首页|环氧乙烷灭菌橡胶检查手套不同包装材料下的质量研究

环氧乙烷灭菌橡胶检查手套不同包装材料下的质量研究

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目的:探究环氧乙烷灭菌条件下橡胶检查手套在不同包装下的产品质量风险.方法:采用不同时间点取样检测的方法,对江西云鸽橡塑有限公司生产的相同产品在聚乙烯包装、纸塑包装形式下的10组一次性使用橡胶检查手套灭菌前后产品的无菌、环氧乙烷残留、拉伸性能三项指标进行对比,同时对市场流通的8组聚乙烯包装和纸塑包装的产品进行质量检测对比.结果:自主生产的产品各个取样时间点均符合质量标准,随机外购的4组纸塑包装的产品均符合质量标准,4组聚乙烯密封包装的产品有3组出现了染菌现象,且聚乙烯包装的环氧乙烷解析普遍较慢,但对拉伸性能,两种包装材质无明显差异.结论:纸塑材料包装的橡胶检查手套各质量指标更优于聚乙烯材质包装的橡胶检查手套.
Study on the Quality of EO Sterilized Rubber Inspection Gloves Under Different Packaging Materials
Objective:To study the product quality risk of rubber inspection gloves under different packaging under oxirane conditions.Methods:The method of sampling detection at different time points,the aseptic,oxirane residue and tensile properties of 10 sets of disposable rubber inspection gloves made by Jiangxi Yun Pigeon Rubber and Plastic Co.,Ltd.were compared before and after sterilization,at the same time,the market circulation of 8 groups of PE packaging and paper and plastic packaging products for quality inspection.Results:In each sampling point of the self-produced product conforms to the quality standard,4 groups of the paper-plastic packaging products purchased at random conform to the quality standard,3 groups of the 4 groups of the PE sealed packaging products appear the phenomenon of bacterial contamination,the EO analysis of PE packaging was generally slow,but for tensile properties,there was no significant difference between the two packaging materials.Conclusion:The quality index of the rubber inspection gloves packed with paper and plastic materials was better than that of the rubber inspection gloves packed with PE materials.

ethylene oxidepackaging materialssterility testethylene oxide residuetensile propertiesrubber inspection gloves

曹伟、付彩群、孙寅田、林鹏、朱智青、朱轶骐

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江西省药品检查员中心 (江西 南昌 330000)

江西云鸽橡塑有限公司(江西 上饶 334000)

环氧乙烷 包装材料 无菌检查 环氧乙烷残留 拉伸性能 橡胶检查手套

江西省药品监督管理局计划项目

2022JS43

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(17)