Sterile packaging rarely penetrates the public’s consciousness, creating an awareness gap that the Sterilization Packaging Manufacturers Council (SPMC®) has been striving to close since 1994 and continues with ongoing guidance on issues affecting the industry.
“Sterile packaging gets safe and sterile medical devices and medical products to a hospital, which will then be used to treat a patient,” says Nick Packet, industry vertical manager with the DuPont™ Tyvek® Healthcare Packaging team. “It could be somebody’s mom or grandmother, or somebody’s brother. Sterile packaging is ultimately maintaining and preserving patient safety through the sterility of that product.”
As a working group of the Flexible Packaging Association (FPA), SPMC® addresses the unique interests of sterile packaging suppliers, converters, and associated enterprises. SPMC® alerts lawmakers to the potential consequences of sustainability and recycling regulations on patient safety, educates package designers on thorny technical issues, and engages medical device manufacturers in recognizing the ways sterile packaging makes their lifesaving products possible.
The work of the 11-member SPMC® drives through three committees: technical, marketing, and the newest addition, sustainability and regulatory, which was formed in 2022 and is releasing new guidance this year.
Sustainability and Regulatory Committee
The sustainability and regulatory committee was created to meet a demonstrated need, says Dhuanne Dodrill, CEO of PAXXUS, Inc., and SPMC® chair.
According to Dodrill, the European Union Packaging and Packaging Waste Directive’s amendments of 2018 updated measures to promote recycling and extended producer responsibility (EPR) schemes. The unique factors of pharmaceutical packaging were addressed, but medical device packaging was overlooked. In Europe, the Sterile Barrier Association is the European trade association for companies that produce sterile barrier systems for the healthcare industry.
“Until the Sterile Barrier Association got involved, no one had been on top of ensuring that the regulators understood the unique requirements of medical device manufacturing,” Dodrill says. Although medical device packaging was “very late to the game in trying to drive change there,” it succeeded in getting a partial carveout when the directive became regulation recently, she adds.
Lessons learned are now in play in the U.S., where a rising tide of recycling and sustainability mandates and proposals include EPR requirements and President Joseph Biden’s executive order calling for displacing 90% of today’s petroleum-based plastics with bio-based polymers by 2043.
“We saw a need for someone to closely monitor these proposed regulations as they relate to medical device packaging and highlight the often very conflicting requirements of the proposed legislation versus the FDA (Food and Drug Administration) regulations,” Dodrill says. “We want to make sure that the unique requirements of highly regulated medical device packaging are considered in the rulemaking process.”
White papers and guidance documents produced by SPMC® committees constitute a key part of the SPMC® advocacy and education strategy. The sustainability and regulatory committee expects to release its first white paper this year. The paper with sections on recyclability and recycled content is intended to educate lawmakers on the regulatory contradictions of imposing content mandates on sterile packaging.
“Sterile packaging has standards saying that unless there is traceability of all the materials in our products, you can’t put it in, but there isn’t necessarily trace-ability in single-stream recycling that’s getting picked up curbside,” says Packet, chair of the sustainability and regulatory committee. “It’s a direct contradiction between what legislation could put in place and what the standards are telling us to do.”
Because sterile packaging must remain aseptic from distribution to opening and presentation, the white paper is meant as “an educational tool for lawmakers that gives them some perspective and understanding around the importance and criticality of healthcare packaging,” he adds. “We want to avoid sweeping legislation that could have unintended consequences with undue burdens and challenges that can’t be met and that, ultimately, put the risk of patient safety on the line.”
Since its days of intensive standards writing, the technical committee has morphed into an educational resource for the industry, Dodrill says. That includes white papers and an FAQ page on the SPMC® website (sterilizationpackaging.org/faqs) where packaging professionals and engineers who utilize the materials made for sterile packaging can post questions—such as “What are generally recognized storage conditions for flexible barrier materials?” or “What things do I need for high-quality printing?”—and get answers.
When a particular FAQ gains traction or a new standard is anticipated, the technical committee might produce a white paper to illuminate the topic and provide a source that can be pointed to, says Bill Cassidy, product development manager for Amcor Flexibles and chair of the SPMC® Technical Committee.
Past editions included “Package Integrity Testing,” “Polymeric Gels in Flexible Medical Device Packaging,” “A Guide to Writing Rollstock Specifications,” and its companion, “A Guide to Writing Pouch Specifications.”
Committee members draft different sections, and when the group convenes in person—twice per year during American Society for Testing and Materials conferences—it reviews and refines the language. “It is a way to get multiple individuals from different companies with a common voice to make it a more powerful statement,” Cassidy says.
Dodrill, a past technical committee member, notes that the FAQ answers and white papers represent “a consensus answer” among committee members. “There were definitely hard discussions but always respectful discussions, and always with the goal of making sure the science was understood and we were providing solid information,” she says.
The committee also presents webinars and trade show presentations, often to promote an upcoming white paper. The technical committee’s upcoming paper answers the “why?” questions that suppliers field about recommendations for storing and handling rollstock, with a follow-up planned for pouches.
“When storing our pouches in their inventory, medical device manufacturers often have questions regarding temperature, relative humidity, and shelf life,” Cassidy says. “This paper provides insight into the potential impacts temperature and humidity can have on various packaging materials. It’s more of an educational piece. If there’s any kind of storage deviation, they’re better prepared to understand the real risks, rather than assume the product’s not acceptable.”
Cassidy sees the volunteer effort of serving on the committee and producing white papers “as a service, giving back to our customers and the industry, and to help new engineers succeed in their positions,” he says. “If we can pass on some useful piece of knowledge, that’s something we like to do. Most of us sitting in the committee have worked in the industry, in most cases for 20-plus years, so we have a lot to bring to the table.”
Medical device manufacturers (MDMs) put their primary focus on making lifesaving instruments, and not on engineering their packaging. And yet, as Dodrill points out, “You don’t get to use the device unless it’s been packaged somehow.”
Too often, manufacturers create a revolutionary new device but find themselves in a frantic scramble to devise a packaging solution in time to launch.
That’s why customers themselves, those MDMs, are the target audience of the SPMC® Marketing Committee.
“Hopefully, we’re helping to encourage organizations to bring packaging into the discussion at the beginning of the process,” Dodrill says. “Let’s be more thoughtful about that process. Many companies do it very well, but others have room for improvement.”
Starting the packaging design process early is essential because sterile packaging undergoes a rigorous gauntlet of testing, says Kathleen Daly Mascolo, vice president and director of sales and marketing at Beacon Converters, Inc., and chair of the SPMC® Marketing Committee.
“Devices can break during transportation if they’re not well packaged, or sterility can be compromised if the package opens,” Mascolo says. “They must protect the sterility of the device until the time of use.”
The marketing committee has long conducted outreach via traditional avenues, such as promoting the technical committee’s webinars, but its newest effort is the one generating all the buzz. Since its virtual launch in 2021, Sterile Packaging Day is now an MD&M West annual mainstay, recognizing and thanking all supply chain partners engaged in delivering safe, innovative, and sterile medical devices.
Sterile Packaging Day was the brainchild of Don Alip, former committee chair who recently took a position outside the sterile packaging industry. Always held during the middle day of MD&M West—February 7 in 2024—Sterile Packaging Day stages events and engages attendees in spotlighting the inestimable value of sterile packaging in protecting medical devices.
Activities have included a scavenger hunt for sterile-packaged home products, Tech Talks and podcast appearances, and an annual blood drive for the American Red Cross.
“People are always excited to rally around Sterile Packaging Day and celebrate our industry’s dedication to patient safety,” Mascolo says. “Of our close to 1,000 followers on LinkedIn, many initially became aware of our efforts thanks to this event.”
The event reminds manufacturers that their products aren’t doing their job if the sterile packaging, with its precise specs dictated by a complex array of factors, isn’t functioning, Mascolo says.
“The role of sterilization packaging is not really on the minds of consumers outside the industry,” Mascolo says. “You don’t think about it, but if you’re in a hospital, you certainly want to feel confident that the devices used in your care are sterile when they need to be. It’s always important to recognize the value of this in the industry. It’s not only the medical device or the pharmaceutical that the packaging is protecting. It’s the patient.”
Call to Action
SPMC® members marvel at the collegiality of their group of competitors as they work for the betterment of the industry and the patients they serve. Meetings are always monitored by FPA legal counsel to protect intellectual property and to prevent any talk of pricing, but the conversations inevitably coalesce around shared interests.
“We’ve made a lot of headway,” Mascolo says. “The process of collaboration and achieving consensus across the supply chain for the benefit of the end user is rare, and it speaks to the dedication of SPMC® members to the greater good.”
Dodrill notes that SPMC® is always seeking members who have a focus on the healthcare space.
“There are some big issues facing our industry, and it would be wonderful to have more people contributing,” she says. “The more expertise we can gather, the more work we can produce, and the more we can get good information out there.
M. Diane McCormick is a freelance writer and editor based in York, Pennsylvania.