Temperature and humidity requirements for production environment of pharmaceutical GMP workshop
Temperature and humidity requirements for production environment of pharmaceutical GMP workshop
The clean area of u200bu200bthe pharmaceutical GMP workshop is generally controlled at 20-24°C and the relative humidity is 45%-60%. The production workshop and auxiliary workshop with certain cleanliness requirements are generally controlled at 18-28°C and the relative humidity is 50%- 65%. Different levels of GMP workshops and clean areas and non-clean areas...
Text label: GMP pharmaceutical cleanroom design, GMP workshop engineering, ambient temperature and humidity requirements
Pharmaceutical GMP workshop production environment temperature and humidity requirements
The clean area of u200bu200bthe pharmaceutical GMP workshop is generally controlled at 20-24°C and the relative humidity is 45%-60%. The production pharmaceutical cleanroom and auxiliary pharmaceutical cleanroom with certain cleanliness requirements are generally controlled at 18-28°C and the relative humidity is 50%- 65%. The static pressure difference between different levels of GMP workshops and the clean area and the non-clean area should be greater than or equal to 5Pa, and the relative negative pressure should be maintained between the operation room where the dust is raised in the production process and other operation rooms or front rooms; Equipment that is in direct contact with no drugs should be made of materials that do not work with drugs, and the combination of the finished product conveyor belt and the sub-packaging conveyor belt in the pharmaceutical workshop should be avoided as much as possible to prevent return pollution. , A sterilizing ultraviolet lamp is set in the window, and a plexiglass dust cover is set on the upper part of the sub-packaging belt; when different varieties are produced in the same production area, strict management and isolation measures should be taken to prevent mixing and cross-infection.
All kinds of pipes, lamps, tuyere and other public facilities in the clean space should be designed and installed to avoid parts that are not easy to clean; the waste gas discharged from the production of penicillin should be purified and meet the requirements , the air outlet should be far away from the air inlet of other air purification systems; the water seal must be set up below the water outlet in the pharmaceutical GMP workshop; the dynamic noise should not exceed 60dB(A)-75dB(A), and the lighting fixtures should be ceiling-mounted. And set up emergency lighting as needed. In order to sterilize the surface, you should also set up ultraviolet lamps in appropriate locations, supplemented by other disinfection and sterilization measures. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and sterile workshops.
The air-conditioning purification system is divided according to different varieties, because different varieties such as 'sterile drugs' have different requirements for air cleanliness and prevention of cross-contamination; according to different dosage forms, because the dosage form has different effects on the parameters, The requirements of the method are different; according to different cleanliness levels, because the parameters and air volume of different levels are different; according to the operating shift, because it is conducive to energy saving and management; according to the floor or plane partition, because it is convenient to arrange pipelines and machine rooms .
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