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How can a clean room be maintained to prevent a drop in air cleanliness?

日期:2020-07-09 16:09
浏览次数:26
摘要:In the process of drug production, it is necessary to prevent air particle and microbial pollution and cross-contamination. Clean room is a controlled indoor environment to meet the high cleanliness production environment, and its stable operation is an important guarantee for the clean production of pharmaceutical enterprises. The industry said that the correct and reasonable design is the premise to ensure the stable operation of clean room, but if you do not pay attention to
In the process of drug production, it is necessary to prevent air particle and microbial pollution and cross-contamination. Clean room is a controlled indoor environment to meet the high cleanliness production environment, and its stable operation is an important guarantee for the clean production of pharmaceutical enterprises.





The industry said that the correct and reasonable design is the premise to ensure the stable operation of clean room, but if you do not pay attention to the operation and maintenance or scientific operation, will make the clean room air cleanliness gradually decline, resulting in the actual production environment of a number of indicators deviate from the requirements, thus product quality decline, even unqualified situation. Therefore, correct and scientific maintenance of clean rooms is very important. So what do you need to pay attention to when maintaining a clean room?



First, personnel pollution is the main source of pollution, the activities of staff in the clean environment, will significantly increase the degree of pollution in the clean environment. Therefore, enterprises should formulate the duties of full-time management personnel, the access system for clean room personnel, personnel training and education regulations, and the "human net procedure" management for entering clean room personnel.



Secondly, the facilities in the clean room, such as floor, wall, ceiling and so on, are diffusing particles. Therefore, when materials enter, all kinds of equipment into, and related equipment, pipeline maintenance management, should do not bring particles, microorganisms into the room. At the same time, enterprises should formulate the cleaning and sterilization methods for various equipment and facilities in the clean room, and make clear provisions on the cycle and inspection to prevent and eliminate the generation, retention and reproduction of dust particles and microorganisms in the clean room.



Third, staff entering the clean room need to wear clean clothes, clothing materials, use, cleaning and other issues need to be taken seriously. Enterprises should do a good job in the management of clean clothes, including the purchase and production of clean clothes, clean clothes use management, clean clothes cleaning provisions and so on.



Fourthly, the safe operation of various types of equipment is the prerequisite to ensure the safety of clean room shall formulate the corresponding operational procedures, ensure all kinds of equipment, the facility functioning as required, including purifying air conditioning system, all kinds of hydropower systems, production techniques, equipment and instruments, etc, to ensure that the product production process requirement and air cleanliness level.



In addition, enterprises should conduct regular maintenance and inspection of clean rooms. For example, at a specified time, place, with a particle counter to determine the number of particles control particle size; To determine the number of sedimentation colonies or the number of bacteria in the specified time and place; In terms of temperature and humidity, measure and check the continuous measurement records at the specified time and place.



Another example is to measure the differential pressure of the filter in the purifying air conditioning system, check whether the air filter is blocked, whether the sealing gasket installed is intact or the leakage situation caused by the damage of the filter, and use the anemometer to check the air volume of the local exhaust device; Use the noise measuring instrument to measure the noise value at the specified time and place.



To sum up, pharmaceutical companies need to strictly control the cleanliness of clean rooms from the aspects of personnel, equipment, facilities, reasonable management, regular maintenance and inspection. Ensure pharmaceutical enterprise of pharmaceutical production environment clean is a key factors to ensure drug safety production, enterprise in addition to select reasonable design of clean room and clean system, also need to clean room for the correct and reasonable maintenance and management, always put the safety and quality production to hang in the heart, perfecting dust-free workshop clean room facilities and equipment of the isolation system to avoid a cross contamination with the device itself, for the improvement of drug quality lay a solid foundation.