Additional Methods For Dye
Penetration Test For Porous Medical Packaging
Two new dye application methods have been added to
the ASTM F1929-12 Standard Test Method for Detecting Leaks in Porous Medical
Packaging by Dye Penetration.
Committee worked on these additions for quite some
time to ensure definitive inter laboratory study results. Additionally, some
minor editorial changes were made to offer a better interpretation of the often
misrepresented 5-20 second dye dwell time. The same dye solution formula is used
with the same test method sensitivity of 50μm channels.
The edge dip technique is one of the additions. This
method now is documented, standardized, and round-robin tested. It involves
dipping the side of the porous pouch, bag, or tray into the dye solution and
allowing for capillary action to pull the dye up, detecting a seal channel.
Since it does not require a syringe for injection, it is safer, much less messy,
and uses less dye solution.
The other technique uses an eye dropper or pipette
to apply the dye solution to the outer edge of the package seal. This method is
especially useful for lidded trays with a stepdown flange or when the seal is
set back from the edge.
Users of the ASTM dye penetration test now have the
flexibility of three proven and standardized methods to choose from when
performing package seal integrity testing.