ABSTRACT
INTRODUCTION Aseptic processing is acknowledged as one of the most, if not “the most” critical process challenge within the global healthcare industry. Technological improvements in this area have raised performance capabilities substantially over the years (1). Significant improvements in aseptic processing capability had already occurred prior to the introduction of the latest technologies for aseptic processing such as isolators, restricted access barrier systems (RABS), closed transfer systems for aseptic connection, and closed vial technology. The wider adoption of these technologies will improve the safety of aseptically produced materials to levels unattainable in the past. The traditional means for evaluation of an aseptic process is the process simulation test or media fill. These tests are conducted periodically to demonstrate the capabilities of the aseptic practices, and controls. This chapter reviews methods for the assessment of performance where the newer technologies available are employed.
