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Published in 2018 at "PDA Journal of Pharmaceutical Science and Technology"
DOI: 10.5731/pdajpst.2018.008722
Abstract: This paper provides recommendations for quality oversight, manufacturing operations, and industry perspective of regulatory expectations to enable aseptic facilities to move toward real-time and continuous microbiological environmental monitoring, thereby reducing interventions and future replacement of…
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Keywords:
bfpc;
continuous microbiological;
contamination;
process ... See more keywords