Published Article

PUBLISHED ARTICLE

How Clean is Clean Enough?

Published In: MD+DI

June 25, 2018

Here are some takeaways from ISO 19227 for orthopedic implants.

ISO 19227 Implants for Surgery–Cleanliness of Orthopedic Implants–General Requirements is a long-awaited guidance document that was finalized and published early 2018. This guidance document is intended to assist orthopedic medical device manufacturers address the cleaning of their devices. One of the requirements of the good laboratory practices (GLPs) mandated by FDA is that medical devices be free from manufacturing residuals. Determination of what is needed to fulfill this requirement has largely been up to manufacturers and has been a topic hotly debated across the industry.

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Audrey Turley

RM (NRCM), CBA (ASQ)
Director of Expert Advisory Services & Biocompatibility Expert

Audrey Turley has over 25 years of experience working in research, laboratory, and test design functions in the medical device industry. She is a biocompatibility expert, having performed all the in vitro tests offered at Nelson Labs, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM, and NIH methods),...

Matthew R Jorgensen, Ph.D.

Chemistry and Materials Scientist

Dr. Jorgensen is an expert in chemistry and materials science. He has over a decade of experience designing, synthesizing, and analyzing complex materials. To characterize materials, Dr. Jorgensen has extensively used a wide variety of techniques including GC/MS, LC/MS, FTIR, UV/VIS, SEM, NMR, and several types of advanced spectroscopic techniques. His Ph.D. in Physical Chemistry from the University of Utah was based on the fabrication and analysis of titanium dioxide and silicon dioxide photonic crystals templated from the three-dimensional structure found in the exoskeleton of exotic weevils. During his time at the University of Utah, he received the Henry Eyring Research Fellowship, the DOW Chemical First Year Scholarship, and additional grants to travel and present his research at national and international conferences. His research has resulted in over 30 peer-reviewed publications.

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.