Pre-filled syringe and packaging considerations for VHP (VH2O2) sterilization applications

Vaporized Hydrogen Peroxide (VHP or VH2O2) is a growing option for sterilizing pre-filled syringes that contain an aseptically filled biological product. The sterilization of the syringe exterior surfaces, packaging, and associated components allows for a sterile presentation to the patient reducing the risk of infection. The recently published ISO 22441 standard defines the development, validation, and controls for VHP sterilization, however, there are several steps to consider as part of the feasibility process for pre-filled syringe products. This presentation will focus on the key areas to consider for pre-filled syringe designs used in a VHP sterilization process. Items discussed will include best design practices for vacuum tolerance, materials, and flow path considerations.