Call it group therapy for packaging engineers. On February 9 at MD&M West’s Center Stage, IoPP-Certified Packaging Professionals Karen Greene and Minda Grucela will be speaking in the Panel Discussion: “How to Connect the Dots and Develop an Effective Engineering Rationale for Packaging Validation.” Greene currently serves as President of Life Pack Labs and Vice President of Client Solutions, Western Region, for Network Packaging Partners, and Grucela is Staff Packaging Engineer for Dexcom. The discussion will be moderated by Daphne Allen, Executive Editor, Pharmaceutical & Medical Packaging News, Packaging Digest, and Qmed.
To kick off the discussion, Greene and Grucela will share a couple case histories exploring some of the challenges packaging engineers face when validating packages—and potential solutions. They’re also inviting the audience to share their own experiences and to ask questions for a truly interactive experience.
“When engineers are starting out—at packaging 101— they typically have a good general overview. But when you dig into applications, you run into a lot of questions,” adds Grucela. “Some of these questions are actually pretty common across the industry.”
For instance, Grucela will be exploring the challenges faced when deciding what shipping configurations need to be validated. “A shelf carton with a packaged device can often see up to 15 different shipping configurations,” she says. “It isn’t being shipped just one way. For instance, you may have 10 or 50 shipped in one box, you may be shipping one overnight in a Fed-Ex box, you may be shipping it along with another lighter or heavier carton, and so on. You’ve also got different filler materials. Can you validate all of these options? You probably don’t have enough staff, time, or money, nor is it practical to validate every combination. And if you did, you’re not setting yourself up for flexibility in the future.
“So the question is, can you identify what the worst-case configurations are, either through logical mechanical structural analysis or feasibility studies?” Grucela continues. “And where there is room to allow for flexibility, how can you ensure that you’ve identified the worst case? You’ve got to think through practical applications.”
Greene will be exploring the challenge of testing high-value medical device or pharmaceutical products. She will explore ideas on how to substitute or develop an equivalent product system for the high-value items. Greene will discuss some potential approaches to either product simulation or equivalence and some hands-on approaches on how to proceed with testing. Packaging system characterization scenarios will be discussed as well as proposals for the type and extent of data that might be important to generate to support your validation strategy.
Once you’ve determined a course of action for testing and validation, you’ve then got to put together your documentation. “But what does it look like to write a justification?” asks Grucela. “How do you show FDA that you’ve done your due diligence?”
Another issue is that “there’s no guidance on how to write a rationale,” says Greene. “How do you meet an objective when it’s not prescribed? What people really struggle with in writing a rationale is the development of an effective risk assessment of the packaging system and the mitigations in place to either reduce the risk severity or eliminate the risk altogether. If the rationale presents a risk assessment approach and how the packaging system and process(es) have addressed the risks, a solid rationale is within hand."
Adds Grucela: “FDA really wants to know whether you have thought through the possible failure modes and understand your design.
“If you do the thinking early and review all possible use cases, you can be strategic and have confidence in your processes,” she continues. “And if you don’t have confidence in or knowledge about the outcome, do feasibility studies. Employ the good old scientific method and develop a hypothesis and test it. And lean on your suppliers and test labs and mechanical engineers. Get creative in exploring sources of knowledge.”
Another tough question is, where does this rationale reside? “Is it in a packaging protocol? A report? A technical memo?” Grucela asks. “In the Design History File?” asks Greene. “How and what would an auditor look at for this rationale?"
We’ll be exploring these questions and more during the February 9 panel discussion. Greene and Grucela call the session an open forum for interactive discussion and shared wisdom, so please join us at Center Stage at 1:45 pm on February 9. Expo attendees can attend the Center Stage discussion free of charge.