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ASTM F99-07(2011)

(Practice)

Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials

Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials

SIGNIFICANCE AND USE
Flexible barrier materials are universally used across industries and produced by a myriad of suppliers. They may be monolayer materials or complex composite structures. However, even with the diversity of material, there are still basic requirements that all flexible barrier materials should exhibit.
Flexible barrier material requirements may be divided into two categories, initial material qualification, and routine production and receipt requirements to ensure the purchaser receives exactly what is ordered. While all requirements may be included in the written specification, initial qualification tests may only be needed prior to the first order. Routine production and receipt requirements should be adhered to on every order. Initial qualification requirements are indicated with each clause, where applicable.
This guide provides an understanding of the requirements needed for the manufacture, purchase, and acceptance of flexible barrier materials. Appropriate test methods for compliance are also cited.
Note 1—All test methods for a particular requirement may not be cited due to specific or unique circumstances. For additional guidance on applicable methods, refer to Guide F2097.
The specification and its requirements should be mutually agreed to by the supplier and purchaser of the product. This helps ensure that the flexible barrier materials will comply with the specified requirements.
SCOPE
1.1 This guide defines the requirements and considerations for flexible barrier materials.
1.2 This guide addresses some critical printing requirements for flexible barrier materials.
1.3 Guidance is provided on specification requirements and considerations for flexible barrier materials intended to be purchased as rollstock.
1.4 If the flexible barrier material is intended to be purchased in the form of a pre-made sterile barrier system, Guide F2559 should be referenced.
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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
31-Jul-2011
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 F99-07 - Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
Effective Date
01-Aug-2011
Referred By
ASTM F2902-16e1 - Standard Guide for Assessment of Absorbable Polymeric Implants
Effective Date
01-Aug-2011
Referred By
ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
01-Aug-2011

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ASTM F99-07(2011) - Standard Guide for Writing a Specification for Flexible Barrier Rollstock MaterialsASTM F99-07(2011) - Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
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ASTM F99-07(2011) - Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
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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:F99 −07(Reapproved 2011)
Standard Guide for
Writing a Specification for Flexible Barrier Rollstock
Materials
This standard is issued under the fixed designation F99; the number immediately following the designation indicates the year of original
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F2475 Guide for Biocompatibility Evaluation of Medical
Device Packaging Materials
1.1 This guide defines the requirements and considerations
F2559 Guide forWriting a Specification for Sterilizable Peel
for flexible barrier materials.
Pouches
1.2 Thisguideaddressessomecriticalprintingrequirements 3
2.2 TAPPI Standard:
for flexible barrier materials.
T 437 Dirt in Paper and Paperboard
1.3 Guidance is provided on specification requirements and 2.3 FDA Document:
21 CFR 178 Indirect FoodAdditives:Adjuvants, Production
considerations for flexible barrier materials intended to be
purchased as rollstock. Aids, and Sanitizers
1.4 If the flexible barrier material is intended to be pur-
3. Terminology
chased in the form of a pre-made sterile barrier system, Guide
3.1 Definitions—For definitions and terms used in this
F2559 should be referenced.
guide, see Terminology F17.
1.5 This standard does not purport to address all of the
3.2 Definitions:
safety concerns, if any, associated with its use. It is the
3.2.1 carbon particles—carbon particles are bits of parent
responsibility of the user of this standard to establish appro-
material (resin) that have seen excessive heat in processing.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use. 3.2.2 gels—smallparticlesofresinwithhigher-than-average
molecular weight and that appear as small, hard glassy par-
2. Referenced Documents
ticles. Gels are not foreign material and are inherent to many
2.1 ASTM Standards: polymer-based materials.
D4321 Test Method for Package Yield of Plastic Film
3.2.3 specification—an explicit set of requirements to be
F17 Terminology Relating to Flexible Barrier Packaging
satisfied by a material, product, system, or service. Examples
F88 Test Method for Seal Strength of Flexible Barrier
of specifications include, but are not limited to, requirements
Materials
for; physical, mechanical, or chemical properties, and safety,
F2097 Guide for Design and Evaluation of Primary Flexible
quality, or performance criteria. A specification identifies the
Packaging for Medical Products
test methods for determining whether each of the requirements
F2203 TestMethodforLinearMeasurementUsingPrecision
is satisfied.
Steel Rule
3.2.4 telescoping—transverse slipping of successive winds
F2250 Practice for Evaluation of Chemical Resistance of
of a roll of material so that the edge is conical rather than flat.
Printed Inks and Coatings on Flexible Packaging Materi-
als
4. Summary
F2251 Test Method for Thickness Measurement of Flexible
4.1 This standard provides guidance for writing a specifica-
Packaging Material
tion for flexible barrier materials. Materials, method of
manufacture, physical properties, performance requirements,
This guide is under the jurisdiction of ASTM Committee F02 on Flexible
dimensioning, appearance, printing, and labeling are all issues
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on
that need to be addressed in a flexible barrier material
Package Design and Development.
Current edition approved Aug. 1, 2011. Published November 2011. Originally specification.
approved in 1976. Last previous edition approved in 2007 as F99 – 07. DOI:
10.1520/F0099-07R11.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from TechnicalAssociation of the Pulp and Paper Industry (TAPPI),
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 15 Technology Parkway South, Norcross, GA 30092, http://www.tappi.org.
Standards volume information, refer to the standard’s Document Summary page on Available from Food and Drug Administration (FDA), 5600 Fishers Ln.,
the ASTM website. Rockville, MD 20857, http://www.fda.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F99−07 (2011)
NOTE 4—Minimum seal strength is typically that which maintains
Appropriate requirements and test methods are suggested for
package integrity through the processing, handling, and distribution
preparing a specification.
systems. Maximum seal strength is that which, if exceeded on peelable
applications, may result in the perception that the package is too difficult
5. Significance and Use
to open or causes fiber tear or delamination between one or more of the
bonded substrates. Maximum seal strength does not apply to weld seal
5.1 Flexible barrier materials are universally used across
applications.
industries and produced by a myriad of suppliers.They may be
6.2.3.1 The sealing conditions (temperature, pressure, and
monolayer materials or complex composite structures. How-
ever, even with the diversity of material, there are still basic dwell), and the product to which the material should be sealed
should be specified.
requirements that all flexible barrier materials should exhibit.
6.2.3.2 Seal strength is generally measured using a tensile
5.2 Flexible barrier material requirements may be divided
test method such as Test Method F88. Test Method F88
into two categories, initial material qualification, and routine
indicates three different tail holding methods for the test
production and receipt requirements to ensure the purchaser
sample: unsupported, supported 90° (by hand), and supported
receives exactly what is ordered. While all requirements may
180°. Because the effect of each of these on the results is
be included in the written specification, initial qualification
varied, consistent use of one technique should be negotiated
tests may only be needed prior to the first order. Routine
with the supplier and indicated in the specification.
production and receipt requirements should be adhered to on
6.2.4 Barrier (if applicable)—The flexible barrier material
every order. Initial qualification requirements are indicated
should provide an appropriate physical barrier (oxygen, water
with each clause, where applicable.
vapor, light, and so forth) and/or microbial barrier. This
5.3 This guide provides an understanding of the require-
requirement should be evaluated during the initial material
mentsneededforthemanufacture,purchase,andacceptanceof
qualification and is not typically performed on a routine
flexible barrier materials. Appropriate test methods for com-
production basis.
pliance are also cited.
NOTE 1—All test methods for a particular requirement may not be cited
6.3 Application Requirements (incorporate if applicable):
due to specific or unique circumstances. For additional guidance on
6.3.1 Compatibility with Sterilization Process—The flexible
applicable methods, refer to Guide F2097.
barrier material should be compatible with the intended steril-
5.4 The specification and its requirements should be mutu-
ization process. This requirement should be evaluated during
ally agreed to by the supplier and purchaser of the product.
the initial material qualification and is not typically performed
Thishelpsensurethattheflexiblebarriermaterialswillcomply
on a routine production basis.
with the specified requirements.
6.3.2 Toxicity—The flexible barrier material should be non-
toxic and appropriate for the given application (see
6. Specification
21 CFR 178 and/or Guide F2475 (intended for medical device
NOTE 2—Sufficient requirements should be included to ensure that all
applications)).Thisrequirementshouldbeevaluatedduringthe
batches, lots, or deliveries conform to the specification. Incorporating
unnecessary requirements into the specification is likely to increase cost initial material qualificati
...

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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.  
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4.2.1 Technique A: Unsuppor...
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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.  
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.  
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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.
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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.  
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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.
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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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SIGNIFICANCE AND USE
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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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ASTM
ASTM F119-82(2022)(Test Method)
Standard Test Method for Rate of Grease Penetration of Flexible Barrier Materials (Rapid Method)

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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