Multiobjective decision-support tools for the choice between single-use and multi-use technologies in sterile filling of biopharmaceuticals

Abstract

In sterile filling of biopharmaceuticals, two equipment technologies are available, namely, a conventional multi-use technology using stainless steel fixed facilities, and a new single-use technology using resin-made disposable equipment. For the choice between these technologies, this study proposes a set of three multiobjective decision support tools. The first tool is to evaluate cost, environmental impact, product quality, and supply robustness; the second uses a set of weighting factors to produce a total score; the third conducts a sensitivity analysis to investigate the influence of the weighting factors on the final decision. The use of these tools was described as an activity model by a method called "the type zero method of integration definition for function modeling" (IDEF0). A case study was conducted to demonstrate the tools and the activity model in different production patterns, i.e., from small-scale and multiproduct to large-scale and single-product.