Key Factors For Optimized Microbial Air Sampling

Microbiological sampling in a pharmaceutical manufacturing facility is carried out using a variety of techniques, including surface sampling, passive aerosol (air) environmental sampling, and active aerosol (air) environmental sampling. Each microbiological sampling method yields results based on the growth of microbial colonies on the surface of collection media, typically agar. However, the tools and techniques used can vary across methods.

No single sampling result can confirm aseptic conditions; instead, all sampling data should be considered collectively to support sterility assurance, as outlined in the current version of EU GMP Annex 1: 2022. Additional regulations, including details on surface and passive monitoring are outlined elsewhere in the document. For all sampling methods, it is crucial to ensure samples accurately represent the microbiological state of the environment, which is often evaluated by collection efficiency. Read on to learn more about active air sampling and the characteristics of each sampling method that are designed to optimize collection efficiency.