Pilot‑Scale Production Upgrade for UK Generic Pharma Client
A large UK generic pharmaceutical company sought to reposition one of its sites for developing new compounds, running small‑scale batches, and optimising mature products outside the main production streams.
Unable to justify new‑equipment investment, the client appointed Epsilon to single‑source and deliver an “as‑new” pilot‑scale manufacturing line (up to 15 L batches) featuring:
Core Equipment Requirements
- Fluid bed multiprocessor
- Tablet coater
- High‑shear mixer
- Ancillary support equipment
Scope of Work
- Detail design and utilities impact assessment, with full fixed‑cost report
- CE/ATEX risk assessment and mitigation planning
- Certified decontamination and 316L stainless‑steel material certification
- Replacement of all serviceable parts, seals and bearings
- Equipment upgrades and new inlet air handler for fluid bed and coater
- Refurbished fan with new HEPA‑grade filters
- Explosion isolation valves, earth‑proving systems and Pred machine compliance calculations
- New S7 PLC / WinCC control system to GAMP 5 standards, fully wired panels
- Tablet coater overhaul with new machine guarding
- Fluid‑bed internal repolishing
- High‑shear mixer interlocks, inverter drives and bowl repolishing
- Complete DQ package and CE‑mark Technical Files
Turnkey Delivery
Epsilon managed the full turnkey installation and project management as a single “one‑stop‑shop” solution. From factory acceptance testing to site commissioning and qualification, all services were provided under one contract.
Key Results
- ✅ Delivered in 7 months—approximately half the cost of new equipment
- ✅ Fully compliant with cGMP, ATEX and CE standards
- ✅ Pilot‑scale flexibility for new compound development and batch optimisation
