基于定制试验设计法的注射用冷冻干燥用卤化丁基橡胶塞残留水分测量相关影响因素研究

目的：为保证注射用冷冻干燥用卤化丁基橡胶塞水分测量结果的准确性，对关键操作步骤及相关因素开展影响因素研究，确定其影响显著性，以指导试验操作。方法：采用定制试验设计筛查试验，研究水分测定过程中相关影响因素对测量结果的影响。结果：4个相关影响因素：清洗灭菌干燥操作，剪碎处理，测定方法，胶塞类型，它们对测量结果都有显著影响。结论：定制试验设计可经济、高效筛查出水分测量影响因素，可作为测量方法影响因素研究的有力工具。

Objective: To study the influencing factors of the key operation steps for improving the accuracy of moisture measurement of freeze drying closures for injection vials. Methods: The customized test design was applied to design the experiment to study the influence of factors. Results: The factors including the process of cleaning,sterilizing and drying,the cuting rubber closures to segments,the methods for moisture measurement,the types of rubber closures had significant effect on the measurement results. Conclusion: The customized test design can be used to screen out the influential factors of moisture measurement efficiently and economically,and it can be used as a powerful tool to study the influential factors of measuring methods.

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