All processes germane to the steril

All processes germane to the sterilization and formation of a package having integrity are to be evaluated against the user requirement specifications established in the package development phase, including likely process extremes. For example, inherent package integrity verification may consider extremes of package assembly variables such as line speed, heat-sealing temperature, screw-cap application torque, and vial-capping forces, as well as resterilization processes, labeling, and secondary and tertiary packaging processes. Validation test requirements and scope should fit the statistical requirements and capabilities of each process, taking into account both package and package-line complexity, as well as prior experience with similar product–packages.