CE marking of filtration plant

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

Ongoing project at Xellia Pharmaceuticals about CE marking of a filtration plant in connection with installation of new filtration units for API cleaning.

The process

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

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

CE-mærkning

Service and scope of the project

Our services and the scope of the project include:

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