Airborne Microbiological Monitoring of Clean Rooms in a Pharmaceutical Production Site - Bertin Instruments

Food/Pharma/Veterinary Industry

Airborne Microbiological Monitoring of Clean Rooms in a Pharmaceutical Production Site

Sources: Faure Ingenierie (France)

Context

Pharmaceutical production sites are most of the time built around several clean rooms, from A to D grades.
These specific « rooms » have to be controlled frequently in terms of surface and airborne microbiological contamination (ISO 14698, GMP…).
In this study, the airborne contamination of 22 rooms (B, C and D grades) has been measured and compared. The sampling has been done with 2 different methods : the referent one, the impaction on agar plates (+incubation for 72h) and the cyclonic sampling method, based on a patented technology transferring airborne particles onto a liquid collection media (+ solid phase cytometry analysis).

Results

● 33 measures with each sampling method into 22 rooms of the production site.
● A better representativeness of the airborne contamination in the controlled environments with the couple Coriolis®μ + ScanRDI® is observed, especially for D grade room which are the most contaminated rooms and thus give the most exploitable results.04131-203-SL009 ZAC_FAURE ING ENG

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