GE AKTAprime plus Operating Instructions Manual

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GE Healthcare Life Sciences
ÄKTAprime™ plus
Operating Instructions
Original instructions
Page 2
Page 3
Table of Contents
Table of Contents
51 Introduction ..........................................................................................................
61.1 Important user information .............................................................................................................
101.3 Instrument ...............................................................................................................................................
131.4 Monitoring and evaluation ...............................................................................................................
141.5 User documentation ...........................................................................................................................
162 Safety instructions ...............................................................................................
162.1 Safety precautions ...............................................................................................................................
242.2 Labels .........................................................................................................................................................
262.3 Emergency procedures ......................................................................................................................
272.4 Recycling information .........................................................................................................................
282.5 Declaration of Hazardous Substances (DoHS) ........................................................................
313 Installation ............................................................................................................
313.1 Site requirements ..................................................................................................................................
313.2 Transport ..................................................................................................................................................
323.3 Unpacking ................................................................................................................................................
323.4 Connections ............................................................................................................................................
323.5 Spare parts and accessories ...........................................................................................................
334 Operation ..............................................................................................................
334.1 Operation overview .............................................................................................................................
334.2 Starting the instrument ......................................................................................................................
344.3 Preparations before start ..................................................................................................................
394.4 Performing a run ...................................................................................................................................
414.5 Procedures after a run .......................................................................................................................
435 Maintenance .........................................................................................................
435.1 General ......................................................................................................................................................
445.2 User maintenance schedule ...........................................................................................................
465.3 Cleaning ....................................................................................................................................................
475.4 Component maintenance ................................................................................................................
475.5 Disassembly and assembly of components and consumables .....................................
485.6 Calibration ................................................................................................................................................
495.7 Storage ......................................................................................................................................................
506 Troubleshooting ...................................................................................................
506.1 UV curve problems ...............................................................................................................................
516.2 Conductivity curve problems ..........................................................................................................
536.3 pH curve problems ...............................................................................................................................
566.4 Pressure curve problems ..................................................................................................................
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Table of Contents
577 Reference information ........................................................................................
577.1 Specifications .........................................................................................................................................
577.2 Chemical resistance ............................................................................................................................
617.3 System recommendations ...............................................................................................................
627.4 Health and Safety Declaration Form ...........................................................................................
647.5 Ordering information ..........................................................................................................................
65A Connection diagram - Liquid flow path ...........................................................
66B Tubing ....................................................................................................................
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1 Introduction
Purpose of the Operating Instructions
The OperatingInstructions provide you withthe instructions needed to handleÄKTAprime plus in a safe way.
Prerequisites
In order to operate ÄKTAprime plus as is intended, the following pre-requisites must be fulfilled:
The user should have a general understanding of how a PC and the Microsoft™ Windows™ operating system works. (if a computer is used)
The user must understand the concepts of liquid chromatography.
The user must read and understand the Safety Instructions in this manual.
ÄKTAprimeplus andsoftware shouldbe installed, configured and calibratedaccording to these Operating Instructions.

1 Introduction

About this chapter
This chapter contains important user information, a description of the intended use of ÄKTAprime plus, regulatory information, list of associated documentation, definitions of safety notices and so on.
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1 Introduction

1.1 Important user information

1.1 Important user information
Read this before operating ÄKTAprime plus
All users must read the entire Operating Instructions before installing, operating or maintaining ÄKTAprime plus.
Always keep the Operating Instructions at hand when operating ÄKTAprime plus.
Do notoperate ÄKTAprime plusin any otherway than described in the user documenta­tion. 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
ÄKTAprime plus is a compact liquid chromatography system designed for one-step pu­rification of proteins at laboratory scale.
ÄKTAprime plus is intended for research use only, and shall not be used in any clinical procedures, or for diagnostic purposes.
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 resultin death or serious injury. It is important not to proceed until all stated conditions are met and clearly understood.
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Cautions
Notices
Notes and tips
Note:
Tip:
1 Introduction
1.1 Important user information
CAUTION CAUTION indicates a hazardous situation which, if not avoided,
could result in minor or moderate injury. It is important not to proceed untilall stated conditions are metand clearly understood.
NOTICE NOTICE indicates instructions that must be followed to avoid
damage to the product or other equipment.
A note is used to indicate information that is important for trouble-free and optimal use of the product.
A tip contains useful information that can improve or optimize your procedures.
Typographical conventions
Software items are identifiedin the text by bold italic text. A colon separates menulevels, thus File:Open refers to the Open command in the File menu.
Hardware items are identified in the text by bold text (e.g., Power switch).

1.2 Regulatory information

In this section
This section describes the directives and standards that are fulfilled by ÄKTAprime plus.
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1 Introduction
1.2 Regulatory information
Manufacturing information
The table below summarizes the required manufacturing information. For further infor­mation, see the EC Declaration of Conformity document.
manufacturer
CE conformity
This product complies with the European directives listed in the table, by fulfilling the corresponding harmonized standards.
A copy of the EC Declaration of Conformity is available on request.
ContentRequirement
GE Healthcare Bio-Sciences AB, Björkgatan 30,Name and address of
SE-751 84 Uppsala, Sweden
TitleDirective
Machinery Directive (MD)2006/42/EC
Low Voltage Directive (LVD)2006/95/EC
CE marking
Electromagnetic Compatibility (EMC) Directive2004/108/EC
The CE marking and the corresponding Declaration of Conformity is valid for the instru­ment when it is:
used as a stand-alone unit, or
connected to other CE marked instruments, or
connected to other products recommendedor describedin theuser documentation, and
used inthe same stateas it was delivered from GEHealthcare, except for alterations described in the user documentation.
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International standards
This product fulfills the requirements of the following standards:
1 Introduction
1.2 Regulatory information
NotesDescriptionStandard
EN/IEC 61010-1, UL 61010-1, CAN/CSA-C22.2 No. 61010-1
EN 61326-1
EN ISO 12100
Regulatory compliance of connected equipment
Any equipment connected to ÄKTAprime plus should meet the safety requirements of EN 61010-1/IEC 61010-1, or relevant harmonized standards. Within the EU, connected equipment must be CE marked.
Environmental conformity
Safety requirements for electrical equipment for measurement, control, and laboratory use
Electrical equipmentfor measure­ment, control and laboratory use
- EMC requirements
Safety of machinery. General principles for design. Risk assess­ment and risk reduction.
EN standard is harmonized with EU directive 2006/95/EC
EN standard is harmonized with EU directive 2004/108/EC
EN ISO standard is harmo­nized with EU directive 2006/42/EC
TitleRequirement
Restriction of Hazardous Substances (RoHS) Directive2011/65/EU
2012/19/EU
Regulation (EC) No 1907/2006
ACPEIP
ÄKTAprime plus Operating Instructions 28-9597-89 AB 9
Waste Electricaland ElectronicEquipment (WEEE) Direc­tive
Registration, Evaluation, Authorization and restriction of CHemicals (REACH)
Administration on the Control of Pollution Caused by Electronic Information Products, China Restriction of Hazardous Substances (RoHS)
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1
2
3
4
5
6 7
8
9
10
17
16
15
14
13
12
11
1 Introduction

1.3 Instrument

1.3 Instrument
Product description
ÄKTAprime plus is a compact liquid chromatography system designed for one-step pu­rification of proteins at laboratory scale.
Figure 1.1: The main parts of the instrument.
FunctionPartFunctionPart
Switch valve10Fraction collector1
Conductivity cell11Monitor and controller2
Flow restrictor12LCD display3
UV flow cell13Push buttons4
Column14Pump5
Sample loop15Pressure sensor6
Flow diversion valve16Mixer7
Column holder17Injection valve8
10 ÄKTAprime plus Operating Instructions 28-9597-89 AB
Buffer valve9
Page 11
The Power switch is located at the rear of the system.
l
0
l
0
Drop Sensor
Frac Valve
RS-232
Recorder
Rec. On/off
pH-Ground
pH-Probe
Conductivity Flow Cell
UV
UV-lamp
Mains
Voltage
220-240 V
100-120 /
Power max
90 VA
autorange
~
Frequency
50-60 Hz
(SYSTEM NO.)
(CODE NO.)
1
2
3
4
5
6
7
8
9
10
11
Electrical and communication connections
1 Introduction
1.3 Instrument
ConnectionNo.ConnectionNo.
pH electrode7RS-232 to computer1
Conductivity flow cell8Flow diversion valve2
Optical unit9Fraction collector3
Power switch10Measurement data to recorder4
Mains power inlet11On/off signals to recorder5
UV lamp6
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end
OK
Esc
pause
/cont
hold
/cont
feed tube
1 Introduction
1.3 Instrument
Navigation menu
The system is operated from the push buttons and LCD display at the front panel.
Figure 1.2: Push buttons.
DescriptionButton
or
hold /cont
pause /cont
Find a specific menu option
Enter a menu.OK
Return one menu level.Esc
Interrupt method operation before the run is completed.end
Stop manual operation.
Hold method time or volume and the gradient at the cur­rent concentration. Pump and fraction collector continue uninterrupted.
Continue the normal method operation.
Pause all operation without ending the method. All func­tions, including pump and fraction collector, are stopped.
Continue the normal method operation.
Advance the fraction collector one position.feed tube
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Basic flow path
IN
IN
P
M
UV
C
pH
F
W
V2
V1
B
SW
Figure 1.3: Basic flow path.
1 Introduction
1.3 Instrument
DescriptionPartStage
P, V11
Pump P pumps buffer from a buffer container connected to the buffer valve V1.
SW, B2
To form a gradientthe switch valve (SW)can be usedto pull liquid from buffer container (B).
The mixer (M) mixes the buffers.M3
V24
Sample is applied from the sample loop connected to injection valve (V2)that has been previously filledmanually usinga syringe.
UV, C, pH5
From the injection valve, the flow is directed to the column, and then to the UV, Conductivity, and optional pH monitor.
F, W6
From the monitors, the flow is directed to the Fraction collector F or the Waste W.

1.4 Monitoring and evaluation

PrimeView™ software
PrimeView isa softwarethat allows real time monitoring,evaluation andreport generation on an external computer.
For moreinformation aboutPrimeView evaluationsystem and instructionsfor installation, see the PrimeView User Manual supplied.
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1 Introduction
1.4 Monitoring and evaluation
Paper chart recorder
It is possible to connect a chart recorder to ÄKTAprime plus to get real time monitoring. For more information see the ÄKTAprime plus User Manual.

1.5 User documentation

In addition to these Operating Instructions, the documentation package supplied with ÄKTAprime plus also includes product documentation binders containing detailed specifications and traceability documents.
The mostimportant documents in the documentpackage withregard totechnical aspects of ÄKTAprime plus are:
System-specific documentation
ContentUser documentation
ÄKTAprime plus Operating Instructions
ÄKTAprime plus User Manual
ÄKTAprime plus Cue Cards
ÄKTAprime plus training video
EC Declaration of Conformity for ÄKTAprime plus
All instructionsneeded to operate the in­strument in a safe way, including brief system description, installation, and maintenance.
Detailed systemdescription. Comprehen­sive user instructions, method creation, operation, advanced maintenance and troubleshooting.
Short step-by-stepinstructions for select­ed applications using the prepro­grammed method templates. System preparation and value table for the method templates.
Covers the system introduction, step by step installation, setting-up the run and evaluation of results.
Document whereby the manufacturer ensures that the product satisfies and is in conformity with the essential require­ments of the applicable directives.
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Software documentation
Together witheach system, the following software documentation is supplied providing additional information that applies to ÄKTAprime plus, independent of the specific configuration:
1 Introduction
1.5 User documentation
Purpose/ContentsDocument
PrimeView User Manual
Component documentation
Documentation for components produced both by GE Healthcare and by a third-party are, if existent, also included in the document package.
A completecontrol software packagefor supervision of ÄKTAprime plus automated liquid chromatogra­phy systems.
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2 Safety instructions

2 Safety instructions
About this chapter
This chapter describes safety compliance, safety labels, general safety precautions, emergency procedures, power failure and recycling of ÄKTAprime plus.

2.1 Safety precautions

Introduction
The ÄKTAprime plus instrument is powered by mains voltage and handles pressurized liquids that may be hazardous. Before installing, operating or maintaining the system, you must be aware of the hazards described in this manual. Follow the instructions
provided to avoid personal injury or damage to the equipment .
The safety precautions in this section are grouped into the following categories:
General precautions
Using flammable liquids
Personal protection
Installing and moving the instrument
System operation
Maintenance
General precautions
Always follow these General precautions to avoid injury when using the ÄKTAprime plus instrument.
WARNING
Do not operate ÄKTAprime plus in any other way than described in the ÄKTAprime plus and PrimeView manuals. If the equipment is used ina manner not specifiedby the manufacturer,the protec­tion provided by the equipment may be impaired.
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2 Safety instructions
2.1 Safety precautions
WARNING
Operation anduser maintenanceof the ÄKTAprime plusinstrument should be performed by properly trained personnel only.
WARNING
Before connecting a column to the ÄKTAprime plus instrument, read the instructions for use of the column. To avoid exposing the column to excessive pressure, make sure that the pressure limit is set to the specified maximum pressure of the column.
WARNING
Do not use any accessories not supplied or recommended by GE Healthcare.
WARNING
Do not use ÄKTAprime plus if it is not working properly, or if it has suffered any damage, for example:
damage to the power cord or its plug
damage caused by dropping the equipment
damage caused by splashing liquid onto it
CAUTION
Waste tubesand containers must be secured andsealed to prevent accidental spillage.
CAUTION
Make sure that the waste container is dimensioned for maximum possible volume when the instrument is left unattended.
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2 Safety instructions
2.1 Safety precautions
Using flammable liquids
When usingflammable liquids with theÄKTAprimeplus instrument, followthese precau­tions to avoid any risk of fire or explosion.
NOTICE
Avoid condensation by letting the unit equilibrate to ambient tem­perature.
WARNING
Fire Hazard. Before starting the system, make sure that there is
no leakage.
WARNING
A fume hood or similar ventilation system shall be installed when flammable or noxious substances are used.
Personal protection
WARNING
Always useappropriate PersonalProtective Equipment(PPE) during operation and maintenance of ÄKTAprime plus system.
WARNING
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 ÄKTAprime plus.
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Installing and moving the instrument
2 Safety instructions
2.1 Safety precautions
WARNING
Spread ofbiological agents. Theoperator has to take allnecessary
actions to avoid spreading hazardous biological agents in the vicinity of the instrument. The facility should comply with the na­tional code of practice for biosafety.
WARNING
High pressure. ÄKTAprime plus operates under high pressure.
Wear protective glasses and other required Personal Protective Equipment (PPE) at all times.
WARNING
Supply voltage. Make sure that the supply voltage at the wall
outlet corresponds to the marking on the instrument , before con­necting the power cord.
WARNING
Protective ground. ÄKTAprime plus must always be connected to
a grounded power outlet.
WARNING
Power cord. Only use power cords with approved plugs delivered
or approved by GE Healthcare.
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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.
WARNING
Installing the computer. The computer should be installed and
used according to the instructions provided by the manufacturer of the computer.
NOTICE
Any computerused withthe equipment shall comply withIEC 60950 and beinstalled and used according tothe manufacturer's instruc­tions.
NOTICE Disconnect power. Toprevent equipmentdamage, alwaysdiscon-
nect power from the ÄKTAprime plus instrument before an instru­ment module is removed or installed, or a cable is connected or disconnected.
System operation
WARNING
Hazardous chemicals during run. When using hazardous chemi-
cals, run System CIP and Column CIP to flush the entire system tubing with distilled water, before service and maintenance.
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2 Safety instructions
2.1 Safety precautions
WARNING
Hazardous biological agents during run. When using hazardous
biological agents, run System CIP and Column CIP to flush the entire system tubing with bacteriostatic solution (e.g. NaOH) fol­lowed by a neutral buffer and finally distilled water, before service and maintenance.
WARNING
There must always be a sample loop connected to ports 2 and 6 of the injection valve. This is to prevent liquid spraying out of the ports when switching the valve. This is especially dangerous if hazardous chemicals are used.
CAUTION Hazardous chemicals in UV flow cell. Make sure that the entire
flow cell has been flushed thoroughly with bacteriostatic solution, for example NaOH, and distilled water, before service and mainte­nance.
NOTICE
If the ÄKTAprime plus is kept in acold room, coldcabinet or similar, keep the system switched on in order to minimize the risk of con­densation. (The UV lamp can be turned off to save lamp life time when the system is not in use.)
NOTICE
When switchingoff the cold cabinet, make surethat youalso switch off the ÄKTAprime plus system and leave the door to the cold cabinet open to avoid overheating.
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2 Safety instructions
2.1 Safety precautions
Maintenance
WARNING
Electrical shock hazard. All repairs should be done by service
personnel authorized by GE Healthcare. Do not open any covers or replace parts unless specifically stated in the user documenta­tion.
WARNING
Disconnect power.Always disconnect powerfrom the instrument
before replacing any component on the instrument, unless stated otherwise in the user documentation.
WARNING
Hazardous chemicals during maintenance.When using hazardous
chemicals for system or column cleaning, wash the system or columns with a neutral solution in the last phase or step.
WARNING
Do not perform any type of maintenance work while the system is powered electrically or whenthe piping systemis pressurized.Note that the piping system can be pressurized even when the system is closed down.
WARNING
Only spare parts and accessories that are approved or supplied by GE Healthcare may be used for maintaining or servicing ÄKTAprime plus.
WARNING
Make sure that the piping system is completely leakage free before performing any CIP on the system.
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2 Safety instructions
2.1 Safety precautions
WARNING
NaOH is corrosive and therefore dangerous to health. When using hazardous chemicals, avoid spillage and wear protective glasses and other suitable Personal Protective Equipment (PPE).
WARNING
After assembly, the piping system must be tested for leakage at maximum pressure for continued protection against injury risks due to fluid jets, burst pipes or explosive atmosphere.
WARNING
Before disassembly, check that there is no pressure in the piping system.
WARNING
Disconnect power.Always disconnect powerfrom the instrument
before replacing fuses.
WARNING
Decontaminate theequipment beforedecommissioning to ensure that hazardous residues are removed.
CAUTION Fire hazard. Follow instructions in ÄKTAprime plus Operating
Instructions for correct installation of a new UV-lamp. If the lamp is not installed properly it may be overheated and cause a fire hazard.
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2 Safety instructions
2.1 Safety precautions

2.2 Labels

CAUTION
The systemuses highintensity ultra-violet light. Do not remove the UV lamp while the system is running. Before replacing a UV lamp, ensure that the lamp is disconnected to prevent injury to eyes.
If the mercury lamp is broken, make sure that all mercury is re­moved anddisposed accordingto nationaland local environmental regulations.
NOTICE Cleaning. Keep the instrument dry and clean. Wipe regularly with
a softdamp tissue and,if necessary, amild cleaning agent . Let the instrument dry completely before use.
In this section
This sectiondescribes the instrument labels andlabels concerninghazardous substances that are attached to the ÄKTAprime plus instrument. For information about marking of the computer equipment, refer to the manufacturer’s instructions.
Labels on the instrument
The illustration below shows an example of the identification label that is attached to the ÄKTAprime plus instrument .
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Symbols used in instrument labels
MeaningLabel
Warning! Read the user documentation before using the system. Do
not open any covers or replace parts unless specifically stated in the user documentation.
The systemcomplies withthe requirements for electromagneticcompli­ance (EMC) in Australia and New Zealand.
The system complies with applicable European directives.
This symbol indicates that ÄKTAprime plus has been certified by a Na­tionally RecognizedTesting Laboratory(NRTL). NRTLmeans an organiza­tion, which is recognized by the US Occupational Safety and Health Ad­ministration (OSHA) as meeting the legal requirements of Title 29 of the Code of Federal Regulations (29 CFR), Part 1910.7.
2 Safety instructions
2.2 Labels
Labels concerning hazardous substances
MeaningLabel
This symbol indicates that the waste of electrical and electronic equip­ment must not be disposed as unsorted municipal waste and must be collected separately.Please contactan authorizedrepresentative of the manufacturer for information concerning the decommissioning of equipment.
This symbol indicates that the product contains hazardous materials in excess ofthe limits established by theChinese standardSJ/T11363-2006 Requirements for Concentration Limitsfor Certain Hazardous Substances in Electronics.
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2 Safety instructions

2.3 Emergency procedures

2.3 Emergency procedures
In this section
This sectiondescribes howto doan emergencyshutdown of the ÄKTAprime plussystem. The section also describes the result in the event of power failure.
Emergency shutdown
In an emergency situation, do as follows to stop the run:
ActionStep
Power failure
1
2
The result of a power failure depends on which unit that is affected.
ÄKTAprime plus
Computer
To pause the runwithout ending the method, pressthe Pausebutton located at the instrument front.
If required, switch off power to the instrument by pressing the Main power switch to the 0 position. The run is interrupted immediately.
will result in...Power failure to...
The run is interrupted immediately, in an undefined
• state
The data collected up to the time of the power failure
• is available in PrimeView
The PrimeViewcomputer shuts downin an undefined
• state
The run continues, but data cannot be saved in
• PrimeView.
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2.4 Recycling information
Decontamination
ÄKTAprime plus shall be decontaminated before decommissioning and all local regula­tions shall be followed with regard to scrapping of the equipment .
Disposal, general instructions
When taking ÄKTAprime plus out of service, the different materials must be separated and recycled according to national and local environmental regulations.
Recycling of hazardous substances
ÄKTAprime plus contains hazardous substances. Detailed information is available from your GE Healthcare representative.
2 Safety instructions

2.4 Recycling information

Disposal of electrical components
Waste ofelectrical and electronic equipment must not bedisposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of equipment.
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2 Safety instructions

2.5 Declaration of Hazardous Substances (DoHS)

2.5 Declaration of Hazardous Substances (DoHS)
Introduction
The following product pollution controlinformation is providedaccording to SJ/T11364­2006 Marking for Control of Pollution caused by Electronic Information Products.
根据SJ/T11364-2006《电子信息产品污染控制标识要求》特提供如下有关污染 控制 方面的信息
Symbols used in pollution control label
电子信息产品污染控制标志说明
MeaningLabel
This symbol indicates the product contains hazardous materials in ex­cess ofthe limits established by theChinese standardSJ/T11363-2006 Requirements for Concentration Limits for Certain Hazardous Sub­stances in Electronic Information Products. The number in the symbol is theEnvironment-friendly UsePeriod (EFUP), which indicates theperiod during whichthe toxic or hazardous substances or elementscontained in electronic information products will not leak or mutateunder normal operating conditions so that the use of such electronic information products will not result in any severe environmental pollution, any bodily injury or damage to any assets. The unit of the period is “Year”.
In order to maintain the declared EFUP, the product shall be operated normally according to the instructions and environmental conditions as definedin the product manual, and periodic maintenanceschedules specified in Product Maintenance Procedures shallbe followed strictly.
Consumables or certain parts may have their own label with an EFUP value lessthan theproduct. Periodicreplacement ofthose consumables or parts to maintain the declared EFUP shall be done in accordance with the Product Maintenance Procedures.
This product must not be disposed of as unsorted municipal waste, and must be collected separately and handled properly after decom­missioning.
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MeaningLabel
该标志表明本产品含有超过SJ/T11363-2006《电子信息产品中有毒 有害物质的限 量要求》中限量的有毒有害物质。标志中的数字为本 产品的环保使用期,表明本 产品在正常使用的条件下,有毒有害物 质不会发生外泄或突变,用户使用本产品 不会对环境造成严重污染 或对其人身、财产造成严重损害的期限。单位为年。
为保证所申明的环保使用期限,应按产品手册中所规定的环境条件 和方法进行正 常使用,并严格遵守产品维修手册中规定的期维修和 保养要求。
产品中的消耗件和某些零部件可能有其单独的环保使用期限标志, 并且其环保使 用期限有可能比整个产品本身的环保使用期限短。应 到期按产品维修程序更换那 些消耗件和零部件,以保证所申明的整 个产品的环保使用期限。
本产品在使用寿命结束时不可作为普通生活垃圾处理,应被单独收 集妥善处理
List of hazardous substances and their concentrations
产品中有毒有害物质或元素的名称及含量
2 Safety instructions
2.5 Declaration of Hazardous Substances (DoHS)
Indication for each major part if substance exceeds limit
MeaningValue
O
X
ÄKTAprime plus Operating Instructions 28-9597-89 AB 29
Indicates that this toxic or hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement in SJ/T11363-2006.
表示该有毒有害物质在该部件所有均质材料中的含量均在SJ/T11363­2006 标准规定的限量要 求以下
Indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement in SJ/T11363-2006.
Data listed in the table represents best information available at the
• time of publication
表示该有毒有害物质至少在该部件的某一均质材料中的含量超出 SJ/T11363-2006 标准规定的
限量要求
此表所列数据为发布时所能获得的最佳信息
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2 Safety instructions
2.5 Declaration of Hazardous Substances (DoHS)
List of hazardous substances
Component name
Hazardous substance
有毒有害物质或元素
部件名称
Pb
Hg
Cd
Cr6+
六价铬
PBB
多溴联苯
PBDE
多溴二苯醚
0000XXÄKTAprime plus
1
1
The product has not been tested as per the Chinese standard SJ/T11363-2006 Requirements for Concentration Limits for Certain Hazardous Substances in Electronic Information Product.
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3 Installation
ÄKTAprime plus is delivered in protective packing material and shall be unpacked with great care.
Any equipment connectedto ÄKTAprime plus must fulfill applicablestandards and local regulations.
A videodescribing theinstallation process,is suppliedwith each ÄKTAprime plus system.
For detailed information on Installation, see ÄKTAprime plus User Manual.

3.1 Site requirements

3 Installation

RequirementParameter
100-240 V, 50-60 HzElectrical power
4°C to 40°CAmbient temperature

3.2 Transport

The equipment can be transported on a trolley capable of supporting at least 20 kg.
Before moving the system:
disconnect all cables and tubing connected to peripheral components and liquid containers.
remove any loose items from the top of the instrument.
grasp the instrument firmly by placing the fingers under the base of the main unit and lift.
For more information on transport, see ÄKTAprime plus User Manual.
Stable laboratory bench e.g. 120 × 80 cmPlacement
20% to 95%, non-condensingHumidity
NOTICE
Lift the instrument in the upright position. Do not use the fraction­ation arm as a lifting handle.
ÄKTAprime plus Operating Instructions 28-9597-89 AB 31
Page 32
3 Installation

3.3 Unpacking

3.3 Unpacking
Check for damage
Check the equipment for damage before starting assembly and installation. There are no looseparts inthe transport box. All parts are either mounted on thesystem orlocated in the accessory kit box. If any damage is found, document the damage, and contact your local GE Healthcare representative.
Unpack the system
Remove straps and packing material. Then set the equipment upright before starting installation.

3.4 Connections

Communication
Connect thesystem according to the electricaldrawings in Electrical and communication connections, on page 11.
Flow path
All parts and tubing are mounted on the system at delivery.
Connect a waste tube, buffer and sample bottles, and optional accessories.
Electrical power
Connect the power cord to a grounded power outlet specified in Section3.1 Site require­ments, on page 31.

3.5 Spare parts and accessories

For correct up to date information on spare parts and accessories visit: www.gelifesciences.com/AKTA
32 ÄKTAprime plus Operating Instructions 28-9597-89 AB
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4 Operation
About this chapter
This chapter provides instructions for the use of ÄKTAprime plus.

4.1 Operation overview

Workflow
The typical workflow in ÄKTAprime plus, after turning on the system, can be divided into a number of steps.

4 Operation

SectionActionStep
Section 4.3 Preparations before start, on page 34Prepare the system for a run1
Liquid flow path
See Appendix A Connection diagram - Liquid flow path, on page 65 for an illustration of the liquid flow path in ÄKTAprime plus.

4.2 Starting the instrument

If the system is not already turned on:
1
Turn on the system using the Power switch at the rear panel. The system now per­forms a self-test.
2
First thesystem name and software version number aredisplayed. Severalmessages are then shown during the self-test. If an error is detected during the self-test, an error message is shown.
3
All parameters are automatically set to factory default values during the self-test.
Section 4.4 Performing a run, on page 39Start a run using a method2
Viewing the run, on page 40During arun -view and changeparameters3
Section 4.5 Procedures after a run, on page 41Procedures after a run4
See PrimeView user documentation.Evaluate the results5
ÄKTAprime plus Operating Instructions 28-9597-89 AB 33
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4 Operation
4.2 Starting the instrument
4
The self-test takes about 30–40 seconds. When the test is completed, the display shows the Templates menu.
Note:
The system can be used for most applications after 15 min of lamp warm-up but the full specifications are not obtained until after 1 hour.

4.3 Preparations before start

Buffer preparation
Prepare buffers according to ÄKTAprime plus cue cards.
Sample preparation
1
Adjust the sample composition to the binding buffer by:
diluting the sample in binding buffer, or
buffer exchange using HiTrap™ Desalting or HiPrep™ 26/10 Desalting column.
2
Filter the sample through a 0.45 µm filter.
Purification setup
Removing storage solution from the flow path
At delivery and during storage, the flow path is filled with 20% ethanol. This should be removed before continuing the setup.
Note:
To flush out the ethanol using deionized water:
1
2
3
4
5
34 ÄKTAprime plus Operating Instructions 28-9597-89 AB
Do not use buffer with high salt concentration to flush out the ethanol. It might cause too high backpressure.
Put the inlet tubing A1A8 that is used and B in deionized water.
Note:
Put all waste capillaries, W1W3, in waste.
Select Templates in the main menu using the and buttons and press OK.
Select Application Template and press OK.
Select System Wash Method and press OK.
At delivery, only A1 and B are installed.
Page 35
1
2
3
4
5
6
7
8
9
10
ml
4 Operation
4.3 Preparations before start
6
Choose to wash the A2A8 inlet tubing that is used by pressing OK at those cursor positions. A1 and B will always be washed.
Note:
7
Scroll to OK and press the OK button.
8
Press OK to start the method.
9
When the method is finished, replace the first collection tube. It will contain a small
At delivery, only A1 and B are installed.
amount of water after the system wash.
Purging the pump and inlet tubing
If there are large amounts of air in the tubing or if you suspect air in the pump, use the Purge kit to purge the flow path. Air bubbles that still are trapped in the pump (causing increased pulsation) can beremoved by flushing 100% ethanolthrough thepump. These two procedures are described in the following two sections.
Purging the flow path using the Purge kit:
1
Remove the stop plug from the pump.
2
Connect the Purge kit to the pump.
3
Put the used inlet tubing in the appropriate buffers.
4
Run the pump at 0.1 ml/min.
Filling inlet tubing A1A8:
1
Go to Set Buffer Valve using the arrow buttons.
2
Set the chosen A inlet and press OK. The valve switches to the selected port.
3
Draw buffer with the purge syringe until liquid enters the syringe.
4
Repeat step 1–3 until all chosen A inlet tubing is filled.
Filling inlet tubing B:
ÄKTAprime plus Operating Instructions 28-9597-89 AB 35
1
Go to Set Concentration %B and set the concentration to 100%.
Page 36
1
2
3
4
4 Operation
4.3 Preparations before start
2
Press OK. The switch valve turns to the inlet B port.
3
Draw buffer with the purge syringe until liquid enters the syringe.
4
Replace the purge tubing with the stop plug.
5
Stop the pump by pressing end and then OK.
Flushing the pump with 100% ethanol:
1
Put inlet tubing A1 in deionized water.
2
Run the pump at 40 ml/min for 1 min and press pause/cont.
3
Move inlet tubing A1 to 100% ethanol
4
Press pause/cont, run the pump for 10–20 s and press pause/cont.
5
Set the flow rate to 5 ml/min using the arrow buttons.
6
Press pause/cont, run the pump for at least 30 s and press pause/cont.
7
Move inlet tubing A1 to deionized water.
8
Press pause/cont and run the pump for 1 min.
9
Finish by pressing end and then OK.
Preparing the tubing and column
1
Put inlet tubing A1 in the binding buffer.
2
Put inlet tubing B in the elution buffer.
3
Put the threewaste capillaries (brown color)from port 4 and 5 on the injection valve and port NO on the fraction collector valve in waste.
4
Connect a column, for example a HisTrap™ HP 1 ml column, between port 1 on the injection valve and the upper port of the UV flow cell. Use a suitable length of PEEK tubing and 1/16" male connectors.
36 ÄKTAprime plus Operating Instructions 28-9597-89 AB
Page 37
5 mm
1
2
5.
3.
4.
1.
2.
4 Operation
4.3 Preparations before start
DescriptionNo.DescriptionNo.
HisTrap column3Tubing from injection valve1
UV cell41/16" male connector2
Note:
Other unions and connectors might be required for other columns.
Preparing the fraction collector
1
Fill the fraction collector rack with, for example, 18 mm tubes (minimum 40 pcs.).
2
Adjust the height of the delivery arm using the lock knob (1) so that the bottom of the tubesensor (2) is about 5mm below thetop of the tubes. Thetubes should always be below the horizontal mark on the tube sensor.
3
If necessary, adjust the length of the tubing exposed according to the sequence shown below (the hole in the delivery arm used in step 3 and 4 is only used for ad­justing the tubing length).
ÄKTAprime plus Operating Instructions 28-9597-89 AB 37
Page 38
2
1
3
4 Operation
4.3 Preparations before start
4
Check that the tube sensor (1) is in the correct position for the tube size. The eluent tubing should be over the center of the collection tube. Use the red sensor control knob (2) to position the tube holder (3).
5
Rotate the rack by hand until the rear half of the tube sensor rests against the first tube.
6
Press feed tube on the front panel (see Figure 1.2). The bowl moves to the correct position to collect the first fraction in the first tube.
7
Make sure that drop synchronization is turned on.
Note:
Drop synchronization can NOT be used at flowrates above 3 ml/min.
Preparing the monitors
1
Check the UV lamp filter position and the lamp position.
2
Calibrate the pH electrode (optional).
See ÄKTAprime plus User Manual for more information.
Filling the buffer inlet tubing
When running an application templates, the buffer inlet tubing will automatically be filled with buffer.
For other applications, fill the inlet tubing manually with buffer as described in the ÄKTAprime plus User Manual.
Filling the sample loop
Using an injection fill port
38 ÄKTAprime plus Operating Instructions 28-9597-89 AB
Page 39
3
1
4 Operation
4.3 Preparations before start
1
Connect a sample loop between port 2 and 6 on the injection valve. Make sure that the sample loop is large enough for your sample.
2
Connect a luer female/1/16" male union to port 3.
3
Fill a syringe with five loop volumes of deionized water or binding buffer.
4
Fit the syringe in the Luer union (1) and carefully inject the buffer.
5
Remove the syringe and fill it with at least two loop volumes of the sample.
6
Carefully inject the sample into the sample loop. Do NOT remove the syringe after the injection because the loop might otherwise be emptied due to self-drainage or air may be introduced in the flow path.

4.4 Performing a run

Selecting template and starting the run
1
Select Templates in the main menu and press OK.
2
Select Application Template and press OK.
3
Select theappropriate template,for example His Tag Purification HisTrap, and press OK.
4
Set the sample volume and press OK.
5
Press OK to start the purification run.
ÄKTAprime plus Operating Instructions 28-9597-89 AB 39
Page 40
4 Operation
4.4 Performing a run
Viewing the run
When the pump starts running, the progress of the run can be viewed in the two panes in PrimeView.
The Curves pane displays monitor signal values graphically.
The Logbook pane displays all actions (e.g. method start and end, base instructions and methodinstructions) andunexpected conditions(e.g. warningsand alarms).The log is saved in the result file.
Selecting curves to be displayed
1
In PrimeView module, select View:Properties.
2
In the Properties dialog, click the Curves tab.
3
In the Display curves list, select the curves you want to display.
4
Click OK.
For more information on customizing the view panes, see PrimeView User Manual.
40 ÄKTAprime plus Operating Instructions 28-9597-89 AB
Page 41
Ending the run
Press OK at the Method Complete prompt. This will cause all valves to return to their default positions.
To stop the run on a system before it is finished:
1
Press the end button.
2
Select yes and press OK.
Error indication
When a warning or an alarm is issued from a system, an error code is displayed. See ÄKTAprime plus User Manual for guidance.
Evaluate the results
PrimeView Evaluation module provides facilities for the presentation and evaluation of separation results.
To start PrimeViewEvaluation module, click PrimeView Evaluationicon on the Windows desktop.
4 Operation
4.4 Performing a run
See ÄKTAprime plus User Manual and PrimeView User Manual for how to evaluate the results.

4.5 Procedures after a run

Cleaning after a run
NOTICE
Do not allow solutions which contain dissolved salts, proteins or other solid solutes to dry out in the UV flow cell.
ÄKTAprime plus Operating Instructions 28-9597-89 AB 41
Page 42
4 Operation
4.5 Procedures after a run
Buffers notcontaining any saltcan be left in the system for ashort time aftera run, even overnight (not in the pH electrode, see instructions below).
To flush the flow path:
1
Fill a syringe with five times the sample loop volume of deionized water.
2
Rinse the sample loop by injecting the water through the fill port on the injection valve.
3
Put all used inlet tubings in water.
4
In theTemplates menu,select Application Template and thenSystem Wash Method.
5
Select the used inlet ports. Inlets A1 and B will always be washed.
6
Press OK to start the method. The system flow path is now automatically flushed.
For informationon cleaning andlong-term storage, see Section 5.3 Cleaning, on page46 and Section 5.7 Storage, on page 49.
NOTICE
Do not allow particles to enter the UV flow cell as damage to the flow cell might occur.
NOTICE
If a buffer containing salt has been used, the flow path must be flushed with deionized water.
42 ÄKTAprime plus Operating Instructions 28-9597-89 AB
Page 43
5 Maintenance
About this chapter
This chapter provides instructions for routine component maintenance and a mainte­nance schedule.

5.1 General

Regular maintenanceis important for safe andtrouble-free operationof your instrument. The usershould perform daily and monthlymaintenance. Preventive maintenanceshould be performed on a yearly basis by qualified service personnel.
For maintenance of a specific component, carefully read the component manual and follow the instructions.
WARNING
Electrical shock hazard. All repairs should be done by service
personnel authorized by GE Healthcare. Do not open any covers or replace parts unless specifically stated in the user documenta­tion.

5 Maintenance

WARNING
Disconnect power.Always disconnect powerfrom the instrument
before replacing any component on the instrument, unless stated otherwise in the user documentation.
WARNING
Hazardous chemicals during maintenance.When using hazardous
chemicals for system or column cleaning, wash the system or columns with a neutral solution in the last phase or step.
ÄKTAprime plus Operating Instructions 28-9597-89 AB 43
Page 44
5 Maintenance
5.1 General
WARNING
Do not perform any type of maintenance work while the system is powered electrically or whenthe piping systemis pressurized.Note that the piping system can be pressurized even when the system is closed down.
WARNING
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 ÄKTAprime plus.
CAUTION Fire hazard. Follow instructions in ÄKTAprime plus Operating
Instructions for correct installation of a new UV-lamp. If the lamp is not installed properly it may be overheated and cause a fire hazard.
NOTICE Cleaning. Keep the instrument dry and clean. Wipe regularly with
a softdamp tissue and,if necessary, amild cleaning agent . Let the instrument dry completely before use.

5.2 User maintenance schedule

Table 5.1 provides a guide to maintenance operations and intervals at which these op­erations should be performed by the user. The user is however responsible for deciding the type of operations and length of intervals necessary to maintain system function and safety.
44 ÄKTAprime plus Operating Instructions 28-9597-89 AB
Page 45
Table 5.1: User maintenance schedule
5 Maintenance
5.2 User maintenance schedule
Instructions/referenceActionInterval
Visually inspect the system for leaks.Leak inspectionDaily
Wash thesystem flow path
Calibrate pHelectrode (optional)
Check inlet filtersWeekly
(if applicable)
Flow restrictorMonthly
For cleaningthe flowpath, seeCleaning-In-
1
Place, on page 46.
For leaving the system for a few days, see
2
Section 5.7 Storage, on page 49.
Calibrate thepH electrode(if applicable) accord­ing to Monitor pH/C-900 User Manual.
Check theinlet filters visually and replace them if necessary.
Replace the on-line filter.Replace on-line filter
Check thatflow restrictor generates the follow­ing back-pressure:
FR-904: 0.4 ±0.05 MPa
Check the back-pressure as follows:
Disconnect the flow restrictor.
1
Connect a tubing (approx. 1 m, i.d. 1 mm)
2
to the waste port (port 5) on the injection valve. Set the injection valve manually to Waste position.Put the open end ina waste container.
Run the pump manually at 10 ml/min with
3
water. Note the back-pressure (Bp1) on the pump display, or in the Run Data window.
Set the system to Pause and connect the
4
flow restrictor to the openend ofthe tubing (observe theIN marking). Putthe flow restric­tor in the waste container.
Press Continue so that the pump run at 10
5
ml/min with water. Note the back-pressure (Bp2) on the pump display, or in the Run Data window.
Calculate the back-pressure generated by
6
the flow restrictor (Bp2-Bp1). Replace it if it is not within limit.
ÄKTAprime plus Operating Instructions 28-9597-89 AB 45
Page 46
5 Maintenance
5.2 User maintenance schedule
Instructions/referenceActionInterval

5.3 Cleaning

Cleaning before planned maintenance/service
To ensure the protection and safety of service personnel, all equipmentand work areas must beclean and freeof any hazardous contaminantsbefore a Service Engineerstarts maintenance work.
Please complete the checklist in the On Site Service Health & Safety Declaration Form or the Health & Safety Declaration Form for Product Return or Servicing, depending on whether theinstrument is goingto be serviced on site or returned forservice, respectively. Copy theform you need from Section7.4 Health and Safety Declaration Form, on page 62 or print it from the PDF file available on the User Documentation CD.
Cleaning-In-Place
All components in the system are designed for ease of CIP.
After repeated separation cycles, contaminating material might progressively build up in the system and on the column. This material may not have been removed by the cleaning step described above. The nature and degree of contamination depends on the sampleand the chromatographic conditions employed.These should be considered when designing a cleaning protocol.
Routine cleaning should be performed at intervals aimed at prevention rather than cleaning the system from growth or contamination.
Valve inspectionYearly
Check for external or internal leakage. Replace channel plate and distribution plate yearly or when required. Refer to the relevant valve in­struction sheet.
WARNING
Make sure that the piping system is completely leakage free before performing any CIP on the system.
46 ÄKTAprime plus Operating Instructions 28-9597-89 AB
Page 47
5 Maintenance
5.3 Cleaning
Make sure that the process control method for cleaning flushes all possible flow paths in the system. After cleaning, rinse the entire system with water or suitable liquid until the piping/tubingsystem iscompletely freefrom theCIP solution(monitors inthe system can be used as detectors). Do not leave NaOH or other cleaning agents in the system for long periods.
WARNING
Hazardous chemicals during maintenance.When using hazardous
chemicals for system or column cleaning, wash the system or columns with a neutral solution in the last phase or step.
WARNING
NaOH is corrosive and therefore dangerous to health. When using hazardous chemicals, avoid spillage and wear protective glasses and other suitable Personal Protective Equipment (PPE).
See also Section 5.7 Storage, on page 49.

5.4 Component maintenance

Maintenance andpreventive replacement ofparts of the major componentsare described in the respective manuals included in the system documentation.
The system documentation also includes a spare part list to be used to find common spare parts and their code numbers for ordering. This list can also be found online at www.gelifesciences.com/AKTA.
5.5 Disassembly and assembly of components and con­sumables
The operator must carefully read and understand the instructions supplied for each component before disassembly and assembly of the component. When replacing con­sumables, suchas tubing and tubing connectors,all neccessary safety precautions must be taken. Contact your local GE Healthcare representative if further information or help is needed.
WARNING
Disconnect power.Always disconnect powerfrom the instrument
before replacing any component on the instrument, unless stated otherwise in the user documentation.
ÄKTAprime plus Operating Instructions 28-9597-89 AB 47
Page 48
5 Maintenance
5.5 Disassembly and assembly of components and consumables
WARNING
Before disassembly, check that there is no pressure in the piping system.
WARNING
After assembly, the piping system must be tested for leakage at maximum pressure for continued protection against injury risks due to fluid jets, burst pipes or explosive atmosphere.

5.6 Calibration

The table below lists the type and frequency of calibrations that can be done on the in­strument. Refer toPrimeView user documentation and tothe individual component User Manuals and Instructions for descriptions of how to perform these calibrations. The calibrations are performed from PrimeView by selecting System:Calibrate in System Control.
flow cell
Cell constantConductivity
Temperature
Entering a new cell con­stant
How oftenComponent
Every day.pH monitor (if applicable)
When required.Pump (if applicable)
When required.Pressure reading
Only necessary if specific conductivity with high accuracy is measured (Cond_Calib).
Must be done when changing the conductivity flow cell (Temp).
Must be done when changing the conductivity flow cell (Cond_Cell).
48 ÄKTAprime plus Operating Instructions 28-9597-89 AB
Page 49
5.7 Storage
General recommendation
For storage, the system must first be cleaned as described in Cleaning-In-Place, on page 46. After cleaning, the system must be filled with 0.01 M NaOH or 20% ethanol
solution.
Columns and media shall be stored according to their respective instructions.
Storage conditions
The following conditions shall be maintained while the system is in storage:
Temperature: 2°C to 30°C (preferably room temperature)
Relative humidity: 0% to 95%, non-condensing (preferably low humidity).
After storage,clean the system, calibrate allmonitors, and performa leakage testbefore using the system.
5 Maintenance

5.7 Storage

ÄKTAprime plus Operating Instructions 28-9597-89 AB 49
Page 50

6 Troubleshooting

6 Troubleshooting

6.1 UV curve problems

Corrective actionPossible causeError symptom
Ghost peak
nal drift or instability
Dirt or residues in the flow path from previ­ous runs. Air in the eluents.
Residue inthe column from previous runs
Incorrect mixer func­tion
Dirty UV cellNoisy UV-signal, sig-
Impure buffer
Air in the pump or in the UV cell
Clean the system. Make sure air is removed.
Clean thecolumn according to the column instructions.
Check the mixer function by plac­ing astirrer baron top of the mixer housing. The stirrer bar should ro­tate when the system is in Run mode. Themixer function can also be checkedby running the installa­tion test.
Clean the UV cell by flushing Decon™ 90, Deconex™ 11 or equivalent.
Check ifthe signalis still noisy with water.
Purge the pump according to Pump User Manual. Run a system wash with buffer.
50 ÄKTAprime plus Operating Instructions 28-9597-89 AB
Page 51
6 Troubleshooting
6.1 UV curve problems
Corrective actionPossible causeError symptom
Aging UV lampLow sensitivity
UV lamp in wrong po­sition
The theoreticalextinc­tion coefficient too low

6.2 Conductivity curve problems

Baseline drift or noisy signal
Air in the pump or the flow cell
Leaking tubeconnec­tions
Incorrect mixer func­tion
Check thelamp runtime according to and replace if necessary. Refer to ÄKTAprime plus User Manual.
Check that the lamp position and the filter position are both set to the wavelength tobe used, 280 nm or 254nm. Refer to ÄKTAprimeplus User Manual.
Calculate thetheoretical extinction coefficient of the protein. If it is ze­ro or very low at 280 nm, the pro­tein cannot be detected.
Corrective actionPossible causeError symptom
Check the flow restrictor after the flow cell.
Tighten the clamps. If necessary, replace the clamps.
Check the mixer function by plac­ing astirrer baron top of the mixer housing. The stirrer bar should ro­tate when the system is in Run mode. Themixer function can also be checkedby running the installa­tion test.
Dirty conductivity cell
Column notequilibrat­ed
Dirty flow cellConductivity measure­ment with the same buffer appears to de­crease over time
ÄKTAprime plus Operating Instructions 28-9597-89 AB 51
Decrease in ambient
temperature
Clean the conductivity cell by flushing 1M NaOH or 20% ethanol.
Equilibrate the column. If neces­sary, clean the column using a method plan for column cleaning.
Clean the flow cell according to procedure in Monitor User Manual.
Use a temperature compensation factor. See Monitor User Manual.
Page 52
6 Troubleshooting
6.2 Conductivity curve problems
Corrective actionPossible causeError symptom
Waves on the gradi­ent
in the gradient profile
slow response to %B changes
Incorrect pump func­tion
Dirty mixing chamber
Insufficient mixing chamber volume
Incorrect motor func­tion
Air in the flow cellGhost peaks appear
Dirty tubingUnlinear gradients or
ume
Check that the pump is operating and is programmed correctly.
Check that the mixing chamber is free from dirt or particles.
Change to a larger mixing cham­ber volume if necessary.
Check the motor operation. Place a hand on the mixer and start it by starting the pump at a low flow rate. You shouldboth hear and feel the mixer motor and stirrer when they are spinning.
Check for loose tubing connec­tions. Use the flow restrictor.
Wash the tubing and check pump is operating properly.
Change to smaller mixer volume.Incorrect mixer vol-
52 ÄKTAprime plus Operating Instructions 28-9597-89 AB
Page 53
6 Troubleshooting
6.2 Conductivity curve problems
Corrective actionPossible causeError symptom
Incorrect or unstable reading

6.3 pH curve problems

Loose connection of
conductivity flow ca-
ble
Incorrect pump and
valves function
Incorrect temperature
compensation factor
Dirty or incorrectly
equilibrated column
Incorrect mixer func-
tion
Check that the conductivity flow cell cable is connected properly.
Check that the pump and valves operate correctly.
If temperature compensation is being used,check thatthe temper­ature sensoris calibrated, and that the correct temperature compen­sation factor is in use.
Check thatthe columnis equilibrat­ed. If necessary clean the column.
Check the operation of the mixer. The mixer function is checked by placing a stirrer bar on top of the mixer housing. The stirrer bar should rotate when the system is in Run mode. The mixer function can also be checked by running the installation test.
Corrective actionPossible causeError symptom
No response to pH changes
changes
ÄKTAprime plus Operating Instructions 28-9597-89 AB 53
Faulty electrode con-
nection
Damaged electrode
Incorrectly connected
pH monitor
Dirty pH electrodeSmall response to pH
Check that the electrode cable is connected properly.
The electrode glass membrane may becracked. Replace the elec­trode.
Check that the pH monitor is cor­rectly connected according to the ÄKTAprime plus User Manual.
Clean thepH electrode as detailed in Monitor pH/C-900 User Manual.
If theproblem remains,replace the pH electrode.
Page 54
6 Troubleshooting
6.3 pH curve problems
Corrective actionPossible causeError symptom
Slow pH response or Calibration impossible
Contaminated elec­trode glass mem­brane
Membrane has dried out
Check the electrode glass mem­brane. If it is contaminated, clean the electrodefollowing theinstruc­tions in Monitor pH/C-900 User Manual.
If themembrane has dried out, the electrode may be restored by soaking it in buffer overnight.
54 ÄKTAprime plus Operating Instructions 28-9597-89 AB
Page 55
6 Troubleshooting
6.3 pH curve problems
Corrective actionPossible causeError symptom
Incorrect or unstable pH reading
Problem with elec-
trode
Check that the electrode cable is connected properly.
Check thatthe electrodeis correct­ly inserted in the flow cell and, if necessary, hand-tighten the nut.
Check that the pH electrode is not broken.
Calibrate the pH electrode.
Clean the pH electrode if required, see MonitorpH/C-900 User Manual.
Compare the response of the pH electrode with that of another pH electrode. If the response differ greatly, the electrode may require cleaning or replacement.
In organic solvents such as ethanol, methanoland acetonitrile, stable pH measurements are not possible since dehydration of the membrane will occur. It is recom­mended that the pH electrode is not used in applications using or­ganic solvents. Mount the dummy electrode instead.
Incorrect pump or
valve operation
Air in the flow cell
Check that the pump and valves operate correctly.
If air in the flow cell is suspected, tap the flow cell carefully or tilt it to remove the air. Alternatively, flush the cell with buffer at 20 ml/min (E100 system)or 10 ml/min (E 10 system) for 1/2 min. Use the flow restrictor FR-902 after the pH electrode.
Static interference
There may be interference from static fields. Connect the pH flow cell and the rear panel of the monitor usinga standardlaborato­ry 4 mm “banana plug” cable.
ÄKTAprime plus Operating Instructions 28-9597-89 AB 55
Page 56
6 Troubleshooting
6.3 pH curve problems
Corrective actionPossible causeError symptom
pH values vary with varied back pressure
electrode

6.4 Pressure curve problems

Erratic flow, noisy baseline signal,irregu­lar pressure trace
through or trapped in the pump
Inlet or outlet check valves notfunctioning correctly
Piston seal leaking
Replace the pH electrode.Problem with the
Corrective actionPossible causeError symptom
Check all connections for leaks.Air bubbles passing
Check thatthere is sufficient eluent present in the reservoirs.
Use degassed solutions.
Purge the pump.
Follow the instructions in ÄKTAprime plus User Manual.
Clean the valves according to Pump P-920 User Manual.
Clean the valves according to ÄKTAprime plus User Manual.
Replace the piston seal according to the instructions in .ÄKTAprime plus User Manual.
Flush through to clear blockage.Blockage or part
blockage of flowpath
56 ÄKTAprime plus Operating Instructions 28-9597-89 AB
If necessary, replace tubing.
Check inlet tubing filter. It can be­come clogged if unfiltered buffers or samplesare applied.See instruc­tions for flushing through at the end of the run in ÄKTAprime plus User Manual.
Page 57
7 Reference information
About this chapter
This chapter contains technical data, regulatory and other information.

7.1 Specifications

ValueParameter
Housing: IP20Ingression protection
Flow cells: IP44
100-120/220-240 V ~, 50 to 60 HzSupply voltage
90 VAPower consumption
T 1.0 AH 250 VFuse specification

7 Reference information

7.2 Chemical resistance

Chemical
Exposure < 1 day
up to 2 months
OKOKAcetaldehyde
OKOKAcetic acid, < 5%
530 × 400 × 450 mmDimensions (H × W × D)
13 kgWeight
4°C to 40°CAmbient temperature
10% to 95%Relative humidity tolerance (non-condensing)
84 to 106 kPa (840 to 1060 mbar)Atmospheric pressure
CommentsEEC no.CAS no.Exposure
200-580-764-19-7OKOKAcetic acid, 70%
200-835-275-05-8OKOKAcetonitrile
FFKM, PP and PE swell.
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7 Reference information
7.2 Chemical resistance
Chemical
ride
bonate
phate
Exposure < 1 day
up to 2 months
AvoidOKAcetone, 10%
OKOKAmmonium bicar-
OKOKAmmonium nitrate
OKOK1-Butanol
OKOK2-Butanol
AvoidOKChloroform
CommentsEEC no.CAS no.Exposure
PVDF is affected by long term use.
231-635-37664-41-7OKOKAmmonia, 30%
Silicone is affected by long-term use.
235-186-412125-02-9OKOKAmmonium chlo-
231-984-17783-20-2OKOKAmmonium sul-
249-576-729340-81-6OKOKCitric acid
Kalrez™, CTFE, PP and PE are affected by long term use.
OKOKCyclohexane
OKOKDetergents
200-664-367-68-5AvoidAvoidDimethyl sulphox-
ide
AvoidAvoid1, 4-Dioxane
PVDF is affected by long term use.
ETFE, PP, PE and PVDF are affected by long term use.
200-837-375-08-1OKOKEthanol, 100%
AvoidOKEthyl acetate
Silicone not resis­tant. Pressure limit for PEEKdecreases.
203-473-3107-21-1OKOKEthylene glycol,
100%
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7 Reference information
7.2 Chemical resistance
Chemical
drochloride
0.1 M
> 0.1 M
Exposure < 1 day
up to 2 months
OKOKGuanidinium hy-
AvoidOKHexane
AvoidOKHydrochloric acid,
CommentsEEC no.CAS no.Exposure
200-579-164-18-6OKOKFormic acid, 100%
Silicone not resis­tant.
200-289-556-81-5OKOKGlycerol, 100%
Silicone not resis­tant. Pressure limit for PEEKdecreases.
231-595-77647-01-0OKOKHydrochloric acid,
Silicone not resis­tant.
Silicone not resis­tant. Titanium isaf­fected bylong term use.
200-661-767-63-0OKOKIsopropanol, 100%
200-659-674-93-1OKOKMethanol, 100%
AvoidOKNitric acid, diluted
Silicone not resis­tant.
AvoidAvoidNitric acid, 30%
Elgiloy™ is affected by long term use.
231-633-27664-38-2AvoidOKPhosphoric acid,
10%
Titanium, alumini­um oxide and glass are affected by long term use.
209-529-3584-08-7OKOKPotassium carbon-
ate
231-211-87447-40-7OKOKPotassium chloride
AvoidAvoidPyridine
ETFE, PP and PE not resistant.
OKOKSodium acetate
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7 Reference information
7.2 Chemical resistance
Chemical
ate
2 M
ed
medium concentra­tion
Exposure < 1 day
up to 2 months
OKOKSodium bicarbon-
OKOKSodium bisulphate
OKOKSodium borate
OKOKSodium carbonate
AvoidOKSulphuric acid, dilut-
AvoidAvoidSulphuric acid,
CommentsEEC no.CAS no.Exposure
231-598-37647-14-5OKOKSodium chloride
215-185-51310-73-2AvoidOKSodium hydroxide,
PVDF and borosili­cate glass are af­fected bylong term use.
231-820-97757-82-6OKOKSodium sulphate
PEEK and titanium are affected by long term use.
AvoidAvoidTetrachloroethy-
lene
AvoidAvoidTetrahydrofuran
Silicone, PP and PE are not resistant.
ETFE, CTFE, PP and PE arenot resistant.
AvoidOKToluene
Pressure limit for PEEK decreases.
200-927-276-03-9OKOKTrichloroacetic
acid, 1%
200-929-3176-05-1OKOKTrifluoroaceticacid,
1%
200-315-557-13-6OKOKUrea, 8M
AvoidOKo-Xylene and p-Xy-
lene
PP and PE are af­fected bylong term use.
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7.3 System recommendations
Refer to ÄKTAprime plusUser Manual, or contact your local GE Healthcarerepresentative for the most current information.
7 Reference information

7.3 System recommendations

ÄKTAprime plus Operating Instructions 28-9597-89 AB 61
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GE Services On Site Service Health &
Safety Declaration Form
Service Ticket #:
To ensure the mutual protection and safety of GE Healthcare service personnel and our customers, all equipment and work areas must be clean and free of any hazardous contaminants before a Service Engineer starts a repair. To avoid delays in the servicing of your equipment, please complete this checklist and present it to the Service Engineer upon arrival. Equipment and/ or work areas not sufficiently cleaned, accessible and safe for an engineer may lead to delays in servicing the equipment and could be subject to additional charges.
Yes No
Please review the actions below and answer “Yes” or “No”. Provide explanation for any “No” answers in box below.
Instrument has been cleaned of hazardous substances.
Please rinse tubing or piping, wipe down scanner surfaces, or otherwise ensure removal of any dangerous residue. Ensure the area around the instrument is clean. If radioactivity has been used, please perform a wipe test or other suitable survey.
Adequate space and clearance is provided to allow safe access for instrument service, repair or installation.
In some cases this may require customer to move equipment from normal operating location prior to GE arrival.
Consumables, such as columns or gels, have been removed or isolated from the instrument and from any area that may impede access to the instrument.
All buffer / waste vessels are labeled. Excess containers have been removed from the area to provide access.
Provide explanation for any “No” answers here:
Equipment type / Product No: Serial No:
I hereby confirm that the equipment specified above has been cleaned to remove any hazardous substances and that the area has been made safe and accessible.
Name in Capital letters:
Company or institution:
Position or job title: Date (Year/month/date): 200000/00000/00000
GE, imagination at work and GE monogram are trademarks of General Electric Company. GE Healthcare Bio-Sciences Corp, 800 Centennial Avenue, P.O. Box 1327, Piscataway, NJ 08855-1327, USA. © 2010-12 General Electric Company—All rights reserved. First published April 2010.
28-9800-26 AB 05/2012
Signed:
DOC1149542
7 Reference information

7.4 Health and Safety Declaration Form

7.4 Health and Safety Declaration Form
On site service
62 ÄKTAprime plus Operating Instructions 28-9597-89 AB
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GE Services
Health & Safety Declaration Form for Product Return or Servicing
DOC1149544
To ensure the mutual protection and safety of GE Healthcare personnel, our customers, transportation personnel and our environment, all equipment must be clean and free of any hazardous contaminants before shipping to GE Healthcare. To avoid delays in the processing of your equipment, please complete this checklist and include it with your return.
1. Please note that items will NOT be accepted for servicing or return without this form
2. Equipment which is not sufficiently cleaned prior to return to GE Healthcare may lead to delays in servicing the equipment
and could be subject to additional charges
3. Visible contamination will be assumed hazardous and additional cleaning and decontamination charges will be applied
Equipment type / Product No: Serial No:
I hereby confirm that the equipment specified above has been cleaned to remove any hazardous substances and that the area has been made safe and accessible.
Name in Capital letters:
Company or institution:
Position or job title: Date (Year/month/date): 200000/00000/00000
GE, imagination at work and GE monogram are trademarks of General Electric Company. GE Healthcare Bio-Sciences Corp, 800 Centennial Avenue, P.O. Box 1327, Piscataway, NJ 08855-1327, USA. © 2010-12 General Electric Company—All rights reserved. First published April 2010.
28-9800-27 AB 05/2012
Return authorization number: and/or Service Ticket/Request:
To receive a return authorization number or service number, please call local technical support or customer service.
Please specify if the equipment has been in contact with any of the following:
Yes No Radioactivity (please specify):
Yes No Infectious or hazardous biological substances (please specify)
Yes No Other Hazardous Chemicals (please specify)
Equipment must be decontaminated prior to service / return. Please provide a telephone number where GE Healthcare can contact you for additional information concerning the system / equipment.
Telephone No:
Liquid and/or gas in equipment is: Water Ethanol None, empty Argon, Helium, Nitrogen
Liquid Nitrogen Other, please specify:
Signed:
7.4 Health and Safety Declaration Form
Product return
7 Reference information
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7 Reference information

7.5 Ordering information

7.5 Ordering information
For ordering information visit www.gelifesciences.com/AKTA.
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Cond
1
2
3
4
5
6
7
W1
W2
W3
G5
410
W3
1000
W2
1000
W1
G6
550
F1
G3
300
250
A1
1250
B
1250
1
2
3
4
5
6
7
8
A
170
AB
510
G4
650
UV
pH
1100
G1 87
G2 98
1
2
3
4
5
6
7
8
10
9
11
12
13
14

A Connection diagram - Liquid flow path

Appendix A Connection diagram - Liquid flow path
Flow path and components
DescriptionNo.DescriptionNo.
Loop (500 μl)8Buffers1
Waste9Buffer valve2
Column10Gradient switch valve3
Male/Male11System pump4
Flow restrictor (0.2 MPa)12Pressure monitor5
Flow diversion valve13Stop plug6
Fraction collector14Mixer7
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B Tubing

Appendix B Tubing
Names in the Label column in TableB.1 refer to tubing labels in the liquid flow path connection diagram, see Appendix A Connection diagram - Liquid flow path, on page65.
Table B.1: Tubing specifications for ÄKTAprime plus
Cond - Flow restrictor
1/16" male / 1/16" male
MaterialLabelUse
Length (mm)
I.D. (mm)
2.91250FEPA1Inlet A11
2.9170FEPAInlet A1
2.91250FEPBInlet A2
1.6510FEPABSwitch valve - Pump A3
Volume (μl)
8.2 × 10
1.1 × 10
8.2 × 10
1.0 × 10
660.75150PEEKG1Pump - Pressure monitor
530.75120PEEKG2Pressure monitor - Mixer
1330.75300PEEKG3Mixer - Valve
2870.75650PEEKG4Valve - UV (Column)
1100.75250PEEKG5UV - Cond
70.5038PEEKUnion,
2430.75550PEEKG6Flow restrictor – Frac. coll.
1810.75410PEEKF1Frac. tubing
7851.01000PEEKW1, W2, W3Waste
3
3
3
3
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Page 68
For local office contact information, visit
imagination at work
www.gelifesciences.com/contact GE Healthcare Bio-Sciences AB
Björkgatan 30 751 84 Uppsala Sweden
www.gelifesciences.com/AKTA
GE, imagination at work and GE monogram are trademarks of General Electric Company.
HiPrep, HisTrap, HiTrap, PrimeView and ÄKTAprimeare trademarks of GE Healthcare companies.
Decon is a trademark of Decon Laboratories Ltd.
Deconex is a trademark of Borer Chemie AG.
Elgiloy is a trademark of Elgiloy Limited Partnership.
Kalrez is a trademark of DuPont Performance Elastomers L.L.C.
Microsoft and Windows are trademarks of Microsoft Corporation.
Any use of PrimeView is subject to GE Healthcare Standard Software End-User License Agreement forLife Sciences SoftwareProducts. A copy of this Standard Software End-User License Agreement is available on request.
PrimeView © 2011-2013 General Electric Company.
© 2009-2013 General Electric Company – All rights reserved. First published Aug. 2009
All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare whichsupplies them. A copy of these terms and conditions is available onrequest. Contact your local GE Healthcare repre­sentative for the most current information.
GE Healthcare Europe GmbH Munzinger Strasse 5, D-79111 Freiburg, Germany
GE Healthcare UK Limited Amersham Place, Little Chalfont, Buckinghamshire, HP7 9NA, UK
GE Healthcare Bio-Sciences Corp. 800 Centennial Avenue, P.O. Box 1327, Piscataway, NJ 08855-1327, USA
GE Healthcare Japan Corporation Sanken Bldg. 3-25-1, Hyakunincho Shinjuku-ku, Tokyo 169-0073,Japan
28-9597-89 AB 05/2013
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