Container Closure Integrity: 6 Considerations for Evaluating CDMO Capabilities

Container closure integrity (CCI) is a critical element of sterile product quality, but evaluating a CDMO’s CCI capabilities requires more than confirming that testing is available.
The appropriate approach depends on the drug product, container closure system, manufacturing process, lifecycle risks, and applicable regulatory requirements. For pharmaceutical companies selecting or qualifying a CDMO, understanding how a manufacturing partner approaches these variables can provide useful insight into the maturity of its overall quality program.
Oliver Stauffer, CEO of PTI (Packaging…