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公开(公告)号：US20220160972A1
公开(公告)日：2022-05-26
申请号：US17440906
申请日：2020-04-22
申请人： AMGEN INC.
发明人： Cheng-Chieh Chou , Mingda Eu , Ren-Yo Forng , Malak Guirguis , Olivia Alice Henderson , Jessica Hai Liu , Robert W. Swift , Chia-Jung Wu
摘要： 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.
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公开(公告)号：US20210077645A1
公开(公告)日：2021-03-18
申请号：US17022695
申请日：2020-09-16
申请人： AMGEN INC.
发明人： 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
摘要： 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.
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公开(公告)号：US12059555B2
公开(公告)日：2024-08-13
申请号：US17009868
申请日：2020-09-02
申请人： AMGEN INC.
发明人： 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分类号： A61M5/31 , A61M5/00 , A61K38/17 , A61K39/395 , A61M5/315
CPC分类号： A61M5/3137 , A61M5/002 , A61K38/179 , A61K39/395 , A61M5/001 , A61M2005/3139 , A61M5/31505
摘要： 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.
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公开(公告)号：US20220362104A1
公开(公告)日：2022-11-17
申请号：US17770355
申请日：2020-10-23
发明人： Cornelius Pompe , Nicholas J. Clark , Wei Qi , Arnold J. McAuley , MIchael Schneider , Chia-Jung Wu , Twinkle R. Christian , Heather N. Franey , Bharadwaj Jagannathan , Jeffrey Abel , Franz Dietzel
摘要： An approach for determining material compatibility for components of a drug delivery system is provided that includes using surface zeta-potential analytical method to evaluate surface interactions between a desired molecule and at least one material present within a given IV-bag system.
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公开(公告)号：US20220087901A1
公开(公告)日：2022-03-24
申请号：US17425412
申请日：2020-02-12
申请人： AMGEN INC.
发明人： Nicholas J. Clark , Chia-Jung Wu , Mingda Eu , Artemio A. Alanis , Jennifer Lyn Sawicky , Monica Goss , Jennifer Stevenson , Heather N. Franey , Deirdre Piedmonte , Stephen Robert Brych
摘要： 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.
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公开(公告)号：US20210060258A1
公开(公告)日：2021-03-04
申请号：US17009868
申请日：2020-09-02
申请人： AMGEN INC.
发明人： 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分类号： A61M5/315 , A61M5/00 , A61M5/31 , A61K38/17 , A61K39/395
摘要： 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.
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公开(公告)号：US20200253823A1
公开(公告)日：2020-08-13
申请号：US16782306
申请日：2020-02-05
申请人： AMGEN INC.
摘要： A drug delivery system includes a delivery container, a first drug insertion port, at least one additional drug insertion port, and an IV connection port. The delivery container includes upper, lower, first side, and second side portions, and further includes a tapered region extending between the first side portion and the second side portion. The first drug insertion port is positioned at the lower portion of the delivery container and has a first coupling mechanism. The at least one additional drug insertion port is also positioned at the lower portion of the delivery container, but includes a second coupling mechanism that is different than the first coupling mechanism. The IV connection port is positioned at the lower portion of the delivery container adjacent to a lower portion of the tapered region.
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