ABSTRACT
INTRODUCTION There are instances in the manufacture of pharmaceutical products and medical devices where an item must be sterilized, yet its properties eliminate methods of sterilization based on moist or dry heat or radiation. The simplicity and speed of heat and radiation sterilization makes them the methods of choice in most instances; however, the effects of these sterilization processes on many materials are detrimental to essential material properties. When faced with these circumstances, the practitioner often turns to chemical methods where microorganisms are destroyed by exposure to chemical agents in gas, vapor, or liquid form. This chapter will review the available processes, outline their development, describe suitable validation approaches, and delineate the necessary routine process control requirements.
