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Template-Company 

IQ / OQ  

Template-SN 

Page 3 of 29  

Flexar Analytical / FX-10 UHPLC Pumps

 

IQ/OQ Rev. D June 2009

 

Introduction 

Objective 

 

The objective of this document is to detail the environmental and facilities requirements necessary for proper 
installation and operation of the Flexar Analytical /  / FX-10 UHPLC Pump. The completed process demonstrates 
that the equipment meets the vendor-developed standards of operation and safety, and performs the functions 
specified by the manufacturer. 

Scope and Responsibility 

PerkinElmer is responsible for providing trained personnel, the IQ/OQ elements outlined in this plan and verifying 
that these elements are fully executed and documented. 
Template-Company is responsible for accepting the terms of this plan and providing the facility with all 
environmental requirements for the proper installation of the Flexar Analytical /  / FX-10 UHPLC Pump. 
Template-Company is responsible for providing personnel and assistance to PerkinElmer for implementing the 
IQ/OQ outlined in this document. 

Warranty Period and Service 

Full details of PerkinElmer’s instrument warranty have previously been provided with quotations, order 
acknowledgements and invoices.  PerkinElmer’s instrument warranty covers all parts and labor, but excludes 
consumable materials.  Exceptions may apply to instruments purchased 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 time, failure to 
perform the recommended preventive maintenance may reduce the reliability of some systems. 

Need to Re-Qualify 

The instrument may need to qualified again following modifications made to the original configuration or if the 
instrument is serviced or moved. 

Notices 
Except as specifically set forth in its terms and conditions of sale, PerkinElmer makes no warranty of any 
kind with regard to this document, including, but not limited to, the implied warranties of merchantability 
and fitness for a particular purpose. 

PerkinElmer shall not be liable for incidental or consequential damages in connection with the furnishing or use 
of this document. 

Copyright Information 

 

This document contains proprietary information that is protected by copyright. 
All rights are reserved.  No part of this publication may be reproduced in any form whatsoever or translated into 
any language without the prior, written permission of PerkinElmer, Inc. 

Copyright © 2009

 

PerkinElmer, Inc

Trademarks 

Registered names, trademarks, etc. used in this document, even when not specifically marked as such, are 
protected by law.  PerkinElmer is a registered trademark of PerkinElmer, Inc. 

All other trademarks and registered trademarks not owned by PerkinElmer, Inc. or its subsidiaries that are 
depicted herein are the property of their respective owners.

 

Содержание FX-10 UHPLC

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 26: ...____________________ ________________________________________________________________________________ ________________________________________________________________________________ _________________...

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

Страница 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...

Страница 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...

Страница 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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