A container closure system includes a primary packaging (packaging in direct contact with the product) and a secondary packaging that supports the packaging assembly, such as an aluminum cap serving as a secondary seal for a vial.
Container closure systems for sterile product packaging integrity must keep product contents in and environmental contaminants out.
Package integrity and container seal integrity are terms used interchangeably. These terms are the same, depending on the definition of container closure integrity. Learn more about the package integrity testing procedures, by navigating the internet.
Container Closure Integrity is crucial in maintaining the stability and sterility of sterile injections. A visual inspection will not detect defects in sterile vials that leak. Good container closure integrity has been associated with maintenance of sterility.
A container that loses or does not have good sealing integrity runs the risk of microbial contamination. However, the context of the integrity of container closures has broadened over the years.
These defects include winding, cracks, and microscopic scratches on the glass. Temporary defects, such as a pop up stopper that causes temporary leakage from the container, are examples of such defects.
Container closure integrity was used in the past to refer to packages that passed or were able to pass a Microbiological Challenge Test. Container closure integrity is now synonymous with package integrity according to the USP 1207.
According to USP 1207, integrity refers to the absence of leakage from the containers that could compromise the product's quality. This means that the packaging is not damaged and there are no leaks.
For package integrity testing, the terms package integrity and container seal integrity are often used interchangeably.