化学药品大容量注射剂的包装系统组件较多，结构设计和制备工艺具有一定的复杂性，增加了潜在泄漏风险点。大容量注射剂的包装系统密封完整性（CCI）是保障药品无菌性、稳定性及患者用药安全的关键质量属性。对于输液袋这类柔性包装系统，影响其密封完整性的因素较多，如输液袋的膜材质量、制袋工艺参数、输液袋体积、灭菌工艺参数、贮藏及运输条件等。根据现阶段国内外监管机构对CCI的要求和审评工作经验，梳理大容量注射剂CCI研究的关键注意事项及常见问题，为业界密封性研究的合规实践提供有价值的参考。

The packaging system for chemical drug large-volume parenteral (LVP) comprises multiple components, and its structural design and manufacturing process are considerably complex, which increases potential leakage risk points. The container closure integrity (CCI) of the packaging system for LVPs is a critical quality attribute (CQA) that ensures drug sterility, stability, and patient medication safety. For flexible packaging systems such as infusion bags, numerous factors can affect their CCI, including the quality of the film material, bag-making process parameters, bag volume, sterilization process parameters, and storage and transportation conditions. Based on the current requirements of domestic and international regulatory agencies for CCI and review experience, this paper summarizes the key considerations and common issues in CCI research for LVPs, aiming to provide valuable references for the industry’s compliance practices in seal integrity studies.

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