Low(er) Energy Radiation Solutions – Accelerating Acceptance
John Logar1.
1MQSA, J&J, Raritan, NJ, United States
The healthcare industry continues to transform at a rapid pace, and the need for streamlined in-house solutions are being evaluated as viable alternatives to traditional contract sterilization solutions. Two such alternatives are low energy e-beam (0.3-5 MeV) and low energy X-ray (~300 keV). Typically, implementation and acceptance of alternative sterilization solutions can take a long time and be put under additional scrutiny, creating long implementation-timelines, necessitating large amounts of testing and data collection, and resulting in uncertainty in the requirements for regulatory approval. This presentation will present the current opportunities, innovations, and irradiation solutions available for these equipment categories. In addition, this presentation will report the highlights and outcomes from an Industry Scientific Exchange being conducted in March 2024, that is focused on scale-up and acceptance of several alternative sterilization modalities. An output of this Exchange will be the creation of strategic roadmaps detailing the submission requirements for products to be sterilized by low(er) energy radiation solutions.