Microbiological air sampling systems must be validated before use according to the ISO14698 guidelines, which means that it must be demonstrated that the requirements it has to fulfil can indeed be fulfilled. This extensive testing consists of Instruction Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ). However, PQ is very time-consuming and is difficult for the user to carry out in full.

To assist the user to perform his own validation on his RCS air sampling system, Biotest HYCON® has developed a validation manual. The manual is in two parts: a Validation section and a Qualification section:

> The Validation section contains all the details and information that the user needs to undertake a simplified performance validation of the RCS system. All the tests presented there have been conducted according to the ISO14698 guidelines and the results are described and explained in detail.

> A Qualification Plan in the following section contains step-by-step guidance on conducting the complete qualification of an RCS air sampler.
For completeness, the manual also contains forms for recording the qualification.

For further information please refer to Newsletter 73.