ABSTRACT
Sterile products are sterilized either by terminal sterilization technologies or by filtration, followed by aseptic processing. The majority of small-volume injectables are aseptically processed. What aseptic processing means is that components of the final product are separately sterilized, and then put together under aseptic conditions with no terminal sterilization step after the product is filled, stoppered, and sealed. While significant advances have been made in sterility assurance of aseptic production processes, such assurance will never be greater than that achieved with terminal sterilization processes. At the time of the publication of this book, almost all drug products recalled by the Food and Drug Administration (FDA) with either confirmed or suspected issues with sterility assurance were products produced by aseptic processes. Therefore, significant scrutiny is placed upon all aspects of the production facility, processes, personnel, procedures, and documentation with regard to validation of aseptic processing.
