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ASTM F392/F392M-23

(Practice)

Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability

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.  
5.3 This practice does not measure or condition materials for abrasion related to flex failure.  
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.
FIG. 1 Planar Evolution of Gelbo Shaft Helical Groove 30.70 mm [1.20 in.] Diameter Shaft  
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.
SCOPE
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.  
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.

General Information

Status
Published
Publication Date
30-Sep-2023
ICS
55.040 - Packaging materials and accessories
Technical Committee
F02 - Primary Barrier Packaging
Drafting Committee
F02.50 - Package Design and Development
Current Stage
Ref Project

Relations

Replaces
ASTM F392/F392M-21 - Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability
Effective Date
01-Oct-2023
Refers
ASTM F2097-23 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
01-Oct-2023
Refers
ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
01-May-2020
Referred By
ASTM F1052-20 - Standard Test Method for Pressure Testing Vapor Protective Suits
Effective Date
01-Oct-2023
Referred By
ASTM F1296-08(2023) - Standard Guide for Evaluating Chemical Protective Clothing
Effective Date
01-Oct-2023
Referred By
ASTM F3352/F3352M-23b - Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
Effective Date
01-Oct-2023

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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.
Designation: F392/F392M − 23
Standard Practice for
1
Conditioning Flexible Barrier Materials for Flex Durability
This standard is issued under the fixed designation F392/F392M; the number immediately following the designation indicates the year
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.
1. Scope* 3. Terminology
1.1 This practice covers conditioning of flexible barrier 3.1 pinhole, n—a small opening of non-specific shape or
materials for the determination of flex resistance. Subsequent
dimension that passes completely through all layers of a
testing can be performed to determine the effects of flexing on
flexible material.
material properties. These tests are beyond the scope of this
3.1.1 Discussion—The use of the term “pin” provides the
practice.
relative size reference as in a small hole made with or as if with
a pin.
1.2 The values stated in either SI units or inch-pound units
are to be regarded separately as standard. The values stated in
4. Summary of Practice
each system may not be exact equivalents; therefore, each
system shall be used independently of the other. Combining
4.1 Specimens of flexible materials are flexed at standard
values from the two systems may result in non-conformance
atmospheric conditions defined in Practice E171, unless other-
with the standard.
wise specified. Flexing conditions, number of cycles, and
1.3 This standard does not purport to address all of the
severity of flexing strokes vary with the type of material
safety concerns, if any, associated with its use. It is the
structure being tested. Except for condition E, the flexing
responsibility of the user of this standard to establish appro-
condition consists of a twisting motion followed, in conditions
priate safety, health, and environmental practices and deter-
A to D, by a horizontal motion, thus, repeatedly twisting and
mine the applicability of regulatory limitations prior to use.
crushing the film. The frequency is at a rate of 45 cycles per
1.4 This international standard was developed in accor-
minute (cpm).
dance with internationally recognized principles on standard-
4.2 The effect of flexing on a material is determined by
ization established in the Decision on Principles for the
measuring the effect of the flex conditioning on the barrier
Development of International Standards, Guides and Recom-
and/or mechanical performance of the structure. The property
mendations issued by the World Trade Organization Technical
to be evaluated determines the appropriate conditioning level.
Barriers to Trade (TBT) Committee.
4.3 The various flex conditioning levels are summarized as
2. Referenced Documents
follows:
2
2.1 ASTM Standards: 4.3.1 Condition A—Full flex for 1 h (that is, 2700 cycles).
E171 Practice for Conditioning and Testing Flexible Barrier
4.3.2 Condition B—Full flex for 20 min (that is, 900 cycles).
Packaging
4.3.3 Condition C—Full flex for 6 min (that is, 270 cycles).
F1249 Test Method for Water Vapor Transmission Rate
4.3.4 Condition D—Full flex for 20 cycles.
Through Plastic Film and Sheeting Using a Modulated
4.3.5 Condition E—Partial flex for 20 cycles.
Infrared Sensor
F2097 Guide for Design and Evaluation of Primary Flexible
5. Significance and Use
Packaging for Medical Products
5.1 This practice is valuable in determining the resistance of
flexible packaging materials to flex-formed pinholes. Condi-
1
This practice is under the jurisdiction of ASTM Committee F02 on Primary
tioning levels A, B, or C are typically used. Reference Practice
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on
E171 and Guide F2097.
Package Design and Development.
Current edition approved Oct. 1, 2023. Published November 2023. Originally
5.2 Conditions D and E are typically used for determining
approved in 1974. Last previous edition approved in 2021 as F392/F392M – 21.
the effect of flexing on barrier properties and transmission rates
DOI: 10.1520F0392_F0392M-23.
2
related to gas and/or moisture.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
5.3 This practice does not measure or condition materials
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. for abrasion related to flex failure.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

----------
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F392/F392M − 21 F392/F392M − 23
Standard Practice for
1
Conditioning Flexible Barrier Materials for Flex Durability
This standard is issued under the fixed designation F392/F392M; the number immediately following the designation indicates the year
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.
1. Scope Scope*
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.
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.
2. Referenced Documents
2
2.1 ASTM Standards:
E171 Practice for Conditioning and Testing Flexible Barrier Packaging
F1249 Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor
F2097 Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
3. Terminology
3.1 pinhole, n—a small opening of non-specific shape or dimension that passes completely through all layers of a flexible material.
3.1.1 Discussion—
The use of the term “pin” provides the relative size reference as in a small hole made with or as if with a pin.
4. Summary of Practice
4.1 Specimens of flexible materials are flexed at standard atmospheric conditions defined in Practice E171, unless otherwise
specified. Flexing conditions, number of cycles, and severity of flexing strokes vary with the type of material structure being tested.
1
This practice is under the jurisdiction of ASTM Committee F02 on Primary Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on Package Design
and Development.
Current edition approved May 1, 2021Oct. 1, 2023. Published April 2022November 2023. Originally approved in 1974. Last previous edition approved in 20152021 as
F392/F392M – 11 (2015).F392/F392M – 21. DOI: 10.1520F0392_F0392M-21.10.1520F0392_F0392M-23.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 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 the ASTM website.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F392/F392M − 23
Except for condition E, the flexing condition consists of a twisting motion followed, in conditions A to D, by a horizontal motion,
thus, repeatedly twisting and crushing the film. The frequency is at a rate of 45 cycles per minute (cpm).
4.2 Flex failure The effect of flexing on a material is determined by measuring the effect of the tested flex conditioning on the
barrier and/or mechanical performance of the structure. The property to be evaluated determines the appropriate conditioning level.
4.3 The various flex conditioning levels are summarized as follows:
4.3.1 Condition A—Full flex for 1 h (that is, 2700 cycles).
4.3.2 Condition B—Full flex for 20 min (that is, 900 cycles).
4.3.3 Condition C—Full flex for 6 min (that is, 270 cycles).
4.3.4 Condition D—Full flex for 20 cycles.
4.3.5 Condition E—Partial flex for 20 cycles.
5. Significance and Use
5.1 This practice is valuable in determining the resistance of flexible packaging materials to flex-formed pinhole failures. pinholes.
Conditioning levels A, B, or C are typical
...

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4.1 Seal strength is a quantitative measure for use in process validation, capability, and control. Seal strength is not only relevant to opening force and package integrity, but to measuring the packaging processes’ ability to produce consistent seals. Seal strength at some minimum level is a necessary package requirement, and at times it is also desirable to have an upper limit to the strength of the seal to facilitate opening.
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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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SIGNIFICANCE AND USE
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5.2 The resistance of material surfaces to abrasion, as measured on a testing machine under laboratory conditions, is only one of several factors contributing to wear performance or durability as experienced in the actual use of the material. While abrasion resistance and durability are frequently related, the relationship varies with different end uses and different factors may be necessary in any calculation of predicted durability from specific abrasion data.  
5.3 The resistance of material surfaces to abrasion may be affected by factors including test conditions of temperature and humidity, type of abradant, pressure between the specimen and abradant, mounting or tension of the specimen, and type, kind, or amount of finishing materials such as coatings or additives. Other causes of variation include local material movement during testing, material direction alignment, material characteristics, and mandrel and stylus wear. For consistency, samples to be evaluated under special environmental conditions shall be conditioned under those same conditions. It is important that the test instrument be shown to operate properly under special environmental conditions.  
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1.1 This test method covers the determination of the abrasion resistance of flexible non-conductive films and packaging materials using a weighted stylus that wears completely through a film by oscillating or reciprocating back and forth along a linear path until an electrical circuit is completed shutting down the test.  
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SCOPE
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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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.  
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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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ASTM
ASTM F2391-22(Test Method)
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas

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:  
5.4.1 A design tool,  
5.4.2 For tooling qualification,  
5.4.3 Process setup,  
5.4.4 Process validation tool,  
5.4.5 Quality assurance monitoring, or  
5.4.6 Research and development.
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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ASTM
ASTM F2638-22(Test Method)
Standard Test Method for Using Aerosol Filtration for Measuring the Performance of Porous Packaging Materials as a Surrogate Microbial Barrier

SIGNIFICANCE AND USE
6.1 This test method has been developed as a result of research performed by Air Dispersion Limited (Manchester, UK) and funded by the Barrier Test Consortium Limited. The results of this research have been published in a peer-reviewed journal.4 This research demonstrated that testing the barrier performance of porous packaging materials using microorganisms correlates with measuring the filtration efficiency of the materials.  
6.2 This test method does not require the use of microbiological method; in addition, the test method can be conducted in a rapid and timely manner.  
6.3 When measuring the filtration efficiency of porous packaging materials a typical filtration efficiency curve is determined (see Fig. 1). Since the arc of these curves is dependent upon the characteristics of each individual material, the appropriate way to make comparison among materials is using the parameter that measures maximum penetration through the material.
FIG. 1 A Typical Curve Showing Penetration as a Function of Flow Rate
Note 1: The point of maximum penetration is indicated by the upward pointing triangle.  
6.4 The particle filtration method is a quantitative procedure for determining the microbial barrier properties of materials using a challenge of 1.0 µm particles over range of pressure differentials from near zero to approximately 30 cm water column (WC) (2942 Pa). This test method is based upon the research of Tallentire and Sinclair4 and uses physical test methodology to allow for a rapid determination of microbial barrier performance.
SCOPE
1.1 This test method measures the aerosol filtration performance of porous packaging materials by creating a defined aerosol of 1.0 μm particles and assessing the filtration efficiency of the material using either single or dual particle counters.  
1.2 This test method is applicable to porous materials used to package terminally sterilized medical devices.  
1.3 The intent of this test apparatus is to determine the flow rate through a material at which maximum penetration occurs.  
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, 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.

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