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Our content explains pharmacopoeial and regulatory requirements in our own words, for learning. For exact requirements, always refer to the current official text and your site's approved SOPs. More

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Container Closure Integrity: The Basics

Why container closure integrity matters for sterility, how test methods differ and what USP <1207> and Annex 1 expect.

What you will practise

Understand container closure integrity testing from the microbiologist's point of view.

Why CCI matters
Deterministic and probabilistic methods
100 % testing of fused containers
CCI versus the sterility test

Based on

USP <1207> Package integrity evaluation
EU GMP Annex 1 (2022) 8.22–8.24
FDA Guidance: CCI testing in lieu of sterility testing in stability (2008)

Every attempt uses new data. You need 70 % to pass. Explanations appear after each step.

About 8 minutes

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