Reliability and consistency of analytical results requires a proper instrument qualification at the time of installation as well as periodic performance checks. This article, from issue 16 of the Analytix Reporter and coauthored with the Metrohm AG, outlines the tests that should be part of the instrument qualification process for ion chromatography instruments.
Ion (-exchange) chromatography (IC) is a well-established analytical technology that separates ions and polar molecules based on their respective charged groups. IC can handle a wide range of varying analyte concentrations, from parts per trillion to the percent range. IC is commonly used in the pharma, food, and environmental sectors to analyze samples for specific components and to verify compliance with norms and standards.
Today's Ion Chromatographs are sophisticated analytical instruments. To guarantee reliable, reproducible, and traceable results from day one, professional installation and system qualification are key to their success. To keep the instrument in its peak performance over time, regular maintenance and periodic requalification are strongly advised.
Steps of instrument qualifications (quick introduction)
Especially in the pharmaceutical industry, instrument qualification and documentation of the findings is a must to fulfill the requirements of the various regulatory bodies. USP <1058> for instance defines the Analytical Instrument Qualification (AIQ) as “the collection of documented evidence that an instrument performs suitably for its intended purpose”. To support customers in this task, the Metrohm Compliance Service has developed standardized test procedures and extensive documentation to comply with these regulatory demands.
Analytical Instrument Qualification Steps (Overview):
- User Requirement Specification (URS) / Risk Assessment (RA)
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Instrument Discontinuation
Major instrument upgrades: Steps 1 to 5
On going requalification: Steps 4 to 5
To focus as much as possible on the performance evaluation of the system itself, it is essential to exclude or at least minimize as much as possible, sources of error that are not directly linked to the tested components.
One source of error that can easily be controlled, are the standard solutions used in the holistic system tests. Relying on prepared CRM solutions is the safest way to exclude critical sources of error related to standards preparation from raw materials or stock solutions. Such sources of error could be originating from pipetting, weighing, and dilution steps, in addition to other risk factors like possible contamination of glassware and/or tools, and operator performance.
Read the full article to explore:
- The main components of an ion chromatography system
- Specific tests involving standard solutions
- IQ/OQ/PQ kit for ion chromatography
- A variety of charts and figures on tests and procedures
