公开(公告)号：US20250018122A1

公开(公告)日：2025-01-16

申请号：US18710112

申请日：2022-11-28

Applicant: AMGEN INC.

Inventor： Ryan Oba ,  Mher Asadourian ,  Sandra Sanchez ,  Chelsea Balli-Cruz ,  Joshua Tamsky

IPC: A61M5/31 ,  G01M99/00

Abstract: A testing system for a drug delivery device includes a frame member having first and second ends, a driving member positioned near the frame member, a surrogate syringe barrel operably coupled with the frame member, a flange extender adapted to couple with a portion of the surrogate syringe barrel, and a plunger rod adapted to couple with the flange extender and be at least partially disposed within the surrogate syringe barrel while being movable therein. The driving member is movable in an axial direction between the first end and the second end of the frame member. The plunger rod includes first and second ends and a longitudinal length therebetween, the first end being positioned near a portion of the driving member. The driving member measures a maximum urging force exerted on the plunger rod when moving in the axial direction towards the second end of the frame member.

公开(公告)号：US20240408308A1

公开(公告)日：2024-12-12

申请号：US18697770

申请日：2022-09-30

Applicant: AMGEN INC.

Inventor： Seyed Reza Mirhassani Moghaddam ,  Julian Jazayeri ,  Sandra Sanchez ,  Edgardo Halili ,  Cindy Saldana ,  Sergio Giovanni Valenzuela

IPC: A61M5/20 ,  G01L5/00 ,  G16H20/17

Abstract: Apparatuses, systems and methods are provided that characterize a rear sub-assembly for an autoinjector (AI). Apparatuses, systems and methods are also provided that generate injection time (IT) models for autoinjectors (AIs). Autoinjectors (AIs) (e.g., mechanical AIs, spring-loaded AIs, etc.), components for use within AIs (e.g., prefilled syringes (PFS), rear sub-assemblies (RSAs), etc.), and related methods may utilize mathematical modeling along with design for six sigma (DFSS) and design for reliability and manufacturability (DRM) to establish upstream controls that ensure injection time (IT) robustness of mechanical autoinjectors (AIs). For example, break-loose and extrusion (BLE) alert limit, rear sub-assembly (RSA) area under the curve (AUC), and RSA minimum force.