A new major chapter dealing with container closure integrity was released by the United
States Pharmacopeial Convention. Chapter< 1207> provides a significant amount of …

The sterility of drug products intended for parenteral administration is a critical quality
attribute (CQA) because it serves to ensure patient safety and is thus a key requirement by …

Biologics are being developed more and more as parenteral combination products with drug
delivery devices. The maintenance of sterility is imperative for such medical devices …

One of the main purposes of a container closure system is to protect its contents from the
surrounding environment. In the case of sterile products, this means maintaining the sterility …

Container closure integrity (CCI) testing, along with other engineering and administrative
controls, must be incorporated into a holistic approach to ensure overall integrity of a …

Closures that form part of the container-closure system are an important component in the
packaging of sterile products. Container-closures maintain the sterility of parenteral …

This chapter starts with the fascinating history of sterile packaging. Understanding the history
of sterile packaging and the rationales behind today's approaches is essential for every …

Container closure integrity (CCI) is one of the requirements for a sterile packaging system.
For vial-based systems, the capping process is a critical step in creating and ensuring an …

Container closure integrity (CCI) is a critical factor to ensure that product sterility is
maintained over its entire shelf life. Assuring the CCI during container closure (C/C) system …

Leakage across the parenteral vial/closure seal interface is quantitatively measured in terms
of mass of gas per unit time using a differential pressure method of leakage measurement …