General points for the design of terminally sterilized large-volume injection (large infusion) workshop

2021-02-08

The design should be clearly divided. According to GMP regulations, it can be seen from the schematic diagram of the large infusion production process and environmental area division that the large infusion production is divided into general production areas, class D clean areas, class C and partial class A clean areas. The general production area includes bottle washing, particle treatment, sterilization, light inspection, packaging, etc.; class D clean area includes bottle rough washing, capping, etc.; class C clean area includes bottle fine washing, preparation, filtration, filling, pressing Stopper, where the exposed part of the bottle after fine washing to the filling and sealing process needs to be partial A grade. The functional areas related to production should be close to each other in order to achieve smooth logistics and short pipelines, such as material flow: raw and auxiliary materials weighing, concentrated mixing, thin mixing, and potting processes are as close as possible.

When designing the workshop, people and logistics should be arranged reasonably, and the intersection of people and logistics should be avoided as much as possible. The flow of people includes people entering the general production area, class D clean area, and class C clean area through different dressings; the logistics of entering and leaving the workshop are generally as follows: the entry of bottles or plastic particles, the entry of raw materials and the entry of outsourcing materials And the export of finished products.

Mastering the process production equipment is the key to designing the 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 options. For example, the bottle washing process for glass bottled infusion includes a drum-type bottle washer that includes coarse and fine washing and a box-type bottle washer that integrates coarse and fine washing. . Differences in process equipment necessitate different workshop layouts, and current infusion production uses linkage lines.

Arrange the auxiliary rooms reasonably. Auxiliary rooms are an important part of production quality assurance and GMP certification in large infusion workshops. The proper layout of auxiliary rooms is the key to the success or failure of workshop design. General auxiliary rooms of large infusion production workshops include C-level tool cleaning storage room, D-level tool cleaning storage room, laboratory, bottle washing water preparation room, non-conforming product storage room, sanitary ware room, etc.

Clean room system control

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