Ethylene Oxide Residual Analysis
Ethylene Oxide (EO) is known to exhibit a number of biological effects which include irritation, organ damage, mutagenicity and carcinogenicity in human and animals, and reproductive effects in animals. When determining the suitability of ethylene oxide for sterilization of medical devices, it is important to ensure that the levels of residual EO, ethylene chlorohydrin (ECH) and ethylene glycol (EG) pose a minimal risk to the patient in normal product use.
The biological evaluation and testing requirements, combined with the EO-sterilisation process residue limits, form the justification that an EO-sterilised device is acceptable for use.
PRINCIPLE OF TEST:
The maximum allowable daily doses of EO and ECH for a medical device is calculated based on the duration of contact. Devices can be categorized as:
- Limited exposure – devices whose cumulative single, multiple or repeated use or contact is up to 24 hours.
- Prolonged exposure – devices whose cumulative single, multiple or repeated long-term use or contact is likely to exceed 24 hours but not 30 days.
- Permanent contact – devices whose cumulative single, multiple or repeated use or contact exceeds 30 days.
The guiding principle in selecting appropriate extraction methods for the determination of EO is the evaluation of the dose to the patient in order to show compliance with the requirements set out in ISO 10993-7:2008, using simulated use wherever possible. For devices in the prolonged exposure category, it is important to note that the device must also meet the residue requirements of the limited exposure category, and that devices in the permanent contact category must also meet the residue requirements of the prolonged exposure and limited exposure categories, whichever extraction condition is used. Where residues are shown to be within these requirements for products tested by exhaustive extraction, there is no need to further challenge the device by simulated-use extraction.
- Exhaustive Extraction using Ethanol
- Simulated-Use Extraction using Deionised Water
Three blank samples (unsterilised) of each product are required for controls and validation work. Client decides how many sterilised samples for each product to test. The more replicate of results, the more analytically sound the result will be. As a minimum, two replicates for each product from each aeration time are recommended.
Five working days from receipt of samples and signed submission form given no further aeration time is needed.