Abstract: The present invention provides a method and apparatus for sterilizing a pharmaceutical composition, the method comprising providing a sterilization system including a heat exchanger for elevating and then lowering the temperature of the fluid in a time period; measuring temperature at an input of the heat exchanger, measuring temperature at an output of the heat exchanger and measuring temperature at least one point in the heat exchanger intermediate to the input and output; calculating a coefficient of heat transfer for the sterilization system using the temperature measurements; calculating a degree of sterilization (F.sub.o) using the coefficient; and adjusting the temperature of the heat exchanger to minimize degradation of the pharmaceutical composition while maintaining an acceptable degree of sterilization.

Abstract: A sterilization system for sterilizing a solution such as a parenteral solution or diluent generally includes an arrangement for supplying a solution to be sterilized from an associated source, at least one first heat-exchanger for elevating the temperature of the solution, and at least one second heat-exchanger for subsequently cooling the solution. The system further includes an arrangement for pressurizing the system with sterile gas which is used to effect "dry-start up" of the system and to shut-down the system to minimize product losses.