I1a: Risk Assessment of Microbial Contamination in Cleanrooms

Ernest N. Morial New Orleans Convention Center 

Reducing bioburden presents significant challenges for design and operation cleanrooms and it requires continuous monitoring of viable and non-viable particle loads. Certifiers and industrial hygienists routinely support operators of cleanrooms with air and surface sampling. However, when it comes to interpretation of test results and risk assessment, we frequently notice a lack of know-how and confidence that needs to be addressed. A risk assessment for microbial contamination quantifies the likelihood and severity of contamination to protect products and human health, especially in pharmaceutical and healthcare settings. It involves identification of primary sources of contamination such as personnel, materials, and airflow whilst assessing their dispersion and transfer potential.

The assessment maps out space as well as processing steps into functional sections (grids) which are scored based on risk. We discuss environmental sampling data from a sterile compounding facility in a case study and walk through a risk assessment including an excursion investigation. Systematic evaluation of microbial monitoring data helps implement effective corrective actions to reduce contamination and ensure product quality and patient safety.

Michael W. Berg, Pace Building Sciences, Minneapolis, MN, USA. 

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Biological Monitoring

Regulatory compliance

Risk assessment and management

Safety