Prince Sterilization Services, LLC bolsters contract sterilization offering, adds in-house low temperature hydrogen peroxide terminal sterilization capabilities for medical devices….
Derek Prince
FDA Encourages Vaporized Hydrogen Peroxide Medical Device Sterilization: Reducing Reliance on Ethylene Oxide (EtO) The path towards utilizing vaporized hydrogen…
Releasing sterile product from a validated terminal sterilization process does not require the performance of a compendial sterility test such as that outlined in USP <71> Sterility Tests or EP 2.6.1. Sterility. The only way to achieve a proper sterility assurance level (SAL) on a pharmaceutical product or medical device is through exposure to a validated sterilization process that is designed to deliver the appropriate lethal conditions to the specific product. The compendial sterility tests are not designed nor intended to make the determination of whether or not the entirety of a sterilized batch of products/devices is sterile. While not the intention of this article, the limitations of the sterility test are well defined and accepted [1]. Below is an excerpt taken directly from USP <71> Sterility Tests.
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.
Prince Sterilization Services LLC achieves ISO 13485 certification PINE BROOK, N.J. — Prince Sterilization Services, LLC, a contract sterilization services…
Steam sterilization is an important process which needs to be done for the wellbeing of patients who are admitted at…
Doctors, dentists, and surgeons have to routinely deal with the cleanliness of their medical instruments. After all, it directly affects…
Liquid filled products manufactured aseptically are usually assumed to be inappropriate for steam sterilization due to possible heat liability of…
by Daniel Prince FDA has published guidance for industry to assure patient safety public that glass containers such as vials,…