The allografts are recovered aseptically from donors who are selected according to strict criteria including the patient medical record and other exposures or habits to exclude risc factors. They are tested to exclude the presence of viruses and bacteria. The donor screening includes infectious, malignant, neurological, and autoimmune disease and other exposures or habits of the donor that might result in unsatisfactory tissue. The screening is in accordance with the recommendations of the competent authorities, regulatory agencies and Associations of Tissuebanks. The donor’s serum is screened for the following: HIV-1/2 -Ab, HTLV-I/II-Ab, HbsAg, HBc-Ab, HCV-Ab, TPHA; utilizing qualified and licensed testing laboratories. In addition, the screening for HIV and hepatitis is performed with nucleic-acid amplification (NAT, PCR).
The allografts are processed with supercritical CO2 technology, dried, double-packaged in blisters, pouches or glas vials and sterilized with gamma irradiation of minimum 25 kGy. For impregnated products the sterile allograft is impregnated and finally dried in an aseptic process. All processes are performed using qualified technologies, all critical processes are validated.
The processing laboratory is in possession of the necessary permits and licenses and is GMP-certified. National and international health inspectors of the competent authorities inspect the laboratory at regular intervals and have issued a permit to process bone tissue, respectively to bring the processed allografts on the market.