Dye Penetration Leak Test Record (ASTM F1929)

This template is for documenting dye penetration leak checks on sealed packages where visible dye intrusion along a seal is the acceptance signal. It fits pouches, trays, and other sealed barrier packages when your procedure calls for a seal integrity check by dye penetration. It is not a general package inspection form for label checks, carton damage, or shipping damage. If your package format or validation plan uses a different integrity method, customize the record to match that method.

Use it whenever your SOP, validation protocol, or quality plan requires a seal integrity check. That can mean every lot, a defined sampling plan, setup qualification, changeover verification, or investigation of a suspected seal issue. The template is designed to support routine production checks as well as non-routine rechecks after equipment adjustment. If your process is validated, align the cadence with the approved sampling and release criteria.

A trained inspector, quality technician, or other designated operator should complete the record, with the person performing the test identified on the form. The key is that the user understands the procedure, the acceptance criteria, and how to recognize channels, gaps, or wicking. If your site requires independent review, add a second sign-off or QA approval step in the disposition section. Keep the role assignment consistent so the record is traceable.

It is structured to support documentation of dye penetration leak testing under ASTM F1929-style procedures, but it does not replace your validated method or the standard itself. The form captures the essentials: sample identification, test setup, dwell time, observed dye intrusion, and final disposition. You should still follow your internal SOP, any validated acceptance criteria, and applicable quality system controls. If your procedure includes additional controls, add those fields before use.

The most common issues are incomplete sample identification, missing dwell time, and vague results such as "pass" without noting where the seal was inspected. Another frequent problem is failing to document the dye solution, tool condition, or ambient conditions when the procedure requires them. Inspectors also sometimes record a defect without identifying the seal segment or severity, which makes follow-up difficult. This template is built to prevent those gaps.

Yes. You can add fields for package type, seal width, test station, line number, lot release status, photo attachment, or electronic approval. Many teams also add acceptance criteria, sample size, and linked deviation or CAPA numbers. Keep the core structure intact so the record still shows what was tested, how it was tested, what was found, and what happened next.

An ad-hoc note often misses the details needed to prove traceability or support a non-conformance review. This template standardizes the record so each test captures the same critical information: identity, setup, observed leak path, and disposition. That makes trend review, batch release, and audit response much easier. It also reduces the chance that a real seal defect gets buried in free-text comments.

Record the exact location, the seal segment, and the severity of the observed channel, gap, or wicking. Then mark the disposition according to your SOP, which may include rejection, rework, retest, or escalation as a non-conformance. If the issue could affect product integrity, stop and follow your site’s containment and investigation process. The template gives you a clean place to capture that decision.