Newsletter | January 20, 2026

01.20.26 -- Microbial Monitoring That Supports Annex 1 Compliance

Optimizing Microbial Air Sampling To Reduce False Positives In Cleanrooms

In controlled environments such as cleanrooms, maintaining sterility is critical. A vital process in this context is microbial air sampling. Explore how modern advancements can improve the efficiency of microbial air sampling while minimizing the chances of false positives in cleanrooms.

 

Key Factors For Optimized Microbial Air Sampling

For all microbiological sampling methods in a pharmaceutical manufacturing facility, it is crucial to ensure samples accurately represent the state of the environment, which is often evaluated by collection efficiency. Learn about active air sampling and the characteristics of various sampling methods designed to optimize collection efficiency.

 

Normalized Data In Microbial Continuous Monitoring

Discover how EU GMP Annex 1 (2022) transforms cleanroom air monitoring by prioritizing continuous viable sampling in Grade A and B areas to ensure real-time contamination control and compliance for aseptic manufacturing environments.

 

Optimal Microbial Sampling Criteria

Maintaining sterile conditions in cleanrooms requires more than a single approach. Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. Gain insight into how the EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.

 

Contamination Control Strategies For Manufacturing Environments

Many GMP standards recommend sampling process gases for contamination before use in critical areas of manufacturing. This step, along with many others that make up a contamination control strategy, contributes to the purity and quality of the final product. Delve into relevant regulatory requirements, microbial survival, and more.

 

SOLUTIONS

BioCapt®: Microbial Impactor

Microbial impactors for continuous viable monitoring, minimize false positives, and are Annex 1 compliant. The BioCapt® microbial impactors by Particle Measuring Systems (PMS) are an air sampling solution superior to the use of settle plates that creates validated and actionable data.

• Request Information

 

 

 

PMS® Advisory And Training Services

At Particle Measuring Systems, we have the experts to support you at every step in your contamination control process. Whether it be non-compliance issues, setting up a new process, or training employees, our team has the background, education, and industry expertise you need.

• Request Information