| DOI: https://doi.org/10.14456/mujps.2016.14 | Pharm Sci Asia 2016; 43(3), 115-126 |
Novel rapid method in ecological risk assessment of air-borne bacteria in pharmaceutical facilityM.E. Eissa*
- Microbiological quality control section, HIKMA Pharma pharmaceutical company, Egypt
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. A quantitative risk index was adopted to reflect the potential impact of the environmental aerial bacteria type on the possible health hazard of the final consumers through the medicinal dosage form. Interestingly, this risk index showed that the greatest risk came from Enterobacteriaceae followed by Streptococcaceae then Staphylococcaceae with more than 99% contribution to the total risk provided that the all other parameters are constant such as batch size, clean area classification, preservation power and the reduction factor of microorganisms by the manufacturing process such as heating and compression. The quantitative risk index used in this study provides milestone in the assessment of the possible hazard that could arise from environmental contamination of the medicinal product to the final consumer.
Keyword:
environmental monitoring, clean rooms, good manufacturing practice, Pareto chart, quantitative risk index
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