ASTM D3078-02(2021)e1

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

ABSTRACT
This test method covers the determination of gross leaks in flexible packaging containing a headspace gas by bubble emission. A vacuum chamber shall be any transparent container capable of withstanding approximately one atmosphere pressure differential, fitted with a vacuum-tight cover. A vacuum gage, an inlet tube from a source of vacuum, and an outlet tube to the atmosphere shall be connected to the chamber cover. Use an immersion fluid which does not degrade the package being tested. The test sample and test fluid shall be at equilibrium with normal room temperature. The procedures for testing are presented in details.
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 × 10−5 atm cm3/s (1 × 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 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered 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.  
1.5 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.

General Information

• Status: Published
• Publication Date: 14-Jan-2021
• ICS: 55.040 - Packaging materials and accessories
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.40 - Package Integrity

Relations

• Refers: ASTM E515-05 - Standard Test Method for Leaks Using Bubble Emission Techniques
• Effective Date: 01-Dec-2005
• Refers: ASTM E515-95(2000) - Standard Test Method for Leaks Using Bubble Emission Techniques
• Effective Date: 10-May-2000

Overview

ASTM D3078-02(2021)e1 is an internationally recognized standard developed by ASTM International. Titled "Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission", this document specifies a practical and widely used procedure to identify gross leaks in flexible packaging containing a headspace gas. The method is vital in quality assurance for packaging materials, especially in sectors where package integrity is critical for safety and regulatory compliance.

Flexible packaging, such as pouches, bags, and wraps, is susceptible to leakage that can compromise product quality, sterility, and shelf life. ASTM D3078 provides a systematic approach to evaluate whether packaging maintains its barrier properties by using the bubble emission technique in a vacuum chamber.

Key Topics

• Test Scope and Limitations

  • The method is designed to detect gross leaks only. Small or micro-leaks may not be identified due to factors such as product viscoelasticity or plug formation under positive pressure.
  • The sensitivity typically reaches up to 1 × 10⁻⁵ atm·cm³/s, depending on the product and test parameters.
  • The size and contents of the package can affect detection capability.

• Equipment and Materials

  • A vacuum chamber, capable of withstanding differential pressure, is essential. It must be transparent and equipped with a vacuum-tight cover, vacuum gauge, and inlet/outlet tubes.
  • Immersion fluids, such as water, denatured alcohol, or mineral oil, are chosen for compatibility with the packaging material and low surface tension for optimal bubble visibility.
  • Test samples must be conditioned to room temperature along with the test fluid.

• Test Procedure

  • The packaging specimen is submerged in the test fluid inside the vacuum chamber.
  • Vacuum is applied to achieve an appropriate pressure differential, with the package observed for bubble emission, indicative of leakage.
  • Bubbles directly attributed to leaks result in test failure, while isolated bubbles from trapped air are disregarded.
  • Post-vacuum, the package is checked for fluid ingress as another indicator of leakage.

• Result Interpretation and Reporting

  • Detailed documentation is required, including vacuum levels, duration, observation of bubbles, type of fluid, and package identification.
  • The method does not cover all safety aspects - users must address health, safety, and environmental precautions.

Applications

ASTM D3078 is widely applied in:

• Food and Beverage Packaging
  • Ensuring packaging integrity to maintain product freshness and prevent contamination.
• Pharmaceutical and Medical Device Packaging
  • Maintaining sterile barriers and regulatory compliance.
• Industrial and Consumer Goods Packaging
  • Protecting product quality during shipping and storage.
• Quality Assurance and Process Validation
  • Used as part of routine inspection and qualification protocols during packaging line production.

By detecting gross leaks efficiently, this test method helps manufacturers reduce risks associated with package failures, product recalls, and non-compliance.

Related Standards

Several ASTM and international standards complement or are referenced by ASTM D3078, increasing its relevance in a comprehensive quality assurance program:

• ASTM E425 - Definitions of Terms Relating to Leak Testing
• ASTM E515 - Practice for Leaks Using Bubble Emission Techniques
• ASTM F98 (Withdrawn) - Practice for Determining Hermeticity of Electron Devices by a Bubble Test

Understanding the relationships between these standards supports best practices in packaging leak detection and broadens the range of available testing strategies.

---

Keywords: ASTM D3078, flexible packaging, leak detection, bubble emission method, vacuum chamber, quality assurance, packaging integrity, headspace gas, packaging standards.

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.
´1
Designation: D3078 − 02 (Reapproved 2021)
Standard Test Method for
Determination of Leaks in Flexible Packaging by Bubble
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 (´) indicates an editorial change since the last revision or reapproval.
ε NOTE—Keywords were added editorially in January 2021.
1. Scope 2. Referenced Documents
1.1 Thistestmethodcoversthedeterminationofgrossleaks 2.1 ASTM Standards:
in flexible packaging containing a headspace gas. Test sensi- E425Definitions of Terms Relating to Leak Testing (With-
−5 3 −6 3 3
tivity is limited to 1×10 atm cm /s (1×10 Pa m /s) or drawn 1991)
even less sensitive as indicated in a recent interlaboratory test E515Practice for Leaks Using Bubble EmissionTechniques
(reported in Section 12). F98Recommended Practice for Determining Hermeticity of
Electron Devices by a Bubble Test (Withdrawn 1990)
1.2 Small leaks may not be detected by this procedure.
Viscoelastic effects on the products, or entrapped air, become
3. Terminology
significant and prevent passage through small openings. Posi-
3.1 Definitions:
tive pressure inside the pouch after the vacuum is drawn may
3.1.1 leak—any opening in a flexible package that, contrary
force the product to plug small leaks. The size of the leak that
to intention, either allows the contents to escape or substances
can be detected is dependent upon the products contained, the
to enter.
nature of the packaging material, and the test parameters
selected.
4. Apparatus
1.3 The values stated in inch-pound units are to be regarded
4.1 Vacuum Chamber—Any transparent container capable
as standard. The values given in parentheses are mathematical
of withstanding approximately one atmosphere pressure
conversions to SI units that are provided for information only
differential, fitted with a vacuum-tight cover.Avacuum gauge,
and are not considered standard.
aninlettubefromasourceofvacuum,andanoutlettubetothe
1.4 This standard does not purport to address all of the
atmosphere shall be connected to the chamber cover. The inlet
safety concerns, if any, associated with its use. It is the
and outlet tubes shall be equipped with hand valves.Attached
responsibility of the user of this standard to establish appro-
to the underside of the cover shall be a transparent plate that
priate safety, health, and environmental practices and deter-
willcloselyapproximatetheinsidedimensionsofthecontainer
mine the applicability of regulatory limitations prior to use.
and be such a distance from the top of the container that when
1.5 This international standard was developed in accor-
it is two-thirds filled with fluid, the attached plate will be
dance with internationally recognized principles on standard-
positioned 1 in. (25 mm) under the fluid.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
5. Materials
mendations issued by the World Trade Organization Technical
5.1 Immersion Fluids—Use an immersion fluid which does
Barriers to Trade (TBT) Committee.
notdegradethepackagebeingtested.Fluidswithalowsurface
1 2
ThistestmethodisunderthejurisdictionofASTMCommitteeF02onPrimary For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Barrier Packaging and is the direct responsibility of Subcommittee F02.40 on contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Package Integrity. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Jan. 15, 2021. Published February 2021. Originally the ASTM website.
approved in 1972. Last previous edition approved in 2013 as D3078–02 (2013). The last approved version of this historical standard is referenced on
DOI: 10.1520/D3078-02R21E01. www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
´1
D3078 − 02 (2021)
tension are generally more sensitive. Examples include water, 10.3 If there are no bubbles observed attributable to leaks,
water treated with a wetting agent, denatured alcohol, and and if no test fluid attributable to a leak is inside a specimen,
mineral oil. Other possible fluids are listed in Practice E515 the specimen passes the test.
and Recommended Practice F98.
11. Report
6. Sampling 11.1 Report the following information:
11.1.1 A statement that the test was conducted in compli-
6.1 The number of specimens used in the test sample may
ance with this test method or a description of the deviations
be varied according to the nature of the product, its cost, its
from this test method.
size, and whether the specimens are taken from a production
11.1.2 Identification of the specimen and the specific mate-
line in a normal packaging operation, or are few in number, or
rial tested.
are to be used only for purposes of comparative evaluation of
11.1.2.1 Identification of the test fluid and the maximum
procedures or materials.
vacuum level employed;
11.1.2.2 Astatementregardingtheapproximateaverageand
7. Test Specimen
range of sample expansions when at maximum vacuum; and
7.1 Flexible Package, with or without its intended contents.
11.1.2.3 The time period held at maximum vacuum.
11.1.3 A statement whether or not leakage occurred, and if
8. Conditioning
possible, a report of the location of each leak.
8.1 The test sample and test fluid shall be at equilibrium
11.1.4 Astatement of the number of specimens included in
with normal room temperature.
the test and the number of failures, if any.
11.1.5 Whenthetestisperformedtocheckcompliancewith
9. Procedure
requirements, a statement that the sample did or did not meet
9.1 Submerge the specimen in fluid contained in the vessel the requirement, and identification of the source for the
within the vacuum chamber. The uppermost surface of the requirement.
specimen shall be covered by not less than 1 in. (25 mm) of 11.1.6 When the test is conducted to evaluate or compare
fluid. products, materials, or methods, a statement of any observa-
tions that may l
...