FPA’s Sterilization Packaging Manufacturers Council (SPMC®) convenes on a regular basis with like-minded companies to develop consensus documents that benefit the entire industry. It’s an effective framework that has not wavered in nearly 30 years.
Amcor Flexibles; Beacon Converters, Inc.; PAXXUS, Inc.; PPC Flexible Packaging; Printpack Medical; SteriPax; and Technipaq, Inc. comprise the SPMC®. These companies convert raw materials into flexible packaging or packaging components for sterilizable medical devices, products, and medications used by doctors, nurses, and first responders to deliver safe medical treatment. Combined, they produce the majority of all sterilizable flexible packaging materials used in the United States and a significant portion of the sterilizable flexible packaging materials used worldwide.
“Every one of SPMC®’s member companies is equally committed to patient safety …”
—Henk Blom, PAXXUS
These same companies also encourage their most accomplished technical, regulatory, and engineering personnel to volunteer on SPMC®’s Technical Committee. Here they lend their time and expertise to the creation of technical guidance for medical and pharmaceutical sterile packaging requirements. The group has donated thousands of man hours to develop standards that provide consistency and reproducibility to the design and production of sterilizable flexible packaging, improving understanding and communication throughout the packaging supply chain.
“For us, it’s simple. Every one of SPMC®’s member companies is equally committed to patient safety, and everything we do revolves around that central mission,” says Henk Blom, vice president of research and technology at PAXXUS. Blom also chairs SPMC®’s Technical Committee.
Indeed, ensuring that sterilized flexible packages retain their integrity and efficacy until they are opened is the reason SPMC® was formed in 1994 as a council of FPA. The founding members recognized the need for guidance and reproducible methods that could test the integrity of sterilized packages after being transported and stored under varying conditions and for various lengths of time.
In 1996, SPMC® developed its first standard for peel strength, which was later incorporated into ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials. SPMC® followed with the publication of Standards and Test Methods in 1998 and the Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products in 2000.
The group has developed over 100 frequently asked questions ranging in topics from materials and package development to testing and validation, which are available on SPMC®’s website.
Through the years, SPMC®’s technical representatives have served on standard-setting organizations such as ASTM International, which provides a global forum for the development and publication of voluntary consensus standards for materials, products, systems, and services used around the globe. SPMC® also collaborates with organizations such as the Association for the Advancement of Medical Instrumentation (AAMI) and the Institute of Packaging Professionals (IoPP).
The Technical Committee has participated in several industry webinars including:
- A Guide to Gels and Sterile Barrier Integrity Measures in 2019
- Sterilization: A Sterile Packaging Perspective in 2013
- Package Integrity: A Look at False Alarms in 2010
- Understanding the Nuances of ISO 11607 in 2008
Today, SPMC®’s Technical Committee is writing white papers that can help inform sterile packaging decisions. “Package Integrity Testing” and “Polymeric Gels in Flexible Medical Device Packaging” were released in 2019. “A Guide to Writing Rollstock Specifications” and “A Guide to Writing Pouch Specifications” were finalized this summer.
There are also some active ASTM workgroups that the Technical Committee is participating on relating to seal strength specifications, accelerated aging, material changes, and dye-penetration testing. All of this important work supports the SPMC® commitment to patient protection and ultimately improving patient outcomes.
Lourdes Pogue is a marketing consultant at C5 Communications in Richmond, Virginia. Reach her at Lourdes@C5CI.com.