Like many packaging engineers, I learned early in my career that packaging is often treated as an afterthought during the product development process. And when it comes to the relationship between sterilization and a sterile barrier system, that was no exception. As a packaging process engineer, I was tasked with validating seals with a strength that would withstand the associated sterilization cycle. Later, as I shifted my focus to packaging design, I developed prototypes for a distribution test that were subsequently subjected to sterilization. In both scenarios, the sterilization cycle was already defined and my knowledge of it was generally limited. At times, it felt like sterilization was simply a box to check during the packaging validation process. It only took one testing failure to change that perspective.
Sterile barrier system defects take many forms, and each sterilization modality presents unique challenges for package design and material compatibility. Whether it’s a material that becomes brittle after irradiation or a seal that starts to creep during a vacuum cycle in gas sterilization, an unexpected defect can derail a project … or worse, create serious downstream issues if not found in the test environment, imposing a risk to patient safety.
Over time, I have shifted my focus to understanding more about each sterilization cycle that a sterile barrier system is subjected to. While it’s not typical for a packaging engineer to define a sterilization cycle, it is essential for them to understand what happens during the process and how it affects a sterile barrier system. As industry continues the journey with exploration of alternative sterilization modalities, that concept is of upmost importance. Resources on this topic have become more widely available in recent years; AAMI TIR 17 “Compatibility of Materials Subject to Sterilization” is a great starting point.
At Oliver, we have conducted a series of screening tests for conventional and alternative sterilization modalities. Our goal is to identify material combinations that remain stable after each sterilization modality and subsequent aging studies, while flagging defects like discoloration, film delamination, and brittleness of a film that may compromise functional properties. These findings are compiled into detailed reports, which are available upon request, and will serve as our foundation for recommending the best flexible packaging solutions for each application.
I am excited to see the collaboration happening across industry groups. Organizations that typically compete in the marketplace are working side by side to collect and share data while building collective knowledge around sterilization compatibility. Anyone with interest in this field can contribute—by asking questions, sharing challenges, and offering insights—so that together we can accelerate the development of safe, reliable solutions. For more information, download our alternative sterilization research summary here.
