The process has been developed including Quality by Design QbD Elements The team utilized structured multivariate experimentation DOE The design is a response surface custom experiment with 21 runs ID: 926983
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Slide1
A pharmaceutical R&D group is developing a new drug product that involves the need for wet granulation.
The process has been developed including Quality by Design (
QbD
) Elements.
The team utilized structured, multivariate experimentation (DOE)
The design is a response surface custom experiment with 21 runs
4 process inputs are included to evaluate the effects on 5 responses
Slide2https://www.glatt.com/en/processes/granulation/high-shear-granulation/
What is Granulation?
Granulation is a way to increase and communize particle size to maintain dose uniformity and/or aid in compression
Slide3Initial Goals:
Confirm the factors that are important for the process outputs
Rank the factors by the amount of effect on the process outputs
Make predictions on outputs and find optimum settings
Extended Goals:
Utilize the experiments with known variability of inputs to set practical expectations for process outputs
Find a control space for the process to include in manufacturing cards
Determine the robustness of the control space without having to expend resources by making several actual batches
Slide4The executed design
The design space; experimental coverage