03.11.25 -- Microbial Air Monitoring: The Right Solutions For Compliance & Control

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

Viable air monitoring is a key part of any environmental monitoring program in pharmaceutical manufacturing. Examine updates to the EU GMP Annex 1 as well as current regulatory standards to better understand potential future trends and changes in guidance.

The Growth Promotion Test (GPT) evaluates whether the culture media in use is suitable for environmental monitoring sampling. The test ensures the medium’s nutritive properties, functionality, and overall quality are sufficient for detecting and counting microbial contaminants. Explore recommendations to follow to ensure a successful GPT.

The Annex 1 revision emphasizes validation and qualification for sterile drug production. Gain insight into the key differences between validation and qualification as well as their importance in pharmaceutical processes, and discover how to ensure product quality and contamination control in your processes.

Equip yourself with the essential knowledge needed for effective environmental microbial monitoring by learning about the critical requirements outlined in EU GMP Annex 1 and ISO/EN standards for monitoring airborne microorganisms in cleanrooms.

Hear from industry expert Mark Hallworth, a member of the ISO14644 TR-21 committee, provide an in-depth overview of ISO 14644. With the focus on TR-21, he explains the rationale behind the creation of this document, which gives insight into the development of the TR and practical insights designed to aid in its interpretation and application.

Discover an innovative, light, and mobile microbial air sampler that is EU GMP Annex 1 compliant for continuous microbial monitoring. It simplifies the job of microbial air sampling by applying modern data management capabilities that save time and reduce operator error in air sampling data.

Learn about a single-use impactor that secures the process, product, and, ultimately, the patient by avoiding contamination risks. This continuous monitoring microbial sampling system provides you with the superior knowledge, technology, quality, and service you need to successfully meet regulatory requirements and manufacture your product.