Radiation Technology Transfer Methodology

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.

Proper definition of sterilization and max dose values is critical to the creation of a robust radiation sterilization process as part of your product’s route to market. Radiation Technology Center Senior Manager Pierre Reppert shares best practice for processing samples to define these values for gamma, e-beam and X-ray radiation processing.

The validation of healthcare products and sterile barrier packaging prior to placing on the market is of the upmost importance to the safety of end user and patient. This presentation will give an overview of supporting testing and provide guidance on conducting successful studies.

The presentation will look in some detail how aging / stability studies are established and address the following What is aging / stability? What is purpose of aging / stability testing? What about relative humidity? What risks are involved? How long is the shelf life of your product?