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ÄKTAxpress Operating Instructions

1. pump Loop valve Inj valve LoopV2 ETFE 260 1 204 Sample loops L1 5 ETFE 12800 1 10 x 10 each Outlet valve Fraction collec Frac ETFE 260 1 204 tor Fraction outlets from outlet F3 11 color ETFE 1500 1 1 2 x 10 each valve marked Waste tubing from Injection Waste ETFE 1500 1 1 2 x 10 each and Outlet valves Rinsing solution inlet to Rinse In PTFE 1350 1 2 1 5 x 103 pump Rinsing tubing between Rinse Silicone 200 3 14 x 10 pump heads Rinsing solution outlet from Rinse Out PTFE 1350 1 2 1 5 x 103 AKTAxpress Operating Instructions 28 9579 08 AC 77 C Column positions Appendix C Column positions Protocol Column position Maxno On ofsam column 1 2 3 4 5 ples tag cleavage possible 1 AC IEX AC IEX AC IEX AC IEX AC IEX 4 Yes step 1 DS GF DS GF 4 No 2 AC DS GF AC AC AC AC DS GF 4 Yes step gt EX DS GF IEX IEX IEX IEX DS GF 4 Yes DS AC IEX AC IEX DS 2 No 3 AC DS AC IEX AC AC AC ACI2VIEX DS 3 Yes ste P EX DS AC IEX IEX IEX IEX AC IEX 2 DS 5 Yes DS AC IEX AC IEX DS 1 DS 2V GF 2 No DS GF 4 AC DS IEX AC AC IEX DS 1 DS 2V GF 2 Yes step DS GF AC DS AC AC AC AC 2 DS 1 DS 2 GF 2 Yes DS GF EX DS AC IEX IEX AC DS 1 DS 2 GF 2 Yes DS GF EX DS IEX IEX IEX IEX 2 DS 1 DS 2 GF 2 Yes DS GF 78 Or one sample injected four times when u
2. CE marking CE 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 used in the same state as it was delivered from GE except for alterations described in the user documentation 8 AKTAxpress Operating Instructions 28 9579 08 AC 1 Introduction 1 2 Regulatory information International standards This product fulfills the requirements of the following standards Standard Description Notes EN IEC 61010 1 Safety requirements for electrical EN standard is harmonized UL 61010 1 equipment for measurement with EU directive CAN CSA C22 2 control and laboratory use 2006 95 EC No 61010 1 EN 61326 1 Electrical equipment for measure EN standard is harmonized ment control and laboratory use with EU directive EMC requirements 2004 108 EC EN ISO 12100 Safety of machinery General EN ISO standard is harmo principles for design Risk assess nized with EU directive ment and risk reduction 2006 42 EC 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
3. KTAxpress Operating Instructions 28 9579 08 AC 67 7 Reference information 7 2 Chemical resistance Chemical Exposure Exposure Comments lt 1day upto 2 months Sodium bicarbon OK OK ate Sodium bisulphate OK OK Sodium borate OK OK Sodium carbonate OK OK Sodium chloride OK OK 7647 14 5 231 598 3 Sodium hydroxide OK Avoid 1310 73 2 215 185 5 PVDF and borosili 2M cate glass are af fected by long term use Sodium sulphate OK OK 7757 82 6 231 820 9 Sulphuric acid dilut OK Avoid PEEK and titanium ed are affected by long term use Sulphuric acid Avoid Avoid medium concentra tion Tetrachloroethy Avoid Avoid Silicone PP and PE lene are not resistant Tetrahydrofuran Avoid Avoid ETFE CTFE PP and PE are not resistant Toluene OK Avoid Pressure limit for PEEK decreases Trichloroacetic OK OK 76 03 9 200 927 2 acid 1 Trifluoroacetic acid OK OK 176 05 1 200 929 3 1 Urea 8M OK OK 57 13 6 200 315 5 o Xylene and p Xy OK Avoid PP and PE are af lene fected by long term use 68 AKTAxpress Operating Instructions 28 9579 08 AC 7 Reference information 7 3 System recommendations 7 5 System recommendations Refer to AKTAxpress User Manual or contact your local GE representative for the most current information AKTAxpress Operating Instructions 28 9579 08 AC 69 7 Reference information 7 4 Health and
4. Figure 4 1 The UNICORN Manager window Control system in UNICORN To open the System Control module in UNICORN click the System Control icon in the UNICORN Manager window see Figure 4 1 Connecting an instrument to UNICORN Up to twelve instruments can be connected in the System Control module The separation systems that are available in UNICORN are shown in the vertical bar at the left hand side of System Control Disconnected systems are identified by a blue connector symbol 40 AKTAxpress Operating Instructions 28 9579 08 AC 4 Operation 4 3 Starting the control system SYS 1 V4 Left click the symbol of the system to be connected The system is connected and the symbol changes to a white status indicator see Figure 4 2 The run data curves and logbook for the system is shown E System Control SYS 1 File View Manual System Help Continue End Connection Status Acc Volume grk B gt gt Ez uy Cond Cond Conc Pressure Instant Run mAU 600 500 400 300 200 100 100 200 300 400 Figure 4 2 The System Control window 4 44 Setting uparun Create a method plan There are two main types of method plan available e Prepare and Maintain Preparation and maintenance of the system and or columns e Purify Purification of protein To create a method plan 1 Clickthe New Method icon in the UNICORN Manager window
5. Prepare buffers solutions and inlets 1 Prepare buffers and solutions required for the run 2 Immerse all inlet tubing in the appropriate liquid containers as described in the Summary check list Purging the pump and inlet tubing Fill the pump and inlet tubing with liquid if small amounts of air need to be removed or if the inlet tubing is empty To fill the inlet tubing manually in System Control 1 Make sure that no method plan has been started 2 Select which system to fill by left clicking on the symbol for the system to the left in System control 44 AKTAxpress Operating Instructions 28 9579 08 AC 4 Operation 4 5 Preparations before start 3 Setalow flow in System Control Manual Pump Flow for example 0 5 ml min 4 Click Execute 5 Set the inlet valve to the appropriate position in System Control Manual Flowpath In letValve 6 Connect a syringe to the purge valve 8 Slowly draw solution into the syringe When fluid starts to enter the syringe continue to draw a few milliliters before closing the purge valve Check that there is no visible air left in the tubing 9 Repeat for the other purge valve 10 To fill inlet B1 and B2 AKTAxpress Operating Instructions 28 9579 08 AC 45 4 Operation 4 5 Preparations before start d In System Control Manual Pump Gradient select Target 10096 B and Mode A1 B1 to fill B1 or Mode A2 B2 to fill B2 Wait for the valve to turn a clicking sound before starting the
6. WARNING Access to power cord Do not block the rear and side panel of the instrument The power cord must always be easy to disconnect WARNING Installing the computer The computer should be installed and used according to the instructions provided by the manufacturer of the computer CAUTION Heavy object Use suitable lifting equipment when moving the systems Two people are required to lift the system safely NOTICE Disconnect power To prevent equipment damage always discon nect power from the AKTAxpress instrument before an instrument module is removed or installed or a cable is connected or discon nected NOTICE AKTAxpress shall be installed and prepared by GE personnel or third party authorized by GE Healthcare 20 AKTAxpress Operating Instructions 28 9579 08 AC 2 Safety instructions 2 1 Safety precautions NOTICE e Any computer used with the equipment shall comply with IEC 60950 and be installed and used according to the manufacturer s instruc tions System operation WARNING Hazardous chemicals during run When using hazardous chemi cals run System CIP to flush the entire system tubing with distilled water before service and maintenance WARNING Hazardous biological agents during run When using hazardous biological agents run System CIP and flush the entire system tubing with bacteriostatic solution e g NAOH followed by a neu
7. Checkthat all tubing connections are properly tightened and that all valves are connected to a tube or termination AKTAxpress Operating Instructions 28 9579 08 AC 34 4 Operation 4 2 Starting the instrument 1 If the system unit number is shown in the display RUN ee j v The system is set in Idle mode No action is required because the system was turned on when the power cord was inserted Two segments might flash to indicate no communication with the UNICORN computer 2 If only one segment is shown in the display RUN PAUSE The system is set in Standby mode Turn on the system by pressing the On button on the front panel The display indicates Idle mode and the system identity 1 12 is shown RUN ee j v 3 Check that the system identity is correct The separation system should have a unique identity within the interval 1 12 which might have been set from factory If the identity is incorrect it has to be set see AKTAxpress Installation Guide 38 AKTAxpress Operating Instructions 28 9579 08 AC 4 Operation 4 3 Starting the control system 4 5 Starting the control system Starting UNICORN 1 Turnonthe monitor computer and optional printer according to the manufacturer s instructions Wait for the computer to start up 2 Verify that the power indicator on the USB CAN converter is on when the computer has been turned on 3 Logon to Windows operating system 4 Start UNICORN by double clicki
8. 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 28 AKTAxpress Operating Instructions 28 9579 08 AC 2 Safety instructions 2 5 Declaration of Hazardous Substances DoHS A 9B EI SL TUSRES SES E Name and Concentration of Hazardous Substances Pg REUREUIR SULSSIS ST ESSE Table of Hazardous Substances Name and Concentration BOTTA S Component name ABASYMANTR Hazardous substance KR ta RNE Pb Hg Cd Cr6 2R PBDE 18 6645 01 x 0 0 0 0 0 RARZASASVREBREM SRM SH SB ES 111363 2006 tr EM EH BR BE RAE X AURVUCB SUB EMI ze AP Te SE RS 3 15 oc PER B SB H35 111363 2006 EM EM REE ERFIR GEA An RT PIT BEDA SE Ec fS 8 0 Indicates that this toxic or hazardous substance contained in all of the homogeneous ma terials for this part is below the limit requirement in SJ T11363 2006 X Indicates that this toxic or hazardous substance contained in at least one of the homoge neous materials used for this part is above the limit requirement in SJ T11363 2006 e Data listed in the table represents best information available at the time of publication AKTAxpress Operating Instruct
9. Please note that items will NOT be accepted for servicing or return without this form 2 Equipment which is not sufficiently cleaned prior to return to GE may lead to delays in servicing the equipment and could be subject to additional charges 3 Visible contamination will be assumed hazardous and additional cleaning and decontamination charges will be applied Please specify if the equipment has been in contact with any of the following Radioactivity please specify Infectious or hazardous biological substances please specify Telephone No Other Hazardous Chemicals please specify Equipment must be decontaminated prior to service return Please provide a telephone number where GE can contact you for additional information concerning the system equipment Liquid and or gas in equipment is Water Ethanol None empty Argon Helium Nitrogen Liquid Nitrogen Other please specify Equipment type Product No area has been made safe and accessible hereby confirm that the equipment specified above has been cleaned to remove any hazardous substances and that the Serial No Company or Name institution Position or job title Date YYYY MM DD Signed To receive a return authorization number or service number GE 2nd GE monogram are trademarks of General Electric Company please call local technical support or customer servic
10. ide long term use 1 4 Dioxane Avoid Avoid ETFE PP PE and PVDF are affected by long term use Ethanol 10096 OK OK 75 08 1 200 837 3 Ethyl acetate OK Avoid Silicone not resis tant Pressure limit for PEEK decreases Ethylene glycol OK OK 107 21 1 203 473 3 100 66 AKTAxpress Operating Instructions 28 9579 08 AC 7 Reference information 7 2 Chemical resistance Chemical Exposure Exposure Comments lt 1 day upto 2 months Formic acid 100 OK OK 64 18 6 200 579 1 Silicone not resis tant Glycerol 100 OK OK 56 81 5 200 289 5 Guanidinium hy OK OK drochloride Hexane OK Avoid Silicone not resis tant Pressure limit for PEEK decreases Hydrochloric acid OK OK 7647 01 0 231 595 7 Silicone not resis 0 1M tant Hydrochloric acid OK Avoid Silicone not resis gt 0 1M tant Titanium is af fected by long term use Isopropanol 100 OK OK 67 63 0 200 661 7 Methanol 100 OK OK 74 93 1 200 659 6 Nitric acid diluted OK Avoid Silicone not resis tant Nitric acid 30 Avoid Avoid Elgiloy is affected by long term use Phosphoric acid OK Avoid 7664 38 2 231 633 2 Titanium alumini 10 um oxide and glass are affected by long term use Potassium carbon OK OK 584 08 7 209 529 3 ate Potassium chloride OK OK 7447 40 7 231 211 8 Pyridine Avoid Avoid ETFE PP and PE not resistant Sodium acetate OK OK
11. see Figure 4 1 The Method Editor module opens AKTAxpress Operating Instructions 28 9579 08 AC 41 4 Operation 4 4 Setting up a run Click the Method Wizard icon in the Method Editor module v The Method Wizard dialog opens Choose one of the alternatives that follows e New to create a new method plan or e anexisting method plan to edit or view Method Wizard xi Create or Change Method Plan Method plan Note E Use this Method plan if you want to create a new AC DS IEX GF plan AC GF no airs f CIP reg 4 Click Next The Main Selections page appears 5 Select the main type of method plan to be created and click Next Method Wizard Main Selection Prepare and Maintain Purify 6 Oneach new page select the appropriate parameters and click Next to continue 42 AKTAxpress Operating Instructions 28 9579 08 AC 4 Operation 4 4 Setting up a run 7 Onthe last page ClickFinish to save the selections as a method plan The Save As page appears or Click Next to enter the Advanced Zone to view or edit default values For more information about the Advanced Zone see AKTAxpress User Manual Note Do not change any values in the Advanced zone unless the conse quences are fully understood 8 Onthe Save As page Select destination folder in the Method plan tree or create a new one if needed e Type any additional information in the Note field for example changes ma
12. Conductivity curve problems Corrective action Check the flow restrictor after the flow cell Leaking tube connec tions Tighten the clamps If necessary replace the clamps Dirty conductivity cell Clean the conductivity cell by flushing 1 M NaOH or 20 ethanol Column not equilibrat ed Equilibrate the column If neces sary clean the column using a method plan for column cleaning Conductivity measure ment with the same buffer appears to de crease over time Dirty flow cell Clean the flow cell according to procedure in Monitor User Manual Decrease in ambient temperature Use a temperature compensation factor See Monitor User Manual Waves on the gradi ent Incorrect pump func tion Check that the pump is operating and is programmed correctly Dirty mixing chamber Check that the mixing chamber is free from dirt or particles Ghost peaks appear in the gradient profile Air in the flow cell Check for loose tubing connec tions Use the flow restrictor Unlinear gradients or slow response to B changes Dirty tubing Wash the tubing and check pump is operating properly Incorrect or unstable reading Loose connection of conductivity flow ca ble Check that the conductivity flow cell cable is connected properly Incorrect pump and valves function Check that the pump and valves operate correctly Dirty or incorrectly equi
13. Safety Declaration Form 7 4 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 delays in the servicing of your equipment please complete this checklist and present it to the Service Engineer upon arrival Equipment and or work areas not sufficiently cleaned accessible and safe for an engineer may lead to delays in servicing the equipment and could be subject to additional charges Please review the actions below and answer Yes or No Provide explanation for any No answers in box below Instrument has been cleaned of hazardous substances Please rinse tubing or piping wipe down scanner surfaces or otherwise ensure removal of any dangerous residue Ensure the area around the instrument is clean If radioactivity has been used please perform a wipe test or other suitable survey Adequate space and clearance is provided to allow safe access for instrument service repair or installation In some cases this may require customer to move equipment from normal operating location prior to GE arrival Consumables such as columns or gels have been removed or isolated from the instrument and from any area that ma
14. and a mainte nance schedule 5 1 General Regular maintenance is important for safe and trouble free operation of your instrument The user should perform daily and monthly maintenance Preventive maintenance should be performed on a yearly basis by qualified service personnel For maintenance of a specific component carefully read the component manual and follow the instructions WARNING Electrical shock hazard All repairs should be done by service personnel authorized by GE Healthcare Do not open any covers or replace parts unless specifically stated in the user documenta tion WARNING Disconnect power Always disconnect power from the instrument before replacing any component on the instrument unless stated otherwise in the user documentation WARNING Hazardous chemicals during maintenance When using hazardous chemicals for system or column cleaning wash the system or columns with a neutral solution in the last phase or step 54 AKTAxpress Operating Instructions 28 9579 08 AC 5 Maintenance 5 1 General WARNING Do not perform any type of maintenance work while the system is powered electrically or when the piping system is pressurized Note that the piping system can be pressurized even when the system is closed down WARNING When using hazardous chemical and biological agents take all suitable protective measures such as wearing protective glasses and gloves res
15. and troubleshooting AKTAxpress Cue Cards and Short step by step instructions for selected appli AKTAxpress MAb Cue Cards cations using the preprogrammed method tem plates System preparation and value table for the method templates AKTAxpress Installation Guide Instructions for installation and installation test EU Declaration of Conformity for Document whereby the manufacturer ensures AKTAxpress that the product satisfies and is in conformity with the essential requirements of the applicable direc tives Software documentation Together with each system the following software documentation is supplied providing additional information that applies to AKTAxpress independent of the specific configuration Document Purpose Contents UNICORN manual package e The manuals contain detailed instructions on how to administer UNICORN work with methods perform runs and evaluate results e The Online help contains dialog descriptions for UNICORN The Online help is accessed from the Help menu Component documentation Documentation for components produced both by GE and by a third party are if existent also included in the document package AKTAxpress Operating Instructions 28 9579 08 AC 15 2 Safety instructions 2 Safety instructions About this chapter This chapter describes safety compliance safety labels general safety precautions emergency procedures power failure and recy
16. is cautioned that any changes or modifications not expressly approved by GE 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 B digital device pursuant to part 15 of the FCC Rules These limits are designed to provide rea sonable protection against harmful interference in a residential installation This equip ment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver e Connect the equipment into an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help AKTAxpress Operating Instructions 28 9579 08 AC 9 1 Introduction 1 2 Regulatory information Regulatory compliance of connected equipment Any equipment connected to AKTAxpress should meet the safety requirements of EN 61010 1 IEC 61010 1 or releva
17. restrictor 8 V4 V5 The outlet valve directs the flow either to a waste container or to the fraction collector It can also direct fractions to the sample loops via the injection valve to allow reinjection on the next column 14 Control software UNICORN control software UNICORN is a complete software for control and supervision of AKTAxpress The software runs under Microsoft windows operating system UNICORN is supplied with an AKTAxpress method wizard which provide easy creation of methods for purification For more information about UNICORN control system see the UNICORN user manuals supplied 15 User documentation In addition to these Operating Instructions the documentation package supplied with AKTAxpress also includes product documentation binders containing detailed specifica tions and traceability documents The most important documents in the document package with regard to technical aspects of AKTAxpress are 14 AKTAxpress Operating Instructions 28 9579 08 AC 1 Introduction 1 5 User documentation System specific documentation User documentation Content AKTAxpress Operating All instructions needed to operate the instrument Instructions in a safe way including brief system description installation and maintenance AKTAxpress User Manual and Detailed system description Comprehensive user AKTAxpress MAb User Manual instructions method creation operation ad vanced maintenance
18. the picture below 32 AKTAxpress Operating Instructions 28 9579 08 AC 3 Installation 3 4 Assembly Installing the tube holder Insert the tube holder according to the picture below Installing the flask holder Insert the flask holder according to the picture below AKTAxpress Operating Instructions 28 9579 08 AC 33 3 Installation 3 5 Connections 3 9 Connections Communication 34 Connect the network signal cables and computer according to the electrical drawings in Electrical and communication connections on page 12 Make sure that UNICORN control software is installed on the computer Note For detailed information on Installation see AKTAxpress User Manual and AKTAxpress Installation Guide Connecting USB CAN converter The USB CAN converter is needed between the AKTAxpress instrument and the computer 1 Keep the computer turned off while connecting the USB CAN converter Note Ensure that UNICORN control software and USB CAN driver have been pre installed on the computer AKTAxpress Operating Instructions 28 9579 08 AC 3 Installation 3 5 Connections 2 Connect the USB CAN converter according to the drawing below No Description 1 UniNet 2 USB CAN converter 3 USB 3 Connecta termination plug to the empty UniNet 1 socket Flow path All parts and tubing are mounted on the system at delivery AKTAxpress Operating Instructions 28 9579
19. 08 AC 35 3 Installation 3 5 Connections Electrical power 5 6 36 Connect the power cord to a grounded power outlet specified in Section 3 1 Site require ments on page 30 Spare parts and accessories For correct up to date information on spare parts and accessories visit www gelifesciences com AKTA AKTAxpress Operating Instructions 28 9579 08 AC 4 Operation 4 Operation About this chapter This chapter provides instructions for the use of AKTAxpress 4 1 Operation overview Workflow The typical workflow in AKTAxpress after turning on the system and connecting it to UNICORN can be divided into a number of steps Step Action Section 1 Create a method plan Create a method plan on page 41 2 Prepare the system for a run Section 4 4 Setting up a run on page 41 Section 4 5 Preparations before start on page 44 3 Start a run using a method plan Section 4 6 Performing a run on page 47 4 During a run view and change parame Viewing the run on page 50 ters 5 Procedures after a run clean the system Section 4 7 Procedures after a run on page 52 and columns 6 Evaluate the results See UNICORN user documentation Liquid flow path See Appendix A Connection diagram Liquid flow path on page 73 for an illustration of the liquid flow path in AKTAxpress 4 2 Starting the instrument Ensure that the waste container and needed buffer bottles are correctly connected
20. 11363 2006 HF ER MPSS OAH IR 4 BER FREWER YA sh WEE ANT RHR RA lt 7 FREER EAWREAT ABASWAFSAEMWMRRSE AP CARAS m TAPHASDOEREUSOSO SONEOSE UPR SRSHRR BUA 23 f uEP T FR B3 E D EBA ERT in FA PPE BRA SKE BEA APERET g HE TF TED BUE B HB A848 AU URS ER T ha FP BG RE HERO CES SE EF RT BE RA EUR SFR HB Rs HBR IMR FRHEBER ES RELL in ZI EE BS EUR SS RR EIR in EIE ETT BIR AB ESF MS SIME CRUE PT AR ABA SEA 77 Ga BI EID fe FIR RS AF an ERAREMA RNT RIETI SE I IU SS This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese standard SJ T11363 2006 Requirements for Concentration Limits for Certain Hazardous Substances in Electronic Information Products The number in the symbol is the Environment friendly Use Period EFUP which indicates the period during which the toxic or hazardous substances or elements contained in electronic information products will not leak or mutate under normal operating con ditions so that the use of such electronic information products will not result in any severe environmental pollution any bodily injury or damage to any assets The unit of the period is Year In order to maintain the declared EFUP the product shall be operated normally ac cording to the instructions and environmental conditions as defined in the product manual and periodic maintenance schedules specified in Product Maintenance Pro cedures shall be followed strictly
21. 19 Fraction Collector 10 Manual inject AKTAxpress Operating Instructions 28 9579 08 AC 75 B Tubing Appendix B Tubing Names in the Label column in Table B 1 refer to tubing labels in the liquid flow path connection diagram see Appendix A Connection diagram Liquid flow path on page 73 Table B 1 Tubing specifications for AKTAxpress Material Buffer inlets A1 8 B1 2 FEP 1500 1 6 3 0 x 10 each Sample inlets S1 4 color FEP 500 1 6 1 0 x 103 each marked Inlet valve Switch valve SW1 SW2 FEP 350 1 6 704 each Inlet valve Air sensor AirS FEP 190 1 6 382 Air sensor Pump Pump FEP 230 1 6 462 Pump Mixer Mix1 Mix2 ETFE 120 1 94 each Mixer Pressure sensor Press ETFE 160 1 126 Pressure sensor Inj valve Mixinj ETFE 260 1 204 Inj valve Column valve ColV ETFE 350 1 275 Column valve inlets Clin C5in ETFE 350 1 275 each Column valve outlets Clout C5out ETFE 190 1 382 each Column and Loop valve by Bypass 2 ETFE 160 1 126 each pass Column valve UV cell UV ETFE 200 1 157 UV cell Conductivity cell Cond ETFE 200 1 157 Cond cell Restrictor Restr ETFE 350 1 275 Restrictor Outlet valve OutV ETFE 160 1 126 Outlet valve Loop valve Loop ETFE 500 1 393 Inj valve Loop valve LoopV1 ETFE 260 1 204 76 AKTAxpress Operating Instructions 28 9579 08 AC Material B Tubing
22. 579 08 AC 61 6 Troubleshooting 6 Troubleshooting 6 1 62 Error symptom Ghost peak UV curve problems Possible cause Dirt or residues in the flow path from previ ous runs Air in the eluents Corrective action Clean the system Make sure air is removed Residue in the column from previous runs Clean the column according to the column instructions Noisy UV signal sig nal drift or instability Dirty UV cell Clean the UV cell by flushing Decon 90 Deconex 11 or equivalent Impure buffer Check if the signal is still noisy with water Air in the pump or in the UV cell Purge the pump according to Pump User Manual Run a system wash with buffer Low sensitivity Aging UV lamp Check the lamp run time according to and replace if necessary Refer to KTAxpress User Manual UV lamp in wrong po sition Check that the lamp position and the filter position are both set to the wavelength to be used 280 nm or 254 nm Refer to KTAxpress User Manual The theoretical extinc tion coefficient too low Calculate the theoretical extinction coefficient of the protein If it is ze ro or very low at 280 nm the pro tein cannot be detected KTAxpress Operating Instructions 28 9579 08 AC Error symptom Baseline drift or noisy signal Conductivity curve problems Possible cause Air in the pump or the flow cell 6 Troubleshooting 6 2
23. AKTAxpress Operating Instructions Original instructions Page intentionally left blank Table of Contents Table of Contents LL MIUNOUNLUDU Laudate Mb adu MM E eens eee 5 1 1 Important user information tette 6 1 2 Regulatory information 7 1 3 Instrument sss ve 11 TA ControlSOFtWOle ertt n reiten p eie ta e io soccnsstobeavesseelcaostanses 14 1 5 User docurmentatloriastenc e rm obese beet bee eb tob TE t te EC 14 2 Safety iNStrUCUONS ETT 16 2T Safety precautioris sa eerte rb RR tu ERE Ep tee o ERN 16 2 MEME M P 23 25 Emergency procedules encanto trente terit Ester eret ai 25 24 Recycling information ss 26 2 5 Declaration of Hazardous Substances DoHS 28 S AnS O PRENNE RN RR 30 3 1 Site requirements oo eeccsccsssessssscsssssssccsssssssececcsssssssccesssssusscessssnssssecessssnsccessssssseesssnssneceesessusnseceesessueeseeees 30 3 2 Transport 31 3 3 Unpacking e 31 3 4 Assembly 32 c Meet 34 3 6 Spare parts arnd decessories uerit ten iiiter A E tiber 36 LE o o o e Q 37 4 1 Operation OVerVieW oaneeecssessccssssssssssccsssusssecsccsssssssccsssssssceecessssnscssssssssssessssssnsesessesuusscesssssueeseceesssneceess 37 42 Starting the Istemient uiae iecit bn Rp ettet rere nk 37 4 5 Starting the control system seen ttttttttne
24. EX 263 12 ml Base SameAsMain 263 12 ml Block Peak Frac Parameters 263 12 ml Base SameAsMain 263 12 ml Peak FracParametersUV Level AND Slope 0 50 min 30 000 mAU 30 000 mAU 50 000 mAU min 100 000 mAU min 0 50 263 12 ml End Block 263 12 ml Block Fractionation_Volume 263 12 ml Base SameAsMain 263 12 ml Peak_Fractionation 0 100 ml 263 12 ml End Block 263 12 ml End Block 263 12 ml Block Elution_IEX 263 12 ml Base SameAsMain 263 12 ml Flow 1 00 ml min Buffer 0 10 ml min Yes 263 12 ml Block Gradient_Segment_1 263 12 ml Base CV 1 92 ml HiTrap SP HP 1 ml X2 50 263 12 ml Gradient 50 0 B 20 00 CV A2 B2 For Help press F1 Q Run Gradient Segment 1 No watch Controlled By Pia Up to three view panes Run Data Curves and Logbook can be displayed showing dif ferent aspects of the run in real time The Run Data view pane displays the current values for selected run parameters The Curves view pane displays the monitor signal values graphically e The Logbook view pane shows the actions as the run proceeds All actions and un expected conditons are logged with date time and current user name The log book provides a complete history of the run and is saved in the result file Customize the view panes To customize the view panes right click in the respective view pane and select Properties For more information about customizing the view panes see the UNICORN user docu mentation AKTAxp
25. TICE e 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 menu levels thus File Open refers to the Open command in the File menu Hardware items are identified in the text by bold text e g Power switch 1 2 Regulatory information In this section This section describes the directives and standards that are fulfilled by AKTAxpress AKTAxpress Operating Instructions 28 9579 08 AC 7 1 Introduction 1 2 Regulatory information Manufacturing information The table below summarizes 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 Directive Title 2006 42 EC Machinery Directive MD 2004 108 EC Electromagnetic Compatibility EMC Directive 2006 95 EC Low Voltage Directive LVD
26. aring protective glasses and gloves resistant to the substances used Follow local and or national regulations for safe operation and maintenance of AKTAxpress 18 AKTAxpress Operating Instructions 28 9579 08 AC 2 Safety instructions 2 1 Safety precautions WARNING Spread of biological agents The operator has to take all necessary actions to avoid spreading hazardous biological agents in the vicinity of the instrument The facility should comply with the na tional code of practice for biosafety WARNING High pressure AKTAxpress operates under high pressure Wear protective glasses and other required Personal Protective Equip ment PPE at all times WARNING Personal Protective Equipment PPE Whenever packing unpack ing transporting or moving AKTAxpress wear e Protective footwear preferably with steel lining e Working gloves protecting against sharp edges Protective glasses Installing and moving the instrument WARNING Supply voltage Make sure that the supply voltage at the wall outlet corresponds to the marking on the instrument before con necting the power cord WARNING AKTAxpress must always be connected to a grounded power outlet AKTAxpress Operating Instructions 28 9579 08 AC 19 2 Safety instructions 2 1 Safety precautions WARNING Power cord Only use power cords with approved plugs delivered or approved by GE Healthcare
27. ately in an undefined state 2 4 Recycling information Decontamination AKTAxpress shall be decontaminated before decommissioning and all local regulations shall be followed with regard to scrapping of the equipment Disposal general instructions When taking AKTAxpress out of service the different materials must be separated and recycled according to national and local environmental regulations Recycling of hazardous substances AKTAxpress contains hazardous substances Detailed information is available from your GE representative 26 AKTAxpress Operating Instructions 28 9579 08 AC 2 Safety instructions 2 4 Recycling information Disposal of electrical components Waste of 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 equipment AKTAxpress Operating Instructions 28 9579 08 AC 27 2 Safety instructions 2 5 Declaration of Hazardous Substances DoHS 25 Declaration of Hazardous Substances DoHS 38185J 111364 2006 BFS nis HE SIESIRSER i n TS X538 HESS ILE e The following product pollution control information is provided according to SJ T11364 2006 Marking for Control of Pollution caused by Electronic Information Products T f amp IJ on 25 RHE oll zs H Explanation of Pollution Control Label Wine BA m e BExSJT
28. ce it if it is not within limit Yearly Valve inspection Check for external or internal leakage Replace channel plate and distribution plate yearly or when required Refer to the relevant valve in struction sheet 5 3 Cleaning Cleaning before planned maintenance service To ensure the protection and safety of service personnel all equipment and work areas must be clean and free of any hazardous contaminants before a Service Engineer starts maintenance work Please complete the checklist in the On Site Service Health and Safety Declaration Form or the Health and Safety Declaration Form for Product Return or Servicing depending on whether the instrument is going to be serviced on site or returned for service respectively AKTAxpress Operating Instructions 28 9579 08 AC 57 5 Maintenance 5 5 Cleaning Copy the form you need from Section 7 4 Health and Safety Declaration Form on page 70 or print it from the PDF file available on the User Documentation CD Cleaning In Place 58 All components in the system are designed for ease of CIP After repeated separation cycles contaminating material might progressively build up in the system and on the column This material may not have been removed by the cleaning step described above The nature and degree of contamination depends on the sample and the chromatographic conditions employed These should be considered when designing a cleaning protocol A method
29. ches the labelling on the system A deep well plate with 96 wells or 24 wells can be used 4 6 Performing a run 1 Select method plan 2 d InSystem Control click Instant Run b Select the required Method plan from the list 3 Select systems for the run Select on which System s the method plan will be run and the Number of Samples on each system 4 Specify samples 5 variables AKTAxpress Operating Instructions 28 9579 08 AC 47 4 Operation 4 6 Performing a run d Enter identification names for the samples either via the keyboard or using a bar code reader b For each sample it is possible to enter e isoelectric point pl extinction coefficient for the protein Ext Coeff e molecular weight of the protein MW The data can also be automatically imported from an import file if it has been prepared and placed in the specified folder and the location must be specified in Import File Location in Advanced Zone settings pages See UNICORN user documentation for further information Cc Enter optional text for example culture batch number Edit result file location and names If required edit the folder path and file names of the result files to be created Print out Summary Print out the Summary by clicking Print Preparations completed Make sure that the preparations according to Section 4 5 Preparations before start on page 44 has been performed Check the flow path Check against the Summary an
30. cling of AKTAxpress 2 1 Safety precautions Introduction The AKTAxpress instrument is powered by mains voltage and handles pressurized liquids that may be hazardous Before installing operating or maintaining the system you must be aware of the hazards described in this manual Follow the instructions provided to avoid personal injury or damage to the equipment The safety precautions in this section are grouped into the following categories e General precautions Using flammable liquids e Personal protection Installing and moving the instrument e System operation e Maintenance General precautions Always follow these General precautions to avoid injury when using the AKTAxpress in strument WARNING Do not operate AKTAxpress in any other way than described in the AKTAxpress and UNICORN manuals If the equipment is used in a manner not specified by the manufacturer the protection provided by the equipment may be impaired 16 AKTAxpress Operating Instructions 28 9579 08 AC 2 Safety instructions 2 1 Safety precautions WARNING Operation and user maintenance of the AKTAxpress instrument should be performed by properly trained personnel only WARNING Before connecting a column to the AKTAxpress instrument read the instructions for use of the column To avoid exposing the column to excessive pressure make sure that the pressure limit is set to the specified maximum pressure of th
31. d make sure that e there is enough buffer available e the correct inlet is placed in each buffer e the outlets are placed in correct bottles e the columns are placed in correct positions e the chosen fraction collector microplate is in correct place Al A2 B1 B2 A3 A8 10 Prepare the samples 48 AKTAxpress Operating Instructions 28 9579 08 AC 4 Operation 4 6 Performing a run The samples should have been prepared and clarified using centrifugation and or filtration through a 0 45 um filter If using crude columns clarification is not needed a Place the sample tubes in the tube or optional flask holder or inject the sample into the Superloop depending on chosen method plan b If Fillsample inlets is included in the method plan the inlets should be placed in affinity binding buffer During the run the system will pause after initial buffer filling and a message will appear requesting each sample inlet tubing to be gently moved to its sample e If Fill sample inlets is not included gently move the already buffer filled sample inlet tubing to each sample before starting the run Make sure that no air enters the tubing Place the tubing close to the bottom of the liquid container but not too tight against the bottom C Secure the tubing with the tubing holder 11 Final check Perform a final check that tubing columns solutions and buffers are placed according to the Summary 12 Start the ru
32. de in Advanced Zone Method plan Note 2003 12 18 CIP Regular Installation Test MUN Purification Protocol E Affinity Step Desalting lon Exchange Gel Filtration Normal Affinity Column Sample Loading Level Running Condition Room Temperature Columns HisTrap_HP_1_ml Global HiPrep_26 10_Desalting Global RESOURCE 6 1 ml Global HiLoad 15 60 Superdex 75 prep grade Global Folder select a folder in Method plan tree Method plan name e Cancel N Create Folder Delete Help 9 Type the name of the method plan and click OK The method plan is saved It can now be started from the System Control module on a single or on several AKTAxpress instruments AKTAxpress Operating Instructions 28 9579 08 AC 43 4 Operation 4 5 Preparations before start 4 5 Preparations before start Print out Summary The Summary list can be printed from System Control and it is useful during the preparation of the system columns and all solutions The list includes e Buffers solutions volumes and inlets Sample inlet positions Usage of inlet and outlet position e Type of column and column positions Loop positions e Microplate type To create the Summary 1 InSystem Control click Instant Run 2 Select the required Method plan from the list 3 Select on which System s the method plan will be run and the Number of Samples on each system 4 Printoutthe Summary by clicking Print
33. e GE Healthcare Bio Sciences Corp 800 Centennial Avenue PO Box 1327 Piscataway NJ 08855 1327 US 2010 14 General Electric Company All rights reserved First published April 2010 D0C1149544 28 9800 27 AC 05 2014 AKTAxpress Operating Instructions 28 9579 08 AC 71 7 Reference information 7 5 Ordering information 7 5 Ordering information For ordering information visit www gelifesciences com AKTA 72 AKTAxpress Operating Instructions 28 9579 08 AC A Connection diagram Liquid flow path Appendix A AKTAxpress Operating Instructions 28 9579 08 AC 73 A Connection diagram Liquid flow path Connection diagram Liquid flow path Flow path and components Frac H I A Waste 18 8 8 3 0 2 MPa m o BP 15 10 LoopV2 Waste 4 i Mixin 74 KTAxpress Operating Instructions 28 9579 08 AC A Connection diagram Liquid flow path No Description No Description y Samples 11 Loop Valve 2 Buffers 12 Column Valve 3 Inlet Valve 13 Bypass 4 Switch Valves 14 UV monitor 5 Air sensor 15 Conductivity monitor 6 Pump 16 Restrictor 7 Mixer 17 Outlet Valve 8 Pressure sensor 18 Waste 9 Injection Valve
34. e column WARNING Do not use any accessories not supplied or recommended by GE WARNING Do not use AKTAxpress if it is not working properly or if it has suf fered any damage for example PP PP e damage to the power cord or its plug e damage caused by dropping the equipment e damage caused by splashing liquid onto it CAUTION Waste tubes and containers must be secured and sealed to prevent accidental spillage CAUTION Make sure that the waste container is dimensioned for maximum possible volume when the instrument is left unattended AKTAxpress Operating Instructions 28 9579 08 AC 17 2 Safety instructions 2 1 Safety precautions NOTICE Avoid condensation by letting the unit equilibrate to ambient tem perature Using flammable liquids When using flammable liquids with the AKTAxpress instrument follow these precautions to avoid any risk of fire or explosion WARNING Fire Hazard Before starting the system make sure that there is no leakage WARNING A fume hood or similar ventilation system shall be installed when flammable or noxious substances are used Personal protection WARNING Always use appropriate Personal Protective Equipment PPE during operation and maintenance of AKTAxpress system WARNING When using hazardous chemical and biological agents take all suitable protective measures such as we
35. equip ment 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 equipment This symbol indicates that the product contains hazardous materials in Lory excess of the limits established by the Chinese standard SJ T11363 2006 I i Requirements for Concentration Limits for Certain Hazardous Substances in Electronics 2 5 Emergency procedures In this section This section describes how to do an emergency shutdown of the AKTAxpress system The section also describes the result in the event of power failure Emergency shutdown In an emergency situation do as follows to stop the run Step Action 1 To pause the run from UNICORN click the Pause button 2 Press the Power ON Stand by button on the instrument If required discon nect the mains power cord The run is interrupted immediately AKTAxpress Operating Instructions 28 9579 08 AC 25 2 Safety instructions 2 3 Emergency procedures Power failure The result of a power failure depends on which unit that is affected Power failure to will result in AKTAxpress e The run is interrupted immediately in an undefined state e The data collected up to the time of the power failure is available in UNICORN Computer e The UNICORN computer shuts down in an undefined state e The run is interrupted immedi
36. for cleaning in place CIP is available in the UNICORN Method Wizard It gives many possibilities to design a powerful cleaning protocol for individual problems with up to 9 cleaning segments Routine cleaning should be performed at intervals aimed at prevention rather than cleaning the system from growth or contamination WARNING Make sure that the piping system is completely leakage free before performing any CIP on the system Make sure that the process control method for cleaning flushes all possible flow paths in the system After cleaning rinse the entire system with water or suitable liquid until the piping tubing system is completely free from the CIP solution monitors in the system can be used as detectors Do not leave NaOH or other cleaning agents in the system for long periods WARNING Hazardous chemicals during maintenance When using hazardous chemicals for system or column cleaning wash the system or columns with a neutral solution in the last phase or step WARNING NaOH is corrosive and therefore dangerous to health When using hazardous chemicals avoid spillage and wear protective glasses and other suitable Personal Protective Equipment PPE AKTAxpress Operating Instructions 28 9579 08 AC 5 Maintenance 5 3 Cleaning See also Section 5 8 Storage on page 60 5 4 Component maintenance Maintenance and preventive replacement of parts of the major components are desc
37. g AKTAxpress wear e Protective footwear preferably with steel lining e Working gloves protecting against sharp edges Protective glasses NOTICE o Lift the instrument in the upright position Do not use the front panel bar as a lifting handle Before moving the system e disconnect all cables and tubing connected to peripheral components and liquid containers remove all items from the top of the instrument e grasp the system firmly by the base of the unit and the side rails and lift For more information on transport see AKTAxpress User Manual 5 5 Unpacking Check for damage Check the equipment for damage before starting assembly and installation There are no loose parts in the transport box 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 representative AKTAxpress Operating Instructions 28 9579 08 AC 1 3 Installation 3 3 Unpacking Unpack the system Remove straps and packing material Then set the equipment upright before starting installation 3 4 Assembly The following parts must be added to the AKTAxpress instrument before it can be used Tubing holder Tube holder USB CAN converter Various buffer and sample bottles Flask holder optional Pump rinse solution 20 EtOH in a 50 ml Falcon tube Installing the tubing holder Insert the tubing holder according to
38. iN 70 5b Ordering nforfmalion uoc ete eerie te errato rcr OR 72 AppendixA Connection diagram Liquid flow path 73 Appendix B TUDING cO HA RU ORGRIN DEN QUI DEED FUP eH iR NI IN NM 76 Appendix Column positi OBS aiunt ceen sin ad tenias tutae enn ta ato sacss 78 4 AKTAxpress Operating Instructions 28 9579 08 AC 1 Introduction 1 Introduction Purpose of the Operating Instructions The Operating Instructions provide you with the instructions needed to handle AKTAxpress in a safe way Prerequisites In order to operate AKTAxpress as is intended the following pre requisites must be ful filled e The user should have a general understanding of how a PC and the Microsoft Windows operating system works e The user must understand the concepts of liquid chromatography e The user must read and understand the Safety Instructions in this manual AKTAxpress and software should be installed configured and calibrated according to these Operating Instructions About this chapter This chapter contains important user information a description of the intended use of AKTAxpress regulatory information list of associated documentation definitions of safety notices and so on AKTAxpress Operating Instructions 28 9579 08 AC 1 Introduction 1 1 Important user information 1 1 Important user information Read this before operating the product All users must read the entire Ope
39. ilable on request Contact your local GE Healthcare repre sentative for the most current information GE Healthcare Europe GmbH Munzinger Strasse 5 D 79111 Freiburg Germany GE Healthcare UK Limited Amersham Place Little Chalfont Buckinghamshire HP7 9NA UK GE Healthcare Bio Sciences Corp 800 Centennial Avenue P O Box 1327 Piscataway NJ 08855 1327 USA GE Healthcare Japan Corporation Sanken Bldg 3 25 1 Hyakunincho Shinjuku ku Tokyo 169 0073 Japan 28 9579 08 AC 02 2015 a4
40. in good shape it is important to clean both the tubing and the outside of the system regularly 1 Inthe Method Editor module in UNICORN create a method plan for cleaning the system 2 Wash the outside of the inlet tubings with water and or ethanol 3 Immerse the tubing ends to be used in the container with cleaning solution 1 4 Ifthe column valve is to be cleaned remove the columns and reconnect the tubings to the column valves 5 Ifall outlets are to be cleaned remember to also insert a microplate 6 Run the cleaning method plan as described in Section 4 6 Performing a run on page 47 52 AKTAxpress Operating Instructions 28 9579 08 AC 4 Operation 4 7 Procedures after a run Cleaning columns When running different types of purification methods and different samples after each other the columns should be cleaned between the runs according to the column instruc tions This will remove unspecific bound proteins and prevent column clogging 1 Inthe Method Editor module in UNICORN create a method plan for column cleaning in place CIP 2 Immerse the tubing ends to be used in the correct containers according to the Summary page for the chosen run 3 Runthe cleaning in place method plan as described in Section 4 6 Performing a run on page 47 AKTAxpress Operating Instructions 28 9579 08 AC 53 5 Maintenance 5 Maintenance About this chapter This chapter provides instructions for routine component maintenance
41. ions 28 9579 08 AC 29 3 Installation 5 Installation NOTICE e AKTAxpress shall be installed and prepared by GE personnel or third party authorized by GE Healthcare NOTICE Any computer used with the equipment shall comply with IEC 60950 and be installed and used according to the manufacturer s instruc tions KTAxpress is delivered in protective packing material and shall be unpacked with great care Any equipment connected to AKTAxpress must fulfill applicable standards and local regulations For detailed information on Installation see AKTAxpress User Manudl 5 1 Site requirements Parameter Requirement Operation site Indoor use Altitude Maximum 2000 m Placement Stable laboratory bench e g 200 x 80 cm Electrical power 100 120 220 240 V AC 1096 50 60 Hz Transient overvoltages Overvoltage category Il Ambient temperature 4 C to 40 C Humidity 20 to 95 non condensing Atmospheric pressure 84 to 106 kPa 840 to 1060 mbar Pollution degree 2 30 AKTAxpress Operating Instructions 28 9579 08 AC 3 Installation 3 2 Transport 5 2 Transport The equipment weighs 30 kg and requires at least two people to lift and move it unless a suitable lifting device is used The equipment can be transported on a trolley capable of supporting at least 50 kg WARNING Personal Protective Equipment PPE Whenever packing unpack ing transporting or movin
42. istant to the substances used Follow local and or national regulations for safe operation and maintenance of AKTAxpress CAUTION Fire hazard Follow instructions in AKTAxpress Operating Instructions for correct installation of a new UV lamp If the lamp is not installed properly it may be overheated and cause a fire hazard NOTICE Cleaning Keep the instrument dry and clean Wipe regularly with a soft damp tissue and if necessary a mild cleaning agent Let the instrument dry completely before use o0 gt PRP b 5 2 User maintenance schedule Table 5 1 provides a guide to maintenance operations and intervals at which these op erations should be performed by the user The user is however responsible for deciding the type of operations and length of intervals necessary to maintain system function and safety AKTAxpress Operating Instructions 28 9579 08 AC 55 5 Maintenance 5 2 User maintenance schedule Table 5 1 User maintenance schedule Interval Action Instructions reference Daily Leak inspection Visually inspect the system for leaks Wash the system flow 4 For cleaning the flow path see Cleaning In path Place on page 58 2 For leaving the system for a few days see Section 5 8 Storage on page 60 Weekly Replace on line filter Replace the on line filter if applicable Change pump rinsing Change rinsing solution Always use 20 solution ethanol with 10 mM NaOH as rinsing s
43. librated column Check that the column is equilibrat ed If necessary clean the column KTAxpress Operating Instructions 28 9579 08 AC 63 6 Troubleshooting 6 3 Pressure curve problems D 64 Error symptom Erratic flow noisy baseline signal irregu lar pressure trace Pressure curve problems Possible cause Air bubbles passing through or trapped in the pump Corrective action Check all connections for leaks Check that there is sufficient eluent present in the reservoirs Use degassed solutions Purge the pump Follow the instructions in Pump P 900 User Manual Inlet or outlet check valves not functioning correctly Clean the valves according to Pump P 900 User Manual Piston seal leaking Replace the piston seal according to the instructions in Pump P 900 User Manual Blockage or part blockage of flow path Flush through to clear blockage If necessary replace tubing Check inlet tubing filter It can be come clogged if unfiltered buffers or samples are applied See instruc tions for flushing through at the end of the run in Pump P 900 User Manual AKTAxpress Operating Instructions 28 9579 08 AC 7 Reference information 7 Reference information About this chapter This chapter contains technical data regulatory and other information 7 1 Specifications Parameter Value Ingression protection IP20 Supp
44. ly voltage 100 120 220 240 V AC 1096 50 to 60 Hz Power consumption 120 VA Fuse specification T6 3 AL250V Dimensions H x W x D 660 x 250 x 590 mm Weight 30 kg Ambient temperature 4 to 40 C Relative humidity tolerance non condensing 20 to 9596 Atmospheric pressure 84 to 106 kPa 840 to 1060 mbar Noise emission 70dBA 7 2 Chemical resistance Note RPC cannot be performed with AKTAxpress Chemical Exposure Exposure CAS no EEC no Comments lt 1 day up to 2 months Acetaldehyde OK OK Acetic acid lt 5 OK OK Acetic acid 70 OK OK 64 19 7 200 580 7 Acetonitrile OK OK 75 05 8 200 835 2 PPand PE swell AKTAxpress Operating Instructions 28 9579 08 AC 65 7 Reference information 7 2 Chemical resistance Chemical Exposure Exposure Comments lt 1day upto 2 months Acetone 10 OK Avoid PVDF is affected by long term use Ammonia 30 OK OK 7664 41 7 231 635 3 Silicone is affected by long term use Ammonium chlo OK OK 12125 02 9 235 186 4 ride Ammonium bicar OK OK bonate Ammonium nitrate OK OK Ammonium sul OK OK 7783 20 2 231 984 1 phate 1 Butanol OK OK 2 Butanol OK OK Citric acid OK OK 29340 81 6 249 576 7 Chloroform OK Avoid Kalrez CTFE PP and PE are affected by long term use Cyclohexane OK OK Detergents OK OK Dimethyl sulphox Avoid Avoid 67 68 5 200 664 3 PVDF is affected by
45. n Click Run to start the run on the selected systems Be prepared for manual interactions fill loops guided loading of Superloop fill sample inlets etc AKTAxpress Operating Instructions 28 9579 08 AC 49 4 Operation 4 6 Performing a run Viewing the run The progress ofthe run can be viewed in detail in the System Control module By clicking the separation system symbol on the left the current status for the particular system can be displayed f System Control SYS_1 Method Wizard Generated Result o 0per_1 Wizard verification 20031030 ID56 SYS 1001 res File View Manual System Help Hold Pause Continue End amp Instant Run Continue all End all Instruments Connection Run Status Acc Volume Block Volume Acc Time Block Time Inject gt gt Flow gt gt Pressure gt gt UV gt gt UVLamp gt gt Conc gt gt Cond gt gt Cond gt gt XYFRAC gt gt InletValve gt gt LoopSelect ColPos gt gt Qutlet gt gt RemainTime AirSensor gt gt mAU Uv Cond Conc Pressure Flow 704 6004 5004 4004 3004 2004 1004 T T T T T T T T T T T T T T T mi 10 0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 210 220 230 240 250 260 270 280 BSTC Tr Base SaImBASMITE 263 12 ml Watch_Off UV 263 12 ml End Block 263 12 ml Block Fractionation I
46. ng on the UNICORN shortcut icon on the desktop 2 d UNICORN 5 Inthe Logon dialog select a user from the User name list and enter the password If you log on for the very first time select user default and enter the password default Click OK x dk UNICORN logon User name default X Password Cancel Help UNICORN starts and the UNICORN Manager window opens see Figure 4 1 Note See the UNICORN user documentation for instructions about how to create new users AKTAxpress Operating Instructions 28 9579 08 AC 39 4 Operation 4 3 Starting the control system ETIS Results CA default C default Size Type Modified Created Name c Prev Folder is AC 1 sample ETT 248KB Method File 02 19 2009 09 22 02 20 2009 13 39 02162009 is AC4samples ETT 261KB MethodFile 02 24 2009 10 51 02 24 2009 10 51 02172009 is AC 5 samples ETT 265KB Method File 02 24 2009 13 14 02 24 2009 10 51 03102009 ig Immunitettest1 ETT 259KB Method File 05 05 2009 17 16 05 06 2009 13 37 3031 12009 E test ETT 241KB Method File 05 06 2009 13 47 03 11 2009 17 31 05062009 05122009 No Description 1 The Instant Run icon immediately starts the system control wizard used to start a run 2 The New Method icon opens the Method Editor module and displays the New Method di alog box 3 The System Control icon activates the first connected System Control module and displays the Manual instruction dialog box
47. nt harmonized standards Within the EU connected equipment must be CE marked Environmental conformity This product conforms to the following environmental requirements Requirement Title 2011 65 EU Restriction of Hazardous Substances RoHS Directive 2012 19 EU Waste Electrical and Electronic Equipment WEEE Directive 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 10 AKTAxpress Operating Instructions 28 9579 08 AC 1 Introduction 1 3 Instrument 1 5 Instrument Product description AKTAxpress Operating AKTAxpress is a liquid chromatography system intended for automated multi step pu rification processes 1 11 12 2 13 3 4 14 5 AT E 15 A J Ye 16 7 nn D 17 8 mz ML 18 9 os 19 Nu 10 20 21 Figure 1 1 The main parts of the equipment No Description No Description 1 Outlet valve 12 Sample loops 2 Column block 13 Control panel 3 Power ON Stand by 14 Loop valve 4 Column valve 15 UV cell 5 UV optical unit 16 Conductivity cell 6 Column holder 17 Switch valves 7 Pressure sensor 18 Tubing holder nstructions 28 9579 08 AC 11 1 Introduction 1 3 Instrument No Desc
48. olution If the volume of rinsing solution in the storage bottle has increased it can be an indication of internal pump leakage Replace the piston seals according to the User manual If the volume of rinsing solution in the storage bottle has decreased significantly check if the rinsing system connectors are mounted proper ly If the rinsing system connectors are not leaking the rinsing membranes or piston seals may be leaking Replace the membranes and piston seals according to the User manual 56 AKTAxpress Operating Instructions 28 9579 08 AC 5 Maintenance 5 2 User maintenance schedule Interval Action Instructions reference Monthly Flow restrictor Check that flow restrictor generates the follow ing back pressure FR 902 0 2 0 05 MPa Check the back pressure as follows 1 Disconnect the flow restrictor 2 Connect a tubing approx 1 m i d 1 mm to a free port in the injection valve Set the valve manually to this port Put the open end in a waste container 3 Run the pump at 10 ml min with water Note the back pressure Bp1 on the pump display or in the Run Data window 4 Connect the flow restrictor to the open end of the tubing observe the IN marking Put the flow restrictor in the waste container 5 Run the pump at 10 ml min with water Note the back pressure Bp2 on the pump display or in the Run Data window 6 Calculate the back pressure generated by the flow restrictor Repla
49. purging procedure b When all inlets are filled click End Connect columns and Superloop 46 For column positions see the Summary list in Print out Summary on page 44 or Ap pendix C Column positions on page 78 Remove air before connecting columns Air remaining in the system may be removed by purging the pump and by selecting Pump Wash and System Wash 1 Immerse A1 tubing in the buffer to be used 2 Select System Control Manual PumpWash or SystemWash Connecting tubing to columns Refer to column manufacturer s instructions Column attachment drop to drop To avoid air bubbles use the drop to drop procedure when connecting columns S 1 In Prepare and Maintain select Column Attachment to create this method plan and start it This will start a low flow rate over the first column position 2 Click Continue to start filling Column position 1 3 Fixthetubing to the column drop to drop AKTAxpress Operating Instructions 28 9579 08 AC 4 Operation 4 5 Preparations before start 4 Pressthe Next Breakpoint button 1 on the instrument control panel to start filling the next column position OPAUSE Note It is also possible to attach columns manually by starting a low flow see Purging the pump and inlet tubing on page 44 and selecting System Con trol Manual Flowpath ColumnPosition Preparing the fraction collector Place an empty deep well microplate on the sled and check that the labelling A mat
50. rating Instructions before installing operating or maintaining the product Always keep the Operating Instructions at hand when operating the product Do not operate the product in any other way than described in the user documentation If you do you may be exposed to hazards that can lead to personal injury and you may cause damage to the equipment Intended use AKTAxpress is a liquid chromatography system intended for automated multi step pu rification processes The system has been developed and optimized for purification of antibodies and tagged recombinant proteins from clarified or crude cell lysates AKTAxpress is intended for research use only and shall not be used in any clinical pro cedures or for diagnostic purposes Safety notices This user documentation contains WARNINGS CAUTIONS and NOTICES concerning the safe use of the product See definitions below Warnings WARNING WARNING indicates a hazardous situation which if not avoided could result in death or serious injury It is important not to proceed until all stated conditions are met and clearly understood 6 AKTAxpress Operating Instructions 28 9579 08 AC 1 Introduction 1 1 Important user information 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 Notices NO
51. re performing any CIP on the system WARNING NaOH is corrosive and therefore dangerous to health When using hazardous chemicals avoid spillage and wear protective glasses and other suitable Personal Protective Equipment PPE 22 AKTAxpress Operating Instructions 28 9579 08 AC 2 Safety instructions 2 1 Safety precautions WARNING After assembly the piping system must be tested for leakage at maximum pressure for continued protection against injury risks due to fluid jets burst pipes or explosive atmosphere WARNING Before disassembly check that there is no pressure in the piping system WARNING Disconnect power Always disconnect power from the instrument before replacing fuses WARNING Decontaminate the equipment before decommissioning to ensure that hazardous residues are removed NOTICE Cleaning Keep the instrument dry and clean Wipe regularly with a soft damp tissue and if necessary a mild cleaning agent Let the instrument dry completely before use OP gt gt b 2 2 Labels In this section This section describes the instrument labels and labels concerning hazardous substances that are attached to the AKTAxpress instrument For information about marking of the computer equipment refer to the manufacturer s instructions AKTAxpress Operating Instructions 28 9579 08 AC 23 2 Safety instructions 2 2 Labels Labels on the instrumen
52. ress Operating Instructions 28 9579 08 AC 4 Operation 4 6 Performing a run Ending the run To stop the run on a system before it is finished 1 Check that the correct system is selected on the screen 2 Click End above the Run data view pane Status indicator colors The status indicator is located at the bottom of System Control The table below shows how the indicator colors relate to the run status Indicator color Run status White End Green Run or Manual Yellow Hold Red Pause Error indication When a warning or an alarm is issued from a system the background of the system symbol starts flashing and the background color turns yellow An error code is displayed on the instrument control panel See KTAxpress User Manual for guidance Evaluate the results See KTAxpress User Manual and UNICORN user documentation for how to evaluate the results KTAxpress Operating Instructions 28 9579 08 AC 51 4 Operation 4 7 Procedures after a run 4 7 Procedures after a run Emptying drip plate The drip plate located below the microplate in the fraction collector should be emptied and rinsed when necessary Re jj cS 31 Na eU The purpose of the drip plate is to collect any overflow from the microplate Overflow might indicate an error If the drip plate becomes full there is a risk of damage to the system Cleaning system To keep the system
53. ribed in the respective manuals included in the system documentation The system documentation also includes a spare part list to be used to find common spare parts and their code numbers for ordering This list can also be found online at www gelifesciences com AKTA 5 5 Disassembly and assembly of components and con sumables The operator must carefully read and understand the instructions supplied for each component before disassembly and assembly of the component When replacing con sumables such as tubing and tubing connectors all neccessary safety precautions must be taken Contact your local GE Healthcare representative if further information or help is needed WARNING Disconnect power Always disconnect power from the instrument before replacing any component on the instrument unless stated otherwise in the user documentation WARNING Before disassembly check that there is no pressure in the piping system WARNING After assembly the piping system must be tested for leakage at maximum pressure for continued protection against injury risks due to fluid jets burst pipes or explosive atmosphere AKTAxpress Operating Instructions 28 9579 08 AC 59 5 Maintenance 5 6 Replacement of fuses 5 6 Replacement of fuses WARNING Disconnect power Always disconnect power from the instrument before replacing fuses Refer to Section 7 1 Specifications on page 65 for information abou
54. ription No Description 8 Mixer 19 Inlet valve 9 Pump 20 Air sensor 10 Flask holder optional 21 Tube holder 11 Fraction collector Electrical and communication connections No Connection No Connection 1 UniNet network 4 Air sensor 2 Conductivity flow cell 5 AC Power inlet 3 UV monitor optical unit 6 UV monitor lamp 12 AKTAxpress Operating Instructions 28 9579 08 AC 1 Introduction 1 3 Instrument Basic flow path Figure 1 2 Basic principles Step Part Description 1 V1 Sample or buffer pass through the inlet valve which selects a liquid depending on the setting in UNICORN The switch valves will form a gradient between A1 and B1 or A2 and B2 as selected in the method 2 A The air sensor will detect air and e g pause the system if air is detected or continue purification method after all sample has been loaded AKTAxpress Operating Instructions 28 9579 08 AC 15 1 Introduction 1 5 Instrument Step Part Description 3 P A combined sample and buffer pump P pumps liquid through the system 4 M The solution passes through the Mixer M where buffers are mixed 5 V2 Sample is added manually through the injection valve if gel filtra tion or desalting is the first chromatography step 6 V3 Column valve directs flow through a connected column 7 UV C R Liquid returns from the column valve and is directed to the outlet valve via UV and conductivity monitors and the
55. sing Superloop Note This may not be a useful protocol for on column tag cleavage if a tagged protease is used AKTAxpress Operating Instructions 28 9579 08 AC Page intentionally left blank 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 AKTA GE and GE monogram are trademarks of General Electric Company AKTA Superloop and UNICORN are trademarks of GE Healthcare Company or one of its subsidiaries Decon is a trademark of Decon Laboratories Ltd Deconex is a trademark of Borer Chemie AG Elgiloy is a trademark of Combined Metals of Chicago L L C Elgin National Watch Company Kalrez is a trademark of DuPont Performance Elastomers L L C Microsoft and Windows are registered trademarks of Microsoft Corporation 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 UNICORN 2003 2015 General Electric Company 2009 2015 General Electric Company All rights reserved First published Jul 2009 All 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 ava
56. t The illustration below shows an example of the identification label that is attached to AKTAxpress XX XXXX XX X000 Sample Code no XXXXXXXX Voltage IXI XXX XXX XXX VAC Serial no XXXXXXX Frequency XX XX Hz Max Power XXX VA Fuse XX X XXAL 250 V Protection Class XXXX a Us Mfg Year 2014 LEDER ma Made in Sweden GE Healthcare Bio Sciences AB F 751 84 Uppsala Sweden Conforms to ANSI UL Std 61010 1 Cert to CAN CSA Std C22 2 No 61010 1 Symbols used in instrument Label Meaning labels Warning Read the user documentation before using the equipment Do not open any covers or replace parts unless specifically stated in the user documentation The equipment complies with the requirements for electromagnetic compliance EMC in Australia and New Zealand The equipment complies with applicable European directives W Listed Intertek This symbol indicates that AKTAxpress has been certified by a Nation ally Recognized Testing Laboratory NRTL NRTL means an organiza tion which is recognized by the US Occupational Safety and Health Administration OSHA as meeting the legal requirements of Title 29 of the Code of Federal Regulations 29 CFR Part 1910 7 24 AKTAxpress Operating Instructions 28 9579 08 AC 2 Safety instructions 2 2 Labels Labels concerning hazardous substances Label Meaning This symbol indicates that the waste of electrical and electronic
57. t the fuse type and rating If a fuse repeatedly blows switch off the system mains switch and contact your local GE Healthcare representative WARNING For continued protection from fire hazard replace only with same type and rating of fuse 5 7 Calibration The table below lists the type and frequency of calibrations that can be done on the in strument Refer to UNICORN user documentation and to the individual component User Manuals and Instructions for descriptions of how to perform these calibrations The calibrations are performed from UNICORN by selecting System Calibrate in System Control Component How often Pressure reading When required 5 8 Storage General recommendation For storage the system must first be cleaned as described in Cleaning In Place on page 58 After cleaning the system must be filled with 0 01 M NaOH or 2096 ethanol solution Columns and media shall be stored according to their respective instructions 60 AKTAxpress Operating Instructions 28 9579 08 AC 5 Maintenance 5 8 Storage Storage conditions The following conditions shall be maintained while the system is in storage e Temperature 2 C to 30 C preferably room temperature Relative humidity 096 to 9596 non condensing preferably low humidity After storage clean and sanitize the system calibrate all monitors and perform a leakage test before using the system AKTAxpress Operating Instructions 28 9
58. teesiiiet ttti 39 4 amp 4 SettingU p OG FUDisu quee deett ceteris tbe irent proe Dae geben desse paste ea ches iaa 41 45 Preparations Defore SEP ssec terrre Do toorbeeste ter pe 44 46 Performing a run m 47 47 Procedures atterarufi nece te ect tarta rtt ennt 52 5 M a lnten libe cose enira iei atest stetit E 54 54 General subesse cR AREE ERRORS Oe Tat dla 54 5 2 User maintenance schedule 55 Eee 57 5 4 Component Mantenne esnan eerte retos cep ete p c terree 59 5 5 Disassembly and assembly of components and consumables sss 59 5 6 Replacement of FUSES o secsssssssessssssscssssssssssssesssssecsssssssssssssssessessessssssssssusscssseccessssssssusecsessesesssesssess 60 5 7 Calibration E 60 5 8 SOROS MN RR RE 60 6 NOUDIDSDOOU uie deu cer p pd ripe tee Sapa Sr ire dp RM 62 GU MI CUFVeproblelmseec teen ernst en eresettieeeseiud etes dresden 62 6 2 Conductivity curve problems e etteeteennntnnttttttttetttnn teet tttttttttnnnesns 63 AKTAxpress Operating Instructions 28 9579 08 AC 3 Table of Contents 6 5 Pressure curve problems ierann nainis aa HERR 64 7 Reference information eese essent estne tns insta sensns tnts tasas 65 71 SPECIHNCAUONS saan nanus eternidad dieitur medir RH OUI 65 52 Chernicdlresistance ete erbe ratto eec eite tn 65 7 3 System recommendations 69 7 Health and Safety Declaration Form iissesiemenmiinanemnianinenannnn
59. tral buffer and finally distilled water before service and maintenance CAUTION Hazardous chemicals in UV flow cell Make sure that the entire flow cell has been flushed thoroughly with bacteriostatic solution for example NaOH and distilled water before service and mainte nance Maintenance WARNING Electrical shock hazard All repairs should be done by service personnel authorized by GE Healthcare Do not open any covers or replace parts unless specifically stated in the user documenta tion AKTAxpress Operating Instructions 28 9579 08 AC 21 2 Safety instructions 2 1 Safety precautions WARNING Disconnect power Always disconnect power from the instrument before replacing any component on the instrument unless stated otherwise in the user documentation WARNING Hazardous chemicals during maintenance When using hazardous chemicals for system or column cleaning wash the system or columns with a neutral solution in the last phase or step WARNING Do not perform any type of maintenance work while the system is powered electrically or when the piping system is pressurized Note that the piping system can be pressurized even when the system is closed down WARNING Only spare parts and accessories that are approved or supplied by GE may be used for maintaining or servicing AKTAxpress WARNING Make sure that the piping system is completely leakage free befo
60. y impede access to the instrument All buffer waste vessels are labeled Excess containers have been removed from the area to provide access Provide explanation for any No answers here Equipment type Product No Serial No 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 Position or job title Date YYYY MM DD Signed GE and GE monogram are trademarks of General Electric Company GE Healthcare Bio Sciences Corp 800 Centennial Avenue PO Box 1327 Piscataway NJ 08855 1327 2010 14 General Electric Company All rights reserved First published April 2010 DOC1149542 28 9800 26 AC 05 2014 70 AKTAxpress Operating Instructions 28 9579 08 AC Product return or servicing 7 Reference information 7 4 Health and Safety Declaration Form Health amp Safety Declaration Form for Product Return or Servicing Return authorization number and or 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 delays in the processing of your equipment please complete this checklist and include it with your return 1

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