When Novo Nordisk wanted to build an approximately 35,000 sq.m. facility in Kalundborg, Denmark – including all the bulk production facilities for insulin – the company turned to NNE Pharmaplan for a solution that could meet the requirements of this complex build.

A dedicated NNE Pharmaplan team was responsible for all project phases, from the very first scale-up of the process to the completion of operational qualification (OQ). This included procuring and managing many prefabricated complete units, as well as performing detailed design and validation of other parts of the facility.

Major validation within a short timeframe
The project included a major validation effort as well as one of the largest and most advanced part 11-compliant automation systems in the world. There was also a demanding schedule: the first phase of the facility was operational – including OQ – two years after completion of the basic design, and the complete facility was handed over nine months later.

The end result met all of Novo Nordisk’s quality, operability and safety objectives. And the project was recently awarded the Haden Freeman Award for Engineering Excellence by IChemE.