Trends In Pharmaceutical Leak Tightness Testing

By Hemi Sagi, Director, Advance Test Concepts (ATC) Inc.

Tightness Testing Has Caused Confusion, But a New Concept Looks to Clear The Air

Leak tightness of products is an ongoing concern for many product designers, manufacturers and users. Automotive manufacturers, in particular, are facing increasing demands to reduce emission requirements that can be a result of leakage as well as warranty cost.

Great confusion exists in the definition and application of leak tightness. That confusion is a result of improper leak-tightness design specifications. As product leakage is typically a micro-flow phenomenon, there are difficulties in applying relevant tools for testing, correlating and analyzing leak tightness during product manufacturing and quality control. To simplify leak tightness specifications, a clear, generic concept for leak tightness, based on the Equivalent Channel (EC) or Equivalent Diameter (ED) concept, is gaining popularity.

Furthermore, as leak tightness requirements get more stringent, so is the pressure to reduce leak tightness cost and complexity. Traditional low-level leak testing, such as helium mass spectrometry, is replaced with advanced micro-flow sensors and technology that utilize air.