Importance of Container Closure Integrity in Autoinjector

Importance of Container Closure Integrity in Autoinjector
Definition of CCIT
• Container Closure Integrity Testing (CCIT) is an assay that evaluates the adequacy
of container closure systems to maintain a sterile barrier against potential
contaminants.
• Contaminants that could potentially cross a container closure barrier include
microorganisms, reactive gases, and other substance.
• CCIT is commonly referred to as leak detection.
• Leak: There are many risks associated with glass, including issues such as
breakage, delamination, leachable, and physical and chemical compatibility with the
drug product itself that can affect the safety and efficacy of a pharmaceutical product.