It’s important for medical packaging engineers to fully understand all medical packaging requirements and be aware of global medical packaging standards, says Curt Larsen, consultant at Spartan Design Group and a member of PMP News’s Editorial Advisory Board. Such advice may seem obvious, but Larsen says that “in the past, there’s been misinterpretations,” which have resulted in work that is either “not appropriate or not necessary.” Sometimes these “ideas are based on how things were done before,” he adds, but requirements have evolved.
To help medical packaging engineers avoid what Larsen calls “self-inflicted wounds,” he and John Spitzley, also a consultant at Spartan Design Group, will be speaking during a two-part webinar held by AAMI University entitled “Packaging for Terminally Sterilized Medical Devices: How to Find Your Way in This Globally Regulated Industry.” The series will be held August 24 and 25 from 11:00 am - 1:00 pm Eastern each day.
The series will cover the purpose of sterile packages and packaging systems, packaging requirements sources, and shipping tests. Larsen and Spitzley will lead interactive discussions focusing on design considerations and customers, packaging tests, using accelerated and real-time stability studies, and packaging system qualification/validation.
Day-two of the presentation will include a discussion of “15 to 20 of the self-inflicted wounds and what the requirements actually are,” Larsen says. “For example, some professionals don’t fully understand seal-strength requirements, such as what they really mean and how to meet them. Also, some are using the same package samples for design performance qualification testing (i.e., distribution simulation testing) and stability and aging studies, and that is not advised.”
John Spitzley, consultant at Spartan Design Group and also a PMP News EAB Member, will join Larsen during the Webcast
Click here for details on registration. Webinars are also recorded and made available for sale in AAMI University.
"Packaging for Terminally Sterilized Medical Devices: How to Find Your Way in This Globally Regulated Industry" (Two-Part Series) will be held August 24 and 25, 2016 at 11:00 am Eastern.