Dr. Thomas Brinz
Post-doctoral researcher
Title: Quality by Design with Automated Process Development for tablet compression und capsule filling
Biography
Biography: Dr. Thomas Brinz
Abstract
Successful process validation is a crucial step in the development of a new pharmaceutical products. Nowadays with Quality by Design (QbD), a comprehensive understanding of the process is required. The combination of statistical design of experiments with the automated execution of test series offers essential advantages in the development of robust and effective processes. Despite the advantages of statistical design of experiments, the development of tabletting processes and capsule filling is still dominated by the manual execution of individual trials, since different feeders or stirrer blade geometries always require a manual conversion. The high powder consumption is another hurdle for a larger number of trials. This presentation will explain new automation solution for tablet presses and cpaulse filler that allows automatic execution of statistical planned experiments, including an automatic conversion from 2-paddle to 3-paddle feeders and from round to rectangular stirrer blades without manual intervention or conversion. The machine automatically sets all the necessary process parameters and the most important of the critical quality characteristics are measured directly in or on the system. The experiments are performed automatically without, or with only reduced, human interaction. This allows multiple experiments to be performed with reduced time. Different complex powder formulations (difficult flowing, overmixing, capping or sticky) as well as a (classic) tabletting base mix are tested and optimal process parameters are determined. Expecially the handling of complex interaction of process parameters and material attributes in more than 100 experimental studies gets much easier than with the classical one-factor-a-time method.