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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
Applicant: AMGEN INC.
Inventor: 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
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.
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公开(公告)号:US20240208680A1
公开(公告)日:2024-06-27
申请号:US18288549
申请日:2022-05-19
Applicant: AMGEN INC.
Inventor: Devrishi Goswami , Jun Zhang , Deirdre Piedmonte , Vikashni Padmakumar , David Le , Maria Raquel Santos , Wei Qi
Abstract: A method of filing a vial. The method includes providing a pump corresponding to a vial and setting a drip retraction parameter for the pump to any value equal to or less than 20 degrees. The method also includes setting a no adjustment limit for a fill weight of the vial to T1, with T1 being at or in a range of about 2% more or less than a fill weight of a target fill weight T0, wherein a process performance index Cpk (Cpk) for the vial throughout a fil cycle exceeds a minimum value.
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