A dose map, or dose distribution study, helps us determine if all of the product within your case is receiving the necessary sterilization dose. In this study, we take a measurement of the internal doses throughout a case of product.
The case of product is opened by E-BEAM Services, and our trained lab technicians place dosimeters at multiple locations, based on guidance provided in ISO 11137-3. We then run the case through the accelerator in a simulated production scenario, taking an additional measurement of the surface (or surfaces, in two-sided processing) of the case that faces the beam. Once the processing is complete, we read the dosimeters, using the surface reading as a reference dose. We identify the location of the minimum and maximum internal doses within the case, and then relate those to the surface dose using simple ratios.
We then validate these findings–three separate times–and provide you with a report of our results.
Once a successful study has been completed, the minimum and maximum internal dose can then be measured by simply measuring the surface dose in routine production, without the need to open the case and expose the product to the environment.
And what is probably the greatest benefit to you: the fact that E-BEAM will perform this qualification work at the same time on two accelerators, as separate processing centers within the same facility. This means there is always in-house backup capacity for your product. Flexible scheduling. No downtime. No delays for your customers. Now if only the rest of our daily lives had that kind of security!
Ready to schedule your dose map?