Review of the documentation and update of the plan for ethylene oxide dissipation curve for Mölnlycke Health Care

Abstract

Ethylene oxide is a widely used sterilant around the world for medical devices. However, running a successful ethylene oxide sterilization operation and managing the possible residues in the products after sterilization is a rather complex process. ISO 10993-7 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals sets residual limits for sterilized medical devices, which a company needs to comply with in order to release their products to the market. The predominant approaches for indicating compliance with the set residual limits according to ISO 10993-7 section 5 are using either dissipation curves or batch-by-batch testing. However, in some cases manufacturing companies may get more temporal and financial benefits if they choose the dissipation curve method. The objective of the thesis was to combine a clear and up-to-date picture on the dissipation curve tests performed at Mölnlycke Mikkeli factory. The research methods used in this thesis were case study with the combination of literature review to support the outcome of the thesis and to better understand the topic and other factors related to it. The case study revealed that Mölnlycke Mikkeli’s medical devices sterilized with ethylene oxide are compliant with ISO 10993-7 residual limits for adults. The case study was followed by compiling a plan for dissipation curve tests to be performed within the next two years, in addition to a short-term action plan, both of which the commissioner can utilize as they choose. The short-term action plan included measures which could be carried out before the main dissipation curve plan is intended to be put into practice.