Manufacturing process of MinerOss™ A High safety standards After thorough donor anamnesis, maximum safety is assured via a series of strict serological testing combined with C+TBA‘s Allotec® purification procedure and radiological sterilization. First, serology and nucleic acid tests (NAT) are performed to identify infections before antibodies are detected in the blood. Potential viruses are inactivated, and bacteria destroyed during Allotec® purification procedure where non-collagenic proteins are denatured. An oxidative treatment is then used to denature persisting soluble proteins and eliminate potential antigenicity. Finally, the tissue undergoes dehydration via a lyophilization technique that facilitates the sublimation of frozen water from solid phase to gas phase. This stage preserves the material’s structural integrity. The lyophilization process is an accepted and well document procedure that preserves structural properties while improving graft incorpo- ration. [7, 8] The microscopic pores within the material ensure rapid rehydration of the tissue. The final sterilization by gamma irradiation guarantees a sterility assurance level (SAL) of 10-6 while ensuring structural and functional integrity of the product and its packaging. The success factors of the manufacturing process The Allotec® process Wet chemical by Allotec® processing of the granules, blocks and struts Ultrasound bath Purification with volatile reagents Oxidative treatment Explantation from femoral heads (patients undergoing hip surgery) or diaphysis (post-mortem donors) Written consent Donor screening (risk analysis) Serological testing (Ab screening and NAT test) Lyophilization and gamma-sterilization 5-years shelf-life at 5–30 °C High safety standards SEM picture of MinerOss™ A at 500-fold magnification showing microporous structure. SEM picture of MinerOss™ A at 100-fold magnification showing macroporous structure.
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