ASTM International Expands Its Reach
ASTM International’s Committee F02, Flexible Barrier Packaging, met in Prague, Czech Republic, October 6–8, 2009. The committee met for the first time outside North America in an attempt to attract packaging professionals from the European Commission (EC). The attendance was approximately 45 professionals, evenly split evenly between existing members and European guests.
The first and last days were typical committee and subcommittee meetings, while the second day was a workshop.
Highlights of some of the new standards and important revisions going on in the different subcommittees follow. (Editor’s note: All numbered standards mentioned below are ASTM International standards unless otherwise noted. The scope of each subcommittee includes that of providing an avenue for sharing knowledge, promoting clarity, and supporting a global need for standards.)
F02.10 Permeation; Chairperson: Mike Troedel, Troedel & Associates
Scope: The development of standards related to the permeation, permeability, solubility, and transmission rate of flexible barrier packaging and its materials and their applications.
D3985 Standard Test Method for Oxygen Gas Transmission Rate through Plastic Films and Sheeting Using a Coulometric Sensor and F2476 Standard Test Method for the Determination of Carbon Dioxide Gas Transmission Rate (CO₂TR) through Barrier Materials Using an Infrared Detector have hit the five-year ballot cycle and will be reballoted with no substantial technical changes.
Owing to a lack of interest and use, E398 Standard Test Method for Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity Measurement may be balloted for discontinuance or drop. Those companies presently using this standard need to let the committee know if they want it continued.
An O₂ Permeability Guide is being developed to aid readers in choosing the best test method for their application. The first draft of this guide should be presented at the 2010 Spring meeting in St. Louis.
F02.15 Chemical/Safety Properties; Chairperson: Marilyn Baker, The Coca-Cola Co.
Scope: The development of standards for evaluating residuals, extractables, additives, leachables, biocompatibility, microbial barrier properties, and microwave susceptor standards of flexible barrier packaging and its materials.
Several standards are being reviewed and revised for compliance to the dual SI/U.S. units. F2475 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials is being reballoted on the normal five-year cycle. No changes are expected, and there should be no effect on present users.
A suggestion for new work items was discussed as the Chemical Compatibility and Permeation test specified in the 49 CFR. It was also suggested that there might be a gravimetric test for medical device packaging. A joint study between F02 and Committee D10 Packaging will take place before the spring meeting with a recommendation on what direction the subcommittee needs to take.
F02.20 Physical Properties; Chairperson: Marie Tkacik, Beacon Converters Inc.
Scope: The development of standards that apply to the testing of physical properties of flexible barrier packaging and its materials.
The Gelbo Test, F392 Standard Test Method for Flex Durability of Flexible Barrier Materials (Gelbo Test), will be reballoted per the five-year process. No substantial changes are expected.
The F1921 Standard Test Method for Hot Seal Strength (Hot Tack) round-robin study will begin as soon as the task group leader incorporates minor updates to the method and finishes a round-robin protocol to reflect changes in the test since the last ballot. Both methods A and B will be included in the round robin. While no significant change is anticipated for present uses, the research report should offer improvements in the precision.
F88 Standard Test Method for Seal Strength of Flexible Barrier Materials was successfully reballoted to include both SI and US units and revised mode of failure drawings. No changes in methodology were incorporated. A new standard to test the abrasion resistance of flexible films and Tyvek has completed an initial subcommittee ballot. Changes are being incorporated, and an interlab round-robin study will take place concurrently during the main committee balloting prior to the Spring meeting. Efforts may result in a much-needed new standard for evaluating the abrasion resistance of materials that make up a majority of the sterile barrier systems used today.
F02.40 Package Integrity; Chairperson: Nick Winters, Kraft Foods
Scope: The development of standards that allow the determination and characterization of package integrity for flexible barrier packaging and its materials.
A round-robin test for F3078 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission is planned for the next six months. The 250-µm sensitivity is in question; several labs have reported that this test appears to be more sensitive that the 250-µm published value.
The ballot of F1886 Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection was completed. It will be revised to reflect a title change to F1886 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection because it is used in other industries in addition to medical. In addition, the mandatory SI and U.S. units were added. The new revision will appear on the June 2010 Volume 15.10 publication. No significant changes were made.
The F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration revision was discussed in detail. A new round-robin study will take place, and a new research report will be generated. The new round-robin for an external ‘edge dip’ method and an ‘eyedropper’ method will also be run during the round robin. If successful (as anticipated), these two new alternative methods will improve test performance while eliminating the mess usually encountered using the old ‘inject’ method. A new dye-testing draft for nonporous packages was presented. A major difference being proposed from the existing porous package method is changing the way the dye solution is specified; the proposal is to specify a specific surface tension rather than a specific surfactant. This will allow users to select any number of surfactants. A concern for the present surfactant’s environmental impact used in F1929 is driving change. This new method has been needed for years’ filling a gap in the sterile barrier system integrity test tool kit. It should provide a simple, inexpensive, and sensitive integrity test where there are none now.
F02.50 Package Design and Development; Chairperson: Dhuanne Dodrill, Rollprint Packaging Products
Scope: The development of standards that address the design and development issues of flexible barrier packaging and its materials. Terminology associated with flexible barrier packaging also falls within the scope of this Subcommittee.
The new climatic stress guide, presented in the workshop, was discussed in depth. The three conditions will be ‘freeze’, ‘hot/dry’ and ‘hot/humid.’ A statement in the Scope or Significance and Use section will point out that the conditions recommended are based on extremes in the 100 years of data from NOAA and the references found in the Referenced Documents section. A specific statement will be added to the scope stating the guide is applicable to overnight or two-day small parcel delivery system climatic stresses. The order of the three stress conditions are determined based on material sensitivity to condensates. The time between extremes will be whatever time it takes for the sample to become stable. These are stresses in the package design performance qualification process that have been misunderstood and overapplied for years. As a result, the new guide will help the reader choose a more realistic set of stress conditions based on real world data. Prior to the next ballot, additional newly gathered data from ISTA will be considered for inclusion.