Japanese–English glossary
Container closure system
容器施栓系yōki sesenkei
The packaging components that together hold and protect the product: the vial or syringe barrel, the stopper or plunger, the seal or cap, and any other component in contact with the product. It must protect against contamination and loss, be compatible with the product and not release harmful substances. Closure integrity can only be confirmed on the filled product. Changing a product-contact component usually needs extractables and leachables data and integrity data before the MAH can judge which regulatory filing applies.