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ASTM F99-07

(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 F 2097.
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 F 2559 should be referenced.
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-2007
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(2001) - Standard Practice for Preparation of Flexible Barrier Material Specifications
Effective Date
01-Aug-2007
Replaced By
ASTM F99-07(2011) - 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-2007
Referred By
ASTM F2097-20 - Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
Effective Date
01-Aug-2007

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ASTM F99-07 - Standard Guide for Writing a Specification for Flexible Barrier Rollstock MaterialsASTM F99-07 - Standard Guide for Writing a Specification for Flexible Barrier Rollstock Materials
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ASTM F99-07 - 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
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 F2475 Guide for Biocompatibility Evaluation of Medical
Device Packaging Materials
1.1 This guide defines the requirements and considerations
F2559 Guide for Writing a Specification for Sterilizable
for flexible barrier materials.
Peel 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
4
2.3 FDA Document:
considerations for flexible barrier materials intended to be
21 CFR 178 IndirectFoodAdditives:Adjuvants,Production
purchased as rollstock.
Aids, and Sanitizers
1.4 If the flexible barrier material is intended to be pur-
chased in the form of a pre-made sterile barrier system, Guide
3. Terminology
F2559 should be referenced.
3.1 Definitions—For definitions and terms used in this
1.5 This standard does not purport to address all of the
guide, see Terminology F17.
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—small particles of resin with higher-than-
2. Referenced Documents average molecular weight and that appear as small, hard glassy
2
particles. Gels are not foreign material and are inherent to
2.1 ASTM Standards:
many 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 GuideforDesignandEvaluationofPrimaryFlexible
quality, or performance criteria. A specification identifies the
Packaging for Medical Products
test methods for determining whether each of the requirements
F2203 Test Method for Linear Measurement Using Preci-
is satisfied.
sion 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 Materials
F2251 Test Method for Thickness Measurement of Flexible
4. Summary
Packaging Material
4.1 This standard provides guidance for writing a specifica-
tion for flexible barrier materials. Materials, method of manu-
1
This guide is under the jurisdiction of ASTM Committee F02 on Flexible
facture, physical properties, performance requirements, dimen-
Barrier Packaging and is the direct responsibility of Subcommittee F02.50 on
sioning, appearance, printing, and labeling are all issues that
Package Design and Development.
need to be addressed in a flexible barrier material specification.
Current edition approved Aug. 1, 2007. Published September 2007. Originally
approved in 1976. Last previous edition approved in 2001 as F99 – 76 (2001). DOI:
10.1520/F0099-07.
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.
4
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.
1

---------------------- Page: 1 ----------------------
F99–07
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 delam
...

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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.  
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 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:  
5.4.1 Films that stretch and generate a ripple in the abraded region during testing,  
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.
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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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.
SCOPE
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.  
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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.
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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.  
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ASTM F88/F88M-23(Test Method)
Standard Test Method for Seal Strength of Flexible Barrier Materials

SIGNIFICANCE AND USE
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.  
4.2 A portion of the force measured when testing materials may be a bending component and not seal strength alone. A number of fixtures and techniques have been devised to hold samples at various angles to the pull direction to control this bending force. Because the effect of each of these on test results is varied, consistent use of one technique (Technique A, Technique B, or Technique C) throughout a test series is recommended. Examples of techniques are illustrated in Fig. 1.  
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.  
1.7 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.
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.  
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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.  
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 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.
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.  
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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 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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