A systematic techno-economic approach to decide between continuous and batch operation modes for injectable...

Area of Science:

• Pharmaceutical Manufacturing
• Process Engineering
• Economic Analysis

Background:

• Selecting between batch and continuous manufacturing for injectables is complex.
• Existing methods lack a systematic approach considering diverse operational and market factors.
• Pharmaceutical process engineers require decision-support tools for optimal manufacturing mode selection.

Purpose of the Study:

• To develop a comprehensive approach for determining the optimal operational mode (batch vs. continuous) for injectable manufacturing.
• To integrate mathematical modules for discrete and continuous processes with economic evaluation.
• To analyze the impact of key process parameters on manufacturing mode preference.

Main Methods:

• Developed integrated mathematical modules for discrete (batch) and continuous injectable manufacturing.
• Incorporated an economic evaluation module to assess process parameters like lot size, labor, solubility, demand, and raw material costs.
• Applied the developed approach to two case studies to validate its applicability.

Main Results:

• Batch production is preferred at low to moderate raw material costs.
• At higher raw material costs, preference shifts between batch and continuous based on annual product demand.
• Continuous manufacturing becomes increasingly favored for medium to large final dosage volumes and is competitive even at moderate raw material costs.

Conclusions:

• Batch injectable manufacturing is generally preferred due to perceived technology risks associated with continuous manufacturing.
• A significant economic incentive is required to favor continuous manufacturing over batch processes.
• The developed approach serves as a valuable decision-support tool for pharmaceutical process engineers in selecting the optimal manufacturing strategy.