ASTM2338-09

Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method1

Guidance for Industry Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

For questions on the content of the guidance, contact CBER’s Office of Compliance and Biologics Quality at 301-827-3031; CDER’s Office of Pharmaceutical Science at 301-796-1228; CDRH’s Office of Device Evaluation at 240-276-3747; or CVM’s Office of New Animal Drug Evaluation at 301-827-6963.

U. S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Center for Devices and Radiological Health Center for Veterinary Medicine February 2008

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.