摘要
目的建立和验证真空衰减法用于血液制品密封性检查。方法建立血液制品包装密封性检查方法,根据方法学验证的要求进行检测限、线性、范围、准确度、精密度、耐用性的确认;验证后的方法用于血液制品生产过程包装密封性检查。结果该方法检测限为2.5μm,线性相关系数r=1,阳性样品压差值在准确度允许范围之内,耐用性符合要求,重复性试验6次检测结果与中间精密度试验12次结果RSD均<10%,所有验证项目均符合可接受标准。结论真空衰减法可以用于检查血液制品包装密封性。
Objective To establish and verify the vacuum decay method for the tightness inspection of blood products.Methods The method for inspecting the tightness of blood product was established,and the detection limit,linearity,range,accuracy,precision and durability were verified according to the requirements of methodological verification.The validated method was used to check the tightness of blood product packaging.Results The detection limit of this method was 2.5μm,linear correlation coefficient was r=1,the differential pressure of positive sample was within the allowable range of accuracy,and the durability met the requirements.The RSD of results of 6 repeatability tests and 12 intermediate precision tests were both less than 10%,and all validation items met the verification standards.Conclusion Vacuum decay method can be used to check the tightness of blood products.
作者
赵小洁
王亚丽
赵云飞
张齐明
宋明祥
郭玲莉
窦姿
张继鹏
刘晓
ZHAO Xiaojie;WANG Yali;ZHAO Yunfei;ZHANG Qiming;SONG Mingxiang;GUO Lingli;DOU Zi;ZHANG Jipeng;LIU Xiao(Lanzhou Institute of Biological Product Co.,Ltd.,Lanzhou 730046,China;Gansu Institute for Drug Control)
出处
《中国输血杂志》
CAS
2022年第1期89-92,共4页
Chinese Journal of Blood Transfusion
基金
甘肃省药品监督管理局2021年度药品科研项目(血液制品相容性和密封性研究)(2021GSMPA002)。
关键词
血液制品
真空衰减法
密封性检查
blood products
vacuum decay method
tightness inspection