Medical And Combination Device Testing News

Jun 7, 2016 |
MET News,  |

New Standard for Leak Testing Impermeable Pouches and Blisters

Package Integrity Testing Methods Reviewed
Standard ASTM F3039 – 15 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration  has been revised.

There are two methods given in the standard: Method A can detect seal seem leaks down to 50µm and Method B down t 10µm.

This standard differs from ASTM F1929 – 15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration, by using an increased amount of surfactant in the dye solution. This is to overcome the surface tension of the pouch or blister material. Leak paths (channels) can be observed through clear materials. A piece of absorbent material should be paced under the package to highlight any leaks from opaque materials.

These studies form part of a suite of integrity tests available from MET. These include vacuum and pressure decay testing, trace gas analysis and bubble leak tests.