Sterility and safety validation for transport packaging of organs
The bags used in the transport of organs and tissues must be sterile, nontoxic, pyrogen free, and must serve as a barrier throughout their useful life. The goal of this study was to show the sterility, safety, and functionality of bags subjected to irradiation, through validated procedures and techniques. The selected sterilization method was the use of gamma radiation.
The irradiation dose validated to reach the required sterility safety level was 22.5 kGy. The constituent materials and the sterilization method do not generate cellular toxicity, and the product was not modified during the simulated time of 5 years. An article about this research was published in Transplantation Proceedings.
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