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.