The assurance of sterility of a parenteral drug product, prior to any human use, is a
regulatory requirement. Hence, all strategies related to container closure integrity (CCI) must …

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 …

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 …

Utilization of prefilled syringes as a preferred container closure system for biologics has
been increasing [1]. As a primary container closure system, prefilled syringes must provide …

Container closure integrity testing (CCIT) is a critical step in ensuring package integrity and
providing feedback on package designs. In practical applications, CCIT methods, namely …

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 …

In the past, the packaging of pharmaceutical products often took little account of the
microbiological aspects of maintaining product integrity. This was especially true of …

In reaction to the limitations of the traditional sterility test methods, in 2008, the US Food and
Drug Administration issued the guidance “Container and Closure System Integrity Testing in …

Capping completes the closure of parenteral drug products in the final packaging container
and is critical in maintaining an integral seal to ensure product quality. Residual seal force …

To demonstrate maintenance of parenteral product sterility, container-closure integrity over
the shelf life of the product is critical. In the past, sterility testing has been used to ensure …