From Film Engineering to Sterile Packaging: Design Decisions that Matter
A sterile barrier film must do far more than protect a product. Every layer, coating, and material choice influences how reliably the package seals, survives sterilization and distribution, and opens when it matters most. Nicole Schehle, Head of R&D, EK-Pack, and Nils Walters, Director of Global Material Development R&D, Oliver HCP, take a closer look at which decisions have the greatest impact where seemingly small compromises can create costly risks, and why the path to more sustainable packaging begins with collaboration across the entire value chain.
Which film development decisions have the greatest impact on final packaging performance?
Nils: For me, it starts with three simple questions: why, what, and how? The why defines the purpose. The what is the solution, and the how determines how we intend to make it. All three matter. If the purpose is not clearly understood, even a technically sound film can miss the needs of the application.
Nicole: Material selection is therefore one of the most important decisions. Each layer of a film contributes a specific function, such as sealability, strength, puncture resistance, barrier performance, or processability. The challenge is combining those functions in a balanced structure.
Which material properties should be defined at the start of a project?
Nicole: The product and its sterilization process are the main starting points. They determine requirements such as seal integrity, puncture and tear resistance, flexibility, toughness, and the necessary barrier against moisture, oxygen, light, or microorganisms. Compatibility with the selected sterilization method, dimensional stability, and processability are also important.
Nils: These are the characteristics that are critical to quality (CTQs). They should be derived from the intended use and aligned with the customer early in the project.
Nicole: Priorities must also be agreed, as material properties influence one another. This helps avoid overlooking a requirement that could cause problems later.
How do film structure and material selection affect the entire product lifecycle?
Nicole: Material requirements vary throughout the product lifecycle. The film must withstand sterilization, transportation, and storage without losing mechanical performance or seal integrity. At the point of use, reliable opening, controlled peel performance, and low particle generation are essential. Film engineering therefore means balancing all relevant properties rather than maximizing a single one.
Which aspects of material selection are most often underestimated?
Nicole: The interaction between material properties is often underestimated. Changes intended to improve sustainability or reduce costs can affect sealing, processing, aging, appearance, or mechanical durability.
Nils: As mentioned before, it is important to clearly define CTQs. Otherwise, decisions may then be based on assumptions that do not match the customer’s expectations, with problems emerging only at a later stage.
Nicole: Early collaboration between material suppliers, film manufacturers, converters, and medical device companies is therefore essential. It helps identify interactions and avoid costly redesigns or additional validation cycles..
How is sustainability changing film engineering in healthcare packaging?
Nils: Sustainability requirements are becoming increasingly important, driven both by regulations such as the PPWR and by ongoing discussions around substances such as PFAS. At the same time, demand for recyclable and recycle-ready packaging is growing, which makes close collaboration with suppliers essential when developing new materials, material combinations, and solutions containing recycled content.
Nicole: This development is driving innovation in areas such as downgauging, recyclable mono-material concepts, and more efficient manufacturing. In healthcare packaging, however, sustainability must always go hand in hand with patient safety and product protection. Any new solution must therefore meet regulatory requirements, remain compatible with sterilization, and reliably deliver the required package performance throughout its lifecycle.
Which developments will shape sterile packaging films in the coming years?
Nicole: One important area is the development of high-performance recyclable structures that can replace conventional multi-material laminates wherever the application and regulatory requirements allow. At the same time, material development is focusing on better sterilization resistance, greater durability, and lower environmental impact.
Nils: The impact of the PPWR and sustainability requirements more broadly will become more visible over the next several years. Demand for recyclable and recycle-ready packaging will increase. The challenge will be meeting those expectations while preserving the quality characteristics that a sterile barrier system cannot do without.
Nicole: I do not expect one breakthrough material to replace every structure used today. The future will depend on intelligently engineered films that combine safety, functionality, sustainability, and efficient manufacturing for a clearly defined application. The quality of those early decisions determines how reliably the finished package performs.
