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ASTM D3078-02

(Test Method)

Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission

Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission

SCOPE
1.1 This test method covers the determination of gross leaks in flexible packaging containing a headspace gas. Test sensitivity is limited to 1 x 10-5 atm cm3/s (1 x 10-6 Pa m3/s) or even less sensitive as indicated in a recent interlaboratory test (reported in Section 12).
1.2 Small leaks may not be detected by this procedure. Viscoelastic effects on the products, or entrapped air, become significant and prevent passage through small openings. Positive pressure inside the pouch after the vacuum is drawn may force the product to plug small leaks. The size of the leak that can be detected is dependent upon the products contained, the nature of the packaging material, and the test parameters selected.
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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
09-Dec-2002
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 D3078-94 - Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
Effective Date
10-Dec-2002
Replaced By
ASTM D3078-02(2008) - Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
Effective Date
01-Apr-2008
Referred By
ASTM F2391-22 - Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
Effective Date
10-Dec-2002
Referred By
ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
10-Dec-2002
Referred By
ASTM D4991-07(2023) - Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method
Effective Date
10-Dec-2002
Referred By
ASTM D6653/D6653M-13(2021) - Standard Test Methods for Determining the Effects of High Altitude on Packaging Systems by Vacuum Method
Effective Date
10-Dec-2002

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ASTM D3078-02 - Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble EmissionASTM D3078-02 - Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
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ASTM D3078-02 - Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
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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:D3078–02
Standard Test Method for
Determination of Leaks in Flexible Packaging by Bubble
1
Emission
This standard is issued under the fixed designation D3078; 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 (e) indicates an editorial change since the last revision or reapproval.
This standard has been approved for use by agencies of the Department of Defense.
1. Scope 3. Terminology
1.1 Thistestmethodcoversthedeterminationofgrossleaks 3.1 Definition:
in flexible packaging containing a headspace gas. Test sensi- 3.1.1 leak—any opening in a flexible package that, contrary
−5 3 −6 3
tivity is limited to 1 310 atm cm /s (1 310 Pa m /s) or to intention, either allows the contents to escape or substances
even less sensitive as indicated in a recent interlaboratory test to enter.
(reported in Section 12).
4. Apparatus
1.2 Small leaks may not be detected by this procedure.
Viscoelastic effects on the products, or entrapped air, become 4.1 Vacuum Chamber—Any transparent container capable
of withstanding approximately one atmosphere pressure differ-
significant and prevent passage through small openings. Posi-
tive pressure inside the pouch after the vacuum is drawn may ential, fitted with a vacuum-tight cover. A vacuum gage, an
inlet tube from a source of vacuum, and an outlet tube to the
force the product to plug small leaks. The size of the leak that
can be detected is dependent upon the products contained, the atmosphere shall be connected to the chamber cover. The inlet
and outlet tubes shall be equipped with hand valves.Attached
nature of the packaging material, and the test parameters
selected. to the underside of the cover shall be a transparent plate that
willcloselyapproximatetheinsidedimensionsofthecontainer
1.3 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the and be such a distance from the top of the container that when
it is two-thirds filled with fluid, the attached plate will be
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica- positioned 1 in. (25 mm) under the fluid.
bility of regulatory limitations prior to use.
5. Materials
2. Referenced Documents
5.1 Immersion Fluids—Use an immersion fluid which does
2
2.1 ASTM Standards: notdegradethepackagebeingtested.Fluidswithalowsurface
3
tension are generally more sensitive. Examples include water,
E425 Definitions of Terms Related to Leak Testing
E515 TestMethodforLeaksUsingBubbleEmissionTech- water treated with a wetting agent, denatured alcohol, and
mineral oil. Other possible fluids are listed in Test Method
niques
F98 Practices for Determining Hermeticity of Electron E515 and PracticesF98.
3
Devices by a Bubble Test
6. Sampling
6.1 The number of specimens used in the test sample may
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF02onFlexible
be varied according to the nature of the product, its cost, its
Barrier Materials and is the direct responsibility of Subcommittee F02.40 on
size, and whether the specimens are taken from a production
Package Integrity.
line in a normal packaging operation, or are few in number, or
Current edition approved Dec. 10, 2002. Published February 2003. Originally
published in 1972. Last previous edition approved in 1984 as D3078–84. are to be used only for purposes of comparative evaluation of
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
procedures or materials.
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
7. Test Specimen
the ASTM website.
3
Withdrawn. 7.1 Flexible Package, with or without its intended contents.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
D3078–02
8. Conditioning 11.1.4 Astatement of the number of specimens included in
the test and the number of failures, if any.
8.1 The test sample and test fluid shall be at equilibrium
11.1.5 Whenthetestisperformedtocheckcompliancewith
with normal room temperature.
requirements, a statement that the sample did or did not meet
9. Procedure
the requirement, and identification of the source for the
requirement.
9.1 Submerge the specimen in fluid contained in the vessel
11.1.6 When the test is conducted to evaluate or compare
within the vacuum chamber. The uppermost surface of the
products, materials, or methods, a statement of any observa-
specimen shall be covered by not less than 1 in. (25 mm) of
tions that may lead to improvem
...

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SCOPE
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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.  
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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.  
5.2 This test method may be useful in assisting in the development and manufacture of packaging materials having minimal retained packaging ink/adhesive solvents.  
5.3 Modification of this procedure by utilizing appropriate qualitative GC detection devices such as a mass spectrometer in place of the flame ionization detector may provide identification of volatile organics of unknown identity.
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.  
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SIGNIFICANCE AND USE
5.1 The vacuum, bubble test method, as described in Test Method D3078, and various other leak detection methods described elsewhere (Test Method D4991, Guide E432, Test Method E493, Test Method E498, Test Method E499, and Test Method E1603) have been successfully used widely in various industries and applications to determine that a given package is or is not a “leaker.” The sensitivity of any selected leak test method has to be considered to determine its applicability to a specific situation.  
5.2 The procedures presented in this test method allow the user to carry out package and seal integrity testing with sufficient sensitivity to quantify seals in the previously defined moderate to fine seal ranges.  
5.3 By employing seal-isolating leak testing fixtures, packages constructed of various materials can be tested in the full range of seal performance requirements. Design of these fixtures is beyond the scope of this method.  
5.4 These seal/package integrity test procedures can be utilized as:  
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5.4.5 Quality assurance monitoring, or  
5.4.6 Research and development.
SCOPE
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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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