Regulatory Approach for Transitioning from Gamma Ray to X-ray Radiation Sterilization.

When investing in X-ray irradiation facilities around the world, an opportunity exists for defining a regulatory framework for assessing the transition from current gamma irradiation processes. Historically, regulatory strategies for changing the radiation source for routine processing has consisted of repeating the majority, if not all, of the validation activities performed as part of an initial validation and associated submission. Although not a new concept, performing a risk assessment has the potential to be leveraged more fully by increasing the rigor of determining what is changing when product moves from a gamma to an X-ray irradiator, then determining how these differences may affect product characteristics. During these steps, differences can be identified and quantified between radiation sources and potential impacts, if any, to product quality can be elucidated. Based on these risk assessments, the level of action required, or not required, in terms of empirical product testing can be examined and a determination can be made regarding whether a substantial change has occurred.