5.1 Leaks in medical, pharmaceutical, or food product packages can affect product quality and consumer safety. Such leaks can arise from imperfections in package material or between mated components designed to seal the package. Defects can allow unwanted gas (e.g. oxygen or water vapor), particulates, liquids, or microbiological contaminants into or out of the package. Package defect detection can be a critical part of ensuring product quality and consumer safety. Use of a physical CCI test method for sterile products can be used to assure the stability of the package sterility property during transportation and product shelf life.5.2 Mass extraction is a useful non-destructive test method for testing a wide variety of packages. Package shape and dimensions that can be tested using mass extraction are essentially unlimited, as long as a vacuum test chamber can be designed and manufactured to accommodate the package.5.3 This method produces quantitative flow measurement results that are useful in comparing package sealing properties, different batches of product, material properties, and combinations of process parameters.5.4 Applications for mass extraction range from manually loaded and operated machines to automatic unattended work cells. This method can be applied for audit testing or 100% in-line testing.NOTE 2: Leak test methods that rely on gas or vapor transport, such as mass extraction, are not able to detect defects if they become plugged by solid or nonvolatile matter. Plugging is possible by exposure to environmental contaminants. In some cases, the packaged product itself can clog defects. For example, leak paths may become blocked by suspended solids, gelatinous matter or dried-out solutions. Product clogging propensity is a function of the product formulation, defect size and geometry, and may be linked to product storage and handling conditions as well as the time allotted to defect exposure. An investigation into the impact of repeated test condition exposure on defect plugging is recommended if product-package units are to be subject to repeated leak testing. Clogging is a complex phenomenon that is not well characterized or understood. Care must be taken to ensure that any CCI test method based on gas or vapor transport through the leak path is appropriate for the intended product.1.1 This method provides a nondestructive means to detect holes (leaks) in a variety of non-porous rigid and semi-rigid packages.1.2 This test method detects package leaks by measuring the mass flow extracted from a package while the package is enclosed inside an evacuated test chamber. The test system is a closed system during the leakage measurement portion of the test cycle. The closed system includes a vacuum reservoir, Intelligent Molecular Flow Sensor (IMFS), and vacuum test chamber. Mass extracted from the test package into the vacuum test chamber flows to the vacuum reservoir through the IMFS to equalize the system. Mass flow rate from the vacuum chamber to the vacuum reservoir is measured by the IMFS. Based on the conservation of mass law, mass flow into the closed system is equal to the mass loss from the test package. The test system is capable of producing quantitative (variable data) or qualitative (pass/fail) results depending on the requirements.1.2.1 Headspace gas leakage defects equivalent to a 1µm diameter glass micropipette (sharp edge defect) can be detected at a 95% confidence level.1.2.2 Liquid leakage defects equivalent to a 1µm diameter glass micropipette can be detected at a 95% confidence level for glass vials and LDPE bottles. Liquid leakage defects equivalent to a 2 µm diameter glass micropipette can be detected for glass syringes.1.3 Units—The values stated in SI units are to be regarded as standard. Pressure units are expressed as Pa, mbar, or Torr.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.

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5.1 These test methods provide a rapid, simple to apply method to detect small leaks in flexible package seals or walls at the leak rate level of greater than 1 × 10−4 sccs, thus providing a measure of package integrity. Porous barrier film packages made non-porous with an impermeable film forming coating may demonstrate lateral leakage through the barrier material. Verification of leakage differences from background leakage must be included in validation methods. The use of calibrated hole sizes or orifices may be appropriate to determine leakage sensitivity or barrier integrity for these materials.5.2 While theoretical leak rate sensitivity can be established by calculation, the test measurement is in pressure units and the measuring instrument must be calibrated, certified, and verified with these units.5.3 The pressure decay method of leak testing is a physical measure of package integrity. When testing medical packaging which must conform to ISO 11607–1: 2006 standards, it may necessary to verify the results of the pressure decay test method with other sterile package integrity test methods.5.4 Test Method A allows packages to be pressurized without restraint. In Test Method A the pouch, tray, or other type package will contain a volume of air defined by its mechanical configuration and its ability to resist internal pressure applied. This test method requires that the package reach a stable volume configuration (stop stretching) to make a measurement.5.5 Test Method B allows the use of rigid restraining plates against the walls of the package to limit its volume and stabilize the package volume.1.1 These test methods cover the measurement of leaks in nonporous film, foil, or laminate flexible pouches and foil-sealed trays, which may be empty or enclose solid product. If product is enclosed, seals or surfaces cannot be in contact with water, oils, or other liquid.1.2 These test methods will detect leaks at a rate of 1 × 10−4 sccs (standard cubic centimetres per second) or greater, in flexible packages. The limitation of leak rate is dependent on package volume as tested.1.3 The following test methods are included:1.3.1 Test Method A—Pressure Decay Leak Test for Flexible Packages Without Restraining Plates1.3.2 Test Method B—Pressure Decay Leak Test for Flexible Packages With Restraining Plates1.4 These test methods are destructive in that they require entry into the package to supply an internal pressure of gas, typically air or nitrogen, although other gases may be used. The entry connection into the flexible package must be leak-tight.1.5 For porous packages, see 9.3.1.6 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard.1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 Core sampling is widely accepted, when applicable, for obtaining a laboratory sample representative of the clean wool fiber present in a lot of packaged raw wool.5.2 If the wool is so loosely packed that a core cannot be cut, or if it is so highly compressed that the sampling tool cannot readily penetrate into the package to the required depth and in the required direction, core sampling is not applicable. The density of wool in most types of commercial packages is suitable for sampling by this method.5.3 The procedure described in this practice is adapted to the application of statistical methods for estimating the size of sample required to achieve a required level of sample precision at minimum cost.NOTE 1: The basic sampling equipment, operating procedure, and statistical approach used in this practice have been adapted for sampling lots of wool for the determination of other properties that are not affected by boring, such as average fiber diameter, and for sampling lots of other bulk fibers in packages.FIG. 1 Small Diameter Wool Sampling Tool (United States Customs Service)(Metric equivalents may be calculated by multiplying inches by 25.4 to obtain equivalent dimensions in millimetres.)1.1 This practice for sampling covers a procedure for obtaining samples from lots of grease, pulled, or scoured wool or related animal fibers in bales or bags for the determination of the clean wool fiber present by a procedure similar to that described in Test Method D584.1.2 This practice provides a description of suitable core sampling equipment, the sampling procedure, and the method for determining the number of packages to be bored and the number of cores to be taken from each sampled package.1.3 Reliable estimates are given for the standard deviation of the percentage clean wool fiber present between packages and within packages for lots of many types of raw wool.1.4 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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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.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.

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This test method provides an evaluation of the quality of an in-line sealing process on a real time basis for sealed packages. It eliminates the need to expose the specimen to long exposures of high pressure to drive the helium gas into the package to later be detected by the same method herein used. Previously, separate test methods were required to detect large or small leaks. This method provides only one test to accomplish all test levels without potential for specimens with leaks to escape detection within the range of detection being employed (see Practices F 98).Both development and research, along with manufacturing control, may be served by using this test method. Current gross leak test methods and fine leak test methods may be combined into one using this method. No exposure to high pressure processing hazards is involved and safety of operation in production environment is enhanced.1.1 This test method applies to hermetic package leak testing to detect leaks of a broad spectrum in size with a minimum detection level equal to the sensitivity of the helium mass spectrometer equipment used in the test.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.

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4.1 This test method is intended for use for evaluating the performance of thermal insulated packaging used for high-value, high-risk materials. This test method may also be used for any product that requires accurate internal package temperature readings while being exposed to a range of external air temperatures.4.2 Certain items, such as biological materials, pharmaceuticals, diagnostics, and blood products, must be shipped inside temperature-controlled packages. Factors affecting the rate of heat transfer of the package include the insulation of the exterior package, the energy source, and the product payload.4.3 Because of the variety of factors affecting the performance of a thermally insulated package, testing should be conducted with the actual package whenever possible. When simulated packages are used, special care must be exercised so that the simulated payload and coolant will be as close as possible to the actual packages in temperature and other relevant physical properties.1.1 This test method covers the determination of the thermal insulation quality of a package and the thermal stability of its contents when exposed to variable ambient temperature conditions. It is suitable for testing packages with various internal energy sources with or without product payloads.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. Specific precautionary statements are given in 5.3.1.3 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.

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This standard includes Update No. 2. 1. Scope 1.1 General This Standard applies to nonreclosable packages for drugs and any other substances, in either liquid or solid form, that incorporate child-resistant features whereby children are restricted

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