Fundamentals of thermal sterilization processes.

Information has been provided in this chapter on the fundamentals of thermal sterilization processing. The derivation of various equations presented in the text was not discussed; the reader is referred to the references cited for this information. Emphasis was placed on the need for good manufacturing practice and for control of presterilization bioburden. These considerations will have the greatest impact on product quality in the long run. An attempt was also made to dispel the notion that sterilization processes always require the most rigorous biological challenge for validation. Finally, parametric or process control release of terminally sterilized products was discussed. Parametric release is a concept that will find greater application in areas other than most heat sterilization as the industry continues to derive full benefit from validated processes.