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：US20250009976A1

公开(公告)日：2025-01-09

申请号：US18712768

申请日：2022-12-02

Applicant: AMGEN INC.

Inventor： Fatemeh Fallahianbijan ,  Shermeen A. Abbas ,  Albert Ju ,  Oscar Gonzales ,  Vikashni Padmakumar ,  Jeffrey A. Brown ,  Wael Mismar

IPC: A61M5/315

Abstract: A method of placing a plunger into a syringe barrel filled with a drug product. The method includes aligning a stopper with a longitudinal axis of a syringe barrel. The syringe barrel includes a proximal end, a distal end, and a reservoir. The drug product is disposed in the reservoir at the distal end. The method includes applying a vacuum pressure to the reservoir of the syringe barrel. The method includes pushing the stopper with a plunger rod into the reservoir of the syringe barrel to a first depth. The method includes removing the plunger rod from the reservoir of the syringe barrel after pushing the stopper to the first depth. The stopper migrates to a second depth that is different than the first depth in response to a pressure differential in the reservoir of the syringe barrel.

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.