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An improved method to evaluate the quality of glass tubing as a raw material for pharmaceutical articles

机译：一种评估玻璃管作为药品原料的质量的改进方法

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The transformation process used to turn glass tubing into a finished article, causes an inevitable increase of surface alkalinity. A study was designed to quantify and distinguish the endogenous contribution of the tubing from other con-tributions arising from the conversion process. A representative sample was selected from a segregated pallet provided by one supplier, tubing was cut into pieces of suitable length in a way that their surface to volume ratio was of the same order as the cartridges obtained from the same tubing. One end of the pieces were closed with stoppers, the pieces were subject to suitable testing to identify the alkali and other water soluble glass species which are readily available on the inner surface of the raw tubing. Other tests were carried out to isolate the contribution of the autoclaving process and to estimate the total contribution of the glass as a material before being processed on the conversion line. Extracts were analyzed by ICP-OES; the results indicated that a significant amount of alkali could be extracted by simple rinsing and much more during the autoclaving stage. Two main contributions were identified, the inner surface of glass tub-ing as received and the annealing stage, while other contributions from critical steps identified during the conversion process were found to be negligible. It was concluded that the surface state of the tubing as received is a key factor in controlling the alkali release, while the contribution of the annealing stage to the final Na20 release can be estimated to be about 20-25% of the raw material contribution. The method shows good reproducibility and appears to be reliable for predicting before the conversion process whether the finished cartridges will meet the specifications requested by the pharmaceutical companies.
机译：用于将玻璃管制成成品的转换过程不可避免地增加了表面碱度。设计一项研究来量化和区分管道的内源性贡献与转化过程中产生的其他贡献。从一个供应商提供的隔离托盘中选择代表性样品，将管道切成合适的长度，其表面积与体积之比应与从同一管道获得的小柱的数量级相同。用塞子封闭玻璃块的一端，对玻璃块进行适当的测试，以鉴定在裸管的内表面上容易获得的碱金属和其他水溶性玻璃物质。还进行了其他测试，以隔离高压灭菌工艺的作用，并估计在转换线上进行加工之前作为材料的玻璃的总作用。提取物用ICP-OES分析。结果表明，通过简单的漂洗可以提取大量的碱，在高压灭菌阶段可以提取更多的碱。确定了两个主要贡献，即接收到的玻璃管内表面和退火阶段，而在转化过程中确定的关键步骤的其他贡献可忽略不计。结论是，收到的管子的表面状态是控制碱释放的关键因素，而退火阶段对最终Na2O释放的贡献可估计为原料贡献的约20-25％。该方法显示出良好的可重复性，并且在转换过程之前用于预测成品药筒是否符合制药公司要求的规格方面似乎是可靠的。

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