Do you need to purchase a detailed EO sterilization validation protocol for validating EO/EtO sterilization of your device?
Ethylene Oxide Sterilization Validation Protocol
The current standard for EO sterilization validation is ISO 11135:2014. Even if you outsource validation to a vendor with their protocol, you will still need an EO Sterilization Validation procedure. However, if you need a detailed protocol for EO sterilization validation, Matthew Walker was kind enough to write a 19-page Ethylene Oxide Sterilization Validation Protocol.
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
What standards do you need to purchase along with the EO sterilization validation protocol?
In addition to the ISO 11135:2014 standard, you will also need the following international standards:
- ISO 10993-7:2008, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
- ISO 11737-1:2018, Bioburden Testing for Aerobic Bacteria and Fungi
- ISO 11138-1:2017, Sterilization of health care products – Biological Indicators – Part 1: General Requirements
Do you need more help with the validation of your packaging process?
For companies interested in packaging process validation, our procedure for process validation (SYS-014) includes an example from the GHTF for validating a packaging process. Jan Gates was kind enough to develop three other related validation protocols for our company that are available for purchase:
- Distribution Conditioning Shipping Qualification (20 pages)
- Shelf-Life Testing Protocol (13 pages)
- Packaging Performance Testing Protocol (18 pages)
View Our Process Validation Procedure
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About Matthew Walker
Matthew Walker – QMS, Risk Management, Usability Testing, Cybersecurity
Matthew came to us with a regulatory background focused on OSHA and NFPA regulations when he was a Firefighter/EMT. Since we kidnapped him from his other career, he was recently promoted to manage our human factors team as Branch Chief of the Human Factors Division. He is a Junior at Champlain College in Burlington, Vermont, where he specializes in Computer Forensics and Cybersecurity. Matthew participates as a member of our audit team and is passionate about risk management, human factors engineering, and cybersecurity. Always the mad scientist, Matthew pairs his professional life in regulatory affairs with hobbies in the culinary arts, as he also holds a Butchers/Meat Cutters certificate from Vermont Technical College.
Email: Matthew@FDAeCopy.com
Connect on Linkedin: http://www.linkedin.com/in/matthew-walker-214718101/