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Lundbeck Pharmaceuticals Ltd. - P7 Building, Seal Sands, UK
Facility Considerations
 Lundbeck's new multi-million dollar Primary Pharmaceutical Facility
at Seal Sands represents the largest single investment made by the company to
date. The new high-tech plant manufactures Escitalopram, which is the active ingredient
for Cipralex®/Lexapro®, Lundbeck's new antidepressant drug.
The plant features a large-scale Simulated Moving Bed (SMB) unit in addition
to conventional chemical production equipment. SMB is the core technology and
enables separation of the enantiomers of Citalopram (Cipramil®) and therefore
makes production of pure Escitalopram possible.
 To construct the new P7 plant at Seal Sands, England, Lundbeck appointed Foster
Wheeler Energy Ltd as their Engineering, Procurement, Construction and Validation
(EPCV) Contractor.
As 'Speed to Market' was the critical feature of this project, Lundbeck set
a challenge to the project team to meet a 21 month schedule, from award of contract
to mechanical completion. This schedule represents a 10 month saving on normal
projects of this size.
To achieve the desired 'Speed to Market' and ultimate launch of the new drug
the entire team had to be committed to the schedule.
Key areas were identified to ensure the fast track nature of the project was
successful, they included:
• Extensive use of modularization
techniques for all levels of design and construction across all disciplines.
• Contract strategy and subcontractor
scope for both design and construction.
• SMB unit ordered by Lundbeck
prior to apointment of principal contractor to achieve project timescale.
• Nominated civil and building
subcontractor apoointed simulataneously with principal contractor.
• Site works commenced 2 months
after award.
• Early appointment of all
subcontractors.
• Design Strategy - Non-intelligent
model adopted as opposed to PDS.
• Commissioning and Validation
team – commenced 3 months after award.
• Fully Integrated team approach.
Processes/Manufacturing Equipment Employed
Process
The process was previously developed and implemented in several smaller production
facilities in Denmark. The P7 facility provided a world scale, custom-made production
solution for the total manufacture of the API.
Technology
 At the heart of the process technology is the Simulated Moving Bed (SMB) Chromatogram system.
This is a continuous process operation and was by far the largest implementation
of this technology available.
The supplier was Groupe Novasep, based in Nancy, France. Novasep had worked
closely with Lundbeck for several years to develop a separation technique suitable
for industrial scale enatiomeric separation. Chiral Technlogies Ltd. also worked
with Novasep and Lundbeck to provide a suitable stationary phase for the system.
Integration
The facility design concept was based on a modular philosophy - the modular
approach was applied to the whole facility and a wide range of equipment.
From a construction viewpoint, modules were specified to contractors and constructors
on a turnkey basis from detailed design to qualification.
Module fabrication was in many instances performed off site. Larger more complex
modules were also assembled on site.
The pre-constructed modules were easily integrated into the facility specifically
designed to accommodate the modular approach.
The following are significant areas of modularization tendered as complete
packages:
• Jacket service units –
TFS limited
• Pre Assembled Pipe racks
– Cordell
• Compressed Air – Woodside
Pneumatics
• Nitrogen - Air Products
• Steam generation unit –
Cochrans
• Thermal fluid refrigeration
plant – Star Refrigeration
• Adsorber – Sutcliffe
Croftshaw
Equipment
Equipment suppliers were pre-specified to the module constructors.
The basis of selection centered on existing Lundbeck specifications and standards.
These standards provided a basis for commonality on equipment types, which,
in turn:
• Reduced training
• Sped up qualification and
validation
• Reduced spares inventory
• Reduced documentation
• Established and improveed
relationships with suppliers
• Provided greater potential
for financial savings
Some of the equipment choices made at Lundbeck:
• Glass lined reactors –
Pfaudler Balfour
• Level, and flow instrumentation
– Endress & Hauser
• Temperature, pressure and
pH instrumentation – Rosemuont
• Variable Speed drive systems
– Vacon
• Pumps- HMD and Flowserve
• Valves- Worcester and Atomac
H. Lundbeck A/S
Otilliavej 9
Valby-Copenhagen, DK, 2500
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From a vision to a vial in 12 months -
Process development and... 
