GE AKTA ready User manual

ÄKTA™ready
Operating Instructions
Original instructions

Table of Contents
51 Introduction ..........................................................................................................
71.1 Important user information .............................................................................................................
91.2 Regulatory information ......................................................................................................................
121.3 Associated documentation ..............................................................................................................
142 Safety instructions ...............................................................................................
152.1 Safety precautions ...............................................................................................................................
242.2 Labels .........................................................................................................................................................
272.3 Emergency procedures ......................................................................................................................
302.4 Recycling information .........................................................................................................................
312.5 Declaration of Hazardous Substances (DoHS) ........................................................................
333 System description ..............................................................................................
343.1 Overview ...................................................................................................................................................
363.2 Layout ........................................................................................................................................................
453.3 Flow chart ................................................................................................................................................
483.4 Equipment ................................................................................................................................................
523.5 UNICORN control system ..................................................................................................................
554 Installation ............................................................................................................
574.1 Included in the delivery ......................................................................................................................
584.2 Site requirements ..................................................................................................................................
604.3 Transport ..................................................................................................................................................
654.4 Unpacking ................................................................................................................................................
664.5 Positioning the system .......................................................................................................................
674.6 Connections ............................................................................................................................................
745 Starting ÄKTA ready .............................................................................................
755.1 Start and log on to UNICORN ..........................................................................................................
765.2 Start the system ....................................................................................................................................
776 Flow kit installation .............................................................................................
786.1 ÄKTA ready flow kits ............................................................................................................................
806.2 Unpacking the flow kit ........................................................................................................................
816.3 Mounting the flow kit ..........................................................................................................................
977 ÄKTA ready gradient ............................................................................................
987.1 ÄKTA ready gradient pump ..............................................................................................................
997.2 ÄKTA ready gradient flow section .................................................................................................
1037.3 Calibrate and operate the ÄKTA ready gradient pump ......................................................
1078 Component test ....................................................................................................
1088.1 Run a component test ........................................................................................................................
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Table of Contents

1138.2 The test report ........................................................................................................................................
1178.3 Troubleshooting a failed component test .................................................................................
1229 Column installation .............................................................................................
1249.1 Columns ....................................................................................................................................................
1279.2 Installing a column ...............................................................................................................................
1359.3 Optional column test ...........................................................................................................................
1389.4 Optional column rinsing ....................................................................................................................
1399.5 Adding columns to the column list ...............................................................................................
14110 Creating a method ...............................................................................................
14210.1 The Method Editor ................................................................................................................................
14310.1.1 Introduction to the Method Editor ..........................................................................................
14510.1.2 Method Editor layout ....................................................................................................................
14710.1.3 Other Method Editor features ...................................................................................................
15210.2 An example of using the Method Editor .....................................................................................
15310.2.1 Creating the method and selecting a column ...................................................................
15410.2.2 Block 1: Opening valves ..............................................................................................................
15610.2.3 Block 2: Auto-zeroing pressure sensors ...............................................................................
15710.2.4 Block 3: Setting PID parameters ..............................................................................................
15810.2.5 Block 4: Filling the flow kit ..........................................................................................................
16010.2.6 Block 5: Equilibration ....................................................................................................................
16110.2.7 Block 6: Sample load ....................................................................................................................
16310.2.8 Block 7: Washing unbound sample .......................................................................................
16410.2.9 Block 8: Elution ................................................................................................................................
16610.2.10 Block 9: Regeneration ..................................................................................................................
16710.2.11 Saving the method ........................................................................................................................
16810.3 Creating a column efficiency test .................................................................................................
17011 Run a method ........................................................................................................
17111.1 Final preparations before a run .....................................................................................................
17511.2 Starting a run ..........................................................................................................................................
17811.3 Viewing and printing results ............................................................................................................
18011.4 After the run ............................................................................................................................................
18212 Maintenance .........................................................................................................
18412.1 Daily maintenance ...............................................................................................................................
18712.2 Yearly maintenance .............................................................................................................................
19412.3 Spare parts ..............................................................................................................................................
19512.4 Storage ......................................................................................................................................................
19613 Troubleshooting ...................................................................................................
20114 Reference information ........................................................................................
20214.1 Specifications .........................................................................................................................................
20614.2 Process wetted materials .................................................................................................................
20714.3 Chemical resistance ............................................................................................................................
21014.4 Ordering information ..........................................................................................................................
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21414.5 PID control ................................................................................................................................................
21614.6 Checklists ..................................................................................................................................................
22114.7 Health and Safety Declaration Form ...........................................................................................
22314.8 More information ..................................................................................................................................
224Index .......................................................................................................................
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Table of Contents

1 Introduction
Purpose of the Operating
Instructions
The Operating Instructions provides you with the instructions needed to handle ÄKTA ready
in a safe way.
It also describes the procedures required to operate ÄKTA ready on a day-to-day basis,
as well as technical information and instructions for troubleshooting and maintenance.
Prerequisites
In order to operate the system in the way it is intended, the following pre-requisites must
be fulfilled:
•You should have a general understanding of how a PC and Microsoft® Windows®
works.
•The user must have a working knowledge of UNICORN™ software. A user account
has been created according to the UNICORN™ Administration and Technical Manual.
•The user must be acquainted with the use of general bioprocessing equipment and
with handling of biological materials.
•The user must read and understand Chapter 2 Safety instructions, on page 14.
About this chapter
This chapter contains important user information, regulatory information, list of associ-
ated documentation, definitions of safety notices, etc.
ÄKTA ready Operating Instructions 28960345 AD 5
1 Introduction

In this chapter
This chapter contains the following sections:
See pageSection
71.1 Important user information
91.2 Regulatory information
121.3 Associated documentation
6 ÄKTA ready Operating Instructions 28960345 AD
1 Introduction

1.1 Important user information
Read this before using
ÄKTA ready
All users must read the safety instructions in the ÄKTA ready user documentation to
fully understand the safe use of ÄKTA ready, before installing, using, or maintaining the
system.
Do not operate the ÄKTA ready system in any other way than described in the user
documentation. Otherwise, you may be exposed to hazards that can lead to personal
injury, and you may cause damage to the equipment.
Safety notices
This user documentation contains WARNINGS, CAUTIONS and NOTICES concerning the
safe use of the product. See definitions below.
Warnings
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.
Cautions
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.
ÄKTA ready Operating Instructions 28960345 AD 7
1 Introduction
1.1 Important user information

Notices
NOTICE
NOTICE indicates instructions that must be followed to avoid
damage to the product or other equipment.
Notes and tips
A note is used to indicate information that is important for trouble-free and
optimal use of the product.
Note:
A tip contains useful information that can improve or optimize your procedures.
Tip:
Typographical conventions
Software items are identified in the text by bold italic text. A colon separates items in a
group, for example Flowpath:Injection valve refers to the Injection valve item in the
Flowpath group.
Hardware items are identified in the text by bold text (for example, the Power button).
8 ÄKTA ready Operating Instructions 28960345 AD
1 Introduction
1.1 Important user information

1.2 Regulatory information
In this section
This section describes the directives and standards that are fulfilled by ÄKTA ready.
Manufacturing information
The table below summarizes the required manufacturing information. For further infor-
mation, see the EU Declaration of Conformity (DoC) document.
ContentRequirement
GE Healthcare Bio-Sciences AB,Name and address of manufacturer
Björkgatan 30, SE 751 84 Uppsala, Sweden
Conformity with EU Directives
This product complies with the European directives listed in the table, by fulfilling the
corresponding harmonized standards.
A copy of the EU Declaration of Conformity is included in the documentation package.
TitleDirective
Restriction of Hazardous Substances (RoHS) Directive2011/65/EU
Machinery Directive (MD)2006/42/EC
Electromagnetic Compatibility (EMC) Directive2004/108/EC
Low Voltage Directive (LVD)2006/95/EC
ÄKTA ready Operating Instructions 28960345 AD 9
1 Introduction
1.2 Regulatory information

CE marking
The CE marking and the corresponding EU Declaration of Conformity is valid for the in-
strument when it is:
•used as a stand-alone unit, or
•connected to other products recommended or described in the user documentation,
and
•used in the same state as it was delivered from GE Healthcare, except for alterations
described in the user documentation.
International standards
Harmonized standard requirements fulfilled by this product are summarized in the fol-
lowing table:
NotesDescriptionStandard
EN ISO standard is har-
monized with EU direc-
tive 2006/42/EC
Safety of machinery. General
principles for design. Risk as-
sessment and risk reduction.
EN ISO 12100
EN standard is harmo-
nized with EU directive
2006/95/EC
Safety requirements for electri-
cal equipment for measure-
ment, control, and laboratory
use.
EN/IEC 61010-1,
UL61010-1, CAN/CSA
C22.2 No. 61010-1
EN standard is harmo-
nized with EU directive
2004/108/EC
Electrical equipment for mea-
surement, control and laborato-
ry use - EMC requirements
EN/IEC 61326-1
(Emission according
to CISPR 11, Group 1,
class A)
10 ÄKTA ready Operating Instructions 28960345 AD
1 Introduction
1.2 Regulatory information

FCC compliance
This device complies with part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired
operation.
The user is cautioned that any changes or modifications not expressly approved
by GE Healthcare could void the user’s authority to operate the equipment.
Note:
This equipment has been tested and found to comply with the limits for a Class A digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide rea-
sonable protection against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses, and can radiate radio frequen-
cy energy and, if not installed and used in accordance with the instruction manual, may
cause harmful interference to radio communications. Operation of this equipment in a
residential area is likely to cause harmful interference in which case the user will be re-
quired to correct the interference at his own expense.
Environmental conformity
This product conforms to the following environmental requirements.
TitleRequirement
Waste Electrical and Electronic Equipment (WEEE) Directive2012/19/EU
Packaging and Packaging Waste Directive and amendment94/62/EC and
2004/12/EC
Administration on the Control of Pollution Caused by Electronic
Information Products, China Restriction of Hazardous Sub-
stances (RoHS)
ACPEIP
Registration, Evaluation, Authorization and restriction of
CHemicals (REACH)
Regulation (EC)
No 1907/2006
Regulatory compliance of
connected equipment
Any electrical equipment connected to ÄKTA ready should meet the safety requirements
of EN/IEC 61010-1, or relevant harmonized standards. Within EU, connected equipment
must be CE marked.
ÄKTA ready Operating Instructions 28960345 AD 11
1 Introduction
1.2 Regulatory information

1.3 Associated documentation
Generic documentation
Together with each system, the following manuals are supplied providing information
that applies to ÄKTA ready independent of the specific configuration.
Purpose/ContentsDocument
Instructions on how to handle ÄKTA ready in a safe
way (this manual).
ÄKTA ready Operating
Instructions
Detailed instructions on how to use the UNICORN
control system.
UNICORN™ User Manual
package1
1ÄKTA ready can be controlled by both UNICORN 5 and UNICORN 7.
Third-party component
documentation
Documentation for components produced by a third-party are, if existent, also included
in the document package.
12 ÄKTA ready Operating Instructions 28960345 AD
1 Introduction
1.3 Associated documentation

Related literature
Product codeProductDocument
28925644User ManualReadyToProcess™ columns User Manual
28915987Data fileReadyToProcess columns
28915986Data file, including Site
Preparation Guide
ÄKTA ready chromatography system
28998083Preventive Maintenance
PM Fact Sheet
Keep your ÄKTA ready operating in peak
condition
18112156HandbookProcess chromatography: A guide to op-
timization, scale-up and validation
28919821Application noteEfficiency test of ReadyToProcess
columns
28995879Application noteReady-to-use fluid management solu-
tions for chromatography systems
28919856Application notePurification of a monoclonal antibody
using ReadyToProcess™ columns
ÄKTA ready Operating Instructions 28960345 AD 13
1 Introduction
1.3 Associated documentation

2 Safety instructions
About this chapter
This chapter describes safety precautions and emergency shutdown procedures for the
product. The labels on the system and information regarding recycling are also described.
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
This chapter contains the following sections:
See pageSection
152.1 Safety precautions
242.2 Labels
272.3 Emergency procedures
302.4 Recycling information
312.5 Declaration of Hazardous Substances (DoHS)
14 ÄKTA ready Operating Instructions 28960345 AD
2 Safety instructions

2.1 Safety precautions
Introduction
ÄKTA ready 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.
The safety precautions in this section are grouped into the following categories:
•General precautions, on page 15
•Flammable liquids and explosive environment, on page 17
•Personal protection, on page 16
•Installing and moving, on page 17
•Operation, on page 19
•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 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, includ-
ing use of personal protective equipment.
•The customer must make sure that all installation, mainte-
nance, 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.
•Do not operate the product in any other way than described
in the user documentation.
•Do not use ÄKTA ready if it is not working properly, or if it has
suffered any damage, for example:
-damage to the power cord or its plug
ÄKTA ready Operating Instructions 28960345 AD 15
2 Safety instructions
2.1 Safety precautions

WARNING
-damage caused by dropping the equipment
-damage caused by splashing liquid onto it
•Emergency stop. Pressing the EMERGENCY STOP does not
automatically depressurize the flow path.
•Do not use any accessories not supplied or recommended by
GE Healthcare.
CAUTION
•Waste tubes and containers must be secured and sealed to
prevent accidental spillage.
•Make sure that the waste container is dimensioned for maxi-
mum possible volume when the equipment is left unattended.
NOTICE
Any computer used with the equipment must comply with IEC
60950 and be installed and used according to the manufacturer's
instructions.
Personal protection
WARNING
•Always use appropriate Personal Protective Equipment (PPE)
during operation and maintenance of this product.
•Hazardous substances and biological agents. When using
hazardous chemical and biological agents, take all suitable
protective measures, such as wearing protective glasses and
gloves resistant to the substances used. Follow local and/or
national regulations for safe operation and maintenance of
ÄKTA ready.
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2 Safety instructions
2.1 Safety precautions

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.
Flammable liquids and explosive
environment
WARNING
•Flammable liquids. This product is not approved to handle
flammable liquids.
•Explosive environment. The product is not approved for work
in a potentially explosive atmosphere, in areas classified as
Zone 0 to Zone 2 according to IEC 60079-10 2002. The product
does not fulfill the requirements of the ATEX Directive.
Installing and moving
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.
•Heavy object. Because of the significant weight of the product,
great care must be taken not to cause squeezing or crushing
injuries during movement. At least two, but preferably three
or more, people are recommended when moving the unit.
ÄKTA ready Operating Instructions 28960345 AD 17
2 Safety instructions
2.1 Safety precautions

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.
•Protective ground. The product must always be connected
to a grounded power outlet.
•Supply voltage. Before connecting the power cord, make sure
that the supply voltage at the wall outlet corresponds to the
marking on the instrument.
•High voltage. The mains cable must only be connected by
authorized service personnel. Faulty connection might result
in live system parts that can give lethal electric shocks.
•Installing the computer. The computer must be installed and
used according to the instructions provided by the manufac-
turer of the computer.
CAUTION
•The wheels of ÄKTA ready should be locked during normal use.
The wheels should be unlocked only when moving the unit.
•Make sure that all tubing, hoses and cables are placed so that
the risk of tripping accidents is minimized.
•The product is designed for indoor use only.
•Do not use the product in a dusty atmosphere or close to
spraying water.
•Make sure that correct air pressure is always maintained. Too
high or too low air pressure may be hazardous and may cause
erroneous results and leakage.
•If the system is re-configured, the system label must be updat-
ed accordingly. Use a permanent ink pen, or the stickers sup-
plied with the system.
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2 Safety instructions
2.1 Safety precautions

CAUTION
•Do not attempt to lift the system by the handle on the left side
of the system cabinet. The handle is for maneuvring the cabinet
on the floor, not for lifting.
NOTICE
•Do not turn on the Mains power switch before all connections
are made.
•ÄKTA ready shall be installed and prepared by personnel from
GE Healthcare or third party authorized by GE Healthcare.
Contact GE Healthcare if you require re-installation at a new
site.
Operation
WARNING
•Do not operate the ÄKTA ready instrument in any other way
than described in the ÄKTA ready and UNICORN manuals.
ÄKTA ready Operating Instructions 28960345 AD 19
2 Safety instructions
2.1 Safety precautions

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.
•High pressure. The flow rate may under no circumstances
exceed the specified column maximum flow rate. High flows
might affect the packed medium, causing the pressure to ex-
ceed the specified column maximum pressure.
•Use columns that withstand expected pressures. If not, the
columns might rupture, resulting in injury. Preferably use
ReadyToProcess columns from GE Healthcare.
•Over-pressure. Never block the outlet tubing with, for instance,
stop plugs, since this will create over-pressure and might result
in injury.
•Never touch the pump or pump lid while the pump is running.
•Never put fingers or any objects other than the intended tubing
in to the pinch valve opening.
•Corrosive substance. NaOH is corrosive and therefore danger-
ous to health. When using hazardous chemicals, avoid spillage
and wear protective glasses and other suitable Personal Pro-
tective Equipment (PPE).
•Emergency stop. Pressing the EMERGENCY STOP will not shut
off mains power to the cabinet.
•Power failure. During a power failure, or if the EMERGENCY
STOP button is pressed, the equipment may remain pressur-
ized. 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.
•Emergency stop. Pressing the EMERGENCY STOP does not
automatically depressurize the flow path.
20 ÄKTA ready Operating Instructions 28960345 AD
2 Safety instructions
2.1 Safety precautions