Briana Russo, Senior Statistician, Merck
Sterility breaches of pre-filled syringes of a drug product are not directly measured but are known to be a function of syringe dimensions, plunger movement and fill weight. Fill weight is dynamically controlled so a non-parametric fit in the JMP Distribution platform was used to fit a Kernel Density based on real-world data. JSL was used to simulate 10 million iterations based on the non-parametric fit, along with plunger movement simulations based on dimension specifications and measured frictional forces. Different theoretical in-process controls were imposed on the simulated plunger depths to identify which control strategy had a low risk of sterility breaches while minimizing unnnecessary discards of valuable syringes.