Normalized Data In Microbial Continuous Monitoring

According to the latest cleanroom manufacturing guidelines, the standard metric for reporting active air sampling results is Colony-Forming Units per cubic meter (CFU/m³). This unit provides a quantifiable measure of microbial contamination in controlled environments to ensure that air quality remains within acceptable limits during pharmaceutical and aseptic processing. In Grade A cleanroom environments, the EU GMP Vol. 4 Annex 1 (2022 Revision) mandates continuous active air monitoring throughout all critical operations. This includes not only the main processing activities but also the assembly and set-up phases of equipment. The regulation emphasizes that viable air monitoring—whether through active air sampling or settle plates—must be maintained without interruption to ensure the integrity of aseptic conditions. Importantly, the guidance also recommends that a similar risk-based approach be applied to Grade B cleanrooms, recognizing that these areas, while slightly less critical, still play a vital role in maintaining overall sterility.

Given the extended duration of operations and the need for continuous monitoring, the volume of air sampled in these environments often exceeds one cubic meter, depending on the sampling flow rate and time. This highlights the importance of robust air monitoring strategies and equipment capable of handling prolonged sampling periods without compromising accuracy or compliance.

To ensure your cleanroom operations meet these evolving standards, now is the time to evaluate your current air monitoring protocols.