Copyright © 2012 Byung Rae Cho and Sangmun Shin. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Researchers often identify robust design, based on the concept of building quality into products or processes, as one of the most important systems engineering design concepts for quality improvement and process optimization. Traditional robust design principles have often been applied to situations in which the quality characteristics of interest are typically time-insensitive. In pharmaceutical manufacturing processes, time-oriented quality characteristics, such as the degradation of a drug, are often of interest. As a result, current robust design models for quality improvement which have been studied in the literature may not be effective in finding robust design solutions. In this paper, we show how the robust design concepts can be applied to the pharmaceutical production research and development by proposing experimental and optimization models which should be able to handle the time-oriented characteristics. This is perhaps the first attempt in the robust design field. An example is given, and comparative studies are discussed for model verification.