CONTAINERS—PERFORMANCE TESTING

á671ñ CONTAINERS—PERFORMANCE TESTING

容器密闭完整性检测（CCIT）的“精度”与“精度”选择

导言
很多用户在选择设备的时候对设备的精度有比较高的要求，并且在验证的时候要求达到该要求，这对于具有度量衡资质的设备来说直接测量轻而易取；而对于某些密封性检测设备而言，如真空衰减法、压力衰减法等，这些属于应用科学，无法直接测量，需借助外部具有度量衡资质的设备才能对其进行准确计量，因此部分密封性检测设备是只能定性（结果），而不能定量（结果多少）；某些国外厂家对精度的描述也更多采用的是灵敏度（sensitivity）而非实际精度（precision），大部分测量也是采用泄漏率来进行相关计算。

Understanding Container Closure Integrity Testing

Understanding container closure integrity systems, reviewing past observations, and following the regulations and guidance documents are excellent ways to establish a compliant container closure integrity assay. This article describes recent changes to the United States Pharmacopeia (USP) , guidance documents, regulatory observations, common container closure methods, and provides recommendations on developing and validating a compliant container closure integrity test.

基于USP<1207>39中关于真空衰减法的描述与应用详解

真空衰减法原理简介：

“对放置样品的密闭测试腔抽取真空，达到稳定状态后观察真空度的变化，若真空度的变化值小于设定的阈值，或比对值小于设置的参数，则样品包装视为合格；若真空度的变化值大于设定的阈值，或比对值大于设置的参数，则样品包装视为不合格。”

Selection of Containers/Closures for Use in Lyophilization Applications: Possibilities and Limitations

Abstract
The unit operation of freeze-drying is commonly employed in the pharmaceutical industry to enhance the storage stability of relatively fragile biopharmaceuticals. Yet without a suitable container closure system, the advantages of freeze-drying a biopharmaceutical product cannot be fully realized and appreciated. Primary packaging provides the first line of defense for all pharmaceutical products by maintaining the critical quality attributes (CQAs) throughout the product shelf life. Although primary packaging components are intended to provide a stable environment for the pharmaceutical products, without proper understanding they can affect the product adversely by adsorption, absorption, leaching and permeation. For biologic products, proper selection of container and closure (c/c) components is even more important as they are more sensitive compared to other small molecule pharmaceuticals. Additionally, c/c also impacts the lyophilization process development and ultimately the drug product characteristics. The composition and processing history of the packaging components can play significant role as the impurities and residuals can induce destabilization and alter the drug product characteristics. It is critical, therefore, to understand and address all of these concerns related to c/c selection for successfully developing a stable biologic product to avoid potential product incompatibilities.