In order to determine if the necessary sterilization dose is delivered into a case of your product, we first need to perform a dose distribution (dose map) study. This study takes 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 of product in a simulated production scenario, taking an additional measurement of the surface 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 internal dose and the maximum internal dose and relate it to the surface dose using simple ratios. Once a successful study has been completed, the minimum and maximum internal dose can be measured by measuring the surface dose in routine production.
In addition to this initial dose map study, E-BEAM Services will complete a Dose Map Validation Study. The validation study is used to verify the ratio findings of the initial dose map. It involves running three “dose maps” and making adjustments to the surface dose range as needed.
The cost for the initial dose map and three subsequent validation studies is $2500 total. All we need is a case that represents the packaging of the final product for sterilization and for you to tell us the minimum and maximum dose required for a sterile and safe product.