LYOPHILIZATION CLOSURE ASSEMBLY FOR A MEDICAMENT CONTAINER FOR USE DURING A LYOPHILIZATION PROCESS

摘要

A lyophilization closure assembly for a container or vial is disclosed.The lyophilization closure assembly is self-supporting with the container andmay be employed with the container during a lyophilization process, eliminatingthe need for a separate crimping operation outside of the sterile environment inwhich lyophilization is conducted. The lyophilization closure assembly includesa body with a skirt disposed around the rim of the container. The skirt featuresone or more deflectable abutments and one or more deflectable latchespositionable about the rim of the container, and defines one or more vaporpassages. An elastomeric closure is retained within the body for sealing theopen top of the medicament container. The elastomeric closure features a plugfor sealing the open top of the container and a top surface facing away from theopen top of the container. The body defines an opening over the elastomericclosure that delimits an access area on the top surface of the closure. Amembrane is removably secured over the access area of the elastomeric closureand hermetically encloses the access area.