Ethylene Oxide’s (EO) Residues on Medical Devices
Ethylene oxide’s (ETO) extensive material compatibility and efficacy make it a common choice as a sterilising agent for medical devices. However it can leave a residue on the devices being processed. The residues can be harmful to the end user or patient so it is important that all devices meet the limits set out in the AAMI 10993-7 standard.
Companies using ethylene oxide as a sterilant are obliged to demonstrate that ethylene oxide and its common degradants ethylene chlorohydrin (ECH) and ethylene glycol (EG) are removed from the product and packaging.
Demonstrating Compliance with Ethylene Oxide (ETO) Residuals Analysis
Ethylene oxide residuals analysis is used to identify and qualify ethylene oxide, ethylene chlorohydrin and ethylene glycol by gas chromatography. The technique helps manufacturers to demonstrate the safety of products sterilised by ethylene oxide by determining compliance with accepted residual limits.
In addition to the services we provide for Prefilled Syringes, which include device verification and characterisation together with extractables and leachables assessments, Smithers supports your R&D and routine release testing for residual ethylene oxide.
Customized Testing Programs
To ensure that the methodologies are appropriate for your product we offer method development and method validation. This important testing is performed in our chemistry laboratories and can be performed under the principles of cGMP.
We will work with you to determine the appropriate number of samples per batch size and advise on suitable packaging for transportation of the samples. For your ease of reporting and to fit into your quality procedures, our technical staff will work with you to support any specific reporting requirements so that our documentation can be effortlessly placed into your own reporting structure.