Who Should Own SBS Stablity Data?

by Todd McDonald on August 20, 2012

“I thought you were picking up the kids from school!”
“Didn’t you check us in for our flight?”
“I didn’t know I was supposed to confirm our reservation!”

Confusion over the assignment of responsibilities happens often in our everyday life, and usually results in a high level of stress and tension. But what happens when this scenario carries over to the world of business – especially the business of medical device packaging?

Consider a challenge many medical device manufacturers are currently facing – which is trying to meet sustainability goals while also reducing costs. Clearly using different, more recyclable, materials for sterile barrier systems could help them achieve both. However, many MDM’s are often reluctant to explore such options because of a fundamental misunderstanding when it comes to the assignment of responsibilities for meeting the ISO 11607 requirements for stability testing.

In short, until the 2006 version of the ISO 11607 standards, it was commonly misunderstood that it was the sole responsibility of the MDM to generate data to support SBS stability testing – resulting data from many well designed and executed stability studies from other entities being rejected.

This is precisely why our partners, Spartan Design Group principals Curt Larsen and John Spitzley, served on the Working Group 7 of 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 are equally acceptable.

Spartan Design Group has also been critical in helping us apply this to our 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.

While this solution clearly offers many benefits, we realized that MDM’s 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 TEQ 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.

This is just one case of responsibility confusion in business along with a possible solution. Are there others you have come across in your industry? How can the problem can be solved?

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