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Probability of non-sterility

Sterilization is a probability function. In the pharmaceutical industry, an item is deemed sterile if there is less than 1 chance in 1,000,000 that viable microorganisms are present in the sterilized article or dosage form. Therefore there is a 10 probability of non-sterility. In all sterilization processes, the inactivation of microorganisms develops as a first-order chemicalreaction, i.e., at a rate which is approximately logarithmic. ... [Pg.3512]


See other pages where Probability of non-sterility is mentioned: [Pg.325]    [Pg.97]    [Pg.98]   
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Non-sterility

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