色水法包装系统密封性研究策略

周浩, 王欢, 张士博, 李瑶, 王慧洁

中国药学杂志 ›› 2022, Vol. 57 ›› Issue (15) : 1293-1296.

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中国药学杂志 ›› 2022, Vol. 57 ›› Issue (15) : 1293-1296. DOI: 10.11669/cpj.2022.15.011
论著

色水法包装系统密封性研究策略

  • 周浩, 王欢, 张士博, 李瑶, 王慧洁*
作者信息 +

Research Strategy of Dye Ingress Package Integrity Test Method

  • ZHOU Hao, WANG Huan, ZHANG Shi-bo, LI Yao, WANG Hui-jie*
Author information +
文章历史 +

摘要

目的 针对色水法方法开发与验证的挑战进行深入探讨,为建立准确、可靠的包装系统密封性检查方法提供参考。方法 结合《美国药典》<1207>指导原则和研发工作经验,重点研究产品相关因素、测试参数、阳性对照品的制备和检出结果的判断方法对色水法灵敏度的影响,聚焦分析方法验证的基本内容和关键问题。结果 产品相关因素需要考虑包装组件和制剂的特性。测试参数中需重点关注染料溶液的黏度、压差条件、泄漏孔径和染液浸没时间。阳性对照品的制备应综合考虑产品包装形式、制剂特性、测试条件和潜在泄漏风险。检出结果可通过紫外-可见分光光度法和目视检查法进行判断。方法学验证中灵敏度是关键,且必须通过专属性考察确认产品是否影响检出结果判断。结论 制药企业必须基于产品特性、包装形式和预期测试要求评估方法的适用性,建立合理的色水法包装系统密封性检查标准。

Abstract

OBJECTIVE To explore the challenges in the development and validation of dye ingress, and to provide reference for the development of accurate and robust container-closure integrity test method. METHODS Based on the USP <1207> guidelines and practical experiences, this article studied the influence of product-related factors, test parameters, positive control creation and judgment methods of detection results on method′s sensitivity, focusing on the basic contents and key problems of analytical method validation. RESULTS For product-related factors, the characteristics of packaging components and products should be considered. In the test parameters, attention should be paid to the viscosity of dye solution, differential pressure, leak sizes and immersion time of the dye solution. The preparation of positive control should take into account the product packaging form, product characteristics, test conditions and potential risk of leakage. The detection results can be judged by UV-Vis spectrophotometry and visual inspection. The sensitivity is the key point in methodological validation. It is necessary to confirm whether the product affects the judgment of detection results through specificity investigation. CONCLUSION Pharmaceutical companies must assess the suitability of the method based on product characteristics, packaging form, and anticipated testing requirements, establishing reasonable inspection criteria for the dye ingress container-closure integrity test method.

关键词

色水法 / 灵敏度 / 包装系统密封性 / 测试参数 / 阳性对照品

Key words

dye ingress / sensitivity / container-closure integrity / test parameter / positive control

引用本文

导出引用
周浩, 王欢, 张士博, 李瑶, 王慧洁. 色水法包装系统密封性研究策略[J]. 中国药学杂志, 2022, 57(15): 1293-1296 https://doi.org/10.11669/cpj.2022.15.011
ZHOU Hao, WANG Huan, ZHANG Shi-bo, LI Yao, WANG Hui-jie. Research Strategy of Dye Ingress Package Integrity Test Method[J]. Chinese Pharmaceutical Journal, 2022, 57(15): 1293-1296 https://doi.org/10.11669/cpj.2022.15.011
中图分类号: R944   

参考文献

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