Press Release N.2020-05-01


Continuous Microbial Air Monitoring

in Cleanroom

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.

Creative Commons License
This work by orum.admin is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
Permissions beyond the scope of this license may be available at https://www.oruminternational.com/en/note-legali/