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ASTM F99-76(2001)

(Practice)

Standard Practice for Preparation of Flexible Barrier Material Specifications

Standard Practice for Preparation of Flexible Barrier Material Specifications

SCOPE
1.1 This practice covers the preparation of specifications for flexible barrier materials.
1.2  This standard does not purport to address all of the safety problems, 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
31-Dec-2000
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 F99-76(1993) - Standard Practice for Preparation of Flexible Barrier Material Specifications
Effective Date
01-Jan-2001
Replaced By
ASTM F99-07 - Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
Effective Date
01-Aug-2007
Referred By
ASTM F2902-16e1 - Standard Guide for Assessment of Absorbable Polymeric Implants
Effective Date
01-Jan-2001
Referred By
ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
01-Jan-2001

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ASTM F99-76(2001) - Standard Practice for Preparation of Flexible Barrier Material SpecificationsASTM F99-76(2001) - Standard Practice for Preparation of Flexible Barrier Material Specifications
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ASTM F99-76(2001) - Standard Practice for Preparation of Flexible Barrier Material Specifications
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F 99 – 76 (Reapproved 2001)
Standard Practice for
Preparation of Flexible Barrier Material Specifications
ThisstandardisissuedunderthefixeddesignationF 99;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 4. General Requirements
1.1 This practice covers the preparation of specifications for 4.1 Type of Specification—The two conditions that may
flexible barrier materials. exist when preparation of a specification for a flexible barrier
1.2 This standard does not purport to address all of the material is initiated are: (1) an ASTM specification for the
safety concerns, if any, associated with its use. It is the material exists, but is not oriented toward flexible barrier use
responsibility of the user of this standard to establish appro- (that is, polyethylene film prepared as a plastic material
priate safety and health practices and determine the applica- specification) and (2) no publishedASTM specification for the
bility of regulatory limitations prior to use. material exists.
4.2 Specification Coverage—If an ASTM specification for
2. Referenced Documents
the material exists, the specification prepared by Committee
2.1 ASTM Standards:
F-2 will reference the specification and be a delineation of the
D 1898 Practice for Sampling of Plastics requirements therein with the addition of those requirements
E 122 Practice for Calculating Sample Size to Estimate,
covering use as a barrier material. If there is no published
With a Specified Tolerable Error, the Average for a Charac- ASTM specification for the material, then the specification
teristic of a Lot or Process
prepared will include both properties of general interest and
F17 Terminology Relating to Flexible Barrier Materials specific requirements for flexible barrier use.
2.2 Military Standard:
4.3 Specification Format—Specifications will be prepared
MIL-STD-105D Sampling Procedures and Tables for In- in accordance with Form and Style for ASTM Standards. To
spection by Attributes
the maximum extent feasible, the statement of numerical
requirement values shall be in the form of a cell system. These
3. Terminology
in turn should be categorized where possible into degrees of
3.1 specification—a precise statement of a set of require-
severity of service for which the particular property range is
ments to be satisfied by a material, product, system, or service,
intended (that is, mild, moderately heavy, heavy).
indicating, whenever appropriate, the procedure by means of
5. Detailed Requirements
which it may be determined whether the requirements given
are satisfied. As far as practicable, it is desirable that the 5.1 Tolerances—All requirements with numerical values
requirements be expressed numerically in terms of appropriate
will have tolerances stated as ranges: minimum-maximum, or
units together with their limits. plus or minus percentages of the desired value.
3.1.1 There are five important requisites: accuracy and
5.2 Proprietary Values—Requirements should be based on
precision, workability, suitability, flexibility, and acceptability. values representative of more than one manufacturer’s product
3.2 barrier—see TerminologyF17.
where possible.
3.3 flexible—see TerminologyF17. 5.3 Requirements:
5.3.1 Physical requirements shall include the following as
applicable:
This practice is under the jurisdiction of ASTM Committee F2 on Flexible
5.3.1.1 Thickness:
Barrier Materials and is the direct responsibility of Subcommittee F02.50 on
a) Gage.
Package Design and Development.
b) Uniformity.
Current edition approved July 30, 1976. Published October 1976.
For referenced ASTM standards, visit
...

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4.1 Harmful biological or particulate contaminants may enter the medical package through leaks. These leaks are frequently found at seals between package components of the same or dissimilar materials. Leaks may also result from a pinhole in the packaging material.  
4.2 It is the objective of this test method to visually observe the presence of channel defects by the leakage of dye through them.  
4.3 This dye penetrant procedure is applicable only to individual leaks in a package seal. The presence of a number of small leaks, as found in porous packaging material, which could be detected by other techniques, will not be indicated.  
4.4 There is no general agreement concerning the level of leakage that is likely to be deleterious to a particular package. However, since these tests are designed to detect leaks, components that exhibit any indication of leakage are normally rejected.  
4.5 These procedures are suitable to verify and locate leakage sites. They are not quantitative. No indication of leak size can be inferred from these tests. The methods are usually employed as a pass/fail test.  
4.6 The dye solution will wick through any porous material over time, but usually not within the maximum time suggested. If wicking does occur, it may be verified by observing the porous side of the subject seal area. The dye will have discolored the surface of the material. Refer to Appendix X1 for details on wicking and guidance on the observance of false positives.
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1.1 This test method defines materials and procedures that will detect and locate a leak equal to or greater than a channel formed by a 50 µm (0.002 in.) wire in package edge seals formed between a transparent material and a porous sheet material. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration.  
1.2 Three dye application methods are covered in this test method: injection, edge dip, and eyedropper.  
1.3 These test methods are intended for use on packages with edge seals formed between a transparent material and a porous sheet material. The test methods are limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the seal area for a minimum of 5 seconds. Uncoated papers are especially susceptible to leakage and must be evaluated carefully for use with each test method.  
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ASTM F392/F392M-23(Practice)
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.  
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ASTM F1115-16(2023)(Test Method)
Standard Test Method for Determining the Carbon Dioxide Loss of Beverage Containers

SIGNIFICANCE AND USE
5.1 Two procedures, A and B, are outlined in this test method. Procedure A is used most often for development of various beverage container designs to determine the functional characteristics of the package in regard to shelf life. Procedure B is recommended for use in beverage filling operations as a quality control tool in maintaining the desired CO2 fill pressure. A loss of CO2 will affect product taste.  
5.1.1 Procedure A involves the use of sensitive pressure and temperature monitoring equipment where a high degree of accuracy is essential, for example, a micro-pressure transducer and thermocouple for measuring pressure and temperature of the package in a closed system. Alternatively, this procedure may also use bottles closed with roll-on aluminum caps containing rubber septums. The septum is pierced with a hypodermic needle attached to a pressure transducer to obtain pressure readings. This procedure should be confined to laboratories that are practiced in this type of analytical testing.  
5.1.2 Procedure B is more widely used when measuring the carbonation level of the package due to the simplicity of the technique. A simple Manual pressure assembly or an Automated CO2 Analyzer is utilized.
SCOPE
1.1 The objective of this test method is to determine the carbon dioxide (CO2) loss from plastic beverage containers after a specified period of storage time.  
1.2 Factors contributing to this pressure loss are volume expansion and the gas transport characteristics of the package, including permeation and leakage.  
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Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration

SIGNIFICANCE AND USE
4.1 Contaminants may enter the package through leaks. Alternatively, product may be lost from the package through leaks. These leaks are frequently found at seals between package components of the same or dissimilar materials.  
4.2 Ingress or egress of gas or moisture through leaks in a package can also degrade sensitive contents.  
4.3 There is no general agreement concerning the level of leakage that is likely to be deleterious to a particular package. However, since these tests are designed to detect leakage, components that exhibit any indication of leakage may be rejected.  
4.4 These procedures are suitable for use to verify and locate leakage sites. They are not quantitative. No indication of leak size can be inferred from the test. Therefore, this method is employed as a go/no-go test.  
4.5 These tests are destructive. No package or component test samples exposed to dye penetration testing may be used for final product packaging.
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1.2 Method B for this test method also defines a procedure that will detect and locate a leak equal to or greater than 10 µm [0.00039 in] diameter in a nonporous flat sheet. The flat sheet is placed on an absorbent surface and then a dye penetrant is spread across the surface of the sheet, preferably using a small roller to apply pressure on the sheet to ensure adequate contact between the absorbent surface and the bottom surface of the sample being tested. The flat sheet is carefully removed and the absorbent surface is inspected for staining from the dye.  
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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.  
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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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SCOPE
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.  
1.2 Units—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.  
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Standard Test Method for Thickness Measurement of Flexible Packaging Material

SIGNIFICANCE AND USE
4.1 This test method provides a means for measuring a thickness dimension. Accurate measurement of thickness can be critical to meeting specifications and characterizing process, product, and material performance.  
4.2 This test method does not address acceptability criteria. These need to be jointly determined by the user and producer of the product. Repeatability and reproducibility of measurement is shown in the Precision and Bias section. Attention should be given to the inherent variability of materials being measured as this can affect measurement outcome.
SCOPE
1.1 This test method covers the measurement of thickness of flexible packaging materials using contact micrometers.  
1.2 The Precision and Bias statement for this test method was developed using both handheld and bench top micrometers with foot sizes ranging from 4.8 mm to 15.9 mm (3/16 in. to 5/8 in.).  
1.3 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.  
1.4 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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ASTM F34-13(2023)(Practice)
Standard Practice for Construction of Test Cell for Liquid Extraction of Flexible Barrier Materials

SIGNIFICANCE AND USE
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.  
5.3 Test Method D4754 is not an equivalent to this test method. It is for two-sided extraction of films having the same material on both of the exposed surfaces of the film.
SCOPE
1.1 This practice covers the construction of test cells which may be used for the extraction of components from flexible barrier materials by suitable extracting liquids, including foods and food simulating solvents.  
1.2 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.  
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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.  
1.8 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.  
1.9 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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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
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