Seal Integrity Test – ASTM F1929 Method A (Dye Penetration Test)

1. Purpose of the Test

The ASTM F1929 standard describes a method to detect seal integrity failures in sterile medical packaging using a dye penetration technique.

2. Method A – Dye Injection Technique

In this method, dye solution is introduced into the inside of the package. If dye penetrates through the seal area to the outside, it indicates seal failure.

3. Test Procedure

1. Prepare empty sterile barrier system

2. Inject prepared dye solution inside the package (1–10 mL)

3. Tilt or rotate to cover all seal edges

4. Observe seals for any dye leakage

5. Record results

4. Acceptance Criteria

5. Provided by TTS Laboratory Services

✔ ASTM F1929 Method A compliant seal integrity testing
✔ Visual inspection with high detection sensitivity
✔ Compliance with ISO 11607, ISO 13485, and FDA 21 CFR 820
✔ Detailed reports with images/video (optional)