ASTM F02 Committee Meeting Highlights New Standards for Flexible Barrier Packaging
The ASTM International Committee F02 on Flexible Barrier Packaging had a packed schedule at its most recent semiannual meeting, which took place on April 8 to 9 in East Lansing, Michigan. The committee discussed standards that it is in the process of creating or revising, as well as two recently published standards. PMP News spoke to Dhuanne Dodrill, Chairperson of the F02 committee and President at Rollprint Packaging Products, about the new standards that the committee recently published or is working on.
ASTM has published F3039-13, the Standard Test Method for Detecting Leaks in Nonporous Packaging. This method was significant for the industry because there hasn’t been a dye penetration test method for nonporous packaging before, only for porous packaging, says Dodrill.
“The dye penetration test method for detecting leaks in nonporous packaging is very important for our industry to have,” says Dodrill. “It’s a quick, inexpensive test with a high level of sensitivity.”
ASTM also recently published F3004, Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound. This standard covers a relatively new packaging technology.
“Airborne ultrasound is a noncontact, nondestructive technique for evaluating seal integrity and the bond between materials. It can be used for on-line, real-time inspection of seal quality,” says Dodrill.
ASTM F02 is also working on developing the following new standards:
- Test Method for Verifying Flexible Barrier Material Resistance to the Passage of Air
- Test Method for Determining Water Vapor Transmission Rates of Whole Packages
- Test Method for Abrasion Resistance of Flexible Packaging Films
- Test Method for Oxygen Analysis of Packages using Headspace Sampling
- Test Method for Leak Detection in Pharmaceutical Packaging by Vacuum Deflection Method
- Guide for Test Method Validations
- Test Method for Determination of Oxygen Permeability of Plastic Film and Sheeting using Fluorescent Decay
Perhaps of most significance to the medical packaging industry is the standard test method to verify flexible barrier material resistance to the passage of air.
“This is in response to ISO 11607, Packaging for Terminally Sterilized Medical Devices,” says Dodrill. “Part 1, Annex C, describes how to determine if a material can be considered impermeable to microbes… What we have done is turned that into a standard test method and developed precision and bias statements around that method to demonstrate that it is repeatable and reproducible.”
ASTM requires precision statements, which demonstrate the test’s expected variability results, and bias statements, defined by ASTM as “a systematic error that contributes to the difference between the mean of a large number of test results and an accepted reference value,” for standards. 1 These requirements ensure that the standards accurately measure what they are designed to measure, says Dodrill.
“One of the things that differentiate ASTM standards from many of the test methods that are out there is that ASTM requires precision and bias statements for test methods,” says Dodrill. “Inter-laboratory studies are done, in other words, a variety of laboratories are doing the test for repeatability and reproducibility. We also use this process to establish limits of detectability when appropriate. With this information, you can better define if the test method is going to be appropriate for what you are going to test and ensure that the results are meaningful.”
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By Camilla Andersson