F02.10 - Permeation

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 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
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 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
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
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 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 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 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 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 The OTR 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 OTR. 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 Limited statistical data on correlations with Test Method D1434 methods are available4; however, the oxygen transmission rate of a standard reference material (see 12.1) as determined manometrically by NIST, is in good agreement with the values obtained in the coulometric interlaboratory test using material from the same manufacturing lot. Thus, this test method may be used as a referee method.
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 (OTR), (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 OTR. There may be 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. No other units of measurement are included in this standard.  
1.4 This standard does not purport to address all of the safety problems, 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.  
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 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 Bar...

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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
5.1 The purpose of this test method is to obtain values for the water vapor transmission rate of barrier materials.  
5.2 Water vapor transmission rate 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/m2day 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 metric units are to be regarded as the standard. The acceptable units for water vapor transmission rate are usually g/m2day.  
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 and health practices and determine the applicability of regulatory limitations prior to use.

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 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. Agreement with other 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 known at this time. It is suggested that this method not be used for referee purposes unless purchaser and seller can both establish that they are measuring the same quantity to a mutually agreed upon level of precision.  
5.3 Use of the permeability coefficient (involving conversion of the gas transmission rate to a unit thickness basis) is not recommended unless the thickness-to-transmission rate relationship is known from previous studies. Even in essentially homogeneous structures, variations in morphology (as indicated, for example, by density) and thermal history may influence permeability.
SCOPE
1.1 This test method covers the estimation of 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 Two procedures are provided:  
1.2.1 Procedure M—Manometric.  
1.2.2 Procedure V—Volumetric.  
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 and health practices and determine the applicability of regulatory limitations prior to use.

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 the safety concerns 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 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 Standard Test Method D3985 and Standard 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 and health practices and determine the applicability of regulatory limitations prior to use.

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 (PO 2), 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 and health practices and determine the applicability of regulatory limitations prior to use. Specific precautionary statements are given in Section 9.

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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
5.1 Carbon dioxide gas transmission rate (CO2 TR) 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 (P’CO2) , 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 and health practices and determine the applicability of regulatory limitations prior to use.

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 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 and health practices and determine the applicability of regulatory limitations prior to use.

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·m 2 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, F372, and F1770.  
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 and health practices and determine the applicability of regulatory limitations prior to use.

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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
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.  
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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
The purpose of this test method is to obtain reliable values for the WVTR of plastic film and sheeting.
WVTR is an important property of packaging materials and can be directly related to shelf life and packaged product stability.
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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
The OTR 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 OTR. 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.
Limited statistical data on correlations with Test Method D1434 methods are available ; however, the oxygen transmission rate of a standard reference material (see 12.1) as determined manometrically by NIST, is in good agreement with the values obtained in the coulometric interlaboratory test using material from the same manufacturing lot. Thus, this test method may be used as a referee method.
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 (OTR), (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 OTR. There may be 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. No other units of measurement are included in this standard.
1.4 This standard does not purport to address all of the safety problems, 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
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.
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 E 96/E 96M.
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 E 96/E 96M 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 F 1249, F 372, and F 1770.
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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
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.
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. Agreement with other 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 known at this time. It is suggested that this method not be used for referee purposes unless purchaser and seller can both establish that they are measuring the same quantity to a mutually agreed upon level of precision.
Use of the permeability coefficient (involving conversion of the gas transmission rate to a unit thickness basis) is not recommended unless the thickness-to-transmission rate relationship is known from previous studies. Even in essentially homogeneous structures, variations in morphology (as indicated, for example, by density) and thermal history may influence permeability.
SCOPE
1.1 This test method covers the estimation of 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 Two procedures are provided:
1.2.1 Procedure M—Manometric.
1.2.2 Procedure V—Volumetric.
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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
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.
Testing which has compared select instruments with other sensors to the instruments specifically described in Test Method D 3985 is shown in Section 16, Precision and Bias, of this method.
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 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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
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.
Testing which has compared select instruments with other sensors to the instruments specifically described in Test Method D 3985 is shown in Section 16, Precision and Bias, of this method.
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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
This test method is valuable in the development and selection of flexible barrier materials suited for use as grease barriers.
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 the standard. The values given in parentheses are for information only.
1.3 This standard does not purport to address the safety concerns 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
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.
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.
Procedure B is more widely used when measuring the carbonation level of the package due to the simplicity of the technique. A simple Zahm-Nagle pressure assembly or Terris 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 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
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 (PO 2), the permeation coefficient of the film to its thickness (PO 2), and oxygen permeability coefficient (PO2) 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 and health practices and determine the applicability of regulatory limitations prior to use. Specific precautionary statements are given in Section 9.

SIGNIFICANCE AND USE
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.
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.

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 1Values 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.
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
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.
Limited statistical data on correlations with Test Method D 1434 methods are available3 ; however, the oxygen transmission rate of a standard reference material (see 12.1) as determined manometrically by NIST, is in good agreement with the values obtained in the coulometric interlaboratory test using material from the same manufacturing lot. Thus, this test method may be used as a referee method.
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 standard does not purport to address all of the safety problems, 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.
1.3 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.

SIGNIFICANCE AND USE
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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
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.
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 E 96.
1.2 LimitationsThis 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 hm 2 for any WVTR method including the desiccant procedure of Test Methods E 96 at 37.8C (100F), 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 The values stated in SI units are to be regarded as standard. The values gives in parentheses are provided for information purposes only.
1.6 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 F 1249, ASTM F 372, and ASTM F 1770.
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 and health practices and determine the applicability of regulatory limitations prior to use.

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 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
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 Zahm-Nagle pressure assembly or Terris 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 This standard does not purport to address all of the safety problems, 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.

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 (P'O2), and oxygen permeability coefficient (P''O2) in the case of homogeneous materials at given temperature and %RH levels(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 and health practices and determine the applicability of regulatory limitations prior to use. Specific precautionary statements are given in Section 9.

SIGNIFICANCE AND USE
This test method determines the water vapor barrier properties of the package. With proper precautions and background experience, reproducible results can be obtained to aid in the selection of proper package materials required to provide the product shelf-life desired. This test method may be used to establish a performance specification.
SCOPE
1.1 This test method covers the determination of the amount of water vapor transmission for flexible heat-sealed packages under specified conditions of exposure.
Note 1—Adequate heat-seal efficiency should be determined prior to this test method.
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 and health practices and determine the applicability of regulatory limitations prior to use.

SIGNIFICANCE AND USE
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.
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. Agreement with other 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 known at this time. It is suggested that this method not be used for referee purposes unless purchaser and seller can both establish that they are measuring the same quantity to a mutually agreed upon level of precision.
Use of the permeability coefficient (involving conversion of the gas transmission rate to a unit thickness basis) is not recommended unless the thickness-to-transmission rate relationship is known from previous studies. Even in essentially homogeneous structures, variations in morphology (as indicated, for example, by density) and thermal history may influence permeability.
SCOPE
1.1 This test method covers the estimation of 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 Two procedures are provided:
1.2.1 Procedure M Manometric.
1.2.2 Procedure V Volumetric.
1.3 The values stated in SI units are to be regarded as the standard.
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
This test method is valuable in the development and selection of flexible barrier materials suited for use as grease barriers.
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  This standard does not purport to address the safety problems 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
This test method determines the water vapor barrier properties of the package. With proper precautions and background experience, reproducible results can be obtained to aid in the selection of proper package materials required to provide the product shelf-life desired. This test method may be used to establish a performance specification.
SCOPE
1.1 This test method covers the determination of the amount of water vapor transmission for flexible heat-sealed packages under specified conditions of exposure.
Note 1—Adequate heat-seal efficiency should be determined prior to this test 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 and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This test method covered the determination of the amount of water vapor transmission for flexible heat-sealed packages under specified conditions of exposure.
Formerly under the jurisdiction of Committee F02 on Primary Barrier Packaging, this test method was withdrawn in January 2018 and replaced by Test Methods D7709 on Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters.1
Test Method D3079 has no ILS data and a search within ASTM yields no data to justify the statements presented in the precision and bias sections. Additionally, Test Method D3079 is not written as thoroughly as Test Methods D7709. The scope of Test Methods D7709 mentions that it can be adapted for use with flexible pouches. As Test Methods D7709 contains a complete ILS, along with examples of calculations, users should look to this standard for a gravimetric method for the measurement of the WVTR of packages.

SIGNIFICANCE AND USE
The purpose of this test method is to rapidly obtain reliable values for the WVTR of barrier materials.
The WVTR is an important property of packaging materials, which can be related to shelf life and product stability.
In any application, the WVTR of a barrier material is determined by its permeance under the given conditions. In most cases, the WVTR will increase when the absolute humidity is increased on the wet side of the barrier and when the temperature of the environment increases, particularly if a polymeric material is the primary water vapor barrier in the construction.
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 the water vapor are not always linear.
SCOPE
1.1 This test method covers a rapid procedure for determining the rate of water vapor transmission of flexible barrier materials in film or sheet form. This test method is applicable to sheets and films up to 3 mm in thickness, consisting of single-layer or multilayer synthetic or natural polymers and metal foils including coated materials.
1.2 This standard does not purport to address all of the safety problems, 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.
WITHDRAWN RATIONALE
This test method covers a rapid procedure for determining the rate of water vapor transmission of flexible barrier materials in film or sheet form. This test method is applicable to sheets and films up to 3 mm in thickness, consisting of single-layer or multilayer synthetic or natural polymers and metal foils including coated materials.
Formerly under the jurisdiction of Committee F02 on Flexible Barrier Packaging, this test method was withdrawn in May 2009 because it is no longer commonly used.