Patent ID: 7183048

Claim:
A method for assessing the effectiveness of a sterilization process, the method comprising: a) providing a biological indicator comprising a quantity of spores that comprise dipicolinic acid, wherein the biological indicator has a threshold amount of dipicolinic acid or a threshold rate of release of dipicolinic acid from the spores that has been predetermined to correlate to death of the quantity of spores; b) subjecting the biological indicator to a sterilization process c) determining an amount of the dipicolinic acid or a rate of a release of the dipicolinic acid from the spores after the sterilization process; and d) comparing at least one of (i) the amount of the dipicolinic acid after the spores have been subjected to the sterilization process with the threshold amount of dipicolinic acid to determine whether the amount of the dipicolinic acid after the spores have been subjected to the sterilization process is at least or greater than the threshold amount of dipicolinic acid; and (ii) the rate of the release of the dipicolinic acid from the spores after the spores have been subjected to the sterilization process with the threshold rate of release of dipicolinic acid to determine whether the rate of release of the dipicolinic acid after the spores have been subjected to the sterilization process is at least or less than the threshold rate of release of dipicolinic acid from the spores; whereby if the amount of the dipicolinic acid after the spores have been subjected to the sterilization process is at least or greater than the threshold amount of dipicolinic acid or the rate of the release of the dipicolinic acid from the spores after the spores have been subjected to the sterilization process is at least or less than the threshold rate of release of dipicolinic acid from the spores, death of the quantity of spores in the biological indicator is confirmed and the sterilization process is effective.