A feasibility study was conducted for a sensitive and robust dye immersion method for the
measurement of container closure integrity of unopened prefilled syringes using …

The preference of Prefilled syringes is increased over all the vials as container closure
systems for liquid injections, when facilitated or self-administration is required. However …

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 …

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 …

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 …

The development and validation of a simple spectrophotometric method for the
measurement of container-closure integrity of an oil-based product is reported. An oil …

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 …

Part 1 of this series demonstrated that a container closure integrity test performed according
to ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in …

Prefilled syringes (PFSs) are increasingly preferred over vials as container closure systems
(CCSs) for injectable drug products when facilitated or self-administration is required …

Container closure integrity (CCI) plays an important role in maintaining the sterility and
stability of sterile injectable products. The defects that cause a sterile vial to leak are not …