Whitepaper: Stability Study of Ethylene Oxide Solution Stored in 2°- 8°C
According to ISO 11135-7: Sterilization of healthcare products-Ethylene Oxide, when determining the suitability of Ethylene Oxide (EO) sterilization of medical devices it is important to ensure that the levels of residual Ethylene Oxide, ethylene chlorohydrin (ECH) and ethylene glycol (EG) poses a minimal risk to patient use. EO is known to exhibit several biological effects among others organ damage, mutagenicity, carcinogenicity in humans and animals. Therefore, exposure to EO should be minimized and EO residual testing must be conducted.
In order to evaluate the amount of EO residue present in the medical device, the residues must first be extracted. Simulated use extraction as mentioned in Clause 4.4.6.2 is used to evaluate the residue levels that are available to the patient. Medical devices are extracted using reverse osmosis (RO) water to simulate the intended use of the device by flushing the fluid pathway. This is followed by the analysis of the extract using Gas Chromatography (GC) with Flame Ionization Detector (FID).
EO is very soluble in water, but the compound is also very volatile. ISO10993-7:2008/AMD 1:2019 (Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals) indicates the lab shall conduct its stability study of the extract which is EO solution to determine the maximum storage duration where samples are still viable for analysis.
For an in-depth understanding and comprehensive details, please refer to the whitepaper below.
Commentaires