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ASTM F1929-98(2004)

(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
Harmful biological or particulate contaminants may enter the device 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.
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.
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 leakage, components that exhibit any indication of leakage are normally rejected.
Since leaks may change in size with different ambient conditions, comparisons between test stations are not conclusive. Therefore this method is usually employed as a go, no-go test.
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.
When puncturing the packaging to allow injection of the dye penetrant solution, care should be taken not to puncture other package surfaces. Puncturing of the package is facilitated if it is done adjacent to a dummy device inside the package. The device will provide a tenting effect that will separate the two sides of the package, reducing the chance of accidental puncture of both sides.
SCOPE
1.1 This test method defines materials and a procedure that will detect and locate a leak equal or greater than a channel formed by a 50 μm (0.002 in.) wire in package edge seals formed between a transparent film 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 This test method is intended for use on packages with edge seals formed between a transparent film and a porous sheet material. This test method is limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the entire seal area for a minimum of 20 s. Uncoated papers are especially susceptible to leakage and must be evaluated carefully fro use with this test method.
1.3 This test method requires that the dye penetrant have good contrast to the opaque packaging material.
1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.
1.5 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.

General Information

Status
Historical
Publication Date
31-May-2004
ICS
55.040 - Packaging materials and accessories
Technical Committee
F02 - Primary Barrier Packaging
Drafting Committee
F02.40 - Package Integrity
Current Stage
Ref Project

Relations

Replaces
ASTM F1929-98 - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Effective Date
01-Jun-2004
Replaced By
ASTM F1929-12 - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Effective Date
01-Nov-2012
Referred By
ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
01-Jun-2004

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ASTM F1929-98(2004) - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye PenetrationASTM F1929-98(2004) - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
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ASTM F1929-98(2004) - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F1929 − 98(Reapproved 2004)
Standard Test Method for
Detecting Seal Leaks in Porous Medical Packaging by Dye
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.
1. Scope cal Packaging (Withdrawn 2007)
2.2 ANSI Standards:
1.1 This test method defines materials and a procedure that
Z1.4Sampling Procedures and Tables for Inspection by
will detect and locate a leak equal or greater than a channel
Attributes
formed by a 50 µm (0.002 in.) wire in package edge seals
formedbetweenatransparentfilmandaporoussheetmaterial.
A dye penetrant solution is applied locally to the seal edge to 3. Terminology
be tested for leaks. After contact with the dye penetrant for a
3.1 wicking—The migration of a liquid into the body of a
specified time, the package is visually inspected for dye
fibrous material. This is distinct from a leak as defined in
penetration.
Terminology F1327.
1.2 This test method is intended for use on packages with
3.2 dye penetrant—An aqueous solution of a dye and a
edge seals formed between a transparent film and a porous
surfactant designed to penetrate and indicate a defect location
sheet material. This test method is limited to porous materials
in the time prior to the onset of wicking which could mask its
whichcanretainthedyepenetrantsolutionandpreventitfrom
presence.
discoloring the entire seal area for a minimum of 20 s.
3.3 channel—A small continuous open passage across the
Uncoatedpapersareespeciallysusceptibletoleakageandmust
width of a package seal through which microorganisms could
be evaluated carefully fro use with this test method.
pass. It is the objective of this test method to visually observe
1.3 This test method requires that the dye penetrant have
the presence of these defects by the leakage of dye through
good contrast to the opaque packaging material.
them.
1.4 The values stated in SI units are to be regarded as the
standard. The values given in parentheses are for information 4. Significance and Use
only.
4.1 Harmful biological or particulate contaminants may
1.5 This standard does not purport to address all of the
enter the device through leaks. These leaks are frequently
safety concerns, if any, associated with its use. It is the
found at seals between package components of the same or
responsibility of the user of this standard to establish appro-
dissimilar materials. Leaks may also result from a pinhole in
priate safety and health practices and determine the applica-
the packaging material.
bility of regulatory limitations prior to use.
4.2 This dye penetrant procedure is applicable only to
individualleaksinapackageseal.Thepresenceofanumberof
2. Referenced Documents
small leaks, as found in porous packaging material, which
2.1 ASTM Standards:
could be detected by other techniques, will not be indicated.
F1327Terminology Relating to Barrier Materials for Medi-
4.3 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 leakage,
ThistestmethodisunderthejurisdictionofASTMCommitteeF02onFlexible
componentsthatexhibitanyindicationofleakagearenormally
Barrier Materials and is the direct responsibility of Subcommittee F02.40 on
rejected.
Package Integrity.
Current edition approved June 1, 2004. Published June 2004. Originally
approved in 1998. Last previous edition approved in 1998 as F1929–98. DOI:
10.1520/F1929-98R04.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or The last approved version of this historical standard is referenced on
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM www.astm.org.
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
F1929 − 98 (2004)
4.4 Since leaks may change in size with different ambient 7.2 Dummy test items, empty packages, or edge seal
conditions, comparisons between test stations are not conclu- samples may be used for process control, product acceptance,
sive.Therefore this method is usually employed as a go, no-go or material development testing.
test.
8. Calibration and Standardization
4.5 The dye solution will wick through any porous material
overtime,butusuallynotwithinthemaximumtimesuggested. 8.1 These procedures are suitable for use on selected parts
If wicking does occur, it may be verified by observing the duringreceivinginspectionortoverifyandlocateleakagesites
porous side of the subject seal area. The dye will have forproductioncontrol.Theyarenotquantitative.Noindication
discolored the surface of the material. of leak size can be inferred from the test.
4.6 Whenpuncturingthepackagingtoallowinjectionofthe
9. Conditioning
dye penetrant solution, care should be taken not to puncture
otherpackagesurfaces.Puncturingofthepackageisfacilitated 9.1 Packaging must be free of condensation or any other
if it is done adjacent to a dummy device inside the package. source of liquid water. Water already in the seal defects may
The device will provide a tenting effect that will separate the
render them undetectable with a dye penetrant. If there is any
two sides of the package, reducing the chance of accidental indication that the package has been exposed to any liquid, it
puncture of both sides.
must be thoroughly dried at its typical storage temperature
before testing.
5. Apparatus
9.2 Test specimens shall be conditioned prior to testing.
5.1 Meansofbreachingoneofthepackagingmaterialssuch
When no specific conditioning requirements are given, and
as a small knife.
packaging materials are moisture sensitive, a standard condi-
tioning atmosphere of 23 6 2°C (73.4 6 3.6°F) and 50 62%
5.2 Dye Dispenser, such as an eyedropper or syringe for
injection of the dye penetrant solution. relativehumidityisrecommended,foraminimumof24hprior
to testing.
5.3 Microscope or optical loop with magnification of 5× to
20×.
10. Procedure
5.4 Fresh aqueous dye penetrant solution con
...

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ASTM F1929-23(Test Method)
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.  
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Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability

SIGNIFICANCE AND USE
5.1 This practice is valuable in determining the resistance of flexible packaging materials to flex-formed pinholes. Conditioning levels A, B, or C are typically used. Reference Practice E171 and Guide F2097.  
5.2 Conditions D and E are typically used for determining the effect of flexing on barrier properties and transmission rates related to gas and/or moisture.  
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5.4 Failures in the integrity of one or more of the plies of a multi-ply structure may require alternative testing. Supplementary permeation testing using gas or water vapor can be used in conjunction with the flex conditioning to measure the loss of ply integrity. Other test methods may be used after flexing for assessment of presence of pinholes. For a list of test methods, refer to Guide F2097.
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5.4.1 The various conditions described in this practice are to prevent evaluating a material structure with an outcome of too many holes to effectively count (normally greater than 50), or too few to be significant (normally less than five per sample). Material structure, testing basis, and a mutual agreement with specified objectives are to be considered in the selection of conditioning level for testing.
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1.1 This practice covers conditioning of flexible barrier materials for the determination of flex resistance. Subsequent testing can be performed to determine the effects of flexing on material properties. These tests are beyond the scope of this practice.  
1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
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5.1 Two procedures, A and B, are outlined in this test method. Procedure A is used most often for development of various beverage container designs to determine the functional characteristics of the package in regard to shelf life. Procedure B is recommended for use in beverage filling operations as a quality control tool in maintaining the desired CO2 fill pressure. A loss of CO2 will affect product taste.  
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SCOPE
1.1 The objective of this test method is to determine the carbon dioxide (CO2) loss from plastic beverage containers after a specified period of storage time.  
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Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration

SIGNIFICANCE AND USE
4.1 Contaminants may enter the package through leaks. Alternatively, product may be lost from the package through leaks. These leaks are frequently found at seals between package components of the same or dissimilar materials.  
4.2 Ingress or egress of gas or moisture through leaks in a package can also degrade sensitive contents.  
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1.1 Method A of this test method defines a procedure that will detect and locate a leak equal to or greater than a channel formed by a 50 µm [0.002 in.] wire in the edge seals of a nonporous package. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. After contact with the dye penetrant for a minimum specified time, the package is visually inspected for dye penetration or, preferably, the seal edge is placed against an absorbent surface and the surface inspected for staining from the dye.  
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4.2.1 Technique A: Unsuppor...
SCOPE
1.1 This test method covers the measurement of the strength of seals in flexible barrier materials.  
1.2 The test may be conducted on seals between a flexible material and another flexible material, a rigid material, or a semi-rigid material.  
1.3 Seals tested in accordance with this test method may be from any source, laboratory or commercial.  
1.4 This test method measures the force required to separate a test strip of material containing the seal. It also identifies the mode of specimen failure.  
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1.3 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.4 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
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Standard Practice for Construction of Test Cell for Liquid Extraction of Flexible Barrier Materials

SIGNIFICANCE AND USE
5.1 Knowledge of extractives from flexible barrier materials may serve many useful purposes. A test cell constructed as described in this practice may be used for obtaining such data. Another test cell has been found equivalent to the one described in this practice. See the appendix for the source of the alternate cell.  
5.2 United States Federal Regulations 21CFR 176.170 (d)(3), 21CFR 177.1330 (e)(4), 21CFR 177.1360 (b), 21CFR 177.1670 (b), and 21CFR Appendix VI (b) cite this standard practice as the basis for determining the amount of extractables from the surface of a package or multilayer film or modified paper in contact with food. In some cases, it is the only practice defined for this purpose. No alternative detail is given in the regulations for conducting extractions.  
5.3 Test Method D4754 is not an equivalent to this test method. It is for two-sided extraction of films having the same material on both of the exposed surfaces of the film.
SCOPE
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SCOPE
1.1 This test method covers determination of the amount of residual solvents released from within a packaging material contained in a sealed vial under a given set of time and temperature conditions and is a recommended alternative for Test Method F151.  
1.2 This test method covers a procedure for quantitating volatile compounds whose identity has been established and which are retained in packaging materials.  
1.3 The analyst should determine the sensitivity and reproducibility of the method by carrying out appropriate studies on the solvents of interest. The analyst is referred to Practice E260 for guidance.  
1.4 For purposes of verifying the identity of or identifying unknown volatile compounds the analyst is encouraged to incorporate techniques such as gas chromatography/mass spectroscopy, gas chromatography/infrared spectroscopy or other suitable techniques in conjunction with this test method.  
1.5 Sensitivity of this test method in the determination of the concentration of a given retained solvent must be determined on a case by case basis due to the variation in the substrate/solvent interaction between different types of samples.  
1.6 This test method does not address the determination of total retained solvents in a packaging material. Techniques such as multiple headspace extraction can be employed to this end. The analyst is referred to the manual supplied with the GC-Autosampling system for guidance.  
1.7 The values stated in SI units are to be regarded as the standard.  
1.8 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.9 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.

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ASTM
ASTM F119-82(2022)(Test Method)
Standard Test Method for Rate of Grease Penetration of Flexible Barrier Materials (Rapid Method)

SIGNIFICANCE AND USE
4.1 This test method is valuable in the development and selection of flexible barrier materials suited for use as grease barriers.  
4.2 The test is rapid in comparison with other methods because of the extremely small quantity of oil required for detection (about 6 μg). The actual time to failure is a multiple of the values obtained by this test method. When permeation is through an absorbent structure such as kraft paper coated with polyethylene, the failure times will be longer and variable, depending on the variation in porosity and thickness of the structure.
SCOPE
1.1 This test method provides standard conditions for determining the rate of grease penetration of flexible barrier materials. Pinholes, which can be measured by a separate test, will increase the rate of grease penetration as determined by this test method.  
1.2 The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only.  
1.3 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 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.

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