1. According to the production process. The process should be as short as possible to reduce cross reciprocating, and the flow of people and logistics should be reasonable. It must be equipped with personnel purification room (coat storage room, washroom, clean work clothes room and buffer room), material purification room (unpacking room, buffer room and double-layer transfer window). In addition to the room required for product process, it should also be equipped with sanitary ware room, laundry room, temporary storage room, cleaning room for working equipment, etc. each room is independent of each other, and the area of clean workshop should be guaranteed to be basic Under the premise, it is suitable for the production scale.
2. According to the air cleanliness level, it can be written from low to high according to the direction of people flow; the workshop is from inside to outside, from high to low.
3. There is no cross contamination in the same clean room (area) or between adjacent clean rooms (areas). The production process and raw materials will not affect the product quality; there are airlocks or anti pollution measures between clean rooms (areas) of different levels, and materials are transported through double-layer transfer windows.
4. The air purification should meet the requirements of Chapter 9 of GB 50457-2008 code for design of clean workshop in pharmaceutical industry. The amount of fresh air in the clean room should be taken as follows:
1) Compensation of indoor exhaust air volume and fresh air volume required for keeping indoor positive pressure;
2) When there is no one in the room, the fresh air should not be less than 40m3 / h.
5. The per capita area of purification workshop shall not be less than 4mm (except for corridor, equipment and other items) to ensure the operation area.
6. If it is an in vitro diagnostic reagent, it shall meet the requirements of the implementation rules for in vitro diagnostic reagent production (Trial). Among them, the treatment of negative and positive serum, plasmid or blood products should be carried out in an environment of at least ten thousand level, keep relative negative pressure with the adjacent area, and meet the protection requirements.
7. The direction of return air, supply air and water supply pipeline shall be indicated.
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