The cleanliness level applicable pharmaceutical production dosage form and process

ClassA/ClassB

1) Filling of terminally sterilized large-volume injections (≥50 ml);
2) Non-terminal sterilized medicines: preparation of liquid medicines that do not require sterilization and filtration before filling; filling, subpackaging and plugging of injections; packaging materials that directly contact medicines are exposed to the environment after final treatment;
3) Production of biological products that are not sterilized and filtered before filling;
4) Exposure environment of sterile raw materials.

ClassC
1) Terminally sterilized drugs: dilution and filtration of injections; filling and sealing of small-volume injections; final treatment of packaging materials that directly contact drugs;
2) Preparation and filling of sterile eye drops for corneal trauma or surgery;
3) Production of biological products that need to be sterilized and filtered before filling;
4) Preparation of sterile and filtered medicinal liquid before filling.

ClassD
1) Concentrated formulation of terminally sterilized injections or diluted formulation using a closed system;
2) Capping of non-terminal sterilized sterile medicines;
3) The final fine cleaning of the packaging materials that directly contact with the drug;
4) Exposure process of non-terminal sterilized oral liquid medicines;
5) Exposure process of deep tissue trauma topical drugs and ophthalmic drugs;
6) Exposure procedures for oral administration other than rectal administration.

Controlling Area
1) The exposure process of terminally sterilized oral liquid medicines;
2) Exposure process of oral solid drug;
3) Exposure process of epidermal topical drugs;
4) Exposure process of rectal medication;
5) The production exposure environment of non-sterile APIs.