Enhancing Microbiological Monitoring in Grade A Environments: Innovative Solutions and Automation

The Annex 1 requirement for continuous microbiological monitoring in Grade A environments poses a significant challenge in pharmaceutical aseptic manufacturing areas.

This webinar focuses on the operational performance of the BioCapt® Single-Use (BCSU) microbial impactor under continuous active air monitoring conditions, with particular emphasis on usage limits and environmental factors influencing agar dehydration. The analysis is based on data collected from a global survey involving BCSU users across Europe, the Americas, and the Asia-Pacific region, aiming to describe current practices and identify common strategies applied in routine manufacturing environments.

The session will also explore how environmental conditions such as temperature, humidity, airflow, and aspiration flow rate can influence sampling performance during extended monitoring.
In addition, the webinar will address different strategies used to support continuous monitoring, including fractionated sampling approaches, as well as automated and engineered solutions such as robotic or hands-free sampler replacement. These solutions can be particularly valuable in restricted or high-containment environments where manual intervention is not feasible.

The role of Performance Qualification (PQ) and Contamination Control Strategy (CCS) will be highlighted in justifying extended exposure practices.

This webinar is intended for microbiology, quality, and sterility assurance professionals seeking to better understand regulatory expectations and practical considerations for implementing compliant and sustainable continuous microbial air monitoring programs.