The technology and equipment can be used for package design, failure analysis, tooling qualification, line setup and validation, and product quality monitoring. LDA also provides package testing and consulting services. Pharmaceutical, contract packaging, and medical device companies in thirteen countries around the world are presently employing our testing machines and utilizing our technical support and testing services.

Helium leak detection technology is used to confirm the presence or absence of channels and/or holes in packages; in effect, provides verification of package integrity.

The detection of these defects involves the use of a light tracer gas which is capable of locating even the smallest leak quickly. The turnkey SIMS 1284+ unit, offered by LDA, Inc., measures the helium flow rate escaping from the test package through any and all leaks that are present thanks to a calibrated helium-specific mass spectrometer. The rate at which helium escapes from a package can be closely correlated to the rate at which water vapor, oxygen or other gasses may enter or escape from a package.

Packages are filled with helium on-line, or off-line, and then placed in a Vacuum Test Fixture Module to measure the rate at which helium escapes from the package. A Head-Space Analysis Module is then used to measure the concentration of helium in the package, and provide an Actual Helium Leak Rate. Obtaining the helium concentration level normalizes the leak rate to 100% helium, thereby allowing a direct comparison between various package forms and packaging conditions.

The unique configurability of the LDA SIMS 1284+ allows for a range of package systems to be tested. Fixtures tailored to the product-package design enable this compatibility and can be further customized to increase applications to assess specific study goals. Helium leak detection with the SIMS 1284+ is widely accepted as an ideal tool to assess an array of study goals, such as comparing performance of different package components, assembly parameter optimization and validation, inherent integrity evaluation to the product’s maximum allowable leakage limit (MALL), and routine analysis for stability or batch release.

Some of the most common applications of helium leak detection are discussed in more detail.