Establishing a minimum incubation time for biological indicators

For exposed Bis that have only one surviving spore, one of two conditions can exist: the spore has not been damaged in a manner that significantly affects either germination time or post-germination growth rate, or damage has occurred that significantly affects one or both of these characteristics,...

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Veröffentlicht in:Pharmaceutical technology Europe 2013-12, Vol.25 (12), p.42
Hauptverfasser: Gillis, John R, Schneider, Philip M, Mosley, Gregg, Kowalski, John B, Krushefski, Garrett, McCauley, Kurt J
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Sprache:eng
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Zusammenfassung:For exposed Bis that have only one surviving spore, one of two conditions can exist: the spore has not been damaged in a manner that significantly affects either germination time or post-germination growth rate, or damage has occurred that significantly affects one or both of these characteristics, when a sterilisation exposure gives a quantal-zone result of 50% of the Bis testing nonsterile, the Poisson distribution predicts approximately 35 Bis will have only one surviving spore and the remaining 15 will...
ISSN:1753-7967