Device qualification (IQ, OQ, PQ) of electrophoresis devices.

IQ, OQ, PQ are abbreviations that are widely used in FDA, CE and quality departments. But what is the meaning of them?

  • Installation Qualification: Evaluates accommodating new equipment and testing its materials.
  • Operational Qualification: Essential in challenging the equipment parameters.
  • Performance Qualification: The equipment is either put to a final test or an annual retest.

Who is inquiring for qualification..?

There are business segments that more often inquire IQ / OQ / PQ: Pharmaceutical industries, industries with quality control departments, health institutes or contract laboratories, to name a few. Nonetheless, every laboratory that needs to assure a maintaining good performance of a device and wants to be certified to proof that they obtain best working materials is a potential customer.

Our believe…

We believe that there is no use measuring electronic or physical parameters in electrophoresis. Depending on the application, there are many factors that modify the performance of the electrophoretic separation additionally. There are environmental factors, user knowledge or experience, and samples can behave differently in dissimilar electrophoresis applications. Therefore, SERVA decided to offer application based qualification. There is nothing better as a proof with the principle! Applicable marker proteins are separated in preset conditions and the rf value (relative-to-front) of reference runs are compared to a test run.

 

This blog post will be further edited…