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Download the guidance here: https://eu1.hubs.ly/H0nssR80 Single-use systems (SUS) are commonly used in the pharmaceutical industry for manufacturing drug substances and products. After manufacturing and packaging, many single-use systems are sterilized using gamma rays from Cobalt-60. The demand for gamma irradiation (GI) is increasing, but there is a shortage of Cobalt-60 supply. As a result, the biopharmaceutical industry is turning to X-ray irradiation (XI) for sterilization. This document outlines a methodology for evaluating the inclusion of X-ray irradiation for single-use products previously treated with gamma irradiation, including: An X-ray irradiation risk evaluation tool A seven-step process for transitioning to X-ray irradiation A detailed flowchart for risk evaluation during the X-ray irradiation implementation cycle In this webinar, you will learn to navigate the guidance and understand how it can be adapted and modified to suit your own organization's quality management system and to manage the changes associated with the addition of X-ray irradiation as a sterilization technology for single-use systems. Speakers: Louisa Mitchell, BioPhorum Pritam Rajkule, @Takeda-Pharmaceuticals Samuel Dorey, @SartoriusGlobal Chapters: 0:00 Introduction 1:35 Why did we create this? 2:45 Overview of the toolkit contents 3:53 Overview of the guidance and the expected output 5:32 Step one to four 14:40 Final steps 17:32 Risk evaluation example 18:48 Conclusion #xray #singleuse #singleusesystems #gammaradiation #BioPhorum #DrugSubstance #SupplyResilience