New facility for GMP radiopharmaceuticals

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Client: SWAN Isotopen
Location: Bern, Switzerland
Scope: Radiopharmaceuticals, Fill Finish Facility

Project Highlights

Design and construction of a new greenfield facility for the production and research of radiopharmaceutical drugs for human use.

Services Summary

Engineering lead, Concept and Basic Design, process expertise, project management, site works supervision, commissioning, qualification and technical support.

  • Conceptual design of the facility, including process and products identification.

  • URS definition for facility, utilities and services.

  • Basic Design and technical revision of detail design.

  • GMP Review and Safety Review.

  • Support during procurement (suppliers selection, auditing, price negotiation, etc.).

  • Project management and scheduling during all the phases.

  • Construction management.

  • Coordination and execution of the facility commissioning (FAT, SAT).

  • Coordination and execution of the complete qualification of facility and equipment.

  • Development of Maintenance and Calibration plans and procedures.

  • Development of VHP decontamination cycles for isolators.

  • Technical support during GMP inspection.

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