Patent ID: 11860054
Assignee: HOFFMANN-LA ROCHE, INC.
Field: Measurement (Instruments)
Classification: CPC G  B | IPC G

Claim 0:
1. A force testing machine (FTM) validation apparatus for validating a test process using a force testing machine to measure forces involved in operation of a syringe arrangement, particularly a syringe arrangement comprising a staked-in needle prefilled syringe and a needle safety device cooperating with the staked-in needle prefilled syringe, comprising:
a syringe arrangement surrogate; and
a holder arranged to support the syringe arrangement surrogate in a predefined position and orientation in the force testing machine,
wherein the syringe arrangement surrogate comprises a break loose part arranged to mimic a break loose force of the syringe arrangement and an injection force part arranged to mimic an injection force of the syringe arrangement,
wherein the injection force part of the syringe arrangement surrogate has a spring, an outer sleeve housing the spring and an intermediate plunger assembly extending into the outer sleeve, wherein a first rod member of the intermediate plunger assembly is movable relative to the outer sleeve in an axial direction and the spring is arranged to deform when the first rod member is moved in the axial direction into the outer sleeve, and
wherein the break loose part of the syringe arrangement surrogate has a carrier and a distal plunger movable relative to the carrier in an axial direction, and the distal plunger is connected to the carrier such that it is releasable by applying a force corresponding to the break loose force of the syringe arrangement.