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The benefits of standardized test methods for medical packaging
Standardized test methods offer the medical device industry a uniform basis for scrutinizing product characteristics and evaluating materials and products. Many standardized test methods are recognized by the FDA as consensus standards. And as an added benefit, standardized test methods supply much of the needed information for test method validation—especially when precision and bias statements are included—and thereby provide a head start to the test method validation process.
The origins of standardized test methods
Medical packaging test methods come from multiple organizations, with the most widely used resources being ASTM, TAPPI, ISTA, and ISO. These diverse organizations sponsor committees comprised of volunteers from medical device manufacturers, suppliers, consultants, testing facilities, and the FDA. They convene to propose, write, and vote on standards that help the industry harmonize testing. For example, members of The Sterilization Packaging Manufacturers Council (SPMC) of the Flexible Packaging Association (FPA) develop standards which are then submitted to ASTM for adoption.
Factors to consider when choosing a test method
Many factors need to be considered when determining which test method should be used, including the type of material, the size and type of package, and the process being evaluated. For instance, choosing the appropriate strength test method depends on whether the package is a lidded tray, a pouch, or a blister. The type of integrity test required depends on whether a material is porous or nonporous.
In addition, most tests are designed for a particular use; the appropriate test for determining feasibility early in the design phase will differ from the appropriate test for determining product performance in the validation phase.
Help with choosing a test method
ASTM F2097 and ISO 11607 provide excellent guidance when determining the best test method to employ for a specific application. ASTM F2097-08, Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products, is a collection of test methods commonly used to evaluate medical packaging. Included in the compilation are methods for evaluating safety, barrier, durability, package and seal integrity, visibility and appearance, processing, and printing ink properties. While some of the methods are intended for R&D evaluation, others relate to process acceptance requirements. ASTM F2097-08 also directs the user to appropriate tests and provides convenient summaries of each method.
Annex B of ANSI/AAMI/ISO 11607, Packaging for Terminally Sterilized Medical Devices, provides another helpful list of standardized test methods. The annex contains many of the same references as ASTM F2097 but also includes accelerated aging, biocompatibility, conditioning, and other tests utilized in the industry.
For additional assistance, download Oliver Medical technical director Randy Troutman's presentation at HealthPack® 2007, which addresses how to establish a rationale for selecting a test method and acceptance criterion and how to determine test method repeatability and reproducibility.
Conclusion
Standardized test methods provide medical device manufacturers with a means for common understanding and scrutiny of product characteristics. When you choose ASTM and ANSI/AAMI test methods, you benefit from expert review and refinement by knowledgeable industry members and uniform evaluation of your materials and products.
About the author
Geoff Pavey is principal engineer, packaging development at Oliver Medical, and a member of the Oliver Answer Team. Pavey is also a member of several professional committees including the AAMI: ISO 11607 TIR 22 workgroup; the IoPP medical device packaging technical committee and sub-committees; and the AAMI WG7 on packaging.
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