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
Relief of bottlenecks in personnel planning
Standardised work at lines and shift 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 standardised workflows.
5.6% higher yield per batch
Improved yield per batch at consistent quality.
16% lower absentee 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 →
Reducing cycle and lead times and eliminating non-value-adding activities in the fill-and-finish operation are classic lean manufacturing measures to raise efficiency without jeopardising the validated GMP status.
Deviation Management →
The reduction in overdue deviations as a central result of the case study shows the direct link to a structured deviation-management process in sterile manufacturing.
Continuous Improvement Programs →
The continuous monitoring systems introduced to safeguard the process improvements correspond to building a lasting improvement culture rather than one-off measures.
Good Manufacturing Practice (GMP) →
The inconsistent quality management practice and the standardisation of workflows and shift handovers in the fill-and-finish operation touch the core of a GMP-compliant quality system in production.
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Sources
- Entourage project experience (anonymised)
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