Container and Reconstitution Systems for Lyophilized Drug Products
Lyophilization is the process of dehydrating a material at low temperature and reduced pressure. It is used to extend the shelf life of many biologic drug products. This paper discusses two systems essential to these products: container systems and reconstitution (i.e., rehydrating) systems.
Key wordsContainer systems Closures Container closure integrity Extractables Leachables Reconstitution systems Seals
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