The design, production process and environmental zone division of terminal sterilization small-volume injection workshop

The production process of terminally sterilized small-volume injections includes the preparation, compounding, filling and sealing, sterilization, quality inspection, packaging and other steps of raw and auxiliary materials. According to different types of process equipment, it can be divided into two types: stand-alone production process and linked production process. The process and environmental division are shown in the figure below:

The general key points of the design of terminal sterilization small-volume injection workshop include the following aspects:

1：According to GMP regulations, the final sterilization small-volume injection production environment is divided into four areas: general production area, class D clean area, class C clean area, and partial class A clean area under the background of class C. The general production area includes external cleaning of ampoules, sterilization and leak detection of semi-finished products, foreign substance inspection, and package printing; Class D clean area includes material weighing, concentration, quality inspection, washing and drying of ampoules, washing of work clothes, etc.; Class C clean area includes rare-mixing, fine filtration; Filling and sealing is a partial class A clean area under a C-level background. The area with high cleanliness level should maintain a positive pressure difference of not less than 10Pa compared to the area with low cleanliness level.

2：The design of the workshop should implement the principle of separation of people and logistics. When personnel enter the production workshops of various levels, they must first change clothes, and the production areas of different levels need to have corresponding levels of clothing purification measures. The production area should be arranged in strict accordance with the production process. The production areas of the same level are relatively concentrated, and the transfer windows or buffer rooms are set up in the interconnection of rooms with different clean levels to make the material transfer route as short and smooth as possible.

1：One line of the logistics route is raw and auxiliary materials, and the materials are processed by external cleaning for concentration and dilution mixing; the other line is ampoules. After the ampoules are processed by external cleaning, they enter the washing, filling and sealing linkage line for cleaning, drying. Converged in the filling and sealing process. The filled ampoule is sterilized, leaked, bottle wiped, foreign body checked, and finally outsourced to complete the entire production process.

2：Inside the plant, storage areas for raw materials, auxiliary materials, semi-finished products, and finished products that are compatible with the scale of production are set up, and placed in the production areas nearby and in contact with them, to reduce toxicity and pollution during transportation

3：The storage area should be arranged in the waiting area, the qualified product area and the unqualified product area; the storage weighing room, the quality inspection room, the tool cleaning storage room, the cleaning tool washing storage room, the clean work clothes washing and drying room, etc. should be around the process production The layout should be conducive to production management; the air-conditioning room, pump room, power distribution room office, and control room should be located outside the clean area, and should be conducive to the layout of public pipelines including air-conditioning ducts.

4：The water needle production workshop needs to exhaust heat and moisture in the room with concentration and dilution mixing rooms, tool cleaning room, sterilization room, bottle washing room, sanitary ware room, etc. Ventilation should be considered for sterilization and leak detection. The professional design of public works, including water supply and drainage, gas supply, heating, strong and weak electricity, cooling and ventilation, and heating, should comply with GMP principles.

5：The floor in the water jet production workshop is generally made of clean-resistant epoxy artesian floor. The partition wall is made of light color steel plate, and the joints between the wall and the wall, the wall and the ground, and the wall and the ceiling are treated with arc corners. There are dead ends.