION
The wheels of ÄKTA ready XL must be locked during normal use.
The wheels must be unlocked only when moving the system.
CAUTION
Before moving ÄKTA ready XL, make sure that:
1. The power supply to the system is switched off.
2. All power cords to the system are disconnected.
3. All air supply lines to the system are disconnected.
4. All process lines to the system are disconnected.
5. All communication cables to the system are disconnected.
CAUTION
Make sure that the air trap vent is:
•Never exposed to back-pressure.
•Connected to piping with at least the same diameter as the
vent piping.
CAUTION
The handle on the pump wagon must not be used for lifting.
2 Safety instructions
2.1 Safety precautions
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Power supply
WARNING
Protective ground. The product must always be connected to a
grounded power outlet.
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
Fixed power supply. Access to power switch and isolation
switch. The power switch and the isolation switch must always
be easy to access.
WARNING
National Codes and standards (NEC, VDE, BSI, IEC, UL etc.) and lo-
cal codes outline provisions for safely installing electrical equip-
ment. Installation must comply with specifications regarding wire
types, conductor sizes, plugs, branch circuit protection and dis-
connect devices. Non-compliance may result in personal injury
and/or equipment damage.
WARNING
All electrical installations must be performed by authorized
personnel only.
2 Safety instructions
2.1 Safety precautions
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Operation
WARNING
Cap unused connections before operation. Make sure that all
connections not in use are capped or directed to waste to avoid
accidental hazardous leakage during operation.
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
Electrical cabinet doors. During operation, all electrical cabinet
doors 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
Use a harmless fluid in the beginning of the process. This will
make it possible to detect leakage with minimized consequences
and the risk for potential leakage of hazardous fluids is avoided.
WARNING
Power failure. During a power failure, or if the EMERGENCY
STOP button is pressed, the system 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
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WARNING
Use columns that withstand expected pressures. Otherwise the
columns might rupture, resulting in injury. Use external safety
pressure relief devices to protect the column, such as burst or
rupture discs.
WARNING
The filter design pressure shall be same or higher than the flow kit
design pressure.
WARNING
When the system is operated from a remote controlling comput-
er, 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.
CAUTION
Shutdown does not automatically result in depressurizing of the
piping system.
CAUTION
Pinch hazard: Do not insert your fingers into pinch valves.
CAUTION
Make sure that the waste container is dimensioned for maximum
possible volume when the equipment is left unattended.
2 Safety instructions
2.1 Safety precautions
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Maintenance
WARNING
LOCK OUT / TAG OUT (LOTO)! Before any maintenance, service
or decommissioning work is performed on the system, make sure
that:
•the system is empty and depressurized.
•the system is disconnected from process feed, electrical pow-
er and pneumatic supply.
•the system is prevented from accidentally becoming re-ener-
gized during maintenance.
•the system is clearly tagged as taken out of operation.
•all process wetted areas are removed or cleaned and decon-
taminated.
WARNING
Only authorized personnel may perform service, installation, and
maintenance of components inside the electrical cabinet of the
system.
WARNING
Use only approved parts. Only spare parts and accessories that
are approved or supplied by GE Healthcare may be used for main-
taining or servicing the product.
2 Safety instructions
2.1 Safety precautions
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