As the use of medical device software and software as a medical device (SaMD) grows, regulatory bodies around the world are ...

Package integrity can be defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.

Qualification, and demonstration of fit-for-purpose, for a drug product vial/stopper/seal primary package system comprises many factors: protection, compatibility, safety, and performance. One of the ...

Developments in non-destructive, deterministic testing technologies that can achieve optimum assurance in container closure integrity. When assuring the quality of all packaged products, testing ...