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COWI had the responsibility for the entire project process from preparation of the basis on which the decision to execute the project was to be made until commencement of commercial production in the completed factory.The project included design and qualification of the buildings, process equipment and automation systems of the factory including utility systems for supply and cleaning.
The total built-up area is approx. 4,000 m2 on two floors, corresponding to approx. 8,000 m2 floorage, and includes production areas, areas for technical installations and administration.Fulfillment of requirement on cGMP and working & external environment necessitated heavy requirements on process equipment and design and arrangement of the building. The layout of the factory provides a distinct separation of clean and unclean areas, and the ventilation systems are built in such a way that indoor climate and pressure conditions are individually controllable in the various rooms.
The production of nicotine chewing gum is for sale to the North American market, where chewing gum added pharmaceutical materials are considered active medicine.Consequently the factory was designed and built in compliance with all requirements on pharmaceutical production and was inspected - without any observations (483) - by the American Food and Drug Administration, FDA, in May 2004.
Jan Stockmarr Chief Project Manager, IndustryTel.: +45 56 40 65 firstname.lastname@example.org
Project period2001–2004ClientFertin Pharma A/SServices rendered by COWILayout and planning, specification of reqirements and detailed design, tender documents and contract negotiations, selection of suppliers and contracting, construction management and site supervision, management and supervision of suppliers, commissioning, authority approvals, tests and qualification (IQ/OQ/PQ), process and cleaning validation.Sub-consultantsAA ARKITEKTER (architectural work), a/s pentra (qualification), NNE (project management and validation), i2r (automation and qualification)
Pharma and biotech