Dye Penetration Leak Test Record (ASTM F1929)

This template documents a dye penetration leak check on porous medical package seals using ASTM F1929. It captures the package or lot ID, test setup, seal observations, leak location, photographic evidence, disposition, and sign-off. Use it when you need a traceable record of whether a seal shows visible channels or gaps that allow dye penetration.

Use it when you are evaluating porous medical packaging seals for visible dye penetration at the seal edge. It is not the right form for every packaging validation task, such as burst testing, peel testing, or non-porous package leak methods. If your SOP calls for a different integrity method, use the matching record instead of forcing this one to fit.

A trained inspector, technician, or QA associate should complete the test record, with review by a supervisor or QA signer when required by your procedure. The person running the test should be familiar with the approved SOP, the dye application method, and how to identify a true leak indication versus surface staining. If your quality system requires it, the reviewer should confirm the disposition and any hold action.

It is typically used each time a package seal leak check is performed, whether for routine in-process checks, lot release, investigation, or rework verification. The cadence should follow your approved SOP, validation plan, or quality sampling plan. If a non-conformance is found, the same record can be reused to document follow-up testing after corrective action.

This template supports quality documentation aligned with ASTM F1929 and broader medical device quality system expectations. It can also help with ISO 9001-style traceability and internal non-conformance control. The form itself does not replace your validated method, but it helps show that the test was performed under controlled conditions and reviewed appropriately.

Common mistakes include leaving out the lot or package identifier, failing to record the actual dwell time, and not describing the leak location clearly enough to reproduce the issue. Another frequent problem is documenting only a yes/no result without noting whether dye traveled continuously along the seal edge or through a specific channel. Missing photos and missing reviewer sign-off also weaken the record.

Yes. You can add fields for package size, seal width, dye lot, acceptance criteria, or sampling plan if your SOP requires them. You can also rename the disposition options to match your quality workflow, such as hold, rework, reject, or investigate. Keep the core fields intact so the record still shows what was tested, how it was tested, and what was found.

An ad hoc spreadsheet often misses critical context like test conditions, observed leak extent, and formal disposition. This template gives you a repeatable structure that makes review easier and reduces the chance of incomplete records. It is especially useful when multiple inspectors need to document the same method in a consistent way.