期刊论文Pharmaceutical container/closure integrity. VI: A report on the utility of liquid tracer methods for evaluating the microbial barrier properties of pharmaceutical packaging复制

DOI:复制

文献链接: https://pubmed.ncbi.nlm.nih.gov/10969527复制

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PMID: 10969527
作者: L E Kirsch; L E Kirsch; L E Kirsch
摘要: The relationship between a liquid tracer package leak test (Mg ion ingress) and microbial immersion challenge test was demonstrated by direct and indirect correlation techniques. Rubber-stoppered glass vials with micropipette leaks were evaluated by a helium leak rate method, filled with broth, sterilized, and immersed in a bath containing microorganisms (E. coli/B. diminuta) and liquid tracer (Mg ions). After exposure and incubation, each unit was evaluated for liquid tracer ingress by atomic a...