Environmental Monitoring

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Chapter: Pharmaceutical Microbiology : Sterilization Procedures And Sterility Assurance

The levels of microbial contamination in the manufacturing areas are monitored on a regular basis to confirm that the numbers do not exceed specified limits.


ENVIRONMENTAL MONITORING

 

The levels of microbial contamination in the manufacturing areas  are monitored on a regular basis to confirm that the numbers do not exceed specified limits. The concentrations of bacteria and of yeasts/ moulds in the atmosphere may be determined either by use of ‘settle plates’ (Petri dishes of suitable media exposed for fixed periods, on which the colonies are counted after incubation) or by use of air samplers which cause a known volume of air to be passed over an agar surface. Similarly, the contamination on surfaces, including manufacturing equipment, may be measured using swabs or contact plates (also known as Rodac— replicate organism detection and counting—plates) which are specially designed Petri dishes slightly overfilled with agar, which, when set, projects very slightly above the plastic wall of the dish. This permits the plate to be inverted on to or against any solid surface, thereby allowing transfer of organisms from the surface on to the agar.

 

Less commonly, environmental monitoring can extend also to the operators in the manufacturing area whose clothing, e.g. gloves or face masks, may be sampled in order to estimate the levels and types of organisms that may arise as product contaminants from those sources.

 

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