The Flexible Packaging Association’s (FPA) Sterilization Packaging Manufacturers Council (SPMC®) is undertaking a significant initiative to update its web-based frequently asked questions (FAQs). (See sterilizationpackaging.org/FAQs.)
The FAQs serve as a foundational tool for packaging designers, engineers, and other professionals involved in the development, sterilization, testing, and validation of medical flexible packaging. The FAQs address a broad range of practical and technical topics—from material properties and specifications to testing methods, sterilization effects, and worst-case scenarios in validations.
SPMC®’s Technical Committee is conducting the updates, which are on track for completion by the end of the year. The technical representatives who serve on the committee are employed by companies that are industry experts in the unique production requirements of medical and pharmaceutical packaging.
Leading the effort is committee chair Bill Cassidy, product development manager at Amcor Flexibles, who recently shared insights into the motivation and methodology behind the comprehensive review.
“Some of our FAQ responses are over 15 years old,” Cassidy explains. “Materials, technologies, and regulatory expectations continue to evolve and advance, and we want to ensure our response content remains accurate.”
To that end, the committee has developed a methodical and collaborative process for conducting the updates.
Each Technical Committee member has been assigned specific FAQ topics to review.
“If any of the existing responses need to be addressed, we develop the updated response as a group,” Cassidy says.
The answers are consensus-based, meaning every active member of the Technical Committee must agree on the finished response. This meticulous approach is one of the many reasons why the SPMC® has earned the trust of medical packaging professionals and decision-makers around the world.
SPMC®’s FAQs section is also being scoured by the committee for duplicative content that may already be addressed within the council’s growing series of white papers that can be found on the website.
“If any content is already covered in one of our white papers, we plan to remove the topic from the FAQs section,” Cassidy says. “Our white papers dive deeper and shed light on the insight behind the guidance.”
SPMC®’s white paper topics include guides for writing both rollstock and pouch specifications, package integrity testing, polymeric gels in flexible medical device packaging, the storage and handling of rollstock and preformed sterile barrier systems, and the impact of cold storage and transit on medical packaging.
If packaging engineers have a specific technical question that isn’t covered within the FAQs or the white papers, they can use SPMC®’s online Technical Assistance form to submit their inquiry.
“The questions are reviewed and answered by SPMC®’s Technical Committee, and in fact, several of these online inquiries have become part of SPMC®’s FAQs resource,” Cassidy says.
Packaging professionals are encouraged to visit the FAQs section regularly and explore both the updated entries and supporting white papers to stay informed about the latest in sterile packaging best practices. This free, reliable, and relevant knowledge database is designed to support safe, compliant, and effective sterile packaging solutions.
Lourdes Pogue is partner and creative director at Merakke. Reach her at lourdes@merakke.com.