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ASTM F88/F88M-23

(Test Method)

Standard Test Method for Seal Strength of Flexible Barrier Materials

Standard Test Method for Seal Strength of Flexible Barrier Materials

SIGNIFICANCE AND USE
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.
Note 1: Seal strength values are a measurement of the output of the seal separation and may also involve mechanical properties of the materials that form the seal, given the potential for deformation or elongation over the course of the test. This separation is indicative of the area of the package being sampled and does not take into account simulation of a user interfacing with an entire package during the opening process.
Note 2: Lower seal strength specifications are typically utilized to provide assurance of package closure, which can contribute to seal integrity.
Note 3: Upper seal strength specifications are typically utilized to limit the amount of force required to open a package, ensuring that a user is able to open the design. Upper seal strength specifications are typically limited to seals that are intended to be peeled by the end user.  
4.1.1 The maximum seal force is important information, but for some applications, average force to separate the seal may be useful, and in those cases also should be reported.  
4.2 A portion of the force measured when testing materials may be a bending component and not seal strength alone. A number of fixtures and techniques have been devised to hold samples at various angles to the pull direction to control this bending force. Because the effect of each of these on test results is varied, consistent use of one technique (Technique A, Technique B, or Technique C) throughout a test series is recommended. Examples of techniques are illustrated in Fig. 1.  
4.2.1 Technique A: Unsuppor...
SCOPE
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.  
1.5 This test method differs from Test Method F2824. Test Method F2824 measures mechanical seal strength while separating an entire lid (cover/membrane) from a rigid or semi-rigid round container.  
1.6 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.  
1.7 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.  
1.8 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-2023
ICS
55.040 - Packaging materials and accessories
Technical Committee
F02 - Primary Barrier Packaging
Drafting Committee
F02.20 - Physical Properties
Current Stage
Ref Project

Relations

Refers
ASTM F2824-10(2020) - Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids
Effective Date
01-May-2020
Refers
ASTM F17-20 - Standard Terminology Relating to Primary Barrier Packaging
Effective Date
01-May-2020

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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: F88/F88M − 23
Standard Test Method for
1
Seal Strength of Flexible Barrier Materials
This standard is issued under the fixed designation F88/F88M; 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 2. Referenced Documents
2
2.1 ASTM Standards:
1.1 This test method covers the measurement of the strength
D882 Test Method for Tensile Properties of Thin Plastic
of seals in flexible barrier materials.
Sheeting
1.2 The test may be conducted on seals between a flexible
D883 Terminology Relating to Plastics
material and another flexible material, a rigid material, or a
E171 Practice for Conditioning and Testing Flexible Barrier
semi-rigid material.
Packaging
E177 Practice for Use of the Terms Precision and Bias in
1.3 Seals tested in accordance with this test method may be
ASTM Test Methods
from any source, laboratory or commercial.
E691 Practice for Conducting an Interlaboratory Study to
Determine the Precision of a Test Method
1.4 This test method measures the force required to separate
F17 Terminology Relating to Primary Barrier Packaging
a test strip of material containing the seal. It also identifies the
F2824 Test Method for Mechanical Seal Strength Testing for
mode of specimen failure.
Round Cups and Bowl Containers with Flexible Peelable
1.5 This test method differs from Test Method F2824. Test
Lids
Method F2824 measures mechanical seal strength while sepa-
F3263 Guide for Packaging Test Method Validation
rating an entire lid (cover/membrane) from a rigid or semi-rigid
3. Terminology
round container.
3.1 Definitions:
1.6 The values stated in either SI units or inch-pound units
3.1.1 average seal strength, n—average force per unit width
are to be regarded separately as standard. The values stated in
of seal required to fully separate a flexible material from a rigid
each system may not be exact equivalents; therefore, each
material, semi-rigid material, or another flexible material,
system shall be used independently of the other. Combining
under the conditions of the test.
values from the two systems may result in non-conformance
3.1.1.1 Discussion—The average force normally is calcu-
with the standard.
lated by the testing machine from the digitized plot of force
versus grip travel. The plot starts from zero force after slack
1.7 This standard does not purport to address all of the
has been removed from the test strip. The initial ramp-up from
safety concerns, if any, associated with its use. It is the
zero to the force level required to peel the seal is not indicative
responsibility of the user of this standard to establish appro-
of seal strength, and data from that part of the curve should not
priate safety, health, and environmental practices and deter-
be included in the calculation of average strength, nor should
mine the applicability of regulatory limitations prior to use.
the return to zero following complete failure of the specimen.
1.8 This international standard was developed in accor-
The amount of data actually discarded on each end of the
dance with internationally recognized principles on standard-
measured seal-profile curve must be the same for all tests
ization established in the Decision on Principles for the
within any set of comparisons of average seal strength (see
Development of International Standards, Guides and Recom-
6.1.1 and 9.9.1).
mendations issued by the World Trade Organization Technical
3.1.2 maximum seal strength, n—maximum force per unit
Barriers to Trade (TBT) Committee.
width of seal required to fully separate a flexible material from
a rigid or semi-rigid material, or another flexible material,
under the conditions of the test.
1
This test method is under the jurisdiction of ASTM Committee F02 on Primary
Barrier Packaging and is the direct responsibility of Subcommittee F02.20 on
2
Physical Properties. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved May 1, 2023. Published August 2023. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1968. Last previous edition approved in 2021 as F88/F88M – 21. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F0088_F0088M-23. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F88/F88
...

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: F88/F88M − 21 F88/F88M − 23
Standard Test Method for
1
Seal Strength of Flexible Barrier Materials
This standard is issued under the fixed designation F88/F88M; 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
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.
1.5 This test method differs from Test Method F2824. Test Method F2824 measures mechanical seal strength while separating an
entire lid (cover/membrane) from a rigid or semi-rigid round container.
1.6 This test method differs from Test Method F904. Test Method F904 measures the bond strength or ply adhesion of laminates
made from flexible materials such as cellulose, paper, plastic film, and foil.
1.6 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.
1.7 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.
1.8 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:
1
This test method is under the jurisdiction of ASTM Committee F02 on Primary Barrier Packaging and is the direct responsibility of Subcommittee F02.20 on Physical
Properties.
Current edition approved Nov. 15, 2021May 1, 2023. Published December 2021August 2023. Originally approved in 1968. Last previous edition approved in 20152021
as F88/F88M – 15.F88/F88M – 21. DOI: 10.1520/F0088_F0088M-21.10.1520/F0088_F0088M-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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F88/F88M − 23
D882 Test Method for Tensile Properties of Thin Plastic Sheeting
D883 Terminology Relating to Plastics
E171 Practice for Conditioning and Testing Flexible Barrier Packaging
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
F17 Terminology Relating to Primary Barrier Packaging
F904 Practice for Separation of Plies for Bond Strength of Laminated Flexible Materials
F2824 Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids
F3263 Guide for Packaging Test Method Validation
3. Terminology
3.1 Definitions:
3.1.1 average seal strength, n—average force per unit width of seal required to fully separate a flexible material from a rigid
material material, semi-rigid material, or another flexible material, under the conditions of the test.
3.1.1.1 Discussion—
The average force normally is calculated by the testing machine from the digitized plot of force versus grip travel. The plot starts
from zero force after slack has been removed from the test strip. The initial ramp-up from zero to the force level required to peel
the seal is not indicative of seal strength, and data from that part of the curve should not be included in the calculation of av
...

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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.  
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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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ASTM
ASTM F1608-21(Test Method)
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)

SIGNIFICANCE AND USE
5.1 The exposure-chamber method is a quantitative procedure for determining the microbial-barrier properties of porous materials under the conditions specified by the test. Data obtained from this test is useful in assessing the relative potential of a particular porous material in contributing to the loss of sterility to the contents of the package versus another porous material. This test method is not intended to predict the performance of a given material in a specific sterile-packaging application. The maintenance of sterility in a particular packaging application will depend on a number of factors, including, but not limited to the following:  
5.1.1 The bacterial challenge (number and kinds of microorganisms) that the package will encounter in its distribution and use. This may be influenced by factors such as shipping methods, expected shelf life, geographic location, and storage conditions.  
5.1.2 The package design, including factors such as adhesion between materials, the presence or absence of secondary and tertiary packaging, and the nature of the device within the package.  
5.1.3 The rate and volume exchange of air that the porous package encounters during its distribution and shelf life. This can be influenced by factors including the free-air volume within the package and pressure changes occurring as a result of transportation, manipulation, weather, or mechanical influences (such as room door closures and HVAC systems).  
5.1.4 The microstructure of a porous material which influences the relative ability to adsorb or entrap microorganisms, or both, under different air-flow conditions.
SCOPE
1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test materials under conditions that result in the detectable passage of bacterial spores through the test material.  
1.1.1 A round-robin study was conducted with eleven laboratories participating. Each laboratory tested duplicate samples of six commercially available porous materials to determine the Log Reduction Value (LRV) (see calculation in Section 12). Materials tested under the standard conditions described in this test method returned average values that range from LRV 1.7 to 4.3.  
1.1.2 Results of this round-robin study indicate that caution should be used when comparing test data and ranking materials, especially when a small number of sample replicates are used. In addition, further collaborative work (such as described in Practice E691) should be conducted before this test method would be considered adequate for purposes of setting performance standards.  
1.2 This test method requires manipulation of microorganisms and should be performed only by trained personnel. The U.S. Department of Health and Human Services publication Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH-HHS Publication No. 84-8395) should be consulted for guidance.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.

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