摘要
目的:比较两种除菌级疏水性过滤器完整性测试方法,提出适用性的建议及需要把握的要点,旨在为同行开展此类工作提供参考。方法:阐述无菌制剂生产过程中除菌级过滤器的法规要求,较全面地比较起泡点测试法与水侵入测试法的基本原理、影响因素及其在应用中的优劣性。结果:两种方法基于相同测试原理,适用限制条件略有不同,均能有效保证除菌过滤系统的完整性,降低制药质量风险。结论:水侵入测试法不需要引入有机溶剂等低表面张力溶液进行润湿,操作简便,更适宜于医院无菌制剂生产过程除菌级疏水性过滤器的完整性测试。
Objective： To compare integrity test method of two sterilization level hydrophobic filters, to put forward suggestions for their applicability and the key points to be grasped in order to provide references for peers to carry out similar work. Methods： The regulatory requirements for sterilization level filters used in the process of sterile preparations were discussed. The basic principles, influencing factors, as well as advantages and disadvantages of the bubble point test and water intrusion test were compared. Results： The two methods were based on the same test principle. The applicable restriction conditions were slightly different. Both methods can effectively guarantee the integrity of the sterilizing filtration system and reduce the pharmaceutical quality risk. Conclusion： The water intrusion test does not require the introduction of the organic solvent or other lowsurface-tension solvents for wetting. As a result, it is easy to be carried out and more suitable for the integrity test of the sterilization level hydrophobic filters used in the production process of the sterile preparations in hospitals.
作者
柯志鸿
饶小平
周承芳
韩恵强
陈锦珊
Ke Zhihong;Rao Xiaoping;Zhou Chengfang;Han Huiqiang;Chen Jinshan(The 175th Hospital of PLA,The Affiliated Southeast Hospital of Xiamen University,Zhangzhou 363000,China)
出处
《中国药事》
CAS
2018年第9期1207-1210,共4页
Chinese Pharmaceutical Affairs
关键词
无菌制剂
药品生产
疏水性过滤器
完整性测试
起泡点测试法
水侵入测试法
除菌过滤
sterile preparations
pharmaceutical production
hydrophobic filter
integrity test
bubble point test
water intrusion test
aseptic filtration
