ASTM F1140/F1140M-13(2020)e1

Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages

SIGNIFICANCE AND USE
5.1 These test methods provide a rapid means of evaluating tendencies for package failure when the package is exposed to a pressure differential. Pressure differentials may occur during processes such as sterilization and transportation.  
5.2 These test methods are frequently used to quickly evaluate packages during the manufacturing process and at various stages of the package's life cycle.  
5.3 If correlations between pieces of test equipment are to be made, it is important that all parameters of the test method be exactly the same. Typical parameters may include, but are not limited to, package size, material, seal configuration, test equipment, rate of air flow into the package, sensitivity (machine response to pressure drop), and position of test article (see Fig. 1).
FIG. 1 Open Package Test Positions  
5.4 These test methods do not necessarily provide correlation with actual package seal strength as typically measured using Test Method F88 (or equivalent).
SCOPE
1.1 These test methods explain the procedure for determining the ability of packages to withstand internal pressurization.  
1.2 The burst test increasingly pressurizes the package until the package fails.  
1.3 The creep test maintains a specified pressure for a specified time or until the package fails.  
1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 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: 30-Apr-2020
• ICS: 55.180.40 - Complete, filled transport packages
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.20 - Physical Properties

Relations

• Replaces: ASTM F1140/F1140M-13 - Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
• Effective Date: 01-May-2020
• Refers: ASTM F17-20 - Standard Terminology Relating to Primary Barrier Packaging
• Effective Date: 01-May-2020
• Refers: ASTM F17-18a - Standard Terminology Relating to Primary Barrier Packaging
• Effective Date: 01-Oct-2018
• Refers: ASTM F17-18 - Standard Terminology Relating to Primary Barrier Packaging
• Effective Date: 15-Aug-2018
• Refers: ASTM F17-17 - Standard Terminology Relating to Primary Barrier Packaging
• Effective Date: 01-Jun-2017
• Refers: ASTM F17-13a - Standard Terminology Relating to Flexible Barrier Packaging
• Effective Date: 01-Aug-2013
• Refers: ASTM F17-13 - Standard Terminology Relating to Flexible Barrier Packaging
• Effective Date: 15-Apr-2013
• Refers: ASTM F17-12 - Standard Terminology Relating to Flexible Barrier Packaging
• Effective Date: 01-Nov-2012
• Refers: ASTM F17-08 - Standard Terminology Relating to Flexible Barrier Packaging
• Effective Date: 01-Aug-2008
• Refers: ASTM F17-07a - Standard Terminology Relating to Flexible Barrier Packaging
• Effective Date: 01-Sep-2007
• Refers: ASTM F17-07 - Standard Terminology Relating to Flexible Barrier Materials
• Effective Date: 01-May-2007
• Refers: ASTM F88-07 - Standard Test Method for Seal Strength of Flexible Barrier Materials
• Effective Date: 01-May-2007
• Refers: ASTM E171-94(2007) - Standard Specification for Standard Atmospheres for Conditioning and Testing Flexible Barrier Materials
• Effective Date: 01-Apr-2007
• Refers: ASTM F17-06 - Standard Terminology Relating to Flexible Barrier Materials
• Effective Date: 01-Dec-2006
• Refers: ASTM F88-06 - Standard Test Method for Seal Strength of Flexible Barrier Materials
• Effective Date: 01-Apr-2006

Overview

ASTM F1140/F1140M-13(2020)e1 specifies standard test methods for evaluating the internal pressurization failure resistance of unrestrained packages. Developed by ASTM International, this standard addresses critical quality assurance needs in packaging, particularly where packages may be subjected to pressure differentials during processes like sterilization and transportation. The procedures outlined provide a rapid, reliable means of detecting the tendency for flexible barrier packages or pouches to fail under internal pressure without external restraints.

Key Topics

• Internal Pressurization Testing: The standard details procedures for subjecting unrestrained packages to internal pressure, assessing their ability to resist failure due to pressure differentials.
• Burst Test (Method A): Packages are incrementally pressurized until failure occurs. The maximum pressure at rupture is recorded, providing insight into package integrity.
• Creep Test (Method B): Packages are held at a specified internal pressure for a determined period or until failure, helping evaluate durability over time.
• Creep to Failure Test: This variation maintains pressure until the package fails, measuring time to failure under constant stress.
• Evaluation Parameters: Critical variables include package size, material, seal configuration, test equipment, air flow rate, pressure measurement sensitivity, and package positioning.
• Sampling and Conditioning: Proper sample selection and pre-conditioning according to standardized practices are emphasized to ensure consistent, repeatable results.
• Reporting Requirements: Documentation includes detailed information on test methods, apparatus, specimen characteristics, conditioning, pressure levels, times, failure points, and summary conclusions.
• Package Types: Applicable to both open (partially sealed) and closed (fully sealed) flexible barrier packages, whether empty or containing product.

Applications

The test methods defined in ASTM F1140/F1140M are widely used in various industries, particularly in medical device packaging, food packaging, and pharmaceutical supply chains. Their practical applications include:

• Quality Assurance: Detecting weak seals or material defects during packaging manufacturing or prior to product release.
• Process Validation: Confirming that packaging processes like sterilization or transport do not compromise package integrity due to pressure changes.
• Troubleshooting and R&D: Assessing the performance of new packaging materials or designs under simulated real-world conditions.
• Regulatory Compliance: Meeting validation requirements for packaging used in regulated environments where product sterility and integrity are critical.
• Supply Chain Robustness: Evaluating how packages withstand air pressure changes encountered during shipping, handling, or automated processing.

These methods are especially valuable for rapid, routine assessment at various stages of the packaging lifecycle.

Related Standards

For comprehensive packaging evaluation, the following referenced or related standards support ASTM F1140/F1140M:

• ASTM F88: Standard Test Method for Seal Strength of Flexible Barrier Materials - measures the force required to separate package seals.
• ASTM E171: Practice for Conditioning and Testing Flexible Barrier Packaging - outlines environmental conditioning prior to testing.
• ASTM F17: Terminology Relating to Primary Barrier Packaging - provides standardized definitions for terms used in flexible packaging.

Combining these standards ensures a holistic approach to packaging performance, covering both seal strength and failure due to internal pressure.

---

Keywords: internal pressurization, package failure, burst test, creep test, flexible packaging, unrestrained package, seal integrity, ASTM F1140, pressure differential, packaging validation, medical packaging, transportation integrity.

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: F1140/F1140M − 13 (Reapproved 2020)
Standard Test Methods for
Internal Pressurization Failure Resistance of Unrestrained
Packages
ThisstandardisissuedunderthefixeddesignationF1140/F1140M;thenumberimmediatelyfollowingthedesignationindicatestheyear
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.
ε NOTE—Table 2 was corrected editorially in July 2020.
1. Scope F88 Test Method for Seal Strength of Flexible Barrier
Materials
1.1 These test methods explain the procedure for determin-
ing the ability of packages to withstand internal pressurization.
3. Terminology
1.2 The burst test increasingly pressurizes the package until
3.1 Definitions—For definitions and terms used in this test
the package fails.
method, refer to Terminology F17 for standardized terminol-
1.3 The creep test maintains a specified pressure for a
ogy for flexible barrier packaging.
specified time or until the package fails.
3.2 Definitions of Terms Specific to This Standard:
1.4 The values stated in either SI units or inch-pound units
3.2.1 package failure—refers to rupture of seal or material.
are to be regarded separately as standard. The values stated in
3.2.2 restraint—a mechanism that prevents package move-
each system are not necessarily exact equivalents; therefore, to
ment during inflation.
ensure conformance with the standard, each system shall be
used independently of the other, and values from the two
4. Summary of Test Method
systems shall not be combined.
4.1 Test Method A (Burst Test)—Packages are tested in an
1.5 This standard does not purport to address all of the
apparatus that internally pressurizes the package until the
safety concerns, if any, associated with its use. It is the
package fails. The pneumatic supply and pressurization equip-
responsibility of the user of this standard to establish appro-
ment need the capability to maintain an increasing pressure
priate safety, health, and environmental practices and deter-
until the package bursts. The test measure is the maximum
mine the applicability of regulatory limitations prior to use.
pressure detected before the package fails.
1.6 This international standard was developed in accor-
dance with internationally recognized principles on standard-
4.2 Test Method B (Creep Test)—Packages are tested in
ization established in the Decision on Principles for the
apparatus that internally pressurizes the package to a specified
Development of International Standards, Guides and Recom-
pressure and maintains that internal package pressure for a
mendations issued by the World Trade Organization Technical
specific time. The test measure is pass/fail.
Barriers to Trade (TBT) Committee.
4.3 Test Method B (Creep to Failure)—Packages are creep-
tested and held until the package fails. Test setup is similar to
2. Referenced Documents
2 that of the Creep Test except the pressure setting will need to
2.1 ASTM Standards:
be higher to ensure the package fails in a reasonable amount of
E171 Practice for Conditioning and Testing Flexible Barrier
time (that is, about 15 s). The test measure is the time until
Packaging
failure.
F17 Terminology Relating to Primary Barrier Packaging
5. Significance and Use
These test methods are under the jurisdiction of ASTM Committee F02 on
5.1 These test methods provide a rapid means of evaluating
PrimaryBarrierPackagingandarethedirectresponsibilityofSubcommitteeF02.20
on Physical Properties.
tendencies for package failure when the package is exposed to
CurrenteditionapprovedMay1,2020.PublishedJuly2020.Originallyapproved
a pressure differential. Pressure differentials may occur during
in 1988. Last previous edition approved in 2013 as F1140/F1140M – 13. DOI:
processes such as sterilization and transportation.
10.1520/F1140_F1140M-13R20E01.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
5.2 These test methods are frequently used to quickly
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
evaluate packages during the manufacturing process and at
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. various stages of the package’s life cycle.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
´1
F1140/F1140M − 13 (2020)
5.3 If correlations between pieces of test equipment are to 5.4 These test methods do not necessarily provide correla-
be made, it is important that all parameters of the test method tion with actual package seal strength as typically measured
be exactly the same. Typical parameters may include, but are using Test Method F88 (or equivalent).
not limited to, package size, material, seal configuration, test
6. Apparatus
equipment, rate of air flow into the package, sensitivity
(machineresponsetopressuredrop),andpositionoftestarticle
6.1 Packages are tested under unrestrained conditions as
(see Fig. 1).
follows:
6.1.1 Open Package Tester, used to test flexible packages
with one opened side.
6.1.2 Closed Package Tester, internally pressurizes the com-
pletely sealed package through a puncture.
6.2 The test apparatus for both open and closed package
testing shall include the following:
6.2.1 Means of Measuring the Pressure Inside the Package,
6.2.2 Timer, and
6.2.3 Pressure Regulator, intended to maintain steady or
increasing pressure in the package.
NOTE1—Ifthepressureregulatorcannotprovidethenecessaryvolume,
the porosity of the sample may need to be limited. (See Appendix X1.)
7. Sampling
7.1 Choose the number of test specimens to permit an
adequate determination of representative performance. Testing
of specimens with visual defects or other deviations from
normality may or may not be appropriate, depending on the
purpose of investigation. Indiscriminate elimination of defects
can bias results.
8. Conditioning
8.1 Standard Test Conditions—Conditionpackagesandcon-
duct testing in accordance with Practice E171.
8.2 If the test methods are conducted in other than standard
test conditions, record the temperature and relative humidity at
the time of the test method.
9. Procedure
9.1 Test Method A (Burst Test)—Place the package in the
apparatus and increase the internal pressure until a failure
occurs.
9.1.1 Open Package Test:
9.1.1.1 Package Preparation—The package may be tested
with or without the product enclosed. Record the package test
preparation.
9.1.1.2 Place the package in the test apparatus, and set the
specifiedparameters.Theopenpackagetestermustbeadjusted
such that the tester does not restrain the package from forming
its normal unrestricted height at the time of the burst.
NOTE 2—The package is typically positioned in one of the positions
shown in Fig. 1. Different positions may result in different test values and,
therefore, the final report should specify which position was chosen.
9.1.1.3 Begin the test method by starting the inflation
process. The rate of pressurization may affect the test results
and must not exceed the response rate of the pressure indicator.
Continue pressurization until a failure occurs.
9.1.1.4 Visually examine the package, and note the position
and type of failure (material or seal) and the pressure at which
FIG. 1 Open Package Test Positions it occurred.
´1
F1140/F1140M − 13 (2020)
9.1.2 Closed Package Test: package. A common starting point is 90 % of the burst value.
9.1.2.1 Package Preparation—The package may be tested Note however that the specified creep pressure may be depen-
with or without the product enclosed. Record the package test dent on the materials or sealing mechanism and may be raised
preparation. or lowered to allow testing to occur in an appropriate time
9.1.2.2 Position the completely sealed package in the test range. The time to failure is the test statistic.
apparatus and carefully insert the pressurization entry device 9.2.1 Open Package Test:
(see Fig. 2). The center of the package is the preferred point of 9.2.1.1 Package Preparation—The package may be tested
entry. Location variations of the entry point may affect the with or without the product enclosed. Record the package test
results of the test. Record the location of entry and perform all preparation.
sample testing at this same location. 9.2.1.2 Place the package in the test apparatus and set the
specifiedparameters.Theopenpackagetestermustbeadjusted
NOTE 3—It is important not to damage other package surfaces when
such that the tester does not restrain the package from forming
inserting the needle. If the package material tears easily, reinforce the
its normal unrestrained height during the test. Package position
point of entry with tape or equivalent.
is important, see Note 2
...