Environmental Monitoring
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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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