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GMP Sterile Aseptic ISO Clean Rooms Physical Chemical Laboratories
GMP Sterile Clean Aseptic Laboratory
Non-sterile areas are generally equipped with physical and chemical laboratories and research and development laboratories.
PCR gene amplification laboratory is again not discussed, its layout solidified, rigorous.
Conventional quality control area for GMP field, and the production area, storage area, office area, water and electrical power area constitute a common GMP factory (pharmaceutical factory, medical equipment factory, food factory, cosmetics factory, etc.).
The conventional quality control area includes sterile experimental area, sampling room, physical and chemical laboratory, and research and development laboratory.
Most factories of the sterile area commonly divided into non-clean area preparation room and Class10000 positive control room, class 10000 sterility test room, class 10000 microbial limit test room, and personal clean auxiliary room (hand washing, wear Sterile clothes, hand-buffering, laundry, sanitary ware, stationware washing).
In the three class 10,000 (2013 new GMP C grade) rooms, relative negative pressure on the other two rooms in the positive control room , 100%independent fresh air conditioning and exhausted after high efficiency filtered;
Three laboratories are equipped with ultra-clean benches.
Party A shall decide whether to use the biosafety cabinet between positive controls, and there is no mandatory requirement in the current standard.
Temperature requirements: 22 + 2 ℃,
Humidity RH = 45% ~ 65%; This is different from the low-level production area (18 ~ 28 ℃);
Is the constant temperature and humidity air conditioner used?
Depends on the country area
