Validation, AutoQ, and System Wellness
Performance Qualification (PQ) for IC Systems

Validation is becoming increasingly important to analytical laboratories. Documented evidence must be provided to demonstrate the integrity of data collected and validate the results obtained on laboratory instrumentation.

The Qualification menu in the Chromeleon Browser includes options for Instruments PQ and PQ Setup. Instruments PQ is used to perform the performance qualification. PQ Setup is used to generate the templates required for performing the performance qualification. (This is generally necessary only after a new installation or after changes to the configuration.) The Chromeleon CD provides a datasource with a master template in the PQ\Templates\PQ directory.

PQ should be performed at regular intervals after the initial installation and Operational Qualification (OQ). Dionex recommends performing PQ every six months. A qualified Dionex Service Representative should perform all tests, in accordance with the instructions in the IC System Operational and Performance Qualification User’s Guide. The user’s guide is included in the IC OQ/PQ Kit with Test Cells (P/N 057599) and the IC OQ/PQ Basic/Refill Kit (P/N 057608).

The PQ procedure used to qualify Dionex Ion Chromatography Systems meets the requirements established by the National Institute of Standards and Technology (NIST) and the American Society for Testing and Materials (ASTM). This PQ procedure provides qualification testing for ICS-5000, ICS-4000, ICS-3000, ICS-2500, ICS-2100, ICS-2000, ICS-1600, ICS-1500, ICS-1100, ICS-1000, DX-600, DX-500, DX-320, DX-120, and BioLC systems.