New production facility for biomaterials under GMP conditions

Flexibility was a key criterion for Geistlich Pharma's new facility for biomaterials. Based on advanced process technology, such as lyophilisation, the facility needed to be able to accomodate future technology and production requirements. NNE helped the company to meet the expectations within demanding timeline and budget requirements.

The renowned company Geistlich Pharma, in Wolhusen, Switzerland, was faced with a substantial surge in demand for its biomaterials (“Bio-Oss”) used as bone implant in surgical operations. Consequently, the company decided to build a new production facility comprising demanding process technology such as lyophilisation. Since a fast development of production volume and technology was to be expected in the future, the facility had to be flexible enough to accommodate these changes at a minimum of additional investment in full compliance with all pertinent international regulatory requirements.

The limited technical resources in-house required external support, going as far as a project realisation on a turnkey basis for the process part. The project was under considerable pressure to meet the demanding timeline and budget requirements.

Key to success

Geistlich Pharma selected NNE as contractor for the process part and we took responsibility for the project initiation, the subsequent engineering activities, equipment procurement, installation and full qualification from design qualification to operational qualification up to performance qualification support.

Key to our success was a clear concept for the facility, based on short and medium-term process requirements.

Horst Kellermann, project manager, NNE

“Key to our success was a clear concept for the facility, based on short and medium-term process requirements combined with the careful choice of suppliers,” explains Horst Kellermann, project manager from NNE. “This enabled us to adopt solutions, that accommodate the expected evolution with a minimum of cost, whilst still ensuring full compliance with all regulatory requirements. The excellent cooperation and support we received from Geistlich throughout the project was another help. Bringing these elements together allowed us to finish the project within the demanding frame set originally.”

Quick facts

Customer

Geistlich Pharma AG

Country

Switzerland

Project duration

Jun. 2004 – Mar. 2006

Total investment

USD 22 million (incl. building)

Services provided

Consultancy for project initiation, engineering (conceptual to detailed), turnkey delivery of cleanrooms, HVAC and process equipment, qualification (DQ to OQ, PQ support)