This guidance document and the accompanying XI risk evaluation tool define the BioPhorum approach to risk evaluation of X-ray irradiation for sterilization of single-use systems (SUS) and is a flexible resource for incorporation of supporting tools into end-user quality system documents. End-users are responsible for critically reviewing this content prior to application and selecting the aspects that are most aligned with internal procedures, as well as making refinements as needed to meet local requirements.
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A BioPhorum member only benchmarking survey to understand industry approaches to evaluating containment of single-use closed system failures resulting in spill, splash or aerosol release.
BioPhorum member only survey looking at single-use closed system failures
This template allows suppliers and customers to exchange the right information at the right time and helpa standardize this function and ensure that the ‘minimal required information’ is created and shared.
The single-use audit guide has been designed to help the auditor and auditee understand the areas of focus in SUS audits, referencing relevant requirements and SUS manufacturing ‘elements’. It is also designed to assist the auditor in reporting their assessment of SUS manufacturers to the end-user. It includes sections on general quality management system areas and products and production processes to consider. It is designed to be applicable to audits of single-use system manufacturers.
This toolkit gives users a set of tools to respond to problems and materials to include in their communications and operator training.It will help reduce product losses, investigations, manufacturing disruptions and the number of leaks. It equips industry with tools to help standardize the vocabulary around SUS anatomy and processes and expand its understanding of SUS abnormalities.