1.1 本文所述的三种测试方法用于测量用于包装药品的高阻隔多单元容器（瓶）、高阻隔单单元容器（泡罩）和准阻隔单单元集装箱的水蒸气透过率（WVTR）。对容器进行封闭和密封测试。这些测试方法可用于所有消费者尺寸的初级容器和散装初级容器，其尺寸仅受设备尺寸、天平的称重能力和灵敏度的限制。 1.2 这些测试方法旨在具有足够的灵敏度和精度，以便在目前可用于药品的屏障包装的水平之间进行明确的区分。 1.3 有三种方法:方法A用于瓶子，方法B用于形成的阻挡泡，方法C用于形成的准阻挡泡。方法B和C可以适于与柔性袋一起使用。 1.4 这些试验方法使用重量测量来确定由于水蒸气传输到包装中以及随后被封装在包装内的干燥剂吸收而导致的重量增加率。包装暴露在典型的用于包装中药品加速稳定性测试的环境中（通常为40 °C/75%相对湿度[RH]）。 1.5 对于这些方法，平衡灵敏度、干燥剂的量、每个测试单元的气泡数量和称重频率是在基于测试方法的实验中开发的 96电子/96电子米 。 1.6 试验方法 96电子/96电子米 具体说明了称重频率、建立稳定状态所需的数据点数量、称重期间的最小增重和平衡灵敏度之间的相互作用。 1.7 本标准中的试验方法是专门针对作为封闭容器封闭系统的药瓶和水泡制定的。开发这些方法的实验提供了一个- 编写精确性和偏差声明的实验室研究。研究中的包装是小瓶和水泡，经常用于药物固体口服剂型。 1.8 尽管其应用具有特殊性质，但本标准中的测试方法应适用于其他药品包装以及大多数类型和尺寸的其他消费品包装。 1.9 以国际单位制表示的数值应视为标准。本标准中不包括其他计量单位。瓶子的计量单位是毫克/瓶/天- 天），并且对于水疱，每个水疱腔每天毫克（mg/腔天）。这些单元可用于标准测试和裁判测试。 1.10 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.11 本国际标准是根据世界贸易组织技术性贸易壁垒委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认的标准化原则制定的。 ====意义和用途====== 5.1 这些测试方法的目的是获得WVTR的可靠值，该值可用于区分药品的屏障包装。这些试验方法将建立一个WVTR值，该值表示正在评估的容器封闭系统的水蒸气透过率。它们旨在用于评估或比较，或两者兼而有之，用于药品包装的替代包装的水蒸气阻隔性能。 5.2 虽然这些方法是为特定的、有限的应用而开发的，但它们应该适用于大多数类型和尺寸的消费包装。

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 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.