隔离器VHP过程BI阳性的比例的接受标准

解颐

cxj0205 发表于 2026-2-27 11:07
仔细看了描述，是总阴性大于95%，也就是说如果放了200个BI，那么如果有10个阳性也是合格的，这个估计是内 ...

5%的阳性怎么保证Terminal Sterilisation – The application of a lethal sterilising agent or conditions to a product in its final container to achieve a predetermined sterility assurance level (SAL) of 10⁻⁶ or better (e.g. the theoretical probability of there being a single viable microorganism present on or in a sterilised unit is equal to or less than 1 x 10⁻⁶ (one in a million)).

成慧潫

我定的标准时每个点位3支，阳性不超过1支就算合格。本来还想加上有阳性的点位不超过多少个，但是没有定出来合适的，所以就没有加上去。

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