As defined in Section 12 of ISO 11135:2014, a new or modified (“candidate”) product can be added to a validated Ethylene Oxide (EO) sterilization process if an evaluation shows that the candidate product is either equivalent to or a lesser challenge than an “existing” product or Internal Process Challenge Device (IPCD). Such an outcome could save considerable time and money. By reading this White Paper, Quality Assurance, Project Management, Sterility Assurance and Validation personnel within the medical device, pharmaceutical, commercial and food industries learn the necessary steps to evaluate a candidate product.
