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How to Check the Enclosure Structure of Clean Room in Pharmaceutical Industry

Oct 22,2020

Compliance of process flow

The process layout must be evaluated in detail with the departments of technology, production and quality. The engineering department mainly analyses the layout of function rooms, equipment parameters and performance, including the trend of people flow, the setting of changing rooms, the trend of logistics and the scale of each function. Dressing room should pay attention to the number of personnel and facilities. Processing, production and quality departments should focus on the smoothness of crushing, sieving, granulation, mixing, pressing, filling, outsourcing or preparation, fermentation, filtration and purification, sterilization, filling, sealing, rolling and capping, and other processes in accordance with the product process and production capacity, so as to prevent the process routes from turning back and reduce cross-contamination. If explosion-proof function is needed, attention should be paid to whether the setting of the explosion release surface is in conformity with the regulations. The total area, length and width of each function should be defined, and the room height should be determined according to the equipment height and operation mode. Determining the length and width of the room is the precondition for arranging the air outlets reasonably, and the rectangle is the best one among the main functions. Determine the pressure difference data between the functions, and pay attention to whether the opening of the door between the functions meets the requirements of controlling the pressure difference. The number of air exchange between different functions was determined, and the return air, fresh air ratio, dust collection mode (whether using weighing cover) and exhaust air ratio were discussed.

The more detailed the discussion of the drawings in this stage, the more helpful it will be to the parameter setting of the purification air conditioning unit and the determination of the direction of the air duct, and the more in line with the actual needs of the process.

Enclosure structure

Discuss whether the color steel plate is machine-made or hand-made. Discusses whether the sandwich wall panel is made of rock wool sandwich wall panel, glass-magnesium hollow sandwich wall panel or aluminum honeycomb sandwich wall panel, etc. Discuss the thickness of steel plate and the color of finish paint; Doors and windows (hollow glass window or ordinary purification window); Lamps (embedded LED flat or ordinary purification lamp); Floor (epoxy, PVC, colored sand, etc.) material requirements.

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How to Check the Enclosure Structure of Clean Room in Pharmaceutical Industry

Compliance of process flow

Enclosure structure

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