title: Virus safety of avital bone tissue transplants: evaluation of sterilization steps of spongiosa cuboids using a peracetic acid-methanol mixture.
abstract: The aim of this study was to validate the virus-inactivating/eliminating capacity of the manufacturing process of spongiosa cuboids. Both the sterilization step with peracetic acid (PAA)/ethanol and the defatting step of bones with chloroform/methanol (2:1, v/v) were investigated. Relevant enveloped, non-enveloped, and model viruses belonging to different virus families were included in the investigation: human immunodeficiency virus type 2 (HIV-2), hepatitis A virus (HAV), poliovirus (PV-1), pseudorabies virus (PRV), porcine parvovirus (PPV), and bovine virus diarrhoea virus (BVDV). Treatment of virus-spiked spongiosa cuboids for 4 hours at room temperature (RT) with 1% PAA/24% ethanol (PES) efficiently inactivated most viruses. Titres were reduced by more than 4 log(10)with the exception of HAV. The defatting step with chloroform/methanol reduced HAV titres by a factor of >/=7.0 log(10). From these results it can be concluded that the treatment of spongiosa cuboids with (i) chloroform/methanol and (ii) 1% PAA/24% ethanol solution leads to a virus-safe medicinal product.
authors.affiliation: Institute for Transfusion Medicine, Tissue Bank, University Hospital Charité, Medical Faculty of Humboldt-University Berlin, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Pruss
authors.forename: M
authors.initials: M
authors.lastname: Kao
authors.forename: H
authors.initials: H
authors.lastname: Kiesewetter
authors.forename: R
authors.initials: R
authors.lastname: von Versen
authors.forename: G
authors.initials: G
authors.lastname: Pauli
mesh_terms: D016025:Bone Transplantation / Q000379:methods*; D001842:Bone and Bones / Q000821:virology*; D002725:Chloroform / Q000494:pharmacology; D004202:Disinfectants / Q000494:pharmacology; D006801:Humans; D000432:Methanol / Q000494:pharmacology*; D010463:Peracetic Acid / Q000494:pharmacology*; D013242:Sterilization / Q000379:methods*; D014777:Virus Diseases / Q000517:prevention & control*; D014780:Viruses / Q000187:drug effects
chemical_list: D004202:Disinfectants; D002725:Chloroform; D010463:Peracetic Acid; D000432:Methanol