The Sterilization Packaging Manufacturers Council (SPMC®) recently formed a Sustainability/Regulatory Committee, which will be working on ensuring that legislation around plastics, packaging, and packaging waste considers the unique requirements of medical device packaging. Medical packaging is highly regulated to ensure patient safety and minimize any risk to the patient.
The Sustainability/Regulatory Committee recognizes that strong communication and dialogue are required to avoid conflicts between the U.S. Food and Drug Administration (FDA) and the European Union Medical Device Regulation (EU MDR) medical packaging requirements and new sustainability legislation, while still realizing the mutual goals of improving the sustainability of packaging.
SPMC®’s member companies each identified representatives from their respective organizations to serve on the committee, and their first meeting was held in June.
Technical Committee Work Continues
On the technical front, SPMC®’s Technical Committee is adding value, thought leadership, and collective expertise within health care packaging.
The committee is focusing efforts on the safety and efficacy of sterile barrier systems through the publication of white papers. These papers are designed to inform decision making by clarifying aspects of sterile packaging design and addressing questions that arise from regulatory guidance.
Currently under development is a white paper on the effect of moisture on the degradation of packaging materials. This white paper is intended to supplement ASTM F1980, “Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices,” which now includes control of relative humidity.
The Technical Committee’s engagement with ASTM International remains high. The committee is working on F904 (“Standard Test Method for Comparison of Bond Strength or Ply Adhesion of Similar Laminates Made from Flexible Materials”) and on surfactant identification and qualification work for two dye tests, F1929 (“Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration”), and F3039 (“Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration”).
SPMC®’s Technical Committee also has been meeting in conjunction with ASTM’s meetings, most recently in Seattle in April, and will meet in New Orleans in October.
From a communications standpoint, the SPMC® Marketing Committee’s outreach operation around Sterile Packaging Day offered a unifying point of engagement across the supply chain.
What started as a sterile packaging manufacturer-led initiative in 2021 grew to include and amplify the voices of additional industry segments in 2022 with the theme of “Better Together.”
SPMC® will be sponsoring the Fundamentals of Medical Device Packaging Course to be presented by the Institute of Packaging Professionals (IoPP) at PACK EXPO in late October. This hands-on course covers packaging regulations and standards, materials, equipment, sterilization, design, qualification, and troubleshooting.
Plans are also in full swing for Sterile Packaging Day 2023 to be held on Wednesday, Feb. 8, in conjunction with MD&M West.
Lourdes Pogue is partner and creative director at Merakke. Reach her at firstname.lastname@example.org.