ASTM F2391-05 Standard Test Method for Measuring Package and Seal Integrity


ASTM F2391-05 is a standard test method recognized by the global regulatory community for measuring package and seal integrity using helium technology. Users can utilize this test method to perform package and seal integrity testing with adequate sensitivity to evaluate seals at extremely low levels of sensitivity. Packages made of different materials may be evaluated in the complete range of seal performance requirements using seal-isolating leak testing equipment. This makes the ASTM F2391-05 test method to be utilized efficiently for a wide range of applications.  

Measuring package and seal integrity using tracer gas- helium 

 

The ASTM F2391-05 standard test method generally consists of a number of procedures for determining the overall package and seal barrier performance of a variety of package types and forms, as well as seal/closure types. The use of helium as a tracer gas establishes helium leak testing as a reliable container closure integrity test technique. The 3 basic elements of this method are:  

  • Helium (tracer gas) 
  • Helium leak detector (mass spectrometer) 
  • Package test fixtures 

The majority of helium leak detection applications are destructive in the sense that helium must be injected into the package after it has been sealed. The injection site must be sealed/patched on the outside, which frequently damages its saleability. If helium is injected into the headspace prior to sealing, the approach can be non-destructive because all that is required is to detect helium escaping from the sealed package. Specific test procedure stages for the Vacuum Mode involve placing the sample in a closed fixture and drawing a vacuum that will allow helium to escape via any holes, flaws, or undesired modifications in the packaging system. 

 

Applications of ASTM F2391-05 test method 

 

The ASTM F2391-05 test technique can be used for a variety of applications, including: 

  • Monitoring for quality assurance 
  • Validation of routine processes 
  • As a design tool for a new container and package systems 
  • For tooling qualification programs 
  • Research and development 
  • Process setup for manufacturing, packaging, and sealing  

ASTM F2391-05 standard test method may be applied quantitatively to a wide range of container and packaging systems, including flexible, semi-rigid, and rigid containers and package systems. For package integrity evaluation, Helium leak detection per ASTM F2391 has been widely recognized by the FDA as a consensus standard. The test method is also mentioned in the USP Chapter on Container Closure Integrity (CCI) - USP <1207>. 

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