Fill-and-Finish Turnaround in Sterile Manufacturing
Pharmaceutical company with an in-house fill-and-finish operation
High downtime, recurring batch losses and staffing bottlenecks weighed on the fill-and-finish operation and lowered production efficiency.
The challenge
The situation
High equipment downtime and recurring batch losses shaped daily operations in the fill-and-finish area. Inefficient cycle times, staffing bottlenecks and inconsistent quality management practices compounded the situation, driving down production efficiency while costs rose.
Our approach
What we delivered
Reduction of cycle and lead times in the fill-and-finish process
Easing the bottlenecks in personnel planning, which alongside the equipment downtime were the second cause of the falling production efficiency.
Standardized workflows at lines and shift handovers, against the inconsistent quality management practice that took its heaviest toll at the handovers.
The outcome
Results & impact
51% more production
Increase in production output in the fill-and-finish operation.
52% fewer overdue deviations
Reduction in overdue deviations through standardized workflows.
5.6% higher yield per batch
Improved yield per batch at consistent quality.
16% lower absence rate
Reduced absenteeism across the workforce.
In summary
The fill-and-finish operation delivers a more consistent production output at stable quality, with markedly fewer overdue deviations and lower absenteeism.
Related expertise
Lean Manufacturing →
Value stream mapping, systematic OEE measurement and changeover time reduction via SMED
Deviation Management →
Root cause analysis, OOS investigation and clearing deviation backlogs
Continuous Improvement Programs →
Kaizen workshops and KPI-based performance measurement instead of isolated actions
GMP Consulting (Good Manufacturing Practice) →
Gap analysis against the EU GMP Guide, SOPs, batch records and change control
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Sources
- Entourage project experience (anonymized)
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