Patient Safety Central to Material Testing and Sustainability Initiatives

While all flexible packaging protects the content it contains, sterilized flexible packaging must keep its contents free of contaminants that can potentially harm a medical patient who is often receiving lifesaving care.

Over the years, the sterilization packaging industry developed medical packaging materials that are inherently stable and do not degrade over time. Nonetheless, repetitive and time-consuming stability testing activities on these materials are commonly required by medical device manufacturers.

The Sterilization Packaging Manufacturers Council (SPMC®) is supporting volunteer-based Kilmer Innovations in Packaging (KiiP) on its Wicked Stability Project, which aims to streamline stability testing so time, resources, and engineering talent can be applied to other areas of medical packaging innovation.

The Wicked Stability Project is examining available data sources and compiling aging study results on common sterile packaging materials. By leveraging the aging studies conducted by SPMC® members, the SPMC® technical committee can support and advance this effort. The Wicked Stability Project is exploring the possibility of collecting the data in a general manner and then turning it over for third-party analysis. The resulting report could be used by the Wicked Stability Project to underscore the veracity of the claim that materials used in sterile barrier systems are not undergoing functionally significant degradation.

Henk Blom, Ph.D., vice president of research and technology at PAXXUS, Inc., is the immediate past chair of the technical committee and a team member of the Wicked Stability Project. Blom is lending his expertise in the science of materials and material stability and the preferred methods to measure material stability in SBS materials.

On a separate front, SPMC®’s sustainability/regulatory committee is working to ensure these high-performing materials are not inadvertently compromised or hindered by uninformed environmental initiatives.

In particular, the group is actively monitoring all proposed state legislation surrounding plastics, packaging, and packaging waste. At issue are proposed mandates specifying certain percentages of recycled content or requirements for recyclable packaging.

The committee wants to ensure legislators across the U.S. consider the unique requirements of medical device packaging in protecting patient safety, and they understand the importance of proper caveats for sterile packaging. To this end, the committee is developing key position papers that will help inform legislative decision-making on these issues.

Patient safety is at the center of the sterile packaging industry’s sustainability solutions, which are focused on packaging that requires fewer materials and, therefore, less waste. Recent material innovations have led to down gauging, which reduces the thickness of the material used while retaining packaging integrity and strength.

As the industry continues to make inroads in sustainability, SPMC®’s leadership on technical and regulatory issues is providing guidance to ensure the safety of medical packaging.

Given the volume and level of work the council is undertaking voluntarily, the organization is expanding its membership to include other companies within the medical packaging supply chain. A new Associate Member category allows companies from allied industries that are members of the Flexible Packaging Association to join the SPMC®.

Lourdes Pogue is partner and creative director at Merakke. Reach her at