ABSTRACT

Biological indicators (BI) play a key role in the validation and routine monitoring of nearly all sterilization processes, except radiation. The manufacturer of the sterile product is responsible for the performance of the BI, and there are numerous standards and guidelines that relate to their use and performance. For commercial sterilization processes the achievement of sterility is based on probability considerations. The death of microorganisms proceeds as a logarithmic progression in known sterilization processes. The probability of survival is a function of the number and types of microorganisms on the product the sterilization process lethality and, in some cases, the environment in which the organisms exist during treatment. BI are typically used in the qualification of sterilization equipment, and the development and validation of a sterilization process for a given article as well as in the validation of sterilization processes for equipment, materials and packaging components that may be used in an aseptic assembly operation.