5.1 The major objective of this practice is to provide a common reference document for both applicants and certification authorities on the accepted practices for accomplishing package thermal qualification. Details and methods for accomplishing qualification are described in this document in more specific detail than available in the regulations. Methods that have been shown by experience to lead to successful qualification are emphasized. Possible problems and pitfalls that lead to unsatisfactory results are also described.5.2 The work described in this standard practice shall be done under a quality assurance program that is accepted by the regulatory authority that certifies the package for use. For packages certified in the United States, 10 CFR 71 Subpart H shall be used as the basis for the quality assurance (QA) program, while for international certification, ISO 9000 usually defines the appropriate program. The quality assurance program shall be in place and functioning prior to the initiation of any physical or analytical testing activities and prior to submittal of any information to the certifying authority.1.1 This practice defines detailed methods for thermal qualification of “Type B” radioactive materials packages under Title 10, Code of Federal Regulations, Part 71 (10CFR71) in the United States or, under International Atomic Energy Agency Regulation SSR-6. Under these regulations, packages transporting what are designated to be Type B quantities of radioactive material shall be demonstrated to be capable of withstanding a sequence of hypothetical accidents without significant release of contents.1.2 The unit system (SI metric or English) used for thermal qualification shall be agreed upon prior to submission of information to the certification authority. If SI units are to be standard, then use IEEE/ASTM SI-10. Additional units given in parentheses are for information purposes only.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.4 This standard is used to measure and describe the response of materials, products, or assemblies to heat and flame under controlled conditions, but does not by itself incorporate all factors required for fire hazard or fire risk assessment of the materials, products, or assemblies under actual fire conditions.1.5 Fire testing is inherently hazardous. Adequate safeguards for personnel and property shall be employed in conducting these tests.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.

定价： 843元 / 折扣价： 717 元 加购物车

5.1 This test method allows for the measurement of the torque retention properties of container/continuous thread closure systems of various designs, materials, and manufacture, and is suitable for packaging development and engineering evaluation.5.2 This test method can be used for the evaluation of container/continuous thread closure systems under controlled conditions (where the application torque is known and the applied downward force to the closure is zero).5.3 This test method measures torque retention properties of container/continuous thread closure systems with the use of a non-automated, spring torque-meter (with either a dial indicator or a digital readout) or a torque wrench.1.1 These test methods evaluate the torque retention of continuous thread closures on containers, with matching finishes, for predetermined environmental conditions over time.1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.NOTE 1: The SI unit system is the recommended system.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 515元 / 折扣价： 438 元 加购物车

This practice covers methods of testing, rating, and installation of internal combustion engine packages used in hazardous areas in marine applications. The purpose of this practice is to thermally rate engine packages, and provide additional installation recommendations to reduce the risk of igniting ignitable mixtures that may be present near the hazardous areas of marine vessels. In this specification, only a marine engine suitable for the service, designed and constructed in accordance with the requirements of 3.2.1, is considered. Thermal rating of the engine is determined by the actual readings of engine and exhausts system temperatures within hazardous areas, as defined by the requirements and references in Practices 2.2 and 2.3 or as designated by the authority.1.1 This practice covers the method of testing, rating and installation of internal combustion engine packages for use in hazardous areas in marine applications. The thermal rating of the engine is determined by the actual readings of engine and exhaust system temperatures within hazardous areas, as defined by references in Section 2 of this practice, or as designated by the authority having jurisdiction, or both. The goal of this practice is to thermally rate engine packages, and provide additional installation recommendations, in order to reduce the risk of igniting the ignitable mixtures that may be present within the hazardous areas of marine vessels.1.2 Only a marine engine suitable for the service, designed and constructed in conformance with the requirements of 3.1.2, is considered.1.3 The system of units in this practice shall be SI (metric) form, along with the standard (English) system equivalent placed in parentheses, for example, 20 °C (68 °F).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.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.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.

定价： 515元 / 折扣价： 438 元 加购物车

5.1 This test method allows for the measurement of the torque retention properties of container/continuous thread closure systems of various designs, materials, and manufacture, and is suitable for package development and engineering evaluation.5.2 Each test method can be used for the evaluation of non child resistant container/continuous thread closure systems under controlled conditions such as when the application torque is known and the applied downward force to the closure is zero or for Type I, style “A” push down and turn child resistant container/continuous thread closure systems under controlled conditions such as when the application torque and the applied downward force to the closure is known.5.3 This test method measures torque retention properties of container/continuous thread closure systems with the use of an automated transducer based torque meter operating at a known rotational velocity (rpm) or known torque ramp.5.4 This test method is intended for measurement of dry torque only.1.1 These test methods evaluate the torque retention of continuous thread closures on containers with matching finishes, for predetermined environmental conditions over time. Methods are defined for both Type I, style “A” push down and turn Type II2 child resistant and non child resistant type closures.1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.NOTE 1: The SI unit system is the recommended system.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

定价： 590元 / 折扣价： 502 元 加购物车

1.1 This standard establishes definitions for labeling of packaging materials and packages which communicate environmental attributes to consumers, users, or both. These definitions will include consideration of the production, use, and disposal of packaging materials and packages. (For a definition of packages, see Terminology D996).

定价： 0元 / 折扣价： 0 元

5.1 These test methods provide a rapid means of evaluating tendencies for package failure when the package is exposed to a pressure differential. Pressure differentials may occur during processes such as sterilization and transportation.5.2 These test methods are frequently used to quickly evaluate packages during the manufacturing process and at various stages of the package's life cycle.5.3 If correlations between pieces of test equipment are to be made, it is important that all parameters of the test method be exactly the same. Typical parameters may include, but are not limited to, package size, material, seal configuration, test equipment, rate of air flow into the package, sensitivity (machine response to pressure drop), and position of test article (see Fig. 1).FIG. 1 Open Package Test Positions5.4 These test methods do not necessarily provide correlation with actual package seal strength as typically measured using Test Method F88 (or equivalent).1.1 These test methods explain the procedure for determining the ability of packages to withstand internal pressurization.1.2 The burst test increasingly pressurizes the package until the package fails.1.3 The creep test maintains a specified pressure for a specified time or until the package fails.1.4 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.1.5 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.

定价： 590元 / 折扣价： 502 元 加购物车

5.1 Leaks in medical device, pharmaceutical, and food packages may result in the ingress of unwanted gases (most commonly oxygen), harmful microbiological, or particulate contaminants. Package leaks may appear as imperfections in the package components themselves or at the seal juncture between mated components. The ability to detect leaks is necessary to ensure consistency and integrity of packages.5.2 After initial set-up and calibration, individual test operation may be semi-automatic, automatic, or manual. The test method permits non-destructive detection of leaks not visibly detectable. The test method does not require the introduction of any extraneous materials or substances, such as dyes or gases. However, it is important to physically mask or block off any package porous barrier surface during the test to prevent rapid loss of chamber vacuum resulting primarily from gas migration through the porous surface. Leak detection is based solely on the ability to detect the change in pressure inside the test chamber resulting from gas or vapor egress from a package challenged with vacuum.5.3 This test is a useful research tool for optimizing package sealing parameters and for comparatively evaluating various packages and materials. This test method is also applicable to production settings as it is rapid, non-invasive, and non-destructive, making it useful for either 100 % on-line testing or to perform tests on a statistical sampling from the production operation.5.4 Leak test results that exceed the permissible limits for the vacuum decay test are indicated by audible or visual signal responses, or both.1.1 Test Packages—Packages that can be nondestructively evaluated by this test method include:1.1.1 Rigid and semi-rigid non-lidded trays.1.1.2 Trays or cups sealed with porous barrier lidding material.1.1.3 Rigid, nonporous packages.1.1.4 Flexible, nonporous packages.1.2 Leaks Detected—This test method detects package leaks by measuring the rise in pressure (vacuum loss) in an enclosed evacuated test chamber containing the test package. Vacuum loss results from leakage of test package headspace gases and/or volatilization of test package liquid contents located in or near the leak. When testing for leaks that may be partially or completely plugged with the package’s liquid contents, the test chamber is evacuated to a pressure below the liquid’s vaporization pressure. All methods require a test chamber to contain the test package and a leak detection system designed with one or more pressure transducers. Test method sensitivities cited below were determined using specific product-package systems selected for the precision and bias studies summarized in Table 1. Table 1 also lists other examples of relevant product-package systems that can be tested for leakage by vacuum decay.1.2.1 Trays or Cups (Non-lidded) (Air Leakage)—Hole or crack defects in the wall of the tray/cup of at least 50 μm in diameter can be detected. Nonlidded trays were tested at a Target Vacuum of –4·E4 Pa (–400 mbar).1.2.2 Trays Sealed with Porous Barrier Lidding Material (Headspace Gas Leakage)—Hole or crack defects in the wall of the tray/cup of at least 100 μm in diameter can be detected. Channel defects in the seal area (made using wires of 125 μm in diameter) can be detected. Severe seal bonding defects in both continuous adhesive and dot matrix adhesive package systems can be detected. Slightly incomplete dot matrix adhesive bonding defects can also be detected. All porous barrier lidding material packages were tested at a Target Vacuum of –4·E4 Pa (–400 mbar). The sensitivity of the test for porous lidded packages is approximately E-2 Pa·m3·s-1 using a calibrated volumetric airflow meter.1.2.3 Rigid, Nonporous Packages (Headspace Gas Leakage)—Hole defects of at least 5 μm in diameter can be detected. Plastic bottles with screw caps were tested at a target vacuum of –5·E4 Pa (–500 mbar). Using a calibrated volumetric airflow meter, the sensitivity of the test is approximately E-3.4 Pa·m3·s-1. Air-filled glass syringes were tested at a target vacuum of –7.5·E4 Pa (+250 mbar absolute) and again at a target vacuum of about +1 mbar absolute. The sensitivity of both tests is approximately E-4.1 Pa·m3·s-1 using a calibrated volumetric airflow meter.1.2.4 Rigid, Nonporous Packages (Liquid Leakage)—Hole defects of at least 5 μm in diameter can be detected. This detection limit was verified using a population of water-filled glass syringes tested at a target vacuum of about +1 mbar absolute.1.2.5 Flexible, Nonporous Packages (Gas or Liquid Leakage)—Such packages may also be tested by the vacuum decay method. Sensitivity data for flexible packages were not included in the precision and bias studies, although the use of vacuum decay for testing such packages is well known.1.3 Test Results—Test results are qualitative (Accept/Reject). Acceptance criteria are established by comparing quantitative baseline vacuum decay measurements obtained from control, non-leaking packages to measurements obtained using leaking packages, and to measurements obtained with the introduction of simulated leaks using a calibrated gas flow meter.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.

定价： 646元 / 折扣价： 550 元 加购物车

4.1 This test method is intended to evaluate the ability of packaging to resist the force of concentrated impacts from outside sources, such as those encountered in various modes of transportation and handling. These impacts may be inflicted by adjacent freight jostling against the package in a carrier vehicle, by accidental bumps against other freight when loaded or unloaded from vehicles, by packages bumping against one another during sorting on conveyors or chutes, or many other circumstances.4.2 This test method is intended to determine the ability of packaging to protect contents from such impacts, and to evaluate if there is sufficient clearance or support or both between the package wall and its contents.1.1 This test method covers procedures and equipment for testing complete filled transport packages for resistance against concentrated low-level impacts typical of those encountered in the distribution environment. The test is most appropriate for packages such as thin fluted/lighter grade corrugated boxes or stretch-wrapped packaging.1.2 The test result is a pass/fail determination, based on acceptance criteria previously established, and a record of the energy dissipated by the complete filled transport package during a low level concentrated impact.NOTE 1: This test method discusses the conduct of the test from a prescribed height that either meets or does not meet specific acceptance criteria. It may be possible to conduct this type of testing using modified procedures that provide a numerical response. These might include an incremental test where the drop height (or mass) is increased until a specific failure occurs or an up-and-down or staircase procedure used to find the average height to failure.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.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.

定价： 515元 / 折扣价： 438 元 加购物车

This specification covers the identification of: drug contained in the prefilled syringe or delivery sysetm and the concentration, volume, and total amount of the drug, and whether it is to be diluted prior to administration. The label copy shall comply with the specified requirements. Delivery systems shall not resemble a normal syringe and shall be unsuitable for direct intravenous line injection. The copy for the proprietary name or established name of the drug shall be legible in accordance with the legibility test.1.1 This specification covers the identification of:1.1.1 The drug contained in the prefilled syringe or delivery system.1.1.2 The concentration, volume, and total amount of the drug, and whether it is to be diluted prior to administration.1.2 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.NOTE 1: The values in SI units are the recommended values.

定价： 0元 / 折扣价： 0 元

4.1 This practice provides a guide for the evaluation of shipping units in accordance with a uniform system, using established test methods at levels representative of those occurring in actual distribution. The recommended test levels are based on available information on the shipping and handling environment, and current industry/government practice and experience. The tests should be performed sequentially on the same containers in the order given. For use as a performance test, this practice requires that the shipping unit tested remain unopened until the sequence of tests are completed. If used for other purposes, such as package development, it may be useful to open and inspect shipping units at various times throughout the sequence. This may, however, prohibit evaluating the influence of the container closure on container performance.1.1 This practice provides a uniform basis of evaluating, in a laboratory, the ability of shipping units, weighing up to but not exceeding 150 lb (68 kg), intended for the single parcel delivery system to withstand the hazards associated with the distribution environment. This is accomplished by subjecting them to a test plan consisting of a sequence of anticipated hazard elements encountered in the distribution cycles. This practice is not intended to supplant material specifications or existing pre-shipment test procedures.1.2 The suitability of this practice for use with hazardous materials has not been determined.1.3 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Specific precautionary statements are given in 1.1.

定价： 590元 / 折扣价： 502 元 加购物车

Hermeticity test methods, for example, Test Methods F 134, deal with sealed packages only and do not apply directly to unsealed packages. This test method is most applicable for determining the hermeticity of a package before it has been sealed with a lid or a cover. Packages that are intended for hermetic seal use are manufactured so as to prevent leakage of helium at a rate in excess of 1 × 10 −8 atm cc/s under a pressure differential of 1 atm when tested on a helium mass spectrometer leak detector. This test should be conducted in a clean work area such as would be provided by a laminar flow clean bench as specified in Fed. Std. No. 209. This test method is not recommended for use in commerce until the precision has been determined.Acceptance and rejection criteria for this test method shall be agreed upon by the purchaser and the supplier as part of the purchase contract.Note 1—Packages that are not capable of meeting a maximum leak rate of 1 × 10 −8 atm cc/s of helium at a pressure differential of 1 atm are customarily rejected on the basis that good quality assurance is achieved with this performance level.1.1 The hermetic integrity of hybrid microcircuit packages is an important material or parts acceptance requirement. Determination of this parameter should be made before the hybrid circuit is assembled and sealed inside the package.1.2 This test method covers a test for leaks in a package that is intended to be hermetically sealed after hybrid circuit assembly. Various types of hybrid packages may be tested by this test method. The test method is nondestructive and therefore suitable for 100% inspection.1.3 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of 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.

定价： 0元 / 折扣价： 0 元

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.

定价： 590元 / 折扣价： 502 元 加购物车

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.

定价： 590元 / 折扣价： 502 元 加购物车

3.1 The oxygen content of a package’s headspace is an important determinant of the packaging protection afforded by barrier materials. The package under test is typically MAP (modified atmosphere packaging) packaged.3.2 Oxygen content is a key contributor to off-flavors and spoilage of various products, such as chemicals, food and pharmaceuticals.3.3 The method determines the oxygen in a closed package headspace. This ability has application in:3.3.1 Package Permeability Studies—The change of headspace composition over a known length of time allows the calculation of permeation. Since the headspace oxygen is measured as a percentage, the volume of the container’s headspace must be known to allow conversion into a quantity such as millilitres (ml) of oxygen. The use of this approach to measure permeation generally applies to empty package systems only as oxygen uptake or outgassing of contained products could affect results.3.3.2 Leak Detection—If the headspace contains more oxygen than expected or is increasing faster than expected, a leak can be suspected. A wide variety of techniques can be employed to verify that a leak is present and to identify its location. If necessary or of interest, a leak rate may be calculated with known headspace volume and measured oxygen concentration change over time.3.3.3 Efficacy of the MAP Packaging Process—If the headspace oxygen concentration is found to be higher than expected soon after packaging, the gas flushing process may not be working as well as expected. Various techniques can evaluate whether the MAP system is functioning properly.3.3.4 Storage Studies—As the method is non-destructive, the headspace can be monitored over time on individual samples to insure that results of storage studies such as shelf life testing are correctly interpreted.1.1 This test method covers a procedure for determination of the oxygen concentration in the headspace within a sealed package without opening or compromising the integrity of the package.1.2 This test method requires that chemically coated components be placed on the inside surface of the package before closing.1.3 The package must be either transparent, translucent, or a transparent window must be affixed to the package surface without affecting the package’s integrity.1.4 As this test method determines the oxygen headspace over time, the oxygen permeability can easily be calculated as ingress per unit time as long as the volume of the container is known.1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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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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