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Operational Qualification/ Performance Qualification for ...

Operational Qualification / Performance Qualification for HPLC Instruments Operating Instructions Version: Date: Oktober 2008 2008 DIONEX Doc.: OQ and PQ Operating Instructions OQ and PQ Operating Instructions Table of Contents 1 How to Use this Manual ..1 2 Defining the Limits ..3 Operational Qualification (OQ) ..3 Performance Qualification (PQ) ..3 System Suitability Check (SSC; also: System Suitability Test, SST)..3 Basic Requirements for Successful OQ and PQ ..4 Overview of the UV Detectors Using Analytical Flow UV Detectors Using Non-Analytical Flow 11 Autosamplers .. 13 Pumps .. 18 Thermostatted Column Compartments and Column Ovens .. 22 Fluorescence Detectors .. 24 Refractive Index Detectors .. 25 Evaporative Light Scattering 25 3 General Test 27 Test Procedure for Single Wavelength and VWD-3400RS Detectors.

Usually, Operational Qualification is only performed directly after a new device has been installed. 2.1.2 Performance Qualification (PQ) The purpose of Performance Qualification is to prove and document that an analytical system functions according to a specification that is suitable for the system's routine operation. As a system is

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