Hoffmann-la Roche Inc.

F. Hoffmann-la Roche Ag

Paolo Moroni

Georg Cramm

Sascha Dreher

Thorben Hammerich

Eva Conraths

Martin Vogelmann

A force testing machine (FTM) validation apparatus is disclosed for validating a test process involving a force testing machine to measure forces involved in operation of a syringe arrangement. Particularly a syringe arrangement that includes a staked-in needle prefilled syringe and a needle safety device cooperating with the staked-in needle prefilled syringe. The FTM validation apparatus includes 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. The syringe arrangement surrogate includes 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. Methods are also disclosed for validating a test process that measures forces involved in operation of a syringe arrangement and for measuring forces involved in operation of the syringe arrangement.

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Basel, Switzerland

Paolo Moroni