Case Studies and White Papers
Framing a QbD Design Space with Tolerance Intervals
Given the push for Quality by Design (QbD) by FDA and drug agencies worldwide, statistical methods are becoming increasingly vital for pharmaceutical manufacturers. Response surface methods for DOE provide powerful tools to manage the impact of multiple factors and their interactions.
Researchers aiming to upgrade a fed-batch process observed that basal and feed media have interrelated impacts on process outcomes (a pairing effect). They did a DOE enabled by Design-Expert software for fed-batch cell culture process optimization.
Given the push for Quality by Design (QbD) by the US FDA and equivalent agencies worldwide, statistical methods are becoming increasingly vital for pharmaceutical manufacturers. Design of experiments (DOE) is a primary tool because “it provides structured, organized method for determining the relationship between factors affecting a process and the response of that process." Tolerance intervals (TI) verify that the design space will be robust for meeting the manufacturing specifications on every individual unit, not just on average.
This article explores a therapeutic strategy for treating Huntington's disease.
Design of Experiments for Non-Manufacturing Processes: Benefits, Challenges, and Some Examples
Design of experiments (DOE) is a powerful technique for process optimization that has been widely deployed in almost all types of manufacturing processes and is used extensively in product process design and development. There have not been as many efforts to apply powerful quality improvement techniques such as DOE to improve non-manufacturing processes. Factor levels often involve changing the way people work and so have to be handled carefully. It is even more important to get everyone working as a team. This paper explores the benefits and challenges in the application of DOE in non-manufacturing arena.
Design-Expert Diagnostics Saves Experiment (and Post-Grad Student)
See how the diagnostic features of Design-Expert enabled a post-doctoral researcher to achieve a valid analysis, and graduate on time. Lesson learned: Checking diagnostics just might save your next experiment.
The TRW team used a combination of DOE (response surface methodology RSM) and Monte Carlo analysis to optimize a braking system where one of the objectives was to quickly generate pressure when demanded by the vehicle stability control system.
FLSmidth recently installed two turnkey SuperCell flotation machines the world's largest flotation cells at Rio Tinto's Kennecott Utah Copper concentrator near Salt Lake City, Utah. They used DOE to substantially reduce the amount of testing and fine-tuning required after installation.
DOE was used to determine the optimum setting conditions for three components leading to a high Hg Yield at a lower temperature.
In this presentation design of experiments (DOE) was applied to a chemical process. DOE together with computer modeling lead to a better understanding of the process and the defining of new conditions.