Radiation Sterilization: Part 1

Tuesday November 05, 2024 from 10:00 to 11:20

Room: Guanacaste 1-2

RadSter 1.3 Filling data, education and tool gaps that impede the expansion of x-ray and electron beam for sterilization – progress of Team Nablo, an international collaboration

Leo S Fifield, United States

Chief Scientist
Advanced Materials and Manufacturing
Pacific Northwest National Laboratory

Abstract

Filling data, education and tool gaps that impede the expansion of x-ray and electron beam for sterilization – progress of Team Nablo, an international collaboration

Leo Fifield1, Mark Murphy1, Maddison Heine1, Florent Kuntz2, Nicolas Ludwig2.

1Pacific Northwest National Laboratory, Richland, WA, United States; 2Aerial-CRT, Illkirch, France

Market forces are increasingly pushing manufacturers of polymer-based medical devices and biopharmaceutical production components to consider alternatives to cobalt-60 gamma-rays and ethylene oxide for sterilization. This diversification naturally includes the technically mature but underutilized options of X-ray and electron beam (E-beam). Published studies indicate there are data and education gaps that impede such diversification. To fill the data, education, and tool gaps that challenge transition to these machine alternatives, an international group of collaborators, Team Nablo, was formed in 2018 by the Office of Radiological Security within the United States National Nuclear Security Administration. It currently has over a dozen active member organizations from the radiation processing industry.

This presentation summarizes Team Nablo progress involving ongoing and anticipated projects, including 1) Measurement and comparison of the differences in radiation effects between gamma-ray, X-ray, and E-beam irradiated products; 2) Measurements showing the relative effects of low-energy E-beam energies (~ 1-5 MeV) to those of 10 MeV E-beam; and 3) Identifying and filling needs in E-beam and low-energy dosimetry technologies and in-line process control tools.

The team has generated gamma-ray, X-ray, and E-beam effects comparison data for over a dozen medical devices and constituent polymer samples involving more than 30 polymer types. These results are publicly available via journal publications and the new Tony Faucette Polymer Effects Library. The outcomes show that an international collaborative team such as Team Nablo, with funding support, can provide significant and tangible contributions to the radiation processing industry.


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