Testing Standard:
ASTM F3039 Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials (Dye Penetration)
Standard Number
ASTM F3039
Standard Title
Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
Overview:
ASTM F3039 is a test method that will detect and locate leaks equal to or greater than a channel formed by a 50 μm wire in a nonporous package for Method A. Method B will detect and locate a leak equal to or greater than 10 μm diameter in a nonporous flat sheet. This method is used for both transparent and opaque nonporous surfaces. Purple Diamond Testing offers ASTM F3039 Testing as part of our packaging compliance and validation services.
Rationale:
ASTM F3039 – Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials 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 F3039 is usually conducted during the manufacturing process and at various stages of the package’s life cycle.
Key Points:
- Detects seal defects in medical packaging greater than or equal to 50 μm for Method A and 10 μm for Method B
- Used for both transparent and opaque nonporous surfaces
- Use ISO 11607-1 with this test method to set validation standards
Related Standards:
- ASTM D4332 – Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- ASTM F1929 – Test Method for Detecting Seal Leaks in Porous Medical Packaging (Dye Penetration)
- ISO 11607-1 – Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
Related Testing Standards
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