Proper packaging procedures are an important aspect of any industry. Now ASTM International Committee F02 on Flexible Barrier Packaging has developed a new standard for a relatively new packing technology, airborne ultrasound. F3004, Test Method for Evaluation of Seal Quality and Integrity Using Airborne Ultrasound, was developed by Subcommittee F02.40 on Package Integrity.
“Airborne ultrasound has been on the market for over a decade now and has a very specific
niche in the flexible packaging industry,” says Oliver Stauffer, chief operating officer, PTI
Inspection Systems, and an F02 member. “It is one of the few solutions that nondestructively
measures the physical integrity and quality of a flexible packaging seal.”
According to Stauffer, medical device packaging requires a high level of seal integrity assurance. Typically, device manufacturers have used manual-visual inspection as the preferred test for porous barrier packaging. However, airborne ultrasound offers a faster and more reliable assessment of package seal quality based on a quantitative measure.
“Any flexible packaging operation that applies a final seal to a pouch can deploy an airborne ultrasound sensor on the line for high speed 100 percent seal quality assurance,” says Stauffer.
Airborne ultrasound sensors can be integrated into production lines or a stand-alone system can be installed just after a seal station to confirm seal quality. The technology described in F3004 is used to image seals and evaluate variances across the entire active seal area to ensure even temperature and pressure distribution during the sealing process.
Stauffer says that manufacturers, regulatory bodies and laboratories will all find F3004 useful,
especially as the shift is being made toward more quantitative test measurement solutions,
particularly in the medical device industry.
All interested parties are invited to take part in the standards developing activities of F02.40.
“F3004 may be further developed as sensory capabilities improve,” says Stauffer. “There are
other measurement capabilities that the standard has yet to explore. As F3004 currently stands, it provides a huge stepping stone for those looking to provide nondestructive seal quality assurance.”