包bao裝zhuang測ce試shi放fang在zai首shou要yao的de是shi其qi密mi封feng性xing，是shi指zhi包bao裝zhuang袋dai密mi封feng的de可ke靠kao性xing，通tong過guo該gai測ce試shi可ke以yi確que保bao包bao裝zhuang密mi封feng的de完wan整zheng性xing
，防fang止zhi因yin產chan品pin密mi封feng性xing能neng不bu好hao，而er導dao致zhi泄漏
、汙染、變質等問題。
  baozhuangxitongmifengxing，shizhiyangpindebaozhuangxitong
，fangzhiweishengwuqinruyijiweichiyangpindegexiangzhiliangzhibiaochixufuheanquanhezhiliangyaoqiu。baozhuangxitongmifengxingdeyanjiushiyuchanpindekaifajieduanbingchixuguanchuanchanpinshengmingzhouqi，shishengchanzhiliangyanjiuhepingjiadeyixiangzhongdian，guanxiamianjiangcankaomeiguoyaodian1207係列指導原則從審評角度對無菌包裝相關的內容。

微生物挑戰法密封性測試儀LEAK-02檢測儀器適用於微生物侵入法密封性試驗，廣泛應用於西林瓶、安瓿瓶、輸液袋、預充針、滴眼劑等無菌包裝袋等多種材料的密封性檢測
，適用於藥廠
、醫療器械企業、藥檢
、質檢部門等，也稱為西林瓶密封性測試儀、安瓿瓶密封性檢測儀、輸液袋密封檢測儀、預充針密封試驗儀和滴眼液瓶密封儀等。

測試原理：weishengwutiaozhanfa，youjiaoweishengwuqinrushiyanfa
，shiyizhongjiaoweichangjiandemifengwanzhengxingceshifangfa，tongchangyumoniguanzhuangtongshijinxing。tongguoanzhaomoniguanzhuangyanzhengfanganjinxingpeiyangjimoniguanzhuang，ranhoujinxingyasaizhagaihou，mujianhege，jingyiyanzhengdemiejunguimiejunhou，jiangrongqimifengmianjinrudaogaonongdudejunyezhong，shiyangpinrongqineidepeiyangjichongfenjiechufengkouneibiaomian
，yangpindejingbujifengkoudewaibiaomianyingjinpaozaijunxuanyezhong
，jinpaoyidingshijianhouquchu，dingqipeiyanghoujianzhashifouyouweishengwuqinru
，yiquedingrongqimifengxitongdewanzhengxing。tongshi，xuyaozuoyangxingduizhaoshiyan，querenpeiyangjidecushengchangnengli。

參照標準：參考《化學藥品注射劑包裝係統密封性研究技術指南（試行）》、USP<1207>和PDA第27號技術報告