In the production process, drugs need to prevent particulate and microbial contamination and cross-contamination in the air. The clean room is a controllable indoor environment generated to meet the high-cleanness production environment. Its stable operation is an important guarantee for the clean production of pharmaceutical companies.
According to the industry, correct and reasonable design is the prerequisite for ensuring stable operation of the clean room. However, if the operation and maintenance or unscientific operation is not taken seriously, the cleanliness of the clean room will gradually decrease, resulting in deviation of many indicators in the actual production environment. The requirements are specified, so that the quality of the product is degraded or even unqualified. Therefore, the correct and scientific maintenance of the clean room is very important. So, what should you pay attention to when maintaining the clean room?
First, personnel pollution is the main source of pollution, and the activities of workers in a clean environment will significantly increase the pollution level of the clean environment. Therefore, enterprises should establish the duties of full-time management personnel, the access system for clean room personnel, the regulations for personnel training and education, and the management of "human net procedures" for personnel entering clean rooms.
Second, the facilities in the clean room, such as the ground, walls, ceilings, etc., are spreading particles. Therefore, when materials enter, all types of equipment enter, and maintenance and management of related equipment and pipelines, particles and microorganisms should not be brought into the room. At the same time, enterprises should formulate clearing and sterilizing methods for various equipment and facilities in clean rooms, and make clear regulations on cycle and inspection to prevent and eliminate dust particles, microbial production, retention and reproduction in clean rooms.
Third, workers need to wear clean clothes when they enter the clean room. The materials, use, and cleaning of the clothes need to be taken seriously. Enterprises should do a good job in the management of clean clothes, including the procurement and production of clean clothes, the management of clean clothes, and the cleaning regulations for clean clothes.
Fourth, the safe operation of all kinds of equipment and facilities is the premise to ensure the safety of clean rooms. It is necessary to formulate corresponding operational procedures to ensure that all types of equipment and facilities operate normally according to requirements, including purification of air conditioning systems, various hydropower systems, production process equipment and Appliances, etc., to ensure product production process requirements and air cleanliness levels.
In addition, companies should conduct regular maintenance inspections of clean rooms. For example, at a predetermined time and place, the number of particles controlling the particle size is measured by a particle counter; the number of settled colonies or the number of floating bacteria is measured at a predetermined time or place; and the temperature and humidity are measured and checked at a predetermined time and place. recording.
For example, measuring the pressure difference of the filter of the air conditioning system, checking whether the air filter is clogged, whether the installed gasket is intact or the leakage caused by the filter damage, using an anemometer to check the air volume of the local exhaust device; using noise measurement The instrument measures the noise value at a specified time and place.
In summary, pharmaceutical companies need to strictly control the cleanliness of clean rooms from the aspects of personnel, equipment, facilities, reasonable management, and regular maintenance inspections. Ensuring the clean production environment of pharmaceutical companies is a major factor in ensuring the safe production of medicines. In addition to selecting clean rooms and clean systems with reasonable design, enterprises also need to properly and reasonably maintain and manage clean rooms, and always hang safety and quality products. In the heart, we constantly improve the equipment and facilities of the clean room clean room and the isolation system of the equipment to avoid cross-contamination of the equipment itself, thus laying a solid foundation for the improvement of pharmaceutical quality.
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