When the FDA conducts inspections of aseptic drug manufacturers, they cover systems and areas within systems that present the greatest risk of product contamination and require strict control of processing parameters. Microbial controls and sterility assurance are the main focus of aseptic processing drug inspections. In an aseptic filling process, the drug product, containers, and closures are sterilized separately and then brought together under a high-quality environmental condition designed to reduce the possibility of a sterility breach. Any manual or mechanical manipulation of the sterilized drug, containers, or closures prior to or during aseptic filling and assembly poses the risk of microbial contamination. Humans are a significant source of contamination in aseptic processing, especially in production lines that require operators enter critical areas, Class 100/ ISO 5/Grade A, of the filling line.
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