Fully automated, cryogen-free analysis of ethylene oxide residues in medical devices by multi-step enrichment-headspace-trap
Presented at Pittcon, USA, 2025
The sterilisation of medical devices such as gauzes and bandages is critical for patient safety. A common means of sterilisation is through exposure to ethylene oxide (EtO), which is highly effective at killing bacteria and other microorganisms that might otherwise cause infections. However, any residual EtO remaining after sterilisation may cause irritation and other harms when it comes into contact with patients, so various regulatory bodies mandate limits on EtO levels in medical products. Therefore, methods are required to detect EtO and its degradation product 2-chloroethanol (2CE) in such devices.
Typically, water is used as an extraction agent, with EtO and 2CE partitioning from the device and into the water in which the device is submerged. The water is then subjected to direct headspace extraction, with headspace from the water extract being injected to a gas chromatograph (GC) for separation and downstream detection by mass spectrometry (MS). Headspace extraction is a robust technique, but achieving sufficient efficiency can be challenging.
In this poster, we present a fully automated, solvent-free, environmentally conscious technique in which the static headspace methodology is enhanced by a cryogen-free focusing trap.
