Chapter <1116> is arguably one of the most comprehensive informational chapters from the USP, and it is particularly challenging due to its proposal regarding measurement of microbial contamination based on Contamination Recovery Rates (CRR) rather than the conventional enumeration of colony forming units (cfu).
Claudio Denoya, PhD, and Gilberto Dalmaso, PhD,
Particle Measuring Systems have written a useful overview of USP
<1116> “Microbiological Control Of Aseptic Processing Environments”, for
Pharmaceutical Online.
Here
is an extract:
“The chapter emphasizes that even with a good
total particulate monitoring program in place, “It is not possible to clearly
distinguish between background particulate contamination generated…by
mechanical operations and the total particulates contributed by personnel.”
Therefore, it is standard routine to implement both total particulate and
microbiological monitoring programs. The chapter also discusses the differences
between operating in conventional cleanrooms and open RABS, and more controlled
environments where personnel interventions have significantly less impact on
microbial contamination, such as in closed RABS and isolators. It is clear that
the relative risk of microbial quality depends on the different types of
aseptic barrier systems; the greater the barrier, then the lower the expected
contamination risk.”
Posted by Dr. Tim Sandle
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