Sterility and safety validation for transport packaging of organs

29 March 2018

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.
Click here to read an abstract of the article.
Click here for more information about the NVC project Pharmaceutical Packaging Innovation.
Click here for more information about the Live Online NVC E-Course Pharmaceutical Packaging.

This news item is also included in our monthly overview, the NVC Members-only Update. If you have any questions, please contact us: info@nvc.nl, +31-(0)182-512411.