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Dispersion and Risk Assessment of Airborne Contaminants in Pharmaceutical Clean

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Berit Reinmuller

In many of todays industries, particularly in the health care field, special protection is required against airborne microbiological contamination. Clean rooms and clean zones are used to separate the ambient environment from contamination controlled areas. In clean rooms and clean zones, especially in the pharmaceutical industry, the inherently low levels of microbial contamination make measurement of contamination difficult. The most critical environment within pharmaceutical facilities are commonly so low in contamination that the best available microbial monitoring equipment must operate at or below its limit of detection. A specific analytical method for microbiological risk assessment of airborne contaminants in clean zones is described and experiences with the method are discussed. The method for limitation of risks (LR-Method) uses a non-microbiological approach. The method utilizes the visualization of air movements, a challenge test with particles, and determination of a risk factor for the evaluation of potential risks of airborne microbial contamination.

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