193_0022_01
Contents
1. T 31 715813333 F 31 715813334 info myAntec com www myAntec com Ante SS Antec Industrieweg 12 2382 NV Zoeterwoude The Netherlands LC 110S pump OQ manual 193 0022S Edition 1 2013 ISO 9001 certified Copyright 2013 Antec All rights reserved Contents of this publication may not be reproduced in any form or by any means including electronic storage and retrieval or translation into a foreign language without prior agreement and written consent from the copyright of the owner The information contained in this document is subject to change without notice ROXY potentiostat DECADE II DECADE INTRO Sencell Reactor cell Reactor ISAAC HyREF LINK ADF DECADE Dialogue DECADE II Dialogue are trademarks of Antec Leyden BV Whatman word and device and Whatman word only are trademarks of Whatman International Ltd SOLVENT IFD and AQUEOUS IFD are trademarks of Arbor Technologies Inc Clarity DataApex are trademarks of DataApex Ltd Microsoft and Windows are trademarks of Microsoft Corporation The information provided herein is believed to be reliable Antec Leyden shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing performance or use of this manual All use of the hardware or software shall be entirely at the user s own risk Table of contents Symbols 1 of 19 Explanations of symbols amp labels on the dev2. e instrument may only be opened by au thorized service engineers of the manufacturer or a company authorized by the manufacturer WARNING RISK OF ELECTRIC CHOCK AN DISCONNECT POWER BEFORE SERVICING AVERTISSEMENT RISQUE DE CHOC ELECTRIQUE COUPER L ALIMENTATION AVANT LA MAINTENANCE Place the LC 110 110S on a flat and smooth surface or inside a PR 110 pump rack Connect the detector to a grounded AC power source line voltage 100 240 VAC frequency 50 60 Hz The instrument should be connected to a protective earth via a grounded socket using the power cord supplied by the manufacturer The power source should exhibit mini mal power transients and fluctuations Replace faulty or frayed power cords Solvents Organic solvents are highly flammable Since capillaries can detach from their screw fittings and allow solvent to escape it is prohibited to have any open flames near the analytical system If a leakage occurs turn of the power of the instrument and remedy the situation immediately Regularly check for leaks and clogged LC tubing and connections Do not close or block drains or outlets Do not allow flamma ble and or toxic solvents to accumulate Follow a regulated approved waste disposal program Never dispose of such products through the mu nicipal sewage system Toxicity Organic solvents are toxic above a certain concentration Ensure that work areas are always well ventilated Wear protective glo
3. e passed sign off this document What to do if OQ failed Steps to take when the LC 110 LC 110S pump fails the OQ test 1 Finish the OQ as far as possible If one section is failed it may very well be that also other tests will fail that will help in finding the problem In case tests are failed fill in a non conformance report for every failed test Find the corresponding sections in the service documentation and see what test recommendations and fixes are given to solve the problem vice Verified by customer Comments If not successful in fixing the problem contact Antec Leyden for ser Deviations Y N 16 of 19 OQ procedure LC 110 110S edition 1 OQ certification 17 of 19 CHAPTER 3 OQ certification The Operational Qualification has been carried out in accordance to the OQ procedure and has been carried out to the satisfaction of both parties All tests as described in this document have been successfully completed and all results are within specifications Executing technician Technician name amp signature Customer authorised to sign Name amp signature 18 of 19 OQ procedure LC 110 110S edition 1 Comments Chapter 4 Non conformance record 19 of 19 CHAPTER 4 Non conformance record Any case of non conformance found during the OQ procedure should be documented and signed for acceptance or corrective action taken Table 2 Non con
4. formance record Ref Non conformance and action taken Signature Sign executing customer technician 1
5. h speed and dispense mobile phase in the waste container with a flowrate of 10 mL min Check if no liquid leaks from the outlet port via the PEEK closing plug If leakage occurs make non conformance record retighten the plug and repeat the procedure Result Passed L Failed Test 3 Minimum pressure limit and pressure display This test checks the minimum pressure limit and the correct display of pressure without the application of back pressure 1 Set the min pressure to 5 bar 2 Open the bleed purge valve 3 Start the pump by pressing the start stop button 4 The pump should start pumping and the pressure display should display 0 bar After approximately one minute the pump should switch off showing message Minimum pressure limit on the LCD display Result Passed L Failed Verified by customer c eee eee eee eens Deviations Y N Comments Chapter 2 OQ procedure 11 of 19 Test 4 Maximum pressure limit and leakage rate This test checks the maximum pressure limit and whether the pump head is leaking DS Nn Close the purge valve Close the outlet on the bleed valve using the filler cap Set the flow rate to 0 05 mL min and press start Set the max pressure limit with the 10 mL pump head to 200 bar Switch the pump on using the start stop button The pump will start transporting liquid and the pressure should slowly rise Check if no leakage occurs from the out
6. hall be recorded as comments in the non conformance record The document must be reviewed by a person authorized by one of the laboratory directors The review must be docu mented with the date and signature of this person All relevant documents regarding this operational qualification must be filed together in one loca tion All information in this manual is subjected to changes without prior notice and does not represent a commitment on the part of Antec For details on functionality operation and theory reference is made to the instrument users manual Chapter 1 7 of 19 Determination of the inspection interval The routine functional inspection and review of the technical specifications must be carried out at predetermined intervals based on the intensity of use The following intervals were established 1 Average use from one to max five days per week gt Every 6 months 2 Intense use i e day night or more than five days a week gt Every 3 months 3 Operation with buffer solutions or other salt solutions gt Every 3 months 8 of 19 OQ procedure LC 110 110S edition 1 Required materials to perform an OQ Enter the specifications for the materials in use in the empty fields of the Specification column the serial number is required for devices and the firmware must be entered as required The instruments marked with should be calibrated Specification luent A ethanol water 90 10 v v HPLC quali
7. ice or in user manual Symbol Explanation Hazard symbol indicating microelectronic devices that can be damaged by electrostatic discharge when touched Flow direction symbol for piston back flushing inlet to flush pump Flow direction symbol for piston back flushing outlet from the flush pump Quality mark of a Nationally Recognized Testing Laboratory NRTL in Canada and the United States The certified device or system has successfully passed the quality and safety tests CE Conformit Europ enne mark for equipment that complies with the pertinent EU directives and comes with a declaration of conformity from the manufacturer The caution warning sign denotes a hazard It calls atten tion to a procedure or practice which if not adhered to could result in severe lethal injury or damage destruction of parts or all of the equipment Do not proceed beyond a warning sign until the indicated conditions are fully under stood and met The attention sign signals relevant information Read this information as it might be helpful 2 of 19 OQ procedure LC 110 110S edition 1 Safety practices ZN The following safety practices protective measures are intended to ensure safe operation of the instrument Electrical hazards Never open a device Removal of protective panels on the instrument can result in exposure to potentially dangerous voltages which may lead to severe injury or loss of life Th
8. ion of flush pump This test is used to check whether the flush pump is successfully initialized and is function correctly ate Connect the piston back flushing tubings amp wash bottle 2 Switch the pump off and on using the power switch or using the stand by switch 3 The pump should initialize and the flush pump start The flush pump can be heard and will circulating wash liquid from the wash bottle 4 Within 30 seconds the flush pump should switch off again Result Passed L Failed Verified by customer c cece eee eee Deviations Y N Comments 10 of 19 OQ procedure LC 110 110S edition 1 Test 2 Purge function This test checks the purge function and the fluid conveyance of the pump Oe ONS Switch the pump on using the power switch or stand by switch Connect the bottle with eluent A to the inlet tubing of the pump Close the outlet of the purge valve using a 1 16 closing plug Open the purge valve Set the flow rate to 1 mL min and press start to prime the pump head with eluent Make sure the pump head is filled with liquid if necessary use a 10 mL disposable syringe and connect it to the purge tubing to prime fill the syringe half full to prime pump head Remove the syringe and place the beaker as a waste container be low the outlet of the purge valve Press the purge button and set the flow to 10 mL min when work ing with a 10 mL pump head The motor should run at hig
9. let port via the PEEK closing plug In case of leakage make a non conformance record retighten the plug and repeat the procedure The pressure gradually increases to 200 bar Once the threshold is reached the pump should switch off with a message Maximum pressure limitl Check the pressure display two minutes after the pump switches off The pressure may not be smaller than 190 bar If the pressure is smaller than 190 bar make a non conformance record open and close the purge valve and repeat the test again Result Passed L Failed Test 5 Flow rate accuracy This test is used to check the flow rate accuracy There are two variants of this test A using a flow meter and B gravimetric determination The vari ant not in use should be marked at the end of this section Variant A Flow meter Attach the restriction capillary to the high pressure outlet of the purge valve 2 Close the purge valve 3 Attach the flow meter to the other end of the restriction capillary 4 Set flow to 1 mL min Enter a solvent factor of 0 34 for the eluent 5 Now start the pump using the start stop button Verified by customer cece Deviations Y N Comments 12 of 19 OQ procedure LC 110 110S edition 1 Read the value measured on the flow meter after two four and six minutes The flow meter readings F should be within the following limits 0 97 lt 1 0021 03 mL min Enter the results in the res
10. nd leakage rate 11 Test 5 Flow rate accuracy 11 Test 6 Gradient accuracy 13 What to do if OQ failed 15 OQ certification 17 Comments 18 Non conformance record 19 6 of 19 OQ procedure LC 110 110S edition 1 CHAPTER 1 Introduction The material included in this document is provided to assist authorized personnel in performing a operational qualification It is assumed that the individual using this manual has sufficient training in the use of analytical instrumentation and is aware of the potential hazards including but not limited to electrical hazards chemical solvent hazards exposure to pres surized solvents and UV radiation This document describes the Operational Qualification procedure as ad vised by the manufacturer It is a result from our interpretation of many regulations and laboratory practises In addition feedback from users and representatives helped us to finalize this procedure The objective of this test is to check if the LC 110 LC 110S pump is oper ating correctly in accordance with the manufacturer s specifications A complete OQ of the LC 110 110S consists of a set of functional checks and performance test of the pump hardware All qualification checks have to be approved or should be marked n a if not applicable Any deviation observed must be documented in the non conformance record In addition all courses of action undertaken to resolve the prob lems and remove the deviations s
11. on in a binary high pressure gradient system Attach the mixing chamber behind the outlet of the pressure sensor of the second pump The restriction capillary is installed between the outlet of the mixing chamber and the inlet of the UV detector 1 Connect the outlets of pump 1 and 2 to the inlets of the static gra dient mixer Connect the restriction capillary to the outlet of the gradient mixer and the inlet of the UV detector 2 Connect eluent A to pump 1 w Connect eluent B to pump 2 4 Fill all channels with eluent and make sure there are no air bubbles in the system 5 Enter a solvent factor of 0 34 for the eluents Set flow to 1 mL min D 7 Configure the following gradient program Time A B Flow rate min mL min 0 00 100 0 1 5 00 100 0 1 5 02 90 10 1 10 00 90 10 1 10 02 50 50 1 15 00 50 50 1 15 02 10 90 1 20 00 10 90 1 20 02 0 100 1 25 00 0 100 1 25 02 100 0 1 35 00 100 0 1 Connect the UV detector and set the wavelength to 274 nm 8 Start the gradient program and execute three repeated measure ments The first measurement will not be included in the analysis 9 Inthe resulting gradient curve each gradient step must appear as a pronounced horizontal plateau see fig on the next page The level of each individual plateau must correspond to the pro 14 of 19 OQ procedure LC 110 110S edition 1 grammed B values of the mixt
12. ty Fluid for piston Methanol water 20 80 v v backflush Degasser Material PEEK Oo o fet W sed g N ge Oo n n oO fe _ ol a_i JE m n o o o Oo 5 2 8 a C o E L1G lt gt lt D D TZ D 3 1 mL min 75 cm red red striped PEEK 1 16 OD 127 um ID Disposable syringe eaker for waste jes For flow rate accuracy test variant A Measuring accuracy 1 1 3 D D For flow rate accuracy test variant B I i e xe seb Q x a D sed n Cc Q sed Q Q Cc seb Q 2 Q Q Precision Balance olumetric flask 0 mL For gradient accuracy test Eluent B Methanol water 90 10 v v 0 0025 V m caffeine HPLC quality Mixing chamber UV detector low cell OQ procedure CHAPTER 2 OQ procedure 9 of 19 In this chapter a set of functional and performance tests are described which should be executed to check if the pump s is are operating in ac cordance with the manufacturer s specifications Preparation Were saline eluents or buffer solutions used with the pump O No L Yes If Yes flush the pump head s with water for 30 minutes Then flush the pump head s with eluent A for 30 minutes If No flush the pump head s with eluent A for 30 minutes Carried out L No J Yes Test 1 Initializat
13. ult table T ime min Measured Specification F Results Flow measurement F mL min mL min OAN 0 97 lt F lt 1 03 L Passed L Failed 0 97 lt F lt 1 03 L Passed L Failed 0 97 lt F lt 1 03 L Passed L Failed Variant B Gravimetric measurement Attach the restriction capillary to the high pressure outlet of the purge valve 2 Close the purge valve 3 Weigh the three 50 ml volumetric flasks on the precision scale to an accuracy of 0 01 g 4 Enter a solvent factor of 0 34 for the Eluent 5 Set flow to 1 mL min 6 Place the volumetric flask under the restriction capillary 7 Now start the stop watch and the pump simultaneously using the start stop button 8 After 10 minutes remove the volumetric flask from under the re striction capillary and re weigh it 9 Calculate the weight of the collected eluent by subtraction of the weight of the empty volumetric flasks 10 The calculated weight W should be 9 6 W lt 10 2g Enter the result in the result table Measured W Specification W Result Gravimetric 9 g measurement 9 6 lt WS10 2 L Passed L Failed Method used Varian A Variant B Result L Passed L Failed Verified by customer sesecerecereereerenenn Deviations Y N Comments Chapter 2 OQ procedure Test 6 Gradient accuracy 13 of 19 This test is used to check the accuracy of gradient formati
14. ure ratios Plot the baseline at 0 B and measure signal level Hx of each individual plateau The ac tual mixture ratios Cx received are calculated using the following formula H mAu OE E aka 100 x stands for the programmed step height corresponds to the gra dients H100 is the height of the 100 step in mAU Calculate the actual mixture ratio for each of the three steps Enter the results in the results table on the next page Max deviation of each step 2 in relation to 100 step Run 1 is discarded because its in tended to stabilize the gradient system FESMNDG Method A B met Data A B Repz dat PT TES Ij Bile Ede yew Method Dats Sequence Analysis Control Reports Window teip 12 xj OSM Sirse0 SOO MRR keg eF a MK ampitude 44250 GAD or 33000 ae ae mannes BTA R BANANA AR TN BRANMNK NANA mwn hA AM For Help press Fi mMin Example Chromatogram of gradient run as defined in step 7 Print out the resulting chromatograms and label them with attach ment High pressure gradient_ specify repeated measurement Chapter 2 OQ procedure 15 of 19 Level Height mm C Specification Results Run2 Run3 Run2 Run Run 2 Run 3 PIF 10 8 lt C lt 12 OPUF OPO PLIF PIF 50 48 lt C lt 52 OPO OPO PIF 90 88 lt C lt 92 OPUF OPO 100 100 Reference Result C Passed C Failed When all steps of the OQ ar
15. ves safety glasses and other relevant protective clothing when working on the device Table of contents 3 of 19 Identification The undersigned engineer certifies that he she is trained and qualified to perform an OQ on the LC 110 110S pump Performer Company Title Antec Leyden representative trained and qualified to perform PQ procedures The undersigned reviewer customer accepts that the above mentioned engineer is trained and qualified to perform an OQ on the LC 110 110S pump Reviewer Customer Company Title Owner designated authorized person 4 of 19 OQ procedure LC 110 110S edition 1 Instruments O LC110 p n s n O LC110S p n s n O Isocratic O HPG Firmware version eeeesesesesesesesesesesesesesaesesesaiaiaitststsesss Clarity version eeesesesa i iw Manufacturer Antec Supplier Date of delivery Warranty until In case of a binary HPG system this OQ also has to be performed on the second pump Table of contents 5 of 19 Table of contents Symbols 1 Safety practices 2 Electrical hazards 2 Solvents 2 Identification 3 Instruments 4 Table of contents 5 Introduction 6 Determination of the inspection interval 7 Required materials to perform an OQ 8 OQ procedure 9 Preparation 9 Test 1 Initialization of flush pump 9 Test 2 Purge function 10 Test 3 Minimum pressure limit and pressure display 10 Test 4 Maximum pressure limit a
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