公开(公告)号：US20210077645A1

公开(公告)日：2021-03-18

申请号：US17022695

申请日：2020-09-16

Applicant: AMGEN INC.

Inventor： Wael Mismar ,  Jessica Hai Liu ,  Chia-Jung Wu ,  Shermeen A. Abbas ,  Shaun Devitt ,  Kenneth G. Schalhoub ,  Anthony Bitong ,  Mads Schjoth Due ,  Malak Guirguis ,  Rami Saifan

IPC: A61L2/20 ,  A61L2/26

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.

公开(公告)号：US12059555B2

公开(公告)日：2024-08-13

申请号：US17009868

申请日：2020-09-02

Applicant: AMGEN INC.

Inventor： Wael Mismar ,  Jessica Hai Liu ,  Dylan Bourelle ,  Chia-Jung Wu ,  Shaun Devitt ,  Kenneth G. Schalhoub ,  Tej Desai ,  Mads Schjoth Due ,  Anthony Bitong ,  Arin Keshishian ,  Chelsea Balli-Cruz ,  Pierre Burquel ,  Ryan Oba ,  Malak Guirguis

IPC: A61M5/31 ,  A61M5/00 ,  A61K38/17 ,  A61K39/395 ,  A61M5/315

CPC classification number: A61M5/3137 ,  A61M5/002 ,  A61K38/179 ,  A61K39/395 ,  A61M5/001 ,  A61M2005/3139 ,  A61M5/31505

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.

公开(公告)号：US11826481B2

公开(公告)日：2023-11-28

申请号：US18069682

申请日：2022-12-21

Applicant: AMGEN INC.

Inventor： Loic Barbedette ,  Shaun Devitt ,  Wael Mismar

IPC: H01J27/00 ,  A61N5/00 ,  A61L2/08 ,  A61M5/28 ,  A61M5/00 ,  B65B3/00 ,  B65B55/08 ,  A61L2/26 ,  G21F1/02 ,  G21F1/06 ,  G21F1/08

CPC classification number: A61L2/08 ,  A61L2/081 ,  A61L2/087 ,  A61L2/26 ,  A61M5/008 ,  A61M5/285 ,  B65B3/003 ,  B65B55/08 ,  G21F1/02 ,  G21F1/06 ,  G21F1/08 ,  A61L2202/23 ,  A61M5/001 ,  A61M5/002

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.

公开(公告)号：US20240366877A1

公开(公告)日：2024-11-07

申请号：US18674549

申请日：2024-05-24

Applicant: AMGEN INC.

Inventor： Wael Mismar ,  Jessica Hai Liu ,  Dylan Bourelle ,  Chia-Jung Wu ,  Shaun Devitt ,  Kenneth G. Schalhoub ,  Tej Desai ,  Mads Schjoth Due ,  Anthony Bitong ,  Arin Keshishian ,  Chelsea Balli-Cruz ,  Pierre Burquel ,  Ryan Oba ,  Malak Guirguis

IPC: A61M5/31 ,  A61K38/17 ,  A61K39/395 ,  A61M5/00 ,  A61M5/315

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.

公开(公告)号：US20190134296A1

公开(公告)日：2019-05-09

申请号：US16179450

申请日：2018-11-02

Applicant: AMGEN INC.

Inventor： Loic Barbedette ,  Shaun Devitt ,  Wael Mismar

IPC: A61M5/00 ,  A61L2/26 ,  G21F1/08 ,  G21F1/06 ,  G21F1/02

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.

公开(公告)号：US20240194301A1

公开(公告)日：2024-06-13

申请号：US18286242

申请日：2022-05-18

Applicant: AMGEN INC.

Inventor： Nicholas DeSantis ,  Shaun Devitt

IPC: G16C20/10 ,  C12Q1/22

CPC classification number: G16C20/10 ,  C12Q1/22

Abstract: Systems and methods are provided for evaluate inactivation kinetics of a biological indicator using a resistometer that is intended for a gaseous sterilization process. The gaseous sterilization process may include multiple sterilant gas injection phases. Systems and methods are provided for evaluating correlation of D values, obtained by both enumeration and fraction negative methods for determining viable spore counts, and to determine whether there are any serious deviations from a linear survivor curve that is based on the enumeration and fraction negative methods.

公开(公告)号：US20230126037A1

公开(公告)日：2023-04-27

申请号：US18069682

申请日：2022-12-21

Applicant: AMGEN INC.

Inventor： Loic Barbedette ,  Shaun Devitt ,  Wael Mismar

IPC: A61L2/08 ,  A61M5/28 ,  A61M5/00 ,  B65B3/00 ,  B65B55/08 ,  A61L2/26 ,  G21F1/02 ,  G21F1/06 ,  G21F1/08

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.

公开(公告)号：US11565006B2

公开(公告)日：2023-01-31

申请号：US16950312

申请日：2020-11-17

Applicant: AMGEN INC.

Inventor： Loic Barbedette ,  Shaun Devitt ,  Wael Mismar

IPC: G01N23/00 ,  H01J27/00 ,  A61N5/00 ,  G21F5/00 ,  A61L2/08 ,  A61M5/28 ,  A61M5/00 ,  B65B3/00 ,  B65B55/08 ,  A61L2/26 ,  G21F1/02 ,  G21F1/06 ,  G21F1/08

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.

公开(公告)号：US12233177B2

公开(公告)日：2025-02-25

申请号：US17022695

申请日：2020-09-16

Applicant: AMGEN INC.

Inventor： Wael Mismar ,  Jessica Hai Liu ,  Chia-Jung Wu ,  Shermeen A. Abbas ,  Shaun Devitt ,  Kenneth G. Schalhoub ,  Anthony Bitong ,  Mads Schjoth Due ,  Malak Guirguis ,  Rami Saifan

IPC: A61L2/20 ,  A61L2/26

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.

公开(公告)号：US11826480B2

公开(公告)日：2023-11-28

申请号：US16179399

申请日：2018-11-02

Applicant: AMGEN INC.

Inventor： Loic Barbedette ,  Shaun Devitt ,  Wael Mismar

IPC: A61L2/00 ,  G01N21/00 ,  A61L2/08 ,  A61M5/28 ,  A61M5/00 ,  B65B3/00 ,  B65B55/08 ,  A61L2/26 ,  G21F1/02 ,  G21F1/06 ,  G21F1/08

CPC classification number: A61L2/08 ,  A61L2/081 ,  A61L2/087 ,  A61L2/26 ,  A61M5/008 ,  A61M5/285 ,  B65B3/003 ,  B65B55/08 ,  G21F1/02 ,  G21F1/06 ,  G21F1/08 ,  A61L2202/23 ,  A61M5/001 ,  A61M5/002

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.