Design and installation of oral liquid aseptic purification workshop
Design and installation of oral liquid aseptic purification pharmaceutical cleanroom
Water is the most commonly used solvent for the preparation of oral liquid preparations. Distilled or deionized water is commonly used in the preparation of oral liquid preparations; the chemical activity of water is stronger than that of organic solvents, but it is easy to produce microorganisms, which can ferment and decompose certain proteins or carbohydrates. And oral liquids do not...
Text label: oral liquid purification workshop, oral liquid workshop design and installation, oral liquid aseptic pharmaceutical cleanroom
Oral liquid aseptic purification workshop design and installation
Water is the most commonly used solvent for the preparation of oral liquid preparations. Distilled or deionized water is commonly used in the preparation of oral liquid preparations; the chemical activity of water is stronger than that of organic solvents, but it is easy to produce microorganisms, which can ferment and decompose certain proteins or carbohydrates. And the oral liquid is not easy to store for a long time, so the oral liquid must adopt a suitable antiseptic approach; the preparation process of the oral liquid is more complicated than that of the decoction and the mixture, and the preparation process mainly includes the leaching of Chinese medicinal materials, the purification of the leaching solution, concentration, compounding, and separation. packaging, sterilization, packaging and other processes.
Ultrafiltration is a membrane separation technology, which can separate components of different molecular weights in the liquid medicine, with high separation efficiency and low energy consumption; the application of ultrafiltration technology to prepare ginseng essence has less impurity permeation and high filtrate purity; macromolecules Impurities are recovered in the form of a concentrated solution, which still contains a small amount of saponins, and an equal amount of dilute alcohol solution can be added and mixed, and then subjected to secondary ultrafiltration to extract ginsenosides in the concentrated solution and reduce the loss of active ingredients; The purification process should be reasonable, which can not only remove most impurities, reduce the volume, but also extract and retain the active ingredients as much as possible. The prepared medicinal liquid can be roughly filtered and finely filtered according to the requirements of the injection preparation process, then filled in a sterile clean dry container, sealed or melted, and sterilized by an appropriate method. bacteria method, boiling sterilization method or circulating steam sterilization method. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for oral liquid purification workshops and sterile workshops.
Under normal circumstances, the preparation of liquid medicine, selection of bottles, drying and cooling, filling or sub-packaging and sealing and plugging should be carried out in a clean area of u200bu200bclass 100,000; preparation of oral liquid preparations that cannot be autoclaved , filtration, and potting should be controlled at the 10,000-level; other processes are 'general production areasIn the production process of oral liquid, the management of the production environment should be strengthened, the pollution sources of the surrounding environment should be removed, and a clean and hygienic production environment should be maintained; Production requirements; utensils and equipment must be hygienically managed and cleaned according to the regulations; the personal hygiene management of operators must also be strengthened during the production process of preparations, the health and personal hygiene of operators, the standardization of work clothes, and the system for entering the operating room, etc. Strict and standardized management is required.
The container used for oral liquid packaging is oral liquid bottle. In order to prevent the oral liquid from being contaminated by microorganisms and cause the liquid to spoil and deteriorate, in addition to ensuring sterility, the packaging should also be cleaned; Thoroughly clean the oral liquid bottle to ensure that the oral liquid is sterile or basically sterile; in order to prevent cross-contamination, the inner wall of the bottle needs to be cleaned, and the residual water must be removed after each cleaning.
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