Cleanroom Technology: Microbial monitoring: Adapting to new regulatory demands

Embracing Innovation in Microbiological Monitoring

At Cherwell, we're committed to supporting the pharmaceutical and biotechnology industries in meeting the ever-evolving regulatory demands of environmental monitoring (EM). Our latest article, featured in Cleanroom Technology, delves into how the industry is adapting to the 2022 EU GMP Annex 1 regulation update, which heightened standards for cleanroom monitoring.

Here’s an excerpt from the article:

“The pharmaceutical and biotechnology industries face increasing pressure to comply with stringent regulatory standards, especially following the 2022 update to the EU GMP Annex 1 regulation. This update mandates higher environmental monitoring (EM) standards, particularly in Grade A cleanrooms, where continuous air monitoring has become a requirement. As sterile product manufacturers adapt to these new standards, there is a growing interest in rapid microbiology methods (RMMs), such as biofluorescent particle counters (BFPCs), to complement traditional growth-based techniques. The adoption of RMMs, specifically BFPC technology, represents a significant shift from the well-established agar-based methods that are the long-standing reliable cornerstone of EM.”

The article explores the shift from traditional growth-based techniques to Rapid Microbiology Methods (RMMs) such as biofluorescent particle counters (BFPCs), such as BAMS. These innovative technologies promise enhanced detection and faster response times, revolutionising cleanroom monitoring.

The article covers:

• The 2022 EU GMP Annex 1 update has significantly increased cleanroom monitoring requirements, including continuous air monitoring in Grade A environments.
• Traditional agar-based methods are well-established but have limitations, such as long incubation times and the inability to detect transient contamination events.
• Growth-based techniques can miss viable but non-culturable (VNBC) bacteria due to stressed microbial cells.
• Biofluorescent particle counters (BFPCs) such as BAMS offer real-time monitoring, enabling faster responses to contamination risks.
• Validation is critical to ensure the accuracy and reliability of BFPC technology in regulated environments.

This insightful article highlights the importance of innovation in ensuring compliance while enhancing safety and efficiency.

Read the full article to explore how BFPC technology is shaping the future of microbiological monitoring.

For more information on Cleanroom Technology: Microbial monitoring: Adapting to new regulatory demands talk to Cherwell Laboratories Ltd