In the context of risk-based environmental monitoring, certain requirements have been introduced. These include the need for selecting sampling site locations based on risk assessment and supported by airflow visualisation studies. The EU GMP Grade A limit has changed from 1 CFU to ‘no growth,’ necessitating stringent control measures. Moreover, the use of rapid and automated microbiological methods is permitted, provided the facility demonstrates equivalency or superiority to existing methods. Continuous monitoring of viable and non-viable particulates is expected, with an emphasis on evaluating historical trends to inform alert and action levels. These trends also apply to microbial speciation, highlighting the significance of a robust sterility assurance system with focus on design and control for patient safety.

How we can help: MCR Group’s approach to training personnel to ensure procedural compliance reduces the risk of environmental monitoring excursions for both viable and non-viable counts. Our support team is also well versed in risk assessment and statistical trending, ensuring that relevant data is tracked over time to demonstrate the effectiveness of the site’s contamination control strategy over time.