- 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.
Aseptic Area
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment