Establishment and verification of the tightness inspection method of blood products

VernacularTitle:血液制品密封性检查方法的建立与确认
Author: Xiaojie ZHAO ¹ ; Yali WANG ² ; Yunfei ZHAO ¹ ; Qiming ZHANG ¹ ; Mingxiang SONG ¹ ; Lingli GUO ¹ ; Zi DOU ¹ ; Jipeng ZHANG ¹ ; Xiao LIU ¹
Author Information

1. Lanzhou Institute of Biological Product Co., Ltd., Lanzhou 730046, China
2. Gansu Institute for Drug Control
Publication Type:Journal Article
Keywords: blood products; vacuum decay method; tightness inspection
From: Chinese Journal of Blood Transfusion 2022;35(1):89-92
CountryChina
Language:Chinese
Abstract: 【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 2.5 μm, 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.