摘要
目的新型冠状病毒肺炎疫情期间,为加快口罩上市,缩短环氧乙烷的解析时间。方法随机选取10批次按正常灭菌浓度经环氧乙烷灭菌而未进行任何解析处理的医用外科口罩为样本,以气相色谱仪作为检测手段,拆掉样本包装,将样品置超净工作台,在垂直流最大风速情况下,检测不同解析时间环氧乙烷的残留量,对检测结果进行分析。结果与结论通过加大环境空气的流通速度,可使口罩含有的环氧乙烷快速解析,达到标准要求,以合理规避无菌试验前的解析时间,缩短出厂检验周期,加快口罩的上市。
Objective To speed up the marketing of masks and shorten resolution time of ethylene oxide during the coronavirus disease 2019(COVID-19)epidemic.Methods Ten batches of medical surgical masks were randomly selected,which were sterilized with ethylene oxide according to the normal sterilization concentration without any resolution treatment.Gas chromatography was used as the detection method,the samples were unpacked and placed in the ultra-clean working table.Under the condition of the maximum wind speed of vertical flow,the ethylene oxide residues at different resolution time were detected,and the detection results were analyzed.Results and Conclusion The ethylene oxide contained in the mask can be rapidly resolved and meet the standard requirements by increasing the flow rate of ambient air,so as to reasonably avoid the resolution time before sterility test,shorten the cycle of outgoing quality control(OQC)and speed up the marketing of the mask.
作者
周晴
董蓥霖
李丽
曾艳楠
唐静
ZHOU Qing;DONG Yinglin;LI Li;ZENG Yannan;TANG Jing(Chongqing Quality Testing&Inspection Center for Medical Devices,Chongqing,China 401120)
出处
《中国药业》
CAS
2020年第7期52-54,共3页
China Pharmaceuticals
关键词
口罩
环氧乙烷
气相色谱法
超净工作台
快速解析
mask
ethylene oxide
gas chromatography
ultra-clean bench
rapid resolution
作者简介
第一作者:周晴,女,大学本科,工程师,研究方向为无源医疗器械检验及标准化,(电子信箱)93436942@qq.com。
