Lean Six Sigma in Sterile Filling and Packaging
Pharmaceutical company with sterile filling and packaging at one manufacturing site
Implementing Lean Six Sigma in the sterile filling and packaging operations of a pharmaceutical company, focused on cost reduction and a global lean program.
The challenge
The situation
The initial objective was to reduce costs at the site and to deliver a global lean implementation program. Lean elements had previously been introduced only partially and in a fragmented way. An inefficient continuous improvement process and a large number of disruptions were identified. On top of this came inadequate resource planning, unrealistic process standard times, and a lack of employee involvement.
Our approach
What we delivered
Establish OEE measurability for all production lines, because without a shared metric neither losses nor progress were comparable.
Reduce disruptions through more efficient cleaning processes, after the volume of disruptions in the initial state had been identified as high.
Lean Six Sigma improvements for higher process stability
Introduce resource-based planning in place of the inadequate resource planning with unrealistic process standard times.
Sustainable process control through KPIs and key-data reporting that keeps process planning and efficiency management permanently visible.
The outcome
Results & impact
Improved process standards
Further development of the process standards and the management framework at the site.
Reduced losses
Reduction of organizational and technical losses along the production lines.
Greater transparency
Transparency in process planning, key-data reporting, and efficiency management.
+20% OEE
Increase in overall equipment effectiveness (OEE) by 20 percent within 12 months.
In summary
Within 12 months, overall equipment effectiveness (OEE) rose by 20 percent. Process planning and efficiency management became transparent and sustainably manageable.
Regulations & standards considered
- EU GMP Annex 1 (sterile manufacturing)
Related expertise
Lean Six Sigma →
Methodology for process stability and loss reduction in manufacturing.
Lean Manufacturing →
OEE measurability and efficient operations along the production lines.
Continuous Improvement Programs →
Effective continuous improvement instead of fragmented one-off lean measures.
Annex 1 (Sterile Manufacturing) →
Regulatory framework for sterile filling and packaging.
Similar projects
More on Pharma →
Sources
- https://theentourage.de/case-study/lean-six-sigma-sterile-abfuellung/ (live case study, accessed 2026-06-14)
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