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1.3

Regulatory information

Introduction

This section lists the directives and standards that are fulfilled by ÄKTAprocess.

Manufacturing information

The table below summarizes the required manufacturing information. For further infor-
mation, see the EC Declaration of Conformity (DoC) document.

Content

Requirement

GE Healthcare Bio-Sciences AB,

Name and address of manufacturer

Björkgatan 30, SE 751 84 Uppsala,
Sweden

See EC Declaration of Conformity

Place and date of declaration

See EC Declaration of Conformity

Identity of person authorized to sign DoC

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.

Title

Directive

Machinery Directive (MD)

2006/42/EC

Electromagnetic Compatibility (EMC) Directive

2004/108/EC

Low Voltage Directive (LVD)

2006/95/EC

ÄKTAprocess Operating Instructions 29-0252-49 AA

1 Introduction

1.3 Regulatory information

Содержание AKTAprocess

Страница 1: ...GE Healthcare Life Sciences ÄKTAprocess Operating Instructions Original instructions ...

Страница 2: ......

Страница 3: ...components 57 3 3 3 Inlets and outlets 58 3 3 4 Meters and sensors 59 3 3 5 System pump 60 3 3 6 Air trap 61 3 3 7 Valves 65 3 4 Optional components 72 3 5 Flowchart 77 3 6 UNICORN control system 81 4 Installation 82 4 1 Site requirements 84 4 2 Transport 86 4 3 Unpack ÄKTAprocess 88 4 4 ÄKTAprocess Setup 89 4 4 1 Assembly of ÄKTAprocess 94 4 4 2 Setup of control system and network 98 4 4 3 Connec...

Страница 4: ...neral procedure for CIP and sanitization 144 6 3 Storage 146 6 4 Disassembly and assembly 148 6 5 Calibration of pH probe 151 6 6 Repair and calibration 152 6 6 1 Pump calibration 153 6 6 2 Air trap calibration 156 6 6 3 Component replacement 157 7 Troubleshooting 163 8 Reference information 164 8 1 Specifications 167 8 2 Chemical resistance 169 8 3 Gradient performance 171 8 4 Decontamination rep...

Страница 5: ...ces regula tory information intended use of ÄKTAprocess and lists of associated documentation In this chapter See page Section 6 1 1 About this manual 7 1 2 Important user information 10 1 3 Regulatory information 14 1 4 Associated documentation ÄKTAprocess Operating Instructions 29 0252 49 AA 5 1 Introduction ...

Страница 6: ...system configuration for your system is described in the General Specification and on the system label Detailed information regarding columns media and buffer tanks is not covered Typographical conventions Software items are identified in the text by bold italic text A colon separates menu levels thus File Open refers to the Open command in the File menu Hardware items are identified in the text b...

Страница 7: ...se damage to the equipment Intended use of ÄKTAprocess ÄKTAprocess is a low pressure automated liquid chromatography system intended for the precision transportation of fluids to and from chromatography columns of varying sizes The system is intended for process scale up and large scale pharmaceutical manufacturing ÄKTAprocess is not suitable for operation in a potentially explosive atmosphere or ...

Страница 8: ...ty 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 ...

Страница 9: ...on 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 ÄKTAprocess Operating Instructions 29 0252 49 AA 9 1 Introduction 1 2 Important user information ...

Страница 10: ...4 Uppsala Sweden See EC Declaration of Conformity Place and date of declaration See EC Declaration of Conformity Identity of person authorized to sign DoC 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 Title Directive Machinery Directive MD 2...

Страница 11: ... harmonized with 2006 42 EC Safety of machinery General principles for design Risk assessment and risk reduction EN ISO 12100 Additionalregulatorycompliance The table below lists additional regulatory requirements that are fulfilled by ÄKTAprocess Notes Description Requirement Applicable for systems with steel piping All steel piping welds in cluding contact welds ASME BPE Applicable for polymeric...

Страница 12: ...ISO 15607 15609 1 15614 1 5817 6520 3834 2 Environmental conformity ÄKTAprocess complies with the following environmental regulations Title Regulation Restriction of Hazardous Substances RoHS Directive 2011 65 EU Waste Electrical and Electronic Equipment WEEE Directive 2002 96 EC Registration Evaluation Authorization and restriction of CHemicals REACH Regulation EC No 1907 2006 Administration on t...

Страница 13: ...d from GE Healthcare except for alterations described in the user documentation UL conformity The system is listed according to UL508a A UL inspection report is provided in the documentation package Regulatory compliance of connected equipment Any equipment connected to ÄKTAprocess should meet the safety requirements of EN 61010 1 IEC61010 1 orrelevantharmonizedstandards WithinEU connectedequipmen...

Страница 14: ...the entire process flow all components and instruments and the control system P ID Piping and Instrument Diagram Technical data for the system GS General Specification Physical layout Provides all dimensional data AD Assembly Drawing Description of process related compo nents including wetted materials and specifications EQL Equipment List UNICORN function description FS Functional Specification E...

Страница 15: ...ions on how to administerUNICORN work withmethods perform runs and evaluate results The Online help contains dialog descriptions for UNICORN The Online help is accessed from the Help menu UNICORN manual package Component documentation Documentation for components produced both by GE Healthcare and by a third party are if existent also included in the document package ÄKTAprocess Operating Instruct...

Страница 16: ...aintaining ÄKTAprocess all users must read and understand the entire contents of this chapter to become aware of the hazards in volved Failure to do this may cause human injury or death or damage to the equipment In this chapter See page Section 17 2 1 Safety precautions 30 2 2 Labels 34 2 3 Emergency procedures 38 2 4 Recycling information 39 2 5 Declaration of Hazardous Substances DoHS 16 ÄKTApr...

Страница 17: ...for any risks due to the process or pro cess environment Evaluate the effects the use of ÄKTAprocess and the operational processes may have on the classification of the hazardous area The process might cause the area to increase or the zone classification to change Implement the risk reduction measures needed including use of personal protection equipment WARNING The customer must make sure that a...

Страница 18: ...ng the equipment damage caused by splashing liquid onto it WARNING Only personnel authorized by GE Healthcare may open the cabinet doors There is high voltage inside the cabinet that can cause human injury or death WARNING The electric cabinet doors may only be opened when ÄKTAprocess is taken out of operation and subject to LOCK OUT TAG OUT Flammable liquids and explosive environment WARNING Flam...

Страница 19: ...gloves resistant to the substances used Follow local and or national regulations for safe operation and maintenance of ÄKTAprocess WARNING Personal Protective Equipment PPE Whenever packing unpack ing transporting or moving the system wear protective foot wear preferably with steel lining WARNING High pressure ÄKTAprocess operates under high pressure Wear protective glasses and other required Pers...

Страница 20: ...RNING Move transport crates Make sure that the forklift has capacity to safely lift the crate weight Make sure that the crate is properly balanced so that it will not accidentally tip when moved WARNING The system is not fitted with lifting eye bolts or other devices for lifting with telphers or similar equipment The system should only be lifted using the lower part of the frame WARNING Heavy obje...

Страница 21: ...ker The power switch and the circuit breaker must always be easy to access WARNING If the system is operated from a remote controlling computer the operator must always make sure that no one is present and ex posed when the system is started and that no one enters the risk area around the system while it is operating CAUTION The wheels of ÄKTAprocess should be locked during normal use The wheels s...

Страница 22: ... off 2 All power cords to ÄKTAprocess are disconnected 3 All air supply lines to ÄKTAprocess are disconnected 4 All process lines to ÄKTAprocess are disconnected 5 All Ethernet cables to ÄKTAprocess are disconnected CAUTION Make sure that the common waste outlet is Never exposed to back pressure Connected to piping with at least the same diameter as the common waste outlet piping Connected to pipi...

Страница 23: ...k cable with encased RJ45 connectors to protect from liquids Do not replace this cable with an unprotected cable CAUTION To prevent bacterial growth ÄKTAprocess may be partly filled with denaturated alcohol 18 C2H5OH ethanol 2 C3H7OH iso propanol and 80 H2O water at delivery The denatured alcohol mixture can be hazardous to humans if consumed Flush out the denaturated alcohol before assembling tes...

Страница 24: ...nly CAUTION Do not use an Uninterruptible Power Supply UPS outside the range 100 to 240 V For UL classified systems do not use a UPS supply exceeding 120 V CAUTION Connection of an Uninterruptible Power Supply UPS shall only be performed by authorized personnel to avoid mismatching or con nection errors Contact your local GE Healthcare representative for more information Sample pump WARNING Always...

Страница 25: ...m the system It must not be connected directly to mains power CAUTION The handles on the sample pump trolley must not be used for lifting System operation WARNING Safe distance Always maintain a safe distance from ÄKTAprocess during drainage or other activities that may involve splashing WARNING Cabinet doors During operation all doors must always be closed and locked ÄKTAprocess Operating Instruc...

Страница 26: ...KTAprocess outside these limits may damage equipment and bodily harm or death may occur WARNING Power failure During a power failure or if the EMERGENCY STOP button is pressed ÄKTAprocess may remain pressurized Opening a line or vessel at this point could result in the release of potentially hazardous process or cleaning fluid and cause bodily harm When recovering from a power failure or emergency...

Страница 27: ... use to prevent the piping system to leak or break WARNING Alarms signals Make sure to change back to the original alarm level after UNICORN alarm buzzer test CAUTION If an external Uninterruptible Power Supply UPS is used this unit must be powered before any other equipment CAUTION To safely operate ÄKTAprocess knowledge of how to use UNICORN is required Refer to UNICORN user documentation as req...

Страница 28: ...ocess make sure that it is empty and depressurized it is disconnected from process feed electrical power and pneumatic supply it is prevented from accidentally becoming re energized during maintenance it is clearly tagged as taken out of operation all process wetted areas are clean and decontaminated WARNING Only personnel authorized by GE Healthcare may perform service installation and maintenanc...

Страница 29: ...CIP WARNING To avoid injury when servicing the valves on 1 systems make sure that no body parts are caught when turning the valve assemblies CAUTION Do not climb on any parts of ÄKTAprocess except where clearly allowed Follow local regulations and make sure that equipment is properly secured when inspecting ÄKTAprocess at high level CAUTION Decontaminate before service Before performing any servic...

Страница 30: ... Year of manufacture Serial number Pneumatic supply Max system pressure temperature Overall protection class 6 bar g 40 C 3 bar g 60 C Supply voltage 1Φ 100 120 200 208 230 or 240 VAC IP 55 Frequency 50 60 Hz Max power consumption 1500 VA Protection class IP 56 NEMA 4X GE Healthcare Bio Sciences AB Björkgatan 30 S 751 84 UPPSALA Sweden N3732 Cabinet 10 20 ÄKTAprocess ÄKTAprocess The system label i...

Страница 31: ...rements for electromagnetic compliance EMC in Australia and New Zealand System serial number Serial number Manufacturing year Year of manufacture Max system pressure at temperature Max system pres sure temperature Pneumatic supply pressure requirement Pneumatic supply Overall protection class Ingress protection according to IEC 60529 This cover all components of the system except the electric cabi...

Страница 32: ... emergency stop button is red See Section 2 3 Emergency procedures on page 34 for further information regarding the emergency stop WARNING High voltage inside cabinet Authorized personnel only For continued protection against fire only replace fuses with the same type and rating For continued protection against fire replace only with same type and rating of fuse High voltage inside cabinet Authori...

Страница 33: ... Brown 1 P White 2 N Green or Yellow green Yellow green Protective Earth Make sure that authorized personnel perform electrical connections and use appropriate power supply plug Attention cleaning only when USB cover is closed Note This label is located beside the USB port on the side panel of the monitor Attention cleaning only when USB cover is closed C0035304 01 ÄKTAprocess Operating Instructio...

Страница 34: ...er to the cabinet WARNING Power failure During a power failure or if the EMERGENCY STOP button is pressed ÄKTAprocess may remain pressurized Opening a line or vessel at this point could result in the release of potentially hazardous process or cleaning fluid and cause bodily harm When recovering from a power failure or emergency shutdown make sure all lines and vessels are depressurized before ope...

Страница 35: ...ific order for details see Valve shutdown order below If required also switch off the mains power supply using the SYSTEM POWER SWITCH B disconnect the power cord or switch off the fixed power supply circuit breaker 2 Power to the entire system including the computer is lost Data and run status may be lost All valves will shut immediately and not in sequence ÄKTAprocess Operating Instructions 29 0...

Страница 36: ...N will display text saying that communication has been broken and that no data has been recovered When power returns to normal the system will be in End state i e it will not resume the run The UNICORN interface control unit CU 960 has capabilities to store real time data during short disconnection from the computer Data stored on the CU 960 can be up loaded to the computer once communication to t...

Страница 37: ...tdown or power failure Action Step Make sure that the condition that caused the power failure or emergency stop is corrected 1 2 Reset the EMERGENCY STOP button by turning it clockwise Press the Continue button in UNICORN 3 ÄKTAprocess Operating Instructions 29 0252 49 AA 37 2 Safety instructions 2 3 Emergency procedures ...

Страница 38: ...cled according to national and local environmental regulations Recycling of hazardous substances ÄKTAprocess contains hazardous substances Detailed information is available from your GE Healthcare representative Disposal of electrical components Waste electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized r...

Страница 39: ...or mutate under 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 defined in the product manual and...

Страница 40: ...imit Meaning Value 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 O 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 T11363 2006 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 2...

Страница 41: ... 0 0 0 0 X ÄKTAprocess 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 ÄKTAprocess Operating Instructions 29 0252 49 AA 41 2 Safety instructions 2 5 Declaration of Hazardous Substances DoHS ...

Страница 42: ... components including the UNICORN control system In this chapter See page Section 43 3 1 Configurations 44 3 2 Illustrations of ÄKTAprocess 53 3 3 Standard components 65 3 4 Optional components 72 3 5 Flowchart 77 3 6 UNICORN control system 42 ÄKTAprocess Operating Instructions 29 0252 49 AA 3 System description ...

Страница 43: ...d in Section 3 6 UNICORN control system on page 77 The product documentation package includes the Software Configuration De scription which describes all functions of the control software in detail Tubing and cabinet ÄKTAprocess can be delivered with tubing dimensions from 6 mm to 1 and with a cab inet type of Cabinet 10 or Cabinet 30 The differences between the cabinet types are specified in Cabi...

Страница 44: ...ttery limit appears in the tables that explain the illustrations of ÄKTAprocess Battery limit is used to indicate a delimitation point between ÄKTAprocess and the cus tomer process equipment Battery limits denote the points where functional responsibil ity is handed over from the plant to the instrument or vice versa 44 ÄKTAprocess Operating Instructions 29 0252 49 AA 3 System description 3 2 Illu...

Страница 45: ...nt view The illustration below shows a front view of the standard configuration of ÄKTAprocess 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 ÄKTAprocess Operating Instructions 29 0252 49 AA 45 3 System description 3 2 Illustrations of ÄKTAprocess ...

Страница 46: ...on waste outlet 7 Swiveling wheel with brake 4 8 Common waste collection cup 9 Pre column pressure meter 10 Skid maneuvering handle 2 11 Air trap 12 Operator console with keyboard and monitor 13 Indicator lamp ALARM 14 Indicator lamp RUN PAUSE 15 Indicator lamp POWER 16 46 ÄKTAprocess Operating Instructions 29 0252 49 AA 3 System description 3 2 Illustrations of ÄKTAprocess ...

Страница 47: ...on rear view The illustration below shows a rear view of the standard configuration of ÄKTAprocess 17 18 19 20 22 23 24 25 26 21 ÄKTAprocess Operating Instructions 29 0252 49 AA 47 3 System description 3 2 Illustrations of ÄKTAprocess ...

Страница 48: ... STOP 19 Pressure meter 20 Pre column conductivity meter 21 System pump A 22 Moveable air sensor 23 Battery limit System inlets 2 24 Post column conductivity meter 25 System label 26 48 ÄKTAprocess Operating Instructions 29 0252 49 AA 3 System description 3 2 Illustrations of ÄKTAprocess ...

Страница 49: ...view The illustration below shows a front view of an example of ÄKTAprocess with all optional components 27 28 29 30 31 32 33 ÄKTAprocess Operating Instructions 29 0252 49 AA 49 3 System description 3 2 Illustrations of ÄKTAprocess ...

Страница 50: ...lumn 2 connections 2 28 Battery limit CIP AxiChrom valves 29 Pre column pH probe calibration cup 30 Pre column pH probe 31 Sample pump inlet 32 In line filter 33 50 ÄKTAprocess Operating Instructions 29 0252 49 AA 3 System description 3 2 Illustrations of ÄKTAprocess ...

Страница 51: ...r view The illustration below shows a rear view of an example of ÄKTAprocess with all optional components 34 35 36 37 38 39 ÄKTAprocess Operating Instructions 29 0252 49 AA 51 3 System description 3 2 Illustrations of ÄKTAprocess ...

Страница 52: ...ion 2 34 Pressure control valve 35 Flow meter 36 System pump B 37 Battery limit Buffer B inlets 6 38 Battery limit Buffer A inlets 10 39 52 ÄKTAprocess Operating Instructions 29 0252 49 AA 3 System description 3 2 Illustrations of ÄKTAprocess ...

Страница 53: ...ess In this section See page Section 54 3 3 1 Structural components 55 3 3 2 Control system components 57 3 3 3 Inlets and outlets 58 3 3 4 Meters and sensors 59 3 3 5 System pump 60 3 3 6 Air trap 61 3 3 7 Valves ÄKTAprocess Operating Instructions 29 0252 49 AA 53 3 System description 3 3 Standard components ...

Страница 54: ...he structure is designed for handling in a production environment and to be easy to move and keep clean The steel structure protects all installed components while still allowing easy access The structure occupies a small box shaped space that makes it easy to fit into any location in the production facility 54 ÄKTAprocess Operating Instructions 29 0252 49 AA 3 System description 3 3 Standard comp...

Страница 55: ...system on page77 for information on the UNICORN control system Control unit A CU 960 control unit is the controlling interface between UNICORN and the components of ÄKTAprocess The CU 960 control unit is located inside the cabinet Computer The computer is built into the cabinet and fully protected from the outside environment User console The display and input equipment is ergonomically designed f...

Страница 56: ...side of the electrical cabinet as shown in the illustration below For information on where to connect the PROFIBUS signal cable to the AxiChrom Master see the AxiChrom User Manual 1 2 3 4 5 Function Part USB connection port 1 Ethernet connection port 2 Customer I O connection 3 PROFIBUS connection 4 UPS Power 5 56 ÄKTAprocess Operating Instructions 29 0252 49 AA 3 System description 3 3 Standard c...

Страница 57: ...2 ÄKTAprocess has a moveable air sensor that may be connected to any inlet For standard ÄKTAprocess configurations the pressure on the inlets should be in the range 0 to 0 2 bar The outlets can handle backpressure up to 1 bar Drains All drains from ÄKTAprocess are collected to a single drain outlet The drains are first collected in an open cup to ensure that no back pressure is applied on any part...

Страница 58: ... sensors that measure pressure flow con ductivity Cond pH air temperature and UV Measurement of these parameters enables basic isocratic operation and the air sensor before the column also makes sure that no air enters the column during processing Flow meter measurement principle The measuring principle of the flow meter is based on the controlled generation of Coriolis forces Refer to the flow me...

Страница 59: ...the user Pump stroke frequency The pump stroke frequency is controlled by the flow that is set in the UNICORN control software Safety monitoring The system is protected from exceeding the high pressure limit by the electronic module ALP 900 an air level and pressure monitoring system that is situated inside the cabinet The ALP 900 monitors 1 The pressure in each pressure sensor 2 The pressure diff...

Страница 60: ...ensors must be re calibrated if the LED indicator displays a red light while the liquid level is still far from the low or high level markers It is recommended that after a power down a calibration of the level sensors should always be performed See Section6 6 2 Air trap calibration on page153 Note When the air trap is filled with liquid that foams easily for example liquids containing detergents ...

Страница 61: ...on 1 systems make sure that no body parts are caught when turning the valve assemblies Valve LED indicator lights The valve LED indicator lights are illustrated below CLOSED ERROR OPEN POWER FAULT Description when applicable Color Label Steady light Actuator in closed position Orange CLOSED Steady light Programming sensor or internal error Red ERROR Steady light Actuator in open position Yellow OP...

Страница 62: ...ine Air trap valves Bypass Filter valves Bypass_Both Column valves Inlet valves should always be closed when not in use This is essential to ensure gradient accuracy and to prevent buffers from mixing Note Air trap valves The air trap valve blocks are directly connected either to the optional filter valve blocks or to tubing going to the pre column air sensor in order to minimize the dead volume t...

Страница 63: ...en running Out_through_drain unless the system has a flow meter before the air trap However it is possible to use Flow for short periods of time even if the system is not equipped with a flow meter Note If the system is set for max flow when Fill is used the air trap may not be able to close quickly enough and in that case it will overflow Reduce the flow to avoid this Note The UNICORN instruction...

Страница 64: ...et valves the corresponding sample connection valve will also open The sample connection valves cannot be controlled independently by the operator The alarm for the sample inlet valves must be disabled if the sample pump is disconnected See Section5 1 5 Final checks on page123 for UNICORN settings Note Column valves The column valve sets column 1 and the optional column 2 each consist of six valve...

Страница 65: ...be provided with a second system pump The addition of a second system pump enables ÄKTAprocess to operate as a gradient system The B pump can be provided with up to six individually controlled inlets If the System pump B option is selected an extra flow meter can also be provided to enable the individual pump flows as well as the total system flow to be measured The B pump type is identical to the...

Страница 66: ...e two optional inlets feeding the sample pump The sample pump is also provided with an extra pressure meter that protects the system against over pressure Extra pressure meter An extra pressure meter can be installed after the column to accurately measure the pressure drop over the column Extra pH meter An extra pH meter can be installed before the column on a gradient system to enable the gradien...

Страница 67: ...h_drain HV 301 XV 027 XV 072 Drain No flow The Drain valve position is used for example when the filter housing is emptied before replacing the filter The pump s must be set to 0 0 l h when the Drain valve position is used The UNICORN instruction ManFlow must be used when running Out_through_drain unless the system has a flow meter before the air trap However it is possible to use Flow for short p...

Страница 68: ...e and in cludes two additional manual valves for air evacuation as illustrated below 4 1 2 3 Function Part Manual valve HV 301 1 Outlet to manual valve HV 303 2 Capsule filter housing 3 Outlet to manual valve HV 302 4 The layout of the capsule filter valves is illustrated in the following diagram 68 ÄKTAprocess Operating Instructions 29 0252 49 AA 3 System description 3 4 Optional components ...

Страница 69: ...filter housing is emptied before replacing the filter The pump s must be set to 0 0 l h when the Drain valve position is used The UNICORN instruction ManFlow must be used when running Out_through_drain unless the system has a flow meter before the air trap However it is possible to use Flow for short periods of time even if the system is not equipped with a flow meter Note ÄKTAprocess Operating In...

Страница 70: ... control valve option allows the pressure on the inlets to be regulated and the flow through the system via individual system pumps to be controlled ALP2 PCV safety monitoring If ÄKTAprocess is optionally configured to include a pressure control valve or valves the system will also be equipped with an ALP2 air level and pressure monitoring system The ALP2 unit protects against exceeding maximum op...

Страница 71: ...ed can both be analog process readings digital status and handshake signals The Anybus X gateway is located inside the electrical cabinet The interface to the gateway is PROFIBUS Slave through a M12 connector in the bottom of the electrical cabinet The Anybus X gateway copies I O data in both directions thus enabling data exchange between two optically isolated PROFIBUS networks The Anybus X gatew...

Страница 72: ... 038 XV 042 C2T C2B CE TE 102 AE 121 PT 113 AE 131 P1 P3 P5 P7 P9 P10 P8 P6 P4 P2 XV 051 XV 083 XV 084 XV 081 XV 082 BC2 BC1 BC3 BC4 BC5 XV 022 XV 052 XV 031 XV 033 XV 034 XV 032 XV 036 C1T C1B XV 002 XV 035 pH AE 122 M1 M2 P 202 XV 018 XV 017 XV 028 XV 019 XV 012 014 016 P PT 114 XV 003 005 007 009 XV 004 006 008 010 XV 053 XV 060 PCV 341 PCV 342 PT 116 P P PT 115 XV 025 XV 027 XV 072 XV 026 72 Ä...

Страница 73: ... HV 302 Black represents standard components Red represents optional components Note Process components The following table lists the process components that are shown in the flow chart Note Function qty Tag Outlets 1 2 Optional Outlets 3 to 10 Buffer A inlets A1 A2 Optional Buffer A inlets A3 to A10 Air trap AT 221 Part of system pump B option Buffer B inlets B1 to B6 Column 1 top connection C1T ...

Страница 74: ... A Option System pump B P 201 B Option Sample pump P 202 Option Pressure control valve A inlets PCV 341 Option Pressure control valve B inlets PCV 342 Common waste W Buffer A inlet valves XV 001 XV 002 Optional Buffer A inlet valves XV 003 to XV 010 Part of system pump B option Buffer B inlet valves XV 011 to XV 016 Part of sample pump option Sample connection valve XV 017 Part of sample pump opti...

Страница 75: ...ion Column 2 top inlet valve XV 037 Part of column 2 option Column 2 bottom inlet valve XV 038 Part of column 2 option Column 2 top valve XV 039 Part of column 2 option Column 2 bottom valve XV 040 Part of column 2 option Column 2 top outlet valve XV 041 Part of column 2 option Column 2 bottom outlet valve XV 042 Outlet valves XV 051 XV 052 Optional Outlet valves XV 053 to XV 060 Air trap drain va...

Страница 76: ... control also includes a temperature meter Post column conductivity meter CE TE 102 Measures the total system flow System flow meter FT 141 Air trap high level meter LEH 167 Air trap low level meter LEL 166 Option Pre filter pressure meter PT 111 Guards the column from over pressure detects clogged column Pre column pressure meter PT 112 Part of sample pump option Sample pump pressure meter PT 114...

Страница 77: ...le for designing methods which conform to standard operating procedures and Good Manufacturing Practice procedures UNICORN is technically compatible with all relevant sections of FDA 21 CFR Part 11 A part 11 system assessment checklist is available on request through the local GE Healthcare representative Prerequisite knowledge At least basic knowledge of UNICORN is required to operate ÄKTAprocess...

Страница 78: ... a process Workflow The table below outlines the general workflow for using UNICORN for automatic control Action Step Create a method for the selected system using the UNICORN software It is possible to use an existing method or modify an existing method to meet your run objectives 1 Start the run using the method you created 2 Monitor the run s progress using the System Control module All of the ...

Страница 79: ...able below describes the meaning of the indicators on the system Function Color Label Image Power is on Green POWER POWER RUN PAUSE ALARM Flashing UNICORN starting up Steady UNICORN ready UNICORN method is active Flashing UNICORN in state Pause Steady UNICORN in state Run Yellow RUN PAUSE System alarm Check UNICORN for detailed information Red ALARM Warnings Warnings are generated to warn operatin...

Страница 80: ...ions The system indicator lights will also indicate alarms Alarm test The alarm buzzer can be tested from the control system using the buzzer test function Alarms BuzzerTest To test a specific component alarm it is possible to lower the alarm limit for the compo nent below the current process value Reset alarms The alarm is reset through the control system by acknowledging the alarm message or by ...

Страница 81: ...nderstand all contents of the corresponding section s in the Safety instructions chapter as listed below General precautions on page 17 Personal protection on page 19 Installing and moving on page 20 Power supply on page 23 In this chapter This chapter contains the following sections See page Section 82 4 1 Site requirements 84 4 2 Transport 86 4 3 Unpack ÄKTAprocess 88 4 4 ÄKTAprocess Setup 105 4...

Страница 82: ...bient environment The following should be avoided Direct sunlight Strong magnetic or electric fields Vibrations Corrosive gas Dust Temperatures outside recommended operating ranges For ambient environment temperature range see Section 8 1 Specifications on page 164 Electrical power Refer to Section4 5 Power supply on page105 and Section8 1 Specifications on page164 for power voltage and phase requ...

Страница 83: ...ot obstruct processing Refer to Section8 1 Specifications on page164 regarding media supply and delivery re quirements Computer An external computer is not required ÄKTAprocess is provided with a built in industrial computer ÄKTAprocess Operating Instructions 29 0252 49 AA 83 4 Installation 4 1 Site requirements ...

Страница 84: ...nsport Note The crate dimensions are shown below Cabinet 10 111 w x 207 l x 173 h cm Cabinet 30 131 w x 268 l x 193 h cm Moving when unpacked WARNING Heavy object Because of the significant weight of ÄKTAprocess great care must be taken not to cause squeezing or crushing injuries during movement At least two but preferably three or more persons are recommended when moving the unit NOTICE Operator ...

Страница 85: ... the floor quality does not allow rolling ÄKTAprocess on its own wheels it can be moved with a pallet jack or forklift For minimum door aperture size refer to the Assembly Drawing AD in the documen tation package ÄKTAprocess Operating Instructions 29 0252 49 AA 85 4 Installation 4 2 Transport ...

Страница 86: ...process into the intended process context Tools required 13 mm wrench or ratchet wrench with 13 mm socket Electrical screwdriver with Phillips no 2 bit Knife Wooden lever enclosed in crate Visual inspection Check that all equipment is enclosed in the crate according to the packing list the equipment for any apparent damage and document carefully if found If any equipment is missing or damage is fo...

Страница 87: ... black paint 1 Loosen bolts brackets holding the equipment to the crate bottom 2 Roll the system out of the crate using the ramp that is found inside the crate WARNING Heavy object Because of the significant weight of ÄKTAprocess great care must be taken not to cause squeezing or crushing injuries during movement At least two but preferably three or more persons are recommended when moving the uni...

Страница 88: ...nsumed Flush out the denaturated alcohol before assembling testing or integrating ÄKTAprocess into the intended process context In this section See page Section 89 4 4 1 Assembly of ÄKTAprocess 94 4 4 2 Setup of control system and network 98 4 4 3 Connect compressed air supply 99 4 4 4 Guidelines for connections 100 4 4 5 Connect sample pump 102 4 4 6 Connect a column 88 ÄKTAprocess Operating Inst...

Страница 89: ...ioned with the top part of the handle fully inserted so that the bushing is able to ab sorb the weight of the console when the console arm is fully extend ed The console may fall and cause damage and or injury if the console arm is not properly positioned CAUTION When handling the operator console make sure that no body parts are caught between the sections of the console arm The operator console ...

Страница 90: ...g with the system cabinet Instructions for mounting the console are given below Mount operator console on left side Follow the instruction below to mount the operator console on the left side Action Step Open the box and remove the assembled console Do not remove the polystyrene foam protection this can be used for lifting 1 Carefully slide the console arm over the left system handle B until it is...

Страница 91: ...crew cap D should always be in place when the USB connector is not in use Fix the cables neatly together with the existing cables underneaththe cabinet using cable ties as illustrated below 5 ÄKTAprocess Operating Instructions 29 0252 49 AA 91 4 Installation 4 4 ÄKTAprocess Setup 4 4 1 Assembly of ÄKTAprocess ...

Страница 92: ...own below viewed from the front and back 6 Mount the operator console on right side The operator console is mounted on top of the right system handle as described above with the following differences Place the operator console arm carefully over the right system handle instead of the left 92 ÄKTAprocess Operating Instructions 29 0252 49 AA 4 Installation 4 4 ÄKTAprocess Setup 4 4 1 Assembly of ÄKT...

Страница 93: ...illustrated below NOTICE Operator console Do not use the operator console to push or drag the system Do not lean on the console The console arm is only designed to support the weight of the operator console ÄKTAprocess Operating Instructions 29 0252 49 AA 93 4 Installation 4 4 ÄKTAprocess Setup 4 4 1 Assembly of ÄKTAprocess ...

Страница 94: ...t from liquids Do not replace this cable with an unprotected cable Connecting an external computer Follow the instruction below to connect an external computer to the system Action Step Connect the external computer to the socket marked ETHERNET IN under neath the bottom panel of the electronics cabinet 1 Remove the computer s external network cable from the corresponding Ethernet network socket o...

Страница 95: ...ol and communication The connection is similar to a regular network connection using the external ETHERNET IN socket located on the bottom panel of the cabinet The Ethernet cable connecting the external computer and the system computer must be a crossover cable specifically configured for peer to peer type con nections To make sure that the protection of the cabinet is not compromised it is a reco...

Страница 96: ...N Administration and Technical Manual and the UNICORN OPC manual Customer I O connections Customer I O connections are located on the communications panel on the underside of the electrical cabinet There are many different applications for the Customer I O connections Refer to the product documentation package or contact your local GE Healthcare representative for more detailed technical informati...

Страница 97: ... the Out Common is connected to a positive voltage For sinking output the Out Common is connected to the Common used by the customer s appli cation Pins 1 and 9 provide a closing relay contact max 24 V 0 10 A for an alarm module e g a warning light a buzzer or similar unit The external alarm will be triggered when the internal buzzer is activated Pins 11 and 12 are used to receive an On signal fro...

Страница 98: ...nical data on page 164 Connect compressed air supply to ÄKTAprocess Action Step Connect the compressed air as shown in the image above 1 Make sure that the supply pressure to the cabinet is between 5 5 and 7 bar g The manometer is set to 6 bar g at the factory and shall not be changed 2 98 ÄKTAprocess Operating Instructions 29 0252 49 AA 4 Installation 4 4 ÄKTAprocess Setup 4 4 3 Connect compresse...

Страница 99: ...fer to Section8 1 Specifi cations on page164 and the technical information in the system specific documen tation package Keep the tubing lengths as short as possible to minimize hold up volume in the sys tem Route the tubing to minimize the risk of tripping when operating the instrument and connected equipment If any tubing or hose should be violently pulled by an accidental tripping check for dam...

Страница 100: ...ion Step Position the sample pump trolley beside the system Note The best position is adjacent to the right hand corner of the system when facing the operator console Make sure that the sample pump trolley is posi tioned so that it does not block the column valves and the emergency stop switch 1 Log out of UNICORN turn off the computer and shut down the system See Procedures after usage Note The s...

Страница 101: ... corresponding system cable marked E3 4 Connect the pressure sensor cable marked E8 to the corresponding system cable marked E7 Note The sample pump air supply hose ASi cable motor power cable pressure sensor cable and pump diaphragm switch cable are all tied together The corresponding cables on the system side are either T connectors or loose cable ends all protected by caps when not in use 5 Con...

Страница 102: ...ameter use ÄKTAprocess pumps to drive the adapter hydraulically Larger AxiChrom columns 300 mm diameter and above use an AxiChrom Master con nected to the ÄKTAprocess Profibus connector See respective AxiChrom column manuals for information on hose connections For more details regarding using AxiChrom with ÄKTAprocess refer to the AxiChrom user manual Preparations The air sensor alarm s before the...

Страница 103: ...bing to the bottom of the column at this time 1 Set the system column valves to the UpFlow position 2 Using the pump fill the system with an appropriate liquid for column instal lation 3 When the system including the tubing connected to the column bottom system valve is filled with liquid connect the other end of the tubing to the bottom of the column 4 Connect tubing between the top of the column...

Страница 104: ...fill the system with an appropriate liquid for column instal lation 4 When the system including the tubing connected to the column is filled with liquid stop the pump 5 Use the manual valves on the column to change from bypass to in line 6 Final considerations Once the column is connected the following should be taken into consideration Make sure to activate the system alarm s again after the fill...

Страница 105: ...fely installing electrical equipment Installation must comply with specifications regarding wire types conductor sizes plug branch circuit protection and disconnect devices Failure to do so may result in personal injury and or equipment damage WARNING All electrical installations must be performed by authorized personnel only Installation The system power cord is connected in one of the following ...

Страница 106: ...o system ground Ground impedance must conform to the requirements of national and local industrial safety regulations and or electrical codes If the earth leakage current exceeds 10 mA a high leakage current earth connection must be provided and confirmed before connecting power supply Refer to the product documentation package for information regarding the leakage current for your system The inte...

Страница 107: ...power supply or to a connector compatible with IEC 60309 2 Terminal label EU CE marking USA UL marking Function L 1 Black or brown Black Live Phase N 2 Blue or black White Neutral PE GND Yellow green Green or Yel low green Protective ground earth Live and neutral wire cross section area All live and neutral wiring must have a cross section area equal to or greater than the specification in this ta...

Страница 108: ...urrent for such an interrupter must be higher than the earth leakage current as stated in the Test protocol in the product documentation package ÄKTAprocess built according to UL is equipped with a ground fault protector to protect the UV monitor Built in circuit breakers The mains power supply to ÄKTAprocess and the pumps are equipped with circuit breakers inside the cabinet Refer to the system d...

Страница 109: ... computer LCD monitor and instruments in the electric cabinet More information Wiring diagrams for the system voltage power fuse requirements and the tripping current for the fixed power supply ground fault protector can be found in the system documentation package ÄKTAprocess Operating Instructions 29 0252 49 AA 109 4 Installation 4 5 Power supply ...

Страница 110: ...equired to safely operate ÄKTAprocess In this chapter This chapter contains the following sections See page Section 112 5 1 Prepare the system 124 5 2 Perform a run 127 5 3 Shut down the system and software 110 ÄKTAprocess Operating Instructions 29 0252 49 AA 5 Operation ...

Страница 111: ...m operation on page 25 WARNING Before operation all process connections and the piping system must be tested for leakage at maximum pressure for continued protection against injury risks due to fluid jets burst pipes or potentially explosive atmosphere NOTICE Only use chemicals that have been proven not to be harmful to the wetted parts of the unit Refer to Section 8 2 Chemical resistance on page ...

Страница 112: ...ns have been performed including Chapter 4 Installation on page 81 and Actions before operation in Section 6 1 User maintenance schedule on page 130 In this section See page Section 113 5 1 1 Start the system and software 115 5 1 2 Prepare system components 118 5 1 3 Priming and leakage test 121 5 1 4 Set pressure control valve parameters 123 5 1 5 Final checks 112 ÄKTAprocess Operating Instructio...

Страница 113: ...ocked 3 Switch on power to ÄKTAprocess by turning the SYSTEM POWER SWITCH to the ON position See Section3 2 Illustrations of ÄKTAprocess on page44 for location 4 After this sequence is completed the following occurs The built in computer is turned on The POWER indicator lamp flashes When communication with UNICORN software is established the POWER in dicator lamp will show a steady green light Not...

Страница 114: ...f you log on for the very first time select default and enter the password default Note For some UNICORN versions it is also possible to select the Use Windows Authentication checkbox and enter a network ID in the user name field Click OK 3 In the System Control module select System Connect 4 In the dialog shown select the appropriate system name and click OK The system name is specified during in...

Страница 115: ...use pH electrode degeneration When running methods using organic solvents it is recommended that the pH electrode is not inserted in the flow cell Note Action Step Unscrew the plastic fastening nut from the pH cell and remove the pH plug 1 Move the O ring from the pH plug to the electrode adapter 2 Remove the pH electrode adapter from its holder 3 If the electrode is not mounted in the adapter rem...

Страница 116: ...AutoZeroUV can be used to set the relative AU to zero The Monitors Wavelength instruction can be used to set wavelength s One to three wavelengths UV1 UV2 and UV3 can be set within the range 190 to 700 nm for UV 900 monitors The wavelength can be set to 215 260 280 default 405 or 546 nm for UVis 920 monitors by changing filters in the monitor The UNICORN instruction is used for method documentatio...

Страница 117: ...ty of the air sensors as outlined in the table below Make sure that the air sensors are filled with liquid before the alarms are en abled otherwise the alarm will immediately be triggered and cause the system to be set to Pause Note detects bubbles with diameter greater than Sensitivity set to 4 mm 34 μl High 7 mm 180 μl Medium default 16 mm 2 1 ml Low The default position for the movable air sens...

Страница 118: ...ere is any evi dence of leakage attend to the leak and then repeat the filling se quence Each pump must be tested separately if more than one is used Optional Gra dient pump B and or Sample pump in addition to the standard pump A Note Prepare for priming and leakage test Follow the instruction below to prepare ÄKTAprocess for priming and leakage test Action Step Check that the inlet and outlet tub...

Страница 119: ...appropriate inlet and outlet e g Valves InletA1 and Valves Outlet1 1 If a column is connected to the system check that the column is bypassed e g Valves Column Bypass_Both 2 Using the pressure sensor located closest to the inlet used check that the pressure alarm is set less than or equal to the maximum allowed system pressure 3 Furthermore the air sensor alarms before the column must be disabled ...

Страница 120: ...tem capacity and monitor the flow rate value in the UNICORN System Control module to verify that the pump s regulates down and the rate decreases smoothly 11 End the manual session using the END command in UNICORN so that the pump s stop and all valves close 12 The column connections can now be tested for leakage at a flow rate and pressure that is appropriate for the column absorbent Before putti...

Страница 121: ...tion Action Step Start with opening the flow path inlet needs to be pressurized 1 Switch the PCV 341 valve positioner to manual mode 2 Close the valve slowly until no flow is detected by FT 141 The valve can be operated manually through instruction PCV 341 valvepositioner 3 Open the valve slowly until flow is detected by FT 141 4 Close the valve slowly until no flow is detected by FT 141 The valve...

Страница 122: ...control valves must never be completely closed during a run The UNICORN control system will fully open the PCV when the system is in End mode When the system is in Run or Pause mode UNICORN will set the PCV to its Close_limit The Close_limit for the PCV must be entered in UNICORN according to the flow rate to be used If the Close_limit is set to 0 0 the PCV will close completely As the limit setti...

Страница 123: ...r the sample inlet valves must be disabled To avoid having to repeat this instruction the alarm should be disabled in the System Settings in UNICORN System Settings Alarms InletSam ple_Valves_Alarm Disable Do not forget to enable the alarm when the sample pump is connected again Check that the column connection complies with the requirements in the column instruction manual Check that the air sens...

Страница 124: ... Use ear protection whenever working close to the system in operation NOTICE Excessive temperatures may damage the equipment Do not run the system at higher temperatures than the specified maximum operation temperature as stated on the system label NOTICE Operator console Do not use the operator console to push or drag the system Do not lean on the console The console arm is only designed to suppo...

Страница 125: ...display the run progress of the method being executed To interrupt a method during a run you may use the Hold Pause or End icons in System Control A held or paused method run can be resumed by using the Continue icon See the instructions in the table below then If you want to click the Hold icon temporarily hold the method with current flow rate and valve positions sustained click the Pause icon t...

Страница 126: ...he top of the Control module window Result A confirmation dialog will open 1 Click OK in the confirmation dialog to end the run or click Cancel to continue the run Note In the dialog you can choose to save the partial results from the run Note If the run is part of a scouting run series you will be given the choice to end the entire scouting run If you do not end the scouting run then the next run...

Страница 127: ...NICORN Manager depending on the UNICORN version used 1 Shut down the computer from the Windows Start menu 2 When the computer screen has switched off turn off the SYSTEM POWER SWITCH Note Since the system power will be shut down the system cannot be operated from another workstation before the system is powered up again regardless if it is locked or unlocked at shutdown 3 Prepare the system for st...

Страница 128: ...rage 146 6 4 Disassembly and assembly 148 6 5 Calibration of pH probe 151 6 6 Repair and calibration Precautions WARNING Before attempting to perform any of the procedures described in this chapter you must read and understand all contents of the corresponding section s in the Safety instructions chapter as listed below General precautions on page 17 Personal protection on page 19 Power supply on ...

Страница 129: ...iping system must be tested for leakage at maximum pressure After assembly or maintenance Before operation or CIP CAUTION Decontaminate before service Before performing any service work on ÄKTAprocess make sure that the system has been properly decontaminated ÄKTAprocess Operating Instructions 29 0252 49 AA 129 6 Maintenance ...

Страница 130: ... probe on page 148 pH monitor Clean or replace the filter cartridge In line filter if present Check the function Alarms BuzzerTest Alarm buzzer Check the function by running some air through the system and verify that the alarm is triggered and that the system is set to Pause Note The movable air sensor is disabled in UNICORN by default and must be enabled to be tested Air sensor if present Note T...

Страница 131: ... as needed Action Component A preventive maintenance test procedure on all instruments sensors pumps and valves should be performed annually by trained and certified personnel Contact your local GE Healthcare representative Replace all gaskets O rings and valve diaphragms Complete system Inspect stainless steel systems for rust If needed passivate the steel by recirculating a solution of 5 phospho...

Страница 132: ... flow rate may deviate from the displayed It is recommended that the adjustment is per formed by a GE Healthcare service engineer Flow meter Prior to the adjustment it is very important to fill the system completely with liquid so that no air is trapped in the flow meter This is best achieved by applying a slight back pressure when the system is filled by using for example a relief valve on the ou...

Страница 133: ...epresentative To perform a valve calibration use the instruction Valves Calibrate_Valves XVxxx select the valve that is to be calibrated Only one valve can be selected and calibrated at a time Note During the calibration of the valve the connection to the valve is broken and an alarm is triggered To complete the calibration acknowledge the alarm in the Alarm box and then press Con tinue ÄKTAproces...

Страница 134: ...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 ÄKTAprocess WARNING For continued protection against injury risks due to fluid jets burst pipes or potentially explosive atmosphere the piping system must be tested for leakage at maximum pressure After assembly or mainten...

Страница 135: ...with the recommendations of the manufacturer In this section This section contains the following subsections See page Section 136 6 2 1 Important considerations for cleaning 138 6 2 2 Cleaning in place CIP 141 6 2 3 General procedure for CIP and sanitization ÄKTAprocess Operating Instructions 29 0252 49 AA 135 6 Maintenance 6 2 Cleaning ...

Страница 136: ...nance or service Recommended cleaning agents All componentscan be cleanedwith the most commonly used agents such as detergents ethanol weak acids sodium hydroxide and salt solutions Refer to Section 8 2 Chemical resistance on page 167 NOTICE Avoid sodium chloride solutions below pH 4 0 Rinse the system thoroughly with water immediately after it has been in contact with salt solutions Clean the UV ...

Страница 137: ...tside of ÄKTAprocess with a clean cloth Use a mild cleaning agent such as water followed by 70 ethanol Regular wiping and care of the equipment will help keep the surfaces free from corrosion It is not recommended to spray or splash liquids towards external surfaces of ÄKTAprocess ÄKTAprocess Operating Instructions 29 0252 49 AA 137 6 Maintenance 6 2 Cleaning 6 2 1 Important considerations for cle...

Страница 138: ... instruction refer to Section 6 2 3 General procedure for CIP and sanitization on page 141 CIP hook up During the CIP procedure the column can be replaced with a bypass manifold or spool piece Refer to the column instructions for column specific cleaning recommendations 138 ÄKTAprocess Operating Instructions 29 0252 49 AA 6 Maintenance 6 2 Cleaning 6 2 2 Cleaning in place CIP ...

Страница 139: ...P XV 001 A1 A3 A5 A7 A9 A10 A8 A6 A4 A2 B1 B3 B5 B6 B4 B2 P 201 A P 201 B FT 142 PT 111 CE TE 101 XV 011 013 015 XV 002 XV 012 014 016 XV 003 005 007 009 XV 004 006 008 010 XV 083 XV 084 XV 081 XV 082 CIP3 CIP1 CIP2 CIP4 CIP C 1 2 3 3 P PT 115 P PT 116 PCV 341 PCV 342 ÄKTAprocess Operating Instructions 29 0252 49 AA 139 6 Maintenance 6 2 Cleaning 6 2 2 Cleaning in place CIP ...

Страница 140: ...can be set up in UNICORN for regular cleaning and sanitizing of the system and connected components Refer to UNICORN Method manual for comprehensive instructions on how to create a sanitizing CIP method in UNICORN Extended cleaning performance If ÄKTAprocess has been heavily contaminated and the normal CIP procedure is not sufficient cleaning performance can be improved by Extending the CIP time p...

Страница 141: ... is removed perform the following actions Note 1 Spray the surface with 70 ethanol 2 Wipe off the surface by hand 3 Re mount the filter casing 4 Run the CIP method The column and medium should be cleaned separately and is therefore removed before system cleaning The pH electrode should be replaced with a pH CIP cap pH plug before system cleaning Refer to Install the pH electrode on page 115 To mak...

Страница 142: ...ubing from each system inlet then has to be moved manually between tanks filled with the different CIP solutions Note Column valves With the column removed connect the column manifold between the Column top and Column bottom system valves If the system does not have the CIP valves option connect tubing with sanitary fittings between the Column top and Column bottom system valves Note Outlets Conne...

Страница 143: ...be used as detectors The UNICORN method used for filling the system with 1 M sodium hydroxide can also be used for rinsing However the CIP inlet valve has to be changed in the method to CIP 2 water in this example Do not leave sodium hydroxide or other cleaning solutions in the system If the system is to be stored after the CIP Sanitization the same UNICORN method again with a changed CIP inlet CI...

Страница 144: ...ow is applied Contact your GE Healthcare repre sentative regarding purchase and installation of grounding kits NOTICE Fit protective caps on all electrical and optical connectors when not in use NOTICE When ÄKTAprocess is filled with a storage solution the temperature must be high enough to prevent freezing and low enough to prevent evaporation Short term storage The table below describes the proc...

Страница 145: ... term storage The table below describes the procedure for long term storage This procedure is appli cable for storage durations of longer than one month Action Step Perform the actions described for Short term storage above 1 Place ÄKTAprocess in a dust free environment with well controlled climate The temperature should be stable and in the range 4ºC to 25ºC The air humidity and air temperature d...

Страница 146: ...y only be opened when ÄKTAprocess is taken out of operation and subject to LOCK OUT TAG OUT WARNING LOCK OUT TAG OUT Before any maintenance or decommission ing work is performed on ÄKTAprocess make sure that it is empty and depressurized it is disconnected from process feed electrical power and pneumatic supply it is prevented from accidentally becoming re energized during maintenance it is clearl...

Страница 147: ...o remove any components from the system The operator panel This might be required for protection or space reasons if the system shall be moved The pH probe see Section 6 5 Calibration of pH probe on page 148 and Section 6 6 Repair and calibration on page 151 Other components Other than described in this chapter ÄKTAprocess is not designed to be disassembled or assembled by the user If the need for...

Страница 148: ...r calibration of the pH probe pH reference solution for low pH measuring point preferably pH 4 00 pH reference solution for high pH measuring point preferably pH 7 00 Clean cloth Clean water in spray bottle 148 ÄKTAprocess Operating Instructions 29 0252 49 AA 6 Maintenance 6 5 Calibration of pH probe ...

Страница 149: ...required pH range 1 Place the cup with the highest pH solution in the cup holder Insert the pH probe into the holder with the end submerged in the buffer Note Attach the cap to the pH flow cell to prevent foreign objects from entering the flow path 2 Select System Calibrate in UNICORN System Control module 3 Enter the pH value for the first buffer with the highest pH solution in the Reference valu...

Страница 150: ...r with the lowest pH solution in the Reference value 2 field wait for the value to stabilize and press Read value 2 8 Wait for response and if the electrode passed press Close Otherwise press Close refresh changethe pH electrode and repeat the calibrationprocedure 9 Remove the cup from the holder 10 Relocate the pH probe in the flow cell 11 150 ÄKTAprocess Operating Instructions 29 0252 49 AA 6 Ma...

Страница 151: ...red in this manual may not be calibrated or repaired by the user If any such components of ÄKTAprocess do not operate according to specifications contact your GE Healthcare representative WARNING Do not attempt to perform any actions not described in these documents Always contact your GE Healthcare representative for advice if such a need should arise In this section This section contains the fol...

Страница 152: ...ing to the system specifications and should never be changed by the user It is recommended to check the stroke length setting on a regular basis to make sure that it is set correctly To achieve maximum stroke length all knobs for all pumps shall be set to the outermost index The illustration below shows an example of a knob that is set to its outermost index 152 ÄKTAprocess Operating Instructions ...

Страница 153: ...alibrated as described below 2 By pumping in liquid using the Fill_Inline instruction for the air trap see Air trap valves on page 62 slowly increase the liquid level in the air trap Use the Fill instruction if the air trap doesn t fill due to a too low flow rate or pressure 3 Verify that the low level sensor displays a red light when the liquid level ap proaches the sensor 4 Verify that the low l...

Страница 154: ...Follow the instruction below to calibrate the air trap sensors manually Action Step Empty the air trap from liquid using the Drain instruction for the air trap see Air trap valves on page 62 1 Hold a tool made of iron e g a wrench close to the cross hairs on the side of the level sensor for a few seconds 5 sec until the green indicator light is flashing 2 Remove the iron tool The flashing will end...

Страница 155: ...described above To unlock the sensor hold the tool close to the sensors for more than 10 seconds once again until the green light goes off When the tool is removed the green light will come on again 6 Note If the surface of the sensors is touched by a hand the red LED indicators may come on The red lights will go off when the hand is removed and this will not affect the performance of the level se...

Страница 156: ... how to replace the filter Replacement of batteries The built in computer is equipped with a long life Lithium battery for BIOS functions Refer to the product documentation package for instructions concerning replacement and operational life 156 ÄKTAprocess Operating Instructions 29 0252 49 AA 6 Maintenance 6 6 Repair and calibration 6 6 3 Component replacement ...

Страница 157: ...tand all contents of the corresponding section s in the Safety instructions chapter as listed below General precautions on page 17 Personal protection on page 19 Power supply on page 23 Maintenance on page 28 System The table below describes problems that may occur with ÄKTAprocess together with possible corrective actions Possible cause corrective action Problem Component Make sure the system is ...

Страница 158: ...tify the air supply problem b Restart the run by pressing the Continue button Compressed air failure during a run The alarm No air supply to the sys tem is displayed and the system enters Pause mode Compressedair Perform a valve calibration If a Valve error is trig gered a valve calibration may restore the valve func tion For instructions on how to perform a valve calibra tion see Maintenance annu...

Страница 159: ...inlet con tainers Tubing from inlet container causes pressure or flow loss Reasons may be too long tubing too small in ternal diameter tube may have a narrow section or is partly plugged Malfunctioning valve at container battery limit Little or no flow Check that connected outlet is actually used Outlet containers are placed too high relative to the pump Tubing to outlet container causes pressure ...

Страница 160: ...l flow rate may deviate from the set flow rate if the running conditions change such as for example pressure ambient temperature or air content in the solutions It can also deviate if there is a build up of dirt in the flow meter Other reasons for unintended flow are siphoning through the system or too high inlet pressure The actual flow rate devi ates from the displayed flow rate or a flow rate i...

Страница 161: ...table below describes error symptoms that may occur with pressure measurements together with possible corrective actions Corrective action Possible cause Error symptom Check that there is sufficient supply of liquid Gas bubbles passing through or trapped in the pump Erratic flow noisy baseline signal irregular pressure trace Check all connections for leaks Flush through to clear blockage Blockage ...

Страница 162: ...valves Bad pump or valve action Incorrect or unstable reading Checkthetemperaturecompensation see separate manual Temperature compensation not properly set pH curve The table below describes error symptoms that may occur with pH measurements together with possible corrective actions Corrective action Possible cause Error symptom Check the cable connection The cable to the electrode not properly co...

Страница 163: ...red in many different ways To understand the specific configuration that applies to ÄKTAprocess please refer to the product documentation package supplied with the instrument In this chapter This chapter contains the following sections See page Section 164 8 1 Specifications 167 8 2 Chemical resistance 169 8 3 Gradient performance 171 8 4 Decontamination report 172 8 5 UNICORN method for system CI...

Страница 164: ...its Outlet back pressure 0 to 1 bar g Flammable liquids Not allowed Operation in EX rated environment Not allowed Refer to Cabinet type specific data on page 165 Electric power Pressure 5 5 to 7 bar Compressed air Airflow min 50 Nl min during normal operation System IP55 Ingress protection EN 60529 Cabinet IP56 NEMA 4X 72 dBA Noise level Horizontal 1º Floor inclination Up to 2000 m Altitude Temper...

Страница 165: ...age category II Transient level System type specific data The following table provides capacity and dimension information for the system Cabinet 30 Cabinet 10 Property 1 polypropylene or stainless steel tubing 6 or 10 mm polypropylene tubing 3 8 or 1 2 stainless steel tubing Tubing 2000 l h 180 l h 6 mm or 3 8 tubing 600 l h 10 mm or 1 2 tubing Max flow rate 825 kg 430 kg Weight approxi mately 220...

Страница 166: ... System volume The values presented in this table represents approximate hold up volumes for indicated sections of the system Values may vary between individual systems System tubing diameter Flow path section 1 10 mm to 1 2 6 mm to 3 8 2250 ml 550 ml 300 ml From the inlets to the column Air trap Filter and Column s bypassed 590 ml 47 ml 22 ml From the column to the UV cell 350 ml 33 ml 23 ml From...

Страница 167: ...conditions Make sure to use chemicals only under conditions where they are not flammable Refer to local and or national classifications of flammable liquids List of allowed chemicals Usage Max acc expos Max time cycle Concentration Chemical CIP 3000 h 3 h 25 Acetic acid UV cell test Unlimited 1 h 10 Acetone CIP 1000 h 1 h at temp 60 C pH 2 to 2 5 Citric acid Storage Unlimited 12 months 20 Ethanol ...

Страница 168: ...t temp 40 C 3 h at temp 60 C 12 months 1 M at pH 14 0 5 M 0 01 M at pH 12 Sodium hydroxide CIP 3000 h 3 h at temp 60 C 300 ppm Sodium hypochlorite CIP 3000 h 3 h 1 M or 20 Sodium hydrox ide ethanol Purification CIP 5000 h 5 h 8 M Urea CIP 3000 h 3 h at temp 60 C 1 to 6 STERIS CIP 100 0 5 HenkelP3 11 0 2 Micro 0 2 Terg a zyme 0 1 Tween 80 Cleaning solu tions 168 ÄKTAprocess Operating Instructions 2...

Страница 169: ...sing feedback loop technology with an accuracy better than 2 within the operating range see GS in the product documentation package The illustration below shows the programmed blue and the resulting red step gradients left and linear gradients right Parameters used System 1 system Gradient mode Feedback on flow Flow rate 500 l h Back pressure 3 bar ÄKTAprocess Operating Instructions 29 0252 49 AA ...

Страница 170: ...mp Gradient When the Gradient Mode is set to Conductivity Pump GradientRange 0 to 999 99 mS cm for inlet A and B Flow When the system is equipped with two flow meters the pump is regulated by feedback from the flow meter Conductivity Thepumpisregulatedbyfeedbackfromtheconduc tivity meter Off Pump GradientMode Defines if the valve goes back to the default position Bypass_Both or if it remains in po...

Страница 171: ...nation and delays in hand ling the equipment 5 Company Address Phone Fax number 6 Please complete the following sections 6 1 Equipment type 6 2 Serial number 6 3 Details of substances used on the inside outside of the equipment 6 3 1 Substance name s 6 3 2 Precautions to be taken in handling these substances 6 3 3 Action to be taken in the event of human contact 6 3 4 Cleaning fluid to be used if ...

Страница 172: ...t The UNICORN method must be changed accordingly so that it starts with the sample pump inlets Note Main 0 00 Base Time 0 00 Air_Alarm Disabled Disabled 0 00 Gradient 0 0 B 0 00 base 0 00 InletCIP InletCIP1 0 00 InletA InletA1 0 00 AirTrap Inline 0 00 Filter Inline 0 00 Column UpFlow 0 00 Outlet Outlet1 0 00 Flow 450 l hour 0 00 Block Fill_CIP_inlet Fill_CIP_inlet 0 00 Base SameAsMain 0 00 InletCI...

Страница 173: ...1 1 00 InletB InletB2 1 50 InletB InletB3 2 00 InletB InletB4 2 50 InletB InletB5 3 00 InletB InletB6 3 50 Gradient 0 0 B 0 00 base 3 50 InletB Closed 3 50 InletA InletA1 3 50 End_Block 0 00 Block Fill_air_trap Fill_air_trap 0 00 Base SameAsMain 0 00 AirTrap Bypass 1 00 AirTrap Out_through_drain 1 50 AirTrap Fill 2 00 AirTrap Inline 2 00 End_Block 0 00 Block Fill_filter_housing Fill_filter_housing...

Страница 174: ...pass_Both 1 00 Column Bypass_Under 1 50 Column DownFlow 2 00 Column Bypass_Over 2 50 Column UpFlow 2 50 End_Block 0 00 Block Fill_all_outlets Fill_all_outlets 0 00 Base SameAsMain 0 00 Outlet Outlet1 0 50 Outlet Outlet2 1 00 Outlet Outlet3 1 50 Outlet Outlet4 2 00 Outlet Outlet5 2 50 Outlet Outlet6 3 00 Outlet Outlet7 3 50 Outlet Outlet8 4 00 Outlet Outlet9 4 50 Outlet Outlet10 5 00 Outlet Outlet1...

Страница 175: ...ation package Your local GE Healthcare representative will also be able to suggest recommended spare parts and accessories Remaining aspects Regarding Training Service Method optimization Ordering information Other issues not covered by these Operating Instructions Please contact your local GE Healthcare representative for advice Contact information is found on the back cover of these Operating In...

Страница 176: ...171 Disassembly other compo nents 147 Disposal general instruc tions 38 Disposal of electrical compo nents 38 Documentation Software UNICORN 15 Drain outlet 57 Drains 57 E Electrical power 82 Electric cabinet 54 Emergency Procedures 34 Restarting the system 37 Shutdown 35 Stop 35 Explosiveenvironment precau tions 18 Extra flow meter option 65 F Filter Valves 67 Filter in line 65 Flammable liquids ...

Страница 177: ...gency 37 Rinsing after CIP 140 S Safety labels 33 Safety notices 8 Safety precautions 17 Sample pump 24 66 Service 175 Skid 54 Space and floor load 82 Spare parts 175 Storage long term 145 Storage short term 144 System Description 42 System label 30 System operation precau tions 25 System pump standard configuration 59 System pump B 65 T Test leakage 118 Test separate pump 118 Training 175 Transpo...

Страница 178: ...Error 133 158 LED indicator lights 61 Valves general description 61 W Wetted materials 175 178 ÄKTAprocess Operating Instructions 29 0252 49 AA Index ...

Страница 179: ......

Страница 180: ...any within GE Healthcare which supplies them A copy of these terms and conditions is available on request Contact your local GE Healthcare repre sentative for the most current information UNICORN Any use of this software is subject to GE Healthcare Standard Software End User License Agreement for Life Sciences Software Products A copy of this Standard Software End User License Agreement is availab...

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Содержание AKTAprocess

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