What You Don’t Know About Stability Data Requirements May Surprise You

by Todd McDonald on June 27, 2014

Did you know that the polyether urethane used for artificial hearts was first used in ladies’ girdles, or that the Dacron used in vascular grafts was first used in clothing? In fact, many commonly used materials in medical devices were simply repurposed from household applications, making them less than ideal. This begs the question, why aren’t more of these materials being replaced with new ones? The answer lies in the data.

As explained in Brian Buntz’s recent QMed article, A Medtech Materials Catch-22, “Only new materials that are reasonably priced and backed by substantial data are attractive to medical device designers…But creating new materials is a costly enterprise, as is adapting those new materials for mass-production. Furthermore, gathering substantial clinical data to demonstrate the safety of those materials is often cost prohibitive as well.”

This lack of data makes the use of new materials unappealing for many medical product designers, which subsequently impedes the development of new materials. What’s more, current materials have a lengthy history of use for medical applications and are also backed by significant data  – a classic Catch 22.

This challenge is very similar to the one that MDMs face when it comes to medical packaging. Charged with trying to meet sustainability goals while also reducing costs, it seems clear that using a new, more recyclable, material for sterile barrier systems could help them achieve both. However, many MDMs are often reluctant to explore such options because of the perceived cost of required stability testing.

However, when it comes to meeting ISO 11607 requirements for stability testing, the perception that it is the sole responsibility of the MDM to generate data to support SBS stability testing is actually a fundamental misunderstanding.

This is why our partners, Spartan Design Group principals Curt Larsen and John Spitzley served on the Working Group 7 of the ISO Technical Committee 198 to develop the 2006 version of 11607, adding Clause 6.4.7 which clarifies that stability data does NOT necessarily have to be provided by MDMs and that data produced by groups such as SBS materials suppliers (like TEQ) are equally acceptable.

Our partnership with Spartan Design Group was critical in helping us apply this to the TEQethylene™ sterile barrier system (SBS) – a medical packaging solution that utilizes a new, proprietary blend of High Density Polyethylene (HDPE) in combination with adhesive coated TYVEK®, a breathable HDPE thermoplastic lidding material developed by DuPont™.

This new HDPE blend has less environmental impact than other materials while also offering many additional benefits over conventional HDPE such as better clarity for improved visibility and seal inspection, better durability to hold up to the sterilization process and better processing and dimensional control. Additionally, when used with Tyvek lidding, the result is a monopolymer package that is more easily recycled. Plus, customers that move from using a material like PETG or HIPS to TEQethylene can save up to 40% on their thermoforming product.

While this solution clearly offers many benefits, we realized that MDMs may be reluctant to change SBS materials due to the assumption that they would need to conduct a costly and time consuming stability study to meet the requirements of Clause 6.4 of ISO 11607-1:2006. Therefore, we decided to be proactive and enlist the support of our partners at Spartan Design Group to help provide our customers with the stability data they need to meet these requirements.

What about you? Has your company developed a solution that allowed you to incorporate new and better materials or products?

Learn How Our Stability Data Can be Used For 11607-1 Compliance

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