Two-Level Designs: 1 Introduction
Jun 24, 2008 at 12:01PM
prismtc in DX7, Design Expert, Designs, Factorial Designs, Fractional Factorial Designs, Two-Level Designs

dx7logo216.jpgbar_learn.pngTwo-Level Factorial and Fractional Factorial Designs are useful for either screening the vital few factors affecting your process from the many tested, or to evaluate the robustness of your process to small variations of the parameters in a design space predicted to conform to your acceptance criteria. Typically these are resource-efficient studies comprising 10 – 20 experiments.

To handle these design types within the Design Expert DX7 software tool, we have further tipsheets to help you:

   Two-Level Designs: Building the Design
   Two-Level Designs: Analysing your Results
   Two-Level Designs: Diagnosing your Results
   Two-Level Designs: Interpreting your Results

information.pngThese tipsheets are linked to this case study

Granulation Experiment

To set up and analyse the results of a 24-1 granulation experiment in order to understand the effects of four process and ingredient parameters:
  • Magnesium Stearate
  • Granulation Paste Type
  • Filler (Dibasic Sodium Phosphate)
  • Granulation Blend Time

on three properties of tablets of a drug product:

  • Hardness
  • Degradation Rate
  • Dissolution

Then identify conditions and ranges for the four parameters to conform to the specified targets (Goals) for the three responses

  • Hardness: Max > 20lb
  • Degradation Rate: Min < 4.5 mg/h
  • Dissolution: Max >95%
Resize


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