Design and installation of large infusion workshop
Design and installation of large infusion workshop
Large infusion is a terminally sterilized preparation of more than 50ml. The production process includes the preparation of raw and auxiliary materials, concentration and dilution, external washing, rough washing, fine washing of packaging containers, potting, sterilization, Inspection and packaging have their own characteristics compared with the production of small volume injections; bottled...
Text label: large infusion workshop, large infusion production workshop design, large infusion purification pharmaceutical cleanroom installation
Design and installation of large infusion workshop
Large infusion is a terminally sterilized preparation of more than 50ml. The production process includes the preparation of raw and auxiliary materials, concentration and dilution, external washing, rough washing, fine washing of packaging containers, potting, sterilization, Inspection and packaging have their own characteristics compared with the production of small-volume injections; bottled infusion containers include infusion bottles and accessories, which should be cleaned before use. The design of the process is related to the original cleanliness of the container. Generally, there are methods such as direct water washing, acid washing, alkali washing, etc. The rubber stopper used in the infusion bottle has a great influence on the quality of the infusion, and it is required to be soft, elastic, free of debris and resistant to dissolution. , high temperature sterilization, chemical stability and so on.
In the process of infusion preparation, it should be noted that the quality of raw and auxiliary materials has a great influence on the quality of infusion. High-quality raw materials for injection should be selected, fresh water for injection must be used for preparation, and attention should be paid to the quality of water for injection, especially It is pyrogen, PH, etc., and the preparation container and method are the same as those of small-volume injections; for excessive filtration, pressure filtration method is used, and ceramic filter rods, vertical melting filters, plates and frames are used for pre-filtration, and the filter rod is adsorbed first during pre-filtration. A layer of activated carbon is applied, and the filtrate is repeatedly back filtered until the filtrate is clear. The fine filtration mostly uses a microporous membrane with a pore size of 0.65 μm or 0.8 μm. The filling and sealing of the infusion consists of four steps: tank filling, filming, rubber stopper and aluminum rolling. The filling and sealing is an important part of the preparation of the infusion. It must be completed in 4 consecutive steps according to the operating procedures. Loss of isolation, and at the same time, the cleanliness of the room should be strictly controlled to prevent bacterial dust pollution; inspection should be carried out after filling and sealing. If the rolling mouth is not tight and loose, it should be kicked out to avoid plugging during sterilization or deterioration during storage. . Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for large infusion workshops and sterile workshops.
In order to reduce microbial contamination, the infusion should be sterilized immediately after filling and sealing. The infusion should not exceed 4 hours from configuration to sterilization. The water spray gradually cools down to reduce the pressure difference between the inside and outside of the infusion bottle and ensure that the product is completely sealed; in order to prevent the infusion bag from expanding and breaking during sterilization, some use an external cloth bag, or after the sterilization time is reached, a compressed air is introduced to expel the steam in the pot , and then open the sterilizer and take it out after it is cold. The inspection of infusion quality includes clarity and particle inspection, pyrogen-free and sterility inspection, pH and content determination, etc. Infusions that pass the inspection can be labeled and packaged.
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