Abstract: Drug delivery devices, sealing members for containers housed within such drug delivery devices, and related methods of assembly are disclosed. The drug delivery device may include a housing, a container disposed in the housing and having an interior volume, a drug disposed in the interior volume, and a septum. The container may have an opening formed in an end surface and which communicates with the interior volume. The septum may include a proximal end inserted through the opening into the interior volume of the container. Additionally, the septum may include a distal end having a flange disposed outwardly of the proximal end and contacting the end surface of the container. At least an end portion of the flange may be made of a material that is permeable to a gaseous sterilizing agent.

Abstract: Drug delivery devices, sealing members for containers housed within such drug delivery devices, and related methods of assembly are disclosed. The drug delivery device may include a housing, a container disposed in the housing and having an interior volume, a drug disposed in the interior volume, and a septum. The container may have an opening formed in an end surface and which communicates with the interior volume. The septum may include a proximal end inserted through the opening into the interior volume of the container. Additionally, the septum may include a distal end having a flange disposed outwardly of the proximal end and contacting the end surface of the container. At least an end portion of the flange may be made of a material that is permeable to a gaseous sterilizing agent.

Abstract: A syringe sterilization verification assembly includes a syringe, a tip cap assembly, and a biological indicator (BI) member. The syringe includes a barrel having a tip. The tip cap assembly includes an insert having a skirt configured to receive the tip. And the biological indicator (BI) member has an annular portion disposed around at least a portion of the tip and disposed radially between the tip and the skirt of the insert.

Abstract: An approach for preparing a drug delivery device includes providing a prefilled delivery container and transferring a drug product contained in a drug container to the prefilled delivery container. The prefilled delivery container includes a container body containing a predetermined quantity of saline solution and a predetermined quantity of IV stabilizing solution (“IVSS”). The drug product is transferred to the prefilled delivery container via a delivery container adapter.

Abstract: Drug delivery devices, sealing members for containers housed within such drug delivery devices, and related methods of assembly are disclosed. The drug delivery device may include a housing, a container disposed in the housing and having an interior volume, a drug disposed in the interior volume, and a septum. The container may have an opening formed in an end surface and which communicates with the interior volume. The septum may include a proximal end inserted through the opening into the interior volume of the container. Additionally, the septum may include a distal end having a flange disposed outwardly of the proximal end and contacting the end surface of the container. At least an end portion of the flange may be made of a material that is permeable to a gaseous sterilizing agent.

Abstract: Stabilized compositions of specific binding agents to RANKL, specific binding agents to TNF, and/or specific binding agents to IL-1R1 in containers are provided. Methods of making and using such compositions are also provided.