EC Microbiology

ORUM international, which has designed and proposes a specific impact instrument such as the TRIO.BAS, has decided to assess the efficiency of the sampler in recovering microorganisms in the air, to carry out the verification microbiological tests indicated in paragraph E.6.2.2 of the EN 17141:2020 standard.

The "E.6.2 Simplified laboratory method" presented in the EN 17141:2020 standard is an alternative to the aerosol chamber method. The advantage is that the simplified method is performed with naturally microorganisms and not with artificial bio-aerosol. In fact, it could be carried out in premises with different levels of airborne contamination. The simplified method is compared to a qualified reference method like the "membrane filter".

The TRIO.BAS microbial air sampler (active sampling) to be qualified was compared with the MD8 Sartorius microbial air sampler (membrane filter sampling) that is a qualified method.

At the end of the test, the results obtained, shown in the tables and from the calculation obtained with the application of the formula indicated in Chapter E.6.4 of the EN 17141:2020 standard, it was possible to highlight the following: The air sampler TRIO.BAS, as far as biological! efficiency is concerned, while taking into account the losses caused both by the physical collection efficiency and by the effect that sampling has on the vitality of the microorganisms, has a good ability to collect particles carrying viable microorganisms: in fact, the found value of acceptability is included in the limit of acceptability of (100% +/- 50%) foreseen by the standard.

Keywords: Airborne Microorganisms; EN 17141:2020 Standard; TRIO.BAS

1. EN 17141:2020 - Cleanrooms and Associated Controlled Environments - Control of Biocontamination.
2. UNI EN ISO 4833-2:2022 - Microorganisms at 30°C.
3. UNI CEI EN ISO/IEC 17025:2018 - General Requirements for the competence of testing and calibration laboratories.
4. Air Monitoring in Cleanroom Environments by Gelatin Filters according to EN 17141 and ISO 14698 C. Scharwing, E. C. Arakel. Pharmaceutical Quality Control Resources Document, Sartorius Conference (2021): 1-7.