NO2 sterilization is the best choice for pre-filled syringes, combination products, and injectors
ADVANTAGES OF NO2 FOR PRE-FILLED SYRINGES:
Ultra-low temperature process
Minimum vacuum option prevents stopper movement
Low/no ingress through stoppers, maintains drug integrity
Flexible critical process parameters for custom cycles
Compatible with glass, polymer and lubricants
Safe and simple to bring in house, improves supply chain
Terumo study finds that NO2 sterilized WFI-filled syringes have immeasurable NO2 ingress when compared to EO and VHP, Chemical-gas Sterilization of External Surface of Polymer-based Prefilled Syringes and Its Effect on Stability of Model Therapeutic Protein, Fujiwara, et.al., Journal of Pharmaceutical Sciences, September 2021.
Regeneron study notes that Nitrogen Dioxide (NO2) sterilization ensures drug integrity and lowers the risks of adverse effects with IVT, Container Closure and Delivery Considerations for Intravitreal Drug Administration, Parenky, et.al., AAPS PharmSciTech, March 2021.