Project CategoryMain project classification
(1) Final sterilized medicines: 1 to 100,000
(2) Non-final sterilized drugs: 100,000-300,000
(3) Other sterilized medicines: Class 10,000 for the preparation and filling of corneal trauma or surgical eye drops.
(4) Clean work clothes for Dongguan purification project : Clean work clothes for areas above 100,000 should be washed, dried, and cleaned in a clean room (area), and sterilized as required.
4. Requirement of cleanliness of air for API production
(1) For the drug substances with sterility inspection items listed in the statutory drug standards, the exposure environment should be local level 100 or lower.
(2) The exposure environment for the production of other APIs should be no less than 300,000.
5. The air cleanliness requirements for the production of biological products: Class 1-100,000.
6. The air cleanliness requirements for the production of radiopharmaceuticals: the same as the provisions in sterilized drugs, non-sterilized drugs and bulk drugs; the preparation of each component of the radioimmunoassay kit is performed under 300,000 conditions.
7. Cleanliness requirements for the production environment of sterile medical appliances
(1) Dongguan Purification Project: Processing, final cleaning, and assembly of parts (not cleaned) for implants in the body, sterile medical devices that come into direct or indirect contact with circulating blood, bone cavity, or single-package packaging. The production areas such as primary packaging and sealing should be no less than 100,000 cleanliness. Sterile medical devices implanted into blood vessels and sterile medical devices that can realize the entire process of production, assembly and packaging in a local environment should be in a clean room (area of no less than 10,000 (preferably 100)) ) Production.
(2) Except as specified in (1), the processing, final cleaning, assembly, initial packaging, and sealing of sterile medical equipment or single-packed factory parts (non-cleaning parts) should be in a clean room of not less than 300,000 ( Area).
(3) The level of air cleanliness in the area of final cleaning and disinfection of clean work clothes for cleaning, drying and wearing clean work clothes rooms and special station appliances can be lower than that of the production area. The finishing and sterilization of sterile work clothes should be in a class 10,000 clean room (area).