Peristaltic pump filling technology is becoming increasingly common for drug product fill-finish facilities due to its amenability to the single use system concept, which eliminates the need for cleaning and sterilizing stainless steel filling equipment and the associated infrastructure requirements.  This feature of peristaltic pump filling also minimizes product contact surfaces, since the material being filled does not directly contact the filling equipment.  A mechanistic model for peristaltic filling can expedite new product introductions, reducing the characterization activities needed to determine the proper tubings and process parameters for accurate dosing and a clean fill into the primary container.  This presentation will describe such a model for simulating the pressure drop and flow dynamics during peristaltic pump filling.  The model predicts the fluid flow during a peristaltic pump filling stroke based on the pump head geometry, tubing dimensions, fluid physical properties, and rotor rotation dynamics.  The model enables <i>in silico</i> estimation of important attributes such as fill volume and filling time, providing operators a good starting point for confirmatory process development experiments.  The model can also facilitate technology transfer across filling systems with different pump head geometries or parameter control logic, thereby minimizing experimental work needed to optimize process parameters.

Development of a mechanistic model for the peristaltic pump filling unit operation to enable drug product process design

255th National Meeting (2018)

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