Small volume injection workshop layout construction
Layout and construction of small volume injection workshop
According to the continuous development of production equipment and process technology, the cleaning, sterilizing and filling equipment for ampoules has gradually evolved from the decentralized single equipment in the past to the washing and drying tank linkage unit, which is also the core stage in the production process of small volume injections , sterilization equipment is mainly to ensure small capacity injection ...
Text label: Small volume injection pharmaceutical cleanroom, layout and construction of purification workshop
Layout and construction of small volume injection workshop
According to the continuous development of production equipment and process technology, the cleaning, sterilizing and filling equipment for ampoules has gradually evolved from the decentralized single equipment in the past to the washing and drying tank linkage unit, which is also the core stage in the production process of small volume injections , Sterilization equipment is mainly to ensure the sterility of small-volume injections; there are many methods for preparing water for injection, including distillation, ion exchange, electrodialysis, reverse osmosis, etc. The commonly used methods are distillation and reverse osmosis. The water for injection equipment is mainly the equipment of distillation method and reverse osmosis method; the drying and sterilizing equipment of ampoules is the process of drying, sterilizing and depyrogenating the cleaned ampoules, and ensuring that the cleanliness of ampoules meets the requirements of small-volume injections , There are many types of drying equipment, commonly used equipment are intermittent drying oven, continuous far-infrared tunnel oven, continuous electric heating tunnel oven; the main equipment of the batching process is the batching tank and the fine filtration equipment of the material liquid. For the batching tank The selection is mainly based on the determination of the effective volume and material. Commonly used filtration equipment includes plate and frame filter presses and microporous membrane filters.
Filling process is the last process before the small volume injection is loaded into the container, and it is also an important process in the production of injections. The ampoule filling and sealing machine is one of the main equipment for the production of injections. According to the size of the ampoule, it can be divided into 1-2ml , 5-10ml, 20ml three kinds, according to the stand-alone and linkage status can be divided into single-machine wire drawing filling machine and ampoule washing and drying can linkage; small-volume injection belongs to sterile preparations, can be divided into terminal sterilization injection and non-terminal sterilization For injections, for terminally sterilized injections, sterilization of injections after potting is an important and necessary process to ensure the sterility and non-pyrogenicity of injection products; its sterilization equipment mainly includes moist heat steam sterilization and There are two types of water bath sterilization, and moist heat sterilization is mostly used for small-volume injections. The inspection of the clarity of the injection is the key to ensure the quality of the injection. The ampoules that have been sterilized and leak-tested are irradiated with a certain amount of light, and manual or photoelectric equipment can be used to further determine whether there are problems such as rupture, air leakage, overfill or underfill, etc. . Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for small-volume injection workshops and purification workshops.
In the design of clean workshops, the plane layout of the process equipment of the small-volume injection workshop is generally carried out according to its process flow, and the main consideration is the scientificity of the process flow and the intersection of personnel and logistics; foreign countries follow the injection process flow. The layout is suitable for general powder injection, water injection and other production lines with products as the main object. In the graphic design of process equipment, the preparation of water for injection, washing and sterilization of containers, filling and sterilization after filling are mainly used. The layout is carried out through the steps of bacteria, leak detection, light inspection and packaging.
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