How should the clean room be properly maintained and managed

How should the clean room be properly maintained and managed

In the past two decades, domestic clean technology has been developing rapidly, and various scales and grades of clean rooms have played an increasingly important role in the medical, biological and pharmaceutical industries, making important contributions to improving product quality and developing high-tech products.

The correct and reasonable design is the premise to ensure the stable operation of the clean room. However, in the operation and maintenance management, if the operation is not scientific and strict, the air cleanliness of the clean room will gradually decline, resulting in a number of indicators in the actual production environment deviated from the requirements, so that product quality drops, or even unqualified. Therefore, correct and scientific maintenance of clean room is very important.

Personnel management

People are one of the major sources of pollution, especially the activities of workers in the clean environment, which will obviously increase the pollution degree of the clean environment. Therefore, the enterprise shall establish the responsibilities of full-time management personnel, the admittance system for clean room personnel, the education provisions for personnel training, and the management of "clean procedures" for personnel entering clean room.

Logistics management

The entry of materials, the entry of all kinds of equipment, as well as the maintenance and management of related equipment and pipelines, shall not bring microorganism and microorganism into the room.

Cleanliness management

The cleanliness management of clean room includes the purchase and production of clean clothes, use management of clean clothes, cleaning regulations of clean clothes, etc.

Cleaning and sterilization management

To clean and sterilize all kinds of equipment and facilities in dust-free room, the period and inspection shall be clearly stipulated to prevent and eliminate the generation, retention and reproduction of dust particles and microorganisms in dust-free room.

Strict maintenance and management of all kinds of equipment and facilities

Corresponding operating procedures shall be formulated to ensure the normal operation of all kinds of equipment and facilities, including purification of air conditioning system, various water and electricity systems, production process equipment and apparatus, etc., so as to ensure product production process requirements and air cleanliness level.

Regular maintenance inspection

Monitor the normal operation and maintenance of the dust-free room during its use, and check the indoor operation status and related facilities regularly.

For example, a particle counter is used to measure the number of particles controlling the particle size at a specified time and place; Determine the number of sedimentation colony or plankton in the specified time and place; In respect of temperature and humidity, measure and check the continuous record at the specified time and place.

For another example, measure the pressure difference of the high efficiency filter of the purification air conditioning system, check whether the air filter is blocked, whether the sealing gasket installed is intact or leakage caused by the damage of the filter, and use the anemometer to check the air volume of the local exhaust device. Determine noise values at specified time and place using a noise meter.

In addition, the operating state, dust and dirt of the fan bearing and the fan, as well as the corrosion and dirt of the air supply and return pipe interior and air supply outlet shall be checked. Inspect dust-free rooms for maintenance cleaning, roof and wall cracks or corrosion; If there are any abnormal phenomena in the coating state, machinery and equipment, etc., they must be checked one by one, and none of them should be omitted. Use the illumination meter to determine the illumination value at the specified time and place; Use the pressure difference meter to measure the static pressure difference inside and outside the dust-free room.

In the biopharmaceutical industry, it is the duty and responsibility of pharmaceutical companies and pharmaceutical equipment companies to ensure the quality of pharmaceutical production, and it is also an important guarantee for people's health. The reasonable design and correct maintenance and management of clean room of dustless workshop is one of the key elements. Therefore, enterprises should constantly improve the equipment equipment in clean rooms of dustless workshops and the equipment isolation system to avoid cross-contamination of the equipment itself, so as to lay a solid foundation for the improvement of pharmaceutical quality.

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