Challenge
Following regulatory inspection criticism Fisons needed to refurbish their secondary solid dose manufacturing facility. The refurbished facility was required to operate robustly at the new tighter performance criteria. The project had to be phased and fast track to minimise the impact to manufacturing schedules
Solution
Bob lead a project team and specialist contractors to re-design the environmental controls, introduce improved dry ingredient blending and dust explosion protection, procure, construct and modify the existing secondary solid dose manufacturing facility.
Result
The project installation, remediation and dry blender testing had to be phased and fast tracked to minimise the impact to manufacturing schedules. The facility refurbishment was finished on time and successfully re-re-inspected 6 months later to confirm the corrective actions had been followed-through, plant performance met specification and was producing finished drugs in a compliant manner