Generally, there are 4 class standard for the production of sterile drugs in a pharmaceutical facility.
●ISO 5/ Class 100:
High risk operating areas such as filling areas, areas where rubber plugs are placed and open packaging containers in direct contact with sterile preparations and areas where sterile assembly or connection operations shall have the environmental state of the area be maintained with directional flow operating tables (covers).The One Direction flow system shall be fed uniformly, in its working area, with a wind speed of 0.36-0.54m/s (guiding value).There shall be data to prove the state of directional flow and verify. Low wind speed can be used in closed isolation operators or glove boxes.
●ISO 6/ Class 1,000:
Refers to the background area of the Class 100 clean room area for high risk operations such as aseptic preparation and filling.
●ISO 7/ Class 10,000:
It refers to the clean room area with less important operation steps in the production of sterile drugs.
●ISO 8/ Class 100,000:
It refers to the clean room area with less important operation steps in the production of sterile drugs.
