Whitepaper

WHITEPAPER

How Chemical Characterization Can Supplement and Support Biocompatibility Testing

September 8, 2016 | By: Sarah Campbell, Thor Rollins and Audrey P. Turley

Download this whitepaper to examine the various ways in which chemical characterization can augment and refine the biocompatibility testing process.

Using analytical chemistry and data from the compound libraries to assess the finished device can yield more specific data about these extractable compounds than biocompatibility testing. The known properties of the compounds can then be used to create a toxicological risk or safety assessment based on the predicted biological response to the compounds.

Find out more regarding: When to Use Chemical Characterization
Two Types of Tests Under Direct Material Characterization
Examples of Extractable / Leachable Analysis
The Benefits of Chemical Characterization

Sarah Campbell, PhD

DABT
Toxicology Expert

Dr. Campbell is a Board Certified Diplomate of the American Board of Toxicology. She has over 20 years of experience working in toxicological research, 20 years of applied analytical chemistry experience, 14 years of experience in pharmaceutical research (including both clinical and nonclinical), and 12 years of experience as a bench chemist. Her particular areas...

Thor Rollins

RM (NRCM)
Biocompatibility Expert

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...

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),...