Layout design of injection workshop in GMP workshop
Layout design of injection workshop in GMP workshop
GMP workshop mastering the production process is the key to the design of the workshop. The containers for infusion include glass bottles, composite films, etc., and the production processes of different packaging containers are also different; the design should be clearly defined. According to the GMP management requirements, large infusion production is divided into For the general production area, 100,000...
Text label: GMP workshop injection workshop, layout design and installation engineering
Layout design of injection pharmaceutical cleanroom in GMP workshop
GMP workshop mastering the production process is the key to the design of the workshop. The containers for infusion include glass bottles, composite films, etc., and the production processes of different packaging containers are also different; the design should be clearly defined. According to the GMP management requirements, large infusion production is divided into It is a general production area, a class 100,000 clean area, a class 10,000 and a local class 100 clean area. The general production area includes bottle washing, cap treatment, sterilization, light inspection, packaging, etc. The class 100,000 clean area includes raw and auxiliary materials. , concentrated dispensing, bottle rough washing, capping, etc., the 10,000-level clean area includes bottle fine washing, thinning, and potting. Among them, the exposed part of the bottle after fine cleaning to the potting process needs to be protected with 100-grade protection, and the production-related functional area They should be close to each other to achieve smooth logistics and short pipelines; logistics flow direction: raw material weighing-concentrated preparation-thin preparation-potting and sealing processes should be as close as possible, and personnel and logistics should be reasonably arranged during workshop design.
Mastering the process and production equipment is the key to designing a good infusion workshop. Different infusion packaging containers have different production processes, resulting in different production equipment. Even for the infusion of the same packaging container, the production line has different choices, such as glass The bottle washing process of bottle infusion is divided into a drum-type bottle washer for rough washing and fine washing and a box-type bottle washing machine for coarse and fine washing. Due to the difference in process equipment, the workshop layout must be different. The linkage line is adopted; the auxiliary room is an important part of the production quality assurance and GMP certification of the large infusion workshop. The proper arrangement of the auxiliary room is the key to the design of the workshop. Generally, the auxiliary room of the large infusion production workshop includes the cleaning and storage room for the 10,000-level process. , 100,000-level tool cleaning storage room, pharma machinery, bottle washing water preparation room, non-conforming product storage room, sanitary ware room, etc. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and GMP workshops.
The production method of plastic bottle infusion can be divided into one-step method and step-by-step method. The bottle is then completed on the cleaning, filling, and air outlet linkage line; the plastic bottle one-step molding machine has two production processes, including extrusion-blow molding process and injection-stretch-blow molding process. The former is to extrude plastic particles into blanks , and then directly into the compressed air to blow molding; the latter is to inject plastic particles into blanks, and then immediately two-way stretch and blow, in one step on the same machine. The two-step molding process for plastic bottles is that the injection molding machine first plasticizes the plastic particles, injects the melted resin into the mold to make the preform, and then opens the mold to push the preform out and transport it to the storage room for cooling; The preforms are then heated after finishing and feeding. The heated preforms are sent to the drawing and blowing station, and are stretched vertically by adjusting the pneumatic rods, and the horizontal stretching is completed by blowing high-pressure air.
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