Radiation sterilization dose substantiation of single-use systems for pharmaceutical manufacturing and bioprocessing continues to be a complex topic and it often results in the manufacturing of extremely large and complex systems that are difficult to validate and test. The AAMI working group on radiation sterilization (AAMI WG2) initiated the development of a consensus report to address best practices and give guidance on the sterilization validation approach for these systems. Information will be shared in the presentation/poster on general approaches and concepts to be included in the consensus report especially on the topics of fluid path sterility, total product sterility, dosimetry, and rationales for selecting a representative product.

These concepts can assist manufacturers of single-use systems by providing approaches to validation of sterilization processes, which can result in clarifying test development strategies and significant cost savings both initially and on an ongoing basis. Moreover, strategies encompassing multiple sterilization technologies are included (i.e., gamma and X-ray) as these are critical to ensuring business continuity and continued availability of critical raw materials to manufacture patient therapies.