engleski

Viable Environmental Monitoring (EM) of ATMP Production Facility at Tissue Bank, UHC Sestre milosrdnice Zagreb, Croatia

Viable Environmental Monitoring (EM) for an ATMP aseptic manufacturing area includes personnel, air and area surfaces control for the presence of microorganisms. Qualification studies and written procedures should exist for the selection of sampling sites, frequencies and modes of microbial testing. For a given class of air cleanness alert and action levels must be predetermined. Microbiological sampling of our personnel, surfaces and the air was carried out using contact and settle plates and active sampling device. Frequencies’ of microbial testing depended on cleanroom category and for A and B class included each working session. Number of sampling locations per room was calculated from square root of cleanroom zone area in m2. Last year we had in A class: 0.6 % of action levels for both, the air and surface testing. B class showed: 5% alerts and 4% action levels for the air samples and 1% of alerts and action levels for surface testing. 8 bacterial and fungal species were isolated from different room areas. The most detected microorganism in A and B (air -39% ; surface -55%), C (air-35% ; surface-48%) and surface of D class (69%) was CoNS. In the air of D class most detected microorganism was Micrococcus spp. (39%). We have determined the microbial distribution in our cleanroom facility. Several bacterial species were identified as the most probable contaminants that could affect our final product – cultivated epithelial autografts (CEA). Knowing the EM data and undertaking appropriate corrective measures the risk of contamination can be significantly reduced.

cleanroom ; ATMP ; microbiological sampling ; personnel ; air and area surface ; microbiological detection

nije evidentirano