Digital Twin Modeling for Sterile Barrier Design and Validation
What is a Digital Twin?
A digital twin is a real-time virtual model of a physical object or process that helps teams simulate performance, predict behavior, and make better design decisions.
Are Digital Twins being used in healthcare packaging today?
Today, digital twins are being used in broader pharmaceutical manufacturing environments for real-time monitoring, predictive modeling, and quality assurance. Their use in the pharmaceutical industry demonstrates the value they can bring in regulated settings.
Companies such as Gerresheimer and Merck are using digital twins to improve traceability, authentication, and data integrity across their primary packaging. While we are seeing use of “digital twins” in the pharmaceutical industry, it is worth noting that the term is not used within the medical device or diagnostics industry as of today.
Digital twins could be the future of medical packaging and with that, I’m sharing …
5 Ways Digital Twins Could Transform the Packaging Design Process
Early Insight into Packaging Performance
Smarter Material Selection
Fewer Design Iterations
Alignment With Sterilization Needs
Stronger Risk Management
In addition to the benefits above, Digital twins could help to support validation efforts. More realistically though, they would be used to complement physical validation by helping teams enter the process with more refined, robust designs aligned with ISO 116072 expectations.
During validation, they could also be used to accelerate rootcause analysis and parameter optimization to detect performance anomalies early.
As digital twins enter the healthcare packaging industry, it’s likely industry will start to wonder if they can replace physical validation. While possible, in my opinion, it won’t happen anytime soon. Standards such as ISO 11607 require physical evidence demonstrating a sterile barrier system’s ability to maintain sterility and withstand realworld distribution and handling conditions. The healthcare industry is historically slow to make changes (rightfully so) because of the impact on patient health. A change like this would require significant discussion.
Therefore, it is best to look at digital twins as an opportunity to reduce the burden associated with the validation process. This technology can help us identify risks earlier, tighten design parameters, and decrease the number of physical iterations required before formal testing. Thought leaders in packaging and manufacturing emphasize the value of digital twins as complementary tools that enhance predictability and efficiency but not as substitutes for mandated verification processes.
In essence, digital twins won’t eliminate validation, but they can transform it from a reactive checkpoint into a more proactive, datadriven assurance strategy.
Final Thoughts
In my opinion, I’m confident that digital twins will eventually find a meaningful place in the medical packaging space. We’re already seeing strong success stories in pharmaceutical manufacturing, and the momentum is unmistakable. Digital twins have the potential to strengthen the front end of design development by helping teams explore the design space more intelligently. They can also help by providing supplemental evidence when validating packaging, whether that’s refining parameter windows, informing worstcase selection, or supporting revalidation decisions.
Sources:
Fuhrländer‑Völker, D., Lindner, M., von Elling, M., Frieß, T., Karnapp, S., & Weigold, M. (2025). Method for the development and application of digital twins in manufacturing. Production Engineering, 19, 959–973. https://link.springer.com/article/10.1007/s11740-025-01346-x
GlobalVision Editorial Board. (2025, October 6). Medical device packaging validation: A step‑by‑step guide to ISO 11607 compliance. GlobalVision. https://www.globalvision.co/blog/medical-device-packaging-validation
Haley, G. (2025, October 23). Digital twins for packaging: Bridging design, fab, test, and reliability. Semiconductor Engineering. https://semiengineering.com/digital-twins-for-packaging-bridging-design-fab-test-and-reliability/
International Organization for Standardization. (2019). ISO 11607‑1:2019 — Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems. https://www.iso.org/standard/70799.html
Merck Group. (2022, October 27). Gerresheimer and Merck transform primary packaging into digital twins. https://www.merckgroup.com/en/news/gx-collaboration-27-10-2022.html
Oliver Healthcare Packaging. (n.d.). Packaging 101: ISO 11607. https://www.oliverhcp.com/news-and-resources/packtalk/packaging-101-iso-11607
Pack 3.0. (n.d.). Virtual packaging simulation. https://www.pack3-0.com/our-technology-2/
Pathri, B. P., & Ganduri, K. V. (2025). From smart cities to manufacturing: A comprehensive study on digital twin applications and barriers. IET Research. https://ietresearch.onlinelibrary.wiley.com/doi/pdf/10.1049/dgt2.70014
Wang, G., Xiong, X., Ma, Y., & Xu, X. (2024). Application of a digital twin model in the packaging process of the panel furniture industry. Forest Products Journal, 74(1), 98–106. https://fpj.kglmeridian.com/view/journals/fpro/74/1/article-p98.xml
World Pharma Today. (2025). Digital twin solutions for pharma packaging. https://www.worldpharmatoday.com/biopharma/digital-twin-solutions-for-pharma-packaging/
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