The Effect of Gas Chromatographic Headspace Analysis on Simultaneous Detection of Residual Amounts of Ethylene Oxide and 2-Chloroethanol in Disposable Sterile Medical Device Products
Objective To investigate the effectiveness of gas chromatographic headspace analysis in simultaneously detecting residual levels of ethylene oxide(EO)and 2-chloroethanol(ECH)in disposable sterile medical device products sterilized with ethylene oxide(EO),and to analyze the residual levels of EO and ECH in typical disposable sterile medical device products sterilized with EO.Methods With the selection of water as the extraction medium,the changes in chromatographic peak areas with different conditions were investigated.With the optimal equilibrium temperature of 80 ℃,equilibrium time of 30 min and extraction ratio of 0.5 g/ml determined,the specificities and linear relationships of headspace-gas chromatography detection as well as the detection limits and quantitation limits of EO and ECH were analyzed.In addition,the precisions and recovery rates of the method were verified.Finally,this method was used to detect the residual levels of EO and ECH in typical disposable sterile medical device products.Results The gas chromatographic headspace analysis had strong specificity;For EO,the linear relationship was good within the concentration range of 0.25～20.00 μg/ml,and for ECH,the linear relationship was good within the concentration range of 2.50～200.00 μg/ml;The detection limit for EO was 0.03 μg/ml,the quantification limit was 0.08 μg/ml,and the detection limit for ECH was 0.50 μg/ml,the quantification limit was 1.50 μg/ml;The precisions of EO and ECH were good and met the testing requirements;The average recoveries of EO and ECH in two blank substrates with different addition levels met the detection requirements.Two typical product samples were tested for EO,with an EO content of 0.22 μg/g in disposable PVC infusion sets and 2.60 μg/g in medical cotton pads.In addition,no ECH was detected in any of the products.Conclusions The headspace gas chromatography method established through optimal equilibrium temperature,equilibrium time,and extraction ratio can scientifically and effectively evaluate the residual risk of EO and ECH in disposable sterile medical device products sterilized with EO.With its simple operation,strong specificity,accurate quantification,and good reproducibility,it can serve as a useful supplement to the current standards for disposable sterile medical devices.
Ethylene oxide2-ChloroethanolHeadspace gas chromatography methodMedical devicesResidual amount
万方数据
维普
