Validating the packaging process using factorial designs.
The development of an effective process requires a comprehensive understanding of two factors: the variables that can affect the process and the ability of the process to control those variables. This article examines the application of factorial designs in the qualification and validation of packaging systems. Using a case study to illustrate the concept, it describes a three-step approach that allows a reduction in the quantity of sampling compared with other experimental methods.
Merritt
J
J
Rexam Medical Packaging, Singapore.
D004864:Equipment and Supplies; D005163:Factor Analysis, Statistical; D006801:Humans; D008962:Models, Theoretical; D019064:Product Packaging / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data*; D015203:Reproducibility of Results; D012449:Safety