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Creation of Channels for Dye Test Validation

Q.

Do you have any experience or recommendations for successfully creating channels in tray/lidstock sterile barrier system for the purposes of the dye integrity test method validation?

A.

In validating ASTM F1929, a 0.002” tungsten wire was used to create the channels. The wire was sealed within a seal and then pulled out after cooling. To facilitate removal, one end of the wire may be left spooled or wrapped around a cylinder.

Last updated on 2008-05-15 21:45:57 UTC
Keywords: dye test, test method, test method validation

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