The ATS Family of Companies (FoC) performs ASTM F2054 testing to measure minimum burst strength and identify weak seals in medical device packaging samples. Flexible medical packaging must endure pressure differentials during sterilization and transportation processes, whether by air or land. Extreme pressure differentials can cause an inadequate seal to fail (i.e., rupture or burst). If a seal opens prematurely, the package contents may spill or spoil, resulting in cleaning, repair, and/or replacement costs. Manufacturers test their flexible medical device packaging to reduce operational costs and time to FDA approval, maximize efficiency and profit, and ensure their product reaches the patients who need it in the best possible condition.
The ASTM F2054 Standard
In ASTM F2054, the tester gradually pressurizes a flexible package until it ruptures in one or more places. ASTM F2054 provides a reliable measure of burst strength and seal weaknesses by restraining the specimen between two plates and spreading the internal air pressure more evenly throughout the package. The ATS FoC is qualified to test products according to ASTM 2054 and other burst testing standards, such as ASTM F1140.
Burst Testing Procedures
The ASTM F2054 standard outlines two testing procedures, each requiring a different test apparatus configuration. Our technicians can perform whichever configuration best serves the client’s needs.
Open Package Configuration
Manufacturers frequently request the open package configuration to evaluate a package after production. This procedure seals three of the package’s four sides and inserts an inflation nozzle outfitted with a pressure sensor into the remaining open seal. After clamping the fourth seal around the nozzle, the expert pressurizes the sample until it ruptures along one of the seals.
Closed Package Configuration
The closed package configuration typically applies to finished and fully sealed products. Unlike the open package procedure, all four sides of the package remain sealed before testing. To supply air to the package, the expert punctures the package and affixes the inflation nozzle against the product. Finally, the technician pressurizes the package until rupture occurs.
Qualified ASTM F2054 Testing Lab
The ATS FoC’s mechanical testing lab is ISO/IEC 17025:2017 accredited to perform ASTM F2054 and other package testing standards. Our qualified experts perform this method and related testing to evaluate whether their medical packaging meets our customers’ needs:
- Product function and quality
- Regulatory compliance
- Safety
- Reliable and traceable documentation
Comprehensive Reporting
After completing the test procedure(s), our experts provide a documented report of the test results and their observations. The reports help clients make informed decisions about the product’s ability to meet specifications and functional requirements. Per ASTM F2054, the report also includes the following:
- Open or closed configuration
- Gap distance between restraining plates
- Pressure(s) when failure(s) occurred
- Rupture modes, positions, and areas
- Mean and standard deviations (for multiple samples)
ASTM F2054 is not appropriate for determining seal integrity and uniformity. We can test for these with other mechanical and environmental standards, such as:
The ATS FoC
The ATS FoC leverages the expertise found across a nationwide network of testing, inspection, and consulting providers to deliver high-quality services to a diverse range of clients. Our qualified, professional team of experts provides high-quality customer service with quick turnaround times and comprehensive reporting.
We operate according to an ISO 9001:2015 registered Quality Management System, maintaining several ISO/IEC 17025:2017 accreditations across our organization in mechanical testing as well as nondestructive inspections, calibrations, chemistry, and electrical testing.
Contact Us
Request a quote today by calling us at (888) 287-5227 or completing the webform on this page. The ATS Family of Companies will devote its testing expertise to helping your company reach its quality and compliance goals for your medical device.
