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hameln pharmaceuticals: NNE contributed to operational excellence

In 2009, hameln pharmaceuticals’s sterile production plant designed by NNE was awarded the prestigious international ISPE Facility of the Year Award in the Operational Excellence category.

For more than 50 years the German company hameln pharmaceuticals has been a specialist contract manufacturer of parenteral solutions and suspensions. hameln pharma’s activities involve the manufacturing and marketing of liquid pharmaceuticals, primarily for hospitals and intensive medicine. 

New sterile production plant

NNE helped hameln pharmaceuticals establish the 9,200 m² sterile production plant that won the award for operational excellence. Well before the engineering and construction phases, hameln pharma contacted NNE in order to set the qualification concept, conduct a risk analysis and prepare the validation master plan. NNE was also responsible for reviewing and reworking the conceptual design, the basic design, process engineering and qualification. The award jury highlighted the facility’s Lean production concepts, which were implemented throughout the design and construction of this facility. For example, the U-shaped structure of the filling systems reduced traffic in the highest class of cleanroom, increasing the plant’s productivity. 

Significantly increased production capacity

The innovative, flexible sterile facility was built and put into operation after a project time of only 25 months at hameln pharmaceuticals’s headquarters in Hameln, Germany. The facility has increased the company’s production capacity significantly and created space for the implementation of innovative technologies.

Customer
hameln pharmaceuticals gmbh, Germany

Customer’s success criteria
Meet time deadlines, within budget, high standard

Project duration
Mar. 2006 – Jul. 2008

Services provided
Review and rework of conceptual design,
basic design for process, building and building services, utilities and automation, detailed design for process equipment, procurement support for process equipment, execution of FAT tests for process equipment, validation master plan, risk analysis, qualification, preparation and execution of qualification documents for DQ, IQ, OQ, preparation of qualification documents for PQ