Virus safety of avital bone tissue transplants: Evaluation of sterilization steps of spongiosa cuboids using a peracetic acid-methanol mixture

The aim of this study was to validate the virus-inactivating/eliminating ca pacity of the manufacturing process of spongiosa cuboids. Both the steriliz ation step with peracetic acid (PAA)/ethanol and the defatting step of bone s with chloroform/methanol (2:1, v/v) were investigated. Relevant enveloped , non-enveloped, and model viruses belonging to different virus families we re included in the investigation: human immunodeficiency virus type 2 (HIV- 2), hepatitis A virus (HAV), poliovirus (PV-1), pseudorabies virus (PRV), p orcine parvovirus (PPV), and bovine virus diarrhoe 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,, with the exception of HAV. The defatting step with chloroform/methanol reduced HAV titres by a factor of greater than or equal to 7.0 log(10). From these results it can be concluded that the trea tment of spongiosa cuboids with (i) chloroform/methanol and (ii) 1% PAA/24% ethanol solution leads to a virus-safe medicinal product, (C) 1999 The Int ernational Association for Biologicals.