Theoretical Approach for Integrity Test of Virus Removal Filter

Abstract

This article is intended to approach theoretically the integrity test of the virus removal filter on the basis of the worst case of pore size distribution. To enable the theoretical approach, it was assumed that the performances are expressed with the logarithmic rejection formulae, that the streams through the pores are independent of each other, that the similarity of the flow holds between the virus removal and the integrity test, and that the virus removal and the integrity test both have the ideal size exclusive mechanisms. On the basis of these assumptions, the following conclusions were obtained. 1) To be able to guarantee the virus removability of a filter by an integrity test, it is necessary that the pore size which can not remove viruses is larger than the pore size detected by the integrity test. 2) The guarantee level of the virus removability of a filter is equal to the integrity test value under the optimized integrity test condition.