F02 - Primary Barrier Packaging

SIGNIFICANCE AND USE
5.1 Coating weight is an indicator of certain functional characteristics of coated substrates (for example, sealability, peelability, appearance). The methodology described in this practice is a means of determining coat weight.  
5.2 This practice does not address acceptability criteria. These need to be jointly determined by the user and producer of the product.  
5.3 The methodology described in this practice includes operator assessment of effective coating removal. This is a subjective assessment and requires operator training for consistent results.  
5.4 This practice is applicable to coated substrates in which only the coating is soluble in the chosen solvent. The solvent used is critical to the success of the coating removal process. The coated substrate manufacturer must provide guidance in choice of solvent.
SCOPE
1.1 This practice covers a procedure for determining the amount of coating applied to a substrate, (for example, film, paper, nonwoven). The amount of coating is expressed as a weight per given area, (for example, g/m2, lb/ream).  
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 are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
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.

SIGNIFICANCE AND USE
4.1 Harmful biological or particulate contaminants may enter the medical package through leaks. These leaks are frequently found at seals between package components of the same or dissimilar materials. Leaks may also result from a pinhole in the packaging material.  
4.2 It is the objective of this test method to visually observe the presence of channel defects by the leakage of dye through them.  
4.3 This dye penetrant procedure is applicable only to individual leaks in a package seal. The presence of a number of small leaks, as found in porous packaging material, which could be detected by other techniques, will not be indicated.  
4.4 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 leaks, components that exhibit any indication of leakage are normally rejected.  
4.5 These procedures are suitable to verify and locate leakage sites. They are not quantitative. No indication of leak size can be inferred from these tests. The methods are usually employed as a pass/fail test.  
4.6 The dye solution will wick through any porous material over time, but usually not within the maximum time suggested. If wicking does occur, it may be verified by observing the porous side of the subject seal area. The dye will have discolored the surface of the material. Refer to Appendix X1 for details on wicking and guidance on the observance of false positives.
SCOPE
1.1 This test method defines materials and procedures that will detect and locate a leak equal to or greater than a channel formed by a 50 µm (0.002 in.) wire in package edge seals formed between a transparent material and a porous sheet material. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration.  
1.2 Three dye application methods are covered in this test method: injection, edge dip, and eyedropper.  
1.3 These test methods are intended for use on packages with edge seals formed between a transparent material and a porous sheet material. The test methods are limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the seal area for a minimum of 5 seconds. Uncoated papers are especially susceptible to leakage and must be evaluated carefully for use with each test method.  
1.4 These test methods require that the dye penetrant solution have good contrast to the opaque packaging material.  
1.5 The values are stated in International System of Units (SI units) and English units. Either is to be regarded as 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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
5.1 This practice can be used to check devices used to measure the application and removal torques of continuous or intermittent thread and lug closures.  
5.2 This practice can be used to determine the amount of torque to either apply or remove a closure.
SCOPE
1.1 This practice covers the calibration and use of torque meters of the type normally used in packaging applications.  
1.2 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.  
1.3 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.

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.

SIGNIFICANCE AND USE
4.1 This design and evaluation guide describes multiple categories for evaluating flexible medical packages and packaging materials. These include safety, barrier, material and package performance attributes and characteristics, package integrity, visibility and appearance, processing, printed ink, distribution simulation, and conditioning.  
4.2 The intent of this design and evaluation guide is to evaluate all cited categories and select those that are applicable. Once the product has been characterized and the sterilization methodology has been defined, there are numerous sets of requirements for any specific package. This design and evaluation guide provides an avenue for assessing these requirements and choosing test methods for both evaluating the package design and monitoring package compliance.
Note 1: Many of the standards included in this guide are consensus standards that are recognized by the United States Food and Drug Administration (FDA). Selection and use of a U.S. FDA recognized consensus standard is voluntary and the sole responsibility of the user in determining its applicability. For further information, consult the U.S. FDA Standards and Conformity Assessment Program at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/standards-and-conformity-assessment-program  
4.3 Product characterization shall include mass or weight, geometry (length and width, height, and shape) and product composition.  
4.4 All categories must be considered for applicability.  
4.5 The Summary of Test Methods for Medical Packaging Design and Evaluation (Fig. 1) provides a compact graphical presentation of the test methods referenced in this guide.
SCOPE
1.1 This guide provides directions for the design and evaluation of primary flexible packages for medical products. The package materials must be selected appropriately for manufacturing process, end use, and the product being packaged.  
1.2 This guide provides a compendium of test methods, practices, and procedures. Specific individual test methods must be selected based on the pertinent characteristics of the specific product to be packaged and the purpose for testing, research and development, or compliance. Not all test methods will be applicable.  
1.3 This guide does not address acceptability criteria, which need to be determined jointly by the package producer and the medical products manufacturer.  
1.4 This guide does not assess the product to be packaged or the sterilization method to be used.  
1.5 The units cited in the referenced standard should be used.  
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.

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.  
1.8 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.

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.  
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.  
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.

SIGNIFICANCE AND USE
5.1 The purpose of this test method is to obtain reliable values for the WVTR of plastic film and sheeting.  
5.2 WVTR is an important property of packaging materials and can be directly related to shelf life and packaged product stability.  
5.3 Data from this test method is suitable as a referee method of testing, provided that the purchaser and seller have agreed on sampling procedures, standardization procedures, test conditions, and acceptance criteria.
SCOPE
1.1 This test method covers a procedure for determining the rate of water vapor transmission through flexible barrier materials. The method is applicable to sheets and films consisting of single or multilayer synthetic or natural polymers and foils, including coated materials. It provides for the determination of water vapor transmission rate (WVTR).  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.

SIGNIFICANCE AND USE
5.1 The purpose of these test methods is to obtain reliable values for WVTR that can be used to discriminate among barrier packages for pharmaceutical products. These test methods will establish a WVTR value that represents the water vapor transmission of the container closure system being evaluated. They are intended for use in evaluating or comparing, or both, the water vapor barrier performance of alternative packages for use in packaging of pharmaceutical products.  
5.2 While these methods were developed for a specific, limited application, they should be suitable for most types and sizes of consumer packages.
SCOPE
1.1 The three test methods described herein are for measurement of water vapor transmission rates (WVTRs) of high-barrier multiple-unit containers (bottles), high-barrier single-unit containers (blisters), and quasi-barrier single-unit containers used for packaging pharmaceutical products. The containers are tested closed and sealed. These test methods can be used for all consumer-sized primary containers and bulk primary containers of a size limited only by the dimensions of the equipment and the weighing capacity and sensitivity of the balance.  
1.2 These test methods are intended to be of sufficient sensitivity and precision to allow clear discrimination among the levels of barrier packages currently available for pharmaceutical products.  
1.3 There are three methods: Method A is for bottles, Method B is for formed barrier blisters, and Method C is for formed quasi-barrier blisters. Methods B and C can be adapted for use with flexible pouches.  
1.4 These test methods use gravimetric measurement to determine the rate of weight gain as a result of water vapor transmission into the package and subsequent uptake by a desiccant enclosed within the package. The packages are exposed to environments typical of those used for accelerated stability testing of drug products in the package (typically 40 °C/75 % relative humidity [RH]).  
1.5 For these methods, balance sensitivity, amount of desiccant, number of blisters per test unit, and weighing frequency were developed in an experiment based on Test Methods E96/E96M.  
1.6 Test Methods E96/E96M gives specific instruction on the interactions among weighing frequency, number of data points necessary to establish steady state, minimum weight gain in a weighing period, and balance sensitivity.  
1.7 The test methods in this standard were developed specifically for pharmaceutical bottles and blisters as closed container-closure systems. The experiment from which the methods were developed provided an inter-laboratory study from which the precision and bias statement was written. The packages in the study were small bottles and blisters used regularly for pharmaceutical solid oral dosage forms.  
1.8 In spite of the specific nature of their application, the test methods in this standard should be suitable for other pharmaceutical packages and most types and sizes of other consumer packages.  
1.9 The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard. The units of measure for bottles are milligrams per bottle per day (mg/bottle-day) and for blisters, milligrams per blister cavity per day (mg/cavity-day). These units may be used for both standard and referee testing.  
1.10 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.  
1.11 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 Ba...

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.  
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.  
1.5 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.

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.  
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.

SIGNIFICANCE AND USE
5.1 These measurements give semiquantitative estimates for the gas transmission of single pure gases through film and sheeting. Correlation of measured values with any given use, such as packaged contents protection, must be determined by experience. The gas transmission rate is affected by conditions not specifically provided for in these tests, such as moisture content (Note 2), plasticizer content, and nonhomogeneities. These tests do not include any provision for testing seals that may be involved in packaging applications.
Note 2: The tests are run using gas with 0 % moisture changes.  
5.2 The historic Interlaboratory testing has revealed that permeances measured by these procedures exhibit a strong dependence on the procedure being used, as well as on the laboratory performing the testing. The historic method relied upon manual calibrations of Hg capillary columns and manual data readings of pressure. The references and use of Hg and capillary columns have been removed from this standard as current D1434 instruments rely upon readily calibrated vacuum gauges and automated recording of data. It is planned that the next revision of this standard includes an updated ILS with modern instrumentation. Additionally, it has been noted that an agreement with other gas transmission rate methods is sometimes poor and may be material-dependent. The materials being tested often affect the between-laboratory precision. The causes of these variations are not precisely known at this time, but is likely due to the fact that this method analyzes ALL gasses from the sample and not just the Test gas. This includes pre-absorbed water vapor within the sample and any free solvents remaining within the specimen. The 48 hr desiccator drying period outlined within the method may not be long enough for all materials. Additionally, other gas transmission rate methods (as those used for oxygen transmission rate, water vapor transmission rate and carbon dioxide transmission rate) often...
SCOPE
1.1 This test method utilizes a manometric method to determine the steady-state rate of transmission of a gas through plastics in the form of film, sheeting, laminates, and plastic-coated papers or fabrics. This test method provides for the determination of (1) gas transmission rate (GTR), (2) permeance, and, in the case of homogeneous materials, (3) permeability.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.

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.  
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.

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.  
1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

SIGNIFICANCE AND USE
5.1 In form-fill operations, sealed areas of packages are frequently subject to disruptive forces while still hot. If the hot seals have inadequate resistance to these forces, breakage can occur during the packaging process. These test methods measure hot seal strength and can be used to characterize and rank materials in their ability to perform in commercial applications where this quality is critical.
SCOPE
1.1 These two test methods cover laboratory measurement of the strength of heatseals formed between thermoplastic surfaces of flexible webs, immediately after a seal has been made and before it cools to ambient temperature (hot tack strength).  
1.2 These test methods are restricted to instrumented hot tack testing, requiring a testing machine that automatically heatseals a specimen and immediately determines strength of the hot seal at a precisely measured time after conclusion of the sealing cycle. An additional prerequisite is that the operator shall have no influence on the test after the sealing sequence has begun. These test methods do not cover non-instrumented manual procedures employing springs, levers, pulleys and weights, where test results can be influenced by operator technique.  
1.3 Two variations of the instrumented hot tack test are described in these test methods, differing primarily in two respects: (a) rate of grip separation during testing of the sealed specimen, and (b) whether the testing machine generates the cooling curve of the material under test, or instead makes a measurement of the maximum force observed following a set delay time. Both test methods may be used to test all materials within the scope of these test methods and within the range and capacity of the machine employed. They are described in Section 4.  
1.4 SI units are preferred and shall be used in referee decisions. Values stated herein in inch-pound units are to be regarded separately and may not be exact equivalents to SI units. Therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.  
1.5 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. The operator of the equipment is to be aware of pinch points as the seal jaws come together to make a seal, hot surfaces of the jaws, and sharp instruments used to cut specimens. It is recommended that the operator review safety precautions from the equipment supplier.  
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.

SIGNIFICANCE AND USE
5.1 This test method is of particular use as a quality control tool for a molding or synthesis operation. Acetaldehyde is a volatile degradation product generated during melt processing of PET. Thus, it becomes trapped in the sidewalls of a molded article and desorbs slowly into the contents packaged therein. In some foods and beverages AA can impart an off-taste that is undesirable, thus, it is important to know its concentration in PET articles that are to be used in food contact applications.  
5.2 The desorption conditions of 150 °C for 60 min are such that no measurable AA is generated by the sample during the desorption process.
SCOPE
1.1 This test method covers a gas chromatographic procedure for the determination of the ppm residual acetaldehyde (AA) present in poly(ethylene terephthalate) (PET) homo-polymers and co-polymers which are used in the manufacture of beverage bottles. This includes sample types of both amorphous and solid-stated pellet and preform samples, as opposed to the bottle test, Test Method D4509, an acetaldehyde test requiring 24 h of desorption time at 23 °C into the bottle headspace and then the concentration of the headspace quantified by a similar GC method.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.

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.  
1.5 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.

SIGNIFICANCE AND USE
5.1 This test method is intended to measure volatile extractables that may be emitted from a microwave susceptor material during use. It may be a useful procedure to assist in minimizing the amount of volatile extractables either through susceptor design or manufacturing processes.  
5.2 Modification of this procedure by utilizing appropriate qualitative GC detection such as a mass spectrometer in place of the flame ionization detector may provide identification of volatile extractables of unknown identity.
SCOPE
1.1 This test method covers complete microwave susceptors.  
1.2 This test method covers a procedure for quantitating volatile compounds whose identity has been established and which are evolved when a microwave susceptor sample is tested under simulated use conditions.  
1.3 This test method was collaboratively evaluated with a variety of volatile compounds (see statistical evaluation). For compounds other than those evaluated, the analyst should determine the sensitivity and reproducibility of the method by carrying out appropriate spike and recovery studies. 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 techniques in conjunction with this test method.  
1.5 A sensitivity level of approximately 0.025 μg/in.2 is achievable for the compounds studied in Table 1. Where other compounds are being quantitated and uncertainty exists over method sensitivity, the analyst is referred to Practice E260 for procedures on determining sensitivity of chromatographic methods.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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. Specific safety hazards warnings are given in 10.2, 11.1, and 11.6.  
1.8 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.

SIGNIFICANCE AND USE
5.1 The Oxygen Transmission Rate is an important determinant of packaging functionality afforded by packaging materials for a wide variety of packaged products including food, pharmaceuticals and medical devices. In some applications, sufficient oxygen must be allowed to permeate into the package. In others, the oxygen ingress must be minimized to maintain product quality.  
5.2 Other ASTM Standard Methods to measure the oxygen transmission rate are described in Test Method D3985 and Test Method F2622.
SCOPE
1.1 This test method covers a procedure for determination of the transmission rate of oxygen gas through plastics in the form of film, sheeting, laminates, coextrusions, coated or uncoated papers or fabrics.  
1.2 This test method is not the only method for measurement of the oxygen transmission rate (OTR). There are other methods of OTR determination that use other oxygen sensors and procedures.  
1.3 The values stated in SI units are to be regarded as standard. Commonly used metric units used to report Oxygen Transmission Rate are included in Terminology, Procedure, Precision and Bias sections and in the Calculation section of the Appendix.  
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.  
1.5 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.

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.

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...

SIGNIFICANCE AND USE
5.1 This test method allows for the measurement of the torque retention properties of container/continuous thread closure systems of various designs, materials, and manufacture, and is suitable for package development and engineering evaluation.  
5.2 Each test method can be used for the evaluation of non child resistant container/continuous thread closure systems under controlled conditions such as when the application torque is known and the applied downward force to the closure is zero or for Type I, style “A” push down and turn child resistant container/continuous thread closure systems under controlled conditions such as when the application torque and the applied downward force to the closure is known.  
5.3 This test method measures torque retention properties of container/continuous thread closure systems with the use of an automated transducer based torque meter operating at a known rotational velocity (rpm) or known torque ramp.  
5.4 This test method is intended for measurement of dry torque only.
SCOPE
1.1 These test methods evaluate the torque retention of continuous thread closures on containers with matching finishes, for predetermined environmental conditions over time. Methods are defined for both Type I, style “A” push down and turn Type II2 child resistant and non child resistant type closures.  
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.
Note 1: The SI unit system is the recommended system.  
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.

SIGNIFICANCE AND USE
4.1 This test method provides a means for measuring linear dimensions. Accurate measurement of dimensions can be critical to meeting specifications and characterizing process performance.  
4.2 This test method should not be applied to tolerance ranges of less than 3 mm (1/8 in.) when it is preferable that test error does not exceed 30 % of tolerance range. See Precision and Bias Section for gauge repeatability and reproducibility results.  
4.3 This test method does not address acceptability criteria. These need to be jointly determined by the user and producer of the product.
SCOPE
1.1 This test method covers the measurement of linear dimension of flexible packages and packaging materials. It is recommended for use with an allowable tolerance range of 3 mm (1/8 in.) or greater based on gauge repeatability and reproducibility presented in the Precision and Bias section.  
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 are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.  
1.3 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.

SIGNIFICANCE AND USE
5.1 Laminates are made by bonding together two or more layers of material or materials, where each layer might be a single or multi-layer material. When the bonding agent is reactive and requires time to reach full performance, the bond strength is typically measured as a green (un-cured) bond and a cured bond. For processes that intentionally create a nonlaminated edge, that edge is generally used to initiate the bond strength measurement. The techniques described in this practice can be used to initiate separation of plies when a non-laminated edge is not present.
SCOPE
1.1 This practice describes techniques for separating plies of laminates made from flexible materials such as cellulose, paper, plastic film, and foil to enable the measurement of the bond strength or ply adhesion of the laminate. This includes laminates made by various processes: adhesive laminates, extrusion coatings, extrusion laminates, and coextrusions.  
1.2 The values stated in SI units are to be regarded as the standard. The values given in parentheses are provided for information purposes 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. Specific precautionary statements are given in 6.1.1.  
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.

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.

SIGNIFICANCE AND USE
4.1 The loss of sterile barrier system integrity may occur as a result of physical properties of the materials and adhesive or cohesive bonds degrading over time or by subsequent dynamic events during shipping and handling, or both. Accelerated and real time aging verifies the time-related aspects of potential integrity loss only.  
4.2 ANSI/AAMI/ISO 11607–1: 2019, sub-clause 6.1.3, states that “the packaging system shall provide physical protection in order to maintain integrity of the sterile barrier system.” Sub-clause 6.1.6 states that, “A terminally sterilized sterile barrier system with its protective packaging, if included, shall be designed to, maintain sterility through exposure to expected conditions and hazards during the specified processing, storage, handling, and distribution until that SBS is opened at the point of use or until the expiry date.” Sub-clause 8.3.1 states, “Stability testing shall demonstrate that the sterile barrier system maintains integrity over time.” Sub-clause 8.3.3 states, “Stability testing, using accelerated aging protocols, shall be regarded as sufficient evidence for claimed expiry dates until data from real-time aging studies are available.”  
4.3 Real time aging programs provide the best data to ensure that sterile barrier system/medical device materials and sterile barrier system/medical device integrity do not degrade over time. However, due to market conditions in which products may become obsolete in a short time, and the desire to get new products to market in the shortest possible time, real time aging studies do not meet this objective. Accelerated aging studies can provide an alternative means of screening for possible aging-related failure mechanisms in the SBS or medical device. To ensure that accelerated aging studies represent real time effects, real time aging studies must be conducted in parallel to accelerated studies. Real time studies must be carried out to the claimed shelf life of the product and be perf...
SCOPE
1.1 This guide provides information for developing accelerated aging protocols to model the possible effects of the passage of time on the sterile integrity of the sterile barrier system (SBS), as defined in ANSI/AAMI/ISO 11607–1: 2019 and the physical properties of their component packaging materials. Guidance for developing accelerated aging protocols may also be used for medical devices and medical device materials.  
1.2 Information obtained using this guide may be regarded as sufficient evidence for expiration date claims for medical devices and sterile barrier systems until data from real-time aging studies are available.  
1.3 The accelerated aging guideline addresses sterile barrier systems as a whole with or without devices. The sterile barrier system material and device interaction compatibility that may be required for new product development or the resulting evaluation is not addressed in this guide.  
1.4 Real-time aging protocols are not addressed in this guide; however, it is essential that real-time aging studies be performed to confirm the accelerated aging test results using the same methods of evaluation. Real-time aging (stability) is the requirement of ANSI/AAMI/ISO 11607–1: 2019.  
1.5 Methods used for sterile barrier system performance validation, which include, environmental challenge, distribution, handling, and shipping events, are used for package performance (event-related loss of integrity) testing and are beyond the scope of this guide.  
1.6 This guide does not address environmental challenging that simulates extreme climactic conditions that may exist in the shipping and handling environment. Refer to Practice D4332 for standard conditions that may be used to challenge the sterile barrier system to realistic extremes in temperature and humidity conditions. See Terminology F17 for a definition of “environmental challenging.”  
1.7 The data obtained from accelerated aging studies is no...

SIGNIFICANCE AND USE
3.1 Use of this guide, supplemental to the use of properly designed and maintained equipment and effective management of the production unit process, is expected to minimize costs and product loss. Training of operational personnel is essential. Each of the topics stated in this guide should be addressed in the producers program of training for operators and supervisors to ensure that each individual is aware of them and consciously employs them wherever the need or opportunity exists.
SCOPE
1.1 This guide is recommended for use by all producers of food in retort pouches. Adherence to this guide will help prevent damage to the pouches by preventing and avoiding known causes of damage that occur in the processing environment.  
1.2 This guide for flexible retort food pouches is based on the recommendations of a task force created by the Department of the Army in 1986.2 The purpose of the task force was to determine the possible causes of holes in pouches of food product produced for operational rations for the Department of Defense at that time. Members of the task force visited several food processors to observe and evaluate manufacturing methods commonly being used for processing retort pouches. The recommendations in this guide should be useful as the basis for good manufacturing practices and employee training programs used by food pouch processors.3  
1.3 This standard may involve hazardous materials, operations, and equipment. 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.

SIGNIFICANCE AND USE
5.1 Medical device peel pouches are universally used by the industry and produced by a myriad of suppliers. They may be constructed of many different materials including films, foils, paper, nonwovens such as Tyvek, and combinations thereof. However, even with the diversity of materials, there are still basic requirements that all pouches should exhibit. Above all, the pouches must contain and protect the device while maintaining sterility during all physical handling.  
5.2 Pouch requirements may be divided into two categories, initial pouch and material qualification, and routine production and receipt requirements to ensure the purchaser receives exactly what is ordered. While all requirements should 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 within each clause, where applicable.  
5.3 This guide provides an understanding of the requirements needed for the manufacture, purchase, and acceptance of a preformed peelable pouch. 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 pouches. This helps ensure that pouches will comply to specified requirements.  
5.5 Standards such as ISO 11607-1 and ISO 11607-2 have established criteria for consideration in material testing and for validation. This guide supports the expectations of appropriate materials and package testing occurring within a system of validations supporting demonstration of compliance to ISO 11607-1 and ISO 11607-2.
SCOPE
1.1 This guide defines the requirements and considerations for flexible peel pouches with one open, unsealed end that are intended to be sterilized containing medical devices. These are also known as preformed sterile barrier systems.  
1.2 Pouch styles are categorized as chevron, header, and corner peel. These pouches are typically manufactured by heat sealing, or in some cases, by cohesive cold sealing. The sealing bond is intended to be peeled open to aseptically dispense the contents.  
1.3 Pouch materials may be either porous, nonporous, or any combination of the two.  
1.4 This guide addresses some critical printing requirements on the pouch.  
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.  
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.

SIGNIFICANCE AND USE
5.1 The exposure-chamber method is a quantitative procedure for determining the microbial-barrier properties of porous materials under the conditions specified by the test. Data obtained from this test is useful in assessing the relative potential of a particular porous material in contributing to the loss of sterility to the contents of the package versus another porous material. This test method is not intended to predict the performance of a given material in a specific sterile-packaging application. The maintenance of sterility in a particular packaging application will depend on a number of factors, including, but not limited to the following:  
5.1.1 The bacterial challenge (number and kinds of microorganisms) that the package will encounter in its distribution and use. This may be influenced by factors such as shipping methods, expected shelf life, geographic location, and storage conditions.  
5.1.2 The package design, including factors such as adhesion between materials, the presence or absence of secondary and tertiary packaging, and the nature of the device within the package.  
5.1.3 The rate and volume exchange of air that the porous package encounters during its distribution and shelf life. This can be influenced by factors including the free-air volume within the package and pressure changes occurring as a result of transportation, manipulation, weather, or mechanical influences (such as room door closures and HVAC systems).  
5.1.4 The microstructure of a porous material which influences the relative ability to adsorb or entrap microorganisms, or both, under different air-flow conditions.
SCOPE
1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test materials under conditions that result in the detectable passage of bacterial spores through the test material.  
1.1.1 A round-robin study was conducted with eleven laboratories participating. Each laboratory tested duplicate samples of six commercially available porous materials to determine the Log Reduction Value (LRV) (see calculation in Section 12). Materials tested under the standard conditions described in this test method returned average values that range from LRV 1.7 to 4.3.  
1.1.2 Results of this round-robin study indicate that caution should be used when comparing test data and ranking materials, especially when a small number of sample replicates are used. In addition, further collaborative work (such as described in Practice E691) should be conducted before this test method would be considered adequate for purposes of setting performance standards.  
1.2 This test method requires manipulation of microorganisms and should be performed only by trained personnel. The U.S. Department of Health and Human Services publication Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH-HHS Publication No. 84-8395) should be consulted for guidance.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.  
1.5 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.

SIGNIFICANCE AND USE
4.1 These practices facilitate the determination of laboratory heat sealability of flexible barrier materials. While it is necessary to have a heat seal layer that provides adequate seal strength for the application, other material properties, such as the overall construction and thickness, will impact the sealing properties of the material. These practices allow the impact of changes in material properties on heat sealability to be measured.  
4.2 Due to differences between a laboratory sealer and manufacturing equipment (for example, scale, size of sealing area, and processing speed), there may be a significant difference between the capability and output of a laboratory heat sealer and that of manufacturing equipment. Hence, care must be taken when applying a heat seal curve study as outlined in these practices to manufacturing equipment. The heat seal curve and the corresponding seal strength data are intended to provide a starting point for determination of sealing conditions for full scale manufacturing equipment.
SCOPE
1.1 These practices cover laboratory preparation of heat seals. These practices also cover the treatment and evaluation of heat seal strength data for the purpose of determining heat sealability of flexible barrier materials. It does not cover the required validation procedures for the production equipment.  
1.2 Testing of seal strength or other properties of the heat seals formed by these practices is not included in this standard. Refer to Test Method F88 for testing heat seal strength. These practices do not apply to hot tack testing, which is covered in Test Methods F1921.  
1.3 The practices of this standard are restricted to preparing heat seals using a sealer employing hot-bar or impulse sealing methods, or both.  
1.4 These practices are intended to assist in establishing starting relationships for sealing flexible barrier materials. Additional guidance may be needed on how to set up sealing conditions for flexible barrier materials on commercial/production sealing equipment.  
1.5 Seals may be made between webs of the same or dissimilar materials. The individual webs may be homogeneous in structure or multilayered (coextruded, coated, laminated, and so forth).  
1.6 Strength of the heat seal as measured by Test Method F88 is the sole criterion for assessing heat sealability employed in these practices.  
1.7 Other aspects of heat sealability, such as seal continuity, typically measured by air-leak, dye penetration, visual examination, microorganism penetration, or other techniques, are not covered by these practices.  
1.8 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.  
1.9 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.  
1.10 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.

SIGNIFICANCE AND USE
5.1 The purpose of this test method is to obtain values for the WVTR of barrier materials.  
5.2 WVTR is an important property of materials and can be related to shelf life; product stability, breath-ability, and wearing comfort.  
5.3 Data from this test method is suitable as a referee method of testing, provided that the purchaser and seller have agreed on sampling procedures, test conditions, and acceptance criteria.
SCOPE
1.1 This test method covers a procedure for determining the rate of water vapor transmission ranging between 500 to 100 000 g/(m2·day) through nonwoven and plastic barrier materials. The method is applicable to films, barriers consisting of single or multilayer synthetic or natural polymers, nonwoven fabric, and nonwoven fabrics coated with films up to 3 mm (0.1 in.) in thickness.  
1.2 This test method provides for the determination of (1) water vapor transmission rate (WVTR), and (2) the permeance to water vapor.  
1.3 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. The acceptable units for WVTR are usually g/(m2·day).  
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.  
1.5 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.

SIGNIFICANCE AND USE
4.1 Penetration resistance is an important end-use performance of thin flexible materials where a sharp-edged product can destroy the integrity of a barrier wrap. This will permit package entry/exit of gases, odors, and unwanted contaminates, causing potential harm to the product and reducing shelf-life. Material response to penetration will vary with numerous factors, such as film thickness, elastic modulus, rate of penetration, temperature, shape and type of probe. Consequently, material responses from puncture to stretch may be observed and quantified using this method. Although numerous combinations of experimental factors can be devised and used to simulate specific end-use applications, the recommended conditions in this method should be followed for standard comparisons of materials.
SCOPE
1.1 This test method permits flexible barrier films and laminates to be characterized for slow rate penetration resistance to a driven probe. The test is performed at room temperature, by applying a biaxial stress at a single test velocity on the material until perforation occurs. The force, energy, and probe penetration to failure are determined.  
1.2 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.  
1.3 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.

ABSTRACT
This test method covers the determination of gross leaks in flexible packaging containing a headspace gas by bubble emission. A vacuum chamber shall be any transparent container capable of withstanding approximately one atmosphere pressure differential, fitted with a vacuum-tight cover. A vacuum gage, an inlet tube from a source of vacuum, and an outlet tube to the atmosphere shall be connected to the chamber cover. Use an immersion fluid which does not degrade the package being tested. The test sample and test fluid shall be at equilibrium with normal room temperature. The procedures for testing are presented in details.
SCOPE
1.1 This test method covers the determination of gross leaks in flexible packaging containing a headspace gas. Test sensitivity is limited to 1 × 10−5 atm cm3/s (1 × 10−6 Pa m3/s) or even less sensitive as indicated in a recent interlaboratory test (reported in Section 12).  
1.2 Small leaks may not be detected by this procedure. Viscoelastic effects on the products, or entrapped air, become significant and prevent passage through small openings. Positive pressure inside the pouch after the vacuum is drawn may force the product to plug small leaks. The size of the leak that can be detected is dependent upon the products contained, the nature of the packaging material, and the test parameters selected.  
1.3 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.  
1.4 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.  
1.5 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.

SIGNIFICANCE AND USE
5.1 Harmful biological or particulate contaminants may enter the package through imperfections such as pinholes or cracks in trays.  
5.2 After initial instrument set-up and calibration, the operations of individual tests and test results do not need operator interpretation.  
5.3 Leak test results that exceed the permissible threshold setting are indicated by audible or visual signal responses, or both, or by other means.  
5.4 This non-destructive test method may be performed in either laboratory or production environments and may be undertaken on either a 100 % or a statistical sampling basis. This test method, in single instrument use and current implementation, may not be fast enough to work on a production packaging line, but is well suited for statistical testing as well as package developmental design work.
SCOPE
1.1 This non-destructive test method detects pinhole leaks in trays, as small as 50 μm (0.002 in.) in diameter, or equivalently sized cracks, subject to trace gas concentration in the tray, tray design and manufacturing tolerances.  
1.2 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.  
1.3 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.

SIGNIFICANCE AND USE
5.1 These test methods provide a rapid, simple to apply method to detect small leaks in flexible package seals or walls at the leak rate level of greater than 1 × 10−4 sccs, thus providing a measure of package integrity. Porous barrier film packages made non-porous with an impermeable film forming coating may demonstrate lateral leakage through the barrier material. Verification of leakage differences from background leakage must be included in validation methods. The use of calibrated hole sizes or orifices may be appropriate to determine leakage sensitivity or barrier integrity for these materials.  
5.2 While theoretical leak rate sensitivity can be established by calculation, the test measurement is in pressure units and the measuring instrument must be calibrated, certified, and verified with these units.  
5.3 The pressure decay method of leak testing is a physical measure of package integrity. When testing medical packaging which must conform to ISO 11607–1: 2006 standards, it may necessary to verify the results of the pressure decay test method with other sterile package integrity test methods.  
5.4 Test Method A allows packages to be pressurized without restraint. In Test Method A the pouch, tray, or other type package will contain a volume of air defined by its mechanical configuration and its ability to resist internal pressure applied. This test method requires that the package reach a stable volume configuration (stop stretching) to make a measurement.  
5.5 Test Method B allows the use of rigid restraining plates against the walls of the package to limit its volume and stabilize the package volume.
SCOPE
1.1 These test methods cover the measurement of leaks in nonporous film, foil, or laminate flexible pouches and foil-sealed trays, which may be empty or enclose solid product. If product is enclosed, seals or surfaces cannot be in contact with water, oils, or other liquid.  
1.2 These test methods will detect leaks at a rate of 1 × 10−4 sccs (standard cubic centimetres per second) or greater, in flexible packages. The limitation of leak rate is dependent on package volume as tested.  
1.3 The following test methods are included:  
1.3.1 Test Method A—Pressure Decay Leak Test for Flexible Packages Without Restraining Plates  
1.3.2 Test Method B—Pressure Decay Leak Test for Flexible Packages With Restraining Plates  
1.4 These test methods are destructive in that they require entry into the package to supply an internal pressure of gas, typically air or nitrogen, although other gases may be used. The entry connection into the flexible package must be leak-tight.  
1.5 For porous packages, see 9.3.  
1.6 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.  
1.7 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.  
1.8 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.

SIGNIFICANCE AND USE
5.1 Harmful biological or particulate contaminants may enter the package through incomplete seals or imperfections such as pinholes or cracks in the trays.  
5.2 After initial instrument set-up and calibration, the operations of individual tests and test results do not need operator interpretation. The non-destructive nature of the test may be important when testing high value added products.  
5.3 Leak test results that exceed the permissible threshold setting are indicated by audible or visual signal responses, or both, or by other means.  
5.4 This non-destructive test method may be performed in either laboratory or production environments. This testing may be undertaken on either a 100 % or a statistical sampling basis. This test method, in single instrument use and current implementation, may not be fast enough to work on a production packaging line, but is well suited for statistical testing as well as package developmental design work.
SCOPE
1.1 This non-destructive test method detects leaks in non-porous rigid thermoformed trays, as well as the seal between the porous lid and the tray. The test method detects channel leaks in packages as small as 100 μm (0.004 in.) diameter in the seal as well as 50 μm (0.002 in.) diameter pinholes, or equivalently sized cracks in the tray, subject to trace gas concentration in the package, package design and manufacturing tolerances.
Note 1: This test method does not claim to challenge the porous (breathable) lidding material. Any defects that may exist in the porous portion of the package will not be detected by this test method.  
1.2 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.  
1.3 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.

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.

SIGNIFICANCE AND USE
3.1 The oxygen content of a package’s headspace is an important determinant of the packaging protection afforded by barrier materials. The package under test is typically MAP (modified atmosphere packaging) packaged.  
3.2 Oxygen content is a key contributor to off-flavors and spoilage of various products, such as chemicals, food and pharmaceuticals.  
3.3 The method determines the oxygen in a closed package headspace. This ability has application in:  
3.3.1 Package Permeability Studies—The change of headspace composition over a known length of time allows the calculation of permeation. Since the headspace oxygen is measured as a percentage, the volume of the container’s headspace must be known to allow conversion into a quantity such as millilitres (ml) of oxygen. The use of this approach to measure permeation generally applies to empty package systems only as oxygen uptake or outgassing of contained products could affect results.  
3.3.2 Leak Detection—If the headspace contains more oxygen than expected or is increasing faster than expected, a leak can be suspected. A wide variety of techniques can be employed to verify that a leak is present and to identify its location. If necessary or of interest, a leak rate may be calculated with known headspace volume and measured oxygen concentration change over time.  
3.3.3 Efficacy of the MAP Packaging Process—If the headspace oxygen concentration is found to be higher than expected soon after packaging, the gas flushing process may not be working as well as expected. Various techniques can evaluate whether the MAP system is functioning properly.  
3.3.4 Storage Studies—As the method is non-destructive, the headspace can be monitored over time on individual samples to insure that results of storage studies such as shelf life testing are correctly interpreted.
SCOPE
1.1 This test method covers a procedure for determination of the oxygen concentration in the headspace within a sealed package without opening or compromising the integrity of the package.  
1.2 This test method requires that chemically coated components be placed on the inside surface of the package before closing.  
1.3 The package must be either transparent, translucent, or a transparent window must be affixed to the package surface without affecting the package’s integrity.  
1.4 As this test method determines the oxygen headspace over time, the oxygen permeability can easily be calculated as ingress per unit time as long as the volume of the container is known.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.

SIGNIFICANCE AND USE
5.1 This method allows for the evaluation of seal quality by passing an ultrasound signal through the sealed area of a package or item. Poorly sealed areas will not transmit as much ultrasonic energy as properly sealed areas.  
5.2 This method relies on quantitative analysis of ultrasound signal strength, providing a non-subjective approach to assessing package seal quality and detecting defects.  
5.3 This technique has been used for inspecting a variety of materials including flexible pouch seals, rigid tray seals and other packaging components such as affixed valves. The precision and bias for any specific package and seal configuration needs to be individually determined and validated.  
5.4 The C-Scan approach is useful for laboratory applications or off-line seal inspection. The L-Scan approach can be used for on-line, real time inspection of seal quality. The sensitivity of either approach to detect a given defect size and level of severity needs to be individually determined.  
5.5 Sound waves propagate at different speeds through different materials generally moving faster through more dense materials. The acoustic impedance (expressed as g/cm2·μs) is the product of density (g/cm3) and velocity (cm/μs). Of particular importance is the extreme difference between the impedance of air and that of any solid material. Any gap or poorly bonded area can be readily detected.    
Material  
Velocity
(cm/μsec)  
Density
(g/cm3)  
Acoustic
Impedance
(g/cm2-μsec)  
Air (20°C, 1 bar)  
0.0344  
0.00119  
0.000041  
Water (20°C)  
0.148  
1.0  
0.148  
Polyethylene  
0.267  
1.1  
0.294  
Aluminum  
0.632  
2.7  
1.710
SCOPE
1.1 This standard method describes the technology and testing procedures that can be used to detect seal defects in the size range of 1 mm and characterize seal quality in a variety of packaging styles using airborne ultrasound technology.  
1.2 This test method does not purport to be the only method for measurement of seal quality.  
1.3 Heat seals and other package components can be tested in flexible, semi-rigid and rigid packages. Only the precision and bias for flexible package seals were evaluated in a recent ILS included in the method. The precision and bias for any specific package needs to be individually determined.  
1.4 On-line, real time inspection of seals can be considered particularly in the L-Scan mode.  
1.5 This method provides a non-destructive, quantitative, non-subjective approach to flexible package seal inspection.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.  
1.8 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.

SIGNIFICANCE AND USE
5.1 Leaks in medical device, pharmaceutical, and food packages may result in the ingress of unwanted gases (most commonly oxygen), harmful microbiological, or particulate contaminants. Package leaks may appear as imperfections in the package components themselves or at the seal juncture between mated components. The ability to detect leaks is necessary to ensure consistency and integrity of packages.  
5.2 After initial set-up and calibration, individual test operation may be semi-automatic, automatic, or manual. The test method permits non-destructive detection of leaks not visibly detectable. The test method does not require the introduction of any extraneous materials or substances, such as dyes or gases. However, it is important to physically mask or block off any package porous barrier surface during the test to prevent rapid loss of chamber vacuum resulting primarily from gas migration through the porous surface. Leak detection is based solely on the ability to detect the change in pressure inside the test chamber resulting from gas or vapor egress from a package challenged with vacuum.  
5.3 This test is a useful research tool for optimizing package sealing parameters and for comparatively evaluating various packages and materials. This test method is also applicable to production settings as it is rapid, non-invasive, and non-destructive, making it useful for either 100 % on-line testing or to perform tests on a statistical sampling from the production operation.  
5.4 Leak test results that exceed the permissible limits for the vacuum decay test are indicated by audible or visual signal responses, or both.
SCOPE
1.1 Test Packages—Packages that can be nondestructively evaluated by this test method include:  
1.1.1 Rigid and semi-rigid non-lidded trays.  
1.1.2 Trays or cups sealed with porous barrier lidding material.  
1.1.3 Rigid, nonporous packages.  
1.1.4 Flexible, nonporous packages.  
1.2 Leaks Detected—This test method detects package leaks by measuring the rise in pressure (vacuum loss) in an enclosed evacuated test chamber containing the test package. Vacuum loss results from leakage of test package headspace gases and/or volatilization of test package liquid contents located in or near the leak. When testing for leaks that may be partially or completely plugged with the package’s liquid contents, the test chamber is evacuated to a pressure below the liquid’s vaporization pressure. All methods require a test chamber to contain the test package and a leak detection system designed with one or more pressure transducers. Test method sensitivities cited below were determined using specific product-package systems selected for the precision and bias studies summarized in Table 1. Table 1 also lists other examples of relevant product-package systems that can be tested for leakage by vacuum decay.    
1.2.1 Trays or Cups (Non-lidded) (Air Leakage)—Hole or crack defects in the wall of the tray/cup of at least 50 μm in diameter can be detected. Nonlidded trays were tested at a Target Vacuum of –4·E4 Pa (–400 mbar).  
1.2.2 Trays Sealed with Porous Barrier Lidding Material (Headspace Gas Leakage)—Hole or crack defects in the wall of the tray/cup of at least 100 μm in diameter can be detected. Channel defects in the seal area (made using wires of 125 μm in diameter) can be detected. Severe seal bonding defects in both continuous adhesive and dot matrix adhesive package systems can be detected. Slightly incomplete dot matrix adhesive bonding defects can also be detected. All porous barrier lidding material packages were tested at a Target Vacuum of –4·E4 Pa (–400 mbar). The sensitivity of the test for porous lidded packages is approximately E-2 Pa·m3·s-1 using a calibrated volumetric airflow meter.  
1.2.3 Rigid, Nonporous Packages (Headspace Gas Leakage)—Hole defects of at least 5 μm in diameter can be detected. Plastic bottles with screw caps were tested at a target vacuum...

SIGNIFICANCE AND USE
5.1 The O2GTR is an important determinant of the packaging protection afforded by barrier materials. It is not, however, the sole determinant, and additional tests, based on experience, must be used to correlate packaging performance with O2GTR. It is suitable as a referee method of testing, provided that the purchaser and the seller have agreed on sampling procedures, standardization procedures, test conditions, and acceptance criteria.  
5.2 Testing which has compared select instruments with other sensors to the instruments specifically described in Test Method D3985 is shown in Section 16, Precision and Bias, of this method.  
5.3 The Precision and Bias section of this method shows results using several instruments with non-coulometric and coulometric sensors.
SCOPE
1.1 This test method covers a procedure for determination of the steady-state rate of transmission of oxygen gas through plastics in the form of film, sheeting, laminates, coextrusions, or plastic-coated papers or fabrics. It provides for the determination of (1) oxygen gas transmission rate (O2GTR), (2) the permeance of the film to oxygen gas (PO2), and (3) oxygen permeability coefficient (P′O2) in the case of homogeneous materials.  
1.2 This test method does not purport to be the only method for measurement of O2GTR. There may be other methods of O2GTR determination that use other oxygen sensors and procedures.  
1.3 This test method has intentionally been prepared to allow for the use of various sensors, devices, and procedures. The precision and bias of each design needs to be individually established to determine the applicability of that instrument or method to meet the needs of the user.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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.

SIGNIFICANCE AND USE
5.1 O2GTR at a given temperature and %RH is an important determinant of the packaging protection afforded by barrier materials. It is not, however the sole determinant, and additional tests, based on experience, must be used to correlate packaging performance with O2GTR. It is suitable as a referee method of testing, provided that purchaser and seller have agreed on sampling procedures, standardization procedures, test conditions and acceptance criteria.
SCOPE
1.1 This test method covers a procedure for determination of the rate of transmission of oxygen gas, at steady-state, at a given temperature and %RH level, through film, sheeting, laminates, co-extrusions, or plastic-coated papers or fabrics. This test method extends the common practice dealing with zero humidity or, at best, an assumed humidity. Humidity plays an important role in the oxygen gas transmission rate (O2GTR) of many materials. This test method provides for the determination of oxygen gas transmission rate (O2GTR), the permeance of the film to oxygen gas (PO2), the permeation coefficient of the film to its thickness (P”O2), and oxygen permeability coefficient (PʹO2) in the case of homogeneous materials at given temperature and %RH level(s).  
1.2 The values stated in SI units are to be regarded as 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. Specific precautionary statements are given in Section 9.  
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.

SIGNIFICANCE AND USE
5.1 Carbon dioxide gas transmission rate (CO2TR) is an important determinant of the packaging protection afforded by barrier materials. It is not, however, the sole determinant, and additional tests, based on experience, must be used to correlate packaging performance with CO2TR. It is suitable as a referee method of testing, provided that purchaser and seller have agreed on sampling procedures, standardization procedures, test conditions and acceptance criteria.
SCOPE
1.1 This method covers a procedure for determination of the steady-state rate of transmission of carbon dioxide gas through plastics in the form of film, sheeting, laminates, coextrusions, or plastic-coated papers or fabrics. It provides for the determination of (1) carbon dioxide gas transmission rate (CO2TR), (2) the permeance of the film to carbon dioxide gas (PCO2), and (3) carbon dioxide permeability coefficient (P’CO2) in the case of homogeneous materials.  
1.2 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.  
1.3 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.

SIGNIFICANCE AND USE
5.1 No single set of test conditions can represent all climatic and use conditions, so this WVTR test method serves more to compare different materials at a stated set of conditions than to predict their actual performance in the field under any conditions.  
5.2 The water vapor transmission rate, under known and carefully controlled conditions, may be used to evaluate the vapor barrier qualities of a sheet. Direct correlation of values obtained under different conditions of test temperature and relative humidity will be valid provided the barrier material under test does not undergo changes in solid state (such as a crystalline transition or melting point) at or between the conditions of test.
SCOPE
1.1 This test method covers dynamic evaluation of the rate of transfer of water vapor through a flexible barrier material and allows conversion to the generally recognized units of water vapor transmission (WVT) as obtained by various other test methods including the gravimetric method described in Test Methods E96/E96M.  
1.2 Limitations—This test method is limited to flexible barrier sheet materials composed of either completely hydrophobic materials, or combinations of hydrophobic and hydrophilic materials having at least one surface that is hydrophobic.  
1.3 The minimum test value obtained by this test method is limited by the leakage of water vapor past the clamping seals of the test instrument. A reasonable value may be approximately 0.01 g/24 h·m2 for any WVTR method including the desiccant procedure of Test Methods E96/E96M at 37.8 °C, and 90 % relative humidity. This limit can be checked for each instrument with an impervious specimen such as aluminum foil. Calibration procedures can compensate for the leakage rate if so stated.  
1.4 This test method is not suitable for referee testing at this time, but is suitable for control testing and material comparison.  
1.5 Several other ASTM test methods are available to test a similar property. This test method is unique in that it closely duplicates typical product storage where a transfer of moisture from a package into the environment is allowed to proceed without constantly sweeping the environmental side with dry gas. Methods with constantly swept dry sides include Test Methods F1249 and F3299.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.  
1.8 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.

SIGNIFICANCE AND USE
5.1 The purpose of this test method is to obtain reliable values for the WVTR of plastic film and sheeting.  
5.2 WVTR is an important property of packaging materials and can often be directly related to shelf life and packaged product stability.  
5.3 Data from this test method is suitable as a referee method of testing, provided that the purchaser and seller have agreed on sampling procedures, standardization procedures, test conditions, and acceptance criteria.
SCOPE
1.1 This test method covers a procedure for determining the rate of water vapor transmission through flexible barrier materials. The method is applicable to sheets and films up to 3 mm (0.1 in.) in thickness, consisting of single or multilayer synthetic or natural polymers and foils, including coated materials. It provides for the determination of (1) water vapor transmission rate (WVTR), (2) the permeance of the film to water vapor, and (3) for homogeneous materials, water vapor permeability coefficient.  
Note 1: Values for water vapor permeance and water vapor permeability must be used with caution. The inverse relationship of WVTR to thickness and the direct relationship of WVTR to the partial pressure differential of water vapor may not always apply.  
1.2 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.  
1.3 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.

SIGNIFICANCE AND USE
5.1 Oxygen gas transmission rate is an important determinant of the protection afforded by barrier materials. It is not, however, the sole determinant, and additional tests, based on experience, must be used to correlate package performance with O2GTR. This test method is suitable as a referee method of testing, provided that the user and source have agreed on sampling procedures, standardization procedures, test conditions, and acceptance criteria.
SCOPE
1.1 This test method covers a procedure for the determination of the steady-state rate of transmission of oxygen gas into packages. More specifically, the method is applicable to packages that in normal use will enclose a dry environment.  
1.2 The values stated in SI units are to be regarded as 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.

SIGNIFICANCE AND USE
5.1 This test provides a rapid means of evaluating tendencies for package seal failure when the package is exposed to a pressure differential. Pressure differentials may occur during such processes as sterilization and transportation. This test method provides an indicator of the burst strength of a package, where the burst will normally occur in one or more areas of the seal. An indicator of the minimum burst strength may be of importance to the package manufacturer and end user in ensuring adequate package integrity. This test method cannot provide a measure of package seal uniformity. This test method also cannot provide an evaluation of overall package integrity or the burst strength of areas of the package that contact the surface of the restraining plates used. This test method should be combined with other methods of evaluating overall package integrity, uniformity of the package seal, or opening functionality, if so required.  
5.2 This test frequently is used to quickly evaluate package seal strength during the manufacturing process and at various stages of the package's life cycle.  
5.3 If correlations between pieces of test equipment are to be made it is important that all parameters of the test be equivalent. Typical parameters can include, but are not limited to the package size, material, type and configuration of seal, rate of air flow into the package, pressure detection sensing mechanism and sensitivity (machine response to pressure drop), position of test article, rigidity of restraining plates, and distance between restraining plates. See Appendix X2 for further information.  
5.4 This test may not necessarily provide correlation with package seal strength as typically measured using Test Methods F1140 or F88 (or equivalents).
SCOPE
1.1 This test method covers the procedure for determining the minimum burst strength of a seal placed around the perimeter of a flexible package as it is internally pressurized and enclosed within restraining plates.  
1.2 The test methods described herein are functionally similar to Test Methods F1140 with the exception of the use of restraining plates. Test Methods F1140 describes methods of burst testing that do not include the use of restraining plates and are suitable to determine a packages general ability to withstand pressurization stresses. Under Test Methods F1140 the stresses are not distributed uniformly to all areas of the package seal. Under unrestrained conditions the stress on the package is highest at the middle of the pouch where it inflates to the packages maximum diameter; therefore, Test Methods F1140 may not reliably detect the weakest area of the seal.  
1.3 The burst test internally and increasingly pressurizes a package until an area of the package seal around the perimeter “bursts” open in response to pressurization. By placing the package within restraining plates during pressurization, the dimensional stability of the package is maintained in a manner that results in stresses applied more uniformly along the perimeter of the package, where seals are normally placed. This allows the test to have a higher probability of detecting the weakest area of the seal and provide a measurement of the pressure required to “burst” open the package.  
1.4 This test only applies to flexible packages with seals placed around the perimeter of a flexible package (often referred to as a pouch). In particular it is intended as applicable to packages with seals that have a peelable seal feature (peeled open by end user to remove contents of package).  
1.4.1 Porous barrier materials' failure to reach adequate pressure to burst the package seals may be due to insufficient volume flow. See Appendix X4 for information.  
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 are not necessarily exact equivalents; therefore, to ensure conformance with t...

SIGNIFICANCE AND USE
3.1 This material challenge is presented in ISO-11607-1 Annex C as a normative test method to demonstrate that a material is nonporous and satisfies the microbial barrier requirements.
SCOPE
1.1 This test method is to be used to verify a specific material design property. Some flexible barrier materials are designed to have a resistance to the passage of air through the membrane structure. These materials are characterized as nonporous. This test method provides a means to verify this property by challenging a material with a given volume of air under pressure over a specific time period.  
1.2 This test method is not intended to measure the diffusion properties of a material nor to identify or quantify the presence of pinhole damage to the design that may result in leaks.  
1.3 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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.  
1.5 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.

SIGNIFICANCE AND USE
3.1 This classification scheme defines the type of motions, skills, or tools required for a particular type of child-resistant package and provides examples of current packaging within that type.  
3.2 Reference to a particular package in this classification is not intended in any manner to denote endorsement or approval of the package by ASTM.  
3.3 Packages have been included as examples based on manufacturers' claims of child-resistance. Child-resistant package functionality for any specific product type must be determined by the packager/manufacturer following the guidelines of the PPPA of 1970 and the most current version of the CFR Title 16 Part 1700 and Title 40 Part 157.2 The listing of a package in this classification is not an indication of whether or not it has been successfully tested in accordance with the aforementioned guidelines.  
3.4 Additions or deletions to the examples should be reported to Subcommittee F02.50 on Package Design and Development, for incorporation into this classification during the next revision.  
3.5 Additions require F02.50 Task Group review of CFR Title 16 Part 1700 full protocol testing reports. Reports should cover procedures and all CFR Title 16 Part 1700 required reporting elements. Additional information may be requested.  
3.6 Use of a package cited in this classification allows for the statement “CONFORMS TO ASTM D3475,” and does not allow for the use of the ASTM logo or result in an ASTM certification mark.
SCOPE
1.1 This classification covers various types of child-resistant packages.  
1.2 The examples for each type of child-resistant packaging are not intended to be all-inclusive, but are included only as an aid in the understanding and comprehension of each type of classification.  
1.3 Listings are not to be considered endorsements or approval of the package by ASTM.  
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.

SIGNIFICANCE AND USE
5.1 Test Method F88 has been the standard for the mechanical peel strength testing of peelable seals since the 1960s. Normally the testing is run on a portion of the seal. The result is an actual seal strength picture of that portion of the seal. This test method is different in that the entire package seal is peeled open and data collected for the entire sealed area.  
5.2 This test method is a tool for quality assurance use as well as performance evaluation of a seal during separation.  
5.3 With appropriate software, data is collected depicting the seal strength of the entire length of the seal. As a result, it is possible to see seal strength variations, as the seal is peeled apart, thereby evaluating the consistency and uniformity of the seal (see Fig. 1).
SCOPE
1.1 This test method describes a method for the measurement of mechanical seal strength while separating the entire lid (cover/membrane) from a rigid or semi-rigid round container.  
1.2 This test method differs from Test Method F88. Test Method F88 tests a portion of the seal where as this test method tests the force required to separate the entire lid (cover/membrane) from the container.  
1.3 This test method is used to determine the continuous and maximum forces required to separate the lid (cover/membrane) from the container.  
1.4 This test method uses an angle of pull of 45°, however other angles of pull may be used provided results are documented noting the used angle of pull and said procedure is validated.  
1.5 Typical examples of container shapes that could be tested using this or a similar method include oval, rectangular, and circular with single or multiple cavities having a sealed lid (cover/membrane). Examples of products packaged in these types of containers are: ready meals, creamers, coffee, yogurts, household fresheners, chemical and pharmaceutical products, and numerous others not mentioned. However, this test method, described within, is specifically for round containers.  
1.6 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.  
1.7 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.  
1.8 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.