Ethylene Oxide Sterilization Validations

The Ethylene Oxide Validation test assists the manufacturer in performing an appropriate sterilization validation to demonstrate the appropriate sterility assurance level and ensure repeatability. All types of products, whether sterilized in-house or performed by a contract sterilizer should undergo this test to ensure compliance with national and international standards. This test is recommended by ANSI/AAMI/ISO 11135-1:2007 and 11135-2:2008. Various AAMI TIRs offer guidance in meeting the requirements of the sterilization standard. Nelson Labs qualified personnel have extensive knowledge and experience in validating sterilization processes either in-house or at contract sterilizers. Nelson experts have performed sterilization validations and sterilization consulting for customers in the U.S. and abroad. Nelson experts are members of the AAMI sterilization standards committee and are actively involved in the standards writing process. We can partner with you throughout the entire process from protocol generation to final report completion.