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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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Standards Content (Sample)

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
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 cal Packaging (Withdrawn 2007)
4
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
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,
1
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.
4
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

---------------------- Page: 1 ----------------------
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,butusuallynotwith
...

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Standard Test Method for Abrasion Resistance of Flexible Packaging Films Using a Reciprocating Weighted Stylus

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5.1 Materials such as engineered thermoplastic films are often used for flexible barrier packaging. However, handling and transportation can cause abrasion to the packaging film and possibly compromise the integrity of the contents (for example, sterility of a medical device). This test method provides a comparative ranking of material performance that can be used as an indication of relative end-use performance.  
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5.4.2 Films that have a thickness greater than 0.25 mm (0.010 in.), or are of such rigidity that forming over the mandrel would cause internal stresses that weaken the film, and  
5.4.3 Conductive films.
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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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4.4 These procedures are suitable for use to verify and locate leakage sites. They are not quantitative. No indication of leak size can be inferred from the test. Therefore, this method is employed as a go/no-go test.  
4.5 These tests are destructive. No package or component test samples exposed to dye penetration testing may be used for final product packaging.
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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...
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5.1 This test method is intended to measure volatile organic compounds that are emitted from packaging materials under high-temperature conditions.  
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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.  
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Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas

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SCOPE
1.1 This test method includes several procedures that can be used for the measurement of overall package and seal barrier performance of a variety of package types and package forms, as well as seal/closure types. The basic elements of this method include:  
1.1.1 Helium (employed as tracer gas),  
1.1.2 Helium leak detector (mass spectrometer), and  
1.1.3 Package/product-specific test fixtures.  
1.1.4 Most applications of helium leak detection are destructive, in that helium needs to be injected into the package after the package has been sealed. The injection site then needs to be sealed/patched externally, which often destroys its saleability. Alternatively, if helium can be incorporated into the headspace before sealing, the method can be non-destructive because all that needs to be accomplished is to simply detect for helium escaping the sealed package.  
1.2 Two procedures are described; however the supporting data in Section 14 only reflects Procedure B (Vacuum Mode). The alternative, Sniffer Mode, has proven to be a valuable procedure for many applications, but may have more variability due to exactly the manner that the operator conducts the test such as whether the package is squeezed, effect of multiple small leaks compared to fewer large leaks, background helium concentration, package permeability and speed at which the scan is conducted. Further testing to quantify this procedure’s variability is anticipated, but not included in this version.  
1.2.1 Procedure A: Sniffer Mode—the package is scanned externally for helium escaping into the atmosphere or fixture.  
1.2.2 Procedure B: Vacuum Mode—the helium containing package is placed in a closed fixture. After drawing a vacuum, helium escaping into the closed fixture (capture volume) is detected. Typically, the fixtures are custom made for the specific package under test.  
1.3 The sensitivity of the method can range from the detection of:  
1.3.1 Large leaks—10-2 Pa·m 3/s to 10-5 Pa·m3/s (10–1 cc/sec/atm to 10-4 cc/sec/atm).  
1.3.2 Moderate leaks—10-5 Pa·m 3/s to 10-7 Pa·m3/s (10-4 cc/sec/atm to 10-6 cc/sec/atm).  
1.3.3 Fine leaks—10-7 Pa·m 3/s to 10-9 Pa·m3/s (10-6 cc/sec/atm to 10-8 cc/sec/atm).  
1.3.4 Ultra-Fine leak—10-9 Pa·m 3/s to 10-11 Pa·m3/s (10-8 cc/sec/atm to 10-10 cc/sec/atm).
Note 1: Conversion from cc/sec/atm to Pa·m3/s is achieved by multiplying by 0.1.  
1.4 The terms large, moderate, fine and ultra-fine are relative terms only and do not imply the acceptability of any leak rate. The individual application dictates the level of integrity needed. For many packaging applications, only “large leaks” are considered unacceptable and the ability to detect smaller leaks is immaterial. All leak rates referred...

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