Model-Based Robust Parametric Design of Automatic Cleaning Process
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The goal of pharmaceutical industry is to manufacture products that meet patients’ needs and expectations, while satisfying the regulatory requirements. The products need to meet the required quality and purity characteristics that are represented to possess. Therefore, in a multi-product manufacturing facility, appropriately designed cleaning processes are essential to avoid cross-contamination between products and ensure patients’ health and safety. The latest trend in the development of cleaning validation is using quality by design methodology (QbD) to determine the most appropriate parameters of the cleaning processes that will reduce the risks of cross-contamination. The present study highlights the model-based approach for robust engineering design in order to achieve an efficient, reliable, and cost-effective cleaning process simultaneously.
KeywordsQuality by design Cleaning development Cleaning validation Robust parametric design Statistical modeling Multiobjective optimization
The authors gratefully acknowledge M. Paleva for her assistance in analytical testing and Prof. I. Vuchkov for his valuable comments on this work.
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