SMU Medical Journal

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Pharmaceutical clean rooms are controlled area in which the concentrations of viable and non-viable airborne particles are controlled to specified limits. The viable monitoring includes microbiological assessment. Viable contamination controlled environments are used for a variety of purposes within the pharmaceutical industry. Different sources are there due to which pharmaceutical controlled environments are getting contaminated but one of the main sources is air born particulate matter. The predictable microbial assessment of the contamination can be done by applying best microbiological approaches, methodologies and historical data of the area used for the manufacturing. This review article outlines the, designs, control measures, risk of microbiological contamination and quality rationales related to the clean rooms.


Keywords

Bio-Burden, Clean Room, Contamination, Environment, Particulate Matter.
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