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Cleanroom maintenance and management

Cleanroom maintenance and management

In the past two decades, clean domestic technology has developed rapidly. Clean rooms of various scales and levels play an increasingly important role in medical, biopharmaceutical, and other industries and contribute to improving product quality and developing high-tech products. Correct and reasonable design is the prerequisite to ensure the stable operation of the cleanroom. However, suppose the operation and maintenance management are unscientific and not strict. In that case, the air cleanliness of the cleanroom will gradually decrease, causing many indicators in the actual production environment to deviate from the specified requirements, resulting in product quality degradation or even unqualified Happening. Therefore, it is crucial to maintain a clean room correctly and scientifically.

Personnel management

Among the many pollution sources in the clean workshop, people are one of the primary pollution sources, especially the activities of the staff in the pristine environment, which will significantly 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, personnel training and education regulations, and the management of “personal clean procedures” for personnel entering the cleanroom.

Logistics management

The entry of materials and the maintenance and management of related equipment and pipelines shall ensure that no particles and microorganisms enter the room. Cleanliness management The cleanliness management of the cleanroom includes the procurement and production of clean clothes, the direction of the use of clean clothes, and the cleaning regulations of clean clothes.

Cleaning and sterilization management

The cleaning and sterilization methods, cycles, and inspections of various equipment and facilities in the cleanroom are stipulated to prevent and eliminate the generation, retention, and reproduction of dust particles and microorganisms.

Cleaning and sterilization management

The cleaning and sterilization methods, cycles, and inspections of various equipment and facilities in the cleanroom are stipulated to prevent and eliminate the generation, retention, and reproduction of dust particles and microorganisms.

Strict maintenance and management of various equipment and facilities

The corresponding operating procedures should be developed to ensure the regular operation of various equipment and facilities as required, including air-conditioning purification systems, water and electricity systems, production process equipment and appliances, etc., to ensure product production process requirements and air cleanliness levels.

Regular maintenance inspection

Monitor the regular operation and maintenance of the cleanroom during use, and conduct regular inspections of the indoor operating conditions and related facilities. For example, at a specified time and place, use a particle counter to measure the number of particles with controlled particle size; measure the number of settled colonies or planktonic bacteria at a specified time and place; in terms of temperature and humidity, measure and check the continuous measurement at the specified time and place recording. For another example, measure the pressure difference of the high-efficiency filter of the air conditioning system, check whether the air filter is blocked, whether the installed gasket is intact or the leak caused by the filter damage, use an anemometer to check the air volume of the local exhaust device; use noise The analyzer measures the noise value at the specified time and place. In addition, check the operation status of the blower bearing, blower, dust, and dirt, as well as the corrosion and dirt inside the air supply and return ducts and the air supply outlet; check whether the cleanroom is kept clean and whether there are cracks or cracks on the ceiling and wall. Corrosion, coating status, machinery, and equipment for abnormal phenomena, etc., must be checked one by one, and no one can be omitted; use the illuminance meter to measure the illuminance value at the specified time and place; use the differential pressure meter to determine the indoor and outdoor cleanroom Static pressure difference, etc.

In the biopharmaceutical industry, ensuring the quality of pharmaceutical products is the duty and responsibility of pharmaceutical companies and pharmaceutical equipment companies. It is also an essential guarantee for people’s health. Good design and correct maintenance and management of the cleanroom in the cleanroom are crucial elements. Therefore, companies should continue to improve the equipment and equipment in the cleanroom of the cleanroom and the isolation system of the equipment to avoid cross-contamination of the equipment itself to lay a solid foundation for the improvement of pharmaceutical quality.

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