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Ethylene Oxide Sterilization Validations

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 Laboratories 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.

Applicable Standards

  • ANSI/AAMI/ISO 11135
  • AAMI TIR 16

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product.

Code Test TAT (days) Request Quote
OSV110 On-site Validation: Ethylene Oxide Sterilizer 23 Add
PCD105 Sterilization: PCD - Preparation (Sponsor Supplied), each 5 Add
PCD705 Sterilization: PCD - Minimum order charge (per set) 5 Add
SVE110 Sterilization Validation: EO Full Validation Study (Single Use Products) 90 Add
SVE120 Sterilization Validation: EO Re-validation Study (Single Use Products) 45 Add
OSV110 - On-site Validation: Ethylene Oxide Sterilizer
23 days
PCD105 - Sterilization: PCD - Preparation (Sponsor Supplied), each
5 days
PCD705 - Sterilization: PCD - Minimum order charge (per set)
5 days
SVE110 - Sterilization Validation: EO Full Validation Study (Single Use Products)
90 days
SVE120 - Sterilization Validation: EO Re-validation Study (Single Use Products)
45 days

Study Outline

Nelson Laboratories experts have performed on-site Ethylene Oxide Sterilization Validations in the U.S. and around the world. We’re actively involved in developing the standards that govern testing including: AAMI/ST/WG 01 committee working group for industrial EO sterilization, AAMI/ST/WG 04 biological indicators, AAMI/ST/WG 63 sterilization residuals, AAMI/ ST/WG 91 resistometer and AAMI/ST/WG 92 process challenge devices.

Our sterilization specialists will guide you through pre-validation testing and cycle development, as well as the validation process, routine monitoring and revalidation requirements. We offer customized protocols and an all-in-one summary final report that includes cycle run data, temperature/humidity distribution studies,  a copy of the protocol, a process summary and all testing results for easy reference.