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