A Discussion on Bio-Fluorescent Particle Counters: Summary of the Process and Environmental Monitoring Methods Working Group Meeting with the FDA Emerging Technology Team

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.

Keywords: Bio-fluorescent particle counting (BFPC); FDA Emerging Technology Team (ETT); auto-fluorescence unit (AFU); environmental monitoring; rapid microbiological method (RMM).