Applicable Standards
- ANSI/AAMI/ISO 11135
- AAMI TIR14
- AAMI TIR16
- AAMI TIR28
Sterilization Overview
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. 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 sterilization facilities through the entire process from protocol generation to final report completion. Our sterilization specialists will guide you through pre-validation testing and cycle development, as well as the validation process, routine monitoring and revalidation requirements.
Similar to the Radiation Validation method, one of the benefits of Ethylene Oxide Sterilization is that it employs a cold gas sterilization process. Low temperature sterilization protects heat sensitive materials that cannot be exposed to high temperatures such as plastics. Preventing destruction of the product allowing for multiple passes of sterilization.
