The Applied Technical Services (ATS) Family of Companies performs ASTM F3039 testing because we understand that patient safety depends on the sterility of medical devices — and that sterility relies on a product’s packaging remaining uncompromised through shipping and storage. Our decades of experience supporting the medical industry underpin our proficiency with this method, helping clients ensure compliance with this FDA-recognized consensus standard.
ASTM F3039 pertains to validating packaging seal integrity so that manufacturers can distribute reliable products without risk of spillage, contamination, and waste. The standard applies to medical package seals with flexible barriers or nonporous materials such as foils and polymers.
Medical Device Packaging Leak Testing Lab
Leak testing is one of many mechanical tests that a package design must pass before reaching the market. We perform both Method A, used to detect leaks or channels in the sample packaging’s seal, and Method B, used to detect leaks or holes in a flat section of packaging material, as described in ASTM F3039.
ASTM F3039 Testing Expert Analysis
ASTM F3039 is a destructive, pass/fail test for packaging seal and material integrity. Our specialists can help clients understand the test results to know whether a design is ready for FDA submission or requires further testing. This testing standard is limited to detecting holes, channels, or perforations in sample packaging seals or constituent material. Clients should pursue additional testing to build a comprehensive assessment of their packaging’s performance. Our experts can perform supplementary testing to determine other performance data for their product, such as:
About ATS FoC
The ATS FoC consists of dozens of qualified testing, inspection, and calibration firms operating nationwide. Each facility operates according to our ISO 9001:2015 registered quality management system to guarantee consistency and excellence in documentation, reporting, and procedure. We maintain ISO/IEC 17025:2017 accreditation to perform a variety of mechanical testing procedures on packaging materials (including ASTM F3039), ensuring reproducible, trustworthy, and traceable results.
With decades of experience, we have cultivated a reputation for delivering exceptional customer service. Our clients trust the ATS FoC for testing and inspection services for several reasons:
- Cost-effective services
- Faster turnarounds
- Custom-tailored test procedures
- Support for regulatory approval
- Qualified testing experts and regulatory consultants
Contact Us
Reach the market faster with the ATS FoC. Call (888) 287-5227 or complete the request form on this page for ASTM F3039 medical packaging testing.
