Continuous Microbial Air Monitoring in Cleanroom

Press Release N.2020-05-01

The microbiological monitoring of the Cleanroom environment is very important for the production of sterile pharmaceutical products. Aseptic filling lines, where a product is filled without terminal sterilization, is the most critical point in the manufactureing process.

Regulatory guidances and authorities request sampling < 1 CFU per 1000 litres (1 m3) of air. Considering a working shift is several hours long, it is necessary to standardize a continuous air monitoring protocol that covers the complete production process.

Continuous microbiological monitoring can be implemented with the use of multihead air samplers. The working shift can be monitored for 1 to 8 hours using TRIO.BAS DUO or TRIO.BAS TRIO air samplers.

The reported method of using multiple aspirating heads at one time vs sampling with a single head for multiple cycles is also effective for reducing human intervention. Preparing multiple aspirating heads at one time lowers the risk of secondary contamination during preparation.