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When Do I Really Need to Perform an EO Requalification?

Published In: Medical Product Outsourcing

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.

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