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Whitepaper

WHITEPAPER

Lessons from the Lab eBook

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.

Alpa Patel

Alpa Patel

BS, RM (NRCM)
Principal Scientist

Alpa Patel is a certified microbiologist and has been part of the medical device industry for 18 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 principal scientist at Nelson, involves overseeing test method validations for reprocessing, writing standard test...

Jennifer Gygi

Jennifer Gygi

BS, SM (NRCM)
Packaging Expert

Jennifer Gygi is an Expert Technical Consultant at Nelson Laboratories; a microbiological testing company specializing in improving the quality of life by ensuring medical products are safe, sterile, and functional. Jennifer has over 26 years of laboratory experience at Nelson Labs. She has worked in the Microbiology, Bioburden, Organism IDs, Packaging and QC Validations groups....

Lise Vanderkelen

Lise Vanderkelen

PhD
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

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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.

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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

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