摘要
采用液下气泡法考察塑料软袋包装注射用水的密封完整性,通过设置不同压力参数(6.9、20.7和41.4 kPa)以及制备不同缺陷尺寸的毛细管阳性样品(内径5、10、15、20和30μm),验证液下气泡法在测试大容量塑料软袋包装系统密封完整性中的应用。结果显示,在41.4 kPa压力下观察15 s,15μm的缺陷尺寸毛细管阳性样品可视为液下气泡法密封性测试的检测限,该阳性样品孔径的平均值为3μm。样品测定结果显示,50个包装注射用水的塑料软袋样品均未观察到大于3μm的泄漏孔产生。液下气泡法易于操作,结果真实可靠,可以检测和定位该包装系统的泄漏,同时也为该方法在塑料软袋包装系统中的应用提供参考。
The seal integrity of plastic flexible bags containing water for injection was investigated by the submerged bubble method.The application of submerged bubble method in the seal integrity of the large-volume plastic flexible bag packaging system was verified by setting different pressure parameters(6.9,20.7,and 41.4 kPa)and preparing capillary positive samples(inner diameters of 5,10,15,20,and 30μm)with different defect sizes.The results showed that the capillary positive sample with the inner diameter of 15μm could be regarded as the detection limit of the submerged bubble method under the pressure of 41.4 kPa for 15 s,and the average pore size of this positive sample was 3μm.The sample test results showed that no leak greater than 3μm was observed in fifty plastic flexible bags packed with water for injection.The submerged bubble method is easy to operate,and the results are reliable,which can detect and locate the leak of the packaging system,and also provide a reference for the application of this method in the plastic flexible bag packaging system.
作者
陆维怡
李凌梅
罗娜
LU Weiyi;LI Lingmei;LUO Na(Shanghai Food and Drug Packaging Material Control Center,Shanghai 201203;Baxter Healthcare(Suzhou)Co.,Ltd.,Suzhou 215028)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2022年第8期1192-1195,共4页
Chinese Journal of Pharmaceuticals
关键词
液下气泡法
大容量注射剂
塑料软袋包装
内部加压
容器密封完整性
submerged bubble method
large-volume injection
plastic flexible bag packaging
internal pressurization
container seal integrity
