公开(公告)号：WO2023064119A1

公开(公告)日：2023-04-20

申请号：PCT/US2022/045303

申请日：2022-09-30

Applicant: AMGEN INC.

Inventor： MOGHADDAM, Seyed, Reza Mirhassani ,  JAZAYERI, Julian ,  SANCHEZ, Sandra ,  HALILI, Edgardo ,  SALDANA, Cindy ,  VALENZUELA, Sergio, Giovanni

IPC: A61M5/142 ,  A61M5/48

Abstract: Apparatuses, systems and methods are provided that characterize a rear sub-assembly for an autoinjector (Al). Apparatuses, systems and methods are also provided that generate injection time (IT) models for autoinjectors (Als). Autoinjectors (Als) (e.g., mechanical Als, spring-loaded Als, etc.), components for use within Als (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 (D RM) to establish upstream controls that ensure injection time (IT) robustness of mechanical autoinjectors (Als). For example, break-loose and extrusion (BLE) alert limit, rear sub-assembly (RSA) area under the curve (AUG), and RSA minimum force.