14th Latin American and Caribbean Congress on Transplantation
Organ donation
Sterility and Safety Validation for Transport Packaging of Organs and Tissues

https://doi.org/10.1016/j.transproceed.2017.12.050Get rights and content

Abstract

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 the bags subjected to irradiation, through validated procedures and techniques. The selected sterilization method was the use of gamma radiation. The sterilization dose was determined based on validated standards for the sterilization of medical products, ISO 11137-2: 2013 and ISO/TS 13004: 2013, using the Verification Dose Maximum method on samples belonging to 3 manufacturing lots. The ISO 10993-5: 2009 standard was used in the cytotoxicity tests, by means of extracts test and quantitative technique of MTT, 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide. The tests to determine the expiration date of the kit were performed by ASTM F1980, accelerated aging, and ASTM D3078 to evaluate hermeticity. The irradiation dose validated to reach the required sterility safety level was 22.5 kGy. The constituent materials and the sterilization method do not generated cellular toxicity, and the product was not modified during the simulated time of 5 years. Sterilization by irradiation is a method that leaves no residue, does not harm the properties of the material because it is conducted in cold, and as the sterilizing agent, the energy absorbed by the product is highly penetrating and can be treated in its final packaging, with no risk of postcontamination. It is for this reason that it is prioritized over other methods of sterilization.

Section snippets

Materials and Methods

The set of bags for transporting organs is made up of the primary bag, which contains 3 bags that comprise the barrier of 3 sterile layers (30 × 40 cm), together with the corresponding plastic seals and paper labels. All bags are 100-μm polyethylene and heat-sealed. Sixty bags are contained in a closed cardboard box, which were subjected to the chosen procedure to sterilize.

It is important to clarify that the procedure for preparing the bags was conducted according to protocol, in such a way

Results

The microbial count (internal bag) presented a range between 1 and 5 CFU per bag. In the microbial count of the bag set, the results were between 15 and 63 CFU. Microorganisms resistant to the method were not found. Based on these results and considering the most contaminated sets, the irradiation dose validated to reach the required sterility safety level was 22.5 kGy.

The test of cytotoxicity was satisfactory, with a cell viability >80%. This outcome shows that the bags, the constituent

Discussion

Sterilization by irradiation could be adequately validated for the kit bags for organ transportation, showing that they comply with the levels of sterility required for this type of product. In addition, results of the cytotoxicity tests confer assurance that the material of the bags do not give off toxic substances, including when in contact with a medium similar to the preservation of the organs.

With respect to the expiration date and stability of the constituent materials of the bags, there

Conclusions

Sterilization by irradiation is a method that leaves no residue, does not harm the properties of the material because it is carried out in cold, and as the sterilizing agent, the energy absorbed by the product is highly penetrating and can be treated in its final packaging, with no risk of postcontamination. It is for this reason that it is prioritized over other methods of sterilization.

References (6)

  • ANMAT regulation 3266 Regulation of Mercosur Resolution GMC N° 20/11 “Mercosur technical regulation of good practices...
  • ISO 11137-2:2013 Sterilization of medical products. Radiation. Part 2: Establishing the sterilization...
  • ISO/TS 13004:2013 Sterilization of medical products. Radiation. Substantiation of preselected sterilization doses:...
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