ABSTRACT
Global regulatory agencies including the US Food and Drug Administration and the European Medicines Agency have undertaken many initiatives either to improve the quality and safety of sterile drug products in response to specific incidents or to incorporate scientific and technological advancements. Sterilization of a medicinal product is achieved either by terminal sterilization of a drug in its final container or by aseptic processing techniques. There are fundamental differences between the production of sterile drug products using aseptic processing versus production using terminal sterilization. Terminal sterilization usually involves filling and sealing product containers under high-quality environmental conditions. roducts are filled and sealed in this type of environment to minimize the microbial and particulate content of the in-process product and to help ensure that the subsequent sterilization process is successful. Aseptic processing involves the interplay between a number of different processes, all of which must be designed, executed, and controlled in order to yield sterile products.
