Container Closure Integrity Testing (CCIT), commonly referred to as leak detection, is a non-destructive packaging inspection system to maintain an aseptic barrier against potential contaminants.
What is container integrity?
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 substances (USP <1207>).30 Sept 2016
Why is container closure integrity important?
Container closure integrity (CCI) plays an important role in maintaining the sterility and stability of sterile injectable products. The defects which cause a sterile vial to leak are not necessarily defects that will be detected by a visual inspection process.
What is a container closure system?
A container closure system refers to the sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product.
What is dye ingress testing?
For routine testing, the dye ingress method uses ten test samples and three positive controls. The samples are placed in a vacuum chamber with dye and either pressure or vacuum is applied to the samples. The positive controls are punctured with a microtube to allow dye into the vials.
What is container closure integrity testing?
Container Closure Integrity Testing is performed to evaluate the adequacy of a closure in maintaining a sterile barrier. Of primary concern is whether the container can provide an effective barrier against ingress of microorganisms and other substances that may compromise or contaminate the product.27 Feb 2013
What is CCIT in pharmaceutical industry?
For the long-term stability of a lyophilized drug product, the container closure and integrity is a critical aspect. Various parameters are to be investigated during container closure integrity testing (CCIT) in order to assure the optimal performance of the primary packaging.