Hello group,
I'm working on the validation of a manufacturing process for compression of tablets for the pharmaceutical industry. The aim is to test whether the hardness and tablet weight can be controlled during the compression process by adjusting certain parameters of the machine. I want to make a screening to establish the factors that affect the hardness and weight.
My question is:
1. Before the experimental process and do the screening, what kind of pre-study analysis should be carried out to establish the upper and lower bounds for the variables that were identified as crucial to produce a robust tablet?
2. When using a fractional factorial design, how many experiments must be added to the central point in design to test the nonlinearity (ie, the curvature in the data)?
3. How to determine if you have to add center points to the design to test the nonlinearity?
4. How to test for lack of fit to the model equation?
Attentive to your comments. Thanks in advance.