Lilly is evaluating biofluorescent particulate counting (BFPC) technology to simultaneously replace conventional active and passive (continuous) microbiological air monitoring as well as total non-viable particulate monitoring in Grade A critical filling zones. Microorganisms produce naturally fluorescent compounds, such as riboflavins and NADH, which emit detectable fluorescence when excited by a laser at specific wavelengths. BFPC is a non-culture-based technology specifically designed for real-time detection and quantification of airborne microbes based on excitation/detection of the unique fluorescence given off by those cellular components. Expected benefits implementation include: Enabling real-time discard strategies to reduce sterility assurance riskImproved process knowledge associated with environmental and contamination control.Streamlining of filling line design and monitoring through replacement of all existing conventional microbiological and particulate sampling equipment.Reduced EM media quantities required in Grade A filling zones.Elimination of inherent interventions required to perform passive and active microbiological air monitoring.Improved data integrity for EM sampling results through automation.To establish equivalence/superiority of BFPC, Lilly performed in situ bioaerosol testing to assess the microbial detection efficiencies of BFPC technology versus the recovery efficiencies of conventional culture-based microbial air recovery methods.
Ellen Moretti (Thu,) studied this question.