GMP Workshop
GMP workshop is a type of dustproof workshop. The walls and ceiling panels of the clean room are generally made of 50mm thick sandwich color steel plates, which are beautiful and rigid. The arc corners, doors, window frames, etc. are generally made of special anodized aluminum profiles.
GMP clean room purification parameters:
Ventilation times: 100000 level ≥15 times; 10000 level ≥20 times; 1000 ≥30 times. Pressure difference: the main workshop to the adjacent room ≥5Pa Average wind speed: 10 level, 100 level 0.3-0.5m/s; temperature in winter >16℃; in summer <26℃; fluctuation ±2℃. Humidity 45-65%; the humidity of the GMP powder workshop is preferably around 50%; the humidity of the electronic workshop is slightly higher to avoid static electricity. Noise ≤ 65dB(A); Fresh air supplement is 10%-30% of the total air supply; Illuminance 300LX.
Structural materials:
1. The floor can be made of epoxy self-leveling floor or high-grade wear-resistant plastic floor. If there is an anti-static requirement, the anti-static type can be selected.
2. The air supply and return ducts are made of hot-dip galvanized plates, and flame-retardant PF foam plastic plates with good purification and heat preservation effects are pasted.
3. The high-efficiency air supply outlet uses a stainless steel frame, which is beautiful and clean, and the perforated mesh plate uses a painted aluminum plate, which is rust-free and dust-free and easy to clean.
Celine Pharma can provide whole line turnkey project solution from design, material supply to installation, we accept customized material base on clients' requirement to meet GMP standard.
Hygiene management:
In order to prevent cross contamination in GMP workshops, the tools for cleaning the facilities in the cleanroom should be used according to the product characteristics, process requirements, and air cleanliness levels. The garbage should be put into dust bags and taken out. The cleaning of the GMP workshop must be carried out before and after get off work and after the production process operation; the cleaning should be carried out after the air conditioning system in the cleanroom is running; after the cleaning work is completed, the clean air conditioning system should continue to operate until the specified clean level is restored, and the startup time is generally not shorter than the self-cleaning time of the GMP workshop. The disinfectant used should be replaced regularly to prevent microorganisms from developing drug resistance. When large objects are moved into the workshop, they should first be vacuumed and purified with a vacuum cleaner in the general environment, and then allowed to enter the cleanroom and further processed with a clean room vacuum cleaner or wiping method; large objects are not allowed to be moved into the cleanroom during the period when the purification system of the GMP workshop is stopped.
The GMP workshop should be disinfected and sterilized, which can be done by dry heat sterilization, moist heat sterilization, radiation sterilization, gas sterilization, and disinfectant disinfection. Radiation sterilization is now introduced, which is mainly suitable for the sterilization of heat-sensitive substances or products, but it must be proved that the radiation is harmless to the product. Ultraviolet radiation disinfection has a certain bactericidal effect, but there are many problems in its 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 it is not suitable for spaces with personnel activities and airflow. These reasons make ultraviolet disinfection not accepted by foreign GMP. Ultraviolet sterilization requires long-term irradiation of the exposed object. For indoor irradiation, when the sterilization rate is required to reach 99%, the general bacterial irradiation dose is about 10000-30000uw.S/cm. A 15W ultraviolet lamp 2m above the ground has an irradiation intensity of about 8uw/cm, which requires irradiation for about 1h. Within this 1h, the irradiated place cannot be entered, otherwise it will also damage human skin cells and have obvious carcinogenic effects.