Layout and installation of injection purification workshop
Injection is a sterilizable small-volume injection. The prepared liquid is poured into the ampoule and sealed, and the sterilized injection is prepared by steam autoclaving. The injection production process includes: configuration and weighing, preparation, coarse filtration, Fine filtration, ampoule cutting and round mouth, ampoule detergent drying and sterilization,...
Text label: injection purification workshop, injection purification workshop layout, injection purification workshop design
Injection purification workshop layout and installation
Injection is a sterilizable small-volume injection. The prepared liquid is poured into the ampoule and sealed, and the sterilized injection is prepared by steam autoclaving. The injection production process includes: configuration and weighing, preparation, coarse filtration, Fine filtration, ampoule cutting and round mouth, ampoule detergent drying and sterilization, filling, sterilization, lamp inspection, printing and packaging; the production process of injections mostly adopts plane layout, and can use a single-story workshop or a floor in a building, such as If the liquid dispensing, rough filtration and other processes are placed on the upper layer of the main production workshop, a multi-layer arrangement can be adopted, but the bottle washing to packaging should still be completed in the same flat layer.
Powder injection belongs to aseptic subpackage injection. Most of the required sterile subpackage is not heat-resistant. The final product produced by powder injection is not sterilized. Therefore, the production process must be aseptically operated and sterile subpackaged. In particular, freeze-dried products are highly hygroscopic, so special attention should be paid to the relative humidity of the packaging room, the drying of containers and tools, and the tightness of packaging of finished products; the powder injection workshop includes bottle sorting, bottle washing, tunnel drying and sterilization, and bottle cooling. , inspection, sub-packaging, plugging, capping, inspection, labeling, boxing, boxing, etc.; powder injection should be located on the same floor from bottle washing to packaging, and bottle washing, sub-packaging, and capping to small packaging should be Arranged adjacent to each other according to the process, so that the vials after drying and sterilization, the liquid medicine and the treated rubber stoppers are collected and sub-packed into the sub-packaging and capping rubber stoppers, and then processed in the capping clean room modular. The aluminum cover is then rolled. Zhongjing Global Purification can provide consultation, planning, design, construction, installation, transformation and other supporting services for injection purification workshops and sterile workshops.
The temperature of the main production process is 20-22℃, and the relative humidity is 45%-50%. Among them, the production positions such as bottle washing, tunnel drying and sterilization, bottle cooling, sub-packaging, stoppering and capping use air cleaning technology and devices ;The main processes such as bottle sterilization, cooling, sub-packaging, stoppering, and capping processes that are exposed to space must be designed as C+A-level purification workshops, and bottle washing and bottle drying are C-level purification workshops, and adopt technical interlayer, process The packaging room and warehouse are common production areas, and sanitary passages, material passages, safety passages and visiting passages are also set up; the flow of people and logistics in the workshop is one-way flow to avoid cross-contamination and mixing, and the flow of people Sanitary passages must be buffered, changing shoes, changing clothes, showering, first, second, and third shifts, and entering production posts through the air shower; the entry and exit passages for subpackaged raw materials must be surface-treated, and the outer packaging of raw materials can be scrubbed and disinfected with 75% alcohol , and then irradiated and sterilized by a UV lamp transfer frame, and then entered the storage room, and then sent to the sub-packaging room; the aluminum cover was washed and dried, dried in a double-door electric heating oven, and then put into a barrel for cooling.
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