Virtual dose mapping as a tool to minimize dose uniformity ratios (DUR) and maximize throughput
Tobias Funk1, Daniel S Badali1.
1Dose Insight, Newark, CA, United States
Dose Insight has developed a virtual dose mapping tool to accurately model the dose that a device receives during radiation sterilization. This enables to study the vast design space on how to exactly package medical devices during sterilization.
The goal of optimizing a sterilization configuration is to minimize the DUR of all devices in a shipping box and, at the same time, maximize the sterilization throughput in terms of devices per volume.
Here we demonstrate that with modelling we can explore packaging configurations of a simple medical device like a syringe suitable for e-beam sterilization. The exploration starts with the simple question which beam direction is advantageous, with the beam either parallel or perpendicular to the long axis of the syringe. This can be done for a single device or with an increasing number of devices to explore how many devices can be penetrated while maintaining a reasonable DUR. For further exploration, we investigated possible packaging schemes such as parallel or antiparallel orientations of neighboring devices and the optimal distance between devices.
In our study, we found that the perpendicular beam direction is advantageous in terms of DUR, with a 30% reduction in the DUR compared to the parallel configuration. This conclusion holds for both a single device and a shipping box of 3x3x4 devices, as shown in the figure below. Moreover, the perpendicular configuration enables penetration through two shipping boxes in a row with a reasonable DUR, and so results in considerably higher throughput.
In conclusion, virtual dose mapping is a powerful tool to optimize medical device sterilization by identifying the packing configuration that results in the best DUR and highest cost savings by maximizing the throughput.