CE marking of drying cabinet system
Project description
Ongoing 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 is responsible for 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.
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