Concept, Basic and Detailed Design and CQV for a multi-product single use purification facility housed in a standalone building, with black utilities fed from the existing CUB.
Location:Ireland
Sector:Biopharmaceutical
About This Project
The new building is designed as a standalone facility independent of the existing manufacturing building with fallow area for future development. The single use design results in a flexible facility, suitable for multiple product introduction, facilitating a fast track project with minimum time to construct and commission. The concept and basic design phases were delivered to a very aggressive schedule of 14 week, including submission of planning, EIS, fire and DAC to the local authorities. This was achieved by close co-operation of the DPS and client representatives, an intensive technology transfer period in the USA and rapid mobilisation of a high quality engineering team in DPS. The following major elements formed the scope of the project
Purification Train
Single Use Pooling and Clarification
Single Use pH Adjustment with concentrates
Hydrophobic Interaction Chromatography 1
Single Use Precipitation and Viral Inactivation
Cation Exchange Chromatography
Single Use Nanofiltration, Membrane Chromatography and Ultrafiltration
Hydrophobic Interaction Chromatography 2
Support
Buffer Preparation (Single Use and Stainless Steel)
Single Use Bulk Dispensing
Equipment Preparation and CIP
Reverse Osmosis Water and Water For Injection
Building
Proprietary Grade D cleanrooms
Personnel changing rooms
GMP Gowning rooms
Building control room
Plant rooms
Future fallow area for 2nd purification suite
Achievements
Cutting edge single use design
Designed with low utility and energy usages
Closed process design allowing Grade D cleanrooms to be used