Collection: CCIT(Container closure integrity testing)

Leak testing is crucial for drug packaging lines, as per pharmaceutical standards like USP 1207 and EU Annex 1. These processes, also known as CCIT (Container Closure Integrity Testing), require positive controls or certified leak defects for test method development and validation to ensure that the equipment functions properly.

CCIT is an important part of drug quality control, which can ensure that sterile drugs are not affected by external factors during production, storage and transportation.

Positive Control Utilization in CCI testing!
For gas based CCI methods in which the measurement signal is a direct indicator of leakage. positive controls are used to prove leaks at specific package locations can be detected; To determine the impact of product presence and other factors on leak detection.

For other CCI methods in which the measurement signal is a direct indicator of leakage Liquid tracer leak tests (e.g., dye ingress) Microbial challenge leak tests. Positive controls are used to prove leaks at specific package locations can be detected determine the impact of product presence and other factors on leak detection; To confirm limit of detection.

For physicochemical CCI methods in which the measurement signal is an indicator of leakage vacuum decay/pressure decay/mass extraction Electrical conductivity/capacitance test (HVLD). Positive controls are used to verify that the measurement signal is a function of leak presence/size/rate vs. other interfering factors; To confirm limit of detection.