Sterile Packaging

Medical device companies are turning to trusted supply chain partners to determine the best approach to sterilize and package their products. Our films division started 70 years ago with a focus on blown film, extrusion, and conversion.

Today, Spectrum operates 35 blown film extrusion lines and 7 converting lines for making header bags, pouches, flow wraps, Ziploc® and adhesive polybags, and a variety of custom polybags in various colors and sizes. Additional services include four-color printing, venting, folding, slitting, and perforation as needed.

Our sterile barrier packaging is available in a wide range of peelable, tear-open, breathable, and non-breathable pouches. We also offer mono-layer and co-extruded films and film conversion for a wide array of bags, pouches, and lids. Spectrum is also just one of a few authorized DuPont™ Tyvek® converters in the world.

Understanding the chemical interactions between the selected packaging material and the selected sterilization method is critical for success. The material must be able to withstand repeated cycles in the harsh sterilization environment. The material also needs sufficient breathability (for gas-based sterilization) to allow penetration of the sterilant and to equilibrate during sharp changes in pressure that occur within sterilization chambers.

Spectrum collaborates with customers to create highly specific and highly effective customized packaging solutions for their products—especially those that have special components or sensitive materials. Key considerations for customization include:

• Sterilization method
• Size of the device being packaged 
• Sharp or rough edges on the device
• Timetable for delivery to market 
• Cost limitations 
• Printed or unprinted with colors or text
• Volumes (mid to high volumes are most cost-efficient)
• Equipment used to fill and seal the device

The ability to customize through the utilization of different materials is also a key advantage when dealing with supply chain shortages. Spectrum works with a high-quality network of reliable material providers to find effective alternative materials that will still deliver or exceed desired performance expectations.

Packaging is a key part of the medical device manufacturing process—it is critical that the product arrives undamaged and sterile. This needs to be considered early in the design for manufacturability (DFM) process. Product and packaging design must be considered together to reduce the risk of delays that can cost time, money, and opportunity. Package validation is actually a complex series of processes, especially for sensitive or delicate products; proven contract manufacturer expertise can help manufacturers navigate the challenges of package validation testing.  

Gamma radiation and ethylene oxide (EO) are the most popular methods of sterilization. Depending on the material and application, other methods to consider are electron beam, X-ray, chlorine dioxide, nitrogen dioxide, vaporized hydrogen peroxide, vaporized hydrogen peroxide gas plasma, vaporized peracetic acid, vaporized hydrogen peroxide and ozone, and supercritical carbon dioxide.

Production volume will impact packaging design. Packaging designs differ from small lot cycle versus a multi-pallet system. The choice of packaging also comes into play with how the product will be shipped. For example, if shipping via air or long distances, will the package be able to handle the decompression of an airplane flying at 40,000 feet?

Simulation testing is taking on a greater role in bringing optimal packaging products to market more effectively, especially for sensitive and/or complex products. Simulation offers the opportunity to save time, money, and other resources and mitigates risk by exploring ‘what if’ scenarios, allowing engineers to design engineering safety factors, remove uncertainty from package designs, and improve speed to market. Simulation is also a powerful analytical tool for product investigation and root cause analysis to understand field failures of existing products.

Medical device manufacturers are intent on using sustainable materials and processes that enable recyclability, smaller footprints, sustainable materials, and waste reduction—all of which improve operations, reduce environmental impacts, and improve brand image. Reducing waste can be achieved by optimizing packaging design, which can reduce material usage, as well as improve packaging functionality. Another way Spectrum can help sustainability is by converting Tyvek into high-density polyethylene. Simulation testing can identify critical quality attributes and create optimal packaging from the start, thereby improving sustainability.

Medical device companies and their contract manufacturers can work together early in the design process to develop systems that fully protect a single product or a class of products through their packaging and shipping journey. Packaging design and validation studies can take months to complete, so it is beneficial and cost-effective to include contract manufacturers up front in the design phase.

Spectrum works closely with MDMs as a trusted technology and material advisor and injection molder to develop and manufacture their most innovative and complex products. Our deeply experienced teams of designers and engineers consistently deliver solutions that meet or exceed a customer’s very-specific needs for packaging performance, functionality, and product protection.

Contact us today to discuss your next project.