ASTM to Advance New Test Methods at International Meeting
ASTM International Committee F02 on Flexible Barrier Packaging is holding its fall meeting in Barcelona, Spain, on September 26–27. Speakers will include medical device packaging experts from both Europe and the United States, including from the U.S. FDA.
PMP News asked Dhuanne Dodrill, chairman of ASTM International Committee F02 and president of Rollprint Packaging Products Inc. (Addison, IL), for an overview of the standards development activity scheduled to take place during the meeting. Dodrill offers the following updates:
Puncture resistance. One of the testing gaps that currently exists for evaluating flexible barrier materials is a method for sharp puncture and cut resistance. As with abrasion testing, this is an important component for assessing a materials ability to maintain its integrity during distribution and handling. The task group, headed by Henk Blom from Rollprint, will be providing an update on their progress. Interested parties are welcome to join the task group.
Dye Penetration. Current methods for evaluating the integrity of nonporous packaging materials either require relatively expensive equipment to perform or have limited sensitivity. ASTM WK25128 Detecting Leaks in Non-porous Packages or Flexible Barrier Materials by Dye Penetration was developed to provide an inexpensive but sensitive method for assessing the integrity of nonporous materials. The just completed ILS results will be reviewed by Henk Blom of Rollprint in Barcelona.
The main committee ballot for the revised ASTM F1929 Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration will be reviewed. This method differs from the work item above in that it applies only to packaging that uses porous material. It has been updated to include two alternate approaches, edge dip and injection, for performing the test along with the corresponding ILS. Geoff Pavey from Oliver-Tolas is the technical contact for the update.
Barrier Determined by Infrared. The results of the ILS study and the proposed P&B statement for ASTM F2476 Determination of Carbon Dioxide Gas Transmission Rate through Barrier Materials Using an Infrared Detector will be discussed. This method determines the rate that CO₂ passes through a barrier material. Understanding the CO₂ transmission rates of packaging materials aid in material selection and in predicting product shelf life. As a result, this test is usually performed by packaging engineers during a product’s design and development phase. A precision and bias statement was not previously developed so this addresses that gap. Joel Fischer from Mocon is coordinating the work on this standard.
Barrier Determined by Air. ASTM WK30771 Test Method for Verifying Flexible Barrier Material Resistance to the Passage of Air is being balloted prior to the Barcelona meeting and the results discussed. This method is important because it can be used as an indirect method for determining the ability of a material to block the passage of micro organisms into a package. It can be used to fulfill the impermeability testing of materials as defined in ISO 11607-1 Annex C. It’s usually performed by packaging professionals during the product design and development phase. Marie Tkacik from Beacon Converters is the technical contact on this standard.
Water Vapor Transmission Rate. One other activity worthy of note is the collaborative ILS being conducted for the comparison of different standard test methods on water vapor transmission rate (WVTR). E96 Water Vapor Transmission of Materials (Committee C16), E398 Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity Measurement (Committee F02), and F1249 Water Vapor Transmission Rate Through Plastic Film and Sheeting Using Modular Infrared
Sensor (Committee F02) are the standards being compared. Twenty seven laboratories are involved, and the results are expected to be discussed in Barcelona.
Terminology. ASTM F17 Terminology Relating to Flexible Barrier Packaging is also being updated to include several new terms. Hal Miller is coordinating this work.
In addition to discussing new and revised standards, each Subcommittee meeting will have an expert speaking on a topic relevant to that area. The talks include:
• Executive Subcommittee F02.90—“ASTM International: ASTM Mechanics and Overview,” presented by Diane Trinsey, ASTM International F02 manager.
• F02.10 on Permeation—“Future Trends in Permeation Measurements,” presented by Franz Sturm, Lipke.
• F02.15 on Chemical and Safety—“Microbial Barrier Test Methods for Porous Sterile Barrier Materials,” presented by Thierry Wagner, DuPont Medical and Pharmaceutical
• F02.20 on Physical Properties—“Towards a Package Durability Predictive Model,” presented by Henk Blom, Rollprint Packaging Products.
• F02.40 on Packaging Integrity—“Package Integrity: Methods of Detection,” presented by Wendy Mach, Nelson Laboratories.
• F02.50 on Package Design and Development—“Use of Design Guide F2097 and U.S. FDA Recognition,” Hal Miller, PACE Solutions LLC.
• F02 Main Committee—“U.S. FDA Perspective: The Use of Standards in Premarket Submissions and Auditing the Medical Device Packaging Process,” presented by Pat Weixel, U.S. Food and Drug Administration.
• F02 Main Committee—“Sterile Medical Device Package Performance Testing and the Nebulous Effect of Vibration in Transit,” presented by Pat Nolan, DDL. 0
More information on each of the talks is available on the ASTM website at http://www.astm.org/COMMIT/F02/