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Flexar Analytical / FX-10 UHPLC Pump

IQ/OQ Rev. D June 2009

Appendix D- Document History

Revision

Description of Change

Page(s)

Date

First release

May 2009

Corrected math in instructions and typo in
results

May 2009

Corrected footers.

All

June 2009

Corrected footers

All

June 2009

Summary of Contents for FX-10 UHPLC

Page 1: ...col Number Template Protocol Issue Date 27 May 2009 Date Tested Valid if tested within 1 year of Issue Date Recertification Period Recommended at 12 Months Recertification Due Date Release History Par...

Page 2: ...2 3 PerkinElmer Service Engineer Training 11 1 3 Installation Qualification 11 1 4 Installation Qualification Verification 12 Part II Operational Qualification 13 2 1 Operating Procedure References 14...

Page 3: ...d used Contact your PerkinElmer service provider for a service plan which may be purchased to extend coverage beyond warranty PerkinElmer recommends contracting regular preventive maintenance Over tim...

Page 4: ...he two digit format for each entry Error Codes When an error is corrected a single horizontal line through the error will be used The line will then be initialed and dated along with an error code fro...

Page 5: ...rounded up if above 5 and rounded up if fifth digit is 5 Failure Mode Responses If a test result is determined to be outside of the precision parameters set forth by manufacturer of instrument it will...

Page 6: ...rroneous entries may exist within the document that can be corrected by client s Once an error is found 1 simply strike the erroneous word or entry with a black pen 2 enter the correct word or entry a...

Page 7: ...plate Company have agreed to proceed with the procedures described in this document Template Company Signature Name Title Date PerkinElmer LAS Signature Name Title Date Final Approval This is to certi...

Page 8: ...Template Company IQ OQ Template SN Page 8 of 29 Flexar Analytical FX 10 UHPLC Pumps IQ OQ Rev D June 2009 This page intentionally blank...

Page 9: ...Template Company IQ OQ Template SN Page 9 of 29 Flexar Analytical FX 10 UHPLC Pumps IQ OQ Rev D June 2009 Part I Installation Qualification...

Page 10: ...to respective documents for specific requirements for the location of the instrument Requirements are typically space actual size bench space and weight requirements especially if heavy environment po...

Page 11: ...raining Certificate 1 3 Installation Qualification Verify the following list and mark as appropriate Description Verified 1 3 1 The working environment is suitable with reference to the appropriate se...

Page 12: ...propriate instructions in the user s guide 1 3 14 Firmware verification 1 3 15 Software installed and appropriate panels displayed 1 3 16 Instrument control software installed if applicable 1 3 17 Dat...

Page 13: ...Flexar Analytical FX 10 UHPLC Pumps IQ OQ Rev D June 2009 Part II Operational Qualification...

Page 14: ...t covered in the OQ 2 2 2 Record the Serial Number and Calibration Date for each item of Test Equipment used 2 2 3 Record the Batch Lot Number and Expiration Date of each Standard Reagent and Solvent...

Page 15: ...Number Pump Users Manual Not needed for testing Reference only Pump Service Manual Not needed for testing Reference only IQ OQ Certification Sticker 09934512 Test Equipment Manufacturer Model Serial N...

Page 16: ...pumps solvent flow as measured at 1ml and 3ml per minute For the FX 10 UHPLC pumps solvent flow as measured at 0 3ml and 0 9ml per minute Compositional Accuracy For Binary Quaternary Analytical pumps...

Page 17: ...quired to obtain the required back pressure Monitor the displayed pressure readout for 1 minute Note the observed maximum and minimum pressures Using the numbers obtained determine 1 The difference be...

Page 18: ...opwatch or other timing device Let the pump run for 5 minutes When 5 minutes has elapsed remove the tube from above the collection vessel and insert it into the waste Weigh the collection vessel with...

Page 19: ...from above the collection vessel and insert it into the waste Weigh the collection vessel with the water Subtract the weight of the collection vessel The remaining weight of the water should be 15 gr...

Page 20: ...collection vessel with the water Subtract the weight of the collection vessel The remaining weight of the water should be 3 grams 0 03 g 2 97 to 3 03 g 0 3 mL min 10 min 3 g water weighs 1 gram per mL...

Page 21: ...ther timing device Let the pump run for 10minutes When 10minutes has elapsed remove the tube from above the collection vessel and insert it into the waste Weigh the collection vessel with the water Su...

Page 22: ...or other device length of tubing for example to create the necessary back pressure Fill reservoirs A and C if testing a quaternary model with HPLC grade water Pipette 1 0 mL of acetone into approxima...

Page 23: ...and Quaternary Reservoirs A and B STEP TIME FLOW A water B acetone CURV AU absorbance or mV 0 5 0 5 0 100 0 0 0 1 1 0 5 0 100 0 0 0 2 3 0 5 0 0 100 0 0 AU1 3 3 0 5 0 10 90 0 0 AU2 4 3 0 5 0 49 51 0 0...

Page 24: ...lute 5 mL min Channel A and B Solvent B 10 49 51 90 49 51 Delta Range Between 1 5 and 2 5 Channel C and D Solvent D 10 90 Comments 2 5 Operational Qualification Verification The Flexar Analytical FX 1...

Page 25: ...Flexar Analytical FX 10 UHPLC Pump IQ OQ Rev D June 2009 Part III Appendices...

Page 26: ...____________________ ________________________________________________________________________________ ________________________________________________________________________________ _________________...

Page 27: ...____________________ Reasoning and Justification for Change ________________________________________________________________________________________ ___________________________________________________...

Page 28: ...Sign and date Entries for up to 20 Attachments are available Additionally label each page of each Attachment as follows Attachment Number as per this table Page X of Y total Pages of the Attachment In...

Page 29: ...v D June 2009 Appendix D Document History Revision Description of Change Page s Date A First release May 2009 B Corrected math in instructions and typo in results 20 May 2009 C Corrected footers All J...

Page 30: ...Log Book Cut out the label below and insert into the spine of the Instrument System Log Book then destroy the remainder of this page as it is no longer required Instrument System Log Book Template Com...

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