ABSTRACT
This chapter demonstrates how products can be considered to be free from living microorganisms. Disease-causing organisms or pathogens are of principal concern when considering pharmaceutical products, especially those preparations administered through the otherwise protective skin, parenteral products. Initially explored for the sterilization of food products, the technology has been extended to the sterilization of form/fill/seal products for which the pulsed characteristic of the process is ideally suited for application to a production line. Depending on the intensity of the killing process, for example, the temperature or length of time in the case of heat or the concentration, temperature, and length of time for a biocidal agent, microbes themselves have varying susceptibility as follows: Total inactivation: everything from bacterial spores to lipid encapsulated viruses are killed. Partial inactivation: most vegetative organisms (but not spores) are killed. Selective inactivation: only vegetative bacteria, most viruses, and fungi are affected.
