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首页> 外文期刊>European Journal of Glass Science and Technology, PartA. Glass Technology >Testing the glass material to predict delamination in pharmaceutical glass containers
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Testing the glass material to predict delamination in pharmaceutical glass containers

机译：测试玻璃材料以预测药物玻璃容器中的分层

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摘要

Glass delamination is a huge obstacle to the safe delivery of injectables handed out in borosilicate containers. The root causes of delamination are the intrinsic nature of the glass itself and the conversion process of the glass tube into containers. While the conversion process can be improved by appropriate control of its parameters, the composition of the available borosilicate glass can vary within a narrow range. Up to now the delamination propensity of pharmaceutical containers has been predicted on the basis of tests carried out on the container itself. In the present study the focus was placed on the raw glass tubing which is thermally treated and tested by a conventional delamination test. Results for extracted silica were used to establish a correlation between glass strips of the raw tubes and the corresponding vials which were known to delaminate. Glass slabs obtained from experimental melting on lab-scale of glasses of variable compositions, including aluminosilicates, were thermally treated, tested as above and compared with the reference glass. Important information on the delamination propensity of glass as a material can be achieved without the need to have it in tubular form and eventually container form.
机译：玻璃分层是在硼硅酸盐容器中发出的注射剂的安全交付的巨大障碍。分层的根本原因是玻璃本身的内在性质和玻璃管的转换过程到容器中。虽然通过适当控制其参数可以改善转化过程，但可用硼硅酸盐玻璃的组成可以在窄范围内变化。到目前为止，已经基于容器本身进行的测试来预测药物容器的分层倾向。在本研究中，将重点放在原料玻璃管上，通过传统的分层试验热处理和测试。用于提取二氧化硅的结果用于在原料管的玻璃条和相应的小瓶之间建立相关的相关性，该玻璃条与分层已知的。从实验熔融获得的玻璃板在实验室熔化的可变组合物的玻璃级，包括硅硅酸盐，如上测试，并与参考玻璃进行比较。关于玻璃的分层倾向作为材料的重要信息，可以在不需要用管状形式和最终容器形式中具有它的材料。

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