固体药品检测容器密闭完整性测试CCIT

固体药品检测中的容器密闭完整性测试CCIT是无菌剂型质量保证的重要组成部分。由于某些容器/设备的几何形状以及无法使用关键密封件，因此执行CCI测试可能会遇到问题。许多标准讨论了这个问题，并且FDA提供了有关“CCI测试代替其他无菌测试方法”的指南。

USP <1207>章建议使用确定性方法（可以验证）而不是使用随机行为定义泄漏的概率方法。提供了许多无菌药品，包括预装注射器、药筒、小瓶和自动注射器。如果要避免污染和节省配方剂量，CCI测试是这些产品设计和过程验证的组成部分。佳测试方法因产品而异。当没有一种方法被认为是理想的时，我们经常会推荐两种方法。

CCI测试如何工作？它用于通过确定是否可以在容器的内容物及其周围环境之间建立联系来确定容器内有害物质释放以及固体、液体或气体污染可能性。测试方法可以分为破坏性和非破坏性，以及确定性和概率性。

非破坏性的类型Non-destructive tests are often preferred over destructive tests. Non-destructive test options include trace gas analysis and vacuum decay. Vacuum decay testingVacuum decay method uses pressure change measurement to indirectly determine the flow rate from a vial to a fixed volume chamber. Quality extraction variables measure the flow rate required to maintain a constant vacuum level (ASTM F2338 and ASTM F 3287). Place the vial or other container in a closed tool, then close it and apply vacuum. If there is leakage, it will reduce the expected vacuum around the tool inside.

This is a deterministic method because electronic equipment can measure precise pressure values, and consistent results can be obtained by repeating the test on samples. When it is possible to place the chamber tightly around the test item without any voids inside, vacuum and pressure decay testing works well. This is because the smaller space for leakage makes pressure changes less diluted, making it more sensitive. This makes it an ideal testing method for ampoules but not so ideal for prefilled syringes that have space between needle guard and piston rod.

The disadvantage of this method (and most testing methods) is that viscous fluids inside containers may block leaks and hide them.

In conclusion, container closure integrity testing CCIT plays an important role in ensuring quality assurance of sterile drug products due to its ability to detect potential contamination risks associated with faulty packaging materials or manufacturing processes.