Operational Excellence in Practice—the Application of a Takt-Time Analysis in Pharmaceutical Manufacturing

Introduction: Due to increasing cost pressures and structural changes in the pharmaceutical industry in recent years, pharmaceutical manufacturers have been forced to focus on the optimization of their production processes. Therefore, operational excellence is receiving broader attention throughout the pharmaceutical industry. However, too many of these practices are attempting to reduce the cycle time or increase the output of single-process steps rather than optimizing the overall process from a holistic perspective. Objective: This paper addresses the concept of a "Takt-time” analysis for pharmaceutical manufacturing. A Takt-time diagram is a tool to identify bottlenecks in a production process. It visualizes the cycle time of a product and the times per process step and relates it to customer demand (Takt time). Thus, the bottlenecks in the production flow are revealed, and production can be reorganized. However, the application of the Takt-time analysis to pharmaceutical manufacturers shows specific challenges because of their manufacturing characteristics, such as batch processing. Methods: The concept for a Takt-time analysis was developed while working on a project with a CMO of an imaging agent to address the practical challenges in implementing its concept in pharmaceutical manufacturing. Results: The concept creates the basis for a process redesign at a multiproduct production site. It lays the foundation that customer demands can be matched with an aligned production process, and that a seamless production flow driven by customer demands can be realized