变更。 Ifclearlyvisiblegrowthisnotobtainedinthepresenceoftheproducttobetested,parabletothatinthecontrolvesselswithoutproduct,theproductpossessesantimicrobialactivitythathasnotbeensatisfactorilyeliminatedundertheconditionsofthetest.Modifytheconditionsinordertoeliminatetheantimicrobialactivity,andrepeatthevalidationtest.如果用肉眼与没有产品的对照容器比较,无法在存在供试产品的情况下得到清晰可见的生长,则该产品在试验条件下所具有的抗微生物活性尚未令人满意地消除。变更条件以便消除抗微生物活性,并重复验证试验。 Thisvalidationisperformed(a)whenthetestforsterilityhastobecarriedoutonanewproduct;and(b)wheneverthereisachangeintheexperimentalconditionsofthetest.ThevalidationmaybeperformedsimultaneouslywiththeTestforSterilityoftheProducttobeExamined.当(a)一个新产品必须进行无菌试验时,和(b)无论何时该试验的试验条件发生改变时,则需进行此验证试验。该验证可以与供试产品的无菌试验同时进行。TESTFORSTERILITYOFTHEPRODUCTTOBEEXAMINED供试产品的无菌检查NumberofArticlestoBeTested供试物品数量
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