Once processed, the allografts should be sealed in sterile pouches and clearly labeled with a unique donor and tissue ID, product ID code, allograft description, size, expiration date and storage instructions.
After individual allografts are prepared and preserved via freezing to -80ºC or freeze-drying (lyophilization), they should undergo a final review by a highly qualified and specialized individual. This step should include a careful visual inspection of the allograft, verification of its labeling, sizing and expiration date.
Allografts should be exposed to a validated terminal sterilization process. Low-dose, low temperature gamma irradiation between 10 and 15 kGy (1.0 to 1.5 Mrads) can provide a sterility assurance level (SAL) of 10-6 without jeopardizing the structural or biomechanical properties of the allograft. An SAL of 10-6 means there is a less than one in one million chance that a single microorganism survived the sterilization process. This is the same sterility level recommended for all other medical implants.
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