Many medical devices, and occasionally pharmaceutical products, require some form of terminal sterilization. Ethylene oxide is often chosen because it is effective and does not adversely affect many of the materials used to make medical devices. The use of ethylene oxide as a sterilant obligates companies to demonstrate that ethylene oxide (EO) and its common degradants ethylene chlorohydrin (ECH) and ethylene glycol (EG) are removed from the product and packaging.
Ethylene oxide residual testing evaluates the efficacy and compliance of your sterilization procedures, often by applying standards set by the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or ISO 10993-7 guidance. We help medical device and pharmaceutical manufacturers perform this testing and mitigate any concerning results. Since many factors can influence residual levels, our team also investigates undesirable findings by applying packaging, raw materials, sterilization cycle parameters, and load density expertise.
Our analytical ethylene oxide residual testing of terminally sterilized medical devices uses currently accepted Gas Chromatography (GC) methods, including:
Gas Chromatography with Solid-Phase Micro Extraction
Gas Chromatography using headspace sampling for ethylene oxide (EO)
Gas Chromatography water extracts for ethylene oxide (EO)
Gas Chromatography water extracts for ethylene chlorohydrin (ECH) and ethylene glycol (EG)
Ready to Get Started? Connect with our team to discuss your testing and development needs.