The material selection process for the primary packaging of medical devices can be critical to commercial success. Knowing the options and which materials offer the best sterile barrier performance for your specific medical device can make all the difference.
What types of materials are used for sterile packaging?
There are several sterile packaging material types: foils, films, papers/nonwovens, and rigid/semi-rigid plastics. Medical devices will require either flexible or rigid packaging—pouches are flexible, trays are rigid, or even a hybrid of the two.
What factors must be considered to determine the optimal materials for packaging my medical device?
Identifying ideal packaging materials is dictated by the features, function and composition of the medical device. Perhaps more importantly, knowing its sensitivities. Sensitivities are characteristics that create risks, such as medical device:
- Shape, size and weight
- Irregularities such as sharp protrusions
- Multiple parts to the device
Sensitivities may also be found in outside conditions that can affect the materials, such as temperature, moisture, pressure.
Trusted Packaging Materials
“From my experience, I can say that PETG, TPU and Tyvek® are a big part of my daily life in medical device packaging,” says Johnny Kieu, Senior Packaging Engineer at PCL.
Medical Grade PETG (Polyethylene Terephthalate Glycol)- Semirigid, nonporous film. A trusted, versatile material choice.
PROS
- Durable—impact friendly
- High clarity transparency, but available in translucent or opaque colors
- Excellent heat-sealing rating
- Hygienic surface
- Excellent chemical resistance (for EO and gamma sterilization)
- Recyclable
- Moldable
CONS
- Potential weaker gas barrier
- UV sensitive
- High-heat sensitive
- Scratch sensitive
- Requires temperature monitoring during thermoforming (degrading transparency/strength)
- Requires analysis for suitability with high chemical concentrations
Tyvek®, (DuPont® brand nonwoven)- Flexible, porous, nonwoven HDPE. While often casually referred to as a “paper,” in the medical device industry, it is not.
PROS
- Lightweight
- Porous in nature
- Printable
- Excellent microbial barrier
- Tear and puncture resistant
- All-method sterilization friendly: EO, Gamma, E-beam, H2O2 and certain steam processes
- Greater water resistance than medical grade papers
CONS
- Higher cost
- Must be right-sized
- Water penetration risk with prolonged exposure by pressure or duration
Medical Grade TPU (Thermoplastic Polyurethane)- A flexible film that is popular for orthopedic implants, diagnostic and anesthesia-related devices.
PROS
- Strong/Durable
- Chemically stable
- Excellent compression
- Excellent tear and puncture resistance
- Superior elasticity
- EO sterilization friendly (implants)
- TPU specification-dependent for gamma (disposables)
CONS
- Thorough analysis required for sterilization compatibility (potential hardening/brittleness)
- Moisture sensitive
- Requires aeration/validation post EO sterilization for chemical residue
Other Key Considerations
Aside from the physical nature of the medical device, the physical properties of packaging materials and the interactions that result, there are other important conversations that go into the materials selection process.
Other considerations to discuss are the quantities you expect to produce and the longevity of the medical device. There is a big difference between how many special bandages will be sold vs. how many neonatal endotracheal tubes. The packaging materials and design must be aligned to those goals to ensure high performing products are, flawlessly packaged and delivered.
Key Takeaways
Selecting the right primary packaging materials is a foundational decision that directly impacts sterile barrier performance, regulatory success, and overall product viability. Medical device packaging must be tailored to the device’s design, sensitivities, and exposure risks. Materials like PETG, Tyvek®, and TPU offer proven benefits but come with important tradeoffs related to sterilization compatibility, durability, and cost. Beyond material properties alone, factors such as production volume, intended use, and product lifespan should guide material selection to ensure the packaging performs reliably through end use.
