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LIVE WEBINAR

Cleaning Evaluations of Newly Manufactured Devices

January 26, 2022

1:00 pm ET

Erin Bakes

With the implementation of ISO 19227:2018 Implants for surgery – Cleanliness of orthopedic implants – General requirements, evaluation of residual levels after the final manufacturing process has become a regular expectation from both OEM customers and regulatory bodies. However, determining a test strategy based on the device use remains a challenge. Learn about cleaning validations for newly manufactured devices and considerations for devices outside the scope of ISO 19227. This webinar will focus on the cleaning-validation plan, from the identification of potential contaminants to test strategy and the evaluations of results.

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Erin Bakes

Erin Bakes is an associate technical consultant with the Technical Advisory Group at Nelson Labs and has been part of the medical-device industry for 17 years. Prior to her role in consulting, Erin was the department manager for the Nelson Labs chemistry group, where she oversaw operations for various analytical-test methods, method development, and equipment validations. Erin joined the Technical Advisory Group in 2017 as a technical consultant for cleaning validations for newly manufactured devices and chemical characterizations with extractable and leachable analysis. Erin is a member of the ASTM F04 technical committee for medical and surgical materials and devices. She also participated on the ISO/TC 150 working group for 19227:2018 Implants for surgery – Cleanliness of orthopedic implants – General requirements.