A method for the detection of the viruses depletion for the validation of filters and filtration processes

摘要

A method for the detection of the viruses depletion for the validation of filters, filtration processes, physical and chemical inactivation methods or of adsorptive depletion methods with predetermined process conditions, which in the small scale be readjusted:– in a first step, to be cultured viruses in suitable cell lines,– in a second step according to any one cell breakdown is obtained a virus suspension,– in a third step, the biomass is obtained a test protein solution are added and– in a fourth step, the virus containing protein solution to be validated by the filter filtered, and then is analyzed, the virus depletion,characterized by the,that after the second step, the virus suspension initially via a membrane adsorber is processed, that the viruses bound to the membrane adsorber, and contamination with the aid of a washing buffer are removed andthat the bound, purified viruses of the membrane adsorber surface and, in the third step eluted as a concentrated biomass is to be examined are added to the protein solution.