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Anyone experienced in determining ethylene oxide residuals in medical devices after sterilization according to ISO 10993-7?
I am currently trying to validate a method for this determination but I have some difficulties:
I decided to purchase ethylene oxide solution (certified reference material) to make the calibrations but I have a lot of difficulties defining my peak of interest in the reference solution (which is not normal) .. I believe that the chromatographic parameters are not the most appropriate and also knowing that ethylene oxide is highly volatile ...
My idea will be to optimize the method for the determination of ethylene oxide present in aqueous extracts resulting from the extraction of medical devices in water. I wanted to make this determination by headspace gas chromatography.
Anyone with experience who can give some tips for this early phase of method optimization?
Help please!!
Thank you very much