Surface bioburden study offers insight on non-sterile manufacturing
Microbial load fell within the predefined limit, suggesting contamination was controlled during a single time point.
Microorganism proliferation on dirty equipment in a class D manufacturing facility was managed during a hold time of 96 hours, a bioburden study shows.
The low variability indicated consistent contamination control performance, the author wrote.
While a key part of the cleaning validation process, the dirty-hold time study is “typically overlooked”.
In an environmental monitoring area at the non-sterile facility, samples were
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