Container Closure Integrity: Microbial Ingress Test

Run an immersion microbial challenge: prepare and count the challenge, run the controls, incubate and decide whether the container system is integral.

What you will practise

Perform and interpret a microbial ingress test and understand its place beside deterministic methods.

Test design
Challenge preparation and count
Positive and negative controls
Interpretation and limits of the method

Based on

USP <1207>, <1207.1>, <1207.2>
PDA Technical Report 27
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.