Due to a change of their Operations Data Management System, specifically the Automated-Batch-Approval (ABA) functionality, the Quality Review and Release box found on STERIS Certificate of Processing has been updated. An example of the new certificate is provided in Appendix 1.
The change isn’t affecting the irradiation process, irradiation dose or location of the gamma irradiation. Therefore, this change has no impact on the fit, form or functionality of the product.