Monte Carlo simulation has seen a renewed interest from the sterilization industry with the advent of easy to use and comprehensive package. Initial studies were focused on Operational Qualification (OQ), which often use easy to model products, with as homogeneous a density as possible. The next step in the integration of mathematical modelling in the quality assurance process for sterilization is the implementation of Product Qualification (PQ). The main hurdle with regard to PQ is that the products are not guaranteed to be homogeneous and are often small and intricate devices, requiring a careful parametrization of the simulation. Adding this many detail can lead to difficulty software-wise, with a number of elements a few magnitudes higher than “typical” simulation. This in turn can lead to excessively huge resource consumption, necessitating either dedicated infrastructure or careful simplification in order to run the simulations.

This presentation will detail a case study performed in conjunction with IONISOS (Sterilization Services) and SMAIO (Medical Devices manufacturer), for the PQ of a single use medical device in a gamma irradiator using the 3D Monte Carlo code RayXpert®. We will show how we managed to deal with the required number of product instances, the various simplification used, and the results obtained. We will also discuss the limitation inherent to this technique and the perspective that can be envisioned at this time.