Abstract
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.
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Notes
In Allgemeine Theorie der schönen Künste: in einzelnen, nach alphabetischer …
von Johann Georg Sulzer 1794
In the industry cycle times according to the definition in chapter one relating to batches are referred to as batch times.
Lean thinking according to Womack and Jones’ [17] definition.
Abdulmalek and Rajgopal [1] are referring to managers in the process industries to adopt lean manufacturing tools
In the underlying case, the CMO used the German word “Charge” instead of batch.
Process step weighing was excluded from this analysis.
The University of St. Gallen conducts a benchmarking since 2004, http://www.opexbenchmarking.com. The theoretical foundation has been thematized in Friedli et al. [6].
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Pharmaceutical production, optimization of production, lean philosophy
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Schneider, U., Friedli, T., Basu, P. et al. Operational Excellence in Practice—the Application of a Takt-Time Analysis in Pharmaceutical Manufacturing. J Pharm Innov 10, 99–108 (2015). https://doi.org/10.1007/s12247-014-9210-5
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DOI: https://doi.org/10.1007/s12247-014-9210-5