CCIT.S.A

Nowadays,   it is crucial to determine a strategy for  container closure integrity testing of sterile injectable products. Sterility has historically been connected to container closing integrity. Microbial contamination is possible when a container's closure integrity is compromised. While container closure integrity has evolved through time, the scope of its use has expanded.    Drug packages must have container closure integrity (CCI)  in order to  remain sterile  during their  shelf life. The defects that lead to the leakage of sterile vials are not always defects, that may be recognized visually.  If the defect is hidden by the crimp,  microscopic cracks,  or is a transient one like a stopper pop-up ,  then the container will leak temporarily until it is repaired.    CCI test methods     There is  a lot of uncertainty in the findings of traditional CCIT methods, such as microbiological challenge tests or blue dye ingress tests. This makes it difficult to quantitatively valida