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Template-Company
Template-SN
Flexar Analytical / FX-10 UHPLC Pumps
Installation Qualification (IQ) and Operational Qualification (OQ)
Company Name:
Address:
Location, Room:
Serial Number or System Name:
Protocol Number:
Issue Date:
Date Tested:
Valid if tested within 1 year of Issue Date
Recertification Period
Recertification Due Date:
Release History
Part Number
09234069
Any comments about the documentation for this product should be addressed to:
User Assistance
PerkinElmer LAS (UK) Ltd
Chalfont Road
Seer Green
Beaconsfield
Bucks HP9 2FX
United Kingdom
Flexar Analytical / FX-10 UHPLC Pumps IQ/OQ Rev. D June 2009
Liquid Chromatograph
Template-Company
Template-Address
Template-SN
Template-Protocol
27 May 2009
Recommended at 12 Months
Release
Publication Date
D
June 2009
PerkinElmer Global Technical Support
M/S 215
710 Bridgeport Avenue
Shelton
Connecticut 06484-4794
U.S.A.
IQ / OQ
Page 1 of 29
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Summary of Contents for PerkinElmer FX-10 UHPLC
- Page 1 User Assistance PerkinElmer Global Technical Support PerkinElmer LAS (UK) Ltd M/S 215 Chalfont Road 710 Bridgeport Avenue Seer Green Shelton Beaconsfield Connecticut 06484-4794 Bucks HP9 2FX U.S.A. United Kingdom Flexar Analytical / FX-10 UHPLC Pumps IQ/OQ Rev. D June 2009...
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Page 2: Table Of Contents
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 Flexar Analytical / FX-10 UHPLC Pumps IQ/OQ Rev. D June 2009... -
Page 3: Introduction
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. -
Page 4: Protocol Documentation
On any page where a written entry is made, or data is gathered by a PerkinElmer representative, that page must be signed and dated by the PerkinElmer representative. - Page 5 If a test result is determined to be outside of the precision parameters set forth by manufacturer of instrument, it will be discussed with the customer first and if agreed both by customer and PerkinElmer then it will be repeated a second time to confirm the result.
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Page 6: Error Code Abbreviation, Definition, And Making Correction
The error code abbreviation and definition list below is provided for clients and reviewers to make necessary entries and corrections after the document has been approved. PerkinElmer technical staff and reviewers make all necessary efforts to ensure that this document and related attachments are free of errors and mistakes. However, some typographical, formatting, and inadvertently erroneous entries may exist within the document that can be corrected by client(s). -
Page 7: Approval Page
Preliminary Protocol Approval This is to certify that the Installation Qualification and Operational Qualifications procedures for the Flexar Analytical / / FX-10 UHPLC Pump Serial number Template-SN have been reviewed and both PerkinElmer LAS and have agreed to proceed with the procedures described in this Template-Company document. - Page 8 Template-Company IQ / OQ Template-SN Page 8 of 29 This page intentionally blank Flexar Analytical / FX-10 UHPLC Pumps IQ/OQ Rev. D June 2009...
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Page 9: Part I - Installation Qualification
Template-Company IQ / OQ Template-SN Page 9 of 29 Part I – Installation Qualification Flexar Analytical / FX-10 UHPLC Pumps IQ/OQ Rev. D June 2009... -
Page 10: System Summary
Routine maintenance can be performed by a trained analyst using the instructions found in the respective documents for maintenance and troubleshooting. PerkinElmer has trained service representatives, who perform other planned maintenance service annually or as required. Departmental Standard Operating Procedures (SOPs) shall also be consulted to implement and document the necessary repairs. -
Page 11: Documentation
Part No. Title Flexar Analytical / FX-10 UHPLC Pump User’s Guide 1.2.2 Purchase Order Certification The Flexar Analytical / FX-10 UHPLC Pump Template-SN is in compliance with the specifications of the purchase order. Purchase Order Number Template-PO 1.2.3 PerkinElmer Service Engineer Training Persons authorized by PerkinElmer LAS to perform validations have been properly trained. -
Page 12: Installation Qualification Verification
1.3.23 List Attendees: Installation Qualification Verification The Flexar Analytical / FX-10 UHPLC Pump, Serial Number Template-SN, has been Verified: properly set up and installed, and all appropriate forms and documents supporting the system have been filled out and are available. -
Page 13: Part Ii - Operational Qualification
Part II – Operational Qualification Flexar Analytical / FX-10 UHPLC Pumps IQ/OQ Rev. D June 2009... -
Page 14: Operating Procedure References
Fill in All Appendices, as required. 2.2.10 Complete and sign off the Final Approval 2.2.11 Complete and affix an IQ/OQ Certification Sticker to the instrument. Comments: PerkinElmer LAS Representative: Date: Reviewed By: Date: Flexar Analytical / FX-10 UHPLC Pump IQ/OQ Rev. D June 2009... -
Page 15: 2.3 Operational Qualification Test Description
Acetone All solutions prepared at customer site must be labeled in accordance with the customer requirements Tests Name of Test Description Comments: PerkinElmer LAS Representative: Date: Reviewed By: Date: Flexar Analytical / FX-10 UHPLC Pump IQ/OQ Rev. D June 2009... -
Page 16: Parameter Testing
Flow Accuracy For Analytical 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, accuracy as measured by relative UV absorbance (265 nm) at programmed proportions of 0.2%... -
Page 17: Pressure Pulsations Test
2.4.2 Analytical Pump (100 µ µ µ µ L Piston) Flow Check @ 1 mL/min Test Conditions Chromatographic Conditions: 100 % H 2 O • 1 mL/min Test Prerequisites Comments: PerkinElmer LAS Representative: Date: Reviewed By: Date: Flexar Analytical / FX-10 UHPLC Pump IQ/OQ Rev. D June 2009... -
Page 18: Analytical Pump (100 Μl Piston) Flow Check @ 1Ml/Min
It is important that the volume delivered is correct; the pressure during the delivery is not • critical. There is a minimum pressure requirement of 350 psi for the check valves to operate properly. Comments: PerkinElmer LAS Representative: Date: Reviewed By: Date: Flexar Analytical / FX-10 UHPLC Pump IQ/OQ Rev. D June 2009... -
Page 19: Analytical Pump (100 Μl Piston) Flow Check @ 3Ml/Min
± 1% of 3mL/min µ µ µ µ L Piston) Accuracy: 3 (2.97ml/min to mL/min 3.03ml/min) 2.4.4 FX-10 UHPLC Pump (30 µ µ µ µ L Piston) Flow Check @ 0.3 mL/min Test Conditions Chromatographic Conditions: 100 % H 2 O •... -
Page 20: Uhplc Pump (30 Μl Piston) Flow Check @ 0.3Ml/Min
FX-10 Pump (30 µL ± 1% of 0.3mL/min Piston) Accuracy: 0.3 (0.297ml/min to mL/min 0.303ml/min) 2.4.5 FX-10 UHPLC Pump (30 µ µ µ µ L Piston) Flow Check @ 0.9 mL/min Test Conditions Chromatographic Conditions: 100 % H 2 O •... -
Page 21: Uhplc Pump (30 Μl Piston) Flow Check@ 0.9Ml/Min
Comments FX-10 Pump (30 µ µ µ µ L ± 1% of 0.9 mL/min Piston) Accuracy: 0.9 (0.891ml/min to mL/min 0.909ml/min) Comments: PerkinElmer LAS Representative: Date: Reviewed By: Date: Flexar Analytical / FX-10 UHPLC Pump IQ/OQ Rev. D June 2009... -
Page 22: Analytical Pump Composition Accuracy Test
There is a minimum pressure requirement of 350 psi for the check valves to operate properly. To ensure the valves are operating and seating during the test PerkinElmer runs the test with the pressure approximately >500 psi. This is accomplished by using a length of 0.007” ID tubing or a backpressure device that will create the necessary back pressure on the check valves. - Page 23 Table 2 - Quaternary (Reservoirs C and D) STEP TIME FLOW CURV (water) (acetone) (absorbance or mV) AU7 = AU8 = AU9 = AU10 = Comments: PerkinElmer LAS Representative: Date: Reviewed By: Date: Flexar Analytical / FX-10 UHPLC Pump IQ/OQ Rev. D June 2009...
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Page 24: 2.5 Operational Qualification Verification
% Solvent D Comments: 2.5 Operational Qualification Verification The Flexar Analytical / FX-10 UHPLC Pump, Serial Number Template-SN, operates Verified: and performs according to the stated Operational Qualification, and all appropriate forms and documents supporting the system have been filled out and are available. -
Page 25: Part Iii - Appendices
Part III – Appendices Flexar Analytical / FX-10 UHPLC Pump IQ/OQ Rev. D June 2009... -
Page 26: Appendix A- Deviations
Template-Company representative. If there is no deviation, no signature or date entry is required by Template-Company representative (enter NA for signature and then date). If there are no deviations, the PerkinElmer representative should enter “None” below and then sign and date. ________________________________________________________________________________... -
Page 27: Appendix B- Change Control
Verification of New Component / Software ________________________________________________________________________________________ ________________________________________________________________________________________ Acceptance Criteria Used ________________________________________________________________________________________ ________________________________________________________________________________________ Results of Verification (Attach original data) ________________________________________________________________________________________ ________________________________________________________________________________________ Validation Results Validation Pass/Fail Signature Date Performed By: Approved By: Flexar Analytical / FX-10 UHPLC Pump IQ/OQ Rev. D June 2009... -
Page 28: Appendix C- Attachments List
Appendix C– Attachments List In the table below enter: each attachment; total pages for each attachment; company (OEM, Template-Company, or PerkinElmer). Sign and date. Entries for up to 20 Attachments are available. Additionally, label each page of each Attachment as follows:... -
Page 29: Appendix D- Document History
Appendix D- Document History Revision Description of Change Page(s) Date First release May 2009 Corrected math in instructions and typo in May 2009 results Corrected footers. June 2009 Corrected footers June 2009 Flexar Analytical / FX-10 UHPLC Pump IQ/OQ Rev. D June 2009... -
Page 30: Flexar Analytical / Fx-10 Uhplc Pumps Iq/Oq Rev. D June
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-Company Model Serial Number Protocol ID Flexar Analytical / FX-10 Template-SN Template- UHPLC Pump Protocol Flexar Analytical / FX-10 UHPLC Pump IQ/OQ Rev. D June 2009...