Application of Biofluorescent Particle Counters for Real-Time Bioburden Control in Aseptic Cleanroom Manufacturing

Application of Biofluorescent Particle Counters for Real-Time Bioburden Control in Aseptic Cleanroom Manufacturing

This experimental study examines the use of a real time viable particle counter in pharmaceutical cleanroom operations under ISO class 8/Annex 1 Class C ‘in operation’ conditions. The used measuring system, a Biofluorescent Particle Counter (BFPC), continuously detected particles >1.0 µm as well...

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Autors principals: Behrens, Detlef, Schaefer, Jens, Keck, Cornelia M., Runkel, Frank E.
Format: Article
Idioma:anglès
Publicat: Philipps-Universität Marburg 2022
Matèries:
energy saving
Class C
ISO 8
Pharmakologie, Therapeutik
Biofluorescent Particle Counter (BFPC)
air change rate
real time viable particle counter
pharmaceutical production;
Pharmacology & therapeutics, prescription drugs
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