Requirements for Clean Rooms in Traditional Chinese Medicine Production:

For drugs that use raw medicinal powder directly, the production areas for medicinal materials, crushing, sieving, and mixing should at least be managed as clean areas.

The processes of extraction, concentration, and膏 collection in traditional Chinese medicine should be conducted using closed systems and cleaned online to prevent contamination and cross-contamination. If closed systems are used, the operating environment can be in non-clean areas; if open methods are used, the operating environment should match the cleanliness level of the preparation operation area.

Operations such as膏 collection after extraction, ingredient mixing, crushing, sieving, and mixing of extracts should have a cleanliness level consistent with that of the preparation operation area. If Chinese herbal pieces are crushed, sieved, mixed, and used directly, the facility for these operations should be enclosed, with proper ventilation, dust removal, and other facilities. Personnel and material entry/exit, as well as production operations, should be managed as in clean areas.

The refining process before濃配 for traditional Chinese medicine injections should be completed at least in a Grade D clean area.

Non-traumatizing external-use traditional Chinese medicine preparations and other special preparations can be produced in non-clean facilities but must be effectively controlled and managed.

The traditional Chinese medicine specimen room should be separated from the production area.

Areas managed as clean areas in traditional Chinese medicine production environments should comply with the following regulations:

1.Ventilation measures or air conditioning systems should be implemented;

2.Air supplied to the production area should be treated with primary, medium, or high-efficiency two-stage filters;

3.Indoor positive pressure should be maintained, with a pressure difference of not less than 5 Pa compared to general areas;

4.Rooms where dust is generated during production should be equipped with dust removal systems;

5.Rooms where odors or harmful substances are generated during production should be equipped with exhaust systems;

6.Air supply terminals should preferably use diffuser outlets or double-layer louvered outlets.

Air purification in clean areas should use primary, medium, and high-efficiency three-stage filtration.

Purified air conditioning systems should make reasonable use of return air.

The following rooms should maintain relative negative pressure compared to adjacent clean rooms:

1.Rooms where dust is generated;

2.Rooms where hot, humid gases and odors are generated;

3.Rooms where organic solvents are used;

4.Rooms with special process requirements.

Relevant standards:

"Good Manufacturing Practice for Drugs" (2010)

GB 51069-2014 Technical Standards for Traditional Chinese Medicine Production Engineering

GB 50457-2019 Design Standards for Clean Rooms in the Pharmaceutical Industry

GB 50073-2013 Design Code for Clean Rooms

GB 51110-2015 Code for Construction and Quality Acceptance of Clean Rooms

GB 50019-2015 Design Code for Heating, Ventilation, and Air Conditioning in Industrial Buildings

GB 50243-2016 Code for Quality Acceptance of Ventilation and Air Conditioning Engineering Construction

GB 50016—2014 (2018 Edition) Code for Fire Protection Design of Buildings