Modern manufacturing techniques frequently require clean environments designed, constructed, and maintained to facilitate the highest production yields possible while also meeting predictable ...
Subvisible particle testing addresses regulatory limits for particulate matter in parenteral drugs, ophthalmic solutions, and lipid emulsions.
The latest instruments could be provided by a new vendor or the existing manufacturer. It is common for new models to be sourced due to product obsolescence or enhanced specifications, even when the ...
When using particle counters, many operators are unaware that during conventional manifold sampling, the monitor can undercount the ambient particle concentration. The manifold pump creates an ...
This article outlines guidelines for the testing of high pressure gases utilized in cleanrooms according to the cleanliness limits stated in the FDA cGMP guidelines, the ISO 14644-1 cleanroom ...
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