CE marking of drying cabinet system

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

Project description

Project at Xellia Pharmaceuticals about CE marking of an extra drying cabinet system that is installed in connection with the expansion of their API production. The drying cabinet system includes a drying cabinet, a vacuum pump, a refrigeration unit and a control cabinet.

The process

Xellia Pharmaceuticals was responsible for project management, procurement of equipment, HAZOP, mechanical installation of components and qualification of the new process equipment. Process Engineering reportsed to the project manager from Xellia Pharmaceuticals and provided consulting services on CE marking.

In order to streamline the process, and in partnership with Xellia Pharmaceuticals, we focused on how the tests performed during the CE marking could be integrated in the qualification.

CE-mærkning

Service and scope of the project

Our services and the scope of the project include:

  • CE marking
  • Test report for tests, which could be integrated in the qualification