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Novo Nordisk A/S - The NovoSeven® Facility, Kalundborg, Denmark
Facility Considerations
 Due to an urgent demand for the hemophilia drug, NovoSeven®,
the project design for the new 14,000 square-meter NovoSeven® manufacturing
facility, ordered by Novo Nordisk A/S, was driven by the requirement to reduce
execution time to only 18 months. This implied that the traditional approach of
executing major project components in series, by first constructing a building
and then installing the equipment inside, had to be skipped.
“To meet the tight time schedule the project team constructed process
modules in parallel at offsite locations, where commissioning and qualification
of each system could be conducted without the usual dependencies on adjacent
upstream and downstream equipment”, says Klaus Illum, Engineering Director
at the life science engineering firm, NNE.
 The building was designed and constructed in independent sections, each planned
to accommodate delivery and then meet the specific operating requirements of
its respective process module.
Time was also saved as modular engineering helped achieve a high degree of project
control. As the control focuses on small (compared to the total) uniform modules,
it will be more reliable. Statements such as “we are almost on schedule”
were replaced by “we are on schedule, except for module X which is behind
and Y which is ahead”.
The facility was commissioned and handed over to Novo Nordisk for technical
approval in 2002. According to Kjeld Bjerregaard, Manager of the NovoSeven®
facility, the facility represents an industry milestone that established modular
engineering as an effective tool for rapid execution of a pharmaceutical facility.
Processes/Manufacturing Equipment Employed
 Modules were divided into five subgroups: cell fermentation, chromatographic
separation, raw materials and buffers, clean utilities, and facility utilities.
Each group of modules was purchased from a supplier with expertise in the specific
type of equipment. The modules were ordered as complete functional and operational
units, including instrumentation and power panels.
Distribution piping between modules (product, CIP/SIP, solvents and utilities,
collection of waste, etc.) was a critical path issue for the modular design,
since it had to be installed and ready to connect as each module arrived onsite.
Piping installation could not impede module delivery, and it needed to allow
for adjustment in the event of unavoidable inaccuracies in the building design.
To meet these needs, NNE installed the bulk of the distribution piping in the
basement, which was completed and closed first to enable construction above
ground.
Once modules arrived at the site, all that remained was to verify that off-site
testing had not been invalidated in transit, to connect piping, power and automation
network cable and to perform necessary on-site testing.
To read more about the other finalists, click here.
NNE A/S
Gladsaxevej 372
Soeborg, DK, 2860
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