Parenteral Drug Development: Exploring the Potential Benefits of Terminal Sterilization

Eric Offermann and Bernd Zeiss will speak about Nitrogen Dioxide (NO2) as a new sterilization method and an alternative to EtO gas. A joint study carried out by Gerresheimer, Sterigenics and Früh, showed that NO2 is well suited to terminally sterilize prefilled ophthalmic syringes. The following 5 topics will be addressed in detail: Comparison of EtO vs. NO2 penetration into the filled syringe. Analyze gas ingress through 4 different plunger stoppers including silicone oil-free and standard rubber plungers. Scrutinize gas ingress through 2 different cap designs based on different elastomer properties. Investigate gas permeation through COP plastic barrels compared to glass. Check if the final blister has an influence on either sterilization method. The ultimate objective of this study was to offer the best syringe design and packaging paired with the most suitable sterilization modality to pharma customers.

Packaging is an integral part of the design for pharmaceutical products and medical devices. Not only does one need to take into account the look, feel, and protective qualities of the packaging but design must be considered when determining the sterilization technology. Determining the sterilization technology early in the design process, and concurrently working with your sterilization supplier can minimize risk and optimize outcomes. This presentation will cover packaging basics including materials, methods of sterilization (Ethylene Oxide and Radiation) and also explore packaging design challenges and solutions for Ethylene Oxide process validation

Sterilization is a pivotal step in the pharmaceutical drug development process to help ensure overall safety is maintained. Regulation is clear that, whenever possible, products intended to be sterile should be terminally sterilized in their final container. Only if terminal sterilization is not possible, filtration or aseptic assembly should be applied. This webinar will focus on trends in the concept of sterility assurance including the revision of USP and elements to evaluate prior to selecting aseptic assembly for the manufacturing of sterile drug products. What will you get from this webinar? A deeper understanding of terminal sterilization and aseptic processing of drug products through a regulatory lens as well as that of a manufacturer. Trends in the concept of sterility assurance. Mitigation strategies for the use of terminal sterilization with radiation, ethylene oxide and novel modalities.

This webinar will address: Treatment of packaging material with photon and electron radiation is an essential part of the sterilization process. The effect of irradiation on these materials is crucial for packaging engineering to understand the material effects. Many polymers used in the medical and pharmaceutical fields show some degree of degradation after radiation exposure, which can be determined either by visual or physical measurement. What mechanical properties are important, how are they tested and what degree of degradation might be allowed? This presentation contains a brief overview of ionizing radiation, and how it interacts with materials. Packaging considerations for gamma/X-Ray/electron beam radiations will be reviewed. This webinar originally aired as part of Pharmapack Europe 2021