OMTEC 2015 Speaker Presentations

Lessons from FDA Recalls: Design and Develop the Best Package for Your Device

This presentation will address challenges in the environment in which medical device packaging is used. It will explore critical elements of designing the best package for your device, including considerations of materials and barrier properties, sterilization compatibility, environmental challenges and regulatory compliance. Key guidance documents and standards will be discussed, highlighting some of the best tools available for medical package development, as well as a glimpse at some medical packaging failures that led to FDA recalls in recent years.

Session Takeaways
  • Information to guide the attendee through the packaging development process using design inputs
  • Information regarding selection of ideal materials for product and processing requirements
  • An understanding of available guidance documents and standards
Who Should Attend?
  • Materials/Commodity Management
  • Purchasing
  • Quality Control
  • Regulatory/Clinical Affairs
  • Research & Development
  • Manufacturing

Speaker Bios


Alison Tyler is the Technical Director at Beacon Converters. Her previous roles include Marketing, Sales, Manufacturing and R&D at Alcoa, DuPont, DuPont-Merck Pharmaceuticals and Fisons Pharmaceuticals. Beacon Converters, a manufacturer of sterilizable packaging for medical and healthcare markets, was recently named a top 500 Woman-Owned business in the U.S.

Alison holds a Bachelor of Science degree in both Biotechnology and Packaging Science, in addition to a Masters Degree of Science in Packaging Science from Rochester Institute of Technology where she is currently an Adjunct Instructor in the Department of Packaging Science and a member of the Industrial Advisory Board.

Prepare for this Session

What can be learned from recent packaging failures?

You can learn a lot from failures—perhaps more than from non-failures. I always keep an eye on FDA recalls that involve packaging. They are public record and can be accessed by anyone via FDA’s website. It isn’t about who did or didn’t do what; it is learning how these things happened and being vigilant, making sure your own quality system is solid in the area that failed and resulted in the recall. You will see that some of the biggest and best companies have had huge recalls. They have great people and great quality systems, but somewhere there was a chink in the armor. We should all learn from each other.

More common failures that are realized in validations and commonly in ship testing include insufficient protective packaging and undersized secondary packaging. People often fold the sterile barrier to accommodate a shelf carton size that is dictated by marketing or other requirements. This is a universally bad idea. Folding sterile barrier packaging will often lead to delamination of the Tyvek® or film, and sometimes these internal delamination events visually appear as breaches in sterility. On more than one occasion, I have seen that a complex fold in a sterile barrier pouch has created a hole in the pouch through the action of abrasion at the points of multiple folds.

Trying to take shortcuts can also cost you. Be careful about how high you run accelerated aging protocols. The model has it limits, as do materials. If you design your accelerated aging protocol against your time constraints instead of your packaging system capabilities, you are focusing on the wrong thing. We recommend never exceeding 55°C to 60°C in accelerated aging, and to never add humidity to the chamber. Accelerated aging is based upon a first order reaction rate of temperature, not upon humidity. Adding a high level of humidity will often create testing failures that are not indicative of real life conditions, even worst case ones. Test high humidity challenges separately.

If you are working with a thermoformed tray, it is best to do a significant amount of testing with a prototype first before you order final tooling. There are only so many changes that can be made to a tool, and tooling mistakes can be very costly in time and expense.