Container Closure Integrity Testing has been a growing concern in pharmaceutical packaging. Key authorities including US FDA and EMA are posing major attention to the proper design of robust CCI studies to ensure drug efficacy and safety.
In 2008 the US FDA published a guideline “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products” providing recommendations for using methods other than sterility testing to confirm container and closure system integrity as a part of the stability protocol for sterile biological products, human and animal drugs, and medical devices. The alternative methods included any properly validated physical or chemical container and closure system integrity test (e.g. pressure/vacuum decay, dye penetration tests or microbiological container and closure system integrity tests).
In 2016 The United State Pharmacopeia presented a new guideline: USP <1207> that provides background instruction on the topics of leaks, leakage rate, and package sealing/closure mechanisms, focusing the attention on sterile and critical pharmaceutical products (e.g. vials and syringes).
USP <1207> it's divided in three chapters:
- <1207.1> “Package Integrity Testing in the Product Life Cycle—Test Method Selection and Validation” that describes package integrity verification during three product life cycle phases
- <1207.2> “Package Integrity Leak Test Technologies” provides information guiding the selection and proper use of leak test technologies (also called methodologies, approaches, or methods).
- <1207.3> “Package Seal Quality Test Technologies” summarizes test methods useful for characterizing and monitoring package seal quality and to guide the reader in their selection and use.
A proper Risk assessment on the Container Closure System is something which now is fundamental to understand the steps of the process which represent the most critical in the entire product lifecycle.
