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 | Human Factors Engineering, Cybersecurity & DFIR
Matthew brings a unique background as a former Firefighter/EMT and Rope Rescue Tech with expereince in OSHA and NFPA regulations. For the better part of a decade, he has worked as a Technical/Medical Writer and Lead Auditor. He holds degrees in Fire Science and Computer Forensics and Digital Investigations, graduating Summa Cum Laude from Champlain College. Matthew is also an active member of several academic honor societies including Omicron Sigma Sigma’s Order of the Sword and Shield. His professional focus includes Human Factors Engineering, Risk Management, and Cybersecurity with a special interest in applying Digital Forensics and Incident Response (DFIR) practices to medical technology. He combines regulatory expertise with technical insige to strengthen both product safety and oranizational resiliance. He can be reached by email. You can also follow him on LinkedIn or YouTube.