Assurance of package integrity originates from the use of appropriate materials, accurate and optimum closing properties, proper dimensional fit and consistent control of processes used to assemble the closed package. There are several types of studies recommended to be conducted during development of the container closure system (CCS) and to support filling, final assembly operations … Continued

Challenges for manufacturers are still present, however. Prefilled syringes are a more complex container closure system when compared with traditional vials. There are more pathways and possibilities for a container closure integrity (CCI) issue to occur as there are more container closure interfaces. Evaluating all the interfaces with one technology can be a difficult task, … Continued