1, according to the process of forward layout, to reduce the production process of the roundabout, round trip。 As the process is carried out by the partition, so the layout is compact and smooth. Air Purification Equipment Purification Principle: Airflow → Primary Air Treatment → Air Conditioning → Medium Air Treatment → Fan Air Supply → Purification Piping → High Efficiency Air Supply Door → Clean Room → Take Dust (Bacteria) → Air Recipe → Fresh Air, Chen Xiao Air deal with. Repeat the above process, you can achieve the purpose of purification.
2, clean the plant staff and materials must be set separately, raw materials and finished products should be separated from the entrance to prevent the source material, intermediates and semi-finished products between the cross-contamination. Arrangement to avoid unrelated personnel or logistics through the production area。 Cleaning equipment washing, storage room, maintenance room should not be located in the clean production area; clean overalls washing, drying room clean level generally lower than the production area of a level, and aseptic clothing finishing, sterilization room, its The cleanliness level should be the same as the production area.
3, the production area (including inspection, packaging) and raw materials, finished product storage area to minimize the distance to avoid the transport of drugs due to pollution; for highly polluting materials and waste, if necessary, can be set up a dedicated entrance。 Weighing room should be close to the original material library, the clean level should be the same with the ingredients room。 For 100,000 and more than 100,000 clean room equipment and containers with cleaning room can be arranged in the region, the higher the level of 100, 10000 clean room cleaning room should be located in the clean area, the clean level Can be lower than the production area of a level.
4, personnel and materials into the clean room to have their own purification room and facilities, purification room requirements and production areas of the clean level to adapt. Personnel and materials used in the elevator should be separated, and the elevator should not be set in the clean area, must be set, the elevator should be set before the air valve.
5, the air clean height of the room or area should be placed in the least arrived at the place, and should be close to the air conditioning room. Different clean rooms or areas should be the level of air cleanliness from the inside and outside the layout; cleanliness of the same room or area of the layout should be relatively concentrated. Cleanliness of different rooms when interrelated, to prevent cross-contamination measures such as air lock room, air blowing shower, buffer or transfer window.
6, should try to reduce the clean area of the area, clean room should only place the necessary process equipment and facilities, indoor staff should be controlled at a minimum。 At the same time, should also take into account the raw materials, semi-finished and finished product storage area and production scale to adapt. Technical parameters: pressure difference: the main workshop relative to the adjacent room ≥ 5Pa; temperature: winter> 16 ℃ ± 2 ℃; summer <26 ℃ ± 2 ℃; relative humidity: 45-65% (RH); noise ≤ 65dB (A); Fresh air replenishment: the total air volume of 20% -30%; illumination: ≥ 300Lux.
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