The Future of Aseptic Processing–An Update

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ASEPTIC PROCESSING Last year I wrote in these pages about the future of aseptic processing.At that time the industry was waiting for FDA to publish a replacement for its 1987 “Guideline on Sterile Drug Products Produced by Aseptic Processing” and wrestling with issues such as media-fill acceptance criteria, interventions and intervention management, environmental monitoring practices and acceptance levels, rapid microbial methods, sterility test insensitivity, regulatory harmonization, and how best to implement, control, and monitor improved aseptic processing technologies such as isolators and barrier systems.

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Author(s): 
Russell E.Madsen.
Journal: 
Pharmaceutical Technology .2004.