How Do I Know What Test Method to Use? ASTM F2097 Can Help

What test methods should I be using to qualify my materials or test my package? What are some development tools to select a new material? With several test methods available for a specific property, which one should I use?

Hal Miller

ASTM F2097 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products is a good place to start. The guide is a compendium of test methods, practices, and procedures (with descriptions and applicability for each) for materials and packages.

The guide is organized into eight categories with subcategories:

  • Safety properties -- extractables, toxicity, retained solvents, heavy metals, and particulate inspection
  • Barrier properties
  1. Porous -- porosity and microbial barrier
  2. Non-Porous -- WVTR, oxygen, and gas transmission, and light transmission
  • Durability -- puncture, tear, thickness, tensile, flexure, bond strength, basis weight, and accelerated aging
  • Package integrity & seal strength
  1. Package integrity -- seal and whole package
  2. Seal strength -- tensile peel, burst, restrained burst, and hot tack
  • Visibility & appearance -- haze, gloss, and opacity
  • Processing -- dimensional measurements, friction, seal ability, and coat weight
  • Printed Ink -- rub testing, anchorage, and chemical resistance
  • Package performance -- general simulation, single parcel simulation, and enhanced simulation

Each subcategory lists all known published standards for that particular property. Besides ASTM standards, applicable standards from TAPPI, ISO, ISTA, and US military are also cited. In the compendium, each standard has a described use and the applicability of the standard, which can be particularly useful.

The intent of the design and evaluation guide is to select those categories that are applicable. Once the product has been characterized and the sterilization method defined, there are numerous sets of requirements for any specific package. The design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance.

How would you use it?
Begin by assessing the package requirements in each category based on product characterization and sterilization methodology.

 

The compendium of test methods is arranged to coincide with the summary chart. Select the most appropriate test method based on its description and applicability to your needs. Pay particular attention to the applicability section. ASTM has attempted to provide additional guidance to you for the use of the standards.

 
 

 

This guide is easy to use and provides a wealth of information. We consider it a "living" standard in that it will continue to be revised and updated when new standards are available or brought to our attention. If there are consensus standards you feel that need to be included in this guide, please email me at hfmiller2@att.net.

Stay relevant as a medical device packaging engineer

Hal Miller, President, PACE Solutions

 

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