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高效过滤器检漏方法的探讨

Discussion of Leak Detecting Method for High Ef?ciency Filter
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摘要 高效过滤器的检漏有不同的标准和方法,通过对各标准、检测仪器及不同检测方法进行对比分析,探讨各种方法的原理和技术特点,为高效过滤器的使用单位在实际应用中提供参考。根据技术对比的结果,并结合笔者的实践经验得出:药品生产企业采用光度计作为检测仪,通过气溶胶发尘对高效过滤器进行扫描检漏,是高效过滤器完整性检测的最佳选择。 There are different standards and methods for leak detection of high efficiency filter. Through the comparison and analysis of the standards and the different detection methods, including detection instruments and aerosols, the principle and technical characteristics used in these methods were discussed, which provided some references for application of high efficiency filters in practice. Based on the results of technical comparison and combined with the author's practical experience, it is concluded that: photometer can be usedby pharmaceutical manufacturers as a detector to scan the high-efficiency filter through aerosol dust, which is the best choice for the integrity test of high-efficiency filter.
作者 索晔 匡宏 杨海泉 Suo Ye;Kuang Hong;Yang Haiquan(Shengyang YaodaLei yunshang Pharmaceutical Co., Ltd, Benxi 117004;Wuxi High-tech Zone Science and Technology Innovation Promotion Center, Wuxi 214001;MIRABLE Pharmaceutical Science and Technology Co.,Ltd, Shijiazhuang 050046)
出处 《化工与医药工程》 2019年第2期36-39,共4页 Chemical and Pharmaceutical Engineering
关键词 高效过滤器 完整性 检漏 气溶胶 无菌制剂 风险评估 最易通过粒径 high efficiency filter integrity leak detection aerosol sterile injection risk assessment most penetrating particle size(MPPS)
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