Sterile drug products produced by aseptic processing are the most stringently regulated and require maintenance of the highest-quality critical environment. Each manufacturing step requires validation and control. Manufacturing errors could lead to the distribution of a contaminated product. Assuring sterility of all aspects of the process, reducing manual or mechanical manipulation of the sterilized drug, components, containers, or closures during processing, and limiting operator movement and exposure during all operations are of the utmost importance.
STERIS Barrier Product Solutions product solutions improve compliance with current Good Manufacturing Practices (cGMPs), and reduce the risk of product contamination. Our solutions ensure and maintain sterility, promote aseptic technique during setup and operations, and limit personnel intervention during processing.