DETERMINING AN APPLICATION CONDITION OF STERILANT TO ACHIEVE A STERILITY ASSURANCE LEVEL

Abstract: a system may determine an application condition of sterilant to achieve a sterility assurance level (sal) for an article. the system may determine a hypothesized sterilant resistance (�) that indicates a probability of a micro-organism expressing growth once exposed to a unit of sterilant; determine, based, at least in part, on the hypothesized sterilant resistance, an estimated number of samples that include a micro-organism expressing growth once exposed to the unit of sterilant; determine an observed number of samples that include a micro-organism expressing growth subsequent to exposure to the unit of sterilant; iteratively determine, based on one or more iterations, at least one first correction based on the observed number and the estimated number, and apply convergence criteria to determine whether to perform a next iteration; and determine the application condition of the sterilant, based on the first correction. other aspects are also described and claimed.

Inventor(s): Bradley Lundahl, Jagdishchanr Patel

CPC Classification: A61L2/28 (Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour (apparatus involving enzymes or microorganisms ; methods involving enzymes or microorganisms ))

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