Clean area classification.
The clean or buffer room is the secondary engineering control.
It houses the primary engineering controls (the LAFH, BSC, or CA) where the aseptic compounding is actually performed.
Clean room is a specially constructed enclosed area, which contains one or more clean zones, where the concentration of airborne particles is controlled using HEPA filters, continuous air circulation, and a physical barrier to non-filtered (or outside) air.
Clean rooms establish appropriate environmental levels for airborne particulates, temperature, humidity, air pressure, and airflow patterns.
Clean rooms are categorised by their constant air quality or class.
Clean rooms are rated as given in table:
(Lower the classification number, cleaner is the air.)
Apart from the above mentioned basic components, a clean room also includes:
1) UV irradiation,
2) Air-lock entry portals,
3) Special filtration or treatment systems for incoming air,
4) Sticky mats for removing particulate matter from shoes, and
5) Positive room air pressure for controlling entry of contaminants from adjacent rooms.