Sharon Jaeger Farron Associates Whitepaper: A Hands on Approach to Using ASTM F-2097 (Standard Guide for Design and Evaluation of Primary Packaging for Medical Products)

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A Hands on Approach to Using ASTM F-2097 (Standard Guide for Design and Evaluation of Primary Packaging for Medical Products)

Author            :Sharon Jaeger      Contact The Author

Designation    :Packaging Engineering Consultant

Company        :Farron Associates



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The medical product arena has been deluged with new, revised, updated and harmonized guidelines, directives and standards at an increasing rate during the past few years. Many of these documents were generated to answer the special needs of medical product manufacturers, however, few concentrate on meeting medical product packaging requirements. ASTM Subcommittee F.2.60 has been busy generating test procedures, standards and guidelines aimed at medical packaging. Before the recent surge of methods and procedures, medical packaging evaluation testing (seal integrity, accelerated aging, leak detection, visual inspection, etc.) was far from uniform. Medical package testing was conducted using either “borrowed” ASTM standards intended for another application or new test methods developed by the medical product manufacturer. With the first approach, test methods required modifications and each modification had to be justified in every application. In the second approach, test method development was both time-consuming and expensive. With the wide range of new and revised ASTM standards for medical packaging now in place, manufacturers need only identify appropriate standards, methods or guidelines and apply them. To simplify the selection, ASTM F 2097-01, Standard Guide for Design and Evaluation of Primary Packaging for Medical Products, was generated. As the title implies, the guide supplies direction for design and evaluation of primary packages for medical products. The guide also serves as an index of 43 ASTM methods, standards and guidelines; five TAPPI (Technical Association of the Pulp and Paper Industry) test methods; two ISO (International Organization for Standardization) documents; one FPA (Flexible Packaging Association) test method and one Military (USA) specification. All are applicable to medical product packaging. This paper will briefly review the seven categories for evaluating medical packages and packaging materials listed in the ASTM F 2097 guide, provide insight into category and test selection and highlight one or two approaches to application. The goal of this paper is to increase the general awareness of the guide and to emphasize the benefits that can be derived by using the resource. A wealth of medical package testing and material evaluation information is available to medical product manufacturers in the ASTM F 2097 guide.

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