Structural materials
1. GMP clean room walls and ceiling panels are generally made of 50mm thick sandwich panels, which are characterized by beautiful appearance and strong rigidity. Arc corners, doors, window frames, etc. are generally made of special alumina profiles.
2. The ground can be made of epoxy self-leveling floor or high-grade wear-resistant plastic floor. If there are anti-static requirements, anti-static type can be selected.
3. The air supply and return ducts are made of thermally bonded zinc sheets and are pasted with flame-retardant PF foam plastic sheets that have good purification and thermal insulation effects.
4. The hepa box is made of powder coated steel frame, which is beautiful and clean. The punched mesh plate is made of painted aluminum plate, which does not rust or stick to dust and should be cleaned.
GMP clean room parameters
1. Number of ventilations: class 100000 ≥ 15 times; class 10000 ≥ 20 times; class 1000 ≥ 30 times.
2. Pressure difference: main workshop to adjacent room ≥ 5Pa
3. Average air velocity: 0.3-0.5m/s at class 10 and class 100 clean room;
4. Temperature: >16℃ in winter; <26℃ in summer; fluctuation ±2℃.
5. Humidity 45-65%; the humidity in GMP clean room is preferably around 50%; the humidity in electronic clean room is slightly higher to avoid the generation of static electricity.
6. Noise ≤ 65dB (A); fresh air supplement amount is 10%-30% of the total air supply volume; illumination 300 Lux
Health management standards
1. In order to prevent cross-contamination in GMP clean room, tools for clean room should be dedicated according to product characteristics, process requirements, and air cleanliness levels. Garbage should be put into dust bags and taken out.
2. Cleaning of the GMP clean room must be carried out before commuting and after the production process operation is completed; cleaning must be carried out while the air conditioning system of the clean room is running; after the cleaning work is completed, the purification air conditioning system must continue to operate until the specified cleanliness level is restored. The start-up operation time is generally not shorter than the self-cleaning time of GMP clean room.
3. The disinfectants used must be replaced regularly to prevent microorganisms from developing drug resistance. When large objects are moved into clean room, they must be initially cleaned with a vacuum cleaner in a normal environment, and then allowed to enter the clean room for further treatment with a clean room vacuum cleaner or wiping method;
4. When GMP clean room system is out of operation, large objects are not allowed to be moved into clean room.
5. GMP clean room must be disinfected and sterilized, and dry heat sterilization, moist heat sterilization, radiation sterilization, gas sterilization, and disinfectant disinfection can be used.
6. Radiation sterilization is mainly suitable for the sterilization of heat-sensitive substances or products, but it must be proven that the radiation is harmless to the product.
7. Ultraviolet radiation disinfection has a certain bactericidal effect, but there are many problems during use. Many factors such as the intensity, cleanliness, environmental humidity and distance of the ultraviolet lamp will affect the disinfection effect. In addition, its disinfection effect is not high and is not suitable. For these reasons, ultraviolet disinfection is not accepted by foreign GMP due to the space where people move and where there is air flow.
8. Ultraviolet sterilization requires long-term irradiation of exposed objects. For indoor irradiation, when the sterilization rate is required to reach 99%, the irradiation dose of general bacteria is about 10000-30000uw.S/cm. A 15W ultraviolet lamp 2m away from the ground has an irradiation intensity of about 8uw/cm, and it needs to be irradiated for about 1 hour. Within this 1 hour, the irradiated place cannot be entered, otherwise it will also damage human skin cells with obvious carcinogenic effect.
Post time: Nov-16-2023