Alexion, Purification Facility Project

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
  • Flexible facility
  • Aggressive schedule
  • Future expansion space
  • Planning, Fire Cert and DAC
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