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Rethinking ethylene oxide (EO) sterilization

20 Oct 2025

For decades, ethylene oxide (EO) has enabled sterilization of sensitive medical devices, but its toxicity and regulatory scrutiny pose growing challenges. Manufacturers must now balance sterility assurance with safety, sustainability, and compliance.

Discover the strategies available, including biological indicators (BIs) and process challenge devices (PCDs), that are reducing EO concentrations while maintaining efficacy, to streamline compliance and protect both people and products.

Process Challenge Devices® (PCD®)

Mesa Labs

Process Challenge Devices (PCD®) certified to ISO 13485 quality systems for medical devices. These external PCDs (ePCD) ensure success of terminal sterilization cycles of medical devices, and can be used for both validation and routine monitoring of EO sterilization cycles.

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Rethinking ethylene oxide (EO) sterilization