Objective To verify the effect of solvent/detergent(S/D)treatment and membrane filtration for inactivation and removal of Sindbis virus and porcine parvovirus(PPV)in human coagulation factor Ⅸ.Methods The Sindbis virus in human coagulation factor Ⅸ was inactivated by the S/D treatment,and the virus titer before and after inactivation was de-tected using the plaque assay;Membrane filtration method was used to remove porcine parvovirus(PPV),and cytopathic assay was used to detect the virus titer before and after removal.Results After inactivation by the S/D method,the reduc-tions of Sindbis virus in three batches of human coagulation factor Ⅸ were>4.62 lgPFU/mL,>4.64 lgPFU/mL,and>4.50 lgPFU/mL,respectively.After filtration with Planova 15N membrane,the reductions of PPV in three batches of human coag-ulation factor Ⅸ were≥4.50 lgTCID50/0.1 mL,≥4.56 lgTCID50/0.1 mL,and≥4.38 lgTCID50/0.1 mL,respectively.Conclusion By evaluating the validation effect of the indicator viruses,it has been proven that the S/D treatment and membrane filtration method has good inactivation and removal effect on the Sindbis virus and PPV in human coagulation fac-tor Ⅸ.
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