![]() ![]() Heat lability of the packaging material should not in itself be used to disqualify a product from heat sterilization if it is otherwise heat stable. With respect to a given sterilization modality, steam is the preferred method. For this reason, it is well accepted that sterile drug products be manufactured using aseptic processing only when terminal sterilization is not an option. Terminal sterilization is the only way to provide a SAL to a finished drug product. While USP sterility release testing is often performed on a small percentage of units, the limitations associated with this test are well established. Therefore, the sterility of the drug product released from this type of manufacturing process is based entirely on the manufacturing controls in place at the time of filling. ![]() While strict controls related to current good manufacturing practices (cGMP) are employed to ensure the finished product is in fact sterile, no sterility assurance level (SAL) is obtained from this process. Post filling, the containers are closed off using primary and secondary packaging components such as pre-sterilized elastomeric stoppers, aluminum seals/closures, screw caps, or heat crimping methods. ![]() With respect to pharmaceutical manufacturing, traditional liquid sterile drug products are filled into clean and sterile primary containers such as vials, bottles, syringes, cartridges, or bags. Terminal sterilization is the process of sterilizing products in their final container. Terminal Sterilization of Sterile Filtered Products The important shift towards terminal sterilization ![]()
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