Pharmaceutical & Medical Packaging News staff

A new test method for detecting channel leaks, ASTM F3039 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration, was approved at the last F02 meeting in Jacksonville, FL, and is now available from ASTM's Web site. The method is applicable for clear or opaque pouches made from materials such as film and foil. It could also be used with opaque blisters and cups with the same sensitivity, but they were not part of the initial scope.

This test method will detect and locate a leak equal to or greater than a channel formed by a 50-µm [0.002-in.] wire in the edge seals of a nonporous package. The procedure is identical to ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration with the exception of the dye solution formula and the use of an absorbent material, which will provide evidence of dye staining. The dye solution uses a 3% surfactant as opposed to a 0.5% in the porous package method. An extensive interlaboratory study was conducted, and it demonstrated a very high probability of detection of these channels.

There was an attempt to include detecting pinholes in the size range of 10 μm. Unfortunately, the interlaboratory results varied quite a bit from lab to lab. Further efforts are being made to look at larger holes up to the 50-μm range.

It continues to amaze me that the most-sensitive standardized integrity tests tend to be the simplest methods with regard to technology and expense. Both dye penetration test methods can detect channel leaks down to 50 μm.  It is no wonder that these tests have been used extensively in our industry for decades.

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By Hal Miller, President, PACE Solutions