Helium Leak Detection
Helium leak detection is one of the most sensitive container closure integrity tests available. This test method utilizes helium as a tracer gas to detect leaks in the packaging system. Helium is the ideal tracer gas for this kind of leak detection because of its small atomic size and low natural atmospheric concentration.
What is ASTM F2391?
ASTM F2391, Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas, is a test method used to measure package and seal integrity with helium as a tracer gas. It requires helium mass spectrometer leak detection equipment to quantify fine and ultra-fine leaks in pharmaceutical vials, prefilled syringes, and sealed medical devices.
Unlike visual inspection or probabilistic methods, helium leak testing is a deterministic test method that measures actual leakage rates. Because helium molecules are extremely small and naturally present at very low concentrations in the atmosphere, they provide an excellent tracer gas for identifying leaks that may not be detectable using other techniques.
The result is highly sensitive, repeatable leak rate data that can support package development, validation activities, and container closure integrity (CCI) programs.
Why ASTM F2391 Testing Matters
For sterile pharmaceutical products, even microscopic leaks can compromise sterility, stability, or product performance. Helium leak detection helps manufacturers understand the integrity of their packaging systems long before visible failures occur.
Because the method produces objective numerical leak measurements, it is especially valuable when highly sensitive package integrity data is required.
Frequently asked questions
What is ASTM F2391?
ASTM F2391 is a standard test method that uses helium as a tracer gas to detect and quantify leaks in sealed packages and container closure systems.
Can helium leak testing identify where a package is leaking?
It can. Certain testing approaches described by the standard are intended to help locate the source of a leak, while others are primarily used to measure the overall leak rate.
What industries commonly use ASTM F2391?
ASTM F2391 is commonly used by manufacturers of sterile medical devices, pharmaceutical packaging, combination products, and other applications where package integrity is critical to product quality and sterility.
When should ASTM F2391 be used?
The method is commonly used during package development, process validation, package qualification, manufacturing investigations, and quality assurance activities when highly sensitive leak detection is required.
Is ASTM F2391 an FDA Consensus Standard?
Yes. Helium Leak Detection per ASTM F2391, has long been recognized by the FDA as a consensus standard for package integrity evaluation. The test method is also referenced in the United States Pharmacopeia (USP) Chapter on Container Closure Integrity (CCI) – USP <1207>.