Risk Based Environmental Monitoring Programs

Microrite’s team of cleanroom and microbiology experts develop risk based environmental monitoring programs that meet current regulatory requirements and address the latest in regulatory thinking. Our hands-on experts utilize the latest technology and techniques in assessing real-world contamination risk, and develop a risk based monitoring program as recommended by various regulatory bodies. This includes but is not limited to utilizing investigative smoke studies to establish risk based sampling sites.

We assess and revamp EM programs routinely to ensure that the program is capable of capturing product contamination risk. We also evaluate overkill and streamline EM Programs which saves cost while meeting compliance.

Environmental Monitoring Services:

  • Evaluate microbial contamination and monitoring program effectiveness
  • Perform audit of facility/assess gaps in monitoring
  • Develop or review current environmental monitoring procedures with respect to:
    • Risk based sample site selection
    • Selection of sampling equipment and integration of continuous monitoring devices
    • Adequacy of monitoring frequency and sampling volumes
    • Adequacy of microbiological media and incubation conditions
    • Frequency and level of microbial identification
    • Trending EM data to identify risk to product
    • Evaluation of environmental monitoring investigations for completeness and risk assessment
    • Identification of objectionable microorganisms for non-sterile products
  • Audit testing laboratory performing environmental monitoring
  • Advise on any changes required to meet current regulatory expectations