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Novel rapid method in ecological risk assessment of air-borne bacteria in pharmaceutical facility |
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| รหัสดีโอไอ | |
| Creator | M.E. Eissa |
| Title | Novel rapid method in ecological risk assessment of air-borne bacteria in pharmaceutical facility |
| Publisher | Faculty of Pharmacy, Mahidol University |
| Publication Year | 2559 |
| Journal Title | Mahidol University Journal of Pharmaceutical Sciences |
| Journal Vol. | 43 |
| Journal No. | 3 |
| Page no. | 115-126 |
| Keyword | environmental monitoring,clean rooms,good manufacturing practice,Pareto chart,quantitative risk index |
| ISSN | 0125-1570 |
| Abstract | Environmental monitoring (EM) of microbiological air quality in clean rooms of pharmaceutical plants is not critical only for the control of good manufacturing practice (GMP) but also for assessing the risk associated with aerial bioburden to the final customer through medicinal products. Extensive EM samples were taken from newly established pharmaceutical facility including 59 active and 41 passive air samples of classified area in production area and its associated microbiology laboratory. The gathered samples were incubated then examined for bacterial count populations. Bacterial colonies were then subjected to further identification using BBL? Crystal? Identification System and a distribution profile was made from which Pareto chart was constructed which showed that the following bacterial families: Micrococcaceae, Staphylococcaceae, Bacillaceae, Streptococcaceae, Microbacteriaceae and Corynebacteriaceae contributed by more than 80% of air samples. |
