Investigations into environmental monitoring (EM) excursions can be prolonged and do not always result in clear root causes or CAPAs. This paper outlines how bio-fluorescent particle counting (BFPC) can be used in investigations to eliminate the inherent delays of culture-based methods. The application for investigations supplements routine EM; acting as a risk reduction tool enabling real-time detection of viable microorganisms in air samples − supporting root cause analysis and remedial actions. The paper includes guidance on how to use the technology, a real case study involving a mold excursion, and examples of business benefits achieved by various companies.
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Environmental monitoring (EM): Continuous microbiological EM for process understanding and reduced interventions in aseptic manufacturing
Mar 2019 | COVID 19, Fill Finish
This 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, thereby reducing interventions and future replacement of Grade A settle plates and nonremote active air sampling. The replacement of traditional monitoring with biofluorescent particle-counting systems provides an improvement in process understanding and 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.