PerkinElmer FX-10 UHPLC, Руководство пользователя

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Template-Company IQ / OQ
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Flexar Analytical / FX-10 UHPLC Pumps IQ/OQ Rev. D June 2009
Table of Contents
Introduction ................................................................................................................................... 3
Objective........................................................................................................................................ 3
Protocol Documentation............................................................................................................... 4
Error Code Abbreviation, Definition, and Making Correction .................................................... 6
Approval Page............................................................................................................................... 7
Preliminary Protocol Approval ..................................................................................................... 7
Final Report Approval ................................................................................................................. 7
Part I – Installation Qualification.................................................................................................. 9
1.1 System Summary .............................................................................................................. 10
1.1.1 Instrument Identification......................................................................................................... 10
1.1.2 Specifications ........................................................................................................................ 10
1.1.3 Location Requirements.......................................................................................................... 10
1.1.4 Maintenance and Troubleshooting ......................................................................................... 10
1.1.5 Hazards and Safety Precautions............................................................................................ 10
1.2 Documentation .................................................................................................................. 11
1.2.1 Equipment Manual................................................................................................................. 11
1.2.2 Purchase Order Certification.................................................................................................. 11
1.2.3 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
2.2 Operational Qualification Instruction .................................................................................. 14
2.3 Operational Qualification Test Description......................................................................... 15
2.4 Parameter Testing ............................................................................................................. 17
2.4.1 Pressure Pulsations Test ....................................................................................................... 17
2.4.2 Analytical Pump (100
µ
L Piston) Flow Check @ 1mL/min...................................................... 18
2.4.3 Analytical Pump (100
µ
L Piston) Flow Check @ 3mL/min....................................................…...19
2.4.4 FX-10 UHPLC Pump (30
µ
L Piston) Flow Check @ 0.3mL/min…...............…………………….20
2.4.5 FX-10 UHPLC Pump (30
µ
L Piston) Flow Check@ 0.9mL/min.……………...………………….. 21
2.4.6 Analytical Pump Composition Accuracy Test……………………………………………………….. 23
2.5 Operational Qualification Verification…………………………………………………………… 24
Part III – Appendices................................................................................................................... 25
Appendix A– Deviations ............................................................................................................ 26
Appendix B– Change Control.................................................................................................... 27
Appendix C– Attachments List .................................................................................................. 28
Appendix D- Document History ................................................................................................. 29