ASTM F1929-23
(Test Method)Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
SIGNIFICANCE AND USE
4.1 Harmful biological or particulate contaminants may enter the medical package through leaks. These leaks are frequently found at seals between package components of the same or dissimilar materials. Leaks may also result from a pinhole in the packaging material.
4.2 It is the objective of this test method to visually observe the presence of channel defects by the leakage of dye through them.
4.3 This dye penetrant procedure is applicable only to individual leaks in a package seal. The presence of a number of small leaks, as found in porous packaging material, which could be detected by other techniques, will not be indicated.
4.4 There is no general agreement concerning the level of leakage that is likely to be deleterious to a particular package. However, since these tests are designed to detect leaks, components that exhibit any indication of leakage are normally rejected.
4.5 These procedures are suitable to verify and locate leakage sites. They are not quantitative. No indication of leak size can be inferred from these tests. The methods are usually employed as a pass/fail test.
4.6 The dye solution will wick through any porous material over time, but usually not within the maximum time suggested. If wicking does occur, it may be verified by observing the porous side of the subject seal area. The dye will have discolored the surface of the material. Refer to Appendix X1 for details on wicking and guidance on the observance of false positives.
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 the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Standards Content (Sample)
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.
Designation: F1929 − 23
Standard Test Method for
Detecting Seal Leaks in Porous Medical Packaging by Dye
1
Penetration
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 2. Referenced Documents
2
1.1 This test method defines materials and procedures that 2.1 ASTM Standards:
will detect and locate a leak equal to or greater than a channel F17 Terminology Relating to Primary Barrier Packaging
3
formed by a 50 μm (0.002 in.) wire in package edge seals 2.2 ANSI Standards:
formed between a transparent material and a porous sheet Z1.4 Sampling Procedures and Tables for Inspection by
material. A dye penetrant solution is applied locally to the seal Attributes
edge to be tested for leaks. After contact with the dye penetrant
3. Terminology
for a specified time, the package is visually inspected for dye
3.1 wicking—the migration of a liquid into the body of a
penetration.
fibrous material. This is distinct from a leak as defined in
1.2 Three dye application methods are covered in this test
Terminology F17.
method: injection, edge dip, and eyedropper.
3.2 dye penetrant—an aqueous solution of a dye and a
1.3 These test methods are intended for use on packages
surfactant designed to penetrate and indicate a defect location
with edge seals formed between a transparent material and a
in the time prior to the onset of wicking which could mask its
porous sheet material. The test methods are limited to porous
presence.
materials which can retain the dye penetrant solution and
3.3 channel—refer to definition in F17.
prevent it from discoloring the seal area for a minimum of 5
seconds. Uncoated papers are especially susceptible to leakage
4. Significance and Use
and must be evaluated carefully for use with each test method.
4.1 Harmful biological or particulate contaminants may
1.4 These test methods require that the dye penetrant
enter the medical package through leaks. These leaks are
solution have good contrast to the opaque packaging material.
frequently found at seals between package components of the
1.5 The values are stated in International System of Units
same or dissimilar materials. Leaks may also result from a
(SI units) and English units. Either is to be regarded as pinhole in the packaging material.
standard.
4.2 It is the objective of this test method to visually observe
1.6 This standard does not purport to address all of the
the presence of channel defects by the leakage of dye through
safety concerns, if any, associated with its use. It is the
them.
responsibility of the user of this standard to establish appro-
4.3 This dye penetrant procedure is applicable only to
priate safety, health, and environmental practices and deter-
individual leaks in a package seal. The presence of a number of
mine the applicability of regulatory limitations prior to use.
small leaks, as found in porous packaging material, which
1.7 This international standard was developed in accor-
could be detected by other techniques, will not be indicated.
dance with internationally recognized principles on standard-
4.4 There is no general agreement concerning the level of
ization established in the Decision on Principles for the
leakage that is likely to be deleterious to a particular package.
Development of International Standards, Guides and Recom-
However, since these tests are designed to detect leaks,
mendations issued by the World Trade Organization Technical
components that exhibit any indication of leakage are normally
Barriers to Trade (TBT) Committee.
rejected.
1 2
This test method is under the jurisdiction of ASTM Committee F02 on Primary For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Barrier Packagingand is the direct responsibility of Subcommittee F02.40 on contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Package Integrity. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Nov. 15, 2023. Published December 2023. Originally the ASTM website.
3
approved in 1998. Last previous edition approved in 2015 as F1929 – 15. DOI: Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F1929-23. 4th Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 -----------
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1929 − 15 F1929 − 23
Standard Test Method for
Detecting Seal Leaks in Porous Medical Packaging by Dye
1
Penetration
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 the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and healthsafety, 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
2.1 ASTM Standards:
F17 Terminology Relating to Primary Barrier Packaging
3
2.2 ANSI Standards:
Z1.4 Sampling Procedures and Tables for Inspection by Attributes
1
This test method is under the jurisdiction of ASTM Committee F02 on FlexiblePrimary Barrier Packagingand is the direct responsibility of Subcommittee F02.40 on
Package Integrity.
Current edition approved Oct. 1, 2015Nov. 15, 2023. Published December 2015December 2023. Originally approved in 1998. Last previous edition approved in 20122015
as F1929 – 12.F1929 – 15. DOI: 10.1520/F1929-15.10.1520/F1929-23.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F1929 − 23
3. Terminology
3.1 wicking—the migration of a liquid into the body of a fibrous material. This is distinct from a leak as defined in Terminology
F17.
3.2 dye penetrant—an aqueous solution of a dye and a surfactant designed to penetrate and indicate a defect location in the time
prior to the onset of wicking which could mask its presence.
3.3 channel—refer to definition in F17.
4. Significance and Use
4.1 Harmful biological or particulate contaminants may enter the medical package through leaks. These leaks are frequently found
at seals between package components of the same or dissimilar materials. Leaks may also result from a pinhole in the packaging
material.
4.2 It is the objective of this test method to visually observe the presence of channel defects by the leakage of dye through them.
4.3 This dye penetrant procedure is applicable only to individual leaks in a package seal. The presence of a number of small leaks,
as found in porous packaging material, which could be detected by other techniques, will not be indicated.
4.4 There is no general a
...
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