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首页> 外文期刊>PDA journal of pharmaceutical science and technology >Delamination Propensity of Glass Containers for Pharmaceutical Use: A Round Robin Activity Looking for a Predictive Test
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Delamination Propensity of Glass Containers for Pharmaceutical Use: A Round Robin Activity Looking for a Predictive Test

机译：用于药物用途的玻璃容器的分层倾向：循环罗宾活动寻找预测测试

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Delamination, which is the formation of flakes in drug products owing to specific and localized corrosion of glass vials, is a rare but serious problems, on which the FDA (U.S. Food and Drug Administration) put a warning to the pharma industry in 2011. The Technical Committee (TC) TC12 of the International Commission on Glass (ICG) was created in 2012 with the aim to study the problems related to pharma packaging. The first task of TC12 was to address the problem of predicting the propensity of glass vials to delamination, leaving the study of the mechanism(s) of flake formation as a possible future activity. This paper reports on the results obtained in a round robin test, which involved all the labs of the companies represented in the TC. Five types of vials with different expected delamination propensities were tested using a protocol that includes autoclaving at 121°C of vials filled with NaCl solution adjusted to pH 8 with NaOH solution, a coloration test, and ICP-OES determination of Si, B, and Al. Although there was no flake formation, the results showed that the combination of strong coloration at the bottom of the vials and high silicon concentration in the solution is correlated to an observable morphological modification/corrosion of the inner surface of vials in the bottom region. The test protocol is therefore useful for checking the quality of the vials with respect to the propensity to corrosion. Regarding delamination, no direct correlation with the testing results could be obtained yet. The method allows catching differences in the corrosion behavior, mainly between sets of vials with comparable surface:volume.
机译：分层是由于玻璃瓶的具体和局部腐蚀，药品中薄片的形成是一种罕见但严重的问题，FDA（美国食品和药物管理局）于2011年向制药行业发出警告。该国际玻璃玻璃委员会（ICG）技术委员会（TC）于2012年创建，旨在研究与制药包装有关的问题。 TC12的第一个任务是解决预测玻璃小瓶的倾向的问题，将剥落形成机制的研究作为可能的未来活动。本文报告了循环试验中获得的结果，涉及在TC中所代表的公司的所有实验室。使用具有不同预期分层施力的五种种类的小瓶使用，所述方案通过包括在用NaOH溶液，着色试验和ICP-OES测定Si，B和Si，B和ICP-OES测定Si，B和ICP-OES测定Si，B和ICP-OES测定Si，B和ICP-OES的液体中的121℃下的等方案进行含有不同预期分层施加的小瓶。 al。虽然没有片状形成，结果表明，溶液中底部的强着色和高硅浓度的强色与底部区域中的小瓶内表面的可观察形态学改性/腐蚀相关。因此，测试方案可用于检查小瓶的质量相对于腐蚀的倾向。关于分层，尚未与测试结果直接相关。该方法允许捕获腐蚀行为的差异，主要是在具有可比表面的小瓶组之间：体积。

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