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General technical requirements for terminal sterilization large-volume injection workshop

2021-02-08

  1：The control area of the large infusion workshop includes Class D clean area, Class C clean area, and local Class A under the background of Class C. The temperature of the control area is 18~26℃, and the relative humidity is 45%~65%. Ultraviolet lamps should be installed in each process.

  2：Generally, the height of the clean production area is about 2.7m. Various pipelines including air ducts are arranged in the upper ceiling and maintenance needs are considered. The internal height of the ceiling needs to be 2.5m. Clean floor drains are required for clean production areas, and no floor drains are allowed in Class A areas.

 

  3：The floor in the large infusion production workshop is generally made of clean-resistant epoxy artesian floor. The partition wall is made of light-weight color steel plate. The joints between the wall and the wall, the wall and the ground, and the wall and the ceiling are treated with arc corners, and no dead corners are allowed.

 

  4：Concentrated room, rare room, tool cleaning room, sterilization room, bottle washing room, sanitary ware room need to exhaust heat and moisture. In the process of making bottles and caps of plastic pellets, more heat is generated. In addition to the use of low-temperature water system cooling, the air conditioning system should consider the corresponding load, and the feeding system of plastic pellets must consider dust removal measures. Anti-corrosion and ventilation should be considered in the bottle washing water preparation room.

 

  5：Different environmental areas should maintain a pressure difference of no less than 10Pa.

 

  6：The purified water pipeline can be designed with loop circulation, and the water for injection can be looped with an insulation loop above 70°C. The pipeline installation slope is generally 0.1%~0.35 (1%0~3%0), stainless steel. The length of the blind section of the branch pipe should not be More than 6 times the diameter of the circulating main pipe.