This presentation will review the fundamental considerations when changing from or adding technology to what is initially used in product validation, supporting the use of new technologies. With three available radiation technologies (E Beam, x-ray and gamma), it is common to look at alternative options to meet critical and growing needs in capacity, as well as which is best for individual product needs. This brief discussion will focus on changes from gamma to x-ray, why x-ray is an important tool in maintaining the need for sterilization capacity for medical devices into the future, minimum expectations in testing/assessment for a transfer of an established sterilization dose, transfer of a maximum allowable dose, and considerations of the change to a different irradiator with regard to product qualification (PQ) mapping and assessment of activation.

STERIS Booth #807
Speaker: Betty Howard, Radiation TechTeam Manager