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Other Considerations in Sterilization

"Testing Integrity after Sterilization"

Is it preferred to use the bubble test to validate package integrity? Is it appropriate to use the blue dye penetration test post product conditioning (i.e. environmental / transit)?

Last Updated On May 2, 2014

ASTM F2096 Bubble leak testing is a commonly used test to validate the whole package integrity post distribution conditioning. It is a simple test that requires little capital investment in equipment, but is limited in sensitivity of detection of holes or channels to 0.010” (250µm).

ASTM 1929 Dye penetrant testing on the other hand is a seal integrity test, which has a higher degree of sensitivity at 0.002” (50 µm). ASTM F3039 is a new dye penetration method for evaluating nonporous package seals. These can be utilized in post product conditioning, but are limited to seal evaluation only. A whole package integrity test is still required to evaluate potential holes in the rest of the package.