Case story
CE marking of filtration plant
Project at Xellia Pharmaceuticals about CE marking of a filtration plant in connection with installation of new filtration units for API cleaning.
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
The process
Xellia Pharmaceuticals was responsible for overall project management, procurement of equipment, HAZOP, mechanical installation of components and qualification of the new process equipment. Process Engineering reported 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.
Service and scope of the project
- CE marking
- Separate test report for tests, which could be integrated in the qualification
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