A LYOPHILIZATION CLOSURE ASSEMBLY FOR 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 and may employed with the container during a lyophilization process, eliminating the need for a separate crimping operation outside of the sterile environment in which lyophilization is conducted. The lyophilization closure assembly includes a body with a skin disposed around the rim of the container. The skirt features one or more deflectable abutments and one or more deflectable latches positionable about the rim of the container, and defines one or more vapor passages. An elastomeric closure is retained within the body for sealing the opebn top of the medicament container. The elastomeric closure features a plug for sealing the open top of the container and a top surface facing away from the open top of the container. The body defines an opening over the elastomeric closure that delimits and access area on the top surface of the closure. A membrane is removably secured over the access area of the elastomeric closure and hermetically encloses the access area.