An alternative maximum dose testing method for electron beam sterilization processes

Publication Image


An alternative method is presented for determining the maximum acceptable dose in products irradiated in electron beam processes. When the presentation of an individual product to the radiation field results in a high dose uniformity ratio, this can present a challenge for accurate testing of a product for dose establishment. The conventional interpretation of maximum acceptable dose is based on the minimum dose delivered to a sample which passes a functionality test regardless of maximum dose, which could result in a dose specification that is not achievable, but which also does not represent the actual range of doses that would be seen in normal processing. When there is a high dose uniformity ratio, but the dose distribution is consistent for each product or group of products, then a more reasonable approach would be to base the maximum acceptable dose tests on the range of process target doses that achieve the desired product functionality. The application of this alternative method will provide a more accurate determination of the capability of a radiation process and should enable more products to be safely processed using this technology.

People (1)

Emily Craven has spent the last 20 years finding better ways to use radiation for industrial applications. An engineering physicist and licensed Professional Engineer by training, Emily is a recognized expert in gamma, electron beam and x-ray sterilization. She has been a radiation physicist and a...