文章摘要
潘伟婧,彭兴盛,林梅,张玫,厉高慜.压力变化法测试无菌检查用隔离系统舱体完整性的研究[J].中国药事,2019,33(7):803-808
压力变化法测试无菌检查用隔离系统舱体完整性的研究
Study on the Integrity Test of Sterility-testing Isolator System by Pressure Change Method
投稿时间:2019-03-20  
DOI:10.16153/j.1002-7777.2019.07.013
中文关键词: 隔离系统  压力变化法  完整性测试  温度  大气压  测试时间  测试压力
英文关键词: isolator system  pressure change method  integrity test  temperature  atmospheric pressure  test time  test pressure
基金项目:国家药典委员会药品医疗器械审评审批制度改革有关药品标准研究子课题:无菌检验用隔离系统验证指导原则(编号ZG2016-4-01)
作者单位E-mail
潘伟婧 上海市食品药品检验所, 上海 201203  
彭兴盛 上海市食品药品检验所, 上海 201203  
林梅 上海市食品药品检验所, 上海 201203  
张玫 上海市食品药品检验所, 上海 201203  
厉高慜 上海市食品药品检验所, 上海 201203 007ppk@163.com 
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中文摘要:
      目的:研究压力变化法测试无菌检查用隔离系统舱体完整性的影响因素。方法:从温度、大气压、测试时间和测试压力等关键因素,探讨其对测试结果的影响。结果:各影响因素中,温度的变化对测试结果影响较大,大气压的变化对测试结果影响较小。结论:无菌隔离系统的完整性测试应妥善设计试验条件,在现有仪表条件的基础上,合理设置测试时间和压力,并保持测试周期内温度稳定。
英文摘要:
      Objective:To study the influencing factors of the pressure change method for testing the integrity of the sterility-testing isolator system. Methods:The influences of temperature, atmospheric pressure, test time and test pressure on the test results were discussed. Results:Among the influencing factors, the change of temperature had great influence on the test results while the change of atmospheric pressure had little effect on the test results. Conclusion:The integrity test of the aseptic isolator system should properly design the test conditions. Based on the existing instrument conditions, the test time and test pressure should be properly set and the temperature should be stable during the test cycle.
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