ASTM F1929-15
(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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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 − 15
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.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
3
1. Scope 2.2 ANSI Standards:
Z1.4Sampling Procedures and Tables for Inspection by
1.1 This test method defines materials and procedures that
Attributes
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
3. Terminology
formed between a transparent material and a porous sheet
3.1 wicking—the migration of a liquid into the body of a
material.Adye penetrant solution is applied locally to the seal
fibrous material. This is distinct from a leak as defined in
edgetobetestedforleaks.Aftercontactwiththedyepenetrant
Terminology F17.
for a specified time, the package is visually inspected for dye
3.2 dye penetrant—an aqueous solution of a dye and a
penetration.
surfactant designed to penetrate and indicate a defect location
1.2 Three dye application methods are covered in this test
in the time prior to the onset of wicking which could mask its
method: injection, edge dip, and eyedropper.
presence.
1.3 These test methods are intended for use on packages
3.3 channel—refer to definition in F17.
with edge seals formed between a transparent material and a
4. Significance and Use
porous sheet material. The test methods are limited to porous
materials which can retain the dye penetrant solution and
4.1 Harmful biological or particulate contaminants may
prevent it from discoloring the seal area for a minimum of 5
enter the medical package through leaks. These leaks are
seconds.Uncoatedpapersareespeciallysusceptibletoleakage
frequently found at seals between package components of the
and must be evaluated carefully for use with each test method.
same or dissimilar materials. Leaks may also result from a
pinhole in the packaging material.
1.4 These test methods require that the dye penetrant
solution have good contrast to the opaque packaging material.
4.2 Itistheobjectiveofthistestmethodtovisuallyobserve
the presence of channel defects by the leakage of dye through
1.5 The values are stated in International System of Units
them.
(SI units) and English units. Either is to be regarded as
standard.
4.3 This dye penetrant procedure is applicable only to
1.6 This standard does not purport to address all of the individualleaksinapackageseal.Thepresenceofanumberof
safety concerns, if any, associated with its use. It is the small leaks, as found in porous packaging material, which
responsibility of the user of this standard to establish appro- could be detected by other techniques, will not be indicated.
priate safety and health practices and determine the applica-
4.4 There is no general agreement concerning the level of
bility of regulatory limitations prior to use.
leakage that is likely to be deleterious to a particular package.
However, since these tests are designed to detect leaks,
2. Referenced Documents
componentsthatexhibitanyindicationofleakagearenormally
2
2.1 ASTM Standards:
rejected.
F17Terminology Relating to Flexible Barrier Packaging
4.5 These procedures are suitable to verify and locate
1 leakage sites. They are not quantitative. No indication of leak
ThistestmethodisunderthejurisdictionofASTMCommitteeF02onFlexible
Barrier Packagingand is the direct responsibility of Subcommittee F02.40 on
size can be inferred from these tests. The methods are usually
Package Integrity.
employed as a pass/fail test.
Current edition approved Oct. 1, 2015. Published December 2015. Originally
approved in 1998. Last previous edition approved in 2012 as F1929–12. DOI: 4.6 The dye solution will wick through any porous material
10.1520/F1929-15.
overtime,butusuallynotwithinthemaximumtimesuggested.
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
3
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F1929 − 15
If wicking does occur, it may be verified by observing the 9. Samp
...
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 − 12 F1929 − 15
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 health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
F17 Terminology Relating to Flexible Barrier Packaging
3
2.2 ANSI Standards:
Z1.4 Sampling Procedures and Tables for Inspection by Attributes
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.
1
This test method is under the jurisdiction of ASTM Committee F02 on Flexible Barrier Packagingand is the direct responsibility of Subcommittee F02.40 on Package
Integrity.
Current edition approved Nov. 1, 2012Oct. 1, 2015. Published January 2013December 2015. Originally approved in 1998. Last previous edition approved in 20042012
as F1929 – 98F1929 – 12.(2004). DOI: 10.1520/F1929-12.10.1520/F1929-15.
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 − 15
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
b
...
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