Abstract: An on-body injector system includes a drug container assembly including a container, a seal member, and a sealing interface between the seal member and the container. The container includes an opening and the seal member at least partially covers the opening in the container. A fluid pathway assembly is coupled to the drug container assembly and includes a needle that is movable between a storage position, in which a point of the needle is spaced from the seal member, and a delivery position, in which the point of the needle is disposed at least partially through the seal member. A radiation generator is configured to emit rays of radiation to sterilize and/or disinfect the sealing interface. A barrier is disposed adjacent to the sealing interface and has an opening. At least a portion of the drug container assembly is positioned adjacent to the opening in the barrier.

Abstract: A drug delivery sterilization system includes a housing defining at least one receptacle, a container assembly having first and second ends, an elongated portion extending therebetween, and an electron beam or x-ray generator disposed near the housing. The container assembly includes a container having a container contact region at the second end and an inner volume to contain a medicament, a seal member having a seal member contact region to form a sealing interface with the container contact region, and a coupling device adapted to sealingly couple the seal member to the container. The container assembly is at least partially disposed in the receptacle such that the second end of the container is exposed through the housing. The electron beam or x-ray generator generates a sterilizing beam that penetrates the seal member to sterilize the sealing interface.

Abstract: An on-body injector system includes a drug container assembly including a container, a seal member, and a sealing interface between the seal member and the container. The container includes an opening and the seal member at least partially covers the opening in the container. A fluid pathway assembly is coupled to the drug container assembly and includes a needle that is movable between a storage position, in which a point of the needle is spaced from the seal member, and a delivery position, in which the point of the needle is disposed at least partially through the seal member. A radiation generator is configured to emit rays of radiation to sterilize and/or disinfect the sealing interface. A barrier is disposed adjacent to the sealing interface and has an opening. At least a portion of the drug container assembly is positioned adjacent to the opening in the barrier.

Abstract: An on-body injector system includes a drug container assembly including a container, a seal member, and a sealing interface between the seal member and the container. The container includes an opening and the seal member at least partially covers the opening in the container. A fluid pathway assembly is coupled to the drug container assembly and includes a needle that is movable between a storage position, in which a point of the needle is spaced from the seal member, and a delivery position, in which the point of the needle is disposed at least partially through the seal member. A radiation generator is configured to emit rays of radiation to sterilize and/or disinfect the sealing interface. A barrier is disposed adjacent to the sealing interface and has an opening. At least a portion of the drug container assembly is positioned adjacent to the opening in the barrier.

Abstract: A shielding member for use in sterilizing drug container assemblies includes a housing. The housing includes a first shielding portion and a second shielding portion. The first shielding portion includes a first and second surfaces and a plurality of first bore portions extending between. The second shielding portion having a first and second surfaces and a plurality of second bore portions corresponding to and aligned with the plurality of first bore portions. The first and second bore portions cooperate to form a plurality of receptacles including a plurality of openings in the first surface of the first shielding portion of the housing. The receptacles are sized and configured to receive drug container assemblies, each comprising a container with a container contact region and a seal member disposed adjacent the container contact region to seal the contents of the container at a sealing interface, such that each drug container assembly is exposed out of the housing through one of the openings.

Abstract: A method of externally sterilizing a drug delivery device utilizing Nitrogen Dioxide (NO2) is provided, including placing the drug delivery device in a sterilization chamber, introducing into the chamber a dose of NO2 having a concentration of between about 2 and 20 milligrams per Liter by applying a vacuum level of between about 10 and 600 Torr and holding the vacuum level for a dwell time of between about 2 and 20 minutes, repeating the step of introducing into the chamber a dose of NO2 for a number of pulses between about 1 and 24, purging the sterilization chamber of at least substantially all of the NO2, and aerating the sterilization chamber.

Abstract: An on-body injector system includes a drug container assembly including a container, a seal member, and a sealing interface between the seal member and the container. The container includes an opening and the seal member at least partially covers the opening in the container. A fluid pathway assembly is coupled to the drug container assembly and includes a needle that is movable between a storage position, in which a point of the needle is spaced from the seal member, and a delivery position, in which the point of the needle is disposed at least partially through the seal member. A radiation generator is configured to emit rays of radiation to sterilize and/or disinfect the sealing interface. A barrier is disposed adjacent to the sealing interface and has an opening. At least a portion of the drug container assembly is positioned adjacent to the opening in the barrier.

Abstract: An injection device is provided, including a syringe having a barrel and a flange and a backstop configured to be coupled with the syringe adjacent to the flange. The backstop includes an inner surface generally extending around at least a portion of the syringe, wherein the inner surface includes at least one protrusion extending away from the inner surface and configured to engage the flange and/or the barrel to permit or promote airflow through a space between the inner surface and the syringe.

Abstract: A shielding member for use in sterilizing drug container assemblies includes a housing. The housing includes a first shielding portion and a second shielding portion. The first shielding portion includes a first and second surfaces and a plurality of first bore portions extending between. The second shielding portion having a first and second surfaces and a plurality of second bore portions corresponding to and aligned with the plurality of first bore portions. The first and second bore portions cooperate to form a plurality of receptacles including a plurality of openings in the first surface of the first shielding portion of the housing. The receptacles are sized and configured to receive drug container assemblies, each comprising a container with a container contact region and a seal member disposed adjacent the container contact region to seal the contents of the container at a sealing interface, such that each drug container assembly is exposed out of the housing through one of the openings.

Abstract: A drug delivery sterilization system includes a housing defining at least one receptacle, a container assembly having first and second ends, an elongated portion extending therebetween, and an electron beam or x-ray generator disposed near the housing. The container assembly includes a container having a container contact region at the second end and an inner volume to contain a medicament, a seal member having a seal member contact region to form a sealing interface with the container contact region, and a coupling device adapted to sealingly couple the seal member to the container. The container assembly is at least partially disposed in the receptacle such that the second end of the container is exposed through the housing. The electron beam or x-ray generator generates a sterilizing beam that penetrates the seal member to sterilize the sealing interface.

Abstract: A shielding member for use in sterilizing drug container assemblies includes a housing. The housing includes a first shielding portion and a second shielding portion. The first shielding portion includes a first and second surfaces and a plurality of first bore portions extending between. The second shielding portion having a first and second surfaces and a plurality of second bore portions corresponding to and aligned with the plurality of first bore portions. The first and second bore portions cooperate to form a plurality of receptacles including a plurality of openings in the first surface of the first shielding portion of the housing. The receptacles are sized and configured to receive drug container assemblies, each comprising a container with a container contact region and a seal member disposed adjacent the container contact region to seal the contents of the container at a sealing interface, such that each drug container assembly is exposed out of the housing through one of the openings.