Environmental monitoring (EM) of cleanrooms is the microbiologist’s responsibility and it requires making many decisions such as how often to monitor, where to monitor, what samples to take, which culture media to use, how long to incubate, how to interpret data and which identifications to perform.
The various forms of guidance available leave room for a degree of flexibility, which is sometimes helpful but often difficult. Pharmig’s recent seminar was designed to highlight the various guidance documents, look at where they conflict and highlight what to consider when designing and implementing EM. This overview offers key points from a few of the many informative presentations.
The various forms of guidance available leave room for a degree of flexibility, which is sometimes helpful but often difficult
Tim Sandle, Head of Microbiology at BPL, reviewed the recently produced US Pharmacopeia chapter 1116 (USP <1116>) and considered its impact on microbiology in the pharmaceutical sector. He reminded delegates that only Pharmacopeia chapters below 1000 are required to be implemented to meet a licence, and USP <1116> is only for guidance. Sandle noted that while the chapter has introduced improvements, in places it also clashes with some European Union (EU) good manufacturing practice (GMP) guidance and there are some problematic areas, not least that the new chapter contains input from experts that is sometimes contradictory.
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