In
the paper, the researchers assessed the different operational states within a
biopharmaceutical grade clean room, using a rapid microbiological method. The
method was a novel system, based on spectrometry, designed for sampling,
discriminating, and enumerating airborne particles (a BioVigilant IMD-A® System).
Central
to the study was the aim to determine the microbiological levels as a clean
room went from standard use through maintenance and shutdown, disinfection, and
then back to standard use. The objective was to evaluate whether a rapid method
could replace conventional environmental monitoring using growth-based media.
The
paper concludes that the optical instrument can be used to process sufficient
information, so that clean rooms can be returned to use following a period of
unexpected downtime or following maintenance without the need to wait for the
results from growth-based methods. As such, this type of rapid microbiological
method is worth exploring further for clean room air monitoring.
The
reference is:
Posted by Tim Sandle
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Pharmaceutical Microbiology Resources