A Comprehensive Design Approach for Injectable Manufacturing Processes considering New Technologies and Operational Aspects

An approach is proposed to comprehensively design the injectable manufacturing process considering various options such as batch and continuous operation modes, multi-use and single-use technology (SUT) equipment, and production sequences. The approach comprises four steps: 1) set design objective, 2) obtain base case design, 3) extract characteristic parameters by sensitivity analysis, and 4) obtain deeper understanding by scenario analysis. Modularized models were developed to analyze and evaluate the design alternatives using multiobjective indicators for economic performance and productivity. The approach was demonstrated in a case study. The result indicated that the alternatives using continuous compounding, batch lyophilization, and SUT equipment were the most favorable. Based on the sensitivity analysis and the future development potential, continuous lyophilization was further investigated. The scenario analysis revealed that continuous lyophilization can become competitive or even superior to batch lyophilization because of future technology development and equipment cost reduction.