In a meeting between the US Food and Drug Administration (FDA) Emerging Technology Team (ETT) and the Process and Environmental Monitoring Methods Working Group (PEMM), the FDA addressed several concerns with regards to the implementation of bio-fluorescent particle counting (BFPC) technology. A summary of the meeting’s outcome is outlined below.
BFPC instruments are a type of rapid microbiological method (RMM). They are an example of an enhanced particle counter, capable of the continuous and real-time detection of micro-organisms in air and water. Such systems detect micro-organisms using biologic fluorescence, as opposed to traditional methods, which require operators to wait for sufficient growth so that a colony forming unit (CFU) can be detected.