In medical packaging, sterility is non-negotiable. Whether it’s a rigid tray for surgical instruments or a barrier system for a medical device, packaging must protect the product from contamination, safeguard medical equipment, and withstand the sterilization process without compromising clarity, integrity, or performance.
But not all resins behave the same under sterilization. For engineers, understanding how materials perform under different sterilization methods is key to making informed design decisions. Selecting the right package is essential to maintain sterility and compliance with regulatory requirements — and avoiding costly packaging failures.
Common Sterilization Methods in Healthcare
Sterilization in healthcare typically relies on four main methods: ethylene oxide (EtO), gamma radiation, electron beam (e-beam), and steam. Each has unique benefits and challenges that directly affect material performance. Certain sterilization methods are commonly used for specific packaging materials, as their compatibility and effectiveness depend on the properties of each material.
EtO sterilization is widely used because it operates at relatively low temperatures, which minimizes material stress and allows compatibility with a wide variety of plastics. It is especially effective for complex devices and packaging configurations. However, the process requires an aeration phase to remove residual EtO gas, which adds time and cost considerations. Controlled environments are essential during manufacture to ensure sterility and safety throughout the process.
Gamma radiation provides deep penetration and is effective for bulk sterilization, making it a go-to for large-scale production. The tradeoff is that certain plastics, such as PET, a type of pet plastic, are prone to yellowing, embrittlement, or loss of clarity after gamma exposure, which can compromise both performance and aesthetics. PET is also widely used in food packaging due to its safety, transparency, and compliance with food contact regulations.
E-beam sterilization is similar to gamma but has shallower penetration and faster processing times. It is a good fit for thinner or smaller-format packaging, though it is less effective for larger or denser products. The selection of the right packaging material is crucial to ensure optimal performance with each sterilization method.
Steam sterilization, or autoclaving, is highly effective but extremely demanding on packaging materials. High heat and pressure can cause many plastics to deform, warp, or lose clarity, limiting its use for rigid medical trays. Packaging must also be designed to withstand transportation and handling across multiple facilities, ensuring durability and compliance throughout distribution.
Packaging compliance is essential for gaining market access, as it ensures products meet regulatory standards and are suitable for safe use in healthcare settings.
How Key Materials Perform
Different plastics respond to sterilization in distinct ways, and material choice should always be matched to the expected sterilization process. PETG, for example, offers excellent clarity but is sensitive to gamma radiation, where it may yellow or become brittle. It tends to perform better under EtO and is suitable for EtO sterilization but not for gamma or steam. APET is often used as a cost-effective option, but it can be brittle and shows limited resistance to radiation and steam sterilization. APET is well suited for lightweight medical trays and applications with milder sterilization requirements. Engineers must determine the most suitable material based on the intended application and sterilization method.
Polypropylene, including advanced grades like XPP, stands out for its strong resistance to EtO, gamma, and even steam. Its high heat tolerance and recyclability are making it an increasingly attractive option for next-generation medical packaging. Polyethylene provides toughness and flexibility and is generally EtO-compatible, though its limited clarity can be a drawback in rigid applications. PVC has historically been used in healthcare packaging, but recyclability and regulatory challenges are reducing its role, and its tendency to discolor under radiation is another limitation. These materials are used across various industries, each with unique requirements for medical packaging.
Selecting the right material for medical packaging requires expertise to ensure performance, safety, and compliance with industry standards.
Design Considerations for Engineers
When designing medical packaging, engineers should carefully evaluate which sterilization method the packaging will undergo and validate that the selected material maintains both barrier performance and clarity after processing. Recyclability should also be factored into the decision, as regulations and customer expectations around sustainable packaging continue to grow. While multi-material constructions can sometimes improve short-term performance, they often complicate sterilization and recycling, creating long-term drawbacks.
Working with a dedicated team of experts is essential to ensure that packaging solutions meet all regulatory and performance requirements.
Sustainable Packaging
Sustainable packaging has become a top priority in the medical industry, especially for medical device packaging and pharmaceutical packaging. As healthcare providers and companies face increasing pressure to minimize environmental factors and comply with evolving regulations, the demand for eco-friendly packaging solutions continues to grow. The challenge is to achieve sustainability without compromising patient safety, product quality, or regulatory compliance.
One of the most effective strategies is the use of fully recyclable materials, such as polyethylene terephthalate glycol (PETG) plastic. PETG plastic is exceptionally popular in both consumer and commercial applications due to its outstanding chemical resistance, impact resistance, and durability. In the medical field, these properties make PETG an ideal choice for medical device packaging, where maintaining integrity through sterilization methods like ethylene oxide is essential. Its ability to perform reliably in a controlled environment ensures that patient outcomes and patient safety remain at the forefront.
Material selection is critical when designing packaging for medical devices and pharmaceuticals. The right material must not only withstand rigorous sterilization processes but also support sustainability goals. PETG and other eco-friendly plastics offer the added benefit of being cost effective and fully recyclable, helping companies reduce waste and lower overall costs throughout the product lifecycle.
Innovative packaging solutions such as form fill seal processes and die cutting are also transforming the industry. Form fill seal technology streamlines manufacturing by reducing excess material use and packaging waste, while die cutting enables the creation of customized packaging tailored to the unique needs of each device or pharmaceutical product. These practices not only support sustainability but also enhance efficiency and quality, ensuring that packaging meets the highest level of protection and compliance.
For pharmaceutical packaging, sustainability is equally essential. The safe transportation and storage of pharmaceuticals require a wide array of materials and solutions that balance environmental responsibility with product safety. By choosing materials like PETG plastic, companies can reduce the environmental impact of their packaging while maintaining the safety and efficacy of their products.
Ultimately, sustainable packaging is an essential component of the medical industry’s commitment to quality, safety, and environmental stewardship. By prioritizing eco-friendly materials, innovative processes, and thoughtful material selection, companies can create packaging solutions that protect patients, support healthcare providers, and contribute to a more sustainable future for medical device packaging and pharmaceutical packaging.
Final Thoughts
Sterilization compatibility is one of the most important — and often overlooked — factors in medical packaging design. By understanding how materials perform under EtO, gamma, e-beam, and steam, engineers can avoid failures, reduce costs, and deliver packaging that protects both product and patient.
At Impact Plastics, we’re continually evaluating how our materials perform under sterilization to help customers make informed choices that balance performance, safety, and sustainability.