RadSter-3: Product qualification

Tuesday November 08, 2022 from 13:30 to 15:00

Room: Moon

RadSter-3.4 Sterilization and endotoxins: A review and regulatory alignment

Nick Brydon, United States

Head of Sterilization


Medical device sterilization and endotoxin: a review of literature and regulatory alignment

Nick Brydon1.

1NextBeam, North Sioux City, SD, United States

The effect of sterilization on bacterial endotoxin is an area of increasing interest for medical devices due to the growing popularity of transferring devices from one sterilization modality to another, and the focus on end-to-end microbiological quality. This review documents the effects of sterilization on bacterial endotoxin, with attention drawn to industry regulations to show how such regulations are aligned (or not) with published data. In summary, numerous experiments have shown a dose-dependent reduction in pyrogenicity and/or LAL reactivity of endotoxin following sterilization, in contrast to a number of publications and industry standards that claim – without evidence – that sterilization does not mitigate endotoxin. The results of this review would be useful for device manufacturers when selecting a sterilization modality or deciding whether to test for endotoxin pre- vs post-sterilization, as well as standards developers for future alignment of regulations with published data.

Presentations by Nick Brydon

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