Successful qualification and acceptance of dual technology sterilization strategies, such as X-ray and gamma irradiation, is expected to greatly strengthen business continuity and risk mitigation strategies for sterilization of healthcare goods.  Collaborative industry-aligned approaches for testing and evaluating the risk of qualifying X-ray as an equivalent alternative to gamma irradiation are highlighted for the single-use bioprocess industry.  In addition, a holistic metadata review is shared summarizing a wide range of materials evaluated to date, including strengths and weaknesses in the supporting data, including extractables, for specific categories of materials.    In effort to mitigate delays that could result from regulatory uncertainty, risk assessment and qualification approaches, coupled with supporting data and post approval change strategies, were shared through meetings with multiple stringent health authorities, including the US FDA ETT, US FDA CATT, EMA QIG and Japan PMDA.  The key areas of interest, general points of alignment, and ongoing remaining challenges for post-change approvals are summarized.