Patent ID: 7704453

Claim:
A method for sterilizing objects with radiation, the method comprising the steps of determining a dosage of radiation sufficient to ensure sterilization to a sterility assurance level of 10 −6 and then applying said dosage of radiation to the objects, and wherein the step of determining said dosage includes the steps of: determining a bioburden upon one or more samples of the objects; determining an estimate of the dose that results in a probability of 0.01 of a surviving microorganism on the objects by testing a quantity of samples of the objects at varying dosage levels of radiation to determine a dosage below which not at all samples are sterilized and above which they are sterilized; confirming the estimate of the dose that results in a probability of 0.01 of a surviving microorganism on the objects by testing a quantity of samples of the objects at the dose that was estimated; and calculating a dosage for the sterility assurance level of 10 −6 by adding a factor to the dose that was confirmed to result in a probability of 0.01 of a surviving microorganism on the objects and wherein the factor is proportional to the dose that yields a probability of 0.01 of a surviving microorganism on the objects and inversely proportional to a log of the bioburden, wherein the factor equals PV*(CD/(2+log(BB))), wherein PV represents a proportionality value, CD represents the dose that has been confirmed to result in the selected probability of a surviving organism on the objects and BB represents the bioburden in colony-forming units.