Erratum to: Decision-Support Method for the Choice Between Single-Use and Multi-Use Technologies in Sterile Drug Product Manufacturing

Abstract

Single-use technology has been applied to sterile drug product manufacturing processes as a new technology in contrast with the conventional multi-use technology. This study proposes a decision-support method for choosing between these two technologies in sterile drug product manufacturing. The proposed method consists of four steps: create process evaluation models, calculate evaluation results, perform what-if analysis, and interpret results. We created models for evaluating the production cost and life cycle CO2 emissions of processes using either technology. “What-if” analysis quantifies the effect of the input parameters on the evaluation results, which supports more informed decision-making. Here, it is recommended that the filling speed, which was found to have a significant impact on filling accuracy—a critical quality attribute of sterile drug products—should be investigated. As a case study, the method was applied in two cases of technology selection: (i) single-batch production of a product with different batch sizes and (ii) single-batch production with different production patterns. The single-use technology showed its economic superiority in producing small batches and in producing multiple small-scale products, whereas in the environmental evaluation, it was always better than multi-use technology. What-if analyses revealed the impact of changing input parameters on the economy, environment, and quality. Our method can support the choice of single-use and multi-use technologies in plants having both technologies independently. In the case study, economic evaluation showed a critical point in each design case, whereas the environmental evaluation result was always better in single-use technology.