Endotoxin Is Inactivated by Ethylene Oxide, Gamma, Electron Beam, and Steam Sterilization.

Abstract

The effect of sterilization on bacterial endotoxin is receiving greater attention within the medical device industry. Contributing factors to this increased attention include the growing popularity of transferring devices among sterilization modalities and the focus on aspects of microbiological quality other than sterilization. This systematic review examined the effects of sterilization on bacterial endotoxin, with attention drawn to industry standards and regulations to elucidate whether such documents are aligned with published data. In summary, numerous experiments have shown a reduction in pyrogenicity and/or limulus amebocyte lysate reactivity of endotoxin following sterilization, whereas a number of publications and industry standards have claimed (without data or references) that sterilization does not inactivate 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 poststerilization, as well as for standards developers and regulators in aligning standards and regulations with peer-reviewed data.