文章摘要
王冬伟,张磊,张祥龙,钱承玉.真空衰减法测试西林瓶药品包装的密封完整性[J].中国药事,2020,34(5):589-595
真空衰减法测试西林瓶药品包装的密封完整性
Vacuum Decay Method for the Closure Integrity Testing of Injection Vials
投稿时间:2019-09-18  
DOI:10.16153/j.1002-7777.2020.05.015
中文关键词: 真空衰减法  包装密封完整性  西林瓶包装  染色液穿透
英文关键词: vacuum decay method  closure integrity testing  injection vials  dye ingress method
基金项目:
作者单位
王冬伟 山东省医疗器械产品质量检验中心, 国家药品监督管理局药品包装材料质量控制重点实验室, 济南 250101 
张磊 山东省医疗器械产品质量检验中心, 国家药品监督管理局药品包装材料质量控制重点实验室, 济南 250101 
张祥龙 山东省医疗器械产品质量检验中心, 国家药品监督管理局药品包装材料质量控制重点实验室, 济南 250101 
钱承玉 山东省医疗器械产品质量检验中心, 国家药品监督管理局药品包装材料质量控制重点实验室, 济南 250101 
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中文摘要:
      目的: 测试西林瓶药品包装的密封完整性,保证药品的质量。方法: 采用真空衰减法测试西林瓶药品包装的密封完整性。首先,选择合适的测试腔体,制备了阴性及阳性样品,设置并优化测试参数;然后,通过阳性样品验证了真空衰减仪的灵敏度;最后,测试了西林瓶药品包装的密封完整性,并与染色液穿透法的测试结果进行了比较。结果与结论: 采用真空衰减法能够有效测试西林瓶药品包装的密封完整性,该方法灵敏度较高,操作简单,结果真实可靠。
英文摘要:
      Objective: To test the closure integrity of injection vials and ensure the quality of the drug. Methods: Vacuum decay method was used to test the closure integrity of injection vials. Firstly, the appropriate test chamber was selected, and negative and positive controls were properly prepared. The test parameters were setup and optimized. And then the sensitivity of the vaccum equipment was verified by the positive controls. Finally, the closure integrity of injection vials was tested, and the detection rate of vacuum decay method and dye ingress method were involved in the comparative studies. Results and Conclusion: The vacuum decay method had the highest performance in terms of detection sensitivity. This method has high sensitivity, simple operation and reliable results.
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