GMP pharmaceutical companies to undertake housing, clean electronics plant, food, beverages, cosmetics, biological, chemical, solar, semiconductor, health care products, CDs, sterile laboratory, hospital laminar flow operating room and ICU ward, research institutes and tertiary institutions air purification engineering school in recent years, completed more than one hundred. According to the needs of various industries and industry requirements, purification level from 10 to 300,000, the project works are detected by the relevant authorities, such as local and Drug Administration according to GMP standards of acceptance, one-time pass rate of 100%, and the creation of many successful examples.
A pharmaceutical clean room (area) of temperature and humidity, should meet the following requirements:
1, the production process of temperature and humidity, no special requirements, air cleanliness 100, 10000 pharmaceutical clean room (area) temperature should be 20 ~ 24 ℃, relative humidity should be 45% to 60%; air cleanliness 100000 level, 300,000 medical clean room (area) temperature should be 18 ~ 26 ℃, relative humidity should be 45% to 65%.
2, when the temperature and humidity of the production process with special requirements should be determined according to the process requirements.
3, personnel decontamination and living room with a temperature in winter should be 16 ~ 20 ℃, the summer should be 26 ~ 30 ℃.
Second, the air static pressure difference between the air cleanliness class pharmaceutical clean room (area) and pharmaceutical clean room (area) and non-clean room (area) should be not less than 5Pa, pharmaceutical clean room (area) and outdoor atmospheric static pressure differential of not less than 10Pa.
Third, pharmaceutical clean room (area) should be provided according to the production requirements of illumination, and shall meet the following requirements:
1, the main studio general lighting illuminance values appropriate for the 300lx.
2, auxiliary studio corridors, airlocks, personnel and material purification purification chamber illuminance values should not be less than 150lx.
3, the control of the production sites have special requirements can be set to local lighting.
Fourth, non-unidirectional flow pharmaceutical clean room (area) of the noise level (empty state) should not exceed 60dB (A), the one-way flow and mixed flow pharmaceutical clean room (area) of the noise level (empty state) should not exceed 65dB (A).