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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.

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.

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By Daniel Prince Commercially prepared bacterial spores known as biological indicators (BI) are the preeminent tools used to verify and…