System suitability test method development

System suitability test method development

In order to verify the critical design parameters the instrument must be confirmed that it is working appropriately.  For example, if the autosampler is not working correctly then the results for the rention time reproducibility and peak height/area accuracy could be wrong. Therefore, a System Suitability Test (SST) must be developed to verify each critical quality item.

Brief overview for an SST method is as follows:

1. Verify the autosampler makes injections appropriately -- Check a 1uL injection and a 2uL injection and verify that the peak height or area response is reasonable. In the very beginning this procedure should be done using a UV detector that has already been validated by a qualified method.
2. Verify the mass chromatogram peak area/height linearity.
3. Verify the absolute mass stability
4. Verify the absolute stability of the chromatography peak parameters--retention time, number of theoretical plate, tailing factor, etc.

Detailed procedures for developing SST methods will be discussed in the next section.