Blog

Medistri’s EO Sterilisation Validation Flow

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 sterilised in-house or by a contract steriliser like Medistri, must be validated to ensure compliance with national and international standards.

 

✅ ANSI/AAMI/ISO 11135

✅ AAMI TIR14

✅ AAMI TIR16

✅ AAMI TIR28

 

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.

 

As Europe’s largest independent contract sterilisation company, Medistri partners with our customers through the entire process of sterilisation validation from protocol generation to final report completion.

 

👉 A Technology-First Approach to EO Sterilisation Validation.

 

Our Validation Team leverages Medistri’s in-house laboratory & sterilisation infrastructure to work with you hand-in-hand and the most suitable process for your product to demonstrate compliance with the relevant ISO standards.

 

🎯 To learn more about our EO Sterilisation Validation Services, visit on our website at www.medistri.swiss or directly contact our team at contact@medistri.swiss.

 

  • The Medistri Team

 

#Medistri