Biotech drugs are the fastest growing segment of pharmaceutical and biotech pipelines. About 60-70% of these drugs are delivered in a pre-filled syringe or similar delivery device. Biotech drugs are often highly sensitive to temperature, vacuum and sterilant ingress. Nitrogen dioxide sterilization offers an alternative sterilization method with many advantages important for these drug-device combination products: sterilizes at 10 °C-30 °C, a gas sterilization process that can reach complex geometries, surface sterilant with no to low ingress into the syringe, and vacuum can range from 20 Torr – 500 Torr – ideal for pressure-sensitive delivery devices. NO2 is a recent addition to the sterilization options a company can consider for their product. NO2 was selected by the FDA for Innovation Challenge 1 – Alternative Sterilization Methods (to ethylene oxide) in November 2019. This webinar is intended to walk the participants through assessment of the pre-filled syringe, identify things that should be considered prior to validation, the appropriate ISO and TIR guidelines, a recent case study of a sterilization validation of a pre-filled syringe. The leaders of this proposed webinar have been working with this product from the feasibility study phase – reviewing/revising syringe and packaging design, identifying most challenging location, evaluating lethality cycle parameters, and completing the ingress and external residuals assay. This work was all done as an R&D study to prepare for validation. In addition, Noxilizer and Sterigenics have worked closely with Company X to make sure their product can move from the contract manufacturer to contract sterilization facility and back using a tote system that protects the product during shipping and insures consistent load configuration.
