Wednesday, 9 May 2018

USP 1116 Microbiological Control Of Aseptic Processing Environments And Its Implications


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.”

To view, see Pharmaceutical Online

Posted by Dr. Tim Sandle

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