Serono S A - New Downstream Processing Zone

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This pharmaceutical project was undertaken by Kvaerner.  The scope of the project involved front end design packages, engineering, procurement and validation.

The project had the following features:

• Downstream Processing Suite 4 designed for the purification and concentration of fermented bulk hormone products involving multiple chromatography, ultrafiltration/defiltration and virus removal steps
• Demolition of existing area with only the internal perimeter walls and structural concrete remaining
• Protection of operational areas during construction of new proprietary clean room system
• The air handling systems were helicopter lifted onto the roof and constructed in place
• Upgraded existing site chilled water capacity including a new 70m3 buffer tank within a single 6 hour shutdown
• Purified water, clean steam, heating water, chilled water and gases modified by installing new tie ins to existing services
• New 180 kW -10 deg C glycol chiller system to serve DSP 4 and future production centre
• Areas designed for operation at Grades C & D EU GMP including double wall construction for clean rooms against external walls
• Fully automated buffer preparation room with equipment for materials additions.  All installed under clean conditions
• Fully classified Grade C & D ventilated cold rooms
• 100% fresh air air handling unit systems with terminal HEPA filters on the supply and provision for terminal HEPA filters on the extract
• Lead engineers from process, process services, building services and architectural were based on site to develop the design of the facility with the Client and to liaise with contractors on the designs and selection of components and materials available in Switzerland
• Site supervision and co-ordination personnel were resident on site for the construction, commissioning and validation activities.