MinerOss™ A human bone substitute

Safety aspects Serological testing Virus Test Specification Hepatitis B virus (HBV) HBsAg, HBcAb*, NAT negative Hepatitis C virus (HCV) Ab, NAT negative Human immunodeficiency virus Ab, NAT negative Human T-Lymphotropic virus (HTLV 1/2) Ab, NAT negative Bacteria Test Specification Treponema pallidum (Lues) CMIA, TP Ab negative Only tissue of donors who have been tested negative enters the Allotec® process. * negative for active infection (in case of positive HBcAb C+TBA performs further investigations) The Allotec® process Independent validation of the critical viral inactivation steps of the process Step 6 Double packing and final sterilization by gamma-irradiation guarantees a 5-year shelf-life at 5–30 °C. Step 4 An oxidative treatment further denatures persisting soluble proteins, thereby eliminating potential antigenicity. Step 3 A treatment with alternating durations of diethyl ether and ethanol leaches out cellular components and denatures noncollagenic proteins, thereby inactivating potential viruses. Step 5 Freeze-drying preserves the natural structure of the tissue and maintains a residual moisture of <10 %, allowing quick rehydration and easy handling. Step 1 After crude removal of surrounding soft tissue, fat and cartilage, the donor tissue is brought into its final shape. Step 2 The defatting of the donor tissue allows moderate penetration of solvents during subsequent processing.

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