The Allotec® Process
After shaping and crude cleaning, the donor tissue undergoes ultrasonication to remove blood, cells and tissue components, but mainly to promote the removal of fat from the cancellous structure of the bone, improving the penetration of subsequent substances.
During a chemical treatment non-collagenic proteins are denatured, potential viruses are inactivated and bacteria are destroyed. In the subsequent oxidative treatment, persisting soluble proteins are denatured and potential antigenicity is eliminated.
Finally, the tissue undergoes lyophilization, a dehydration technique which facilitates the sublimation of frozen tissue water from solid phase to gas phase, thereby preserving the structural integrity of the material.
The tissue can be reconstituted rapidly due to microscopic pores within the material, which were created by the sublimating ice crystals. It has been well established that the lyophilization process preserves structural properties that improve graft incorporation.1,2
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.