Integrity Testing

There are a number of approaches for evaluating the integrity of pouches. The table below provides an assessment of each test’s sensitivity, whether or not the test is destructive, associated standard test methods, and popular manufacturers. Care should be taken to ensure that overly stringent sensitivity levels have not been established.

Test Sensitivity Destructive /
Nondestructive
Standard Test Methods Manufacturers Comments
Visual Inspection 0.003″ Nondestructive ASTM F1886 Not applicable Appropriate for packages with one transparent/translucent material. Sensitivity is very dependent upon the contrast between sealed and unsealed areas and the types of material used.
Dye Penetration 0.002″ Destructive ASTM F1929 Dye can be created in-house Quick, simple test. Surfactant and dye level may need to be adjusted to ensure proper detection is achieved with film/film packages.
Internal Pressurization (bubble leak) Gross leaks Destructive ASTM F2096
Bubble Emission (vacuum) 10-6 Pa m3/s Destructive ASTM D3078 Carleton Haug Quality Equipment Small leaks may not be detected with this procedure dependent upon the packaging materials and the product contained. Must have a headspace.
Vacuum Decay 0.0005″ channels
0.0002″ pinholes
Nondestructive ASTM F2338 InterTech
PTI
TM Electronics
Uson
Wilco
Pressure Decay 10-5 Pa m3/s Destructive ASTM F2095 Mocon
Alcatel Vacuum Products
www.adixen-usa.com
Sensitivity dependent upon package volume. Seals or surfaces cannot be in contact with water or other liquid.
CO2 Tracer Gas 0.004″ channels
0.002″ pinholes
10-4 Pa m3/s
Nondestructive ASTM F2227
ASTM F2228
Mocon
Helium Tracer Gas 10-11 Pa m3/s Nondestructive ASTM F2391 Alcatel Vacuum Products Inficon
Leak Detection Associates
Uson
Varian Vacuum Products
Helium must be incorporated into the headspace before sealing to be nondestructive. Helium can also be introduced post-manufacturing in which case this is a destructive test.
Can be used for 100% inspection.
Acoustic Micro Imaging – wet 200Å Nondestructive Sonoscan Can be used for 100% inspection.
Acoustic Micro Imaging – airborne Very sensitive Nondestructive PTI Can be used for 100% inspection.

All tests should be validated and sensitivity verified.