The Pharmaceutical production enterprises must have a clean production environment and a certain amount of green area. It requires the ground of the factory area must be all hardened, and roads and transportation should not cause pollution to the production of pharmaceuticals. What’s more, the overall layout of production, administration, living, and auxiliary areas should be reasonable and mutually exclusive. Separate and must not interfere with each other. Youthtech is a professional cleanroom supply manufacturer in China. In this post, we will share with you the GMP cleanroom requirements for cleanroom.
Clean area surface of gmp cleanroom requirements
The inner surface of the cleanroom (area) should be flat and smooth, free of cracks, tight joints, no particles falling off, and able to withstand cleaning and disinfection. The junction of the wall and the scene should be curved, or other measures should be taken to reduce accumulation and facilitate clean.
Illumination requirements in clean areas
The illuminance of the main studio should not be less than 300 lux; the production parts with special requirements for illuminance can be equipped with local lighting.
Cleanroom (area) air cleanliness requirements
The air cleanliness of the pharmaceutical production clean room (area) is divided into four levels, namely, class 100, class 10,000, class 100,000, and class 300,000.
The air entering the cleanroom (area) must be purified, and the air cleanliness level shall be divided according to the requirements of the production process. The number of microorganisms and dust particles in the air in the cleanroom (area) should be monitored regularly, and the monitoring results should be recorded and archived. Pressure difference requirements between clean room and non-clean room, adjacent rooms of different cleanliness levels
The static pressure difference between adjacent rooms with different air cleanliness levels should be greater than 5 Pa, the static pressure difference between the cleanroom (area) and the outdoor atmosphere should be greater than 10 Pa, and there should be a device (differential pressure gauge) indicating the pressure difference.
Air purification requirements for entering the clean area
The air entering the clean area is filtered by three-stage primary, medium, and high-efficiency filters to make the air reach the required cleanliness level. Since the high-efficiency filter can filter out dust particles less than 1μm (micrometer), the penetration rate of bacteria is 10-6, so the air passing through the high-efficiency filter can be regarded as sterile.
Cleanroom temperature and relative humidity requirements.
The temperature and relative humidity of the cleanroom (area) should be compatible with the requirements of the pharmaceutical production process. When there is no special requirement, the temperature should be controlled at 18～26℃, and the relative humidity should be controlled at 45～65%.
GMP requires that the production enterprise have good production equipment, a good production process, perfect quality management, and a strict inspection system to ensure that the quality of the final product (including food safety and sanitation) meets the legal requirements.
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