Abstract
This white 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 and thereby reducing interventions and the future replacement of Grade A settle plates and non-remote active air sampling. The replacement of traditional monitoring with bio-fluorescent particle counting systems provides an improvement in process understanding, product safety, and reduces operator manipulations assuring product quality and real-time process verification. The future state pharmaceutical technology roadmaps include gloveless isolators with real-time and continuous monitoring for aseptic manufacturing.
- Received March 1, 2018.
- Accepted September 27, 2018.
- Copyright © 2018, Parenteral Drug Association
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