The
environmental testing program is one of the essential elements for controlling
the quality of the pharmaceutical production environment. It is therefore
essential to employ monitoring solutions capable of detecting any deviation
which might lead to loss of this control. In practical terms, environmental
control relies mainly on the use of agar culture media which must permit the
recovery of all potential living microorganisms but also neutralization of any
disinfectant residues which can inhibit the growth of some strains, while
supporting a level of growth that can be seen by an operator.
The
quality of test results depends on the performance of these media as very
clearly does the pertinence of the resultant trend analyses. But validating
culture media that are able to recover stressed bacteria from the environment
in a cleanroom is not so simple! To gain a better understanding of the
interaction between culture media and the disinfectants dedicated to
environmental control, we have studied the properties of the biocides most
commonly used in the pharmaceutical industry and have suggested a methodology
to evaluate their impact on the performance of these media.
Posted by Dr. Tim Sandle
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