A lyophilization closure assembly for a medicament container for use during a lyophilization process

摘要

A lyophilization closure assembly (400) for a container or vial (10) is disclosed. The lyophilization closure assembly is self-supporting with the container (10) and may be 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 (400) includes a body (460) with a skirt (464) disposed around the rim (17) of the container. The skirt (464) features one or more deflectable abutments (470) and one or more deflectable latches (472) positionable about the rim (17) of the container, and defines one or more vapor passages (474). An elastomeric closure (422) is retained within the body for sealing the open top (15) of the medicament container. The elastomeric closure (422) features a plug (424) for sealing the open top (15) of the container and a top surface (426) facing away from the open top of the container. The body defines an opening over the elastomeric closure (422) that delimits an access area on the top surface (426) of the closure. A membrane (434) is removably secured over the access area of the elastomeric closure (422) and hermetically encloses the access area. <IMAGE>