Ethylene Oxide Sterilization Validations
Ethylene Oxide (EO) Sterilization Validation is designed to help develop a sterilization process that provides the manufacturer with the appropriate level of sterility assurance and ensures repeatability for each product type developed. Any product, whether sterilized in-house or with a contract sterilizer, must be certified 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 provide guidance on meeting the requirements of the sterilization standard. EUROLABspecializes in ethylene oxide sterilization validations and we can partner with you and many contract sterilization facilities throughout the entire process, from protocol production to final report completion
Applicable Standards
EUROLAB experts have performed hundreds of Ethylene Oxide Sterilization Validations. AAMI/ST/WG 01 committee working group for industrial EO sterilization, audits of AAMI/ST/WG 04 biological indicators, AAMI/ST/WG 63 sterilization residues, AAMI/ST/WG 91 resistometer and AAMI/ST/WG 92 process testers makes.
Our sterilization experts will guide you through prevention testing and cycle development, as well as the verification process, routine monitoring and re-validation requirements. We provide an all-in-one final report with customized protocols and cycle run data, temperature / humidity distribution studies, a copy of the protocol, a process summary and all test results for easy reference.
EUROLAB, with its highly expert team and internationally accredited laboratories, Ethylene Oxide (EO) Sterilization Test It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
