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The new FDA Aseptic Guidance clearly points out that environmental controls are the most important laboratory controls in aseptic processing and that they should start with a well-defined written program. The Guidance lays down in detail which steps must be included in the written procedures.
It points out that the microbiological quality of air, surfaces and gowning has to be tested. Microbiological alert and action levels should be established. In case of exceeding levels appropriate corrective actions have to be carried out. For monitoring, sample points and sample frequencies have to be defined based upon the relationship to the operation performed. Finally, the various microbiological test methods are discussed.
After incubation plates, strips etc. are evaluated by counting and compared to the alert and action levels. FDA expressively refuses any averaging of results. In case of exceeding alert or action levels prompt investigations must follow.
Characterization of recovered microorganisms provides valuable information for investigation. Modern methods have been shown to be more accurate and precise than traditional ones. Information on the spectrum of microorganisms are needed for all clean zones, the main activities of identification, however, should be concentrated on the critical area.
Near-term and long-term trending of results is necessary. Written procedures should define the system of information.

Key words Aseptische Herstellung • FDA Aseptic Guidance