Efficient Designs to Develop a Design Space in Quality by Design

Purpose: We research on the efficient response surface methodology(RSM) design to develop a design space in Quality by Design(QbD). We propose practical designs for the successful construction of the design space in QbD by allowing different number of replicates at the box points, star points, and the center point in the rotatable central composite design(CCD). Methods: The fraction of design space(FDS) plot is used to compare designs efficiency. The FDS plot shows the fraction of the design space over which the relative standard error of predicted mean response lies below a given value. We search for practical designs whose minimal half-width of the tolerance interval per a standard deviation is less than 4.5 at 0.8 fraction of the design space. Results: The practical designs for the number of factors between two and five are listed. One of the designs in the list could be chosen depending on the experimental budget restriction. Conclusion: The designs with box points replications are more efficient than those with the star points replication. The sequential method to establish a design space is illustrated with the simulated data based on the two examples in RSM.