Cap design for pharmaceutical container closure systems

    公开(公告)号:US12090118B2

    公开(公告)日:2024-09-17

    申请号:US17992412

    申请日:2022-11-22

    摘要: Caps for sealing assemblies for sealing glass containers and maintaining container closure integrity at −80° C. or less are disclosed. The caps include a cap skirt having an annular body and a crimp region. The crimp region is a crimpable metal. The annular body of the cap skirt has a coefficient of thermal expansion (CTE) greater than a CTE of a metal consisting of aluminum, a stiffness greater than or equal to 2 times a stiffness of the crimp region, or both. The greater CTE, stiffness, or both of the cap skirt increase the seal pressure and contact area between the stopper and glass container when cooled to −80° C. or less. The caps enable the sealing assemblies to maintain a helium leakage rate of the sealed glass container of less than or equal to 1.4×10−6 cm3/s at −80° C. or less.

    PHARMACEUTICAL CONTAINERS INCLUDING SEALING ASSEMBLY WITH FILLER MATERIAL

    公开(公告)号:US20230144783A1

    公开(公告)日:2023-05-11

    申请号:US17981037

    申请日:2022-11-04

    IPC分类号: A61J1/14 B65D1/02 B65B7/28

    摘要: A sealed pharmaceutical container including: a shoulder; a neck extending from the shoulder; a flange extending from the neck, the flange including: an underside surface extending from the neck; an outer surface extending from the underside surface, the outer surface defining an outer diameter of the flange; and an upper sealing surface extending between the outer surface and an inner surface defining an opening in the sealed pharmaceutical container, and a sealing assembly including: a stopper including a sealing portion extending over the upper sealing surface of the flange and covering the opening, and an insertion portion extending into the opening and in contact with the inner surface of the flange, the stopper having a first CTE; and a filler member encased within the stopper and having a second CTE, the second CTE being lower than the first CTE.

    CONTAINER CLOSURE SYSTEM AND SEALING ASSEMBLIES FOR MAINTAINING SEAL INTEGRITY AT LOW STORAGE TEMPERATURES

    公开(公告)号:US20230072233A1

    公开(公告)日:2023-03-09

    申请号:US17896850

    申请日:2022-08-26

    IPC分类号: B65D45/18 B65D39/00

    摘要: A sealed pharmaceutical container comprises a flange comprising an underside surface, an outer surface extending from the underside surface, the outer surface defining an outer radius ro of the flange; and an upper surface extending between the outer surface and an inner surface defining an opening in the sealed pharmaceutical container. The upper surface comprises a sealing region extending between the opening and the outer surface and comprising a radius rsr that is less than ro. The sealed pharmaceutical container also comprises a sealing assembly comprising sealing portion in contact with the upper surface at a lower surface of the sealing portion and a cap compressing the stopper against the upper surface. After compression, the sealing portion of the stopper comprises a compressed radius rsc that is less than rsr adjacent the upper surface.

    CAP DESIGN FOR PHARMACEUTICAL CONTAINER CLOSURE SYSTEMS

    公开(公告)号:US20230157927A1

    公开(公告)日:2023-05-25

    申请号:US17992412

    申请日:2022-11-22

    摘要: Caps for sealing assemblies for sealing glass containers and maintaining container closure integrity at −80° C. or less are disclosed. The caps include a cap skirt having an annular body and a crimp region. The crimp region is a crimpable metal. The annular body of the cap skirt has a coefficient of thermal expansion (CTE) greater than a CTE of a metal consisting of aluminum, a stiffness greater than or equal to 2 times a stiffness of the crimp region, or both. The greater CTE, stiffness, or both of the cap skirt increase the seal pressure and contact area between the stopper and glass container when cooled to −80° C. or less. The caps enable the sealing assemblies to maintain a helium leakage rate of the sealed glass container of less than or equal to 1.4×10−6 cm3/s at −80° C. or less.

    GLASS CONTAINERS AND SEALING ASSEMBLIES FOR MAINTAINING SEAL INTEGRITY AT LOW STORAGE TEMPERATURES

    公开(公告)号:US20210212893A1

    公开(公告)日:2021-07-15

    申请号:US17213922

    申请日:2021-03-26

    IPC分类号: A61J1/06 A61J1/14

    摘要: A sealed pharmaceutical container includes a shoulder, a neck extending from the shoulder, and a flange extending from the neck. The flange includes an inclined sealing surface defining an opening in the sealed pharmaceutical container. The sealed pharmaceutical container also includes a sealing assembly including a stopper extending over the sealing surface of the flange and a cap securing the stopper to the flange. The stopper has a glass transition temperature (Tg) that is greater than or equal to −70° C. and less than or equal to −45° C. The sealing assembly maintains a helium leakage rate of the sealed pharmaceutical container of less than or equal to 1.4×10−6 cm3/s as the sealed pharmaceutical container is cooled to a temperature of less than or equal to −45° C.