Analysis on sterilized residues of ethylene oxide for medical devices
Objective To study the residual of ethylene oxide and 2-chloroethanol in medical devices.Methods Thirteen kinds of polymer materials commonly used in medical devices were sterilized,and ethylene oxide and 2-chloroethanol residues were tested by gas chromatography without analysis.After 3,5 and 7 days of analysis,the effects of ethylene oxide residue and resolution rate,as well as the effects of extraction temperature,time and chloride ion concentration on the detection of 2-chloroethanol were detected.Results No 2-chloroethanol was detected in any of the 13 materials after sterilization.Acrylonitrile-styrene-butadiene copolymer(ABS),polyurethane and polyvinyl chloride ethylene oxide residues were 632.27,577.66 and 524.53 μg/g,respectively,while silicone rubber and fluoroplastics had fewer residues of 5.34 and 72.73 μg/g,respectively.There was a significant difference in the resolution rate of different materials,and the resolution rate of fluoroplastics and polyetheramide block copolymers was the fastest,with 100.00%and 98.34%,respectively.The concentration of chloride ions had an effect on the detection of 2-chloroethanol.Conclusion Medical device companies should conduct specific analysis of the selected materials at the beginning of product design,and reduce ethylene oxide residues by controlling sterilization and analysis conditions if necessary,while the control of 2-chloroethanol residues may not be necessary.
ethylene oxide2-chloroethanoldesorptionchloride ion concentration
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