ABSTRACT
OVERVIEW Aseptic processing is an umbrella term for a family of technologies that enable sterilized packaging components and products to be manufactured under conditions that mitigate contamination risk. In the healthcare product manufacturing fields aseptic processing is expected by regulation to be so effective at the reduction of contamination risk that the products can be labeled “sterile.” It is widely used in the food, medical device, biotechnology, and pharmaceutical industries for the manufacture of products whose essential properties would be damaged by terminal sterilization processes using steam, radiation, or other means. There is universal preference for the use of terminal sterilization because of what is considered a superior assurance of sterility; however, the adverse effects of sterilization processes is such that an estimated 85% of sterile pharmaceuticals are made using aseptic processing (1-3).
