ASTM F99-07(2015)

Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials

SIGNIFICANCE AND USE
5.1 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.  
5.2 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.  
5.3 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.  
5.4 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: 30-Sep-2015
• ICS: 55.040 - Packaging materials and accessories
• Technical Committee: F02 - Primary Barrier Packaging
• Drafting Committee: F02.50 - Package Design and Development

Standards Content (Sample)

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 2015)
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
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:
considerations for flexible barrier materials intended to be
21 CFR 178 Indirect FoodAdditives:Adjuvants, Production
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
F2559 should be referenced.
3.1 Definitions—For definitions and terms used in this
guide, see Terminology F17.
1.5 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
3.2 Definitions:
responsibility of the user of this standard to establish appro-
3.2.1 carbon particles—carbon particles are bits of parent
priate safety and health practices and determine the applica-
material (resin) that have seen excessive heat in processing.
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
Printed Inks and Coatings on Flexible Packaging Materi- of a roll of material so that the edge is conical rather than flat.
als
4. Summary
F2251 Test Method for Thickness Measurement of Flexible
Packaging Material
4.1 This standard provides guidance for writing a specifica-
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
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on
dimensioning, appearance, printing, and labeling are all issues
Package Design and Development.
that need to be addressed in a flexible barrier material
Current edition approved Oct. 1, 2015. Published October 2015. Originally
approved in 1976. Last previous edition approved in 2011 as F99 – 07(2011). DOI:
10.1520/F0099-07R15.
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 [e-mail]. 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 (2015)
specification. Appropriate requirements and test methods are materials, a statement that the material will provide a destruct
suggested for preparing a specification. (material failure) seal. (Test Method F88)
NOTE 4—Minimum seal strength is typically that which maintains
5. Significance and Use
package integrity through the processing, handling, and distribution
systems. Maximum seal strength is that which, if exceeded on peelable
5.1 Flexible barrier materials are universally used across
applications, may result in the perception that the package is too difficult
industries and produced by a myriad of suppliers.They may be
to open or causes fiber tear or delamination between one or more of the
monolayer materials or complex composite structures.
bonded substrates. Maximum seal strength does not apply to weld seal
applications.
However, even with the diversity of material, there are still
basic requirements that all flexible barrier materials should
6.2.3.1 The sealing conditions (temperature, pressure, and
exhibit.
dwell), and the product to which the material should be sealed
should be specified.
5.2 Flexible barrier material requirements may be divided
6.2.3.2 Seal strength is generally measured using a tensile
into two categories, initial material qualification, and routine
test method such as Test Method F88. Test Method F88
production and receipt requirements to ensure the purchaser
indicates three different tail holding methods for the test
receives exactly what is ordered. While all requirements may
sample: unsupported, supported 90° (by hand), and supported
be included in the written specification, initial qualification
180°. Because the effect of each of these on the results is
tests may only be needed prior to the first order. Routine
varied, consistent use of one technique should be negotiated
production and receipt requirements should be adhered to on
with the supplier and indicated in the specification.
every order. Initial qualification requirements are indicated
6.2.4 Barrier (if applicable)—The flexible barrier material
with each clause, where applicable.
should provide an appropriate physical barrier (oxygen, water
5.3 This guide provides an understanding of the require-
vapor, light, and so forth) and/or microbial barrier. This
mentsneededforthemanufacture,purchase,andacceptanceof
requirement should be evaluated during the initial material
flexible barrier materials. Appropriate test methods for com-
qualification and is not typically performed on a routine
pliance are also cited.
production basis.
NOTE 1—All test methods for a particular requirement may not be cited
due to specific or unique circumstances. For additional guidance on
6.3 Application Requirements (incorporate if applicable):
applicable methods, refer to Guide F2097.
6.3.1 Compatibility with Sterilization Process—The flexible
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-
6. Specification toxic and appropriate for the given application (see
21 CFR 178 and/or Guide F2475 (intended for medical device
NOTE 2—Sufficient requirements should be included to ensure that all
batches, lots, or deliveries conform to the specification. Incorporating
applications)).Thisrequirementshouldbeevaluatedduringthe
unnecessary requirements in
...

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: F99 − 07 (Reapproved 2011) F99 − 07 (Reapproved 2015)
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. 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 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.
2. Referenced Documents
2.1 ASTM Standards:
D4321 Test Method for Package Yield of Plastic Film
F17 Terminology Relating to Flexible Barrier Packaging
F88 Test Method for Seal Strength of Flexible Barrier Materials
F2097 Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
F2203 Test Method for Linear Measurement Using Precision Steel Rule
F2250 Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
F2251 Test Method for Thickness Measurement of Flexible Packaging Material
F2475 Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
F2559 Guide for Writing a Specification for Sterilizable Peel Pouches
2.2 TAPPI Standard:
T 437 Dirt in Paper and Paperboard
2.3 FDA Document:
21 CFR 178 Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers
3. Terminology
3.1 Definitions—For definitions and terms used in this guide, see Terminology F17.
3.2 Definitions:
3.2.1 carbon particles—carbon particles are bits of parent material (resin) that have seen excessive heat in processing.
3.2.2 gels—small particles of resin with higher-than-average molecular weight and that appear as small, hard glassy particles.
Gels are not foreign material and are inherent to many polymer-based materials.
This guide is under the jurisdiction of ASTM Committee F02 on Flexible Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on Package Design
and Development.
Current edition approved Aug. 1, 2011Oct. 1, 2015. Published November 2011October 2015. Originally approved in 1976. Last previous edition approved in 20072011
as F99 – 07.F99 – 07(2011). DOI: 10.1520/F0099-07R11.10.1520/F0099-07R15.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from Technical Association of the Pulp and Paper Industry (TAPPI), 15 Technology Parkway South, Norcross, GA 30092, http://www.tappi.org.
Available from Food and Drug Administration (FDA), 5600 Fishers Ln., 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 (2015)
3.2.3 specification—an explicit set of requirements to be satisfied by a material, product, system, or service. Examples of
specifications include, but are not limited to, requirements for; physical, mechanical, or chemical properties, and safety, quality,
or performance criteria. A specification identifies the test methods for determining whether each of the requirements is satisfied.
3.2.4 telescoping—transverse slipping of successive winds of a roll of material so that the edge is conical rather than flat.
4. Summary
4.1 This standard provides guidance for writing a specification for flexible barrier materials. Materials, method of manufacture,
physical properties, performance requirements, dimensioning, appearance, printing, and labeling are all issues that need to be
addressed in a flexible barrier material specification. Appropriate requirements and test methods are suggested for preparing a
specification.
5. Significance and Use
5.1 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.
5.2 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.
5.3 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.
5.4 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.
6. Specification
NOTE 2—Sufficient requirements should be included to ensure that all batches, lots, or deliveries conform to the specification. Incorporating
unnecessary requirements into the specification is likely to increase cost and should be avoided.
6.1 Material Identification:
6.1.1 A brief description of the flexible barrier material should be provided. For composite structures, key layers and their
thickness should be noted.
6.1.2 The trade name of the flexible barrier material and the associated manufacturer/supplier may be included if desired.
6.2 Physical Properties:
NOTE 3—There are numerous test methods associated with determining physical properties of flexible materials. Care should be taken in selecting the
most appropriate test for the user’s particular application and use. For guidance in determining which methods to use, refer to Guide F2097. Commonly
used test methods have been indicated where appropriate.
6.2.1 Thickness (if applicable)—the total thickness of the flexible barrier material and associated thickness tolerance should be
identified. (See Test Method F2251.)
6.2.2 Yield—If the flexible barrier material is to be purchased in weight, the yield should be indicated. (See Test Method D4321.)
6.2.3 Seal Strength—If applicable, a seal strength should be specified. This requirement may be a minimum and/or maximum
value, a typical value, or in the case of weld seal materials, a statement that the material will provide a destruct (material failure)
seal. (Test Method F88)
NOTE 4—Minimum seal strength is typically that which maintains package integrity through the processing, handling, and distribution systems.
Maximum seal strength is that which, if exceeded on peelable applications, may result in the perception that the package is too difficult 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 applications.
6.2.3.1 The sealing conditions (temperature, pressure, and dwell), and the
...