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ASTM F99-21

(Guide)

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
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 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, health, and environmental 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.

General Information

Status
Published
Publication Date
14-Jan-2021
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

Refers
ASTM F17-20 - Standard Terminology Relating to Primary Barrier Packaging
Effective Date
01-May-2020

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Standards Content (Sample)

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:F99 −21
Standard Guide for
Writing a Specification for Flexible Barrier Rollstock
1
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 F2097 Guide for Design and Evaluation of Primary Flexible
Packaging for Medical Products
1.1 This guide defines the requirements and considerations
F2203 TestMethodforLinearMeasurementUsingPrecision
for flexible barrier materials.
Steel Rule
1.2 Thisguideaddressessomecriticalprintingrequirements
F2250 Practice for Evaluation of Chemical Resistance of
for flexible barrier materials.
Printed Inks and Coatings on Flexible Packaging Materi-
1.3 Guidance is provided on specification requirements and als
F2251 Test Method for Thickness Measurement of Flexible
considerations for flexible barrier materials intended to be
purchased as rollstock. Packaging Material
F2475 Guide for Biocompatibility Evaluation of Medical
1.4 If the flexible barrier material is intended to be pur-
Device Packaging Materials
chased in the form of a pre-made sterile barrier system, Guide
F2559 Guide forWriting a Specification for Sterilizable Peel
F2559 should be referenced.
Pouches
1.5 The values stated in SI units are to be regarded as
3
2.2 TAPPI Standard:
standard. The values given in parentheses after SI units are
T 213 Dirt in Pulp — Chart Method
provided for information only and are not considered standard.
T 437 Dirt in Paper and Paperboard
1.6 This standard does not purport to address all of the
T 547 Transparent Chart for the Estimation of Defect Size
safety concerns, if any, associated with its use. It is the
4
2.3 FDA Document:
responsibility of the user of this standard to establish appro-
21 CFR 178 Indirect FoodAdditives:Adjuvants, Production
priate safety, health, and environmental practices and deter-
Aids, and Sanitizers
mine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accor-
3. Terminology
dance with internationally recognized principles on standard-
3.1 Definitions—For definitions and terms used in this
ization established in the Decision on Principles for the
guide, see Terminology F17.
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
3.2 Definitions:
Barriers to Trade (TBT) Committee.
3.2.1 carbon particles—carbon particles are bits of parent
material (resin) that have seen excessive heat in processing.
2. Referenced Documents
3.2.2 gels—smallparticlesofresinwithhigher-than-average
2
2.1 ASTM Standards:
molecular weight and that appear as small, hard glassy par-
D4321 Test Method for Package Yield of Plastic Film
ticles. Gels are not foreign material and are inherent to many
F17 Terminology Relating to Primary Barrier Packaging
polymer-based materials.
F88 Test Method for Seal Strength of Flexible Barrier
3.2.3 specification—an explicit set of requirements to be
Materials
satisfied by a material, product, system, or service. Examples
1 of specifications include, but are not limited to, requirements
This guide is under the jurisdiction of ASTM Committee F02 on Primary
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on for; physical, mechanical, or chemical properties, and safety,
Package Design and Development.
Current edition approved Jan. 15, 2021. Published February 2021. Originally
approved in 1976. Last previous edition approved in 2015 as F99 – 07 (2015). DOI:
3
10.1520/F0099-21. Available from Technological Association of the Pulp and Paper Industry
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or (TAPPI), 15 Technology Parkway South, Suite 115, Peachtree Corners, GA 30092,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM http://www.tappi.org.
4
Standards volume information, refer to the standard’s Document Summary page on Available from U.S. Food and Drug Administration (FDA), 10903 New
the ASTM website. Hampshire Ave., Silver Spring, MD 20993, http://www.fda.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F99−21
guidance in determining which methods to use, refer to Guide F2097.
quality, or performance criteria. A specification identifies the
Commonly used test methods have been indicated where appropriate.
test me
...

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
1
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
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
1
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.
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’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
1

---------------------- Page: 1 ----------------------
F99 − 21
F2475 Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
F2559 Guide for Writing a Specification for Sterilizable Peel Pouches
3
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
4
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 th
...

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ASTM F3039-23(Test Method)
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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1.1 Method A of this test method defines a procedure that will detect and locate a leak equal to or greater than a channel formed by a 50 µm [0.002 in.] wire in the edge seals of a nonporous package. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. After contact with the dye penetrant for a minimum specified time, the package is visually inspected for dye penetration or, preferably, the seal edge is placed against an absorbent surface and the surface inspected for staining from the dye.  
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.  
1.3 These test methods are used for both transparent and opaque nonporous surfaces.  
1.4 These test methods require that the dye penetrant have good contrast to the materials being tested and/or the absorbent surface.  
1.5 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.  
1.6 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
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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.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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ASTM F88/F88M-23(Test Method)
Standard Test Method for Seal Strength of Flexible Barrier Materials

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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.  
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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.  
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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ASTM F3300-23(Test Method)
Standard Test Method for Abrasion Resistance of Flexible Packaging Films Using a Reciprocating Weighted Stylus

SIGNIFICANCE AND USE
5.1 Materials such as engineered thermoplastic films are often used for flexible barrier packaging. However, handling and transportation can cause abrasion to the packaging film and possibly compromise the integrity of the contents (for example, sterility of a medical device). This test method provides a comparative ranking of material performance that can be used as an indication of relative end-use performance.  
5.2 The resistance of material surfaces to abrasion, as measured on a testing machine under laboratory conditions, is only one of several factors contributing to wear performance or durability as experienced in the actual use of the material. While abrasion resistance and durability are frequently related, the relationship varies with different end uses and different factors may be necessary in any calculation of predicted durability from specific abrasion data.  
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.  
5.4 This test method may not be suitable for all films, including the following cases:  
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5.4.2 Films that have a thickness greater than 0.25 mm (0.010 in.), or are of such rigidity that forming over the mandrel would cause internal stresses that weaken the film, and  
5.4.3 Conductive films.
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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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ASTM F1884-04(2023)(Test Method)
Standard Test Methods for Determining Residual Solvents in Packaging Materials

SIGNIFICANCE AND USE
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.
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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.  
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ASTM F2251-13(2023)(Test Method)
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.
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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.  
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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.
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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.  
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.  
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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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ASTM
ASTM F2391-22(Test Method)
Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas

SIGNIFICANCE AND USE
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.  
5.2 The procedures presented in this test method allow the user to carry out package and seal integrity testing with sufficient sensitivity to quantify seals in the previously defined moderate to fine seal ranges.  
5.3 By employing seal-isolating leak testing fixtures, packages constructed of various materials can be tested in the full range of seal performance requirements. Design of these fixtures is beyond the scope of this method.  
5.4 These seal/package integrity test procedures can be utilized as:  
5.4.1 A design tool,  
5.4.2 For tooling qualification,  
5.4.3 Process setup,  
5.4.4 Process validation tool,  
5.4.5 Quality assurance monitoring, or  
5.4.6 Research and development.
SCOPE
1.1 This test method includes several procedures that can be used for the measurement of overall package and seal barrier performance of a variety of package types and package forms, as well as seal/closure types. The basic elements of this method include:  
1.1.1 Helium (employed as tracer gas),  
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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