クリーンルームでの人員の汚染を管理する

Clean room: アメリカFDAの分析によると(食品医薬品局) データ, 無菌室のオペレーターによって引き起こされた汚染は 95% 総汚染源の. How to control people’s contamination of drugs is an urgent problem. したがって, in order to ensure the cleanliness of clean rooms, first of all, should control the human factors.

1.Clean room capacity.

The number of people entering the cleanroom must control strictly , generally 4 に 6 people is appropriate, generally 4 に 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

In the clean rooms, the operator must wear clean clothes and cannot bring foreign clothes into the cleanroom. Personnel in clean areas should walk as little as possible. And when they have to walk, their walking speed should reduce 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

The entry and exit of personnel and materials in clean rooms with different air cleanliness levels should prevent from cross-contamination. In terms of material factors, between clean room and non-clean room should set up buffer facilities. And the flow of people and goods in clean room should be reasonable. Personnel flow, equipment transmission, material transfer, 等. 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

クリーンルーム (districts) shall sterilize regularly according to the documents, disinfectants shall not pollute equipment, materials and finished products, and the varieties of disinfectants shall change periodically in order to prevent the emergence of drug-resistant strains. Documents should stipulate the replacement cycle of disinfectant