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Manufacturing Area having independent AHU, these are circulatory
type through a bank of 10 µ - / 5µ and terminal
HEPA filter to achieve class 100000. Class 100,000 is comprises
of air changes more then 20 and particle count for viable
and non-viable and DOP test. There is total 18 Nos of AHU
at mezzanine floor with insulated ducting, 10% fresh air is
used.
The manufacturing, primary packing as well as the dispensing
areas are validated at regular frequency for integrity of
filters, particle counts, air velocities and number of air
changes.
Positive air pressures are maintained in the compounding,
filling and dispensing areas to ensure that outside air does
not enter these areas.
The flooring in the entire core areas as well as the corridors,
dispensing area and sampling area and the also the microbiology
laboratory is coated with epoxy with a clear coat of Poly
Urethane in order to have an impervious microbe resistant
floor.
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