STERIS AST has created a framework for integrating radiation simulation into standardized processes. Virtual dose mapping is still at an early stage, and its adoption depends on factors such as model validation, regulatory approval, and industry acceptance. Key to this is rigorous validation against real world measurements, a cornerstone of ensuring the reliability of simulation models. Knowledge of the radiation source operating parameters, treatment conditions of the site, and product configurations are required to generate a credible output. As a sterilization provider, STERIS AST is well positioned to generate simulation models that are representative of real-world sterilization scenarios.

This study describes a new methodology for evaluating the influence of system parameters on dose mapping results. The simulation results consist of the dose in each voxel of a phantom product and the associated statistical error. To validate this method, experimental measurements of operational qualification dose mapping were compared to Monte Carlo calculated dose results. A range of system parameters were investigated including scan settings, product location, product conveyance, and scattering surfaces. This approach identifies the significant impact system parameters have on dose uniformity during routine processing. Recommendations for tuning operating conditions and product configuration are provided. Simulation may be used in the future to provide assessments for product specific dose mapping.