Sartorius Extractables Simulator: Simplifying E&L Through In-Silico Modelling

The biopharmaceutical industry uses increasingly complex single-use technologies in order to benefit from maximum flexibility on production capabilities and to react to short-term demands. Maintaining, scaling, and combining extractables data has become a crucial step. To facilitate the employment of single-use systems (SUS) in critical processing operations, the industry requires alternatives to a purely test-driven approach. It requires a software-supported environment for a reliable data prediction.

Sartorius has implemented specialized algorithms for the scaling and combination phases based on physical principles rather than intuitive and empirical procedures. We describe the conceptualization of a database and software application, the Extractables Simulator (ExSim). ExSim enables broad insight into device-related extractables under customer process conditions. We outline how this methodology will allow the industry to predict reasonable extractables data that are required as exposure data in risk assessments, even for the numerous, very complex modular systems on the market.