Mixing Calculations In
Batch and semi-batch process of typical fine chemical development
Gap between R&D and production results
Reducing the number of required batches for the validation process in the production stage
The Traditional Approach
Running the process in reactors of increasing size and looking for optimal process and operation parameters at each stage
The VisiMix Analysis
Implementing the mixing calculations in the first development step as part of the characterization of the process. This activity provided an understanding of how hydrodynamics influences the process. By scaling down calculations and setting up the lab equipment according to the output results obtained from the production equipment simulation, it is possible to find the operation surface range for a robust process.
The VisiMix Solution
The relationship between mixing parameters and experimental work, based on “Quality by Design (QbD) practices, provides a deep understanding of the process and the scale up activities, and decreases the out-of-spec material when the process runs with different size batches.
Decreasing the number of batches required for validation in the production step, from around 100 to below 5, produced savings of at least $1,000,000* per project
*Based on an average of 25 out-of-spec batches in production step at cost of $100 per batch of 400 kg per batch (25*100*400=1,000,000)
TASK: Decreasing the number of required batches for the validation process during the production stage
Figure 1: Development methodology
Figure 2: Typical mixing parameters selected with VisiMix The method is taking into account the hydrodynamic parameters that influence process results in the early first step of scaling-up characterization, and setting the lab equipment according to production simulation results.
The scale-up team was able to focus on finding the optimum set of operational parameters based on the evaluation of the process in a real hydrodynamic configuration.
“The VisiMix team and simulation software saved us a lot of time and money. We introduced your simulation software at our plant as part of our scale-up routine and QbD practice…“