Helium Leak Detection is a highly sensitive quantitative test method for evaluating Container Closure System (CCS) components for critical parenteral | injectable applications.

Helium Leak Detection (HeLD) technology is the most sensitive leak detection method providing quantitative leak rate data far exceeding the limits of detection of other methods. The technology is so sensitive that it can help determine the inherent integrity between specific primary container closure system components such as syringe barrel/piston combinations.

Helium leak detection is also valuable to accurately analyze the effect of processing variables on your current container closure system, such as parenteral vial capping applications, elastomeric closure selection or varying sealing parameters.

Another benefit of helium leak detection testing technology is the ability to evaluate a container or packaging system under conditions of use – direct comparison of container/package performance at room temp, -20˚C, -80˚C, and even cryogenic (-178 ˚C) storage for example. In addition, the rate at which helium escapes from a primary container system can be closely correlated to the rate at which water vapor, oxygen or other gasses may enter or escape from a container.

Device Testing
Device Testing
Device Testing

Applying Helium Leak Detection

With experience, the technology is also well suited for package design, failure analysis, tooling qualification, packaging line setup and validation, and product quality monitoring.

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>.

ASTM F 2391-05 (2016)

“Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas”

ZebraSci’s experienced scientists are well versed in helium leak detection and other highly sensitive CCI methods to access primary container and parenteral packaging inherent integrity.

Contact ZebraSci today to learn more about applications for Helium Leak Detection (HeLD) and our other solutions for Container Closure Integrity (CCI).