The provision of a microbiologically controlled environment is a continuous process that is not tested and passed on a batchbybatch basis

The fact that microbiological contamination was found in a Grade A area on, for example, Tuesday when batch A was being made but not on Wednesday when batch B was being made, should not be seen as a "fail batch A, pass batch B" situation.

The situation described could equally result in "pass batch A and pass batch B" or "fail batch A and fail batch B" decisions. The discovery of contamination in microbiological environmental monitoring programs generally means that contamination was actually present (although technician-related contamination should never be discounted). The absence of contamination in a microbiological monitoring program does not mean that there was no contamination, only that none was discovered.

The presence of unexpected contamination, either with respect to numbers or types, or to the locations in which contamination may be found, should never be thought exclusive to the period in which it was detected.

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