The USP Chapter <1207> on the integrity testing (CCIT – Container Closure Integrity Testing) of primary containers of sterile dosage forms was implemented in August of 2016. The directives outlined in this chapter are applicable to primary package components which are defined as those that come into direct contact with the product (i.e. glass vial or syringe). Secondary package components are defined those items that are critical to ensuring correct package assembly (i.e. aluminum cap over a rubber stopper). The key sections of the USP <2017> Chapter Include:
- USP <1207> Sterile Product Packaging-Integrity Evaluation
- USP <1207.1> Package Integrity and Test Method Selection
- USP <1207.2> Package Integrity Leak Test Technologies
- USP <1207.3> Package Seal Quality Testing Methods
Key aspects of the <1207> chapter that must be understood and considered in development of an adequate test plan for your container or package system include:
A simple microbiological challenge test is not considered sufficient.
The USP <1207> Chapter prefers deterministic methods rather than probabilistic methods. Example of probabilistic methods include the bubble leak and blue dye tests.
Deterministic methods highlighted in the chapter include: HELIUM LEAK TESTING, high voltage leak detection (HVLD), laser Headspace analysis and pressure & vacuum decay methods.
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.
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.
