Dye Penetration Testing
Sterilized medical device packages and other packages can be tested for seal leaks through dye penetration testing. The first and most common method for dye penetration testing is the injection method. For the injection method, dye solution is injected to cover the longest package edge to a depth of 1/4 inch. Following administration of the dye, the seal area is visually examined through the transparent side of the package. Any channels in the seals will be readily detected by the technician within five seconds. This process is then repeated for the remaining sides of the package. This test is carried out according to ASTM standards.
Methods for detecting a leak equal to or greater than a 50um (0.002in.) per ASTM F1929:
- Injection Method
- Edge Dip Method
- Eyedropper Method
Methods for detecting and locating a leak equal to or greater than a 50um (0.002 in.) channel in nonporous packaging or a leak equal to or greater than a 10yum (0.00039 in.) in a nonporous flat sheet per ASTM F3039:
Upon completion of test, a final report will be issued and all records and raw data will be held for five years.
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Millstone Testing Services offers comprehensive regulatory testing services backed by more than 90 years of combined experience in the medical device and pharmaceutical sectors.