According to the analysis of American FDA(Food and Drug Administration) data. The pollution caused by operators in the sterile room will reach 95% of the total pollution sources. How to control people’s contamination of drugs is an urgent problem to be solved. Therefore, in order to ensure the cleanliness of clean rooms, first of all, human factors should be controlled.
1.Clean rooms capacity.
The number of people entering the clean room must be strictly controlled, generally 4 to 6 people is appropriate. The number of people entering the clean room should be based on the area of the work area to determine the number of people that can be accommodated in the area, rather than the number of people in the entire clean room (area). If the number of temporary outsiders exceeds the number of people in the area to be entered, they can enter in batches.
2.Personnel management in clean rooms.
In the clean room, the operator must wear clean clothes and cannot bring foreign clothes into the clean room. Personnel in clean areas should walk as little as possible, and when they have to walk, their walking speed should be reduced as much as possible. Do regular physical examination for cleanroom operators. When personnel are not in good health and should not enter the clean room. According to research, a sneeze can produce more than 4000 fine particles per cubic meter.
3.Flow of Personnel and Material in Clean Rooms.
The entry and exit of personnel and materials in clean rooms should be prevented from cross-contamination. In terms of material factors, buffer facilities should be set up between clean room and non-clean room. And the flow of people and goods in clean room should be reasonable. Personnel flow, equipment transmission, material transfer, etc. should avoid cross-contamination and mixing of products, and should pay attention to the layout and area of personnel locker room, and the reasonable distribution of material entry modes. The material entry is not suitable to use pass box, buffer room is appropriate
4.Disinfection of Clean Rooms.
Clean rooms (districts) shall be sterilized regularly according to the documents, disinfectants shall not pollute equipment, materials and finished products, and the varieties of disinfectants shall be changed periodically in order to prevent the emergence of drug-resistant strains, and the replacement cycle of disinfectant varieties shall be stipulated in the documents.