ASTM F2391

ASTM F2391 establishes standardized guidance for helium-based leak detection methods used in container closure integrity testing. Helium testing is highly sensitive and capable of quantifying extremely small leak rates.

The process typically involves introducing helium as a tracer gas into or around a package and measuring helium concentration using mass spectrometry. Because helium molecules are very small, the method can detect minute defects that other technologies may not identify.

ASTM F2391 defines calibration procedures, validation expectations, and leak rate reporting standards. It ensures that helium testing is performed consistently and reproducibly across laboratories and manufacturing sites.

Helium leak detection is commonly used during method development, feasibility studies, and critical leak size determination. Depending on the configuration, it may be destructive or semi-destructive. The method provides direct quantitative leak rate data, which supports risk-based analysis and correlation studies.

ASTM F2391 is highly beneficial for package development applications and identifying aspects of the container closure system for which inherent integrity must be improved. PTI’s Helium leak detection technology has the ability to offer extremely low leak rate characterization and also challenge against cold storage temperatures in alignment with F2391.

PTI incorporates helium testing in specialized applications where extreme sensitivity or detailed leak rate characterization is required. ASTM F2391 strengthens regulatory defensibility by standardizing measurement methodology and performance reporting.