1.1 测试包- 该测试方法可应用于用柔性薄膜密封的无孔泡罩包装，例如用于药物包装的那些。这种泡罩包装通常由热成型聚合物或冷成型铝托盘组成，所述托盘包含多个单独的泡罩袋，片剂或胶囊被放置在其中。然后用聚合物、纸背或箔基柔性层压盖材料密封托盘。 1.2 检测到泄漏- 该测试方法通过测量泡罩包装表面响应于施加的真空的偏转来检测泡罩包装中的泄漏。泡罩包装表面的这种偏转是由泡罩包装内部的气体和所施加的真空之间的压力差引起的。由于泄漏导致的泡罩袋内的空气损失将改变该压力差，从而导致泡罩袋偏转的可测量变化。该测试方法要求将泡罩包装保持在合适的测试室内的合适工具中。 1.3 测试结果- 定性报告测试结果（通过/失败）。适当的验收标准 偏转 , 高度 ，和 崩溃 通过将无泄漏包装与包含已知尺寸缺陷的包装进行比较来确定值。使用该测试方法可以检测层压材料、托盘材料和密封件中适当尺寸的缺陷。该测试方法的灵敏度取决于一系列因素，包括泡罩袋顶部空间、泡罩袋尺寸、封盖材料类型、封盖材料厚度、封盖材料张力、印刷、表面纹理、测试条件和为通过/失败验收标准选择的值。在一项研究中证明了该试验能够检测四种泡罩包装设计中15µm、50µm和灾难性尺寸的孔洞。1.4 以SI单位表示的值被视为标准值，本试验方法不包括其他测量单位。 1.5 本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。 1.6 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 泡罩包装中的泄漏可能影响产品质量，并且此类缺陷可能由包装材料中的缺陷或密封表面之间的粘合引起。5.2 这种泄漏测试方法是一种有用的工具，因为它允许对泡罩包装进行非破坏性和非主观的泄漏测试。它允许操作员评估不同的包装材料和包装机条件如何影响包装的完整性。它还可以提供包装条件中不需要的变化的指示。 5.3 由于其非破坏性、清洁度和速度，此类测试通常用于药品包装生产、稳定性试验以及包装研发操作。

1.1 Test Packages— This test method can be applied to non-porous blister packs sealed with flexible films such as those used in pharmaceutical packaging. Such blister packs typically consist of thermoformed polymer or cold formed aluminum trays that contain a number of individual blister pockets into which tablets or capsules are placed. The trays are then sealed with a polymer, paper-backed or foil-based flexible laminate lidding material. 1.2 Leaks Detected— This test method detects leaks in blister packs by measuring the deflection of the blister pack surface in response to an applied vacuum. This deflection of the blister pack surface results from the difference in pressure between the gas inside the blister pack and the applied vacuum. Air loss from within a blister pocket as a result of a leak will alter this pressure differential causing a measureable variation in blister pocket deflection. This test method requires that the blister packs are held in appropriate tooling inside a suitable test chamber. 1.3 Test Results— Test results are reported qualitatively (pass/fail). Appropriate acceptance criteria for deflection , height , and collapse values are established by comparing non-leaking packs with those containing defects of a known size. Suitably sized defects in the laminate, tray material, and seal can be detected using this test method. The sensitivity of this test method depends upon a range of factors including blister pocket headspace, blister pocket size, lidding material type, lidding material thickness, lidding material tension, printing, surface texture, test conditions, and the values selected for the pass/fail acceptance criteria. The ability of the test to detect 15 µm, 50 µm, and catastrophic sized holes in four blister pack designs was demonstrated in a study. 1.4 The values stated in SI units are to be regarded as standard and no other units of measurement are included in this test method. 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 Leaks in blister packs may affect product quality and such defects can arise from imperfections in the packaging material or bond between the sealed surfaces. 5.2 This method of leak testing is a useful tool as it allows non-destructive and non-subjective leak testing of blister packs. It allows the operator to evaluate how different packaging materials and packaging machine conditions affect the integrity of the packaging. It can also provide indication of unwanted changes in the packaging conditions. 5.3 This type of testing is typically used in pharmaceutical packaging production, during stability trials and for package research and development operations because of its non-destructive nature, cleanliness, and speed.