摘要
目的建立三层共挤输液袋包装系统密封性的快速、高效检测方法。方法分析注射剂生产中常用包装系统密封性检测方法微生物挑战法和质量提取法的优点和缺点,采用这2种检测方法对三层共挤输液袋包装系统不同孔径(5,10,15μm)阳性样品的密封性进行测试,对比2种方法的适用性。结果微生物挑战法的测试周期长,重复性差,具有破坏性,且属概率性检测方法,不适用于工业化生产的实时检测;质量提取法的检测速度快,灵敏度较高,结果准确,且无破坏性,属确定性检测方法。微生物挑战法可检出三层共挤输液袋包装系统15μm孔径漏孔的密封性,而质量提取法可检出5μm孔径漏孔的密封性。结论质量提取法的灵敏度较高,操作简便、快速,结果准确、可靠,可更好地满足大容量注射剂袋包装系统密封性的检测要求,且可实现实时、快速检测,确保药品质量安全、可控。
Objective To establish a rapid and efficient for the container-closure integrity test(CCIT)method of three-layer co-extruded infusion bag packaging systems.Methods The advantages and disadvantages of commonly used CCIT methods such as microbial challenge method and mass extraction method in injection production were analyzed.The two methods were used to test the closure integrity of positive samples of three-layer co-extruded infusion bags with different pore sizes(5,10,15μm),and the applicability of the two methods was compared.Results The microbial challenge method had a long testing cycle,poor repeatability with destruction,and belonged to the probabilistic test method,which was not suitable for real-time detection in industrial production.The mass extraction method had fast detection speed,high sensitivity,accurate results without destruction,and belonged to the deterministic test method.The microbial challenge method could test the closure integrity of the three-layer co-extruded infusion bag packaging system with 15μm pore leaks,while the mass extraction method could test the closure integrity of the three-layer co-extruded infusion bag packaging system with 5μm pore leaks.Conclusion The mass extraction method has high sensitivity,it is simple,fast,accurate and reliable,which can better meet the requirements of closure integrity testing of large-volume injection bag packaging systems,and can achieve real-time and rapid testing to ensure the safe and controllable quality of drugs.
作者
赵海英
吴连文
丛金丽
王丽丽
仙雯
ZHAO Haiying;WU Lianwen;CONG Jinli;WANG Lili;XIAN Wen(China Resources Double-Crane Pharmaceutical Co.,Ltd.,Beijing,China 100121)
出处
《中国药业》
2025年第17期84-89,共6页
China Pharmaceuticals
关键词
三层共挤输液袋
包装系统
密封性
微生物挑战法
质量提取法
three-layer co-extruded infusion bag
packaging system
closure integrity
microbial challenge method
mass extraction method
