Operational Qualification/ Performance …

1 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).

2 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 .. 29 Connecting and Configuring the System .. 29 System 29 Configuration .. 31 Preparations.

3 34 Preparing the hplc System .. 34 Checking the Fluidics ..34 Preparing Chromeleon .. 35 Template Structure ..35 Creating the Sequence 36 Adapting the Report and Method .. 39 Device Names .. 40 Performing the 43 Check Time .. 44 Evaluating the Repeating Checks .. 44 4 Special Test Procedures for Individual Introduction .. 45 Dionex VWD-3x00 Detectors: Noise and Drift with Dummy Flow Cells .. 45 Version: dated Oktober 2008 Contents: I of IV OQ and PQ Operating Instructions Dionex Autosamplers: Sample Temperature 45 Test Procedure.

4 45 Connecting and Configuring the 46 Performing the 47 Duration .. 47 5 Baseline Noise, Drift, and Lamp Intensity of the UV 49 Theory .. 49 Performing and Evaluating the 49 Wavelength Accuracy of the UV 50 Performing the 50 Evaluating the Check for the UV Detector .. 50 Evaluating the Check for the Photodiode Array Detector .. 50 Evaluating the Check for Two-Channel Detectors and the UVD 51 Evaluating the Check for Single Wavelength and VWD-3400RS Detectors .. 51 Linearity of the UV 51 Theory.

5 51 Performing and Evaluating the 52 Precision of the Injection Volume .. 52 Theory .. 52 Performing the 52 Carry-over by the Autosampler .. 54 Theory .. 54 Performing the 54 Linearity of the Injection 54 Theory .. 54 Performing the 55 Sample Temperature Accuracy of 56 Theory .. 56 Performing the 56 Flow Precision .. 56 Theory .. 56 Performing the 56 Solvent Composition of the Gradient Pump: Accuracy, Precision, and Ripple .. 57 Theory .. 57 Performing the 57 Performing the Checks for the Dionex P680 and UltiMate 3000 Pumps.

6 58 Evaluating the Check .. 58 Temperature Accuracy of the Column Compartment .. 59 Theory .. 59 Performing the 59 Baseline Noise and Signal Height of the Fluorescence Detector .. 59 Theory .. 59 Performing the 60 Contents: II of IV Version: dated Oktober 2008 OQ and PQ Operating Instructions Wavelength Accuracy of the Fluorescence Detector .. 60 Performing the 60 Remarks on the Manufacturer Specification .. 60 Baseline Noise and Drift of the RI Detector .. 61 Theory .. 61 Performing and Evaluating the 61 Linearity of the RI Detector.

7 61 Theory .. 61 Performing and Evaluating the 61 Baseline Noise of the ELS Detector .. 62 Theory .. 62 Performing and Evaluating the 62 6 General Notes .. 63 Failure of Individual Checks ..63 UV Detector .. 63 Autosampler .. 64 Pump .. 64 RF2000 Fluorescence Detector .. 64 RI Detector .. 65 ELS Detector .. 65 7 PGM Wavelength Accuracy of the Photodiode Detector .. 67 Baseline Noise, Drift, and Lamp Intensity of the UV 70 Linearity of the UV 72 Precision of the Injection Volume.

8 74 Carry-over by the Autosampler and Linearity of the Injection Volume .. 76 Sample Temperature Accuracy .. 78 Solvent Composition of a Gradient Pump: Accuracy, Precision, and Ripple) .. 80 Temperature Accuracy of a Column 82 Baseline Noise and Signal Height of the Fluorescence Detector .. 84 Wavelength Accuracy of the Fluorescence Detector .. 86 Baseline Noise and Drift of the RI Detector .. 88 Linearity of the RI Detector .. 90 Baseline Noise of the ELS Detector .. 92 8 Example Version: dated Oktober 2008 Contents: III of IV OQ and PQ Operating Instructions Contents: IV of IV Version: dated Oktober 2008 OQ and PQ Operating Instructions 1 How to Use this Manual The layout of this manual is designed to provide quick reference to the sections of interest to the user.

9 However, we recommend that you review the manual thoroughly before starting Operational or Performance qualification in order to obtain full understanding of the procedure. This manual is provided "as is." Every effort has been made to supply complete and accurate information and all technical specifications and programs have been developed with the utmost care. However, Dionex assumes no responsibility and cannot be held liable for any errors, omissions, damage, or loss that might result from any use of this manual or the information contained therein.

10 We appreciate your help in eliminating any errors that may appear in this document. At various points throughout the manual message of particular importance are indicated by the following symbols whose relevance is as follows: Tip: Indicates general information to help obtain optimum Performance of the instrument. The information contained in this document is subject to change without notice. CHROMELEON , Summit hplc , and UltiMate 3000 are registered trademarks of Dionex Corp. Any other mentioned trade or company names are subject to the copyright and the property and trademark rights of the respective companies.