Ceiling : Smooth surface, easy to clean, Epoxy or vinyl coating
Personnel should enter the aseptic area only through an air lock.
Material should be transferred through Pass-box sterilizers.
Prior filling, area should be sterilized with gaseous disinfectant like formaldehyde.
Surface should be sterilized using UV lamp.
HEPA (High efficiency Particulate Air Filter: 99.97 % efficiency, 0.3mcM or larger particles must be retained) filter should be placed in order to control particles.
Air handling unit (AHU) to control temperature and humidity.
Laminar Air Flow: 90 +- 20 ft/min with parallel flow.
DOP test: Dioctylphalate smoke used to measure efficiency of HEPA filter by anemometer.
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