SPMC® Helps Improve Safety for Medical Device Packaging Worldwide

Consistency. Clarity. Reproducibility. In the early 1990s, these three words were in short supply when it came to testing methods for medical device packaging. In June 1994, the founding members of the Sterilization Packaging Manufacturers Council (SPMC®) came together to change that. Thanks to its determination, SPMC® has created and contributed to standards and test methods that have improved the safety of medical device packaging worldwide. 

This year, SPMC® is celebrating its 30th anniversary. As we look back at some of the organization’s technical contributions, it’s important to understand the backdrop against which it originated. 

“There was a proliferation of test methods, procedures, and standards being developed by individual device manufacturers, various organizations, and lab testing equipment suppliers,” says Bob K. Dodrill, one of SPMC®’s founding members, about the situation 30 years ago. “This required the converter to run the same type of lab test using many different procedures and often requiring various types of testing equipment.” 

Knowing that the situation would only grow more cumbersome and confusing, the eight founding member companies pooled their resources to work collaboratively. As flexible packaging converters supplying the sterile medical device manufacturers, they leveraged their shared technical knowledge and expertise to establish standardized testing methods and specifications for the common packaging materials they all produced. 

The first order of business was establishing a technical committee, which was tasked to “cull through the myriad of existing standards and specifications for their appropriateness to the flexible packaging converter’s role,” according to the March 1995 issue of Pharmaceutical & Medical Packaging magazine. 

Work forms the basis for international standards

The SPMC®’s Technical Committee developed the council’s first standard for peel strength in 1996. ASTM International, a global forum for the development and publication of voluntary consensus standards, later incorporated this test method into the ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials. Over time, ASTM would come to recognize other SPMC® standards, which later evolved or formed the basis for five other ASTM standards. 

Reflecting the growing value of SPMC®’s work within ASTM, several SPMC® members began chairing ASTM committees, including the ASTM Subcommittee on Medical Packaging in 2003 and the ASTM Subcommittees for Package Design and Development and Physical Properties in 2006. The enduring contributions are made evident by SPMC® members Marie Tkacik of Beacon Converters, Inc. and Dhuanne Dodrill of PAXXUS, Inc., each receiving the ASTM Award of Merit, the highest recognition for individual contributions awarded by one of the largest voluntary standards development organizations in the world. 

SPMC®’s Technical Committee also played a pivotal role in updates to International Organization for Standardization (ISO) 11607, a key globally recognized standard that focuses on the requirements for the packaging of terminally sterilized medical devices. 

In 2007, SPMC® was recognized as a key contributor to TIR22, a compliance guide to ISO 11607 developed by the Association for the Advancement of Medical Instrumentation (AAMI).

In 2008, SPMC® member Jackie Daly Johnson, president of Beacon Converters, was nominated to head the ISO TC198/WG07 task force, charged with drafting expanded guidance for ISO 11607, and she later co-chaired the AAMI TC198/WG07 Packaging working group.

“Since the beginning of my co-chair role, I have served as a U.S. expert on the ISO committee, bringing SPMC® perspective to the defining standard for packaging of terminally sterilized devices,” Daly Johnson says.

Today, compliance with ISO 11607 is essential for medical device manufacturers. The procedures found in the standard are recognized by the U.S. Food and Drug Administration and the European Union through their CE marking, which ensures consumer safety. 

“From the beginning, we hoped to work with organizations like ASTM, AAMI, and ISO to create clear and consistent test methods that could be easily reproduced and standards that could be readily understood and therefore widely adopted,” says Dhuanne Dodrill, current SPMC® chair. “It’s remarkable to see the impact our group has had on the safety of medical packaging.” 

Lourdes Pogue is partner and creative director at Merakke. Reach her at lourdes@merakke.com.