Ultipor VF DV_(50)除病毒过滤器处理低pH静脉注射用免疫球蛋白

The Capability of Virus Removal of Ultiper VF DV_(50) Membranes in Preparing Low pH Immunoglobulin for Intravenous Use

为探讨 Ultipor VF DV50 除病毒过滤器在人血低 p H静脉注射用免疫球蛋白 (IVIG)中的使用情况 ,分别采用ф4 7m m膜片和 SBF1 DV50 p H4滤芯实验 ,实验前后均进行膜完整性测试。结果显示 :有效过滤面积 9.0 8cm2 的ф4 7m m膜片与 80 0 cm2 的滤芯之间的滤速有较好的放大对应关系 ,过滤前后制品的质量无显著差异。同种样品用除病毒过滤器过滤 Sindbis病毒和 HIV- 1,可分别有效去除大于 10 4 .95PFU/ ml和 10 5.30 TCID50 /

Ultiper VF DV 50 virus removal membrane filter was appled in preparing low pH intravenous immunoglobulin (IVIG). ф47mm membrane and SBF 1 DV 50 pH4 membrane were used separately. Before and after filtrating the memdranes were tested for the membrane module integrity. The results showed the rate of the filtration was correlated linearly with the working filtration area between VF DV 50 membrane, only 9.08 cm 2 , and SBF 1 DV 50 membrane, 800 cm 2 . No significant difference was found in the biological properties of IVIG preparation before and after the filtration. Before and after the filtration with Ultiper VF DV 50 membranes the removal of the amount of virus particles in samples, in which certain amount of Sindbis virus and HIV 1 were added, was evaluated by the cell cultured methods. The virus removal rate for Sindbis virus and HIV 1 was T R >10 4.95 and T R >10 5.3 , respectively.