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Bioburden Analysis of Clean Room

Bioburden is normally defined as the number of bacteria living on a surface that has not been sterilized. Clean rooms and associated controlled environments provide the control of contamination to levels appropriate for accomplishing contamination-sensitive activities. Products and processes that benefit from the control of contamination include those in such industries as aerospace, electronics, medical devices, and pharmaceutical products requiring a variety of clean environments.

Environmental Monitoring (EM) is very important, particularly in pharmaceutical manufacturing facilities where the risk of microbial contamination is controlled through aseptic processing. Microbiological monitoring of an environment involves microbiological air quality evaluations on operators, the inside of the laboratories and surfaces. Such a program controls the viable microbial load (bioburden), and this monitoring provides data about the air system eficiency in operational procedures.

Alert and internal action at specific microbiological levels can be determined through frequent monitoring of the environment and operators. Therefore, deviations from normal conditions can be detected, allowing corrective procedures before product quality is affected.

At EFRAC, the environment division covers various analytical parameters and our scientists of adequate expertise in separation techniques and have profound knowledge of analysing unknown chemical compounds. We perform Bioburden analysis of clean room through settle plate Method for Total bacterial count and yeast & mold count. We also detect pathogens present in the area.