Qualification assistance in establishment of a new production facility

Competencies

Steering group
Project management
Project/design engineer
Specialist competencies
Drawing resources

Project phases

Feasibility study
Conceptual design
Basic design
Detailed design
Installation
Commissioning & handover
Contact me for more information
Kjeld Lemke
Director, Pharma Section
Phone: +45 2679 5755

Project description

Installation of new process plants and upgrade of some of Biofac’s existing process plants in connection with the establishment of a new production facility for production of API Thyodea bulk. Commissioning of new and reconstructed process plants and qualification of these plants after construction was completed.

The process

Biofac was responsible for the overall project management of the commissioning and qualification of the plants. Process Engineering reported to the project manager from Biofac and provided consulting services on commissioning and qualification with regard to the new and reconstructed process plants.

Biofac

Service and scope of the project

Our service and the scope of the project include:

  • Commissioning
  • Preparation of IQ, protocol, test and report
  • Preparation of OQ, protocol, test and report