摘要
目的:西林瓶包装的无菌药品应能防止微生物侵入,西林瓶压塞后应当尽快完成轧盖,并达到轧盖的密封完整性要求,避免产品遭受污染。方法:通过介绍轧盖扭矩检查原理,Mark-10 Corporation CTA12扭矩测试仪在无菌药品西林瓶轧盖时的扭矩检查方法,扭矩检查数据及控制图分析。结果:Mark-10 Corporation CTA12扭矩测试仪实现了无菌药品生产过程中西林瓶轧盖的完整性检查,并通过统计学分析,提供了轧盖扭矩监控的科学数据。结论:轧盖扭矩检查是评价轧盖完整性的一种较好方法,根据不同的包装组合应制定相应的检查、测试标准,达到生产阶段控制产品质量的目标。
Objective： The vial used to package aseptic drugs shall be able to prevent invasion of microorganisms. After sealing, the vial shall be capped as soon as possible, and the capped vial shall pass the integrity test to avoid any contamination of drugs. Methods： By presenting the principle of torque test of capping, test method of Mark-10 Corporation CTA12 torque tester in vial capping for aseptic drugs, and analysis of torque test data as well as control chart. Results： Mark-10 Corporation CTA12 torque tester could be used for capping integrity test for aseptic drugs, and could provide scientific data for capping torque monitoring activity through statistical analysis. Conclusions： It is a preferable method to evaluate the integrity of capped vial by checking torque. Suitable standard of checking and testing shall be set according to the form of packaging combination, in order to achieve the purpose of quality control in the process of manufacturing.
关键词
扭矩
完整性检查
峰值
控制图
torque
integrity test
peak value
control chart
