ABSTRACT
This chapter eview the available processes for these chemical agents, outline their development, describe suitable validation approaches, and delineate the necessary routine process control requirements. There are instances in the manufacture of pharmaceutical products and medical devices where an item must be sterilized; the materials’ properties can eliminate methods of sterilization based upon thermal energy either moist- or dry-heat or radiation. The concentration of the chemical agent has the largest impact on the effectiveness of the sterilization process regardless of the phase present. Sterilization is a process that completely destroys or removes microorganisms. Gas, liquid, and vapor sterilizations are ordinarily carried out in jacketed vessels or chambers much like those utilized for steam sterilization. All materials in a liquid state have some tendency to evaporate into the gaseous form. To assure greater process reliability, external and/or internal mixing is utilized to enhance uniformity of the lethal agent and RH throughout the vessel.
