USP容器密闭完整性测试章节1207

julia朱玉姣

USP Chapter <1207>: Container Closure Integrity Testing

USP容器密闭完整性测试章节<1207>

The USP Chapter <1207> on the integrity testing of primary containers of sterile dosage forms is currently in the second round of review. After a first publication in the UPS-NF Pharmacopeial Forum in September/October 2014 the comments received are now evaluated by the USP Expert Committee. This review process is supposed to be completed in 2015, and it is expected that the new Chapter will become effective in 2016.  

USP关于无菌制剂内包容器的完整性测试章节<1207》现在已进入第二轮审核。2014年9-10月第一次在USP-NF药典论坛公布后，USP专家委员会现在正对收到的意见进行审核。该审核过程预期会在2015年完成，新章节会在2016年生效。

Different from the visual inspection, the leak testing of primary containers (so far) has not to be performed to 100% (with the exception of ampoules). Chapter <1207> makes recommendations here, which are - unlike the USP Chapters with numbers less than 1000 - not binding. So the Chapter is rather similar to a guideline than to a pharmacopoeia monograph. For the USP the container / closure integrity is comprised of a package integrity testing and a package leak testing. A simple microbiological challenge test is not considered sufficient. The chapter furthermore lists various test methods, whereby the USP now prefers deterministic methods rather than probabilistic methods. A probabilistic procedure such as the bubble test or the blue bath method can serve well for locating a leak, though. As deterministic methods are listed e.g.: high voltage leak detection (HVLD), laser Headspace analysis as well as the pressure and vacuum decay methods.

与目视检查不同，内包容器的泄漏测试（到目前为止）还没有100%地实施（安瓿除外）。章节<1207>里给出了建议，与USP其它编号小于1000的章节不同，这个章节并不是强制的。因此，与其说是药典各论，不如说这个章节更类似于一个指南。在USP中，容器/密闭器完整性包括了包装完整性测试和包装泄漏测试。只有微生物挑战试验被认为是不够的。该章节还列出了不同的测试方法，这里相对于概率性测试方法，USP倾向于判定性的方法。当然，概率性测试程序例如，起泡点测试或蓝浴法用于找出漏点是很好的。所列出的判定性方法有高压检漏（HVLD）、辐射顶空分析以及保压和保真空方法。

For the validation of a method it will be important not only to build on the qualification of the testing device, but to examine the different packaging/product combinations, for example with and without defects.

在方法验证中，很重要的一点是不仅要进行仪器确认，还要检查不同包装/药品的组合，例如有或没有缺陷。

The revised chapter will be applied to vials, ampoules, syringes and bags. But certain concepts are also supposed to be transferable to active substances, as well as to intermediate or bulk materials in storage.

修订后的章节将适用于西林瓶、安瓿、注射针和袋。但某些概念可能也会转用于原料药，以及中间体或存贮的散装物料。

The current draft of the chapter <1207> can be found in the Pharmacopeial Forum 40(5) - you only need to register, which is free of charge, though.

目前<1207>的草案可以在药典论坛40（5）找到。只需要免费登记就可以了。

lumang

为何将泡点和色水法归为probabilistic methods呢？

胜利者

国内也有这等市场推手

syhorchid

谢谢分享