METHOD FOR ESTABLISHING RESISTANCE CHARACTERISTICS OF A BIOLOGICAL INDICATOR

摘要

A method is provided for establishing resistance characteristics of a biological indicator in a sterilization process using a sterilant vapor. The method includes the step of creating a biological indicator inactivation profile by obtaining differential sterilant vapor pressure values in a sterilization chamber during sterilant vapor injection and determining D-values as a function of the differential sterilant vapor pressure values obtained. The biological indicator inactivation profile, when represented as a function of differential sterilant vapor pressure, may be linear over the full range of inactivation. The biological indicator inactivation profile may be created by injecting the sterilant vapor into the sterilization chamber and measuring biological indicator survival at different differential sterilant vapor pressure values. The method may include providing biological indicator inactivation data during sterilization at a given sterilization chamber temperature and initial sterilant concentration for use in creating the biological indicator inactivation profile at another temperature and sterilant concentration.

主权项

1. A method for establishing resistance characteristics of a biological indicator in a sterilization process using a sterilant vapor, the method comprising:
obtaining differential sterilant vapor pressure values occurring during sterilant vapor injection into a sterilization chamber, and creating a biological indicator inactivation profile by calculating D-values as a function of the differential sterilant vapor pressure values.