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.
(Ref:
http://www.medicalpackaginginnovation.com/author.asp?section_id=573&doc_id=559506&)
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