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Clean room pharmaceutical production environment requirements
by：PHARMA
2022-05-14
Clean clean room modular pharmaceutical production environment requirements
When the clean room pharmaceutical production process and products have special requirements for temperature and humidity, they should be determined according to the requirements of the process and products; when the process and products have no special requirements for temperature and humidity, the air cleanliness levels are A, B, C Class clean room temperature should be 20℃-24℃, relative humidity...
Text label: clean room engineering, clean room production environment, clean room design
Environmental requirements for clean room pharmaceutical production
When the clean room pharmaceutical production process and products have special requirements for temperature and humidity, they should be determined according to the requirements of the process and products; when the process and products have no special requirements for temperature and humidity, the air cleanliness levels are A, B, C Class D clean room temperature should be 20°C-24°C, relative humidity should be 45%-60%, air cleanliness class D temperature should be 18°C-26°C, relative humidity should be 45%-65%; The air static pressure difference between clean rooms of cleanliness level and between clean room and non-clean room should not be less than 10Pa, and the static pressure difference between clean clean room modular and outdoor atmosphere should not be less than 10Pa. The illuminance value of general lighting in the main studio should be 300lx; the illuminance value of auxiliary studios, corridors, air locks, personnel purification and material purification rooms should be 200lx; production positions with special requirements for contrast can be adjusted locally according to needs.
The noise level of the non-unidirectional flow pharmaceutical clean room should not be greater than 60dB(A), and the noise level of the unidirectional flow and mixed flow clean clean room modular should not be greater than 65dB(A) in the empty state. The temperature range should be 10°C-30°C; the temperature range should be less than or equal to 20°C for a cool storage environment; the temperature range for a cool and dark storage environment should be less than or equal to 20°C, and direct sunlight should be avoided; low temperature The temperature range of the storage environment should be 2°C-10°C; the relative humidity of the storage environment should be 35%-75%; when the storage items have special requirements, the temperature and humidity parameters of the environment should be determined according to the properties of the items. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean rooms and clean workshops.
The general layout of the factory area should meet the general layout design requirements of relevant national industrial enterprises, meet the requirements of environmental protection, and at the same time avoid cross-contamination; clean workshops should be arranged in a clean environment in the factory area, and people and logistics do not cross or rarely cross The production area should be located on the upwind side of the preparation production area with the minimum frequency wind direction throughout the year, and the areas with serious pollution such as three waste treatment and boiler room should be located in the factory area with the minimum frequency wind direction throughout the year. Windward side; a combined factory building with multiple production lines and multiple production workshops should reasonably organize the flow of people and logistics, and at the same time meet the requirements of the production process and fire safety requirements; when there is an animal room in the factory building, the animal room should be It is located on the windward side of the minimum frequency wind direction of its clean workshop throughout the year; the main roads in the factory area should be set up in accordance with the principle of flow of people and logistics, and the road surface around the clean workshop should be made of materials with good integrity and less dust.
The , essentially perfected by extraction machine, is one of the first home appliance to be widely distributed.
SUZHOU PHARMA MACHINERY CO.,LTD. will accomplish this by exceeding the expectations of our customers while conserving resources and preserving the quality of the environment.
Though the cost of these sustainability initiatives as CUSTOM SOLUTION SERVICES can be high, harnessing the power of an ethical supply chain to appeal to conscientious consumers can be a smart move both ethically and financially.
When the clean room pharmaceutical production process and products have special requirements for temperature and humidity, they should be determined according to the requirements of the process and products; when the process and products have no special requirements for temperature and humidity, the air cleanliness levels are A, B, C Class clean room temperature should be 20℃-24℃, relative humidity...
Text label: clean room engineering, clean room production environment, clean room design
Environmental requirements for clean room pharmaceutical production
When the clean room pharmaceutical production process and products have special requirements for temperature and humidity, they should be determined according to the requirements of the process and products; when the process and products have no special requirements for temperature and humidity, the air cleanliness levels are A, B, C Class D clean room temperature should be 20°C-24°C, relative humidity should be 45%-60%, air cleanliness class D temperature should be 18°C-26°C, relative humidity should be 45%-65%; The air static pressure difference between clean rooms of cleanliness level and between clean room and non-clean room should not be less than 10Pa, and the static pressure difference between clean clean room modular and outdoor atmosphere should not be less than 10Pa. The illuminance value of general lighting in the main studio should be 300lx; the illuminance value of auxiliary studios, corridors, air locks, personnel purification and material purification rooms should be 200lx; production positions with special requirements for contrast can be adjusted locally according to needs.
The noise level of the non-unidirectional flow pharmaceutical clean room should not be greater than 60dB(A), and the noise level of the unidirectional flow and mixed flow clean clean room modular should not be greater than 65dB(A) in the empty state. The temperature range should be 10°C-30°C; the temperature range should be less than or equal to 20°C for a cool storage environment; the temperature range for a cool and dark storage environment should be less than or equal to 20°C, and direct sunlight should be avoided; low temperature The temperature range of the storage environment should be 2°C-10°C; the relative humidity of the storage environment should be 35%-75%; when the storage items have special requirements, the temperature and humidity parameters of the environment should be determined according to the properties of the items. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for clean rooms and clean workshops.
The general layout of the factory area should meet the general layout design requirements of relevant national industrial enterprises, meet the requirements of environmental protection, and at the same time avoid cross-contamination; clean workshops should be arranged in a clean environment in the factory area, and people and logistics do not cross or rarely cross The production area should be located on the upwind side of the preparation production area with the minimum frequency wind direction throughout the year, and the areas with serious pollution such as three waste treatment and boiler room should be located in the factory area with the minimum frequency wind direction throughout the year. Windward side; a combined factory building with multiple production lines and multiple production workshops should reasonably organize the flow of people and logistics, and at the same time meet the requirements of the production process and fire safety requirements; when there is an animal room in the factory building, the animal room should be It is located on the windward side of the minimum frequency wind direction of its clean workshop throughout the year; the main roads in the factory area should be set up in accordance with the principle of flow of people and logistics, and the road surface around the clean workshop should be made of materials with good integrity and less dust.
The , essentially perfected by extraction machine, is one of the first home appliance to be widely distributed.
SUZHOU PHARMA MACHINERY CO.,LTD. will accomplish this by exceeding the expectations of our customers while conserving resources and preserving the quality of the environment.
Though the cost of these sustainability initiatives as CUSTOM SOLUTION SERVICES can be high, harnessing the power of an ethical supply chain to appeal to conscientious consumers can be a smart move both ethically and financially.
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