Environmental Bio-contamination control and monitoring

This webinar will give an overview of the recently released UK Pharmaceutical and Healthcare Science Society (PHSS) Technical Monograph #20- Bio-contamination, characterization, control, monitoring and deviation management in controlled/ GMP classified areas. The concept of Risk Profiling and Proactive Response (RPPR) to bio-contamination in GMP classified areas, focusing on preventing contamination and not just monitoring for compliance will be presented. How trending environmental monitoring data holistically across all supporting areas can detect an increasing risk of a contamination event in Grade A zones will be examined. In particular, the value of using real-time airborne viable particle detection as part of holistic monitoring strategy for risk escalation will be discussed.

Many organizations are pro-actively exploring Rapid Microbiological Methods (RMMs). Real-time airborne viable particle counting is an RMM that is generating great interest. The potential opportunities of improved product quality and efficiencies, whilst maintaining patient safety are too significant to ignore. Cases where this technology is providing value today in a pharmaceutical manufacturing environment will be presented. Included will be a brief discussion of critical performance characteristics of real-time viable particle detectors which should be considered when selecting an instrument to monitor GMP classified areas.