Designation

This standard is issued under the fixed designation F1929; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (´) indicates an editorial change since the last revision or reapproval.

1. Scope

1.1

This test method defines materials and procedures that will detect and locate a leak equal to or greater than a channel formed by a 50 µm (0.002 in.) wire in package edge seals formed between a transparent material and a porous sheet material. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration.

1.2

Three dye application methods are covered in this test method: injection, edge dip, and eyedropper.

1.3

These test methods are intended for use on packages with edge seals formed between a transparent material and a porous sheet material. The test methods are limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the seal area for a minimum of 5 seconds. Uncoated papers are especially susceptible to leakage and must be evaluated carefully for use with each test method.

1.4

These test methods require that the dye penetrant solution have good contrast to the opaque packaging material.

1.5

The values are stated in International System of Units (SI units) and English units. Either is to be regarded as standard.

1.6

This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.7

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

2. Referenced Documents

2.1 ASTM Standards:2

2.2 ANSI Standards:3

3. Terminology

4. Significance and Use

4.1

4.2

4.3

4.4

4.5

4.6

5. Apparatus

5.1

5.2

5.3

5.4

5.5

5.6

5.7

6. Safety Precautions

6.1

7. Test Specimen

7.1

8. Calibration and Standardization

8.1

9. Sampling

9.1

10. Conditioning

10.1

10.2

11. Procedure

11.1 Method A (Injection Method):

11.2 Method B (Edge Dip Method):

11.3 Method C (Eyedropper Method):

12. Report

12.1

13. Precision and Bias

13.1 Injection Method:

13.2 Edge Dip and Eyedropper Methods:

14. Keywords

14.1

ASTM F1929 - 23

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

Current

Published:

15 Nov 2023