Something for Nothing
1Agalloco & Associates jagalloco@aol.com.
PDA Journal of Pharmaceutical Science and Technology
|April 21, 2023
Abstract:
This article reviews the evolution of performance standards for aseptic processing as defined by regulatory, pharmacopoeial, and industry activities. The increasing rigor of the expectations for sterility testing, environmental monitoring, and process simulation have made for improvements in capability for sterile manufacturing. The document explains why contemporary requirements are such that satisfying them requires a shift in operating practice from manned clean rooms to isolation technology.
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