Chapter 20 - Achieving sterility in biomedical and pharmaceutical products (part-I): thermal, chemical, and filtration sterilization

Abstract

Sterilization is of utmost importance in the medical device and health-care industries, as failure to adequately remove microorganisms, including bacterial spores, from reusable medical devices, parenteral, and ophthalmic products carry a risk of transmitting pathogenic microbes to patients that could lead to infections. This chapter aims at providing an overview of different means of rendering a product sterile in connection with terminally sterilized products, and at reviewing the critical process and environmental controls that must be made integral to a production system to maintain sterility in connection with aseptic processing. This chapter comprehensively covers traditional methods of sterilization including heat, radiation, filtration, and chemicals, as well as sheds some light on new and innovative methods of sterilization such as plasma, pulsed-light systems, microwaves, and supercritical carbon dioxide, including advancements in the barrier systems designed to support aseptic processing. Sterilization technology as applied in the pharmaceutical industry is discussed in the context of the regulatory requirements of using cleanrooms and associated controlled environments per the Code of Federal Regulations, specifically Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals, and Parts 600 to 680 for biological products, depyrogenation, sterilization-in-place technology and validation, biological indicators, parametric release, and sterility testing.