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Manual title - GE Healthcare Life Sciences

1. NOTICE Check that the Pressure Control Regulator for the system air supply is set to the pressure stated in the specifications KTA ready Operating Instructions 28960345 AD 67 4 Installation 4 6 Connections 68 CAUTION Make sure that correct air pressure is always maintained Too high or too low air pressure may be hazardous and may cause erroneous results and leakage Instruction Step Action 1 Connect your compressed air supply to the air input connector on the back of the system labeled PNEUMATIC AIR SUPPLY Use the supplied 5 m air hose with inner diameter 7 5 mm Switch on the air supply Check for air leaks AKTA ready Operating Instructions 28960345 AD 4 Installation 4 6 Connections Computer Requirements WARNING Installing the computer The computer must be installed and used according to the instructions provided by the manufacturer of the computer UNICORN is the controlling software for AKTA ready It is recommended that the computer used is dedicated to UNICORN and related software Due to the risk for computer viruses it is also recommended that the computer is not directly connected to Internet See the UNICORN manuals for further details about software requirements and installa tion Instruction Two network cables are delivered with the system and should be connected according to the instruction below Step Action Ji Connect the enca
2. AKTA ready gradient pump is optional and used together with the AKTA ready gradient flow section AKTA ready is intended for use with AKTA ready flow kits AKTA ready Low Flow Kit or AKTA ready High Flow Kit and ReadyToProcess columns up to 20 L Flow kits and columns are ordered separately See Chapter 14 Reference information on page 201 for ordering information and lists of available flow kits and columns AKTA ready Operating Instructions 28960345 AD 57 4 Installation 4 2 Site requirements 4 2 Site requirements Precautions WARNING Explosive environment The product is not approved for work in a potentially explosive atmosphere in areas classified as Zone 0 to Zone 2 according to IEC 60079 10 2002 The product does not fulfill the requirements of the ATEX Directive AN CAUTION e Do not use the product in a dusty atmosphere or close to spraying water e The product is designed for indoor use only Dimensions of AKTA ready Property AKTA ready AKTA ready gradient Width Depth Height 100 x 80 x165 cm 116 x 80 x 165 cm Weight 230 kg 250 kg Ambient environment Relative air humidity 20 to 95 non condensing Particle free filtered air Clean and dust free environment Temperature 2 C to 30 C 25 C to 60 C for storage Atmospheric pressure 950 1050 mbar 58 AKTA ready Operating Instructions 28960345 AD 4 Installation 4 2 Site requirements
3. Sensors are checked and if necessary changed by service personnel as part of the yearly service Should a warning be displayed in UNICORN concerning one of the sensors please contact GE Healthcare contact information on back cover Calibrating flow meter Flow readings that differ from zero under no flow conditions e g when system is in its End state and discrepancies between calculated and actual liquid consumption indicate a poorly calibrated flow meter Flow meter calibration is a very simple procedure Step Action J Make sure the flow kit is filled with liquid and that KTA ready is in End mode 2 In the KTA ready System Control module on the System menu click Cali brate in the Calibrate dialog box select FlowCalib 3 Start calibration by clicking Start Calibrate KTA ready Operating Instructions 28960345 AD 187 12 Maintenance 12 2 Yearly maintenance 188 Applying lubricant to flow meter cell Ifthe warning Fine tuning flow meter failed is displayed in UNICORN there may be insufficient lubricant between the flow meter cell and the transducers Follow the instruction below to apply new lubricant Note It is safe to allow the ongoing run to finish before relubricating Impact on flow measurements will be limited with a maximum error less than 1 Step Action 1 Pause the system and remove the transducers 2 Wipe the transducer contact surfaces clean and apply a new layer of Vaseline on
4. Compressed air e Dry and particle free air e Airflow 50 Ni min e Working pressure 5 5 to 10 bar e Air hose connector a 5 m long air hose with an inner diameter of 7 5 mm is supplied with the system Electrical power e Delivered with a permanent power cable equipped with an IEC 60309 connector e Preconfigured for 230V 50 60 Hz AC power supply See Section 4 6 Connections on page 67 for instruction on how to reconfigure the power supply AKTA ready Operating Instructions 28960345 AD 59 4 Installation 4 3 Transport 4 53 Transport Crate dimensions The AKTA ready is delivered in a crate The crate dimensions are different if it is an AKTA ready or an AKTA ready gradient AKTA ready AKTA ready gradient 190 cm Moving the crate Use a pallet jack or forklift with a minimum capacity of 400 kg to move and lift KTA ready in the crate Make sure that intended openings and apertures are large enough to allow passage of the crate when lifted from the floor for transport gt 400 kg g 60 KTA ready Operating Instructions 28960345 AD 4 Installation 4 3 Transport Release wheels to move AKTA ready The AKTA ready can be rolled on hard and level surface with brakes on wheels released ron clas Use the handle to move AKTA ready Use the handle on the left side of the cabinet to maneuver AKTA ready AKTA ready
5. please call local technical support or customer service NJ08855 1327 US 2010 14 General Electric Company All rights reserved First published April 2010 DOC1149544 28 9800 27 AC 05 2014 222 AKTA ready Operating Instructions 28960345 AD 14 Reference information 14 8 More information 148 More information Spare parts and accessories Additional information regarding spare parts and acccessories can be found in the system documentation For lists of documents see Section 1 3 Associated documentation on page 12 Your local GE Healthcare representative will also be able to suggest recommended spare parts and accessories Remaining aspects Regarding e Service e Method optimization e Ordering information first see Section 14 4 Ordering information on page 210 e Other issues not covered by this manual Please contact your local GE Healthcare representative for advice Contact information is found on the back cover of this manual Training GE Healthcare recommends that all new operators attend the training courses available from GE Healthcare The courses will provide all information necessary for inexperienced operators to safely operate AKTA ready Courses in the field of bioprocess development and manufacturing are available from GE Fast Trak Training amp Education For more information about training please contact your local GE Healthcare represen tative AKTA ready Operating Instructions 28960
6. sures at PT 111 and PT 112 is the pressure drop Delta p over the column and the packed bed PT 113 The third is located in the low pressure flow path upstream from the outlet manifold Pressure sensor PT 113 protects the low pressure outlet manifold from overpressure caused by failure in the fluid lines outside the system e g pinched outlet tubing or overfilled bag at out let AKTA ready Operating Instructions 28960345 AD 49 3 System description 3 4 Equipment pH electrode optional The pH electrode AE 121 is an optional accessory see Section 14 4 Ordering information on page 210 The electrode can be mounted in a holder on top of pressure cell PT 112 When a flow kit is delivered a dummy is located in the pH electrode holder Unlike the rest of the flow kit the pH electrode has not been autoclaved or subjected to gamma radiation at delivery and must therefore be cleaned by the user The pH electrode should be calibrated at least once a day see pH calibration on page 186 Flow meter cell Air sensor The flow meter cell FE 141 is placed after the pressure cell PT 112 pH electrode AE 121 in the flow path The flow meter measures the liquid velocity using ultrasound Transduc ers are connected to both sides of a straight channel through the cell The difference between upstream and downstream ultrasound velocity is measured and the result is used to compute the flow In order to
7. 141 Overview 52 Prerequisite 52 Software modules 53 System networks 52 Warnings 53 Work flow 53 UV Stray light calibration 147 Troubleshooting 200 Component test 120 UV cell 51 Mounting 94 V Valve Check function 219 W Wetted materials 206 Wheels 66 AKTA ready Operating Instructions 28960345 AD For local office contact information visit www gelifesciences com contact GE Healthcare Bio Sciences AB Bj rkgatan 30 751 84 Uppsala Sweden www gelifesciences com readytoprocess GE and GE monogram are trademarks of General Electric Company BioProcess Capto MabSelect MabSelect SuRe ReadyToProcess Sepharose UNICORN and AKTA are trademarks of General Electric Company or one of its subsidiaries Microsoft and Windows are registered trademarks of Microsoft Corporation Pluronic is a trademark of BASF SE TRI Clamp is a trademark of Alfa Laval Corporate AB Triton is a trademark of Union Carbide Chemicals and Plastic Company Inc Tween is a trademark of Uniqema Americas LLC Vaseline is a trademark of Unilever Group All other third party trademarks are the property of their respective owner Any use of UNICORN 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 available on request 2009 2015 General Electric Company All rights reserved First published Sep 2009 All
8. In sert the instruction at 0 0 column volumes 5 Set End_Block to 3 00 which means that the equilibration will finish after 3 column volumes To achieve reasonable equilibration at least 1 5 column volumes should be pumped through the column In the text pane the finished MyEquilibration _ _ 5 5 Block MyEquilibration block should look like that in the figure to the MyEquilibration 0 00 Base SameAsMain right 0 00 Column Inline 0 00 Alarm_Delta_PT111_PT112 Enabled 2 00 bar 0 00 Flow 300 0 cm h 3 00 End_Block 160 AKTA ready Operating Instructions 28960345 AD 10 Creating a method 10 2 An example of using the Method Editor 10 2 7 Block 6 Sample load 10 2 7 Block 6 Sample load The block responsible for sample load has the sample volume as finishing criterion Flow and valve positions air trap inline and column inline are maintained from the previous block and do not have to be redefined Step Action t Create a block named MySampleLoad and set its base to Volume 2 Before starting sample injection you need to auto zero the UV sensor This is done by inserting an AutoZero_UV_AT131 instruction group Alarms amp Mon 3 At a volume of 2 liters set the inlet to that which your sample container is connected by inserting an Inlet instruction and setting this to for instance Inlet1 Insert also an Outlet instruction set to Outlet1 Set both AirTrap and Column to ByPass 4 Insert an InjectionMark in group
9. J S 751 84 Uppsala Sweden Conforms to ANSI UL Std 61010 1 Cert to CAN CSA Std C22 2 No 61010 1 CAN ICES 1 NMB 1 Ne A KTA ready Operating Instructions 28960345 AD 2 Safety instructions 2 2 Labels Label text Description Code Number Identifies the system as being an AKTA ready System Number Identifies the unique system installation Manufacturing Year Manufacturing year Supply Voltage The voltage alternatives for AKTA ready Configured For The voltage the system is currently configured for Frequency Supply voltage frequency Max Power Consumption The maximum effect of the system Pneumatic Supply Required pressure for pressurized air supply Protection Class The electrical appliances protection classification ac cording to international standard IEC 60529 This symbol indicates that electrical and electronic equipment must not be disposed of as unsorted mu nicipal waste and must be collected separately Please contact an authorized representative of the manufac turer for information concerning the decommissioning of equipment The system complies with applicable European direc tives The system complies with applicable requirements for Australia and New Zealand 2 mw bs This symbol indicates that the product might contain hazardous materials in excess of the limits established by the Chinese standard SJ T11363 2006 Require
10. Note Be careful when transporting smaller columns e g 2 5 on the trolley Small columns are light and have a narrow base and may therefore be unstable 4 Click Next in the column installation wizard This will open a checklist of ac tions for connecting the column Edit column parameters in UNICORN 7 Create a column type in UNICORN 7 Before you edit the column parameters you must create the column type See UNICORN Method Manual for instructions 130 AKTA ready Operating Instructions 28960345 AD Step Action 9 Column installation 9 2 Installing a column In the Phase Properties tab select the newly created column in the Column type list In the Method Outline click User Defined In the Phase Properties tab edit the values for the different variables e g pressure limits to fit the column and media used See PID control in AKTA ready on page 215 and the user documentation for the column Tip Enter values for Flow_Efficiency_Test I hour and Rinsing_Flow_Rate l hour corresponding to a linear flow of 100 cm h for the column used Tip Column parameter values can also be found in ReadyToProcess columns User Manual Phase Variables Block Initial_Settings Inlet_Priming_Tracer System_Priming_Wash_Liquid Equilibration Tracer_Filling Tracer_Injection Inlet_Equilibration Acceptance_Criteria F Show details V Show unused variables Variable Pressure _Limit bar Pressure _Limi
11. 10 Creating a method About this chapter This chapter describes how to create a method for AKTA ready in the UNICORN 5 Method Editor The same principles for method creation applies for UNICORN 7 but the dialog boxes and menu options may differ See UNICORN Method Manual for more information on how to create methods Ina simple example the general structure of a method is shown along with the different steps required to create it There is also a section discussing the wizard for creating test methods for efficiency testing of columns Note that the discussion in this chapter applies to methods written for the AKTA ready strategy For information about methods in general and for detailed information about the Method Editor please see the UNICORN manuals Courses in UNICORN system control including method design are available from Fast Trak Training amp Education Contact your local GE Healthcare representative for informa tion In this chapter This chapter contains the following sections Section See page 10 1 The Method Editor 142 10 2 An example of using the Method Editor 152 10 3 Creating a column efficiency test 168 AKTA ready Operating Instructions 28960345 AD 141 10 Creating a method 10 1 The Method Editor 10 1 The Method Editor In this section This section contains the following subsections Section See page 10 1 1 Introduction to the Method Editor 143 10 1 2 Method Editor layout 145 10 1 3 O
12. 30 Tracer _Filing Inlet_Tracer Inlett X Tracer_Injection Duration_TracerLoading min 0 30 The default values of variables are e Flow velocity 100 cm h e Equilibration volume 1 30 column volumes e Tracer volume loaded on the column 2 5 of the column volume Note For the method to work correctly changing of the flow velocity requires changing of the tracer volume and vice versa Note Only advanced users should change variables shown in the detailed section only displayed when Show details is checked AKTA ready Operating Instructions 28960345 AD 169 11 Runamethod 11 Runamethod About this chapter Running a method on AKTA ready is a largely automatic procedure User interaction is mainly required in the preparation phase which includes connecting the column and the required containers and checking that all connections are correctly assigned and that flow kit type and volumes are correct 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 Section 2 1 Safety precautions on page 15 as listed below e General precautions on page 15 e Personal protection on page 16 e Operation on page 19 In this chapter This chapter contains the following sections Section See page 11 1 Final preparations before a run 171 11 2 Starting a ru
13. AKTA ready is intended for use with AKTA ready flow kits AKTA ready Low Flow Kit or KTA ready High Flow Kit and ReadyToProcess columns up to 201 Flow kits and columns are ordered separately See Chapter 14 Reference information on page 201 for ordering information and lists of available flow kits and columns AKTA ready Operating Instructions 28960345 AD 35 3 System description 3 2 Layout 5 2 layout AKTA ready 36 Part Function 1 AKTA ready cabinet unit 2 AKTA ready flow kit ordered separately 3 Column trolley 4 ReadyToProcess column ordered separately AKTA ready Operating Instructions 28960345 AD 3 System description 3 2 Layout AKTA ready gradient Function 1 AKTA ready gradient pump 2 AKTA ready gradient flow section AKTA ready Operating Instructions 28960345 AD 37 3 System description 3 2 Layout Components on system cabinet front The drawing below shows the location of components on the AKTA ready cabinet The cabinet is shown without the cabinet door and with a flow kit mounted Components of the flow kit are described in Flow kit components on page 42 Part Component ID tag Function 1 PAUSE CON Press button to pause an ongoing process TINUE button Press again to continue See Pinch valves on and alarm indi page 48 for valve positions cator lamp Lamp shows steady yellow light during pause Flashing yell
14. Capto MMC 2 5 2 5 28929120 RTP Capto MMC 10 10 28929121 RTP Capto MMC 20 20 28929122 Capto Q RTP Capto Q 1 1 28951090 RTP Capto Q 2 5 2 5 28901723 RTP Capto Q 10 10 28901724 RTP Capto Q 20 20 28901725 Capto S RTP Capto S 1 1 28951093 RTP Capto S 2 5 2 5 28901729 RTP Capto S 10 10 28901730 RTP Capto S 20 20 28901731 AKTA ready Operating Instructions 28960345 AD 211 14 Reference information 14 4 Ordering information Resin Product Size I Product code MabSelect RTP MabSelect 1 NS 1 28951128 RTP MabSelect 2 5 NS 2 5 28941522 RTP MabSelect 10 NS 10 28941523 RTP MabSelect 20 NS 20 28941524 MabSelect SuRe RTP MabSelect SuRe 1 1 28951110 RTP MabSelect SuRe 2 5 2 5 28901717 RTP MabSelect SuRe 10 10 28901718 RTP MabSelect SuRe 20 20 28901719 Phenyl Sepharose FF RTP Phenyl Sepharose 6 FF lowsub 1 1 28951111 low sub RTP Phenyl Sepharose 6 FF low sub 2 5 2 5 28901735 RTP Phenyl Sepharose 6 FF lowsub 10 10 28901736 RTP Phenyl Sepharose 6 FF lowsub 20 20 28901737 Phenyl Sepharose 6 FF RTP Phenyl Sepharose 6 FF high sub 1 1 28951197 high sub RTP Phenyl Sepharose 6 FF high sub 2 5 28929108 2 5 RTP Phenyl Sepharose 6 FF high sub 10 28929109 10 RTP Phenyl Sepharose 6 FF high sub 20 28929110 20 CM Sepharose FF RTP CM Sepharose FF 1 1 28951208 RTP CM Sepharose FF 2 5 2 5 28929117 RTP CM Sepharose FF 10 10 2892911
15. Column Installation 20L 1195205019 071 Column Installation 20L 1195205019 071 EfficiencyTest_ UV_131 Column Installation 20L 1195205019 071 EfficiencyTest_ Logbook mAU 70 0 12 00 60 0 50 0 40 0 30 0 20 0 Acceptance criteria As 0 8 1 8 and N m gt 2700 10 0 0 0 0 0 2 0 4 0 6 0 8 0 10 0 Column Insta 12 0 14 0 min ion 20L 1195205019 071 EfficiencyTest_UV_131 01 PEAK No Ret Plate t Plates meter 10 0 Left 10 0 Right Asymmetry min N m min min a 12 00 0 03242 3085 10 99 13 12 1 11 Note Unlike a component test report a column test report does not state whether acolumn has passed or failed a test Instead it is the responsibility of the user to compare the test results with provided acceptance criteria in order to decide if the test was successful or not AKTA ready Operating Instructions 28960345 AD 137 9 Column installation 9 4 Optional column rinsing 9 4 Optional column rinsing Column rinsing A method for column rinsing may be custom designed by the user or the predefined method for column rinsing can be used The predefined method is included as an optional step in the column installation wizard Column rinsing is performed with 6 column volumes to remove all remaining storage solution or tracer solution from the column Preparations If column rinsing was selected in the installation wizard i e Include Rinsing of Column was checked the wizard will include
16. FlowPath at 2 liters This will set the time and volume to zero when the sample inlet valve is opened 5 In order to fill the flow path with sample liquid start a manual flow __ _ which is stopped when the sample ae reaches the UV sensor i e when the Pema non UV readings reach above a defined Timeout gt 000 3993 90 limit The two instructions required a 2 for this are e ManFlow in group Pump which starts the flow and maintains it at a set level in this case 50 ManFlow is not controlled by the flow meter e Hold_Until in group Watch which stops the flow when UV_AT131 readings are Greater_Than a set limit in this case 200 MAU Timeout is set to for instance 15 liters 6 When the flow kit is filled with sample liquid the Column is again set to Inline and a Flow instruction set to for instance 300 cm h is added g Finally set the End_Block instruction to equal the volume of your sample for example 42 8 liters KTA ready Operating Instructions 28960345 AD 161 10 Creating a method 10 2 An example of using the Method Editor 10 2 7 Block 6 Sample load 162 The MySampleLoad block is now defined to run 42 8 liters of sample after first having au to zeroed UV set an injection mark and filled the flow kit with sample liquid W 0 00 Block MySampleLoad MySampleLoad 0 00 Base Yolume 1 00 AutoZero_U _AT131 2 00 Inlet Inlet1 2 00 Outlet Outlet1 2 00
17. Protective Equipment PPE Whenever packing unpack ing transporting or moving AKTA ready wear e Protective footwear preferably with steel lining e Working gloves protecting against sharp edges e Protective glasses WARNING Because of the significant weight of AKTA ready great care must be taken not to cause squeezing or crushing injuries during movement It is recommended that two persons move the system WARNING At least two persons are required to unpack AKTA ready gradient Instructions for unpacking For a full description of how to unpack AKTA ready refer to the following unpacking in structions e KTA ready Unpacking instructions article number 28 9944 89 and e KTA ready gradient Unpacking instructions article number 29 0420 82 AKTA ready Operating Instructions 28960345 AD 65 4 Installation 4 5 Positioning the system 4 5 Positioning the system Note The area required at the production location for AKTA ready is 280 x 300 cm allowing for 100 cm of free space on all sides of the system The AKTA ready gradient needs slightly more free space 280 x 316 cm The space is required to make room for containers and hoses and to allow for easy ac cess to the power switch and to connectors on the back of the unit The back door of the cabinet must furthermore be accessible for service WARNING Access to power switch and power cord The power switch must always be easy to
18. a 2 ob z5 z5 ob ob a zo 7a eo wo a5 min 3 To change the layout of the Chromatogram panel right click and and then click Properties Select which curves to display by marking them in the Curve panel Click OK Refer to the UNICORN manuals for more information about viewing results and customiz ing layout 178 AKTA ready Operating Instructions 28960345 AD 11 Runa method 11 3 Viewing and printing results Printing results Step Action 1 Open the chromatogram you want to print in the Evaluation module 2 Click Print on the File menu 3 In the Print Chromatograms dialog box select print format and layout op tions Print Chromatograms 4 Click Preview 5 In the Customise Report window verify that the layout is correct 6 Click Exit to return to the Print Chromatograms dialog box F4 Click OK Refer to the UNICORN User Manual for more information about printing results KTA ready Operating Instructions 28960345 AD 179 11 Runamethod 11 4 After the run 11 4 After the run General If flow kit and column should be disposed of this must be done in accordance with local regulations Preparing the flow kit and column for disposal involves washing the flow kit and column draining any liquid from them and remounting the protective caps they were delivered with Disconnect the pH electrode when the run is completed Disposing of flow kit and column 180 WARNING Hazardous chemicals
19. a field for selecting the inlet used for the rinsing liquid Rinsing Settings Inlet for column rinsing liquid with six column volumes The rinsing liquid may consist of for instance purified water or a low salt buffer see column documentation for details The volume required depends on the column used Note that the liquid used for rinsing may be the same as that used as wash liquid in a previous efficiency test see Section 9 3 Optional column test on page 135 In such case the same inlet is selected Run the rinsing procedure Column rinsing takes approximately 80 minutes No actions from the user are required during this time It is possible to enter notes during a run 138 AKTA ready Operating Instructions 28960345 AD 9 Column installation 9 5 Adding columns to the column list 9 5 Adding columns to the column list Adding columns It is possible to add columns for example RTP columns on request to the KTA ready installation wizard Follow the steps below to add a new column to the UNICORN column list Note In UNICORN 7 it is possible to add columns and set basic physical parameters in the Column Handling dialog box see UNICORN Method Manual Advanced column parameters e g PID parameters must be added to the method where the column is used see Edit column parameters in UNICORN 7 on page 130 Instruction Step Action 1 Click Column List on the Edit menu in the Method Editor mod
20. access The power cord must always be easy to disconnect AKTA ready arrives preassembled in the transport crate No specific assembly prior to site installation is required After positioning the system at its designated location lock g the wheels figure NOTICE Check that the Pressure Control Regulator for the system air supply is set to the pressure stated in the specifications 66 KTA ready Operating Instructions 28960345 AD 4 Installation 4 6 Connections 46 Connections Connector locations A cable for system power is permanently mounted on the back of the system cabinet Connectors for pressurized air computer network and customer I O are are also located on the back of the system unit at the bottom of the cabinet Two computer network cables and a connector for the customer I O are supplied but not mounted For more information about connector locations see Components on system cabinet back on page 40 Power WARNING High voltage The mains cable must only be connected by autho rized service personnel Faulty connection might result in live system parts that can give lethal electric shocks NOTICE gt Do not turn on the Mains power switch before all connections are made Power connection The mains power supply must be connected and configured by authorized service per sonnel Please contact your GE Healthcare representative Compressed air
21. always use the wizard when installing a new flow kit It helps to ensure that all the steps are performed and performed in the right order The wizard thereby provides a simple way of securing the correctness of a flow kit installation The wizard also includes a component test and provides the option of producing a printed report containing installation information and test results AKTA ready Operating Instructions 28960345 AD 81 6 Flow kit installation 6 3 Mounting the flow kit Before starting 82 System setup e In UNICORN 5 the component list is reached by clicking System Setup on the Admin istration menu in the UNICORN Manager e In UNICORN 7 in the Administration module click System Properties and then click Edit in the System Properties dialog box Select the Profibus_Config5 or Profibus_Config6 checkboxes If you have installed the gradient system both the Akta_Ready_Gradient checkbox and the Profibus_Config6 checkbox must be selected You should also select the pH_Cell checkbox if pH is to be measured the correct flow kit size the LowFlow_Kit checkbox default or the HighFlow_Kit checkbox type of air sensor the Air_AE151 or the Air_AE152 checkbox By selecting the Service checkbox you will have the possibility to display UV_131_S and UV_131_R in RunData Component Select components m Akta_Ready Akta_Ready_Gradient pH_Cell LowFlow_Kit HighFlow_Kit Air_AE151 Air_AE152 Service Profibus_Config5 Pro
22. and risk reduction Notes EN ISO standard is har monized with EU direc tive 2006 42 EC EN IEC 61010 1 UL61010 1 CAN CSA C22 2 No 61010 1 Safety requirements for electri cal equipment for measure ment control and laboratory use EN standard is harmo nized with EU directive 2006 95 EC EN IEC 61326 1 Emission according to CISPR 11 Group 1 class A 10 Electrical equipment for mea surement control and laborato ry use EMC requirements KTA ready Operating Instructions 28960345 AD EN standard is harmo nized with EU directive 2004 108 EC 1 Introduction 1 2 Regulatory information FCC compliance This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation Note The user is cautioned that any changes or modifications not expressly approved by GE Healthcare could void the user s authority to operate the equipment This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to part 15 of the FCC Rules These limits are designed to provide rea sonable protection against harmful interference when the equipment is operated in a commercial environment This equipment generates uses and can radiate radio frequen cy energy
23. as the search result Scan any barcode A text string should appear in the Notepad document The Notepad document may be discarded 5 If the barcode reader does not function locate the Standard Products De fault barcode in the Quick Start Guide and scan it with the barcode reader Repeat the installation procedure AKTA ready Operating Instructions 28960345 AD 73 5 Starting AKTA ready 5 Starting KTA ready About this chapter This chapter describes how to start and log on to UNICORN and AKTA ready 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 Section 2 1 Safety precautions on page 15 as listed below e General precautions on page 15 In this chapter This chapter contains the following sections Section See page 5 1 Start and log on to UNICORN 75 5 2 Start the system 76 74 AKTA ready Operating Instructions 28960345 AD 5 Starting AKTA ready 5 1 Start and log on to UNICORN 5 1 Start and log on to UNICORN UNICORN software The UNICORN control software is delivered with the system UNICORN should be installed on a PC optional with Microsoft Windows operating system Refer to the UNICORN manuals for software installation instructions Starting UNICORN See Alarms on page 54 for more information regarding the UNICORN control system warnings an
24. be 0 00 Insert the instruction into the block by clciking Insert Breakpoint Instructions Parameters 0 00 min O Pump m al Var ra ss FlowPath outa j OdlamstMon e O aaier 7 O Frac eect persed O Watch jies Totale O Other Bae Teer The new instruction will show up in the Text pane below Base amp Ml 0 00 Block MySetup MySetup 0 00 Base Time 0 00 Inlet Inlet6 154 AKTA ready Operating Instructions 28960345 AD Step 10 Creating a method 10 2 An example of using the Method Editor 10 2 2 Block 1 Opening valves Action Following the same general procedure as in step 3 insert also these instruc tions into the block e Attime 0 10 set instruction AirTrap to Bypass e Attime 0 20 set instruction Outlet to Outlet The block is now finished All the in ip 5 r 7 E Main structions are available for reviewing 0 00 Base CY 20 24458 I RTP_MabSelect_SuRe_20 i i S W 0 00 Block MySetu in the Text pane see figure D Bloc set N 0 00 Base Time If you want to modify an instruction 0 00 Inlet Inlet6 E 5 0 10 AirTrap Bypass select it and make the changes in the pean ioral Instructions box AKTA ready Operating Instructions 28960345 AD 155 10 Creating a method 10 2 An example of using the Method Editor 10 2 3 Block 2 Auto zeroing pressure sensors 10 2 3 156 Block 2 Auto zeroing pressure sensors Step Action i Follow the general procedure used fi bl k 1t t bl
25. block will finish when the pump has delivered 2 5 liters of liquid There is now a MyFillFlowKit block with a W 0 00 Block MyFillFlowkit nested MyFillAirTrap block The figure to the Miriona right shows both blocks expanded in the Text man Mantlow 300 6 asai _ pane Note that the nested block is based on ho a Volume while the outer block is based on Time gt 7 ee na tr 0 00 Base Yolume 0 00 ManFlow 50 0 2 00 End_Block 0 30 End_Block AKTA ready Operating Instructions 28960345 AD 159 10 Creating a method 10 2 An example of using the Method Editor 10 2 6 Block 5 Equilibration 10 2 6 Block 5 Equilibration The next block is for equilibrating the column Step Action i Create a new block named MyEquilibration and set its base to Same as main which in this case is column volumes Note Selecting Same as main instead of Column volumes ensures that the volume used is the same as that of the column you selected initially 2 Set a pressure alarm at 2 bar by in z y x arameters serting the instruction oe Var Disabled Enabled Alarm_Delta_PT111_PT112 at 0 col Highlerm 1 00 4 00 umn volumes Make sure the alarm Var 2 00 T bar is Enabled Low larm 1 00 4 00 Vat 1 00 i bar 3 Add a Column instruction and set the column Inline 4 Set a Flow instruction to 300 cm h _ by first selecting Linear flow to fo E EE Set change unit and then typing 300
26. chapter This chapter contains the following sections Section See page 6 1 AKTA ready flow kits 78 6 2 Unpacking the flow kit 80 6 3 Mounting the flow kit 81 AKTA ready Operating Instructions 28960345 AD 77 6 Flow kit installation 6 1 AKTA ready flow kits 6 1 KTA ready flow kits Three parts 78 AKTA ready flow kits are delivered in three parts Each of the three parts constituting the flow path are sanitized and ready for use with the AKTA ready BR nt iid i ra No Part Function 1 Inlet manifold Tubing with 6 connectors for inlets and one for the pump tubing 2 Pump tubing Double pump tubing for mounting in the peristaltic pump with connectors to inlet tubing and to the main part of the flow kit tubing 3 Main part Tubing with all required flow cells pressure flow meter temperature conductivity and UV air trap 6 outlets and connectors to pump tubing and column Note The pH electrode is optional For ordering informa tion see Section 14 4 Ordering information on page 210 KTA ready Operating Instructions 28960345 AD 6 Flow kit installation 6 1 KTA ready flow kits It is possible to assemble a flow kit before it is mounted onto the system cabinet The recommended procedure however is to connect the three parts to each other in con nection with mounting of the flow kit This is the procedure described in this chapter Flow kit types Two diffe
27. column bypass in XV 033 line 11 Air trap vent HV 301 Manual valve controlling level in air trap valve 12 AIR VENT Button controlling air trap ventilation through Air trap ventila valve HV 301 Used for releasing excess air tion button from air trap AKTA ready Operating Instructions 28960345 AD 39 3 System description 3 2 Layout Part 13 Component Installation switch ID tag HS 5 Function Used for releasing and engaging valves dur ing flow kit and column installation Three different positions FLOW KIT INSTALL Opens all valves User can manually open close valve locks RUN Engages all valves User cannot open safety valve locks valves are controlled by UNICORN COLUMN INSTALL Releases valves between airtrap outlet to column inlet Allows for re moval of air in tubing between column and air trap 14 Outlet valves XV 051 to XV 056 6 valves located on the right side of the chromatography unit 15 Air filter The air filter is located in a holder underneath the system cabinet Components on system cabinet back Location of connectors Connectors for system power pressurized air customer I O and computer network are located on the rear of the system unit at the bottom of the cabinet 40 AKTA ready Operating Instructions 28960345 AD 3 System description 3 2 Layout Part Function 1 POWER SUPPLY Syste
28. connect it to the Bottom Inlet tubing on the column Repeat the steps above for the Column outlet connector 2 in figures Connect this tubing to the Top Inlet tubing connector on the column 132 AKTA ready Operating Instructions 28960345 AD 9 Column installation 9 2 Installing a column Finish the installation Step Action 1 Turn the Installation switch in the upper right corner of the system cabinet to the COLUMN INSTALL position This will open STALL STALL a free passage from air trap to column 2 Let liquid drain from the air trap down to the column Release under pressure in the air trap by pressing the AIR VENT button next to the air trap release valve HV 301 If necessary tap flick or squeeze the tubing arrows in figure until it is completely filled with liquid and no more bubbles enter the air trap 3 Turn the Installation switch in the upper right corner of the system cabinet to the RUN posi tion After the column installation wizard has finished UNICORN displays the start protocol with information about the installation and input fields for parameters specifying the current setup The input fields are the same as those for a flow kit installation as discussed in Enter installation information on page 111 with one exception There is an additional field for the column s identification number Similar to the other identification numbers this number can be scanned using a ha
29. dialog box select col umn and the inlets to be used for wash liquid and tracer solution The method variables will be set according to the choice of column Click Finish to leave the method wizard 168 t Method Editor UNTITLED fie Edit Block view Help gon ave m PVE LAN Close N Method Wizard Ctrl M H save Ctrl 5 Main Selection Wizard for creation of efficiency test methods Note Before starting the method the inlets and the system including the air trap must be filed with liquid Technique Al x Column S elect Column Inlet for column wash liquid iniet5 Inlet for tracer solution Inlet v The efficiency test is performed at 100 cm h KTA ready Operating Instructions 28960345 AD 10 Creating a method 10 3 Creating a column efficiency test Editing the method A method created with the method wizard can be later edited in the Method Editor via for instance the Run Setup dialog box Open the dialog box by clicking Run Setup on the View menu Variable value can be changed by clicking the Variables tab and changing the value of CV_Equilibration Start Protocol Questions Result Nan Variables Scouting Notes Gradient Columns Reference Curves Evaluation Procedures Block Variable Value Main Column Template_Default Global Inlet_E quilibration Tnlet_E quilibration Inlet m Equilibration Flow_Efficiency_Test I hour 0 0 CVE quiibration Cv 1
30. 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 If the flow kit and column are to be dismounted and disposed of proceed as follows Step Action 1 While still mounted on the system cabinet wash the flow kit and column with water This is done by connecting water to one or more of the inlets and running a washing method from the AKTA ready 2 Fill the flow kit and column with air by pumping air from an empty inlet Note Use ManFlow when filling the system with air The flow meter which is used to control the pump does not work with air in the system 3 Disconnect all inlet and outlet containers and the column and put back the protective caps delivered with the flow kit the caps that were removed when mounting the flow kit 4 Put the welded tubing ends back on the column s inlet and outlet 5 Open all valves by turning the Installation switch to the FLOW KIT INSTALL position 6 Remove all flow kit sensors from their holders connectors Wipe clean the contact surfaces of the flow cell connectors 7 Open all manual valve locks by turning the black handles 180 degrees AKTA ready Operating Instructions 28960345 AD Step 11 Runa method 11 4 After the run Action 10 Li Remove the pump lid Lift off the still assembled flow kit starting with the inlet and outlet manifolds If required autocl
31. ensure proper transmission of the sound energy the contact surfaces should be coated with a thin layer of Vaseline delivered with the flow kit or similar lubricant before the transducers are connected The air sensors AE 151 and AE 152 are high precision monitors designed for continuous monitoring of air bubbles in the flow path When air is detected the system is either paused or performs an action that is set in the method Temperature sensor 50 The temperature sensor TE 161 is located on the front of the system cabinet beneath the flow meter cell The sensor measures the infrared radiation emitted from a dedicated measurement window in the body of the flow meter cell A lens in front of the sensor focuses the infrared radiation Note Asystem that is not properly temperature equilibrated may produce incorrect temperature readings Therefore if the system or flow kit is moved between rooms with different temperatures time must be allowed for the equipment to adjust to the new ambient temperature In particular the body of the flow meter cell may need several hours to adjust to room temperature AKTA ready Operating Instructions 28960345 AD 3 System description 3 4 Equipment Conductivity sensor The conductivity sensor CE 101 is included with the flow kit for all other sensors the flow kit includes only the flow cells The conductivity sensor is located after the flow meter cell in the flow path It is prim
32. for the parameters are Column volume P B 1l 0 3 25 0 2 51 0 3 25 0 1011 03 150 2011 0 5 10 0 1 AKTA ready High Flow Kits should be used for columns of 10 or more These settings provide fast response and robust control for most operating situations Step Action i Create a new block for setting of PID parameters Name the block MyPIDPa rameters and set Time as its base 2 Insert the FlowTune instruction into the block This instruction has the re quired fields for setting PID parameters ooo an ane oes Ps ea _ 0000 100000 a O FlowPath _LowFlow 10 000 1000 00 yan O AlarmstMon Var 5 000 sec mem D_LowFlow 10 000 1000 000 OFrac Ver 0 000 a sec Replace OwWatch P_HighFlow 0 000 100 000 Oother va ps z a eee Note There are six parameters in total three each for the High Flow Kit and the Low Flow Kit When running the method only those parameters relevant for the flow kit installed are used The PID_Parameters block is a simple block with the main content being the FlowTune in struction Apart from this the block only con tains the required Base and End_Block E Main 0 00 0 00 W 0 00 E W 0 00 W 0 00 Base CY 20 24458 I RTP_MabSelect_SuRe_20 Flow_Warning Disabled Block MySetup Block MyAutozeroPressure Block MyPIDParameters MyPIDParameters 10 Base Time AKTA ready Operating Instruc
33. goods and services are sold subject to the terms and conditions of sale of the company 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 Any use of UNICORN 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 available on request 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 28960345 AD 10 2015 a139
34. h liquid velocity and normally takes approx imately 30 minutes Tip If column conditioning is included in the test it will take longer time than 30 minutes Similar to a component test it is possible to enter notes during the test see Running the component test on page 112 For more information about efficiency testing of columns see the application note Effi ciency test of ReadyToProcess columns see Section 1 3 Associated documentation on page 12 AKTA ready Operating Instructions 28960345 AD 9 Column installation 9 3 Optional column test Test results Results from an efficiency test are stored and processed in a similar way as results from a component test The results are stored at a user defined location and they can be compiled and presented in the form of a printed report using report format AKTA ready_Column_T which includes results from the efficiency test in addition to the installation information in report format AKTA ready_Column In addition to the general information a column test report also contains detailed infor mation about the column used e g volume technique max and default flow rates etc A column test report contains a chart showing the peak in UV response caused by the progressing pulse of tracer solution together with suggested acceptance criteria UNICORN 5 11 Build 407 Run by Anna A 11 16 2007 10 23 40 W Europe Standard Time Result file v Anna A AKTAready installations
35. if used There is also a field for the test solution protocol number Questions 1 Product name l 2 Product number 3 Product batch number 4 Bar code for inlet manifold HighFlow begins with 4 5 Bar code for pump tubing HighFlow begins with 5 6 Bar code for main part HighFlow begins with 6 lt Back Newt gt Cancel Much of the information can be conveniently scanned in using the supplied bar code scanner It can also be manually entered The information supplied will be included in the report Result name The panel Result Name contains fields for the name of and path to the result file where results will be stored Enter a proper name for the result file in other case it will get the name Wizard generated and you may end up with a lot of such files with the same name The Result Name panel also has a Start button When finished entering data click Start to start the test AKTA ready Operating Instructions 28960345 AD 111 8 Component test 8 1 Run a component test Running the component test 112 A component test takes approximately 10 minutes The progress of the test can be fol lowed in UNICORN in charts showing the response curves for different sensors During the run two things will happen that will require user attention e Ashort while after the test has started a warning message will appear on the screen saying that UV stray light reduction is activated This warning message is i
36. installation 9 Column installation About this chapter Precautions 122 This chapter describes how to install a column on the AKTA ready Much of the information in this chapter is available under Column Installation of the AKTA ready installation wizard part of supplied software The chapter also contains instructions for running an efficiency test and for column rinsing Both are optional procedures that can be performed in connection with installing a new column Note that ReadyToProcess columns are factory tested and are supplied with a certificate stating the results from an efficiency test performed on the individual column 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 Section 2 1 Safety precautions on page 15 as listed below e General precautions on page 15 e Operation on page 19 AKTA ready Operating Instructions 28960345 AD 9 Column installation In this chapter This chapter contains the following sections Section See page 9 1 Columns 124 9 2 Installing a column 127 9 3 Optional column test 135 9 4 Optional column rinsing 138 9 5 Adding columns to the column list 139 AKTA ready Operating Instructions 28960345 AD 123 9 Column installation 9 1 Columns 9 1 Columns Column types ReadyToProcess columns are recommended for use with the AKTA ready Other
37. instruction under FlowPath AKTA ready Operating Instructions 28960345 AD 10 Creating a method 10 1 The Method Editor 10 1 3 Other Method Editor features Pressure flow control Follow the instructions to perform pressure flow control with optimal functionality Step Action 1 Select PressureFlowControl and enable the function then select PressureFlowLimit 2 Select the pressure and the pressure sensor that should control the pressure 3 Select the flow rate and the pressure flow control will work as expected 4 Deactivate the function and select a flow to change system status to flow mode AKTA ready Operating Instructions 28960345 AD 151 10 Creating a method 10 2 An example of using the Method Editor 10 2 An example of using the Method Editor About the example Creating a method involves creating and naming the method and adding blocks and instructions to it In this section a simple example is used to illustrate the different steps in the procedure Note The method produced in this example is for training purposes only It is not intended as an example of a production method In this section This section contains the following subsections Section See page 10 2 1 Creating the method and selecting a column 153 10 2 2 Block 1 Opening valves 154 10 2 3 Block 2 Auto zeroing pressure sensors 156 10 2 4 Block 3 Setting PID parameters 157 10 2 5 Block 4 Filling the flow kit 158 10 2 6 Bloc
38. it with the theoretical value from the graph opposite at the temperature of the calibration solution e If the displayed value and the theoretical value correspond no further action is required e If the values differ proceed with step 7 Enter the theoretical conductivity value according to the graph in the Reference value 1 field 97 95 90 85 80 77 Click Read value 1 The new cell constant is automatically calculated and updated Testing the temperature sensor The accuracy of the temperature sensor can be checked using a Temp test tool Sec tion 14 4 Ordering information on page 210 Temperature testing is normally done once a year during preventive maintenance 190 AKTA ready Operating Instructions 28960345 AD 12 Maintenance 12 2 Yearly maintenance Step Action jk Remove the pH electrode or pH elec trode dummy from pressure cell pressure cell PT112 Insert the Temp test tool a in figure and secure it in place with the pH electrode nut b 7 C 2 Insert a temperature probe 3 6 mm in diameter c and tighten the top i nut d on the Temp test tool b 3 Connect a calibrated temperature d meter to the probe and start a manu al flow of approximately 50 for a both high flow and low flow kit 4 Read the temperature on the refer m ence temperature meter and com J PT112 D pare the reading to the temperature displayed in UNICORN Temp_161 Calculate
39. k aano WatchPar_In5_Tot Al or block 1 to create a new block O Pump Vae nulla i hl l Name the block for instance MyAu QFloweah aa a D Tat tozeroPressure and set its Base AlamstMon eration EIT 7 WatchPar_OutletS_Tot to Time O Frac WatchPar_Outlet6_Tot AutoZero_PT111 f O watch AutoZero_PT112 2 Add instructions for auto zeroing Of other o ETIS the pressure sensors by inserting the instructions AutoZero_PT111 AutoZe ro_PT112 and AutoZero_PT113 in group Alarms amp Mon at time 0 10 Note This requires that the system is filled with air If it is filled with liquid the air trap valve has to be opened by pressing the AIR TRAP VENT button with outlet closed and air trap inline The MyAutozeroPressure block now contains three Autozero instructions one for each pressure sensor Mi 0 00 Block MySetup W 0 00 Block MyAutozeroPressure MyAutozeroPressure 0 00 Base Time 0 10 AutoZero_PT111 0 10 AutoZero_PT112 0 10 AutoZero_PT113 0 20 End_Block AKTA ready Operating Instructions 28960345 AD 10 2 4 10 Creating a method 10 2 An example of using the Method Editor Block 3 Setting PID parameters 10 2 4 Block 3 Setting PID parameters Whenever an automated process step requires control of flow the UNICORN control software employs PID type controllers see Section 14 5 PID control on page 214 PID parameters are optimized to fit different column diameters The default settings
40. kit installation 6 3 Mounting the flow kit Mount the inlet manifold Step Action i Open the plastic package containing the inlet manifold and main part of the flow kit 2 Retrieve the inlet manifold and mount it on the system cabinet by inserting each inlet tubing into the correspond ing inlet pinch valve XV 001 to XV 006 Do not yet remove the end caps 3 Close each safety lock on the pinch valves by turning the black handles 180 degrees Attach the main part tubing Step Action I Lift the main part of the flow kit see image using e your left hand to hold the tubing by the air trap e your right hand to hold the UV cell Avoid touching the window 2 Place the air trap in its holder and insert the UV cell in the slot to the right of the air trap Push the UV cell all the way in A soft click indicates that it is properly positioned 3 Place the outlet manifold in the gap between of the cabinet and the front cabinet door for the time being Do not mount it yet 88 AKTA ready Operating Instructions 28960345 AD 6 Flow kit installation 6 3 Mounting the flow kit Connect and mount the pump tubing Step Action 1 Open the plastic bag containing the pump tubing and place the tubing on top of the pump rollers with the larger connector block the block with the connec tor for the main part of the flow kit to the right 2 Push the pump tubing over the mounting knob on the r
41. lower figure No tools should be nec essary 3 Wipe clean the bottom surface of the cabinet and the filter cover 4 Place the new filter in the cover and the gasket on top and then re mount the filter cover using the knurled nuts Use finger force to tighten the nuts AKTA ready Operating Instructions 28960345 AD 12 Maintenance 12 2 Yearly maintenance Pump head Be observant of any changes in the sound of the pump or of vibrations as these may indicate that the pump rotor needs to be replaced Normally the pump rotor is checked and replaced in connection with yearly maintenance AKTA ready Operating Instructions 28960345 AD 193 12 Maintenance 12 3 Spare parts 12 5 Spare parts General Apart from the flow kits KTA ready has very few parts that a user may need to replace Normally parts are checked and if necessary replaced by service personnel during preventive maintenance For a list of available accessories and spare parts see Sec tion 14 4 Ordering information on page 210 Replacing spare parts Pressure cell holder kit The latches and screws holding the pressure cells in place are available as spare parts in the form of a Pressure cell holder kit When mounting a pressure cell holder make sure to turn the latch so it does not interfere with other components when opened Use only finger force to tighten the screws Air filter nuts and cover The knurled nuts holding the air filter cover are m
42. maintenance Before inspecting and maintaining the system shut down and depressurize the sys tem and disconnect the accessories If the system is powered and pressurized accidental pump start up or unexpected pressure release can cause human injury 182 AKTA ready Operating Instructions 28960345 AD 12 Maintenance WARNING e Hazardous chemicals during run When using hazardous chemicals run System CIP and Column CIP to flush the entire system tubing with distilled water before service and mainte nance e Disconnect power Always disconnect power from the instru ment before replacing fuses NOTICE gt Disconnect power To prevent equipment damage always discon nect the power from the product before an instrument module is removed or installed or a cable is connected or disconnected In this chapter This chapter contains the following sections Section See page 12 1 Daily maintenance 184 12 2 Yearly maintenance 187 12 3 Spare parts 194 12 4 Storage 195 KTA ready Operating Instructions 28960345 AD 183 12 Maintenance 12 1 Daily maintenance 12 1 Daily maintenance General Regular maintenance is important for safe and trouble free operation of the KTA ready This section provides instructions for daily maintenance by the user Daily maintenance mainly includes cleaning and calibration of the pH electrode WARNING Electrical shock hazard All installation service an
43. on page 91 Incorrectly mounted pump tubing Check that the pump tubing has been correctly mounted and that the pump lid is properly secured Make sure the pegs on the pump lid are turned all the way down see Connect and mount the pump tubing on page 89 Poor pump tubing con nection Make sure the TC clamps connecting the pump tubing to the main part of the flow kit and to the inlet tubing are properly connected and that the TC gaskets are in right position Cavitation small air bubbles produced by under pressure which results in unstable flow meter readings Cavita tion is recognized by a hissing noise AKTA ready Operating Instructions 28960345 AD Conductivity 8 Component test 8 3 Troubleshooting a failed component test Problems with conductivity can be caused by Problem Solution Poor connection Make sure the conductivity sensor s connector cable is properly connected to the system cabinet see Mount the main part tubing on page 91 Wrong inlets used Check that the wash liquid is connected to inlet 6 and the test liquid to inlet 5 Wrong composition of wash liquid and or test solution Make sure that the liquids used are fresh and correctly prepared see Prepare a test on page 109 Errors in temperature readings Conductivity is temperature compensated and thus de pendent on correct temperature readings The tempera ture window is located on
44. product The labels on the system and information regarding recycling are also described Important WARNING Before installing operating or maintaining the product all users must read and understand the entire contents of this chapter to become aware of the hazards involved In this chapter This chapter contains the following sections Section See page 2 1 Safety precautions 15 2 2 Labels 24 2 3 Emergency procedures 27 2 4 Recycling information 30 2 5 Declaration of Hazardous Substances DoHS 31 14 AKTA ready Operating Instructions 28960345 AD 2 Safety instructions 2 1 Safety precautions 2 1 Safety precautions Introduction AKTA ready is powered by mains voltage and handles materials that may be hazardous Before installing operating or maintaining the system you must be aware of the hazards described in this manual The safety precautions in this section are grouped into the following categories e General precautions on page 15 e Flammable liquids and explosive environment on page 17 e Personal protection on page 16 e Installing and moving on page 17 e Operation on page 19 e Maintenance on page 22 General precautions WARNING e Risk assessment Perform a risk assessment for any risks due to the process or process environment Evaluate the effects the use of the product and the operational processes may have on the classification of the hazardous area The process mi
45. the back of the flow meter cell see Mount the main part tubing on page 91 Possible problems with temperature measurement are e Loose flow meter cell Check that the flow meter cell is properly snapped onto its mounting knobs see Mount the main part tubing on page 91 A gap be tween the temperature window and the sensor may cause incorrect measurements e Dirty or damp temperature window Wipe clean with soft tissue e System temperature not stable with respect to sur roundings If room temperature changes or if the system is moved from one room to another it must be given time to adjust to current room temperature e Make sure the temperature of the process liquid not differs more than 10 C from ambient temperature AKTA ready Operating Instructions 28960345 AD 119 8 Component test 8 3 Troubleshooting a failed component test UV Problems with UV can be caused by Problem Solution Insufficient light trans Check that the UV cell and sensor windows are clean and mission dry Wipe with soft tissue if necessary Incorrect mounting of Make sure that the UV cell is pushed all the way in UV cell Wrong inlets used Check that the wash liquid is connected to Inlet 6 and the test liquid to Inlet 5 Wrong composition of Make sure thot the liquids used are fresh and correctly wash liquid and or test prepared see Prepare a test on page 109 solution Condensation of mois Make sure the
46. the surfaces 3 Reconnect the transducers Calibrating pressure sensors If the readings from the pressure sensors deviate by more than 0 20 bar at any pressure after autozero at atmospheric pressure the sensors need to be calibrated Calibration requires a special pressure calibration cell article 28 9329 42 in Section 14 4 Ordering information on page 210 and a suitable pump The recommended pump is DPI 603 from GE Sensing Calibration is best performed with no flow kit mounted Calibration includes the following steps Step Action 1 Mount the calibration cell on pressure meter PT 111 figure shows calibra tion cell with pump tubing removed 2 Cycle the pressure cell a few times up to 5 bar until the reading at atmo spheric pressure is stable In the KTA ready System Control module on the System menu click Calibrate 3 In the the Calibrate dialog box select Monitor PT111 Make sure that Refer ence value 1 is set to 0 0000 and that the cell is at atmospheric pressure open the vent valve on the pump Click Read value 1 4 Close the venting valve on the pump and pump up to a pressure of 5 bar Make sure that Reference value 2 is set to 5 0000 bar and click Read value 2 AKTA ready Operating Instructions 28960345 AD 12 Maintenance 12 2 Yearly maintenance Step Action 5 Release the pressure and verify that the pressure reading is 0 00 0 01 bar at atmospheric pressure 6 Remove the calibr
47. tip when moved e Heavy object Because of the significant weight of the product great care must be taken not to cause squeezing or crushing injuries during movement At least two but preferably three or more people are recommended when moving the unit AKTA ready Operating Instructions 28960345 AD 17 2 Safety instructions 2 1 Safety precautions WARNING Access to power switch and power cord with plug Do not block access to the power switch and power cord The power switch must always be easy to access The power cord with plug must always be easy to disconnect Protective ground The product must always be connected to a grounded power outlet Supply voltage Before connecting the power cord make sure that the supply voltage at the wall outlet corresponds to the marking on the instrument High voltage The mains cable must only be connected by authorized service personnel Faulty connection might result in live system parts that can give lethal electric shocks Installing the computer The computer must be installed and used according to the instructions provided by the manufac turer of the computer CAUTION The wheels of AKTA ready should be locked during normal use The wheels should be unlocked only when moving the unit Make sure that all tubing hoses and cables are placed so that the risk of tripping accidents is minimized The product is designed for indoor use only Do not use the produ
48. to UNICORN uiccecccesssssssssessesssssccsssssssssssesssssecsssssssssussssessessssssssssssssessssesseessssssassees 5 2 Start EES E Flow kitinstalgtio ees En 6 1 KTA ready flow Kits nuusussennisninineniisnsininiariinasiiis 62 Unpackmgthe flow Kitt cssscssctsacsstenesannsscnsssssssgareesCsanensbennnssasasandetectscesaasessscoscanncecelussnouizadsetbcetddentears 63 Mounting the flow Kit csssssisssssccssssnsssesecsoscsontenssisossssonscosennsonvunsvvsssanesaseccacodsssvssssvtsasononennsienansisosevartzennay ARTA teady gradient sssusa raires r E aaie ERE aS 7 1 KTA ready gradient DUMP s ssssssisisissisisisrirsrsrrresistrrssrstrrsrrsrnrstrsrererrernrtreserstorsnratersnrarnrstrarere trant 7 2 KTA ready gradient flow Section s s susrssisisrssisisissiisisrrsrsrstressrtrrnrstrrnrsrnrnrsrertrnrertrnrertnrst 7 3 Calibrate and operate the KTA ready gradient PUMP s ss is1ssi1isisrirsrsrstsrstsrssrsrsrsnrsrerse COmMpPonent LOSE scissione aaea Ea Area R 8 1 RUN GCOMPONESNU testimisega nn Rn AAS KTA ready Operating Instructions 28960345 AD 10 11 12 13 14 Table of Contents 82 SASS OME ascccestasss3agiasscscccctescasstosa aan E A RRRA 8 3 Troubleshooting a failed component test Columa USD ON ede serizes oo sntaastack cataract ee trcdeectaecccrtonuatihuaderasiartlanachiusls gi COMMIS imsaren aaa A E E T 92 Installing Col M N sssini annaa A Aa RREAN 93 Optional COU HOSE anisses ann a AN AAR i 9 4 Optional column rinsin
49. types of columns may be used but may require special safety precautions More information about columns and separation media can be found in the Product catalog on the GE Healthcare web page address on back cover 124 AKTA ready Operating Instructions 28960345 AD ReadyToProcess columns ReadyToProcess columns are pre packed pre qualified and pre sanitized chromatography columns They are available with a range of BioProcess media such as Capto adhere Capto Core 700 Capto DEAE Capto L non sanitized Capto MMC Capto Q Capto S MabSelect non sanitized MabSelect SuRe MabSelect SuRe LX Butyl S Sepharose 6 Fast Flow Blue Sepharose 6FF CM Sepharose FF DEAE Sepharose FF Phenyl Sepharose 6 Fast Flow low and high sub Q Sepharose FF SP Sepharose FF ReadyToProcess columns are available in the following sizes 11 i d 80 mm bed height 200 mm 2 5 I i d 126 mm bed height 200 mm 10 I i d 251mm bed height 200 mm 201 i d 359 mm bed height 200 mm AKTA ready Operating Instructions 28960345 AD 9 Column installation 9 1 Columns 125 9 Column installation 9 1 Columns Ordering information for ReadyToProcess columns is found in Section 14 4 Ordering in formation on page 210 RTP columns packed with Capto and Sepharose 6FF media can be requested by GE Healthcare even if not listed in ordering list ReadyToProcess columns are qualified by efficiency testing and are deliv
50. value to stabilize and click Read value 1 5 Rinse the electrode in distilled water and place it in the other buffer solution Enter the pH value for the buffer in the Reference value 2 field wait for the value to stabilize and click Read value 2 6 Wait for response and if electrode passed click Close Otherwise click Close refresh change the pH electrode and repeat the calibration 7 Sanitize the pH electrode by spraying it with 70 ethanol 8 Let the pH electrode dry and mount it as described in step 5 in Mount the main part tubing on page 91 KTA ready Operating Instructions 28960345 AD 12 Maintenance 12 2 Yearly maintenance 12 2 Yearly maintenance About yearly maintenance Sensors Preventive maintenance should be performed on a yearly basis by qualified service personnel authorized by GE Healthcare Different service agreements are available Contact your GE Healthcare representative for more information contact information on back cover Although the user is not normally involved in long term periodic maintenance there are a few tasks that can be checked by the user if so desired e Change the air filter e Calibrate the pressure sensors It is important that the user is always attentive about the status and operation of the equipment The cause of any abnormal behavior or aberrant noise should be examined and removed If the problem is non trivial contact your local GE Healthcare representa tive
51. with different flow path ge ometries 3 Valid for max temperature difference of 10 C between liquid and ambient temperature Temperature compensation optional The standard setting of the cell constant for the sensor is 12 5 cm and is not to be changed when replacing flow kits Valid at actual temperature no temperature compensation Temperature compensation not available Cell length 1 8 mm 0 2 mm o y DMN Cell length 1 8 mm 0 2 mm KTA ready Operating Instructions 28960345 AD 205 14 Reference information 14 2 Process wetted materials 14 2 Process wetted materials Materials used The materials used in the manufacturing of AKTA ready have been chosen for their bio logical and chemical compatibility with the solvents used during operation The system has also been designed to comply with the varying hygienic requirements at the different stages of development and production The flow kit tubing has been treated with gamma radiation except for the pump tubing which has been autoclaved the pH electrode has not been treated List of wetted materials Component Materials Tubing Silicone platinum cured reinforced tubing in high pressure flow path Pump tubing Composite of expanded Polytetrafluoroethylene PTFE and platinum cured silicone Connectors Polypropylene PP polyether ether ketone PEEK Flow meter body Polymethylpentene TPX Air trap Polyamide PA transparent
52. 0 1 1 Introduction to the Method Editor Opening the Method Editor 144 Open the Method Editor window from the UNICORN Manager module by clicling Method Editor it in the task bar at the bottom of the screen Step Action 1 Click the Customize panes icon in the Method Editor toolbar 2 Select the Text and Instruction box checkboxes in the Customize panes dialog box shown 3 Click OK The upper part of the Method Editor window now shows the Text pane and the lower part the Instructions box It is possible to also show an op tional flow diagram or a block dia gram in the Method Editor by select ing the appropriate items in the Cus tomize panes dialog box These dia grams can help when programming advanced methods but are not re quired for building or editing a method They are therefore not includ ed in the following discussion OK Cancel Help KTA ready Operating Instructions 28960345 AD 10 1 2 Method Editor layout Text pane The Text pane contains an overview of the method in the form of an expandable list with all blocks and instructions in the method Blocks are marked by blue square symbols The figure to the right shows a method with several blocks and instructions For a newly created method only the Main block is shown with a defined Base The list in the Text pane has a tree structure and individual blocks can be expanded or contracted as indicated by the or signs When expanded
53. 0345 AD 2 Safety instructions 2 3 Emergency procedures Power failure The system power is lost if the Mains power switch on the cabinet is turned off the mains cable disconnected or the power supply is lost The pump stops if the electrical power to the system is lost All valves will immediately revert to default positions Any data that has not been saved at that time may be lost If only the system is affected by the power failure and not the computer UNICORN will display text saying that communication has been broken and that no data are recovered When power returns to normal the system will be in End state i e it will not resume the run A UPS Uninterrupted Power Supply protects against temporary power failures by en abling the system to continue to operate for a limited time A UPS is not included with the system Contact your local GE Healthcare representative for more information about the options for your specific system NOTICE If the compressed air is lost all inlet and outlet valves will close and all valves at the system front will open The pressure is let out via the air trap There is no risk for the user or the system but the product may be damaged Restart after emergency shut down or power failure Step Action 1 Make sure that the condition that caused the power failure or emergency stop is corrected Reset the EMERGENCY STOP button by twisting it clock wise 3 Press the PA
54. 2 13 14 15 16 17 18 19 20 GE a5 0 30 min ManFlow 50 0 a 0 35 min Message Fyll luftf llan till ungef r h lften Screen hoot For Help press F1 Run Main No watch Controlled By Anna The progress of the run can be viewed in detail in the UNICORN System Control module Up to four different panels can simultaneously display different aspects of the run To customize content and layout of a panel right click and then click Properties By clicking Documentation and then Run notes it is possible to add notes during a run Entered notes will be included in the results More information regarding the monitoring possibilities that the UNICORN user interface offers is available in the UNICORN User Manual 176 KTA ready Operating Instructions 28960345 AD 11 Runa method 11 2 Starting a run Ending Normal completion If no unexpected events occur during the run UNICORN enters END state at method completion without need for user interaction End before method has finished To end the run before the method has finished click on the End button at the top of the Control module window This will produce a confirmation dialog box Click OK in the dialog box to end the run or click Cancel to keep running In the dialog box you can choose to save the partial results from the run so far If the run is part of a scouting run you are also given the choice of ending this If you do not the next run will start automatically E
55. 345 AD 223 Index Index 224 A Accessories 210 223 Accessory kit 57 Air sensor 50 AKTA ready Areas of application 35 Associated products 35 Dimensions 58 202 Features 35 Flow chart 45 ncluded in the delivery 57 nstallation 55 ntended use 34 Layout 36 aintenance 182 Run a method 170 Specifications 58 202 Starting 74 Unpacking instruction 65 Weight 58 202 AKTA ready gradient Gradient flow section 97 Gradient range 97 Unpacking instruction 65 Weight 58 Associated products 35 B Barcode reader installation 73 Breakpoint method editor 145 C Calibration pH checklist 220 Pressure sensors 218 Pressure sensors check list 217 CE conformity 9 CE marking 10 Center of gravity 63 Checklists 217 Chemical resistance 207 Chemicals 209 Column Adding to column list 139 Installation 122 127 Optional column rins ing 138 Optional column test 135 ReadyToProcess 125 Types 124 Components Drawing back 40 Drawing front 38 Component test 107 Run a test 108 Test report 113 Troubleshooting 117 Compressed air Connecting 59 Computer 69 Conductivity cell 93 Conductivity sensor 51 Connections 67 Creating a method 141 Customer I O 70 D Delivered items 57 Description 33 Documentation Generic 12 Related literature 13 E Emergency Procedures 27 Restarting the system 29 Shutdown 28 Stop 28 Equipment 48 Explosive e
56. 6 Flow kit installation 6 3 Mounting the flow kit Open the installation wizard Step Action 1 e UNICORN 5 In the KTA ready System Control module on the File menu click Instant Run and then click Run in the dialog box shown e UNICORN 7 In the AKTA ready Method Editor module on the File menu click New Method Click Method Wizard in the New Method dialog box and then click OK In the wizard click Flow kit Installation with Component Test Installation of a new flow kit normally includes a component test Main Selection Flow Kit Installation with Component Test L Print Report Automatically Note Before continuing the correct size of flow kit must be selected in the component list The pH electrode must also be calibrated and prepared in accordance to the AKTAready User Manual Select the Print Report Automatically checkbox if you want to automatically print a report with installation information and test results Note A printed report can also be produced later In the Evaluation module on the File menu click Report In UNICORN 7 the installation wizard creates a new method Save the method and then run it in the System Control module 84 AKTA ready Operating Instructions 28960345 AD 6 Flow kit installation 6 3 Mounting the flow kit Open all safety locks on pinch valves The safety locks keep the pinch valves locked in an open position thereby preventing injuries due to for instan
57. 8 RTP CM Sepharose FF 20 20 28929119 DEAE Sepharose FF 6FF RTP DEAE Sepharose FF 1 1 28951126 RTP DEAE Sepharose FF 2 5 2 5 28929114 RTP DEAE Sepharose FF 10 10 28929115 RTP DEAE Sepharose FF 20 20 28929116 212 KTA ready Operating Instructions 28960345 AD 14 Reference information 14 4 Ordering information Resin Product Size Product code Q Sepharose FF 6FF RTP Q Sepharose FF 1 1 28951125 RTP Q Sepharose FF 2 5 2 5 28929076 RTP Q Sepharose FF 10 10 28929079 RTP Q Sepharose FF 20 20 28929082 SP Sepharose FF 6FF RTP SP Sepharose FF 1 1 28951097 RTP SP Sepharose FF 2 5 2 5 28929105 RTP SP Sepharose FF 10 10 28929106 RTP SP Sepharose FF 20 20 28929107 RTP columns packed with Capto and Sepharose 6FF media can be requested by GE Healthcare even if not listed in ordering list above KTA ready IQ 0Q tools Product Product code Low flow test kit KTA ready 28933680 UV Cond test tools KTA ready 28933688 Pressure calib tool KTA ready 28932942 Temp test tool KTA ready 28938864 KTA ready Operating Instructions 28960345 AD 213 14 Reference information 14 5 PID control 145 PID control Introduction PID control Proportional Integral Derivative control is a well established and widely used method for feedback control of processes This chapter contains a brief discussion about PID control and how it is used in KTA ready Princ
58. 97 13 Troubleshooting Component Air in flow path Problem Air enters the flow path The alarm Uncertain flow is displayed and the system enters PAUSE mode Corrective action Air enters the flow path due to for instance damaged tubing or connector dislocated TC gasket or inlet hose not properly located in liquid In rare cases cavitation due to underpressure may be the cause for air in the flow path Cavitation can be recognized by a hissing noise Check for kinks on flow kit tubing 1 Locate and rectify the problem Check the flow path including the inlet containers 2 Remove any air in the flow path using the ManFlow command in UNICORN 3 Restart the run by pressing the PAUSE CONTINUE button Note Note that small amounts of air are handled by the air trap Larger amounts reaching the flow meter cell cause Uncertain flow alarm Flow meter Warning Fine tuning flow meter failed is displayed The warning message means that the inaccuracy of the flow meter is maximum 1 unit higher than speci fied The lubricant between the flow meter cell and the transducers may be insufficient Lubricate according to the instructions in Applying lu bricant to flow meter cell on page 188 Valves Alarm Valve error is dis played A valve lock may be open Check the valve locks Close if necessary Note Before attempting to close the manual valve lock make su
59. A ready Operating Instructions 28960345 AD 195 13 Troubleshooting 13 Troubleshooting About this chapter This chapter provides required information to enable users and service personnel to identify and correct problems that may occur when operating AKTA ready Note that problems related to sensors and valves normally are revealed during the component test which is discussed in Chapter 8 Component test on page 107 This chapter focuses on mechanical parts such as valves and the pump and on problems caused by a failing power supply or pressurized air If the suggested actions in this guide do not solve the problem or if the problem is not covered by this guide contact your GE Healthcare representative 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 Section 2 1 Safety precautions on page 15 as listed below e General precautions on page 15 e Flammable liquids and explosive environment on page 17 e Personal protection on page 16 e Maintenance on page 22 196 AKTA ready Operating Instructions 28960345 AD 13 Troubleshooting System Component Problem Corrective action Computer No system found when e Make sure the system is switched on starting up UNICORN e Check communication cable and connectors e If system is connected to a switch or hub check that the ext
60. AKTA ready Operating Instructions Original instructions Table of Contents Table of Contents 1 A aa ee 1 1 Important user information 1 2 Regulatory INFOMATION scssisesesscososcsssessivsssscassooneassennsssnssasesvebtossonnsodaoesussesssreetnsenvvnssosssscedeseedteedbinoeses 1 3 ASSOCIALER GOCUMENTALIOM neraninunaniii n a R na Se NStrUC TORNS zeroen ec en ee reer eee ZI Safet HECCUITI ONS sis ssscscssssssscehssavassasaasssccocchcezasa seats sascoavgyezsssavban cbssttncevanseasszasvnaaisevasssssseacentttevten 22 Eabele EAR A 2 3 EPMERG SNE Y proc d fe Ssnan n An NORRAN NANEN 2 4 Recycling information weceeccecscsssssssssssesseesecsscsesssnssneesees 2 5 Declaration of Hazardous Substances DoHS System GESCIOTION sss a E E e E O E EE EAEE E 3 2 MY OUI rne a a E a E E 2A CINE EE AEEA ARE AAEE SA CUNO ST aeee a e a E A AEN 35 UNICORN control syst m messissininisninnimasiamnin niaaa IHstalationosan neea aa e aE Ea aae Poe mere Pent can AT TAGISH ASSIS EY gieisiiinsenudiummmuiann aai enisi 4 2 Site TEGUIFEMOENES aiss tsascscederca eens cesed aia nn i a a a aa 4 3 MANSO Tinan a E a a E E aE 4 4 Unpacking AS Positioning thE Syste saemgisnannanipnnaceann aaan a a 4 6 CONNECHIONS ness sceeeseseesscsscccccscesssnnnesscesccecccessnsnunssssceeccesceessssnssnesseceeseseesssssunasssseseseesasssnneuetseseeseeeseees Starting AKTA reddy sicacnertrsrscentenininccrtnsemeninientierieneneanamanes 5 1 Start and log on
61. AirTrap Bypass 2 00 InjectionMark 2 00 ManFlow 50 0 2 00 Column Bypass 2 00 Column Inline 2 00 Flow 300 0 cm h 42 80 End_Block AKTA ready Operating Instructions 28960345 AD 10 Creating a method 10 2 An example of using the Method Editor 10 2 8 Block 7 Washing unbound sample 10 2 8 Block 7 Washing unbound sample After applying the sample you need to define instructions to wash out any unbound sample from the column Step Action 1 Create a block named MyWashOut Sample and set its Base to Time 2 Select the inlet for the wash liquid by inserting an Inlet instruction at time 0 00 Set the inlet to for instance Inlet6 3 Insert a Hold_Until instruction that is sex ih 5 i W 0 00 Block MyWashOutSample triggered when UV readings are CAyWashoutSampie Less_Than a set limit e g 100 MAU 0 00 Inlet Inlet6 At this point the flow path is consid 0 10 End_Block ered to be clean and the block will finish The MyWashOutSample block first switches to the inlet of the washing liquid and then washes the flow path until the UV readings indicate it is clean KTA ready Operating Instructions 28960345 AD 163 10 Creating a method 10 2 An example of using the Method Editor 10 2 9 Block 8 Elution 10 2 9 Block 8 Elution Similar to sample load and washing in previous blocks elution is controlled by UV re sponse You thus need to define two watch blocks with UV based criteria for starting and stopping the elut
62. Hazardous Substances caused by electrical and electronic products BFS SP m ee oll in ee AB Explanation of Pollution Control Label BreRAAY MER BH GB T 26572 HF BRE m RA BR Qo BER FREWER MEAPRAPFAAP RHSREAM RAA m EER PAWREAT RABRSWAFAREMMRRS APERAS A RFA WME RP BS SRRWRAR UTR SRSHRR HARE FA RUER BAY 2 GR 5 FA BBR AR m EAR PE RRA HE TIE FEA HPT mes FM PMEN ERMAN RAE RK Fan FAY aE A A SE SB RE BR RR HBR ARRAT RELL Pr MASH REAR EIR me Se BIR BD E SREE DRIEPT RA AY NP a BY RE BBR ANF Gn TEE FS on 2 RNT AEA I EAE RI RR Nh This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese standard GB T 26572 Requirements of concentration limits for certain restricted substances in electrical and electronic products The number in the symbol is the Environment friendly Use Period EFUP which indicates the period during which the hazardous substances contained in electrical and elec tronic products will not leak or mutate under normal operating conditions so that the use of such electrical and electronic products will not result in any severe environmen tal 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 ac cording to the instructions and environmental conditions as defined in the product manual and periodic maintenance schedules specified in Product Main
63. KTA ready for example in the air lock if the system is in a clean room 2 Take out the inside plastic bags and move them together with the other flow kit equipment to the system cabinet Open the bags immediately before mounting the flow kit onto the system cabinet Note In addition to the plastic wrappings AKTA ready flow kits are equipped with plastic end caps protecting the connectors from contamination Do not remove any of the end caps until it is time to connect the flow kit to buffer bags tanks and to column which are the last steps in the mounting procedure see Sec tion 6 3 Mounting the flow kit on page 81 and Section 9 2 Installing a column on page 127 Labeling of flow kits The different parts of the AKTA ready flow kits are labeled and equipped with bar codes The bar codes are primarily used for traceability ReadyToProcess Columns have bar codes for the same purpose 80 AKTA ready Operating Instructions 28960345 AD 6 Flow kit installation 6 3 Mounting the flow kit 6 3 Mounting the flow kit Introduction This section contains a step by step description of how to install a flow kit onto the AKTA ready cabinet The procedure described here is an extended version of the proce dure described in the Flow Kit Installation part of the AKTA ready Installation Wizard There is however no direct correspondence between the numbering of the steps in the wizard and the numbering used here You are recommended to
64. KTA ready gradient flow section Step Action T Connect the other end of the jumper tubing to the right side of the KTA ready gradient pump tubing placed on the the system pump 8 Connect the inlet manifold to the left side of the KTA ready gradient pump tubing placed on the KTA ready system pump P 201 using a TC clamp 9 Connect the B buffer tubing to the left side of the AKTA ready system pump tubing placed on the AKTA ready gradient pump P 202 inlet 7 using a TC clamp 102 AKTA ready Operating Instructions 28960345 AD 7 AKTA ready gradient 7 3 Calibrate and operate the AKTA ready gradient pump 7 3 Calibrate and operate the KTA ready gradient pump Introduction The calibration procedure compensates for differences in capacity of pump A P 201 and pump B P 202 at a given motor speed as a result of pump tubing position and properties With the assumption that each pump has a linear behavior of flow rate vs rpm within a given range of operating pressure a compensation factor is determined within the calibration procedure to allow a synchronization of the pumps against a nominal volumetric gradient Pump compensation Step Action 1 Start the system pump at a flow rate planned for the actual separation 2 When flow rate is stable click P201Gain and shift to Gradient 100 3 When flow rate is stable click P202Gain and shift to Gradient 0 and activate Flow_Compensation Calibration procedu
65. NG indicates a hazardous situation which if not avoided could result in death or serious injury It is important not to proceed until all stated conditions are met and clearly understood Cautions CAUTION CAUTION indicates a hazardous situation which if not avoided could result in minor or moderate injury It is important not to proceed until all stated conditions are met and clearly understood AKTA ready Operating Instructions 28960345 AD 7 1 Introduction 1 1 Important user information Notices NOTICE NOTICE indicates instructions that must be followed to avoid damage to the product or other equipment Notes and tips Note A note is used to indicate information that is important for trouble free and optimal use of the product Tip A tip contains useful information that can improve or optimize your procedures Typographical conventions Software items are identified in the text by bold italic text A colon separates items in a group for example Flowpath Injection valve refers to the Injection valve item in the Flowpath group Hardware items are identified in the text by bold text for example the Power button 8 KTA ready Operating Instructions 28960345 AD 1 Introduction 1 2 Regulatory information 1 2 Regulatory information In this section This section describes the directives and standards that are fulfilled by AKTA ready Manufacturing information The table below su
66. New Method Click Method Wizard in the New Method dialog box and then click OK In the wizard click Troubleshoot Failed Component Test Select which components to troubleshoot by selecting one or more of the checkboxes shown Troubleshoot Failed Component Test Pressure Cells Test Failed Flow Meter Cell Test F aled Conductivity Cell Test Failed UV Cell Test Failed Valve Related Issues C Frnt Report Automatically In UNICORN 7 the wizard creates a new method Save the method and then run it in the System Control module AKTA ready Operating Instructions 28960345 AD 117 Flow meter 8 Component test 8 3 Troubleshooting a failed component test Pressure sensors The most likely reason for pressure sensors to return incorrect values is incorrect mounting e Make sure that each flow cell is properly aligned with its adapter Check that there is no gap between flow cell and adapter If necessary loosen the screws and remount the cell according to the instructions in Mount the main part tubing on page 91 The screws holding the latch pressing the flow cell against the adapter should be firmly tightened using finger force Problems with incorrect flow meter readings can be caused by Problem Solution Transducer surfaces not treated with Vaseline Make sure Vaseline has been applied to the contact sur faces of the transducer connectors see Mount the main part tubing
67. Operating Instructions 28960345 AD 61 4 Installation 4 3 Transport Lifting AKTA ready There are no lifting hooks on AKTA ready Use a forklift or a pallet jack with a minimum capacity of 400 kg for lifting the system Appropriate safety precautions should be fol lowed CAUTION Do not attempt to lift the system by the handle on the left side of the system cabinet The handle is for maneuvring the cabinet on the floor not for lifting 62 AKTA ready Operating Instructions 28960345 AD 4 Installation 4 3 Transport Center of gravity The center of gravity for AKTA ready is indicated with a dashed and dotted vertical line in the drawings below Note The line is located slightly towards the back of the cabinet This must be taken into consideration when moving or lifting the cabinet AKTA ready Operating Instructions 28960345 AD 63 4 Installation 4 3 Transport Positioning forks o 64 KTA ready Operating Instructions 28960345 AD 4 4 Unpacking Check for damage 4 Installation 4 4 Unpacking Check the equipment for damage before starting assembly and installation There are no loose parts in the crate All parts are either mounted on the system or located in the accessory kit box If any damage is found document the damage and contact your local GE Healthcare representative Safety Precautions WARNING Personal
68. Part Component ID tag Function 1 Inlet manifold XV 001to Manifold with 6 inlets corresponding to valves XV 006 XV 001 to XV 006 25 mm TRI Clamp TC connectors 2 Pump tubing Double pump tubing for mounting in the peristaltic pump Double tubing increases ef ficiency and reduces pulsation 3 Flow cell for PT 111 Flow cell for pressure sensor PT 111 The pressure sen sensor measures the pressure after the pump sor 4 Air trap AT 221 Air trap allows for removal of air in buffers and sample Air trap is filled air is evacuated by pressing the AIR VENT button 5 Airventtubing Tubing for ventilation of air to from the air trap Manually controlled by the AIR VENT button via valve HV 301 6 Column inlet Connector to column inlet tubing 25 mm TC connector connector 7 Column outlet Connector to column outlet tubing 25 mm connector TC connector 8 Flow cell for PT 112 Flow cell for pressure sensor PT 112 The pressure sen sensor measures the pressure between pump sor and column A pH electrode can be mounted in the flow cell A dummy is placed in the electrode holder when flow kit is delivered 9 pH electrode AE 121 Sensor measuring pH of the liquid Can be optional mounted in flow cell for pressure sensor PT 112 See information about sanitization below ta ble 10 Flow meter FE 141 Flow cell for flow meter sensor FE 141 which cell measures flow using ultrasound 11 Temperature TE 161 Window for temp
69. Polypropylene PP pH electrode Polyoxymethylene POM ceramics junction glass pH electrode dummy Polypropylene PP Conductivity cell Polypropylene PP titanium UV cell Polypropylene PP Sealing materials Ethylene propylene diene monomer EPDM fluoroelastomer FKM thermoplastic elastomer TPE 206 KTA ready Operating Instructions 28960345 AD 14 Reference information 14 3 Chemical resistance 14 3 Chemical resistance External surfaces cabinet e Water with weak detergent should be used for daily cleaning of the cabinet e 70 ethanol or 2 propanol lsopropanol can be used for sanitization Wetted parts You must consider the compatibility of the wetted parts and your process chemicals so that no negative interaction takes place Also ensure that your process chemicals do not damage the system components compromising the safety of the system Contact your local GE Healthcare representative if you are not sure of the compatibility of your chemicals AKTA ready flow paths are resistant to chemical agents used in protein recovery including buffer solutions for adsorption elution and washing and to solutions effective in cleaning and storage The following table lists chemicals that may be used with AKTA ready The concentrations listed are not normally exceeded during an operating cycle The information in the table below is valid for a maximum exposure time of 48 hours Note The tabl
70. Timeout 0 00 9999 90 vVar 5 00 min C INFINITE 158 KTA ready Operating Instructions 28960345 AD 10 Creating a method 10 2 An example of using the Method Editor 10 2 5 Block 4 Filling the flow kit Nested block Filling the air trap Create a separate block for filling the air trap Make this a nested block placed inside the MyFillFlowKit block Step Action 1 Create a new block with the name MyFillAirTrap and set its base to Volume Set From MyFillFlowKit instead of Main and insert the block at time 0 40 The MyFillAirTrap block will now be placed inside MyFillFlowKit 2 If not already selected select the new block MyFillAirTrap in the Text pane to make it available for editing 3 Set an AirTrap instruction to Inline and insert it at volume 0 0 4 Insert a Man_Flow instruction with the flow set to 50 at volume 0 0 5 Insert a Message instruction containing a message to the user that the AIR VENT button must be pressed in order to fill the air trap Set the message to appear on Screen and add a Sound signal if so desired Instructions Parameters OP Base a Message gag ho Var Go to system and press AifVent button until AirTrap OFlowPath End Block Mode OAlamstMon End Method Var Screen wj Flow_Waring Sound Ofiss Hold hoot2 x O Watch Loen End Other New Chromatoaram w 6 Set the End_Block instruction for the nested block at volume 2 50 which means that the
71. USE CONTINUE button The system will continue the run with all settings intact KTA ready Operating Instructions 28960345 AD 29 2 Safety instructions 2 4 Recycling information 2 4 Recycling information Introduction This section contains information about the decommisioning of AKTA ready Decontamination The product must be decontaminated before decommissioning All local regulations must be followed with regard to scrapping of the equipment Disposal of the product When taking the product out of service the different materials must be separated and recycled according to national and local environmental regulations Recycling of hazardous substances The product contains hazardous substances Detailed information is available from your GE Healthcare representative Disposal of electrical components psd Waste electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of the equipment 30 AKTA ready Operating Instructions 28960345 AD 2 Safety instructions 2 5 Declaration of Hazardous Substances DoHS 2 5 Declaration of Hazardous Substances DoHS ARYE SJ T11364 2014 BF RAS mA SYR EAR SRAM LARS RE Aw AES The following product pollution control information is provided according to SJ T11364 2014 Marking for Restriction of
72. all the block instructions and nested blocks are displayed and available for editing Editing is done in the Instructions box in the lower part of the Method Editor window Instructions box 10 Creating a method 10 1 The Method Editor 10 1 2 Method Editor layout H Man The parameters for the block or instruction that is currently selected in the Text pane are displayed and available for editing in the Instructions box in the lower part of the Method Editor window Breakpoint 0 00 Scy Instructions O Pump Parameters Var Base a Mode Block q ntinue Disabled Insert v O FlowPath Beier Var H O AlarmstMon O Frac O Watch Other Loop Loop_End Message New Chromatoaram x Enabled Cn Ready The Instructions box is divided into four areas These are from left to right Breakpoint Contains a field for setting the breakpoint for the instruction or block in the unit currently selected as base the base can be Time or Volume e Instructions Contains controls for selecting an instruction from a list The instruc tions available are grouped according to function Groups are selected using the radio buttons to the left of the list area e Parameters Contains parameter fields for the chosen instruction The parameters will vary between the different instructions AKTA ready Operating Instructions 28960345 AD 145 10 Creating a method 10 1 The Met
73. alves Perform a functional test of all valves in the system by manually switching each valve on off in UNICORN Airtrap valve HV 301 is manually controlled with the AIR VENT button on the front of the system cabinet Check that the flow diagram in UNICORN is updated and that the valve is in its correct state In the record table mark checked function with OK Not OK Valve Open Closed Remark XV 001 XV 002 XV 003 XV 004 XV 005 XV 006 XV 021 XV 022 XV 023 XV 031 XV 032 XV 033 XV 051 XV 052 XV 053 XV 054 XV 055 XV 056 HV 301 KTA ready Operating Instructions 28960345 AD 219 14 Reference information 14 6 Checklists 220 pH calibration Perform a pH calibration as described in pH calibration on page 186 In the table below enter the recorded pH values after calibration Component pH4 Remark AE 121 Installation test method performance Perform a component test as described in Chapter 8 Component test on page 107 The test result printed report is attached to the ITR and filed in the customer log book Component OK Remark Not OK UV Conductivity Flow Pressure sen sors System serial number Installation preformed by Date Installation accepted KTA ready Operating Instructions 28960345 AD 14 Reference information 14 7 Health and Safety Decla
74. and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be re quired to correct the interference at his own expense Environmental conformity This product conforms to the following environmental requirements Requirement Title 2012 19 EU Waste Electrical and Electronic Equipment WEEE Directive 94 62 EC and Packaging and Packaging Waste Directive and amendment 2004 12 EC ACPEIP Administration on the Control of Pollution Caused by Electronic Information Products China Restriction of Hazardous Sub stances ROHS Regulation EC Registration Evaluation Authorization and restriction of No 1907 2006 CHemicals REACH Regulatory compliance of connected equipment Any electrical equipment connected to AKTA ready should meet the safety requirements of EN IEC 61010 1 or relevant harmonized standards Within EU connected equipment must be CE marked AKTA ready Operating Instructions 28960345 AD 11 1 Introduction 1 3 Associated documentation 1 3 Associated documentation Generic documentation Together with each system the following manuals are supplied providing information that applies to AKTA ready independent of the specific configuration Document Purpose Contents AKTA ready Operating Instruction
75. arily used to verify the conductivity of buffer solutions Conductivity measurement is temperature compensated and thus dependent on correct temperature readings The conductivity sensor cable is connected to the system cabinet using a screw on connector secured by a fastening nut The standard setting of the cell constant is 12 5 cm UV cell The UV cell AE 131 is located after the conductivity cell in the flow path The cell consists of a transparent rectangular flow cell The cell is mounted in a holder containing a UV LED emitting at 280 nm and two detectors measuring the UV absorbance of the liquid For correct measurements it is important that UV cell and sensor windows are properly fitted kept clean and dry The temperature of the process liquid must not be lower than 10 C from the ambient temperature Otherwise there is a risk for condensation of moisture on the flow cell window AKTA ready Operating Instructions 28960345 AD 51 3 System description 3 5 UNICORN control system 3 5 UNICORN control system Overview AKTA ready is controlled by UNICORN process control software AKTA ready can be controlled by both UNICORN 5 and UNICORN 7 UNICORN can save established processes as methods The methods include the instructions necessary for process operation and documentation UNICORN includes a comprehensive system of user access levels to be programmed limiting the operations a given user may perform on AKTA ready To sec
76. ation Performed installation test test details below Installation test checklist Calibration pressure sensors Perform pressure sensor calibration as described in Calibrating pressure sensors on page 188 Pressure Perform Sign Remark sensor PT 111 Calibration at 0 bar g Calibration at 5 bar g PT 112 Calibration at 0 bar g Calibration at 5 bar g PT 113 Calibration at 0 bar g Calibration at 5 bar g KTA ready Operating Instructions 28960345 AD 217 14 Reference information 14 6 Checklists 218 Check pressure sensor calibration In the record table below enter the True pressure value reference and the corresponding Read value computer run data Pressure Check True val Read val Remark sensor ue ue PT 111 Calibration at 0 bar g Calibration at 5 bar g PT 112 Calibration at 0 bar g Calibration at 5 bar g PT 113 Calibration at 0 bar g Calibration at 5 bar g Temperature sensor check Verify that the temperature sensor is working and gives a realistic value This can be done by filling a plastic test tube with tempered water and holding it in front of the temperature sensor Then check that the temperature Temp_161 in UNICORN is re sponding Component Sign Remark TE 161 AKTA ready Operating Instructions 28960345 AD 14 Reference information 14 6 Checklists Check function of v
77. ation cell and verify that the reading now is 0 20 bar or less if it is not contact GE Healthcare 7 PT 111 is now calibrated Repeat the procedure for pressure sensors PT 112 and PT 113 Note that PT 112 differs in the mounting of the calibration cell an extra block must be inserted arrow in figure to compensate for the larger distance Calibrating conductivity sensor Note Calibration of the conductivity sensor is normally not necessary in UNICORN because a standard setting of the cell constant is used The procedure for calibrating the conductivity sensor is shown in the following steps Step Action 1 Prepare a calibration solution of 1 00 M NaCl 58 44 g 1000 ml Let the solu tion reach room temperature This is important for exact measurements 2 Set temperature compensation factor CompFactor to zero The CompFactor instruction is found under Monitors in the Settings dialog box 3 Fill the cell completely with the calibration solution by pumping at least 15 ml through the cell using a syringe AKTA ready Operating Instructions 28960345 AD 189 12 Maintenance 12 2 Yearly maintenance Step Action 4 When finished wait for 15 minutes until the temperature is constant in the range 20 C to 30 C In the AKTA ready System Control module on the System menu click Calibrate Select Cond_Cal on the Monitor menu Read the conductivity value displayed under Measured value and compare
78. ave the flow kit contained in for example an autoclave bag Remove the protective caps before autoclaving Dispose of the empty flow kit and column in accordance with local regula tions Also consult the instructions in the column documentation AKTA ready Operating Instructions 28960345 AD 181 12 Maintenance 12 Maintenance About this chapter AKTA ready uses ReadyToProcess flow kits Maintenance tasks performed by the user are therefore few and simple Regular maintenance is however important for safe and trouble free operation of the AKTA ready This chapter provides instructions for mainte nance by the user and for replacing spare parts Preventive maintenance should be performed on a yearly basis by qualified service personnel authorized by GE Healthcare Contact your GE Healthcare representative for more service information 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 Section 2 1 Safety precautions on page 15 as listed below e General precautions on page 15 e Flammable liquids and explosive environment on page 17 e Personal protection on page 16 e Operation on page 19 e Maintenance on page 22 WARNING e Only personnel authorized by GE Healthcare may perform service installation and maintenance of components inside the cabinet e Shut down before
79. ce a faulty compressed air supply To open them Step Action 1 Start the installation by turning the Installation switch in the upper right corner of the sys tem cabinet to its left position FLOW KIT COLUMN FLOW KIT INSTALL UNICORN INSTALL INSTALL must be in END mode 2 Open the safety locks on all pinch valves The valve safety locks are opened by turning the black handles 180 degrees There are 19 valves in total RUN AKTA ready Operating Instructions 28960345 AD 85 6 Flow kit installation 6 3 Mounting the flow kit Remove the pump lid 86 Step Action 1 Locate the bolts holding the pump lid Use the supplied 10 mm wrench located on the in side of the front cabinet door to rotate the right hand bolt counter clockwise and the left hand bolt clockwise until both are fully open It will be neces sary to reposition the wrench Check the position of the two pegs at the back of the lid The pegs indicate when the bolts are fully open closed Lift the pump lid and remove it completely AKTA ready Operating Instructions 28960345 AD 6 Flow kit installation 6 3 Mounting the flow kit Open pressure cell holders Step Action ik Locate the three pressure cell holders for pressure sensors PT 111 PT 112 and PT 113 2 Release but do not remove the screws on the latches and turn the latches open KTA ready Operating Instructions 28960345 AD 87 6 Flow
80. ct in a dusty atmosphere or close to spraying water ake sure that correct air pressure is always maintained Too high or too low air pressure may be hazardous and may cause erroneous results and leakage f the system is re configured the system label must be updat ed accordingly Use a permanent ink pen or the stickers sup plied with the system 18 AKTA ready Operating Instructions 28960345 AD Operation 2 Safety instructions 2 1 Safety precautions CAUTION e Donot attempt to lift the system by the handle on the left side of the system cabinet The handle is for maneuvring the cabinet on the floor not for lifting NOTICE e Donotturn on the Mains power switch before all connections are made e AKTA ready shall be installed and prepared by personnel from GE Healthcare or third party authorized by GE Healthcare Contact GE Healthcare if you require re installation at a new site A WARNING e Do not operate the KTA ready instrument in any other way than described in the AKTA ready and UNICORN manuals AKTA ready Operating Instructions 28960345 AD 19 2 Safety instructions 2 1 Safety precautions WARNING Never exceed the operating limits stated in this document and on the system label Operation of the product outside these limits can damage equipment and cause personal injury or death High pressure The flow rate may under no circumstances exceed the specif
81. ctors Connecting the flow kit parts after they have been mounted on the cabinet is the recom mended procedure since this ensures correct positioning Stray light calibration should be done prior to run of system 96 KTA ready Operating Instructions 28960345 AD 7 AKTA ready gradient 7 KTA ready gradient About this chapter This chapter provides an overview of the details of KTA ready gradient It describes how to install the AKTA ready gradient flow section It also provides an instruction how to calibrate the pump Gradient linearity is 4 between 10 to 90 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 Section 2 1 Safety precautions on page 15 as listed below e General precautions on page 15 e Flammable liquids and explosive environment on page 17 e Personal protection on page 16 e Operation on page 19 In this chapter This chapter contains the following sections Section See page 7 1 AKTA ready gradient pump 98 7 2 AKTA ready gradient flow section 99 7 3 Calibrate and operate the AKTA ready gradient pump 103 AKTA ready Operating Instructions 28960345 AD 97 7 AKTA ready gradient 7 1 AKTA ready gradient pump 7 1 AKTAready gradient pump Introduction AKTA ready gradient pump consists of a stainless steel box containing a pump mot
82. cularly sensitive to NaOH which corrodes the aluminum After cleaning make sure there is no liquid left on the windows of the UV detector If necessary wipe the windows using soft absorbent tissue After cleaning flush the entire system with water or suitable liquid to remove the CIP solution In some instances you can use the system instrumentation to monitor the removal of cleaning solution To avoid corrosion wipe the cabinet dry after cleaning Note Ifa fuse repeatedly blows shutdown the AKTA ready main switch and contact your local GE Healthcare representative AKTA ready Operating Instructions 28960345 AD 185 12 Maintenance 12 1 Daily maintenance pH calibration pH calibration should be done at least once a day Suitable pH buffer solutions are re 186 quired Note It is recommended to use fresh pH buffer solutions at every calibration Step Action Hl Two cups with the buffers representing the actual pH range are placed in the small holder located on the inside of the front cabinet door 2 Release the pH cable from its storage position by unscrewing its lower end from the cabinet Connect the pH electrode by screwing it onto the cable see Mount the main part tubing on page 91 step pH electrode 3 In the AKTA ready System Control module on the System menu click Cali brate 4 Place the pH electrode in one of the buffers enter the pH value for the buffer in the Reference value 1 field wait for the
83. cy press the emergency stop button see Emergency shutdown on page 28 This immediately stops the pump 26 AKTA ready Operating Instructions 28960345 AD 2 Safety instructions 2 3 Emergency procedures 2 3 Emergency procedures In this section This section describes how to do an emergency shutdown of AKTA ready and the result in the event of power failure Precautions WARNING e Emergency stop Pressing the EMERGENCY STOP will not shut off mains power to the cabinet e Power failure During a power failure or if the EMERGENCY STOP button is pressed the equipment may remain pressur ized Opening a line or vessel at this point could result in the release of potentially hazardous process or cleaning fluid and cause bodily harm When recovering from a power failure or emergency shutdown make sure all lines and vessels are depressurized before opening e Emergency stop Pressing the EMERGENCY STOP does not automatically depressurize the flow path AKTA ready Operating Instructions 28960345 AD 27 2 Safety instructions 2 3 Emergency procedures Emergency shutdown In a situation where there is a risk of injury switch off the ongoing run by pressing the EMERGENCY STOP on the front of the system cabinet If required also switch off the mains power supply The EMERGENCY STOP immediately stops the pump motor and sets the system in pause mode 28 AKTA ready Operating Instructions 2896
84. d alarms Step Action cl 2 Switch on the computer Log on to Windows Start UNICORN by double clicking on the UNICORN iconon UNICORN the Windows desktop When the Logon dialog box appears select a user from the Users list and enter the password If you log on for the very first time select the user default and enter the password default Click OK In the System Control module on the System menu click Connect In the dialog shown select the appropriate system name and click OK The system name is specified during installation configuration When UNICORN is connected to the system the Run button in the status bar is enabled The button initially has a green color indicating the system is ready to run AKTA ready Operating Instructions 28960345 AD 75 5 Starting AKTA ready 5 2 Start the system 5 2 Start the system General AKTA ready is normally left switched on between runs The unit is switched off only during monthly maintenance and repair or when not in operation for a longer period of time more than a few days Starting AKTA ready Step Action 1 Switch on power to AKTA ready by turning the Mains Power switch to the I position See Components on system cabinet front on page 38 for loca tion 2 Make sure that UNICORN is started according to the instruction above Wait for connection After this sequence is completed the following occurs e The POWER indicator lamp f
85. d changing the parameter values as required AKTA ready Operating Instructions 28960345 AD 10 Creating a method 10 2 An example of using the Method Editor 10 2 11 Saving the method 10 2 11 Saving the method Finish by saving your new method Click Save or Save As on the File menu in the Method Editor to open the Save as dialog box In this dialog box you specify the folder in which to save the method and also the system and technique it is intended for vA MBon For System x AKT P1 1 Nene yes AKTAready P3 Prev Folder Anna xplorer BJ verif DisP User Folder AnnaPilot Qabjorns metoder User Folder Annae Hakan User Folder rz2 User Folder Bs User Folder TR E ClosedPressi AKTAready P3 Method File tE ClosedPress2 AKTAready P3 Method File Arion Exchange E ClosedPress3 AKTAready P3 Method File Cation_Exchange 2 ClosedPress3 AKTAready P1 1 Method File C lt HII Size_Exclusion Affinity Method name Learning Chromatofocusing Cancel AKTA ready Operating Instructions 28960345 AD 167 10 Creating a method 10 3 Creating a column efficiency test 10 3 Creating a column efficiency test General Methods for testing of column efficiency can be created using the method wizard available in the Method Editor Opening the wizard The wizard is opened from the UNICORN Method Editor module by clicking Method Wizard on the File menu Running the wizard In the method wizard
86. d maintenance of components inside the electronics cabinet should be done by service personnel authorized by GE Healthcare Do not open any covers or replace parts unless specifically stated in the Operating Instructions 184 AKTA ready Operating Instructions 28960345 AD Cleaning 12 Maintenance 12 1 Daily maintenance CAUTION e To avoid contamination make sure the system is thoroughly cleaned before changing the flow kit e Connectors on the cabinet such as connectors for pH conduc tivity network etc that are not used should be plugged to prevent cleaning liquid from entering the connector For proper function the system should be kept clean and dry Chemical stains and dust are removed by wiping the outside surfaces of the cabinet and the pump with a clean tissue wetted with water Water with weak detergent should be used for daily cleaning of the cabinet 70 ethanol or 2 propanol Iso propanol can be used for sanitization If salt buffer is spilled at valves rinse carefully with water to remove salt crystals and wipe dry Clean the system of infectious or aggressive fluids before service or maintenance Make sure that the cleaning procedure flushes all possible flow paths in the system If liquid should have accidentally spilled into the pump clean the inside of the pump lid and the rollers with water To avoid corrosion make sure all surfaces are wiped dry The interior of the pump is parti
87. d samples are compliant with USP Class VI FDA and AFO Used materials are traceable back to their production batches You can find information about the design and materials used for your unit in the System Documentation Chemical resistance is described in Section 14 3 Chemical resistance on page 207 AKTA ready Operating Instructions 28960345 AD 3 System description 3 1 Overview Features AKTA ready features include e Liquid flow rates of up to 510 I h e 4 bar operating pressure e KTA ready flow kits with Product Documentation Animal free origin or equivalent safety certification EMEA 410 01 USP class VI material Areas of application AKTA ready is designed for process scale up and small scale production Scale up to production is predictable and trouble free In small scale production the system can be used to produce purified material for clinical testing programs or for small scale produc tion of diagnostic or therapeutic products WARNING Flammable liquids This product is not approved to handle flammable liquids Explosive environment The product is not approved for work in a potentially explosive atmosphere in areas classi fied as Zone 0 to Zone 2 according to IEC 60079 10 2002 The product does not fulfill the requirements of the ATEX Directive What is included in the delivery See Section 4 1 Included in the delivery on page 57 for a complete list Associated products
88. dy Operating Instructions 28960345 AD 33 3 System description 3 1 Overview 3 1 Overview Intended use of AKTA ready AKTA ready is an isocratic low pressure automated liquid chromatography system using AKTA ready flow kits AKTA ready Low Flow Kit or AKTA ready High Flow Kit and Ready ToProcess columns up to 20 liter The system is based on proven liquid chromatography techniques such as ion exchange affinity chromatography and hydrophobic interaction AKTA ready is biocompatible and hygienic and meets all GLP and cGMP demands for Phase I III in drug development and final scale production KTA ready is controlled by the UNICORN software AKTA ready can be equipped with an extra gradient pump in parallel to the existing pump using AKTA ready gradient sections together with AKTA ready flow kits and ReadyToProcess columns up to 20 liter More information can be found in Chapter 7 AKTA ready gradient on page 97 AKTA ready is not suitable for operation in a potentially explosive atmosphere or for handling flammable liquids Flow kits and columns are ordered separately See Section 14 4 Ordering information on page 210 for ordering information and lists of available flow kits and columns WARNING Do not operate the AKTA ready instrument in any other way than described in the AKTA ready and UNICORN manuals Material compliance 34 All plastic and polymer materials that come in contact with buffers an
89. e i e start with the air trap valves 1B Close the valve safety locks as you proceed Note Make sure the pH cable does not get trapped behind the tubing The cable should be attached to its holder on the cabinet 2A Pressure cells Attach the three pressure cells for sensors PT 111 PT 112 and PT 113 by pushing them onto their respective pressure cell adapters on the cabinet 2B Secure the cells by turning the latch over the pressure cell body and fasten the screws 26 Before firmly fastening the screws check that the cell is correctly positioned and that there is no gap between the cell body and the adapter Apply finger force only AKTA ready Operating Instructions 28960345 AD 91 6 Flow kit installation 6 3 Mounting the flow kit Step Action 3A 3B 3C 92 Flow meter cell Align the holes in the body of the flow meter cell FE 141 with the two knobs on the cabinet see 1 and 2 in figure and push the cell into place Clean the contact surfaces of the transducer connectors bayonet couplings and apply a layer of Vaseline Note Make sure that enough Vaseline is applied to the transducer connectors Any surplus Vaseline will be squeezed out and can be removed with a tissue Connect the transducers to the connectors at the top and bottom of the flow cell see arrows in figure On the back of the flow meter cell is a window for the temperature sensor 3 in figure T
90. e amounts are used Note The test solution should be freshly made so the acetone does not evaporate Step Action 1 Remove the protective end cap from inlet 6 arrow and connect the wash liquid Note Containers must not be placed at a level lower than 1 m below the inlets i e floor level AKTA ready Operating Instructions 28960345 AD 109 8 Component test 8 1 Runa component test Step Action 2 Remove the protective end cap from inlet tube 5 arrow and connect the test solution Note If AKTA ready gradient is installed use inlet tube 7 3 Remove the protective end cap from outlet 6 arrow and connect a waste hose to this outlet WARNING Over pressure Never block the outlet tubing with for instance stop plugs since this will create over pressure and might result in injury 110 AKTA ready Operating Instructions 28960345 AD 8 Component test 8 1 Run a component test Enter installation information After pressing Run in the installation wizard you are directed to the UNICORN start protocol with panels containing data about the installation Start Notes In the first panel Start Notes is a text area where notes about the installation can be entered Any notes written here will be included in the report Questions The Questions panel has fields for entering product number and name and identification data for the different parts of the flow kit and the pH electrode
91. e instrument O O O All buffer waste vessels are labeled Excess containers have been removed from the area to provideaccess ee e e e O Provide explanation for any No answers here Equipment type Product No Serial No 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 Company or institution i ta Date YYYY MM DD Signed GE and GE monogram are trademarks of General Electric Company GE Healthcare BioSciences Corp 800 Centennial Avenue PO Box 1327 Piscataway NJ 08855 1327 2010 14 General Electric Company Allrights reserved First published April 2010 DOC1149542 28 9800 26 AC 05 2014 KTA ready Operating Instructions 28960345 AD 221 14 Reference information 14 7 Health and Safety Declaration Form Product return or servicing Health amp Safety Declaration Form for Product Return or Servicing Return authorization and or number Service Ticket Request To make sure the mutual protection and safety of GE personnel our customers transportation personnel and our environment all equipment must be clean and free of any hazardous contaminants before shipping to GE To avoid delaysin the processing of your equipment please complete this checklist and include it with your return 1 Please note that
92. e should be used only as a guide The effects of a chemical will gener ally be more severe at higher temperatures Note that the combined effects of agents have not been taken into account List of chemicals allowed Note The percentage in the table is given in v v Acetic acid 1M Acetone 2 5 Aqueous buffers pH 2 12 lt 0 3M Arginine 2M Ammonium sulfate 4M Benzyl alcohol 2 DTE DTT 100 mM AKTA ready Operating Instructions 28960345 AD 207 14 Reference information 14 3 Chemical resistance Chemical allowed Concentration EDTA 100 mM Ethanol 20 Formaldehyde 0 1 Glycerol 10 Glycine 2M Guanidine hydrochloride 6M Hydrochloric acid 0 1M Imidazole 1M Mercaptoethanol 20 mM Pluronic F 68 1 Polyethylene glycol PEG 500 5 Polyethylene glycol PEG 1000 1 Polyethylene glycol PEG 5000 1 Potassium phosphate 1M 1 propanol 5 2 propanol 30 SDS 1 Sodium acetate 1M Sodium chloride 4M Sodium citrate 1M Sodium sulfate 1M Sodium hydroxide 0 5 M Maximum exposure time 2 hours Sorbitol 1M Sucrose 1M Triton X 100 1 Tween 20 1 Tween 80 1 208 AKTA ready Operating Instructions 28960345 AD 14 Reference information 14 3 Chemical resistance Chemical allowed Concentration Urea 8M AKTA ready Operating Instructions 28960345 AD 209 14 Reference info
93. en the stray light calibration is performed a warning message is displayed The warning message can be disabled 148 Follow the instruction below to perform a UV stray light calibration Step Action 1 Click Alarms amp Mon and then StraylightCalib_UV_AT_131 in the Instructions box AKTAready Alarmst amp Mon Instructions Instructions UVlemp_UV_AT131 O Pump AutoZero_PT111 O FlowPath Autazes PIN2 Aut 11 AlarmstMon ig OFrac iT O Other Fine_Tune_Fai_ Report Auto update If this is checked the parameter fields wil be updated during method run Enabled is the default option If you click Execute the stray light calibra tion will be performed and a warning message is displayed Stray light reduction calibration Do not perform any other instruction during the next 15 seconds System Control 1 System 1 alarms and warnings Down time Help button is enabled if the selected Click Acknowledge when 15 seconds have passed If you click Disabled and after that Execute the stray light calibration will be performed without the warning message on the screen and without entry in the logbook AKTA ready Operating Instructions 28960345 AD 10 Creating a method 10 1 The Method Editor 10 1 3 Other Method Editor features Disable fine tuning flowmeter failed message When the flow measuring algorithm fails to make a fine tuning of the flow measurement a Fine_tuning_flowmeter_failed mes
94. erature sensor TE 161 The cell sensor measures temperature using infrared light The temperature window is integrated with the flow meter cell AKTA ready Operating Instructions 28960345 AD 43 3 System description 3 2 Layout Part Component ID tag Function 12 Conductivity CE 101 Sensor measuring the conductivity of the liq sensor uid 13 UV flow cell AE 131 Flow cell for UV detector AE 131 14 Flow cell for PT 113 Flow cell for safety pressure sensor PT 113 pressure sen which measures pressure after the sensors sor 15 Outlet mani XV 051to Manifold with 6 outlets corresponding to fold XV 056 valves XV 051 to XV 056 25 mm TC connec tors Sanitization Except for the pH electrode all parts of the flow kit are sanitized at delivery either through gamma radiation inlet manifold and main part of flow kit or autoclaving pump tubing The pH electrode should be sanitized by the user 44 AKTA ready Operating Instructions 28960345 AD 3 System description 3 3 Flow chart 3 3 Flowchart Chart and components The liquid flow through AKTA ready is illustrated in the chart below Black standard components Red optional components XV 001 XV 002 XV 003 XV 004 XV 005 XV 006 The table below specifies the maximum operating pressure the flow path could be pressurized to with the pressure upgrade strategy in the different parts of the system Part De
95. ered with indi vidual certificates Testing includes for example analysis of theoretical plates per m packed bed N m and asymmetry factor A3 Other columns Although ReadyToProcess columns are recommended for use with AKTA ready other columns may be used provided they are capable of withstanding maximum system pressure If not separate pressure safety devices must be used WARNING e High pressure The flow rate may under no circumstances exceed the specified column maximum flow rate High flows might affect the packed medium causing the pressure to ex ceed the specified column maximum pressure e Over pressure Never block the outlet tubing with for instance stop plugs since this will create over pressure and might result in injury Contact GE Healthcare for more information about using products other than ReadyTo Process columns with AKTA ready 126 AKTA ready Operating Instructions 28960345 AD 9 Column installation 9 2 Installing a column 9 2 Installing a column Introduction The steps described in this section follow the steps in the Column Installation trail in the AKTA ready Installation Wizard Refer also to the information provided in the instruc tions for the chosen column Preparation Before installing a column the flow kit must be filled with liquid e g distilled water from inlet 6 to the column valves including the air trap If the column is installed after a component te
96. es Method Editor Method creation and editing for prepro grammed control of AKTA ready System Control Process online control and monitoring using pre defined methods or manual control Evaluation Evaluation and presentation of stored results Note The modules are active when the program is operating and are not closed when minimized A minimized System Control unit may control a process Workflow The workflow for using UNICORN system for automatic control includes these general steps Step Action 1 Program an AKTA ready method run using the UNICORN software It is pos sible to use an existing method or modify an existing method to meet your run objectives Start the run using the method you created Monitor the run s progress using the System Control module All the data about your run is displayed in the System Control module You have a choice of four different panes that can be open one at a time or all at once in sep arate parts of the window After completing the run you can display the data in a detailed report using extensive tools provided by the UNICORN Evaluation Module Warnings Warnings are generated to warn operating personnel that process parameters have exceeded preset high and or low limits and that the process method continues AKTA ready Operating Instructions 28960345 AD 53 3 System description 3 5 UNICORN control system Alarms Signals I
97. est results Note A printed report can also be produced later In the Evaluation module on the File menu click Report Similar to the wizard for installing a new flow kit the column installation wizard contains checklists with actions to be performed Each action is confirmed by selecting the corresponding Completed checkbox in the wizard In UNICORN 7 the wizard creates a new method Edit the column parameters see Edit column parameters in UNICORN 7 on page 130 and save the method in Method Editor Then run the method in System Control AKTA ready Operating Instructions 28960345 AD 9 Column installation 9 2 Installing a column Select a column type The first panel of the column installation wizard is Initial settings The Initial settings panel contains fields for selecting a column type Note In UNICORN 7 there is no predefined list with column types The method created with the installation wizard will contain default column parameters The pa rameters for the column you are installing must be updated to the column type specific values found in the user documentation for the column See Edit column parameters in UNICORN 7 on page 130 Step Action il From the Technique list in the Initial Settings pane select a chromatographic technique from the alternatives All Affinity Anion exchange Cation ex change and Hydrophobic Interaction The selection limits the list of columns available for selection in next ste
98. ether the component in question passed the test or not If the test for a component fails troubleshooting should be done see Section 8 3 Trou bleshooting a failed component test on page 117 AKTA ready Operating Instructions 28960345 AD 115 8 Component test 8 2 The test report Last page The last page of the report has the header Comments under which there is room for comments on the paper copy of the report The page also contains the signature fields Performed by and Approved by where date name and position can be specified 116 AKTA ready Operating Instructions 28960345 AD 8 Component test 8 3 Troubleshooting a failed component test 8 3 Troubleshooting a failed component test Troubleshooting Should a component fail the component test troubleshooting should be done to establish the cause of failure and allow for correction of the problem A failing component is identified in the report or result file by the text TEST FAILED in the component chart Troubleshooting is easiest done using Troubleshooting in the installation wizard The troubleshooting wizard finishes with an additional component test identical with the section previously described Open the installation wizard Step Action 1 3 UNICORN 5 In the AKTA ready System Control module on the File menu click Instant Run and then click Run in the dialog box shown UNICORN 7 In the AKTA ready Method Editor module on the File menu click
99. f equipment is connected that has lower limits than the system the alarm levels must be set accordingly If an analog or digital signal passes the predetermined alarm level several things happen at once e The system is set to Pause mode e The valves and other components on the system are set to their default positions The Valve Pause Function can be enabled in UNICORN for certain components air trap column to retain the original valve positions Test To test a specific instrument alarm it is possible to lower the alarm limit for the instrument below the current process value Reset The alarm is reset through the control system by acknowledging the alarm message The process can be started again using the Continue function in UNICORN if the situation has been rectified Differences between UNICORN 5 and UNICORN 7 54 In UNICORN 5 you start the three installation wizards Flow Kit Installation with Compo nent Test Troubleshoot Failed Component Test and Column Installation by clicking Instant Run on the File menu in the System Control module In UNICORN 7 you start the same wizards by clicking New Method on the File menu in the Method Editor module The installation wizard will create a method that you must save and then run in the System Control module The content of these methods are the same for UNICORN 5 and UNICORN 7 They are described in Chapter 6 Flow kit installation on page 77 Section 8 3 Troubleshooting a fai
100. fety instructions 2 1 Safety precautions CAUTION Knowledge of how to use UNICORN is required to safely oper ate the product Refer to UNICORN user documentation as re quired Do not insert your fingers or other objects into fans or other moving parts Make sure that clothing or other equipment does not get caught in the pinch valves Before use check that the column is not damaged or otherwise defective Damaged or defective columns may leak Do not use chemicals at temperatures above the specified limits NOTICE Only use flow kits supplied by GE Healthcare 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 la bel Check that the Pressure Control Regulator for the system air supply is set to the pressure stated in the specifications Keep UV flow cell clean Do not allow solutions containing dissolved salts proteins or other solid solutes to dry out in the flow cell Do not allow particles to enter the flow cell as dam age to the flow cell may occur The flow rate may under no circumstances exceed the specified column maximum flow rate Excessive flow may affect the packed medium causing the pressure to exceed the specified column maximum pressure Excessive pressure may also damage the flow kit Ensure that the chromatography media columns and system components are compatible wi
101. fibus_Configi v v o v v v K TC clamps Two TC clamps are provided with the flow kit An additional three clamps are required in order to mount the flow kit and run a component test Aseptic solution A suitable disinfectant solution should be available for aseptic treatment of tubing con nectors Connectors can for instance be treated with 70 Ethanol before connecting KTA ready Operating Instructions 28960345 AD 6 Flow kit installation 6 3 Mounting the flow kit End caps At delivery all connectors on the flow kit except those on the pump tubing are covered by protective end caps The caps are removed during installation Remember to save the end caps as they are used to seal the tubing when the flow kit is removed and dis posed of see Section 11 4 After the run on page 180 Test liquids Wash and test liquids required for component testing should be prepared after mounting anew flow kit It is important that the liquids which contain acetone are freshly prepared For details about volumes and concentrations required see description in Prepare a test on page 109 A Test solution preparation protocol template is available on the AKTA ready CD pH calibration If pH is to be measured the pH electrode should be calibrated and sanitized before in stalling the flow kit pH calibration is described in pH calibration on page 186 AKTA ready Operating Instructions 28960345 AD 83
102. flow section on page 210 Installation of gradient flow section 100 If you have selected the KTA ready gradient checkboxes in the component list see System setup on page 82 you can follow the wizard to install the AKTA ready gradient flow section You may also follow the instruction below More information about mounting the flow kits can be found in Section 6 3 Mounting the flow kit on page 81 Step Action 1 Take the AKTA ready pump tubing from the AKTA ready flow kit package For a de scription of the content of the AKTA ready flow kit package refer to Three parts on page 78 AKTA ready Operating Instructions 28960345 AD Step 7 AKTA ready gradient 7 2 AKTA ready gradient flow section Action Place the AKTA ready pump tubing on the AKTA ready gradient pump P 202 Take the AKTA ready gradient pump tubing from the AKTA ready gradient flow section package For a description of the content of the AKTA ready gradient flow section package see Two parts on page 99 Place the AKTA ready gradient pump tub ing from the AKTA ready gradient flow section package on the the AKTA ready system pump P 201 Take the jumper tubing from the AKTA ready gradient flow section package Connect the jumper tubing to the right side of the AKTA ready pump tubing placed on the gradient pump using a TC clamp AKTA ready Operating Instructions 28960345 AD 101 7 KTA ready gradient 7 2 A
103. g s s 9 5 Adding columns to the column list Creating a Method geniena EENE E 101 The Method Editor a cassidsesahiencaiiavieaniaiacaiaianuduiaheatdiamanidaaststanseaetiee 10 1 1 Introduction to the Method Editor 10 1 2 Method Editor layout esses fe 10 1 3 Other Method Editor features eeeeessssssssssssssssssssssssssessnssssssssseeceseessssstussssssssseseesesssesinnanssst 10 2 An example of Using the Method Editor o ccsssssssssssccsssssssssssssssessesscsesssnsssueessesseccessssssssnsees 10 2 1 Creating the method and selecting a column 10 2 2 Block 1 Opening valves eeessssssssssesssssssssseesssssseee 10 2 3 Block 2 Auto zeroing pressure sensors 10 2 4 Block 3 Setting PID parameters 10 2 5 Block 4 Filling the flow kit 10 2 6 Block 5 Equilibration 10 2 7 Block 6 Sample load wececcscssssssssssssseee 10 2 8 Block 7 Washing unbound sample 10 2 9 Block 8 EIUTION sosisenesonnsimn 10 2 10 Block 9 Regeneration 10 2 11 Saving the method a 10 3 Creating a COLUMN efficiency tOSt oe eeccssssscssssssssssessssssssssssssssusssssessesssssssssussusesssscssssssssssassees R n Ne cc eee eee 11 1 Final preparations before a run 11 2 Starting GUN oe ecccseeecsseeeee 11 3 Viewing and printing results ses LLA APSR LING PUT ierann ahead e EEO N R E A RNA MOINtenNaN CS sasana T21 Daily mantena AC E emanan anna AAR EEANN NAAR RUNT 12 2 Yearly maintena
104. ght cause the area to increase or the zone classification to change Implement the risk reduction measures needed includ ing use of personal protective equipment e The customer must make sure that all installation mainte nance operation and inspection is carried out by qualified personnel who are adequately trained understand and adhere to local regulations and the operating instructions and have a thorough knowledge of the product and the entire process e Do not operate the product in any other way than described in the user documentation e Do not use KTA ready if it is not working properly or if it has suffered any damage for example damage to the power cord or its plug AKTA ready Operating Instructions 28960345 AD 15 2 Safety instructions 2 1 Safety precautions WARNING damage caused by dropping the equipment damage caused by splashing liquid onto it Emergency stop Pressing the EMERGENCY STOP does not automatically depressurize the flow path Do not use any accessories not supplied or recommended by GE Healthcare CAUTION Waste tubes and containers must be secured and sealed to prevent accidental spillage Make sure that the waste container is dimensioned for maxi mum possible volume when the equipment is left unattended NOTICE Any computer used with the equipment must comply with IEC 60950 and be installed and used according to the manufacturer s instructio
105. has been created according to the UNICORN Administration and Technical Manual e The user must be acquainted with the use of general bioprocessing equipment and with handling of biological materials e The user must read and understand Chapter 2 Safety instructions on page 14 About this chapter This chapter contains important user information regulatory information list of associ ated documentation definitions of safety notices etc AKTA ready Operating Instructions 28960345 AD 5 1 Introduction In this chapter This chapter contains the following sections Section See page 1 1 Important user information 7 1 2 Regulatory information 9 1 3 Associated documentation 12 6 AKTA ready Operating Instructions 28960345 AD 1 Introduction 1 1 Important user information 1 1 Important user information Read this before using AKTA ready All users must read the safety instructions in the AKTA ready user documentation to fully understand the safe use of AKTA ready before installing using or maintaining the system Do not operate the AKTA ready system in any other way than described in the user documentation Otherwise you may be exposed to hazards that can lead to personal injury and you may cause damage to the equipment Safety notices This user documentation contains WARNINGS CAUTIONS and NOTICES concerning the safe use of the product See definitions below Warnings WARNING WARNI
106. he window is automatically aligned with the temperature sensor when the flow meter cell is mounted No further action is necessary to pre pare for temperature measurements Note Make sure the flow meter cell is properly pushed onto its mounting knobs A soft click indicates correct mounting Improper mounting of the flow meter cell may result in erroneous temperature measurements and leakage AKTA ready Operating Instructions 28960345 AD 6 Flow kit installation 6 3 Mounting the flow kit Step Action 4A Conductivity cell Unscrew the protective cap 1 on the system cabinets conduc tivity connector yo 4B Connect the conductivity sensor by screwing its cable connector 2 onto the connector on the 2 system cabinet A l a 1 Note Before inserting the connector make sure it is correctly positioned There is a small ridge on the male connector and a corresponding groove on the female connector Do not use force when inserting the connector KTA ready Operating Instructions 28960345 AD 93 6 Flow kit installation 6 3 Mounting the flow kit Step Action 5A 5B 5E 5D SE SF pH electrode Unscrew the plastic fastening nut 1 on top of pressure cell PT 112 and pull out the dummy from the electrode holder 2 Release the pH cable from its storage position by unscrewing the lower cable connector from the system cabinet Do not un LT 1 screw the upper connector Calibrate and
107. hod Editor 10 1 2 Method Editor layout 146 e Buttons There are four buttons Insert Change Replace and Delete Change Replace and Delete affect the instruction or block currently selected in the Text pane While Insert adds a new instruction before or after if it has the same breakpoint as an old instruction the current selection Note Changing the breakpoint of an instruction using Change will move not only the instruction itself but also all subsequent instructions in the block Replace on the other hand moves only the selected instruction Instructions placed at the same breakpoint will execute simultaneously while blocks will execute in the order they occur in the Text pane Changing valve positions or changing the speed of the pump does not take place mo mentarily but requires a small amount of time A small time lag such as 0 10 min should therefore be introduced after time based instructions affecting mechanical components Note There is no undo function in UNICORN and you are therefore recommended to regularly save the method you are working with preferably using different version numbers AKTA ready Operating Instructions 28960345 AD 10 Creating a method 10 1 The Method Editor 10 1 3 Other Method Editor features 10 1 3 Other Method Editor features Introduction The method created in the following chapter covers the most basic aspects of how a method is built Follow this example to learn the bas
108. hts up bottom lamp in figure The light flashes slowly when communication with UNICORN is not established AKTAready a Switch on the computer and computer screen and check that a booting process starts Ab a7 UNICORN After booting is finished check that the UNICORN software is installed and available UNICORN symbol visible on the computer s desktop Start UNICORN by double clicking its icon Check that the green POWER lamp now shows a steady green light indicat ing that UNICORN recognizes and can communicate with the system unit 72 KTA ready Operating Instructions 28960345 AD 4 Installation 4 6 Connections Installing the barcode reader The barcode reader is installed and configured as described below Note Installation requires barcodes to be scanned from the Quick Start Guide sup plied with the barcode reader If the Quick Start Guide is lost it can be down loaded from the barcode reader manufacturer s web site Step Action 1 Connect the barcode reader to the computer with a USB cable as shown in the Quick Start Guide 2 Locate the USB Keyboard PC interface barcode in the Quick Start Guide and scan it using the barcode reader 3 Place the barcode reader in its holder The installation is complete when it beeps 4 To verify the barcode function open an empty Notepad document type notepad in the Start menu search field click the Notepad item that is dis played
109. ics of designing a chromatography method A few useful features demonstrated in this example are briefly described here Variables W 0 10 Watch_DeltaP Stable_Baseline 0 3000 Minutes END_BLOCK 0 10 End_Block Ml 0 00 Block TMP_START_STOP 2 00 End_Block Instructions c 2 FT141VTot_WatchPar a 0 00 6 00 Recirc FT142_WatchPar ee c FT142VTot_WatchPar Peimeate FT143_WatchPar 10 00 6 00 RetenFlow_WatchPar Alarms RetFlwVTot_WatchPar pa e i TankLevel_WatchPar Specials PT291_WatchPar ForcePT291_WatchPar Watch ConcFac_WatchPar Other DF X Fet WatchPar fe There is one Var button in the Breakpoint field and a one Var button for each parameter in the Parameter field These are used to create variables representing breakpoints or parameters Variables enables re use of defined breakpoints and instructions in other blocks UV stray light calibration There is an instruction to perform a stray light calibration When a new flow kit is mounted the instruction is activated automatically via the installation wizard It may also be included in the methods if so needed The instruction StraylightCalib_UV_AT_131 is available in the Instructions box under group Alarms amp Mon and is used for a manual calibration AKTA ready Operating Instructions 28960345 AD 147 10 Creating a method 10 1 The Method Editor 10 1 3 Other Method Editor features Manual calibration of UV stray light Wh
110. ied column maximum flow rate High flows might affect the packed medium causing the pressure to ex ceed the specified column maximum pressure Use columns that withstand expected pressures If not the columns might rupture resulting in injury Preferably use ReadyToProcess columns from GE Healthcare Over pressure Never block the outlet tubing with for instance stop plugs since this will create over pressure and might result in injury Never touch the pump or pump lid while the pump is running Never put fingers or any objects other than the intended tubing in to the pinch valve opening Corrosive substance NaOH is corrosive and therefore danger ous to health When using hazardous chemicals avoid spillage and wear protective glasses and other suitable Personal Pro tective Equipment PPE Emergency stop Pressing the EMERGENCY STOP will not shut off mains power to the cabinet Power failure During a power failure or if the EMERGENCY STOP button is pressed the equipment may remain pressur ized Opening a line or vessel at this point could result in the release of potentially hazardous process or cleaning fluid and cause bodily harm When recovering from a power failure or emergency shutdown make sure all lines and vessels are depressurized before opening Emergency stop Pressing the EMERGENCY STOP does not automatically depressurize the flow path 20 AKTA ready Operating Instructions 28960345 AD 2 Sa
111. ight hand side of the pump 3 Stretch the tubing and push it over the left hand mounting knob 4 Using TC clamps connect the right hand connector of the pump tubing to the main part of the flow kit and the left hand connector and the sealings to the inlet manifold GZ AKTA ready Operating Instructions 28960345 AD 89 6 Flow kit installation 6 3 Mounting the flow kit 90 Step Action 5 To attach the pump lid Press down the pump lid with one hand Secure it by rotating the left and right bolts counter clockwise and clockwise using the supplied wrench also see Remove the pump lid on page 86 The pegs at the back of the lid indicate when the bolts have been turned all the way The pegs should be in their lowermost position when the lid is closed Note that the system will not work if the lid is not properly secured Note Do not turn the pump lid the wrong way around The arrow label on the lid indicates the flow direction and should point to the right The pegs should be located at the back of the lid on the side closest to the instrument AKTA ready Operating Instructions 28960345 AD 6 Flow kit installation 6 3 Mounting the flow kit Mount the main part tubing Step Action 1A Pinch valves Insert the tubing into the air trap valves 1 3 in figure the column valves 4 6 and the air release valve 7 Proceed in the order indicated by the numbers in the figur
112. ill pop up since Other New ERANA x inlet and outlet must be set before flow can be started It is also crucial to use Time as base In this type of oa Base CY 20 24458 I RTP_MabSelect_SuRe_20 i i block because if Volume is chosen M A and no pump instruction is used nothing will happen The column chosen is now displayed in the Text pane together with the in struction to disable flow warnings KTA ready Operating Instructions 28960345 AD 153 10 Creating a method 10 2 An example of using the Method Editor 10 2 2 Block 1 Opening valves 10 2 2 Block 1 Opening valves The first block in the method will open valves in the flow path Step Action i In the Method Editor click New on the Block menu stien Name seud 2 In the New Block dialog box shown Base give the block a name for example ae rin MySetup and set the Base to Time lime The From field under Call has the Seca nnn value Main which is the only one 3 r Say Length available initially ake Length 0 00 Call Erom Main At 0 00 cv OK Cancel Help The new block will show up in the 0 00 Block MySet Text pane with the specified name ley pare Gee MySetup and base 0 00 Base Time 3 Insert an instruction that opens the valve for inlet 6 In the Text pane select the Base instruction and in the Instruction Box set the Inlet instruction under FlowPath to Inlet 6 The Breakpoint time should
113. ion About this chapter This chapter provides reference information that may become useful when installing operating maintaining and troubleshooting AKTA ready It also contains ordering infor mation In this chapter This chapter contains the following sections Section See page 14 1 Specifications 202 14 2 Process wetted materials 206 14 3 Chemical resistance 207 14 4 Ordering information 210 14 5 PID control 214 14 6 Checklists 216 14 7 Health and Safety Declaration Form 221 14 8 More information 223 AKTA ready Operating Instructions 28960345 AD 201 14 Reference information 14 1 Specifications 14 1 Specifications General specifications Property AKTA ready AKTA ready gradient Dimensions width x depth 100 x 80 x165 cm 116 x 80 x 165 cm x height Weight 230 kg 250 kg Control system e UNICORN 5 20 or higher versions of UNICORN 5 or e UNICORN 7 01 or higher versions of UNICORN 5 20 or higher versions of UNICORN 5 o U h NICORN 7 01 or igher versions of UNICORN 7 UNICORN 7 AC voltage 1x 100 120 200 208 220 1x100 120 200 208 220 230 240 V 10 230 240 V 10 Frequency 50 60Hz 50 60Hz Max power consumption 1kVA 1kVA Ingress protection IP45 pump IP25 IP45 pump IP25 Compressed air interface 5 5 to 10 bar 50 NI min 5 5 to 10 bar 50 NI min oil and particle free oil and particle free Recommended o
114. ion structions that trigger start and stop of Da a the fractionation phase Using external gt m atch uv aTI31 Greater Than 100 0000 mau Fraction k ae Fraction blocks like this is the recommended way 000 Bare Volume i letFractions 1 I Outlet of defining fractionation in the Method ee aoi wach eats Face tas ein Aed Fraction_Stop Editor Gath DidledEracions O TAT IDA 0 00 End_Block 0 10 End_Block 0 10 End_Block KTA ready Operating Instructions 28960345 AD 165 10 Creating a method 10 2 An example of using the Method Editor 10 2 10 Block 9 Regeneration 10 2 10 Block 9 Regeneration 166 The last step for a complete chromatog raphy cycle is to regenerate the column This is done by defining a block with in structions for selecting inlet and outlet and for setting the air trap and column inline 0 00 Block MyRegenerate MyRegenerate 0 00 Base Time 0 00 Inlet Inlets 0 10 AirTrap Inline 0 20 Column Inline 0 30 Outlet Outlets ER 10 30 Block MyReglenath MyReglength 0 00 Base SameAsMain 2 00 End_Block 0 30 End_Block The finishing criterion is based on SameAsMain i e column volumes and is defined in a nested block The procedure is very similar to that of defining a block for washing unbound sample see Section 10 2 8 Block 7 Washing unbound sample on page 163 When as in this case a similar block already exists time can be saved by copying the existing block renaming it an
115. ion process These blocks in turn refer to two external blocks Fraction and Fraction_Stop The Fraction block Start by defining the external block Fraction Step Action i Create a block in group Other name it Fraction and set its Base to Vol ume it does not matter where the block is created it will be moved in a later later step 2 Insert an OutletFractions instruction into the block with the number of fractions set to 1 in this example only one fraction is retrieved 3 Set the volume to for instance 8 liters and set the fraction outlet to Outlet2 Once defining the Fraction block is complete right click the block and click Delete A di alog box is displayed in which you can choose to Delete or Move the block click Move The block will be stored as Unused in the location you select and will be available for insertion in any method The Fraction_Stop block The procedure for creating the Fraction_Stop block is very similar to that of the Fraction block There are two main differences The Fraction_Stop block has SameAsMain i e column volumes as Base not Volume and the number of fractions in the OutletFractions instruction is set to 0 zero Setting the number of fractions to 0 means that fractionation will stop Store the Fraction_Stop block as Unused for the time being 164 AKTA ready Operating Instructions 28960345 AD 10 Creating a method 10 2 An example of using the Method Editor 10 2 9 B
116. iples A PID controller uses the difference error between the actual measured value and a desired setpoint to compute the adjustment required in order to keep a process within defined boundaries A typical PID controller is tuned using the following three parameters e P The weight of the current error Proportional to the error e The weight of the stationary or long term change in the error Reduces effects of error trends e D The weight of the current rate of change of the error Reduces effects of short term error changes 214 AKTA ready Operating Instructions 28960345 AD 14 Reference information 14 5 PID control PID control in AKTA ready In AKTA ready PID control is used for controlling the pump speed based on flow velocity as measured in the flow meter cell The method instruction FlowTune is used for setting the three PID parameters The FlowTune instruction is available in group Pump in the Instruction Box in the Method Editor module There are two sets of parameter fields under FlowTune one for each flow kit size Default values for the PID parameters are Column volume P D 1l 0 3 25 0 251 0 3 25 V0 10 1t 03 15 0 2011 0 5 10 0 1 AKTA ready High Flow Kits should be used for columns of 10 or more It is usually not necessary to tune the PID parameters the default values can be used unchanged If tuning is required however use large adjustmen
117. ired for the operation Set valve switch time in UNICORN The valve switch operation time is set in UNICORN in the Settings dialog box in the Specials instruction in Inletswitchtime _Outletswitchtime The time range is 0 0 to 5 0 seconds Default is 1 second AKTA ready Operating Instructions 28960345 AD 11 Runa method 11 1 Final preparations before a run Eliminate switch time If the simultaneous opening of two valves as described above needs to be avoided valve switching may be performed sequentially by stopping the pump operation closing the first valve and opening the second valve Follow the instruction below to eliminate the switch time Step Action 1 Stop the system pump 2 Close the valve to be closed 3 Open the valve to be opened 4 Start the system pump Check column Check that the correct column is used and that the column tubing is fitted correctly Check that the column has been equilibrated if this is not included in the method Check flow kit Check that the flow kit is of the same type as that entered in the System setup dialog box in UNICORN Manager in UNICORN 5 or in the Edit System dialog box in UNICORN 7 see Before starting on page 82 Calibrate flow meter It is recommended that the flow meter is always calibrated when the flow kit has been changed Note The flow meter must be calibrated when changing to a different size flow kit To calibrate the flow meter fill the flow ki
118. items will NOT be accepted for servicing or return withoutthis form 2 Equipment which is not sufficiently cleaned prior to return to GE may lead to delays in servicing the equipment and could be subject to additional charges 3 Visible contaminationwillbe assumed hazardous and additional cleaning and decontamination charges willbe applied Please specify if the equipment has been in contact with any of the following Radioactivity please specify Infectious or hazardous biological substances please specify Other Hazardous Chemicals please specify Equipment must be decontaminated prior to service retum Please provide a telephone number where GE 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 Equipment type Product No Serial No hereby confirm thatthe equipment specified above has been cleaned to remove any hazardous substances and that the area has been made safe and accessible n Company or Name institution Position or job title Date YYYY MM DD Signed P iai A GE and GE monogram are trademarks of General Electric Company To receive areturn authorization number or servicenumber GE Healthcare Bio Sciences Corp 800 Centenrial Avenue PO Box 1327 Piscataway
119. k 5 Equilibration 160 10 2 7 Block 6 Sample load 161 10 2 8 Block 7 Washing unbound sample 163 10 2 9 Block 8 Elution 164 10 2 10 Block 9 Regeneration 166 10 2 11 Saving the method 167 152 AKTA ready Operating Instructions 28960345 AD 10 Creating a method 10 2 An example of using the Method Editor 10 2 1 Creating the method and selecting a column 10 2 1 Creating the method and selecting a column Start out by creating an empty method and selecting a column Step Action 1 In the Method Editor click New on the File menu 2 Click the chosen system select _ Method Editor and click OK The new method will show in the Text pane as a Main block with a Base definition figure 3 Click on the field named Columns in fabSelect_SuRe_10 Global the Parameters area in the Instruc ieseana S Global FF llow sub 10 Global gt w k aT tion box This field display a popup ely sar isu list of available columns iL Poe Ee 1220720 kta si_Peptide_C18 12u_50 250 Global siPeptide_C18_12u_ST_4 6 250 Global Select the RTP column thatistobe pasoresavmee a used and click Change Note that ReadyToProcess columns start with RTP in the list 4 Set the Flow_Warning instruction to Disable and click Insert This action on ES a will avoid repeated display of the OFowPah O een warning message No flow in begin O AamstMon ae ning of method one Hold O watch Loop_End The flow warning w
120. kit and the actual flow cells If the response is within specifications for both flow cells the test will pass otherwise the test will fail for one or both flow cells 6 Finally the component test checks that the three pressure sensors are working and that they produce acceptable pressure readings 108 AKTA ready Operating Instructions 28960345 AD 8 Component test 8 1 Run a component test Stage Description After After the test has finished the test results can be printed The results printout shows all registered flow kit bar codes installation procedures notes and test results If page 8 does include any warning or other text the test failed If all flow cell tests passed the system can be used Failure If any part of the test fails there is a troubleshooting guide available see Section 8 3 Troubleshooting a failed component test on page 117 Prepare a test Wash liquid and test solution are required for a component test A Test solution prepara tion protocol template is available on the system CD The volumes depend on the flow kit used e KTA ready High Flow Kit 25 liters of wash liquid and 10 liters of test solution e AKTA ready Low Flow Kit 10 liters of wash liquid and 5 liters of test solution Test solution for the High Flow Kit is prepared as follows 10 liters of 1 0 M NaCl with 1 acetone in purified water i e 584 g NaCl 100 ml acetone in 9 90 liters purified water For the Low Flow Kit half th
121. l compliance 34 Method editor Buttons 146 Undo function 146 Method Editor 143 Blocks 143 nstructions box 145 Text pane 145 Method optimization 223 More information 223 N Notes and tips 8 O Operation precautions 19 Ordering information 210 223 IQ OQ tools 213 ReadyToProcess 212 Spare parts 210 P Parameters method edi tor 145 Parts Drawing 36 225 Index 226 Personal protection 16 pH Calibration checklist 220 pH electrode 50 94 PID control 214 Pinch valves 48 Positioning the system 66 Pressure cells 49 R Recycling information decontamination 30 disposal of electrical compo nents 30 recycling of hazardous sub stances 30 Reference information 201 Regulatory compliance 11 Regulatory information international standards 10 Restart after emergency 29 Run a method 170 S Safety labels 26 Safety notices 7 Safety precautions general precautions 19 34 introduction 15 Sensor Specifications 205 Service 223 Spare parts 210 223 Specifications 58 202 Starting the system 74 Storage 195 Stray light calibration 108 112 System Capacity 203 System label 24 System setup 82 T Temperature Changes 50 Recommended operating conditions 202 Sensor 50 Sensors checklist 218 Training 223 Troubleshooting 196 Typographical conventions 8 U UNICORN Alarms 54 Column efficiency test 168 Control system 52 Creating a method
122. lace and pre venting the valves from accidentally closing during flow kit installation WARNING Never put fingers or any objects other than the intended tubing in to the pinch valve opening Valves Default position Inlet valves XV 001 to XV 006 Closed Air trap valves XV 021 to XV 023 Inline Column valves XV 031 to XV 033 Bypass Outlet valves XV 051 to XV 056 Closed Air Vent Valve HV 301 Closed During pause the air trap valves will remain in the same position as during the run The user can change this by setting the air trap valves to inline during pause in the System Settings in UNICORN AKTA ready Operating Instructions 28960345 AD Pressure cells The pressure cells in the AKTA ready flow kits are designed with a flexible membrane that is brought into contact with a transducer load cell on the system cabinet for measurement of fluid pressure There are three pressure cells continuously mea suring the pressure of the liquid Pressure cell PT 111 Location The first pressure cell is located in the high pressure flow path directly downstream from the system pump 3 System description 3 4 Equipment Function Measures the total pressure over the entire flow path PT 112 The second is located in the medium pressure flow path downstream from the column Measures the total pressure in the flow path after the column The difference between pres
123. lashes See Components on system cabinet front on page 38 for location e When communication with UNICORN software is established the POWER indicator lamp shows a steady green light Note When power is switched on KTA ready will perform a stray light calibration without the UV flow cell installed This will result in a very high calibration factor Therefore it is very important to perform a stray light calibration as soon as the flow kit is mounted and water or any other actual liquid has been purged through the flow kit 76 KTA ready Operating Instructions 28960345 AD 6 Flow kit installation 6 Flowkit installation About this chapter This chapter presents the different flow kits that can be used with the AKTA ready and describes how to install an AKTA ready flow kit Much of the information in this chapter is also available in the AKTA ready installation wizard part of supplied software How to install the gradient flow section is described in Section 7 2 AKTA ready gradient flow section on page 99 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 Section 2 1 Safety precautions on page 15 as listed below e General precautions on page 15 e Flammable liquids and explosive environment on page 17 e Personal protection on page 16 e Operation on page 19 In this
124. led component test on page 117 and Chapter 9 Column installation on page 122 Note In UNICORN 5 there is limited method editing support from the column list in UNICORN In UNICORN 7 the user must enter column parameters manually see Edit column parameters in UNICORN 7 on page 130 AKTA ready Operating Instructions 28960345 AD 4 Installation 4 Installation About this chapter This chapter describes how to transport and install AKTA ready AKTA ready is designed for ease of use As a consequence the system is easy to install and setup for the first run Most of the components are mounted on the system cabinet or on the flow kit There are few loose parts that require assembling or mounting and the physical connec tions are simple and straightforward Installation should however always be performed by experienced personnel authorized by GE Healthcare Apart from a suitable environment for the instrument the prerequisites for installation of AKTA ready include outlets for electrical power and compressed air and access to a computer Some tools are required for unpacking the instrument and test liquids must be prepared 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 Section 2 1 Safety precautions on page 15 as listed below e Installing and moving on page 17 e Perso
125. let set AirTrap to Bypass and Column to Bypass 4 Connect the inlet tubing to appropriate buffer vessels 5 Start pump A B 0 with a ManFlow of 50 ESE Pasmem e eet C FlowPath Potin 0 ae ete Alarms amp Mon Com anin s pescageem rene P202Gain Close Help ManFlow 50 0 T Auto update If this is checked the parameter fields will be updated during method run 6 Run the pump until the flow meter signal is stable 7 Start pump B B 100 with a ManFlow of 50 8 Run the pump until the flow meter signal is stable 104 AKTA ready Operating Instructions 28960345 AD 7 AKTA ready gradient 7 3 Calibrate and operate the AKTA ready gradient pump Calibration Step Action 1 For calibration set Flow to at least 20 I h for LowFlow Kit and 40 I h for HighFlow Kit RTP Pump Instructions 2 Set Column under FlowPath to Inline 3 When flow signal is stable at set flow rate select P201Gain under Pump and click Execute RTP Pump Instructions Gradient 100 0 0 00 AKTA ready Operating Instructions 28960345 AD 105 7 KTA ready gradient 7 3 Calibrate and operate the AKTA ready gradient pump Step Action 5 Select P202Gain under Pump click Execute when flow signal is stable at set flow rate RTP Pump Instructions 6 Select FlowCompensation under Pump and click ON and let the calibration procedure compensate for differences between the capacity of pumps A P 201 and B P 202 Note FlowCompensa
126. lock 8 Elution The Elution block Now that you have defined and saved the Fraction and Fraction_Stop blocks proceed by defining the elution block Step Action 1 Create a block named MyElution and set its Base to Volume 2 Insert an Inlet instruction at time 0 00 The instruction should be set to the inlet used for the elution liquid for example Inlet5 the outlet is left unchanged from previous block a Parameters Hold Until a Test EE AT131 F Watch _Cond_CT101 Bresiere tat y Watch_pH_AT121 Value 7000 0000 7000 0000 Watch_Press_PT111 a Watch_Press_PT112 Vibe Jono aaj TAU Watch_Press_PT113 Action Watch Delta PT111_PT112 i Watch Flow FT141 MEE Freetion Watch_UPS Watch_Inlet1_Totalizer Watch Inlet2 Totalizer Ms 3 Create and insert a watch instruction which starts fractionation when the UV level is above 100 mAU This is done by selecting instruction Watch_UV_AT131 and in the parameters area setting the Test parameter to Greater_Than and the Value parameter to 100 mAU In the popup menu under Action select the Fraction block that you previously created 4 Using the same procedure as in the previous step create another watch instruction for stopping fractionation when UV goes below 90 mAU Set the parameter Test to Less_Than and Value to 90 mAU and select the previously created Fraction_Stop block under Action The MyElution block uses two watch in W 0 00 Block MyElut
127. m fails to perform a fine tuning e If you click Disable and after that Execute the Fine_tuning_flowme ter_failed warning will not be displayed on the screen and there will be no entry in the logbook System Control 1 AKTAready P3 Help button is enabled if the selected message has attached help Select a message and push Help or F1 2 24 min UF 900 0 error 5 Fine tuning flowmeter failed A totalizer monitors the accumulated volumes passing through an actual inlet or outlet There are six inlet totalizers and six outlet totalizers For each totalizer there is a watch instruction allowing for easy programming of needed actions triggered by specific events To define an action based on the totalizer for for instance Inlet 1 1 Enable the totalizer by inserting instruction Inlet1_Totalizer under FlowPath and setting it to Enabled 2 Insert watch instruction Watch_Inlet1_Totalizer under Watch and set values for Test e g Greater_Than Value volume in liters and Action e g END_BLOCK To activate an alarm for an enabled totalizer insert the Alarm_XXX_Totalizer instruction under Alarms amp Mon corresponding to the inlet outlet in question Note that alarms automatically sets the system in pause mode The allowed noise or error for a totalizer can be defined using the appropriate WatchPar_XXX_Tot instruction under Alarms amp Mon A totalizer can be reset to 0 liters by inserting an XXX_Totalizer_Reset
128. m power cable cable mounted 2 PNEUMATIC AIR SUPPLY Compressed air connector 3 SYSTEM COMPUTER Ethernet network connector 4 CUSTOMER 1 O User I O Instructions for connecting the system For instructions on how to connect the system see Section 4 6 Connections on page 67 KTA ready Operating Instructions 28960345 AD 41 3 System description 3 2 Layout Flow kit components AKTA ready uses flow kits that include all the necessary tubing from inlet to outlet in cluding flow cells air trap column connection tubing and pump tubing Specifications regarding the flow kits including materials and chemical resistance tables are found in Chapter 14 Reference information on page 201 The drawing below shows the components of an AKTA ready flow kit 14 5 T 5 4 c 3 gt 11 2 a IY 0 L S gt INS Dp Ey AA ar G ACC ul T nA Hin P 6 The following table gives a brief description of the flow kit components Numbers in the table refer to the figure above Note Several flow kit components are flow cells for sensors located on the system cabinet In such cases the ID tag technically refers to the sensors rather than the flow cells adapters Here however the tags are used for identification of both sensors and their corresponding flow cells 42 AKTA ready Operating Instructions 28960345 AD 3 System description 3 2 Layout
129. ments for Concentration Limits for Certain Hazardous Sub stances in Electronic Information Products AKTA ready Operating Instructions 28960345 AD 25 2 Safety instructions 2 2 Labels Label text Description This symbol indicates that KTA ready has been certi fied by a Nationally Recognized Testing Laboratory q NRTL NRTL means an organization which is recog c US nized by the US Occupational Safety and Health Ad ministration OSHA as meeting the legal requirements Intertek of Title 29 of the Code of Federal Regulations 29 CFR Part 1910 7 Listed Indicates that this product complies with the Canadian CAN ICES 1 NMB 1 standard ICES 001 NMB 001 concerning electromag netic compatibility Safety labels The following table describes the various safety labels that may be found on the product Symbol text Description Warning Read the user documentation before using AKTA ready Do not open any covers or replace parts unless specifically stated in the user documentation Warning Pinch hazard This sign is located next to pinch valves and close to the pump Never put your fingers or any objects other than the intended tubing in the pinch valve openings Ensure that clothing or other equipment do not get caught in the pinch valves Warning Rotating rollers cogwheels This sign is locat ed on the pump Never touch the pump or pump lid while the pump is running In case of emergen
130. mergency stop In case of emergency stop the run by pressing the EMERGENCY STOP button This will immediately stop the pump and close all inlet and outlet valves To restart the system after an emergency stop turn the EMERGENCY STOP button to release it and press the PAUSE CONTINUE button AKTA ready Operating Instructions 28960345 AD 177 11 Runa method 11 3 Viewing and printing results 11 3 Viewing and printing results General Results from a run are viewed in and printed from the UNICORN Evaluation module Viewing results Step Action Locate the result file in the Files panel to the left in the Evaluation module 2 Double click the result file The result file opens in a Chromatogram panel Ugie Edt View Integrate Operations Procedures Window Help 5x DEE Sa Ota 5 Fics Find Poe ae pemeskt hacks 14 zaba pA L ID Uy Le RN T aal 0 S00onaa a bane Ss 3790382003 10 Ls a haoo E 4 U1513091CaptosstepRTPCom Bjuisis0s1captosstepCompare 1200 uts13091CaptoscradCompare jursisoas HETP test 201 30cm fy 99 U U1513089 HETP test 10L 30cm BJuisis08s RTP appl so0cmpert dJuisia089 RTP appl 201 S00cm 1000 iljuis13088 RTP appl 10L 500cm u1513087 RTP appl 2500mL 501 oo u1513087 HETP test 2500mL U U1513086 HETP test 2500m 3 B ursisoe6 HETP test 20L socmq 800 U U1513086 HETP test 10 L 30cm Dorae w a ees
131. mmarizes the required manufacturing information For further infor mation see the EU Declaration of Conformity DoC document Requirement Content Name and address of manufacturer GE Healthcare Bio Sciences AB Bj rkgatan 30 SE 751 84 Uppsala Sweden Conformity with EU Directives This product complies with the European directives listed in the table by fulfilling the corresponding harmonized standards A copy of the EU Declaration of Conformity is included in the documentation package Directive Title 2011 65 EU Restriction of Hazardous Substances RoHS Directive 2006 42 EC Machinery Directive MD 2004 108 EC Electromagnetic Compatibility EMC Directive 2006 95 EC Low Voltage Directive LVD AKTA ready Operating Instructions 28960345 AD 9 1 Introduction 1 2 Regulatory information CE marking The CE marking and the corresponding EU Declaration of Conformity is valid for the in strument when it is e used as a stand alone unit or e connected to other products recommended or described in the user documentation and e used in the same state as it was delivered from GE Healthcare except for alterations described in the user documentation International standards Harmonized standard requirements fulfilled by this product are summarized in the fol lowing table Standard EN ISO 12100 Description Safety of machinery General principles for design Risk as sessment
132. n 175 11 3 Viewing and printing results 178 11 4 After the run 180 170 AKTA ready Operating Instructions 28960345 AD 11 Runa method 11 1 Final preparations before a run 11 1 Final preparations before a run Precautions WARNING e Hazardous substances and biological agents When using hazardous chemical and biological agents take all suitable protective measures such as wearing protective glasses and gloves resistant to the substances used Follow local and or national regulations for safe operation and maintenance of AKTA ready e Corrosive substance NaOH is corrosive and therefore danger ous to health When using hazardous chemicals avoid spillage and wear protective glasses and other suitable Personal Pro tective Equipment PPE CAUTION Do not use chemicals at temperatures above the specified limits AKTA ready Operating Instructions 28960345 AD 171 11 Runa method 11 1 Final preparations before a run Connect containers Buffers Connect the buffer inlet tubing to the appropriate buffer containers Check that there are sufficient buffer volumes available Note Significant differences in the liquid level height of elevation in between con nected inlet outlet lines and containers may cause unintended mixing in be tween the inlet outlet lines if the valve switching time the time of overlap in open valves when switching inlets without pump stop is selected too long Samples C
133. nal protection on page 16 NOTICE gt KTA ready shall be installed and prepared by personnel from GE Healthcare or third party authorized by GE Healthcare Contact GE Healthcare if you require re installation at a new site KTA ready Operating Instructions 28960345 AD 55 4 Installation In this chapter 56 This chapter contains the following sections Section See page 4 1 Included in the delivery 57 4 2 Site requirements 58 4 3 Transport 60 4 4 Unpacking 65 4 5 Positioning the system 66 4 6 Connections 67 AKTA ready Operating Instructions 28960345 AD 4 Installation 4 1 Included in the delivery 4 1 Included in the delivery General AKTA ready is delivered in a wooden box containing the system cabinet a column trolley a smaller box containing an accessory kit system documentation folder and user documentation The accessory kit The accessory kit delivered with the system contains Bar code scanner USB two computer network cables 10 and 3 m and a RJ45 coupling connector key for the back door of the system cabinet compressed air tubing 5 m customer I O connector CD disks containing UNICORN and AKTA ready strategy software documentation including UNICORN and AKTA ready manuals system log book labels for configured voltage A 10mm wrench for the bolts holding the pump lid is also located on the inside of the front cabinet door Associated products
134. nce ee 12S Spare OCIA eraran a EE EES EEEE RaT a AA 1E S 0 1 R EE AA EE EE E E TOUR TS SOO UNG enome RRN Reference ITT net ire cacrncncten niente een eepuene TAL SP CiFICALIONS on eecssscssssssssssssnssseesesssssccsssssssssusssssesecssssssssuussssssessesssssssssusssesstsseesessssssasssueseseeseesessesss 14 2 Process wetted materials 14 3 Chemical resistance oa DAA Ordering iM ormMati N szsaoe inseamna unninn ianiai KTA ready Operating Instructions 28960345 AD Table of Contents T45 PIDECONO anginan A A A E R 214 14 6 Checklists oocccccceccssssessssssesssssseessssseesssene 216 14 7 Health and Safety Declaration Form ar 22l 148 MOre INFORMA ON seasiitaticcensnh a A A TNE AR 223 o E EEE EE E E AAA E E EE AEAT A 224 4 KTA ready Operating Instructions 28960345 AD 1 Introduction 1 Introduction Purpose of the Operating Instructions The Operating Instructions provides you with the instructions needed to handle AKTA ready in a safe way It also describes the procedures required to operate KTA ready on a day to day basis as well as technical information and instructions for troubleshooting and maintenance Prerequisites In order to operate the system in the way it is intended the following pre requisites must be fulfilled e You should have a general understanding of how a PC and Microsoft Windows works e The user must have a working knowledge of UNICORN software A user account
135. nd scanner or it can be entered manually AKTA ready Operating Instructions 28960345 AD 133 9 Column installation 9 2 Installing a column 134 A report similar to the flow kit installation report can also be produced for a column in stallation The report can be either automatically produced or manually created by se lecting the report format AKTA ready_Column in the Report dialog box in the UNICORN Evaluation module The report format AKTA ready_Column_T also contains results from an efficiency test see next section AKTA ready Operating Instructions 28960345 AD 9 Column installation 9 3 Optional column test 9 3 Optional column test Introduction Amethod for efficiency testing of columns can be created in the UNICORN Method Editor from the provided method template or an efficiency test can be run in connection with installation of a column using the installation wizard as described in Section 9 2 Installing a column on page 127 Efficiency testing using the wizard places the test results in the column installation report Column efficiency testing when included in the column installation should be performed under stable conditions in room temperature using the flow rates volumes and buffers prescribed Test results are presented in the installation report Note ReadyToProcess columns are already qualified by efficiency testing and deliv ered with individual certificates Customized methods for efficiency testing
136. nected outlet is actually used e Check that the outlet is not plugged e Toosmall outlet tubing diameter Change to a larger tubing e Flow kit mounted on system for too long causing the inner walls of the tubing to stick together Re place the flow kit AKTA ready Operating Instructions 28960345 AD 199 13 Troubleshooting Component Flow kit Problem Excessive pressure Corrective action Excessive pressure may damage the flow kit If exces sive pressure is detected and the air trap is in line press the AIR VENT button on the system cabinet to reduce the pressure If excessive pressure is detected when the air trap is bypassed perform the following steps 1 In UNICORN set Manual Flow to 0 and set the air trap in line 2 Press CONTINUE in UNICORN or on the system cabinet 3 Press the AIR VENT button on the system cabinet UV Drifting UV signal UV signal does not return to zero Condensation of moisture on the flow cell window The process liquid is too cold must not be lower than 10 C from ambient temperature UV absorption values gt 5 AU even without flow kit installed Stray light calibration performed without cell Install a flow kit and do a stray light calibration accord ing to the instruction Manual calibration of UV stray light on page 148 200 AKTA ready Operating Instructions 28960345 AD 14 Reference information 14 Reference informat
137. nformation only and requires no action from the user The test will proceed normally regardless of if the user closes the message box by clicking Acknowledge or not The warning message can be disabled see Manual calibration of UV stray light on page 148 e A few minutes into the test a message will appear prompting the user to fill the air trap This message requires user action Press the AIR VENT button to open the air vent valve HV 301 allowing for evacuation of air from the air trap Note You must respond to the message regarding evacuation of the air trap If the air trap is not properly filled the test may fail Any time during the test run it is possible to manually add run notes that will be included in the report The notes dialog box is opened by clicking Documentation on the View menu in UNICORN AKTA ready Operating Instructions 28960345 AD Ce General 8 Component test 8 2 The test report The test report Information about an installation including the results from the component test are stored and can be compiled into a printed report If the option Print report automatically was chosen initially in the installation wizard Open the installation wizard on page 84 the results from the component test run will be available in the form of a printed report produced immediately after the test has fin ished If the option Print report automatically was not chosen a printed report can be created at a later
138. nifold which allows for bypassing the air trap and e the column manifold which allows for bypassing the column 46 AKTA ready Operating Instructions 28960345 AD 3 System description 3 3 Flow chart From column to outlet Stage Description 1 Downstream of the column the liquid passes through a second pressure sensor cell PT 112 which has an integrated flow cell for a pH electrode AE 121 2 The liquid then continues through e a flow meter cell FE 141 with integrated temperature sensor TE 161 e a conductivity cell CE 101 and e a UV cell AE 131 3 The last sensor in the path is a third pressure sensor PT 113 4 Downstream from the sensors the liquid continues via the outlet tubing to the outlet manifold where valves KV 051 to XV 056 divert the liquid to either waste or fraction collection Maximum pressures e Atthe outlet manifold the system works under a pressure of max 0 95 bar e Between pump and column the pressure is max 5 bar e Between column and outlet manifold the pressure is max 2 bar e The different pressure zones are monitored by pressure sensors PT 111 to PT 113 AKTA ready Operating Instructions 28960345 AD 47 3 System description 3 4 Equipment 3 4 Equipment Pinch valves 48 Pinch valves are used to control the path of the liquid flow through the system There are 19 pinch valves in total The valves have manually operated safety locks keeping the tubing in p
139. nishing flow kit installation e Make sure that the safety locks on all pinch valves have been properly closed There are 19 safety locks in total e Make sure that the three pressure flow cells are in place and properly connected e Setall pinch valves to run position by turning the Installation switch to RUN FLOW KIT COLUMN INSTALL INSTALL e Check that the end cap on the air vent tubing of the air trap has been removed AKTA ready Operating Instructions 28960345 AD 95 6 Flow kit instal 6 3 Mounting the fl lation ow kit NOTICE The end of the air trap tubing should be directed away from the operator preferably it should be connected to a waste hose A component test should always be performed after mounting a new flow kit If the in stallation wizard is used a component test is automatically included in the installation procedure The component test is described in Chapter 8 Component test on page 107 Alternative mounting procedure To minimize microbiological contamination it is possible to assemble a flow kit in for instance a LAF cabinet before it is mounted onto the system cabinet However if you decide to preassemble a flow kit be careful to check that the angles between the different parts are correct If they are not the flow kit will not fit properly on the cabinet possibly causing kinked tubing To adjust the different parts it is necessary to loosen the TC con ne
140. nlet InletS v Outlet OutletS v unused variables Display tooltip for extended variable cells 3 Check that the sample volume is correct 4 Click Next or Back to navigate through the dialog pages adding the infor mation required as well as your own comments 5 Click START in the Result Name dialog box This will initiate the method run AKTA ready Operating Instructions 28960345 AD 175 11 Runa method 11 2 Starting a run File View Manual System Help oo Pause End aoa EAA Run Data PS Instruments Connection Run Status Acc Volume Block Volume Acc Time Block Time U _131 gt gt aa 01 gt gt pH_121 gt gt Press_111 gt gt Press_112 Press_113 Delta_P1P2 Flow_141 gt gt Temp_161 P201 UVLampMode UVLEDRef FlowKit Ini_Tot In2_Tot In3_Tot In4_Tot In5_Tot In6_Tot Outl_Tot Out2_Tot Out3_Tot Out4_Tot Out5_Tot Out6_Tot a X MEE Cond_101 pH_121 Press_111 ess Press_113 Flow_141 Temp_161 P201 ee dora Int Tot In2_Tot in3_Tot InS_Tot In6_Tot Outt_Tot Out2_Tot Out3_Tot Out4_Tot 3 20ut6_To 18 16 in o 148i 4 5 i 2 wer 12 2 2 a uw as E x a wE E a E a wes o gg w l ce 04 fs 02 AAS 00 T m E S Se ae rae T RF pe 0 0 01 02 03 o4 05 06 07 08 09 1 0 14 1
141. ns Personal protection WARNING Always use appropriate Personal Protective Equipment PPE during operation and maintenance of this product Hazardous substances and biological agents When using hazardous chemical and biological agents take all suitable protective measures such as wearing protective glasses and gloves resistant to the substances used Follow local and or national regulations for safe operation and maintenance of KTA ready 16 KTA ready Operating Instructions 28960345 AD 2 Safety instructions 2 1 Safety precautions WARNING e Personal Protective Equipment PPE Whenever packing unpacking transporting or moving the product wear Protective footwear preferably with steel toe cap Working gloves protecting against sharp edges Protective glasses Flammable liquids and explosive environment WARNING e Flammable liquids This product is not approved to handle flammable liquids e Explosive environment The product is not approved for work in a potentially explosive atmosphere in areas classified as Zone 0 to Zone 2 according to IEC 60079 10 2002 The product does not fulfill the requirements of the ATEX Directive Installing and moving WARNING e Move transport crates Make sure that the lifting equipment has the capacity to safely lift the crate weight Make sure that the crate is properly balanced so that it will not accidentally
142. nvironment precau tions 17 F FCC compliance 11 Flammable liquids precau tions 17 Flow chart 45 AKTA ready Operating Instructions 28960345 AD Flow kit Alternative mounting proce dure 96 Attach main part tubing 88 Before starting Aseptic solution 82 End caps 83 pH calibration 83 TC clamps 82 Test liquids 83 Components drawing 42 Connect and mount pump tubing 89 Finishing installation 95 Flow rates 203 Installation 77 Labeling 80 Mounting 81 Mount inlet manifold 88 Mount outlet tubing 95 Open valve locks 85 Pressure cell holders 87 Remove pump lid 86 Specifications 203 Three parts 78 Types 79 Unpacking 80 What is delivered 80 Flow kits Associated products 35 Ordering information 210 Flow meter Disable warning 149 Flow meter cell 50 G General precautions 15 Gradient flow section 37 99 Installation 100 Ordering information 210 Types 100 Gradient pump 46 98 Calibration 103 Layout 37 Gravity 63 l Installation 55 Finishing 71 Positioning 66 KTA ready Operating Instructions 28960345 AD Index Installation test Checklist 220 Installing and moving precau tions 17 Instructions method edi tor 145 L Labels Safety labels 26 system label 24 System label 24 Layout 36 Layout gradient pump 37 Lifting 62 M Maintenance Daily 184 Spare parts 194 Yearly 187 Maintenance precautions 22 Manufacturing information 9 Materia
143. of other columns can be created using the supplied wizard see Section 10 3 Creating a column efficiency test on page 168 Preparations When selecting the Column Installation alternative in the column installation wizard the user is given the choice of also selecting the Include Efficiency Test of Column checkbox see Section 9 2 Installing a column on page 127 By doing so additional items concerning preparation and connection of wash and test liquids will be included in the wizard s checklists The liquids required for the test are e Column wash liquid A tank with purified water connected to inlet 6 The volume required is shown in the wizard The volume depends on the size of the column e Tracer solution A tank with 5 solution of 2 acetone in column wash liquid con nected to inlet 5 Note If test results are to be compared use the same solvent for wash and test liq uids The wizard recommends using either water 20 ethanol or 2 benzyl alcohol The choice of solvent will affect test results ethanol will produce lower values compared to water AKTA ready Operating Instructions 28960345 AD 135 9 Column installation 9 3 Optional column test Running the column efficiency test 136 A column efficiency test is started by clicking Start in the UNICORN Result Name panel in the Start Protocols dialog box displayed immediately after finishing the installation wizard The test is performed using 100 cm
144. onnect the sample inlet tubing to the appropriate sample containers Check that there is sufficient sample available Tip Use air sensors for optimal sample application Fractionation If fractionation is included in the method connect the outlet tubing from the chosen outlet valves to appropriate fractionation containers Note Check that the fractionation containers will accept the volumes diverted to them during the run Waste Connect the waste tubing to a waste container Check that the waste container is not full and will accept the volume diverted to it during the run Set valve switch time for inlet and outlet valves 172 The UNICORN control strategy features a short overlap in valve switching at the inlet and outlet valves This overlap allows for continuous operation of the pump without the risk for blockage of the flow path due to a closed inlet or outlet manifold When operating the system and switching from one inlet to another from one outlet to another the valve to be closed will be kept open for the period of a defined switch time after opening up the next valve A minimum switch time of 0 1 seconds is required to account for possible delays in the execution of instructions of the system control and to eliminate the risk for a blockage of the flow path respectively The valve switch time between the inlet and outlet valve can be changed in UNICORN It is recommended to keep the valve switch time as short as requ
145. or a pump head and electrical cables It also includes a motor driver installed inside the AKTA ready cabinet The gradient pump is mounted on the left foot of AKTA ready 98 AKTA ready Operating Instructions 28960345 AD 7 AKTA ready gradient 7 2 AKTA ready gradient flow section 7 2 AKTAready gradient flow section Two parts AKTA ready gradient flow section are delivered as two parts Each of the two parts con stituting the flow parts are autoclaved and ready for use with AKTA ready No Part Function 1 Pump tubing Double pump tubing for mounting to system pump P 201 2 Jumper tubing Tubing to be connected to KTA ready gradient pump P 202 KTA ready Operating Instructions 28960345 AD 7 AKTA ready gradient 7 2 AKTA ready gradient flow section Gradient flow section types Two different AKTA ready gradient flow sections are available e KTA ready gradient High Flow section with pump tubing diameter 12 mm and tubing diameter 9 5 mm e KTA ready gradient Low Flow section with with pump tubing diameter 8 mm and tubing diameter 6 4 mm Both flow kits use 25 mm TC connectors for connecting to inlet and outlet containers pump tubing and column NOTICE gt Only use KTA ready flow sections supplied by GE Healthcare Specifications for KTA ready flow kits are found in KTA ready gradient section specifi cations on page 204 Ordering information is in KTA ready gradient
146. ounted as described on Air filter on page 192 Wheels The wheels are screwed onto the system cabinet support from below This requires that the cabinet is lifted slightly Before attempting to replace a wheel carefully read the in structions in the UNICORN Installation Guide concerning lifting and moving the system unit With the unit lifted the four bolts holding the wheel can be loosened and the wheel re moved Mount the new wheel using the same bolts Pump lid See instructions in Remove the pump lid on page 86 regarding mounting of a new pump lid 194 AKTA ready Operating Instructions 28960345 AD 12 Maintenance 12 4 Storage 12 4 Storage If the system is not used for a longer time period more than a few days e Remove the flow kit see Section 11 4 After the run on page 180 e Clean the cabinet this chapter e Ifthe system is moved the system power and air supply should be switched off Note Although the system can be stored at temperatures between 25 C and 60 C room temperature is preferable Flow kits should not be stored at temperatures below 5 C Do not leave a flow kit mounted on the system for an excessively long time The tubing walls may stick together where the tubing is squeezed possibly causing high pressure alarms when running the system NOTICE Do not use 0 5 M NaOH or higher for more than 2 hours Flush afterwards with a suitable rinsing liquid to remove the NaOH AKT
147. ow Kit AKTA ready High Flow Kit Tubing diameter i d 6 4mm 1 4 9 5 mm 3 8 Pump tubing diameter i d 8 mm 12mm Flow rate range 3 to 175 l h 7 5 to 510 l h Total volume 0 055 0 116 Connector i d TC 25 TC 25 Ambient temperature 2 C to 30 C 2 C to 30 C Liquid temperature 2 C to 40 C 2 C to 40 C Estimated shelf life 3 years 3 years Maximum operating pres 5 bar g 72 5 psi 0 5 MPa sure 5 bar g 72 5 psi 0 5 MPa 204 AKTA ready Operating Instructions 28960345 AD 14 Reference information 14 1 Specifications Sensor specifications Acceptancerange Max measure ment error 1 Pressure 1 to 10 bar g Oto 5barg 0 20 bar g Flow O to 510 I h 7 5 to 510 l h 5 actual value High Flow Kit 2 at flow 2 40 I h3 10 actual value at flow lt 40 I h Flow Low Flow Kit 0 to 175 l h 3 to 175 I h 5 actual value at flow 20 l h 10 actual value at flow lt 20 l h Conductivity Oto 199 99mS em 0 to 150 mS cm 5 full scale pH pH 0 to 14 pH 2 to 12 0 2 pH at calibra tion temperature Drift 0 025 pH units h 20 C pH 4 Flow rate sensitivi ty 0 1 pH unit UV 7 to 7 AU 0 01 to 1 0 AU Deviation from lin earity 5 8 Temperature O to 47 C 2 C to 40 C 3 C 1 Max error valid within acceptance range under operation conditions 2 Flow meter cells for High Flow Kit and Low Flow Kit are designed
148. ow light indicates UNICORN alarm 2 RUN indicator Shows green light when system is running lamp No light when system is idle i e between runs or during pause 38 AKTA ready Operating Instructions 28960345 AD 3 System description 3 2 Layout Part Component ID tag Function 3 POWERindica Shows flashing green light during initial com tor munication connection with UNICORN soft ware when power is switched on Steady green light when power is on and communi cation is established 4 EMERGENCY Stops the pump and places the system in STOP button pause mode See Pinch valves on page 48 co for valve positions 5 Mains power System mains power switch located on the switch left side of the unit 6 Inlet valves XV 001to 6 valves located on the left side of the unit XV 006 7 Pump P 201 A peristaltic pump capable of delivering up to 510 I h of buffer and sample liquids at a back pressure of up to 4 bar A peristaltic pump is the simplest type of pump with no valves or seals that can be clogged or corroded The liquid is in contact only with the bore of the tubing eliminating the risk of the pump contaminating the liquid or the liquid contaminating the pump Peri staltic pumps can run dry 8 Air trap valves XV 021to 3 valve arrangement for air trap bypass in XV 023 line 9 Air trap holder Holder for the flow kit s air trap 10 Columnvalves XV 031to 3 valve arrangement for
149. p Default is All which means the list will include all columns available regardless of technique Initial Settings Technique All All Affinity Anion Exchange Cation Exchange Hydrophobic Interaction AKTA ready Operating Instructions 28960345 AD 129 9 Column installation 9 2 Installing a column Step Action 2 From the Column list select the column type that will be used The list is limited to columns relevant for the technique selected in the previous step If All was selected the list will include all columns available regardless of technique Initial Settings Technique All Column Select Column Select Column RTP_Capto_adhere_10 Global RAT P_Capto_adhere_2 5 Global ATP_Capto_adhere_20 Global RATP_Capto_Q_10 Global ATP_Capto_Q_2 5 Global RTP_Capto_Q_20 Global RTP_Capto_S_10 Global RTP_Capto_S_2 5 Global RTP_Capto_S_20 Global RATP_MabSelect_SuRe_10 Global RATP_MabSelect_SuRe_2 5 Global RTP_MabSelect_SuRe_20 Global ATP_Phenyl_Sepharose_6_FF_ low_sub _10 Global RTP_Phenyl_Sepharose_6 FF_ low sub 2 5 Global RTP Phenyl Sepharose _6 FF low sub 20 Global 3 Prepare a column of the selected type and place it on the column trolley Position the column so that the column s inlet tubing marked Bottom Inlet is facing the handle of the column trolley Roll the trolley into position between the system cabinet leg supports and lock the trolley wheels
150. perating conditions Property Value Ambient temperature 2 C to 30 C Liquid temperature 2 C to 40 C Fluid density 950 to 1050 kg m Fluid viscosity 1 0 to 1 3x water viscosity at actual temperature max 2 5 cP 202 AKTA ready Operating Instructions 28960345 AD 14 Reference information 14 1 Specifications System capacity Property AKTA ready Low Flow Kit AKTA ready High Flow Kit Volumetric flow rates 3 to 175 I h 7 5 to 510 I h Pump speed 225 rpm 100 340 rpm 100 Max pressure peri 4 0 bar 4 0 bar staltic pump AKTA ready flow kit specifications AKTA ready Low Flow Kit AKTA ready High Flow Kit Tubing diameter i d 6 4mm 1 4 9 5 mm 3 8 Inlet manifold diame 9 5 mm 3 8 12 7 mm 1 2 ter i d Pump tubing diameter i d 8mm 12mm Flow rate range 3 to 175 W h 7 5 to 510 l h Total volume 0 762 2 145 Air trap volume 0 502 1 619 Connectors type size TC 25 TC 25 No of inlets outlets 6 6 6 6 Max pump speed 225 rpm 340 rpm Pressure rating e 0 6 bar low pressure inlet manifold e 5 0 bar high pressure flow path upstream of col umn e 2 0 bar high pressure flow path downstream of column e 0 95 bar low pressure outlet manifold AKTA ready Operating Instructions 28960345 AD 203 14 Reference information 14 1 Specifications AKTA ready gradient section specifications AKTA ready Low Fl
151. psulated end of the longer 10 m straight cable to to the connector of type RJ45 marked SYSTEM COMPUTER on the back of the system 2 Connect the other end of the long cable to e the controlling computer if a direct connection is used or e the shorter 3 m crossover cable which in turn is connected to a switch or hub the shorter cable is only used when connecting to the controlling computer via a network Note In order not to compromise the protection of the cabinet use only the enclosed communication cables AKTA ready Operating Instructions 28960345 AD 69 4 Installation 4 6 Connections Customer I O 70 Connector The CUSTOMER I O connector C1 in figure below is located on the left side of the system cabinet beneath the inlet valves The connector is a 15 pole IP67 proof Dsub male connector A female mating connector containing a screw terminal block with water tight housing is supplied with the system The CUSTOMER I O connector can be used for an external alarm and to receive a signal indicating that a UPS has been activated This is described below The CUSTOMER I O connector is also used for connecting the air sensors as described below Connection for alarm or UPS Input voltage is 24 V acceptable range 15 to28 V and output signal is 24 V max 1 A The signals are e Pin 1 Remote Alarm A in figure digital output 24 V e Pin 4 GND Digital ground e Pin 11 UPS On B in figure digital in
152. put 24 V e Pin 15 24 V Digital Supply voltage Pins 1 and 4 provide an output for an alarm device e g a warning light a buzzer or simi 24V lar device The external alarm will be triggered when the inter nal buzzer is activated AKTA ready Pins 11 and 15 are used to re AKTA ready ceive an On signal B in figure from an optional UPS during a power failure 24V AKTA ready Operating Instructions 28960345 AD 4 Installation 4 6 Connections Connection for air sensors The air sensors are connected to the CUSTOMER I O as shown in the illustration below Customer I O KTAready connector i Brown Air sensor 1 Black 65 comsv a Orange 6 Signal H Green o7 Ir 3 asv Signal V 5V Air sensor 2 COM5V Orange 6 9 sional H fo mo i Green o1 Signal V Finishing installation Verifying connections Finish installation of KTA ready by verifying that the system is properly connected to mains power to compressed air supply and to the computer Next verify that commu nication between UNICORN and the system unit can be established see instruction below KTA ready Operating Instructions 28960345 AD 71 4 Installation 4 6 Connections Establishing computer connection Step Action 1 Turn on AKTA ready using the Mains power switch located on the left side of the cabinet Check that the green POWER lamp on the front of the unit lig
153. ra cable 3 m is connected in series with the long 10 m cable e Reboot PC shut down Windows switch off the system power switch wait at least 5 sec restart system e Reboot system Communication failure e Make sure the system is switched on Check net during a run work cables and connectors Contactbetweencomput Reboot system and PC er and system is broken Note The system will continue to run even if the connection to the computer is broken Data are stored locally and are transferred to the computer as soon as communica tion is restored Power Power failure duringarun Check circuit breaker both in system and for external supply as applicable Note If the power failure is local affecting only the computer the system will continue to run while locally storing the data Stored data are transferred to the computer as soon as communication with the computer is restored Note If the power failure also affects the system no data can be stored and the run will have to be restarted Compressed air Compressed air failure during a run The alarm No air supply to the sys tem is displayed and the system enters PAUSE mode Insufficient air pressure caused by for instance mal functioning air supply equipment or a leaking air hose a Rectify the air supply problem b Restart the run by pressing the PAUSE CONTINUE button AKTA ready Operating Instructions 28960345 AD 1
154. ration Form 14 7 Health and Safety Declaration Form On site service On Site Service Health amp Safety Declaration Form Service Ticket To make the mutual protection and safety of GE 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 delaysin the servicingof 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 Please reviewthe actions below and answer Yes or No Provide explanation for any No answersin 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 aroundthe instrument is clean If radioactivity has been used please perform a wipe test or other suitable survey Adequate space and clearance is provided to allowsafe access for instrument service repair or installation In some cases this may require customer to move equipment from normaloperating location prior to GE arrival Consumables such as columns or gels have been removed or isolated fromthe instrument and from any area that may impede access to th
155. re Pump A P 201 is ramped up to a target flow rate and the rpm value is recorded by execution of the instruction P201Gain In a second step pump B P 202 is ramped up to the same target flow rate and the actual rpm value is recorded by execution of the instruction P202Gain Then a compensation factor P202Factor is calculated for Pump B to achieve identical flow rate vs rom characteristic as Pump A The compensation factor is generated in UNICORN by switching FlowCompensation to ON The actual FlowCompensation value can be displayed in RunData Note Pump tubing is more sensitive to wear and tear If worn tubing is used the gradient system must be calibrated more frequently AKTA ready Operating Instructions 28960345 AD 103 7 AKTA ready gradient 7 3 Calibrate and operate the AKTA ready gradient pump Set up for calibration The set up for calibration procedure is run to ensure that no air bubbles are present in the system tubings A column should be connected to make the calibration conditions similar to those of a real run Step Action L Open the instructions box in the System Control module 2 Set the flow path in the instructions box under FlowPath Inlet Outlet Air Trap Column RTP FlowPath Instructions x e C FowPah Eza AlamstMon Execute Cr Ree E Hep Iriet6 I Auto update If this is checked the parameter fields wil be updated during method tun 3 Use an appropriate inlet and out
156. re the valve is in an open position If the Valve error alarm is accompanied by No air supply to the system the alarm is caused by a com pressed air failure see above 198 AKTA ready Operating Instructions 28960345 AD Component Pump Problem Pump not working 13 Troubleshooting Corrective action e Emergency button has been pressed e Pump lid not properly attached secured See Connect and mount the pump tubing on page 89 for instructions e No inlet or outlet valve open Check method and valves e Incorrect method Check by entering Pump ManFlow gt 1 e If none of the above contact GE Healthcare service personnel Little or no flow e Check that connected inlet is actually used e Inlet containers are placed too low relative to the pump Check inlet containers e No liquid is supplied to the pump Check inlet con tainers e Flow kit tubing is split or burst Replace flow kit e Kinks or blockages in the flow kit Remount or re place flow kit See Section 6 3 Mounting the flow kit on page 81 for mounting instructions e Pump rotor slipping on the drive shaft contact GE Healthcare service personnel Pulsation of liquid in flow kit Liquid too viscous and or pump speed too slow Check that viscosity of liquid is within specified range see Section 14 1 Specifications on page 202 Increase pump speed Too high outlet pressure e Check that con
157. rent AKTA ready flow kits are available e KTA ready High Flow Kit with tubing diameter 9 5 mm inlet manifold 12 7 mm pump tubing 12 mm Intended for 10 to 20 liter ReadyToProcess columns e KTA ready Low Flow Kit with tubing diameter 6 4 mm inlet manifold 9 5 mm pump tubing 8 mm Intended for columns with a volume of less than 10 liters Both flow kits use 25 mm TC connectors for connecting to inlet and outlet containers pump tubing and column NOTICE Only use flow kits supplied by GE Healthcare Specifications for KTA ready flow kits are found in KTA ready flow kit specifications on page 203 Ordering information is in KTA ready flow kits on page 210 KTA ready Operating Instructions 28960345 AD 79 6 Flow kit installation 6 2 Unpacking the flow kit 6 2 Unpacking the flow kit Flow kit package To protect against contamination AKTA ready flow kits are delivered in double plastic bags The flow kit package contains the following items e The main part of the flow kit and the inlet manifold 6 inlets The main part includes air trap column connection tubing sensor flow cells and outlet manifold 6 outlets e The pump tubing including 2 TC clamps with gaskets e Vaseline e A binder containing product documentation for the flow kit Unpack flow kit Unpack AKTA ready flow kits as follows Step Action 1 Cut open the outer plastic bag in a clean environment near the A
158. rmation 14 4 Ordering information 144 Ordering information Introduction This section contains ordering information for AKTA ready flow kits and ReadyToProcess columns for AKTA ready accessories and spare parts and for related literature AKTA ready flow kits Product Inner diameter mm Product code KTA ready High Flow Kit 9 5 28930183 KTA ready Low Flow Kit 6 4 28930182 KTA ready gradient flow section Product Inner diameter mm Product code KTA ready gradient High Flow 9 5 29021086 section AKTA ready gradient Low Flow 6 4 29021085 section AKTA ready accessories spare parts etc pH electrode 18116877 Column trolley 28931880 Air filter 18116958 Pump track assembly pump lid 28930915 Pressure cell holder kit latch and screws 28929887 Air Sensor AKTA ready 29003879 210 AKTA ready Operating Instructions 28960345 AD 14 Reference information 14 4 Ordering information Product Product code Castor wheel without brake 28931366 Castor wheel with brake 28931377 TC Gasket 25 15 EPDM 44549288 TC Clamp 25 SS 18100131 TC Clamp 25 PP 44050805 ReadyToProcess columns Resin Product Size Product code Capto adhere RTP Capto adhere 1 1 28951109 RTP Capto adhere 2 5 2 5 28901714 RTP Capto adhere 10 10 28901715 RTP Capto adhere 20 20 28901716 Capto MMC RTP Capto MMC 1 1 28951118 RTP
159. s Instructions on how to handle AKTA ready in a safe way this manual UNICORN User Manual package l Detailed instructions on how to use the UNICORN control system 1 KTA ready can be controlled by both UNICORN 5 and UNICORN 7 Third party component documentation Documentation for components produced by a third party are if existent also included in the document package 12 AKTA ready Operating Instructions 28960345 AD Related literature 1 Introduction 1 3 Associated documentation Document Product Product code ReadyToProcess columns User Manual User Manual 28925644 ReadyToProcess columns Data file 28915987 AKTA ready chromatography system Data file including Site 28915986 Preparation Guide Keep your AKTA ready operatingin peak Preventive Maintenance 28998083 condition PM Fact Sheet Process chromatography A guide to op Handbook 18112156 timization scale up and validation Efficiency test of ReadyToProcess Application note 28919821 columns Ready to use fluid management solu Application note 28995879 tions for chromatography systems Purification of a monoclonal antibody Application note 28919856 AKTA ready Operating Instructions 28960345 AD using ReadyToProcess columns 13 2 Safety instructions 2 Safety instructions About this chapter This chapter describes safety precautions and emergency shutdown procedures for the
160. sage is displayed This is mainly a warning that the accuracy of the flow measurement is slightly decreased Step Action 1 Click Settings on the System menu Click Alarms amp Mon and scroll down to Fine_Tune_Fail_Report AKTAready P3 Alarms amp Mon Instructions E3 Instructions Parameters O Pump UVlamp_U _AT131 a Mode Insert AutoZero_PT111 5 O FlowPath AutoZero_PT112 Enable O Disable AutoZero_PT113 AlammstMon Timer Execute O Frac StraplightCalib_UV_AT131 Uvref_Tune Close O Other Fine Tune Fail Report v om Help Auto update If this is checked the parameter fields will be updated during method run e Ifyou click Enable and after that Execute the Fine_tuning_flowme ter_failed warning will be displayed if the system fails to perform a fine tuning e Ifyou click Disable and after that Execute the Fine_tuning_flowme ter_failed warning will not be displayed on the screen and there will be no entry in the logbook AKTA ready Operating Instructions 28960345 AD 149 10 Creating a method 10 1 The Method Editor 10 1 3 Other Method Editor features Totalizers 150 Step Action 2 The report mode can also be changed only for the present run After the run the setting is restored to the previous one Click Alarms amp Mon and then Fine_Tune_Fail_Report in the Manual menu e Ifyou click Enable and after that Execute the Fine_tuning_flowme ter_failed warning will be displayed if the syste
161. sanitize the pH electrode See pH calibration on page 186 for calibration instruc gt AE 121 tions i 4 Make sure the O ring 3 is in place in PT 112 gt O 3 Push the pH cable through the 4 fastening nut and connect the Ss pH electrode AE 121 to the ca SS ble Y pr 112 J Insert the pH electrode in its holder Secure the electrode with the plastic fastening nut Use finger force only UV cell The UV cell is mounted when the main part of the tubing is attached to the system cabinet No further actions are required to connect the UV sensor However make sure that the cell has been pushed all the way in a soft click indicates that the cell is in correct position 94 AKTA ready Operating Instructions 28960345 AD 6 Flow kit installation 6 3 Mounting the flow kit Mount the outlet tubing Step Action 1 Mount the outlet manifold by insert ing each outlet tube into the corre sponding outlet pinch valve valves XV 051 to XV 056 Do not yet remove the end caps 2 Close each valve safety lock by turn ing the black handles 180 degrees 3 Snap the air vent tubing that runs from the top of the air trap onto the holder 1 in figure on top of the sys tem cabinet and remove the protec tive end cap 2 from the end of the air vent tubing Note Remember to remove the protective end cap from the air vent tubing The air trap will not work properly if the cap is left in place Fi
162. scription Pressure A Low pressure over the Inlet Manifold 0 6 bar B High pressure over the air trap manifold and column 5 0 bar C Medium pressure 2 0 bar D Medium pressure over the outlet manifold 0 95 bar The table below describes the system components shown in the flow chart Function XV 001 to XV 006 Inlet 1 to 6 grouped in Inlet Manifold KTA ready Operating Instructions 28960345 AD 45 3 System description 3 3 Flow chart Part Function XV 051 to XV 056 Outlet 1 to 6 grouped in Outlet Manifold PT 111 to PT 113 3 Pressure sensors cells AE 121 pH electrode optional FE 141 Flow meter cell TE 161 Temperature sensor CE 101 Conductivity sensor AE 131 UV cell AT 221 Air trap HV 301 Air vent valve P 201 System pump P 202 Gradient pump optional See Section 3 4 Equipment on page 48 for more information about the parts in the table above Note The gradient pump P202 is described in Chapter 7 AKTA ready gradient on page 97 From inlet to column Stage Description al Inlet valves open the appropriate inlet XV 001 to XV 006 in chart for sample or buffer 2 The system pump P 201 and the gradient pump P 202 deliver the liquid to the column via a pressure sensor cell PT 111 and if preferred via the air trap AT 221 where air in the liquid is removed 3 There are two sets of valves between the pump and the column e the air trap ma
163. st the flow kit is automatically filled and no further preparation is necessary AKTA ready Operating Instructions 28960345 AD 127 9 Column installation 9 2 Installing a column Open the column installation wizard 128 Open the Column Installation trail of the AKTA ready Installation wizard Step Action 1 e UNICORN 5 In the KTA ready System Control module on the File menu click Instant Run and then click Run in the dialog box shown e UNICORN 7 In the AKTA ready Method Editor module on the File menu click New Method Click Method Wizard in the New Method dialog box and then click OK In the wizard click Column Installation Column Installation C Include Efficiency Test of Column J Include Rinsing of Column with six column volumes C Print Report Automatically Note Before continuing the flow path including Inlet6 and am trap must be tiled with the same wash liquid as used during the component test Also tubing for a waste tank bag shall be connected to Outlet If you intend to run a column test or a rinsing program also select the Include Efficiency Test of Column checkbox and or Include Rinsing of Column Column testing is discussed in Section 9 3 Optional column test on page 135 and rinsing in Section 9 4 Optional column rinsing on page 138 Select the Print Report Automatically checkbox if you want to automatically produce a printed report with installation information and t
164. t Column bar P_Low ow_Value _LowFlow_Value sec D_LowFlow_Value sec P_HighFlow_Value _HighFlow_Value sec D_HighFlow_Value sec Inlet_Priming_Tracer Inlet_Priming_Wash Flow_Efficiency_Test hour CV_Equilibration CV Inlet_Tracer Duration_TracerLoading min Inlet_Equilibration Column_Acceptance_Criteria Vale Range 4 00 1 00 5 00 3 00 1 00 4 00 0 300 0 000 100 000 25 000 10 000 10000 00 0 000 10 000 1000 000 0 300 10 000 100 000 15 000 10 000 10000 00 0 000 10 000 1000 000 Inlet5 x Inlet6 M 125 10 0 510 0 1 30 0 00 999999 0 Inlet x 0 30 0 00 999999 0 Inlet6 x Acceptance criteria As KTA ready Operating Instructions 28960345 AD 131 9 Column installation 9 2 Installing a column Connect a column CAUTION Before use check that the column is not damaged or otherwise defective Damaged or defective columns may leak Follow the instructions below to connect a column to the system connectors should be treated aseptically when connecting Step Action 1 Remove the welded tubing end from the Bottom Inlet tubing on the column keep the tubing ends for when the column shall be sealed If necessary fill the inlet tubing with 20 ethanol or 2 benzyl alcohol using e g a squirt bottle Remove the protective end cap from the column inlet tubing on the flow kit 1 in figures and using a TC clamp
165. t with water Perform the calibration as outlined in Calibrating flow meter on page 187 AKTA ready Operating Instructions 28960345 AD 173 11 Runa method 11 1 Final preparations before a run Prime the system Before starting a run make sure that the flow path including hoses to inlet containers are filled with liquid and that no air bubbles remain in the system The air trap can only remove small amounts of air If air reaches the flow meter during a run the alarm Uncertain flow will be displayed and the system will enter pause mode Priming should be done for each inlet starting with inlet 1 Use the ManFlow command to control the pump during priming 174 AKTA ready Operating Instructions 28960345 AD 11 2 Starting a run 11 Runa method 11 2 Starting a run General Starting a run is done from UNICORN after first having checked that all inlets and outlets are correctly assigned and that the volumes of inlet and outlet containers are correct Starting Step Action al In the System Control module click Run on the File menu 2 Select the method to start Click OK A Start Protocol is displayed consisting of a number of dialog boxes On the Variables page it is possible to fine tune the method before proceeding Selecting the Show details checkbox will display more detailed information Variables Variable Flow Value Range 50 0 0 0 100 0 AirTrap_Inline_or_Bypass Bypass w I
166. temperature of the process liquid not is ture on the flow cell lower than 10 C from the ambient temperature window 120 KTA ready Operating Instructions 28960345 AD 8 Component test 8 3 Troubleshooting a failed component test Valves Problems with valves can be caused if Problem Solution Valve safety lock not To close an open valve safety lock closed 1 Switch the Installation switch in upper right corner of cabinet front see Components on system cabinet front on page 38 to position FLOW KIT INSTALL 2 Close the safety lock by turning the handle 180 de grees see Finishing flow kit installation on page 95 3 Turn the installation switch back to RUN Note FLOW KIT INSTALL may fill all parts of the flow kit with fluid from the air trap also inlet and outlets that are cur rently not used To avoid spillage of liquid do not remove the end caps from connections that are not used Tubing not properly in If part of the tubing has not been properly inserted in a serted valve 1 Turn the Installation switch to position FLOW KIT INSTALL 2 Open the valve lock 3 Insert the tubing 4 Close the valve lock 5 Turn the installation switch back to RUN If problems remain If problems continue after checking the points above please contact your GE Healthcare representative contact information on back cover AKTA ready Operating Instructions 28960345 AD 121 9 Column
167. tenance Pro cedures shall be followed strictly Consumables or certain parts may have their own label with an EFUP value less than the product Periodic replacement of those 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 AKTA ready Operating Instructions 28960345 AD Si 2 Safety instructions 2 5 Declaration of Hazardous Substances DoHS ASWRHEMRER Name and Concentration of Hazardous Substances FmhaSMAhtnRee Table of Hazardous Substances Name and Concentration List of hazardous substances Component name Hazardous substance BE E BSA SYMARTLR Pb Hg Cd Cr6 PBB PBDE an KR ra TB BRERA SRA AKTA ready x 0 0 0 0 0 29 0320 38 1 1 The product has not been tested as per the Chinese standard SJ T11363 2006 Requirements for Concen tration Limits for Certain Hazardous Substances in Electronic Information Product 32 AKTA ready Operating Instructions 28960345 AD 3 System description 3 System description About this chapter This chapter provides an overview of the technical properties of AKTA ready In this chapter This chapter contains the following sections Section See page 3 1 Overview 34 3 2 Layout 36 3 3 Flow chart 45 3 4 Equipment 48 3 5 UNICORN control system 52 KTA rea
168. ter the test is finished e inthe UNICORN 7 Evaluation module click View click Run Record and then click the Notes tab e Inthe UNICORN 5 Evaluation module or the UNICORN 7 Evaluation Classic module on the View menu click Documentation and then click the Notes tab 114 AKTA ready Operating Instructions 28960345 AD 8 Component test 8 2 The test report Results from component test The section Results from component test contains the test results The results are pre sented in the form of charts showing the response over time for each of the different sensors An example page is shown in the following figure Note In UNICORN 7 the chromatograms are replaced by text describing the result of the test In both UNICORN 5 and UNICORN 7 chromatograms can be found in the result file UNICORN 5 11 Build 407 Run by Anna 01 31 2008 16 35 00 W Europe Standard Time Result file v Anna LowFlowKit Tests Wizard03T LowFlowKit Mod002 Wizard03T LowFlowKit Mod002 CondPoint _ Wizard03T LowFlowKit Mod002 PT111 Pres Wizard03T LowFlowKit Mod002 CondPoint Wizard03T LowFlowKit Mod002 PT111 Logt mS cm bar 100 0 8 Ss Q m g n Z lt lt a a a 80 A i E T a gs E 0 6 8 a ge 60 2 wn S 3 3 fa 2 5 k 2 0 4 a 2 z 3 40 E amp i 2 gt 0 2 20 2 a E 2 3 3 8 0 0 0 7 30 740 7 50 7 60 7 70 min 11 10 1120 1130 11 40 min A vertical text on each chart shows the acceptance interval used and also wh
169. th NaOH at the concentration time and temperatures used KTA ready Operating Instructions 28960345 AD 21 2 Safety instructions 2 1 Safety precautions Maintenance WARNING Electrical shock hazard All installation service and mainte nance of components inside the electronics cabinet should be done by service personnel authorized by GE Healthcare Do not open any covers or replace parts unless specifically stated in the Operating Instructions Use only GE parts Only spare parts and accessories that are approved or supplied by GE Healthcare may be used for maintaining or servicing the product Hazardous chemicals during run When using hazardous chemicals run System CIP and Column CIP to flush the entire system tubing with distilled water before service and mainte nance Shut down before maintenance Before inspecting and maintaining the system shut down and depressurize the sys tem and disconnect the accessories If the system is powered and pressurized accidental pump start up or unexpected pressure release can cause human injury Disconnect power Always disconnect power from the instru ment before replacing fuses Only personnel authorized by GE Healthcare may perform service installation and maintenance of components inside the cabinet CAUTION To avoid contamination make sure the system is thoroughly cleaned before changing the flow kit Connectors on the cabinet such as connec
170. the deviation 5 If the temperature deviation is greater than that given in the specification Section 14 4 Ordering information on page 210 contact you local GE repre sentative Testing the UV LED Step Action 1 Prepare three acetone solutions with deionized water e 0 5 weight percent e 1 e 2 2 Connect a flow kit or use the UV cell test tool part of AKTA ready UV Cond test tools 3 In the System Control module start a stray light calibration 4 Fill the cell with deionized water and perform UV autozero 5 Fill the cell with the 0 5 acetone solution and record the reading Repeat steps 4 and 5 using the 1 and 2 acetone solutions AKTA ready Operating Instructions 28960345 AD 191 12 Maintenance 12 2 Yearly maintenance Air filter 192 Step Action 6 Check the linearity of the UV absorbtion Linearity should be within 5 Note The UV LED and UV filter should be changed every 5000 hours Contact a representative from GE Healthcare for changing the LED and filter The air filter is normally checked and if necessary changed during the yearly preventive maintenance However under extreme conditions the filter may become clogged Therefore check the condition of the air filter regularly If the filter is dirty change it as follows Step Action 1 Locate the filter beneath the cabinet front panel arrow in figure 2 Remove the filter cover and filter by unscrewing the six knurled nuts see
171. ther Method Editor features 147 142 AKTA ready Operating Instructions 28960345 AD 10 Creating a method 10 1 The Method Editor 10 1 1 Introduction to the Method Editor 10 1 1 Introduction to the Method Editor Description The Method Editor is used to build new methods in a step by step manner using blocks and instructions as building elements The editor can also be used to edit already existing methods Blocks About blocks Blocks are used to organize instructions into functional units A block may for instance contain instructions for loading a sample or for equilibrating a column Blocks can be nested i e a block can contain other blocks Blocks are useful for organizing instructions and structuring methods and also allow for reuse of existing sets of instructions Individual blocks can be moved and used in any method within the same strategy as required Creating a block The general procedure to create a block in the Method Editor is to 1 Click New on the Block menu 2 Inthe dialog box shown give the block a name and select a base Time Volume or Column volumes for the block The choice of base depends on the function of the block e Use Time as base for valve and pump maneuvering e Use Volume for sample application or fractionation e Use Column volumes for blocks used for equilibration and washing AKTA ready Operating Instructions 28960345 AD 143 10 Creating a method 10 1 The Method Editor 1
172. time In the UNICORN Evaluation module click Report on the File menu and then select AKTA ready_FlowkKit What does the report contain A flow kit installation report in AKTA ready_Flowkit format including component test results contains the following parts in the order they occur in the printed document Header A header containing basic information is shown at the top of each report page The in formation includes the UNICORN version number the name of the person who ran the test and the time and date for the test Also the path for the result file is shown in the header Questions The Questions section contains identification information This is the same information as that entered in the Questions panel in UNICORN i e product name and number barcodes for flow kit parts and pH electrode protocol for test solution preparation and the mode for entering codes Method notes The Method notes section contains the name of the system and a list with the different steps that were taken when installing the flow kit The steps are the same and in the same order as the steps in the installation wizard Start notes Start notes include any notes entered before starting the test run in the start protocol Run notes Run notes include any notes comments entered during the test run AKTA ready Operating Instructions 28960345 AD 113 8 Component test 8 2 The test report Evaluation notes Evaluation notes are notes entered af
173. tion is default set to OFF and has to be activated in each run RTP Pump Instructions FlowCompensation ON 106 KTA ready Operating Instructions 28960345 AD 8 Component test 8 Component test About this chapter This chapter describes the component test which should always be run after installing a new flow kit to secure the functionality of the different flow cells The structure and content of a component test report is presented and troubleshooting after a failed test is discussed to secure the functionality of the different flow cells 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 Section 2 1 Safety precautions on page 15 as listed below e General precautions on page 15 e Flammable liquids and explosive environment on page 17 e Personal protection on page 16 e Operation on page 19 In this chapter This chapter contains the following sections Section See page 8 1 Run a component test 108 8 2 The test report 113 8 3 Troubleshooting a failed component test 117 AKTA ready Operating Instructions 28960345 AD 107 8 Component test 8 1 Run a component test 8 1 Run a component test General The component test consists of a number of steps to assure correct function of the components of the AKTA ready in particular the sensors The poin
174. tions 28960345 AD 0 00 FlowTune 0 300 5 000 sec 0 000 sec 0 500 0 00 End_Block 157 10 Creating a method 10 2 An example of using the Method Editor 10 2 5 Block 4 Filling the flow kit 10 2 5 Block 4 Filling the flow kit Next create a block for filling the flow kit including the air trap with liquid This is done by pumping liquid through the flow path until a stable flow is achieved or until a time out a maximum time is reached Step Action 1 l Create a block named MyFillFlowKit and set its base to Time Add the instruction WatchPar_Flow_FT141 in group Alarms amp Mon with parameters Delta_Peak and Delta_Base both set to 2 5 I h Since the test criterion used is based on flow stability this sets an acceptable noise level for flow Insert the instruction Man_Flow in group Pump at time 0 00 The flow is set to 30 The Man_Flow instruction will start pumping liquid through the flow path at a steady rate Define a Hold_Until instruction in group Watch at time 0 10 Set the Signal parameter to Flow_FT141 refers to the flow meter set the Test criterion to Stable_Baseline and set Minutes to 0 5 which means that the flow must remain stable for 0 5 minutes in order for the test criterion to be fulfilled Finally set the Timeout to 5 minutes and insert the instruction into the block Parameters Signal Flow_FT141 Test E 5 table_Baseline w Minutes 00 99930 Var 0 5
175. tors for pH conduc tivity network etc that are not used should be plugged to prevent cleaning liquid from entering the connector 22 AKTA ready Operating Instructions 28960345 AD 2 Safety instructions 2 1 Safety precautions gt NOTICE e Only use 0 5 M NaOH in the flow kit for a maximum time of 2 hours Flush the flow kit tubing with a suitable rinsing liquid to remove the NaOH e Disconnect power To prevent equipment damage always disconnect the power from the product before an instrument module is removed or installed or a cable is connected or disconnected AKTA ready Operating Instructions 28960345 AD 23 2 Safety instructions 2 2 Labels 2 2 Labels Introduction System label This s ection describes the various labels on AKTA ready and their meaning The system label is located on the right side of the leg support of the AKTA ready cabinet Note The specific data shown on this system label is only an example Actual data is specific for each individual system and may vary from system to system ra 2 i i d Code Number System Number Manufacturing Year Supply Voltage 100 120 200 208 220 230 240 V Configured For Frequency 50 60 Hz Max Power Consumption 1 KVA Pneumatic Supply 5 5 7 bar Protection Class IP 45 OOO N LN E ieee GE Healthcare Bio Sciences AB 20 Bj rkgatan 30 AY
176. ts being tested are e Function of flow meter and size of flow kit e Function of UV and conductivity sensors e Function of pressure sensors Note A component test should always be performed after mounting a new flow kit The component test is included in the flow kit installation wizard What does the test do Stage Description 1 Initially in the component test a number of settings are made Inlets are opened and primed and pressures are set to zero 2 Stray light calibration is performed Stray light calibration shuts off the UV LED lamp for approximately 10 seconds During this time stray light from the outside is measured The measured light is later subtracted from the UV measurements made during the run Note Do not change anything on the system or in UNICORN during the time ap proximately 10 seconds stray light is being measured Also note that if stray light calibration is included in a user defined method a delay of at least 0 3 minutes is required before the next instruction 3 After the air trap has been filled with the chosen liquid the function of the flow meter cell is tested if the test fails the test procedure will stop 4 Next the size of the flow meter cell is tested If the selected component does not match the actual component mounted on the system the test procedure will stop 5 UV and conductivity test is performed by pumping a solution of 1 v v acetone and 1 0 M sodium chloride through the flow
177. ts for the I parameter To slow down control double the value and to speed it up set it to half the initial value AKTA ready Operating Instructions 28960345 AD 215 14 Reference information 14 6 Checklists 146 Checklists Performed tasks checklist 216 Step Check Sign Remark 1 Unpacking Contents according to packing list No visible damage on the system 2 Installation System unit positioned with system unit sufficient surrounding space and power switch and emergency stop easily accessible see Section 4 5 Positioning the system on page 66 Wheels of system unit locked see Section 4 5 Posi tioning the system on page 66 Connected to computer see Computer on page 69 Compressed air connected see Compressed air on page 67 Mains power correctly con figured see Power on page 67 and cable connect ed to source KTA ready Operating Instructions 28960345 AD 14 Reference information 14 6 Checklists Step Check Sign Remark 3 Installation UNICORN installed and computer working see UNICORN doc umentation Bar code scanner installed see instructions in the scanners Quick Start Guide AKTA ready strategy soft ware installed and verified see UNICORN documenta tion 4 Preparation Test fluids prepared Installation test Inlet Outlet containers available Flow kit for testing avail able 5 Install
178. ule 2 Select a column supported by the ee m Data for RTP_Capto_Q_20 AKTA ready software i e a ReadyTo EIEEE Process column with the prefix RTP Parmer Value Uni r Height mand 20 0 cm in the list that has the same column digmae bad 9 a volume and average particle diame Sametime wad T resne vt 00 ter as the column to be added vo non 2 i Has ae Nex tease in a marked items in figure This will set Beaut fomats mena Aaa h the advanced parameters that are toh vake brdom compatible with the software E Hion veka shorter r M AS A E 1 Average particle diam gt Stim l 3 Click Edit for the selected column Typical loading range pe Sone Spectra sec 4 Enter appropriate parameter values for the column to be added Max pres sure for instance depends on the type of medium 5 Click Save As to save the column with a new name Save as global only if p the column is to be available to other sere sawas Jil corea Hee _ y t users e g on a network L 5 gt Note Do not click Save If a column is edited and you click Save the edited param eters will be overwritten AKTA ready Operating Instructions 28960345 AD 139 9 Column installation 9 5 Adding columns to the column list Step Action 6 The added column is now be available in the AKTA ready wizard 140 AKTA ready Operating Instructions 28960345 AD 10 Creating a method
179. ure safe operation of the system you should limit access to the system to those qualified and trained in its operation The UNICORN software wizards and the UNICORN user documentation provide complete instructions for programming and for using the software for process control System operators are responsible for designing methods which conform to standard operating procedures and Good Manufacturing Practice procedures UNICORN is compliant with FDA 21 CFR Part 11 Knowledge prerequisite At least basic knowledge of UNICORN is expected to operate KTA ready in a safe manner Information on how to use UNICORN can be obtained from the UNICORN documentation and available tutorials This manual does not cover how to use UNICORN Contact your local GE Healthcare representative for advice if required System networks UNICORN can be installed on a stand alone computer to control one to four locally attached systems However the computer can only show one system at a time Multiple computers can view the output data from one system UNICORN can also be installed on a network 52 AKTA ready Operating Instructions 28960345 AD Software modules 3 System description 3 5 UNICORN control system The UNICORN control software consists of four modules Module Function In UNICORN 5 UNICORN Manager File handling and administration tasks for ex In UNICORN 7 Administration ample definition of systems and managing user profil

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