Risk Evaluation Models for the Design of Parenterals Manufacturing Processes

Abstract

Abstract In the manufacturing of parenterals such as injectables, multi-use technology and single-use technology are available, which have different advantages and disadvantages regarding cost, environment, quality or supply. As a part of the design methodology which considers the choice of these technologies as the prominent decision, this study proposes risk evaluation models for parenterals manufacturing processes. Novel evaluation indicators were developed for product quality and supply risks, which can be aggregated with other indicators, such as cost and environment, to produce a total score. Case study was performed to demonstrate the models following the activities of process synthesis, evaluation, sensitivity analysis, and decision-making. The result indicated that the process using single-use technology is superior when the weighting factors for cost, environment, quality and supply are equal.