🚀 EO Sterilization Validation
Prior to beginning routine ethylene oxide sterilisation, a product with a sterile claim needs to complete a validation process to ensure the Sterility Assurance Level claimed is met according to ISO 11135. The combined resources & complete integration of expertise from our laboratory, sterilisation & quality team allow you to fully integrate the development of your products within your existing operational workflow.
❓ What is EO Sterilisation Validation?
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.
Medistri specializes in ethylene oxide sterilization validations, thanks to our contract sterilization infrastructure, we partner with our customers through the entire process from protocol generation to final report completion. Ensure that your team will be notified and regularly updated with the detailed outcomes of all stages of your validation project.
👉 Medistri’s EO Sterilisation Validation Flow:
0 — Preparation of Validation protocol
All validation steps are documented in a protocol, which includes: :
• Normative references🚀
• Acceptance criteria
1 — Preparation of Process Challenge Device
2 — Preparation of Bioburden Sample
3 — Preparation of Sterility Sample
4 — Preparation of Residual Sample
5 — Load Preparation
6 — Validation Cycles
• (1) Short-Cycles
• (4) Half-Cycles
• (2) Full-Cycles
7 — Final Validation Report
A final report is generated to:
• Document a review of the validation data
• Confirm the acceptability against the approved protocol for the sterilisation process
• Approve the process specification
Medistri will continue our development in the EO sterilisation validation of pharmaceuticals and medical devices and continue to be at the forefront of regulatory requirements and quality proficiency.
Benefit from Medistri’s Sterilisation Infrastructure:
✅ Sterilise Temperature-Sensitive products.
✅ Sterilise a wide range of products & materials.
✅ Allows for multiple packaging variations.
✅ Release your product directly after processing.
✅ Scalable solution for high growth companies.
🎯 To learn more about our EO Sterilisation Validation services, visit on our website at www.medistri.swiss/en or directly contact our team at firstname.lastname@example.org.
— The Medistri Team