Testing Standard:
ASTM F1929 Test Method for Detecting Seal Leaks in Porous Medical Packaging (Dye Penetration)
Standard Number
ASTM F1929
Standard Title
Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Overview:
ASTM F1929 is a test method that will detect and locate leaks equal to or greater than a channel formed by a 50 μm wire in package edge seals formed between a porous sheet material and a transparent material. There are three dye application methods that consist of injection, edge dip, and eyedropper. This test method is limited to porous materials, which can retain the dye solution and prevent it from discoloring the seal area for a minimum of 5 seconds. Purple Diamond Testing offers ASTM F1929 Testing as part of our packaging compliance and validation services.
Rationale:
ASTM F1929 – Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. Its intended use is to observe the presence of channel defects that may allow harmful biological or particulate contaminants to enter. Leaks are frequently found at seals between package components of the same or dissimilar materials. ASTM F1929 is usually conducted during the manufacturing process and at various stages of the package’s life cycle.
Key Points:
- Comprised of three applications including injection, edge dip, and eyedropper
- Detects seal defects in medical packaging greater than or equal to 50 μm
- Use ISO 11607-1 with this test standard to set validation standards
Related Standards:
- ASTM D4332 – Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- ASTM F2096 – Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- ISO 11607-1 – Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
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