Can Your Facility Cleaning, Environmental Monitoring, And Disinfection Process Pass Regulatory Scrutiny?

In the “Can Your Facility Cleaning, Environmental Monitoring, and Disinfection Process, Pass Regulatory Scrutiny” webinar, experts from Eurofins Biopharma Product Testing detailed comprehensive strategies for achieving regulatory compliance in facility cleanliness and contamination control. Moderated by Josh Reier with speakers Diane Lockard and Alexis Matthews, the session introduced the Plan-Do-Study-Act (PDSA) framework as a systematic approach for environmental monitoring and cleaning validation.

The presenters emphasized early and broad stakeholder involvement when preparing the Environmental Monitoring Performance Qualification (EMPQ) to avoid miscommunication and delays. EMPQ design must consider areas, surfaces, personnel, and sampling types (air, surfaces, water, personnel), as well as logistics like scheduling, equipment, and sample storage.

Data from EMPQ and regular environmental monitoring is analyzed for trends, identification of key contaminants, and the establishment of effective alert and action limits. Cleaning validation and disinfectant efficacy studies were highlighted as critical, requiring planning, detailed documentation, appropriate sample matrices, and use of site-specific isolates. Case studies illustrated common regulatory pitfalls such as inadequate documentation, incomplete monitoring protocols, and failure to follow written procedures.

The ACT phase focuses on continuous improvement—ongoing monitoring, managing out-of-specification events, CAPAs, change control, and periodic revalidation when facilities or processes change. Innovations like rapid microbiological methods and data automation were encouraged for process enhancement. Audience questions addressed pest control, challenges with disinfectant studies, and responding to contamination or study failures. Overall, thorough planning, robust monitoring, documentation, and a commitment to process improvement are key for maintaining compliance and ensuring product safety.