Ethylene Oxide (EO) Gas is commonly used in the sterilization of medical devices due to its compatibility with a variety of materials. Understanding what factors are impactful to the validation process will help to avoid pitfalls during the pathway to product launch. The increasing amount of information documents such as ISO 11135 and ISO 10993-7, lay the foundations for development, validation, and routine control. Sterilizing a medical device is one way to ensure patient safety, however, it’s important to consider the residual levels left behind from Ethylene Oxide (EO) Gas that make it difficult to predict when a medical device will be safe for release to the public. Another item that must be considered is the microbial load, which impacts the cycle development.

During this webinar, our experts will provide insights into Ethylene Oxide (EO) Sterilization, such as:

• An introduction to EO Sterilization: Why is it important and when is it appropriate for a medical device?
• Factors impacting EO Sterilization, including effectiveness, release, and dwell/aeration times.
• Validation of EO Sterilization from product development through regulatory submission.
• Types of EO Residuals, testing methods, and ISO 10993-7 considerations.
• An overview of sterility testing, including regulatory requirements and methods.

Presenters:

	Liz Sydnor Director of Microbiology Eurofins Medical Device Testing
As Director of Microbiology at Eurofins Medical Device Testing, Ms. Sydnor oversees the microbiological testing of medical devices. With 10 years of industry experience, specifically in sterility assurance of medical devices and manufacturing, Ms. Sydnor is experienced in standard microbiological test methods, microbiological investigations, protocol validations, test method validations, and data analysis. She spent several years working with leaders in the healthcare testing and manufacturing industries and served in the United States Army as a Petroleum Specialist. Ms. Sydnor holds a B.S. degree in biology from Cleveland State University.
	Leonard Harris Manager – Chemistry and Container Testing Eurofins Medical Device Testing
As Manager of Chemistry and Container Testing at Eurofins Medical Device Testing, Mr. Harris oversees the chemical testing of medical devices. With 25 years of industry experience in pharmaceuticals and medical device chemical testing, and seven years specifically in ethylene oxide residual testing, Mr. Harris is experienced in GMP and ISO test methods and validations, investigations, protocol validations, and data analysis. Mr. Harris holds a B.S. degree in chemistry from Shippensburg University.