The first question that comes to mind after completing an ethylene oxide (EO) sterilization qualification is, “When do I need to perform a requalification study, and what will that entail?” The following is a comprehensive look at the typical validation approach, the factors that determine when requalification is necessary, and how the expectations in ANSI/AAMI/ISO 11135 have changed in recent years regarding requalification.
When Do I Really Need to Perform an EO Requalification?
Published In: Medical Product Outsourcing
April 6, 2016
Ethylene Oxide and Water Systems Expert
Paul Littley is an expert advisor at Nelson Labs. He is a Biomedical Engineer with over 15 years of medical device industry experience working in sterility assurance, quality assurance, manufacturing, and research and development. His expertise includes ethylene oxide sterilization validation, high-purity water system design validation and process controls, device reprocessing, cleaning validations, microbiology testing,...