ABSTRACT

To sterilize something means to render it ‘‘aseptic’’. Moist-heat sterilization is achieved when water vapor at a definite temperature is introduced or generated at the level of the micro-organisms to be inactivated and is maintained in such conditions for a definite time. Moist-heat sterilization is achieved when a suitable combination of temperature and humidity can be introduced at the level of the micro-organisms to be inactivated. Pharmaceutical production practice uses substantially three moist-heat sterilization processes: pressurized saturated steam; superheated water; and steam-air mixture. All sterilizers intended for pharmaceutical use are currently made of class AISI 316 stainless steel, including the valves and piping. Moist-heat autoclaves operating with counterpressure are sterilizers capable of controlling the pressure of their sterilizing medium independently of its temperature. They are used essentially for the terminal sterilization of solutions. The pharmaceutical market more and more often requires rotating-load sterilization autoclaves.