Speaker Interview with Nicole Heider

Nicole Heider is a student of technical physics at the University of Technology in Vienna, Austria. At Octapharma, Nicole is working on computer-based automatization in the context of E&L assessments. Nicole's focus is the development of models for application in pharmaceutical production, including the modeling of diffusion

Modelling the diffusion of extractables from processing materials: use cases and future possibilities

Inspired by the work of Armin Hauk and David Saylor and based on Piringer, a Python-based diffusion model has been developed. The practical uses of that diffusion model are demonstrated based on various real-life examples in the context of E&L assessments including i) interpolation of extractables amounts based on analytical data (e.g. BPOG study) to obtain a more realistic patient exposure and ii) the calculation of extractables in filled containers after inline filtration. The analytical data and the geometry of the material are considered, and diffusion is calculated. If unknown, the diffusion coefficient D, the partition coefficient Kpl and the maximum concentration of the extractable in the liquid phase cmax are fitted. The model delivers results of acceptable accuracy, and it makes additional extractable studies redundant.