How should clean rooms be maintained to avoid a decrease in air cleanliness?
During the production process of medicines, it is necessary to prevent particulate and microbial contamination and cross-contamination in the air. A cleanroom is a controllable indoor environment created to meet a high-cleanliness production environment, and its stable operation is an important guarantee for the clean production of pharmaceutical companies.
According to the industry, correct and reasonable design is the premise to ensure the stable operation of the clean room. If you do not pay attention to operation and maintenance or make an unscientific operation, the air cleanliness of the clean room will gradually decrease, causing many indicators in the actual production environment to deviate from the specified requirements, resulting in a decline in product quality or even unqualified conditions. What aspects need to be paid attention to in the process of maintaining a cleanroom?
First, personnel pollution is the main source of pollution. The activities of the staff in the clean environment will obviously increase the pollution degree of the clean environment. Therefore, enterprises should formulate the responsibilities of full-time management personnel, the access system for cleanroom personnel, the regulations on personnel training and education, and the management of “person-cleaning procedures” for personnel entering the cleanroom.
Second, the equipments in the cleanroom, such as floors, walls, ceilings, etc., are diffusing particles. Therefore, when materials and various equipment enter the cleanroom, and maintenance and management of related equipment and pipelines, it should be ensured that particles and microorganisms are not brought into the room. At the same time, enterprises should formulate cleaning and sterilization methods for various equipment and facilities in the cleanroom to prevent and eliminate the generation, retention and reproduction of dust particles and microorganisms in the cleanroom.
Third, the personnel need to wear clean clothes when entering the clean room, and the material, use, cleaning and other issues of the clothing need to be paid attention to. Enterprises should do a good job in the management of clean clothing, including the procurement and production of clean clothing, the management of clean clothing use, and the cleaning regulations of clean clothing.
Fourth, the safe operation of various equipment and facilities is the premise of ensuring the safety of cleanrooms. Corresponding operating procedures should be formulated to make various equipment and facilities operate normally as required, including purification air conditioning systems, various water and electricity systems, production process equipment and facilities, etc. In order to ensure product production process requirements and air cleanliness level.
For example, at a specified time and place, using a particle counter to measure the number of particles with controlled particle size; at a specified time and place, measuring the number of settled colonies or planktonic bacteria, etc.; in terms of temperature and humidity, measuring and checking the continuous measurement record. In addition, measuring the pressure difference of the filter of the purification air-conditioning system, checking whether the air filter is blocked, whether the installed gasket is in good condition, whether the filter is damaged or not, and check the air volume of the local exhaust device with an anemometer, using a sound level meter to measure noise levels at a specified time and place.
To sum up, pharmaceutical companies need to strictly control the cleanliness of the clean room in terms of personnel, equipment, facilities, reasonable management, and regular maintenance and inspections. Ensuring the cleanliness of the drug production environment of pharmaceutical companies is a major factor in ensuring the safe and quality production of drugs. In addition to choosing a cleanroom and cleanroom system with reasonable design, companies also need to carry out correct and reasonable maintenance and management of the cleanroom to ensure safe and quality production. Pharmaceutical companies need to continuously improve the equipment and facilities of the cleanroom and the isolation system of the equipment to avoid cross-contamination caused by the equipment itself, so as to lay a solid foundation for the improvement of pharmaceutical quality.
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