ASTM F99-21

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 2015) F99 − 21
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 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for
information only and are not considered standard.
1.6 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.7 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
2.1 ASTM Standards:
D4321 Test Method for Package Yield of Plastic Film
F17 Terminology Relating to Primary 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
This guide is under the jurisdiction of ASTM Committee F02 on FlexiblePrimary Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on Package
Design and Development.
Current edition approved Oct. 1, 2015Jan. 15, 2021. Published October 2015February 2021. Originally approved in 1976. Last previous edition approved in 20112015
as F99 – 07 (2015).(2011). DOI: 10.1520/F0099-07R15.10.1520/F0099-21.
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’sstandard’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
F99 − 21
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 213 Dirt in Pulp — Chart Method
T 437T 437 Dirt in Paper and Paperboard
T 547 Transparent Chart for the Estimation of Defect Size
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.
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.
Available from TechnicalTechnological Association of the Pulp and Paper Industry (TAPPI), 15 Technology Parkway South, Norcross, Suite 115, Peachtree Corners, GA
30092, http://www.tappi.org.
Available from U.S. Food and Drug Administration (FDA), 5600 Fishers Ln., Rockville, MD 20857,10903 New Hampshire Ave., Silver Spring, MD 20993,
http://www.fda.gov.
F99 − 21
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)—theThe 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/oror maximum
value, or both, a typical value, or in the case of weld seal materials, a statement that the material will provide a destruct (material
failure) seal. (Test (See 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
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