Transfer of Products for Sterilization Between Irradiation Technologies

STERIGENICS, a member of iia, are hosting a webinar ‘The Transfer of Medical Device and Pharmaceutical Products between Radiation Sterilization Modalities’ on 20th September 2023. The webinar will discuss the considerations when evaluating the transfer between gamma and e-beam sterilization modalities. Topics to include Change Assessment, Evaluation of Process Capabilities, Transfer of Sterilization Dose Levels, Product Dose mapping and Risk Assessment. Regulatory ISO documents 11137 and TIR104 will be used for supporting guidance.  Further details and registration is available at this link.

STERIS, also a member of iia, has published their TechTip document ‘Transferring of the Verification Dose from Electron Beam Technology to Photon Technology (Gamma or X-ray)’. A verification (dose audit) or sterilization dose experiment requires a narrow and specific dose range to be applied to the samples used for tests of sterility as evidence that the routine minimum dose remains appropriate for delivering the require sterility assurance level. Dose requirements for radiation processing are defined in ISO 11137 part 2 ((7.2.5 (Method 1) and 9.2.5 (VDmax method)). Due to the penetration capability of the electrons, this narrow dose range is sometimes not process capable for some types of devices/products. Amongst the detail, this document includes the ‘Flowchart for evaluation of transferring sterilization and verification doses when transferring product between irradiators’. The STERIS document is available at:  Transferring of the Verification Dose from Electron Beam Technology to Photon Technology (Gamma or X-ray) | TechTip | STERIS AST (steris-ast.com).