目的 参照ASTM F3287-17质量提取法检测包装泄漏的标准方法,建立对直立式聚丙烯输液袋(规格:250 mL)的密封完整性测试方法。方法 采用质量提取测试技术,对方法参数进行开发,同时对方法的准确性、检测限、检测范围、重复性、精密度、耐用性等进行方法学验证,并对直立式聚丙烯输液袋包装的氯化钠注射液(规格250 mL:2.25 g)加速0、3、6个月样品进行密封完整性测定、无菌检验研究。结果 质量提取法检测限为3 μm,能够准确地鉴别出具有3 μm及以上泄漏缺陷的样品;重复性的相对标准偏差(RSD)2.07%～3.86%;中间精密度RSD 6.03%～7.83%之间,其结果良好,表明方法耐用性良好,无菌检验符合质量标准。结论 本次研究建立的质量提取法快速、准确、灵敏度高,可用于直立式聚丙烯输液袋(规格:250 mL)的密封完整性检测,同时结合无菌检验研究结果,表明本品的密封质量完好。
Abstract
OBJECTIVE To establish a test method for container closure integrity of upright polypropylene infusion bags(250 mL)referring to ASTM F3287-17 Standard Test Method for Package Leakage Detection.CONCLUSION The mass extraction test technology was used to develop the method parameters, and the accuracy, detection limit, detection range, repeatability, precision and durability of the method were verified. The samples of sodium chloride injection(250 mL: 2.25 g) packed in upright polypropylene infusion bags stored under accelerated test conditions for 0,3,6 months were tested for container closure integrity and sterility.RESULTS The detection limit of mass extraction test method was 3 μm. The method was able to accurately distinguish between intact samples and samples with leakage of 3 μm and above. The results of repeatability(RSDs between 2.07%-3.86%) and intermediate precision(RSDs between 6.03%-7.83%) were good; and the durability of the method was satisfying.Sterility test met the quality standards.CONCLUSION The mass extraction method established in this study is rapid, accurate and highly sensitive, which can be used to detect the sealing integrity of upright polypropylene infusion bags(250 mL).Combined with the sterility test results of this product, it can be concluded that the sealing quality of this product is intact.
关键词
容器密封完整性测试 /
质量提取法 /
直立式聚丙烯输液袋 /
检测限 /
最大允许泄漏限度值
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Key words
container closure integrity test /
mass extraction method /
upright polypropylene infusion bag /
detection limit /
maximum allowable leakage limit
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中图分类号：
R917
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