December 2000, Pharmaceutical & Medical Packaging News

Choosing the right packaging material for a medical or pharmaceutical product involves detailed planning and analysis. Companies must assess the benefits of using one material over another, which material works best with a given product going through its sterilization process, and how quality and performance can be maintained in the many lots that are produced over time. With so many things to consider, who has time to cast about for the right test method?

To ease this process, the Flexible Packaging Association and its Sterilization Packaging Manufacturers Council (SPMC) have drafted the "Guide for Design and Evaluation of Primary Packaging for Medical Products." It is currently being voted on by the American Society for Testing and Materials and should be available for purchase from ASTM in 2001.

Produced by technical representatives from the SPMC working simultaneously as members of FPA and ASTM, the guidance is designed to help companies make informed, efficient decisions when selecting test methods to evaluate and design packaging. Reduced costs for R&D and quality assurance are potential benefits.

The SPMC was formed in 1994 to help establish voluntary standardized testing methods and specifications for various products commonly used or produced by the association's member companies. Additionally, the council came together to address technical concerns, and it sought input from the medical device community and related government agencies in the development of publications that would later be deemed voluntary industry standards.

The draft guidance, originally developed as a list of relevant test methods and general instructions on various characteristics of packages, has been redesigned into a more-focused document that distinguishes clearly between methods used for R&D and those used most often for process and quality control. It identifies seven key categories of requirements for sterile packaging: safety, barrier, durability, integrity and seal, visibility and appearance, processing, and printed ink. The guide comprises a flowchart and a list of test methods in table format along with their descriptions and applicability.
Since some of the tests cited in the standard required special equipment and expertise outside the SPMC, members volunteered their time for research, contacting independent test labs, vendors, and customers to find out what standards they used and the logic behind their choices. Answers to questions about the appropriateness of choosing one method over another and about whether choices were made based on a specific material/test combination, available equipment or materials, or a preference supported by a history of data, were used in the applicability section of the table.

The subcommittee ballot responses from members of the ASTM Technical Subcommittee on Medical Packaging (F02.60) were discussed at the ASTM meeting in Orlando, FL, on October 11-12. At that time, a vote was taken, and a few changes were made to the document, such as the SPMC Determination of Coat Weight and the ASTM Guide to Accelerated Aging. A second vote by subcommittee members will take place by mail, and the results will be discussed as the next ASTM meeting in Phoenix in April 2001.