ABSTRACT
In the United States, The Code of Federal Regulations includes the law that defi nes the application of “Commercial Sterilization” to food products. One of the critical concepts included there is that of a “Process Authority” as the person that carries most of the responsibility for technical decisions related to sterilization processes. The need for a qualifi ed Process Authority to perform or direct the development, validation, and troubleshooting of commercial sterilization processes is evident. Availability of a qualifi ed person to lead this work is of top importance to reduce the risk of failure implicit in the nature of commercial sterilization processes. Currently the availability of computer software programs that perform curve fi tting and other related calculations may mislead some of their potential users to depart from the
legal requirement to have a Process Authority leading the corresponding tasks. This is a risky approach that should be avoided. Therefore, this chapter provides information that should prove useful to process authorities but does not intend to replace them. Although much of the chapter is devoted to thermal inactivation in response to lethal heat treatments, kinetic models for inactivation in response to high pressure as well as curing salts are also addressed later in the chapter.
