Efficient Analysis of Particle Size Distributions with JMP® Non-Linear Models
Rob Lievense, Statistician, Carlos Paz, Raj Thota, and Jack Irwin, Perrigo Company
Particle size distribution (psd) analyses are typically used for solid drug products as physical characteristics and are related to critical quality attributes (CQA) for the end dosage form. Mesh screen testing offers immediate information for a given batch; however, analyses of such data can be incomplete due to focus on weight left on "target" screens. Expended screen testing and analyses with the non-linear modeling tools offer comprehensive psd trending without the need for more complex analytical devices. The tools were used to determine if an intermediate powder, manufactured with two different manufacturing methods, had equivalent particle size distributions.