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Neutral pharmaceutical glass packaging in the international field of application and future


Services bottle packaging material standards promulgated the , glass thread VI control bottles. These standards include 4 types of glass,[link widoczny dla zalogowanych], borosilicate glass 2, that is, Of.: (4 ~ 5) × 10-6K-1 and (3,34-0,1) × 10-6K A 1,[link widoczny dla zalogowanych], low borosilicate glass Of .= (6.2 ~ 7.5) × l0-6K-l and soda-lime glass Of .= (7.6 ~ 9.0) × 10-6K-l, which low borosilicate glass in the international arena is not common. As mentioned earlier, ISO12775 glass composition is not included in the classification of such glass materials, as has been the production of such glass for many years, glass production with the use of such common antibiotics in the control of powder injection injection bottles and control I: 1 服 bottle or can meet their performance requirements, so as the transition to the international and neutral glass particles to the glass most of l-level water law, and some 2 level, from the microscopic point of view the precipitation amount of alkali is much larger than the international neutral glass. International law neutral glass control bottles of water resistance test particle precipitation amount of alkali is generally 20 ~ 30ug / g, while the domestic low B Control of silica glass water bottle test particle method the amount of alkali precipitation mostly in the 57 ~ 62ug / g,[link widoczny dla zalogowanych], and more than 62ug / g, therefore, used to dress acid, alkali and high-grade pharmaceutical drugs, the type of glass chemistry performance is a big difference. In addition, the thermal expansion coefficient of the gap, can lead to dramatic changes in performance against the temperature difference. Third, the international application and future of neutral glass medicines are special commodities, pharmaceutical glass as a packaging material to be directly exposure to drugs, and most drugs should be stored a long time, so some of the glass components in contact with the drug may be caused by leaching or migration between components may also be long-term soaking liquid, erosion off-chip a direct impact on or affect the dose of drug quality. As a wide range of drugs, the effective complexity of active genes, for example, dressed with a strong alkaline ampoule drugs, some components may be dissolved or have pieces of glass off phenomenon, off the glass film is thrombosis The risks, therefore, the performance and quality of pharmaceutical glass directly affects the quality of drugs, and people's health and safety are closely related. China's accession to WTO, standards and markets must be with international standards, standards integration reflected in the glass first , because the glass material determine its main physical and chemical properties, as a medicinal glass of the most important indicator is the chemical stability, low domestic production of chemical properties of borosilicate glass, especially the alkali resistance was significantly lower than the international neutral glass. International standards, the United States Pharmacopoeia, European Pharmacopoeia, the Japanese Pharmacopoeia injection of water containing liquid, there are stringent regulations alkali resistance, so the standards is imperative. In addition,[link widoczny dla zalogowanych], from the market point of view, to the product that I: 1 and integrate into the international market, we must first of all from the glass material and performance with international practice. the development and application of international drug production is neutral glass replacement, and gradually gentrification, a Natural Selection and trends. In recent years, domestic and foreign Some high-tech, high value-added Xinyaoteyao and various types of biological agents, blood products, vaccine type, freeze-dried preparations and other drugs are all high-grade glass materials and a higher performance requirements, various types of water injection Injection-resistant acid, alkali requirements, require the development of international quality neutral glass to achieve the improvement and upgrading of products. the development and application of international neutral glass and improve the quality of packaging, ensuring their quality, make our medicines and medicinal glass significantly into the international market has become a serious problem facing the industry. as soon as possible to solve this major problem, not only need medical glass manufacturers from the technical process and the cost price of a breakthrough, but also the positive use of the pharmaceutical companies, participation and support of government departments need more guidance and macro-control, even when necessary, appropriate enforcement measures formulated, for example, the use of administrative means,[link widoczny dla zalogowanych], in respect of all agents, all drugs must be the period of international neutral glass packaging, time requirements, in batches and gradually expand the application fields of international neutral glass and scope, to accelerate the international neutral glass in the process of application.

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