Terminal sterilization is the process of sterilizing products in their final container. 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. 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. 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.
Steam sterilization is an important process which needs to be done for the wellbeing of patients who are admitted at…
By Daniel Prince Commercially prepared bacterial spores known as biological indicators (BI) are the preeminent tools used to verify and…
FAIRFIELD, N.J. — Operating under Gibraltar Laboratories since 2015, the sterilization services division has successfully spun-off into its own entity…