PerkinElmer FX-10 UHPLC User manual

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Flexar Analytical / FX-10 UHPLC Pumps IQ/OQ Rev. D June 2009
Liquid Chromatograph
Flexar Analytical / FX-10 UHPLC Pumps
Installation Qualification (IQ) and Operational Qualification (OQ)
Company Name: Template-Company
Address: Template-Address
Location, Room:
Serial Number or System Name: Template-SN
Protocol 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
Part Number Release Publication Date
09234069 D June 2009
Any comments about the documentation for this product should be addressed to:
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

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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 µL Piston) Flow Check @ 1mL/min...................................................... 18
2.4.3 Analytical Pump (100 µL Piston) Flow Check @ 3mL/min....................................................…...19
2.4.4 FX-10 UHPLC Pump (30 µL Piston) Flow Check @ 0.3mL/min…...............…………………….20
2.4.5 FX-10 UHPLC Pump (30 µL 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

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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.

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Flexar Analytical / FX-10 UHPLC Pumps IQ/OQ Rev. D June 2009
Protocol Documentation
Documentation protocol may be superseded by customer SOP
Writing Instruments
All writing will be done with a black or blue ink pen.
Signatures
A signature of each party involved with the ownership, management, testing, and quality assurance of each
instrument will be required before testing will proceed and for final approval at completion.
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.
Up to three signature entries are provided each for Customer and PerkinElmer on the Preliminary Report
Approval Page and Final Approval Page. If any signature lines are unused, draw a single diagonal line filling the
Signature area and then write initials and date next to the line.
All signatures will be the signer’s full legal name as legibly as can be written and dated.
Initials
At any point when initials are to be used, they will contain at least two of the initials and include a date.
Date
Dates will be given in the format of DD-MMM-YYYY. If a month or date is only one digit, a zero will be employed
to maintain the 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 from the list found in the protocol.
Spaces
For columns where the protocol is asking whether something has been verified, a “Yes” will be written. If not, a
“No” will be written and an explanation will be stated in the Comments section. A check mark or “N” is
unacceptable. “NA” may be used where the verification was not applicable.
Pass/Fail
For areas where the protocol requires a “Pass/Fail”, the words “Pass” or “Fail” will be written in. If the instrument
passes, Pass will be entered. If the instrument fails, Fail will be entered.
Visual Inspections
All visual inspections will be filled out with a word that indicates the physical condition being observed. If no
damage is observed, use the word “None” if no damage is present. If damage is observed, write a description of
the damage observed. This will apply to any visual inspections.
Calibration/Expiration dates
MM/YY format will be used to denote calibration and reagent expiration dates. The instrument or reagent is valid
until the last day of the month noted.
Temperature
All temperatures will be given in the unit of Celsius (°C)
Blank Areas
If there are no comments for a “Comments” section, “None” is written and the rest of the lines are left blank.
If a section is not applicable, such as an alarm function, “NA” is sufficient.

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Once an entry has been made (other than “None”) any remaining space in the Comments (either single or
multiple blank lines) requires a single diagonal line filling the area, along with initials and date next to the line.
EXCEPTION: DO NOT cross out blank lines on the “Error Code Abbreviation, Definition and Making Corrections”
page. These pages or sections are either copied for future documentation needs or provide space to maintain
records into the future.
Acceptance Criteria
All tests must include values for acceptance criteria and the results of that test must be included.
Precision and Accuracy Measurements
The following areas of precision and accuracy will be noted on a per-test basis.
All instrument precision values (when available) will be noted within the OQ document. All data entered into the
OQ document will reflect these values.
For example: If a precision value of four significant digits is supplied for a test by the manufacturer, then all four
digits will be entered with the last digit being rounded down if the fifth digit is below 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 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. If the second result fails, the instrument owner will be contacted to discuss a
reasonable course of action. If however, the second test passes, a note will be made as to the reason for the
primary failure and the second test data will be used.
Test -> Fail -> Repeat -> PASS -> Report 2nd result
Deviation
Deviations are events that are a departure from the specific protocol procedures as they were approved.
Deviations to the plan are permitted if those deviations are clearly detailed, approved by all parties and entered in
Appendix - Deviations
Change Control
Change control procedures are in place to maintain the validation process after modifications are made to the
original configuration. Any changes to the hardware, firmware or software of a validated system must be clearly
specified and the validation confirmed and recorded.
1. A blank Change Control form is located in Appendix C. Consider making photocopies when blank.
2. If used, insert a completed Change Control Form and its associated data as an Attachment.

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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). Once an error is found, (1)
simply strike the erroneous word or entry with a black pen, (2) enter the correct word or entry above the
erroneous word or entry, (3) enter the code (for example; IE for incorrect entry), and (4) then initial and date.
Space is also provided to create new codes or to enter the codes used and recommended by your compliance
department.
CE Calculation Error NA Not Applicable
IE Incorrect Entry SE Spelling Error
IM Instrument Malfunction TE Transcription Error
IO Inadvertently Omitted TYP Typographical Error
IR Instrument Recalibrated WD Wrong Date Entered
LE Late Entry (of initials or date) WO Writeover
Additional Codes
Code Definition Initials Date

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Flexar Analytical / FX-10 UHPLC Pumps IQ/OQ Rev. D June 2009
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 Template-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 certify that the Installation Qualification and Operational Qualifications procedures for the
Flexar Analytical / / FX-10 UHPLC Pump Serial number Template-SN have been performed and the
configuration installed meets [ ] does not meet [ ] the procedures and specifications described in
this document.
Template-Company
Signature Name Title Date
PerkinElmer LAS
Signature Name Title Date

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Flexar Analytical / FX-10 UHPLC Pumps IQ/OQ Rev. D June 2009
Part I – Installation Qualification

Comments:
PerkinElmer LAS Representative: Date:
Reviewed By: Date:
Flexar Analytical / FX-10 UHPLC Pumps IQ/OQ Rev. D June 2009
1.1 System Summary
1.1.1 Instrument Identification
Manufacturer PerkinElmer
Model Flexar Analytical / FX-10 UHPLC Pump
Equipment Serial # Template-SN
Firmware Version
Instrument Control Software Version
Model options, circle as applicable Isocratic / Binary / Quaternary / FX-10
1.1.2 Specifications
Refer to respective documents for specifications like Voltage requirements, Line Frequency, Power
Consumption, Temperature, Relative Humidity, etc.
Refer to respective documents for minimum PC requirements.
1.1.3 Location Requirements
Refer 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, power
supply, gas supply, etc., and any other needs for the safe and consistent operation of the instrument.
1.1.4 Maintenance and Troubleshooting
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.
1.1.5 Hazards and Safety Precautions
Refer to respective documents for the safety summary outlines and explanation.

Comments:
PerkinElmer LAS Representative: Date:
Reviewed By: Date:
Flexar Analytical / FX-10 UHPLC Pumps IQ/OQ Rev. D June 2009
1.2 Documentation
1.2.1 Equipment Manual
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. Training is
documented, and a certificate is issued by PerkinElmer LAS to that effect.
See Attachment #1 for PerkinElmer LAS Training 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 section in the
user’s manual
1.3.2
The correct basic equipment has been provided in accordance with the purchase
order
1.3.3
The packaging is undamaged
1.3.4
The instrument, PC and other supplied equipment are undamaged
1.3.5
Users Guide is identified
1.3.6
Manufacturer’s specifications included in manual
1.3.7
The power requirement settings of the instrument, PC etc., are compatible with those
of the working environment. Note: It is the responsibility of Template-Company to
ensure proper voltage / current / frequency of the electrical line supplied for
operating the Flexar Analytical / FX-10 UHPLC Pump.
1.3.8
Adequate room for ventilation and servicing the equipment

Comments:
PerkinElmer LAS Representative: Date:
Reviewed By: Date:
Flexar Analytical / FX-10 UHPLC Pumps IQ/OQ Rev. D June 2009
1.3.9
PC’s requirements are met with reference to the appropriate section in the user’s
guide.
1.3.10
Instrument is identified, connected and set up in accordance with reference to the
appropriate instructions in the user’s guide.
1.3.11
Adequate electricity supply available and unit is grounded
1.3.12
Software installed on the PC with reference to the appropriate instructions in the
user’s guide.
1.3.13
Necessary components/accessories installed with reference to the appropriate
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
Data Acquisition Software installed
1.3.18
Operating System (name and version)
1.3.19
Other Software installed if applicable (name and version)
1.3.20
Start-up diagnostics run to completion (instrument initialized)
1.3.21
Warranty and available services explained
1.3.22
System Familiarization and Orientation Completed
1.3.23
List Attendees:
1.4 Installation Qualification Verification
The Flexar Analytical / FX-10 UHPLC Pump, Serial Number Template-SN, has been
properly set up and installed, and all appropriate forms and documents supporting the
system have been filled out and are available.
Verified:

Flexar Analytical / FX-10 UHPLC Pumps IQ/OQ Rev. D June 2009
Part II – Operational Qualification

Comments:
PerkinElmer LAS Representative: Date:
Reviewed By: Date:
Flexar Analytical / FX-10 UHPLC Pump IQ/OQ Rev. D June 2009
2.1 Operating Procedure References
2.1.1 Standard Operating Procedures pertaining to the Flexar Analytical / FX-10
UHPLC Pump
It is responsibility of the customer to follow a SOP for use of the equipment to ensure consistent operations.
The customer SOP may be written after the Qualification and can be added as an attachment after
PerkinElmer completes this IQ/OQ.
2.2 Operational Qualification Instruction
The following instructions apply to the Operational Qualification Test Description
2.2.1 Record Model (or Part Number) and Serial Number of any accessories or components not 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 used,
including those supplied by the customer.
2.2.4 Label all solutions prepared at customer site in accordance with the customer requirements (date,
content, expires by, etc)
2.2.5 Provide the Standard certificates as Attachments.
The following instructions apply to the Parameter Testing
2.2.6 Conduct Parameter Testing and record test data, Pass/Fail and Comments.
2.2.7 Verify the completed OQ in Section 2.5
2.2.8 Sign, date and number attachments of all recordings or printouts made during the test procedure (ex.
settings, spectrograms).
2.2.9 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
2.3 Operational Qualification Test Description
Configurations Covered Flexar Analytical/ FX-10 UHPLC Pump
Model Serial Number
Accessories/Components not
covered
Estimated Certificate Testing Time
Pre-test Stabilization N/A
Testing Time 2.0 Hours
Materials Required
Documentation Part 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
Number
Calibration
Due Date
Restrictor Coil PerkinElmer 02540843 N/A N/A
1000 PSI Back Pressure Regulator PerkinElmer N2910381 N/A N/A
Calibrated Scale or Balance
Calibrated Timing Device
Customer Supplied Manufacturer Part Number Batch/Lot Expiration
H2O
N/A N/A
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
Pressure Pulsations
Pulsations (PSI) at 1 ml/min solvent flow and 1000 PSI backpressure
(approx)
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%
Acetone/Water and Water alone.
PerkinElmer assumes no responsibility for test results.
2.4 Parameter Testing:
2.4.1 Pressure Pulsations Test
Test Conditions

Comments:
PerkinElmer LAS Representative: Date:
Reviewed By: Date:
Flexar Analytical / FX-10 UHPLC Pump IQ/OQ Rev. D June 2009
•The Pressure Pulsations Test is to verify that the output flow fluctuations are within
specification. The specification for this test to pass is 2 % peak-to-peak of the running
pressure at which the test is run.
Test Prerequisites
•Start the pump and let the pressure stabilize
Test Steps
•Connect the pump output to a restrictor coil or 1000 psi backpressure device. Set the
pump flow rate to 1 mL/min. Running pressure for this test must be more than 500 psi.
Adjust tubing length as required 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 between maximum and minimum (Delta).
2. The value of the mid-point pressure (MP).
3. The 2% value of the midpoint pressure. This mid-point value is the pressure used
to compute what the 2 % peak-to-peak error band should be.
Example:
Max 1020 psi, Min 1003 psi, Mid Point (MP Pressure) = 1011 psi.
2 % MP = MP * 0.02 = 20.22 psi
Observed Delta = 17 psi
Spec = Observed Delta <= 2 % MP
2.4.1 Test Results
2.4.2 Analytical Pump (100 µ
µµ
µL Piston) Flow Check @ 1 mL/min
Test Conditions
•Chromatographic Conditions: 100 % H2O
1 mL/min
Test Prerequisites
Parameter Specification Min Psi Max Psi
Delta
MP Pass/Fail Comments
Pressure Fluctuation < 2% of MP PSI

Comments:
PerkinElmer LAS Representative: Date:
Reviewed By: Date:
Flexar Analytical / FX-10 UHPLC Pump IQ/OQ Rev. D June 2009
•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.
Test Steps
•Connect the backpressure regulator to the output of the pump. This device will create the
necessary back pressure on the pump check valves.
•Purge the pump and fill the solvent line to be used for the test with water.
•Zero the scale. Weigh the collection vessel on a calibrated scale or balance.
•Take the collection vessel and go to the pump and set the pump flow for 1 mL/minute.
•Start the pump. (Direct the initial flow of water off to waste until the pressure stabilizes.
•When pressure stabilizes, direct the flow of water into the collection vessel and
simultaneously start a stopwatch 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 the water. Subtract the weight of the collection vessel.
•The remaining weight of the water should be 5 grams ±0.05 g (40.95 to 5.05 g)
1 mL/min * 5 min = 5 g (water weighs 1 gram per mL)
•Divide the weight of the water by 5 to get the volume delivered in a 1 minute interval.
•Record this number in the Test Result field of Flow Accuracy @ 1 mL/min portion of the
IQOQ Test Certificate. Enter N/A if testing FX-10 UHPLC Pump.
2.4.2 Test Results
Parameter Specification Test Result Pass/Fail Comments
Analytical Pump (100 µL
Piston) Accuracy: 1
mL/min
±1% of 1mL/min
(00.99ml/min to
1.01ml/min)
2.4.3 Analytical Pump (100 µ
µµ
µL Piston) Flow Check @ 3 mL/min
Test Conditions
•Chromatographic Conditions: 100 % H2O
3 mL/min
Test Prerequisites
•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
Test Steps
•Connect the backpressure regulator to the output of the pump. This device will create the
necessary back pressure on the pump check valves.
•Purge the pump and fill the line to be used for the test with water.
•Zero the scale. Weigh the collection vessel on a calibrated scale or balance.
•Take the collection vessel and go to the pump and set the pump flow for 3 mL/minute.
•Start the pump. (Direct the initial flow of water off to waste until the pressure stabilizes.
•When pressure stabilizes, direct the flow of water into the collection vessel and
simultaneously start a stopwatch 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 the water. Subtract the weight of the collection vessel.
•The remaining weight of the water should be 15 grams ±0.15 g (14.85 to 15.15 g)
3 mL/min * 5 min = 15 g (water weighs 1 gram per mL)
•Divide the weight of the water by 5 to get the volume delivered in a 1 minute interval.
•Record this number in the Test Result field of Flow Accuracy @ 3 mL/min portion of the
IQOQ Test Certificate. Enter N/A if testing FX-10 UHPLC Pump.
2.4.3 Test Results
Parameter Specification Test Result Pass/Fail Comments
Analytical Pump (100
µ
µµ
µL Piston) Accuracy: 3
mL/min
±1% of 3mL/min
(2.97ml/min to
3.03ml/min)
2.4.4 FX-10 UHPLC Pump (30 µ
µµ
µL Piston) Flow Check
@ 0.3 mL/min
Test Conditions
•Chromatographic Conditions: 100 % H2O
0.3 mL/min
Test Prerequisites
•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
Test Steps
•Connect the backpressure regulator to the output of the pump. This device will create the
necessary back pressure on the pump check valves.
•Purge the pump and fill the line to be used for the test with water.
•Zero the scale. Weigh the collection vessel on a calibrated scale or balance.
•Take the collection vessel and go to the pump and set the pump flow for 0.3 mL/minute.
•Start the pump. (Direct the initial flow of water off to waste until the pressure stabilizes.
•When pressure stabilizes, direct the flow of water into the collection vessel and
simultaneously start a stopwatch or other timing device.
•Let the pump run for 10 minutes.
•When 10 minutes has elapsed, remove the tube 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 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)
•Divide the weight of the water by 10 to get the volume delivered in a 1 minute interval.
•Record this number in the Test Result field of Flow Accuracy @ 0.3 mL/min portion of the
IQOQ Test Certificate. Enter N/A if testing Analytical Pump.
2.4.4 Test Results
Parameter Specification Test Result Pass/Fail Comments
FX-10 Pump (30 µL
Piston) Accuracy: 0.3
mL/min
±1% of 0.3mL/min
(0.297ml/min to
0.303ml/min)
2.4.5 FX-10 UHPLC Pump (30 µ
µµ
µL Piston) Flow Check
@ 0.9 mL/min
Test Conditions
•Chromatographic Conditions: 100 % H2O
0.9 mL/min
Test Prerequisites
•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.
•Test Steps
•Connect the backpressure regulator to the output of the pump. This device will create the
necessary back pressure on the pump check valves.