ABSTRACT
Difficulty in validating microbiologic monitoring methods results from a lack of comprehensive testing standards, reliable test equipment, and reliable methods for correlating sample data to predictions of product quality. Effective microbiologic monitoring of controlled processes usually includes sampling of process air for aerobiologic contamination, and facility, equipment, and operative personnel barriers for surface contamination. Growth Media Growth and collection media used in microbiologic monitoring should be selected on the basis of the target organisms, areas and surfaces sampled, and inhibitory residues that may remain on the sampled surfaces. The different characteristics and operating principles of aerobiological samplers do not facilitate direct and simple comparisons. Effective interpretation of data from microbiologic monitoring of the environment can be the most difficult aspect of the monitoring process. The best statistical methods of evaluation are determined by the nature of the data. There are two types of over-limit results: Random results are due to chance causes, whereas non-random results are due to assignable causes.
