November 8, 2022
Nick Brydon (podium) presenting slides on Medical Device Sterilization and Endotoxin at IMRP20 Nov 8, 2022.
Nick Brydon, Head of Sterilization, presented a set of slides on medical device sterilization and endotoxin during a panel at IMRP20. The focus of the presentation was reviewing dozens of published studies showing sterilization reducing endotoxin, along with numerous publications and regulations stating (always without evidence) that sterilization did not reduce or destroy endotoxin. The slides demonstrated that substantial evidence exists supporting the ability of common sterilization processes to reduce LALreactivity in vitro and/or pyrogenicity in vivo: gamma, electron beam (E-beam), ethylene oxide (EO), hydrogen peroxide (VHP/HPGP), and moist heat.
The intent of the presentation was to facilitate product transfers between gamma and E-beam following AAMI TIR 104. AAMI TIR 104 describes factors to consider for product transfer including device mechanical integrity and sterility assurance. Additional information about bacterial endotoxin being reduced by both gamma and electron beam covers another important factor in overall microbiological quality for products that have to meet certain endotoxin limits.
The panel was hosted by Bart Croonenborghs (Sterigenics). Other panelists included Martell Winters (Nelson Labs), Tony Sollis (Steris), Aaron Neighbour (Nutek Bravo), Pierre Reppert (Steris).
The slides are available in the members library at the international irradiation association (iia). The review paper the slides were based on is currently under peer review for publication.
Later in the week Nick Brydon visited the Thai Institute of Nuclear Technology (TINT), which uses gamma, E-beam, and X-ray for a variety of research, phytosanitary, and sterilization purposes.
