Hello good people of the world! The present post concerns itself with Container Closure Integrity (CCI) testing. CCI testing is an integral part of packaging validation, involving primary packaging such as ampoules, blisters, bottles, vials, syringes, tubes, etc. Biopharmaceuticals are typically packaged in hermetically-sealed containers to prevent the ingress of any liquid or gas that could be reactive or carry microorganisms. Packaging may also by light-resistant, if light could affect the properties of the product.
There are three regulatory/industry guidelines typically cited in the U.S. regarding CCI testing:
- FDA Guidance for Industry (2008), Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
- PDA Technical Report No. 27 (1998), Pharmaceutical Package Integrity (not available for free)
- USP <1207>, Sterile Product Packaging – Integrity Evaluation
CCI testing is either physical (bubble, liquid tracer, vacuum/pressure decay, dye ingress, etc.) or microbial (microbial ingress).
Each has it’s advantages and disadvantages, as shown in the below from American Pharmaceutical Review:
When should these tests be performed? CCI testing is applicable to new container closure systems and can be performed on newly sealed containers to validate sealing performance, and then annually and at the expiration date to validate stability.
What are your preferred methods of Container Closure Integrity Testing?
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