AirCapt MP8 Multipoint Microbial Monitoring System

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Where should I locate my microbial monitoring sample points?

According to the most recent revisions to key regulatory documents on aseptic processing (e.g. EU GMP Annex 1: 2008 and FDA September 2004 update to Pharmaceutical GMP), choice of monitoring locations should be based upon a documented risk assessment. A formally recognized risk assessment method (such as HACCP or FMEA) or other validated equivalent system should be employed to identify potential microbiological hazards to process or product and to identify risk zones where environmental conditions must be controlled to eliminate these hazards. Typically, non-viable particulate monitoring locations coincide with microbiological monitoring locations; however, this choice must be documented by a formal risk assessment process or procedure.

To learn more, read Choosing the Most Suitable Non-viable Sample Point Locations