Lessons from the Lab eBook
May 24, 2022 |
By: Alpa Patel, Brent Terry, Christopher Pohl, Jennifer Gygi, Lee Wence PhD, Lise Vanderkelen, Maria Thomas and Mikaelle Giffin
This eBook addresses common challenges and best practices for medical-device manufacturers with questions about testing their products.
Table of Contents:
- EO Optimization and Potential Effects on Sterile-Barrier Packaging
- Patient-Specific Implants Often Require More Testing
- Extractable Chemical Characterization and Risk Assessment: What is the Worst Case?
- Understanding Biological Evaluation Plans
- What Cleaning Procedure Should You Have in Place for Your Reusable Device
- Four Important Things to Know About Particulate Testing and Medical Devices
Learn more about the authors below.
RM (NRCM)
Director of Scientific Improvement and Reprocessing Expert
Alpa Patel is a certified microbiologist and has been part of the medical device industry for 20 years specializing in cleaning/disinfection and sterilization of reusable medical devices, endoscopes and validation of tissue disinfection or sterilization processes. Her current role as a Director of Scientific Improvement at Nelson Labs involves overseeing test method validations for reprocessing,...
Pharmaceuticals and Microbiology Expert
Lise Vanderkelen received her Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2012. She started at Nelson Labs Europe in 2013 as Study Director Extractables & Leachables, focusing on parenteral applications, and in 2014, she became responsible for the chemical characterization testing of medical devices (ISO 10993-18). In 2016,...
Brent Terry
Associate Biocompatibility Expert
Christopher Pohl
Associate Toxicologist
Christopher Pohl has been in the medical-device field for 9 years. He has worked for a variety of companies and positions, including in R&D, as a biocompatibility engineer, and as a toxicologist. He has been with Nelson Labs for over 2 years, during which time he has assessed medical devices, written toxicological risk assessments, and supported biocompatibility and hemocompatibility testing and evaluations. He was also a Peace Corps volunteer for 2 years. He received his bachelor's degree in materials science and engineering from Boise State University. Currently he is working towards a master's degree in pharmacology and toxicology.
Lee Wence PhD
Technical Writer
Lee received his PhD in chemistry from the University of British Columbia, Canada. He has worked with the Chemistry department at Nelson Labs in Salt Lake City, Utah, where he has prepared reports and testing protocols for extractable and leachable chemical testing of medical devices. He currently works with Expert Advisory Services at Nelson Labs for the preparation of toxicological risk assessments.
Maria Thomas
Technical Writer
Mikaelle Giffin
Associate Toxicologist
