Don’t Forget Packaging!

In this episode, NAMSA’s Senior Product Development Specialist, Ed Arscott, joins our hosts to examine the relationship between packaging and biocompatibility, including how to evaluate primary packaging for biological safety. The discussion also focuses on the direction provided in ASTM F2475-05 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials.

Listeners can expect to learn:

• Where to look for guidance on packaging evaluation for medical devices
• Key points to consider when looking at material contact to medical devices
• Evaluating device/package interaction
• Assessing cases or primary packaging for reusable devices

“I’m happy to help join between the two realms of biocompatibility and packaging.” – Ed Arscott

“One common thing in the past was that you saw a lot of cytos being performed on primary packaging.” – Don Pohl

“The way that packaging interacts especially with implants; things can occur with packaging and implants that relate directly to product safety.” – Ed Arscott

“Part of figuring out what to do or not to do is based on device/packaging interaction.” – Don Pohl

“Let’s discuss metal trays for instruments; A form of packaging to evaluate as well.” – Sheri Krajewski

“Your level of evaluating for the packaging shouldn’t exceed the evaluation of your device.” – Don Pohl

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Also be sure to check out our Biocompatibility Strategy Navigator.

Meet the Speakers

Ed Arscott, BS; Senior Product Development Specialist, NAMSA

Ed first joined NAMSA in 1987; since that time, Mr. Arscott progressed to the role of Manager of Microbiology and In vitro Toxicology before leaving to take a role with Depuy/J&J where he stayed for 14 years. Ed then returned to NAMSA in 2013—first, in a Validation Group position before taking on his current role as a Senior Product Development Specialist. In this role, he consults in the field of medical devices with experience in all terminal sterilization methods (traditional and novel), Biological Indicator (BI) development, packaging shelf-life studies, medical device reprocessing validations, environmental monitoring and cleanroom qualifications. 

Sheri Krajewski; Product Marketing Manager – Biological Safety, NAMSA

Sheri joined NAMSA in 2003 and currently serves as Global Product Marketing Manager of Biological Safety. She has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s biological safety consulting business. Additionally, Sheri created the much sought-after NAMSA Training Series for the biological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.

Don Pohl; Principal Product Development Strategist, NAMSA

Don has over 25 years of experience in the preclinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and Project Manager for Biological Safety and Biological Risk Assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1, as well as the expectations of the U.S. FDA and other global regulatory bodies in their interpretation of the biological safety evaluation of medical devices. Don holds a Bachelor’s degree from Ohio State University.