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:
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Address:
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Location, Room:
Serial Number or System Name:
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Protocol Number:
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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

PerkinElmer FX-10 UHPLC Specifications

General

Brand	PerkinElmer
Model	FX-10 UHPLC
Category	Measuring Instruments
Language	English

Summary

Protocol Documentation

Validation Process Management

Error Code Abbreviation, Definition, and Making Correction

Error Code List and Correction

Approval Page

Preliminary Protocol Approval

Final Approval

Part I - Installation Qualification

System Summary

Installation Qualification Checklist

Checklist for verifying installation components, setup, software, and system familiarity.

Installation Qualification Verification

Confirms successful installation and availability of supporting documents.

Part II - Operational Qualification

Operating Procedure References

Operational Qualification Instructions

Operational Qualification Test Description

Parameter Testing

Details specific tests to verify instrument performance parameters.

Pressure Pulsations Test

Verifies output flow fluctuations by measuring pressure variations.

Flow Accuracy (1 mL/min)

Tests flow accuracy for analytical pumps at 1 mL/min using gravimetric method.

Flow Accuracy (3 mL/min)

Tests flow accuracy for analytical pumps at 3 mL/min using gravimetric method.

FX-10 Flow Accuracy (0.3 mL/min)

Tests flow accuracy for FX-10 pumps at 0.3 mL/min using gravimetric method.

FX-10 Flow Accuracy (0.9 mL/min)

Tests flow accuracy for FX-10 pumps at 0.9 mL/min using gravimetric method.

Composition Accuracy Test

Tests proportioning valve accuracy by measuring absorbance of solvent mixtures.

Operational Qualification Verification