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Andersen Sterilizers & Andersen Scientific First Awardee in FDA's 510(k) Ethylene Oxide Sterility Change Master File Pilot Program | Business

HAW RIVER, N.C.--(BUSINESS WIRE)--Aug 8, 2023--

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Boston Scientific, Sterigenics start tracking ethylene oxide emissions under new EPA rules

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EPA notifies three NC facilities they could be required to report use of cancer-causing chemical that's emitted into the air

Three facilities in North Carolina could be required to report their use of a cancer-causing chemical to the EPA, the agency announced yesterday. Andersen Products in Haw River, Andersen Scientific in Morrisville, and Sterigenics in Charlotte are among 31 facilities nationwide that the EPA is considering to require reports on their usage of ethylene oxide, a…

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Bridging the COVID Gap (Year) | North Carolina Biotechnology Center

Bridging the COVID Gap (Year) | North Carolina Biotechnology Center
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Medical Device Makers See Progress in EO Sterilization

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Medical device manufacturers and contract sterilizers are working with regulators to reduce ethylene oxide (EO) emissions and develop alternative sterilization methods, while assuring product availability.
Public and governmental alarm about the use of ethylene oxide (EO) for sterilization of medical devices is driving device manufacturers, contract sterilizers, and other stakeholders to double down on developing sterilization processes that reduce or eliminate the use of EO.
“Ethylene Oxide Sterilization: An FDA & EPA Update,” presented during 2020 Virtual Engineering Week by Mac McKeen, fellow, regulatory science, at Boston Scientific, presents the regulatory lay of the land, as well as strategies for reducing reliance on EO. Watch the full 30-minute presentation in this video.

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