Abstract
The Process and Environmental Monitoring Methods Working Group, composed of members from industry and instrument manufacturers, met with the FDA Emerging Technology Team to discuss bio-fluorescent particle counting technology, a type of rapid microbiological method. This is a summary of the meeting including submitted questions and answers, and the Process and Environmental Monitoring Methods Working Group′s understanding of the FDA Emerging Technology Team′s points made.
- Bio-fluorescent particle counting (BFPC)
- FDA Emerging Technology Team (ETT)
- auto-fluorescence unit (AFU)
- environmental monitoring
- rapid microbiological method (RMM)
- Received October 2, 2020.
- Accepted December 28, 2020.
- Copyright © 2021, Parenteral Drug Association
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