Most of us are hard-pressed to name an organization where representatives from competing companies work side by side to share knowledge and expertise that can guide the safety of their industry.
Yet, since its founding in 1994, that’s precisely how the Sterilization Packaging Manufacturers Council (SPMC®) has functioned. This subgroup of the Flexible Packaging Association (FPA) historically has comprised FPA member companies whose primary activity is the conversion of raw materials into flexible packaging or packaging components for medical devices. The individuals who serve on the technical committee have contributed thousands of hours over its 28-year history to the development of industry guidance documents, standard test methods, FAQs, and most recently, white papers.
Henk Blom, Ph.D., vice president of research and technology at PAXXUS, Inc., says the transition to writing white papers makes sense.
“We had over 100 online FAQs under our belt, which provided snippets of information on a variety of topics,” Blom says. “A review of the website’s analytics revealed consistent interest in specific FAQ topics. The committee agreed to tackle these topics more broadly and present each in one clean format.”
So far, the technical committee has published four white papers, and a fifth will be released soon. The white papers are “Polymeric Gels in Flexible Medical Device Packaging,” “Package Integrity Testing, A Guide to Writing Pouch Specifications,” and “A Guide to Writing Rollstock Specifications.” The upcoming release will focus on the storage and handling conditions of rollstock.
“When planning a white paper, the group broadly outlines the topic, decides what should be covered, and determines a logical flow,” Blom says.
Members of the technical team then volunteer to write one or more sections of the white paper. When the sections are complete, the committee convenes to review the entire document, which often requires several meetings.
All committee members must agree on every aspect of the guidance being written. This is no small task. It’s meticulous work where phrasing and word choice are painstakingly reviewed and analyzed. The result? Industry guidance that is clear, accurate, and valued.
Blom says the white papers are written largely for medical device manufacturers and the packaging engineering groups within those organizations. The committee aims to provide tools for learning and decision-making that clarify aspects of medical and pharmaceutical packaging.
The collective expertise that goes into the white papers is second to none. “Each committee member works within the research and development or quality side of their respective organizations,” Blom explains. SPMC®’s member companies are industry leaders that represent well over half of the industry.
Many committee members also donate their time and expertise to global initiatives, such as ASTM International and the relatively new Kilmer Innovations in Packaging Group, a sterility assurance value chain collaborative.
“It’s gratifying to work with peers who are not only leaders in the industry but who are so fully committed to helping others tackle sterile barrier challenges that can improve patient safety worldwide,” Blom adds.
To learn more, visit SPMC®’s Learning Tools at www.sterilizationpackaging.org/learning-tools.
Lourdes Pogue is partner and creative director at Merakke. Reach her at lourdes@merakke.com.