Ethylene Oxide Sterilization Validations
An Ethylene Oxide (EO) Sterilization Validation is designed to assist the manufacturer in the development of a sterilization process that delivers the appropriate sterility assurance level and ensures repeatability for each product type developed. All types of products, whether sterilized in-house or by a contract sterilizer, must be validated to ensure compliance with national and international standards.
The requirements for an EO Sterilization Validation are outlined in ANSI/AAMI/ISO 11135 Part 1 & 2. Various AAMI TIRs also offer guidance in meeting the requirements of the sterilization standard. Nelson Labs specializes in ethylene oxide sterilization validations, and we can partner with you as well as many contract sterilizers through the entire process from protocol generation to final report completion. See below for more details.
- ANSI/AAMI/ISO 11135
- AAMI TIR 16