New Final Handling qualification of process and supply 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

Qualification (URS, IQ, OQ and PQ) of a process and supply plant at a new facility at Syntese A/S for API final handling. The facility includes a centrifuge, a vacuum dryer and a powder management plant including a supply facility (GMP and non-GMP).

The process

Process Engineering was responsible for project management in the creation of URS, IQ, OQ and PQ protocols, test and IQ and OQ reports. We had two weekly whiteboard meetings to follow up on status and progress in the projects. In order to streamline the process we focused on using commissioning material such as raw data in the qualification. All of this took place in partnership with Syntese A/S.

The process plants included a centrifuge, a vacuum dryer and powder management, and the supply plants included alcohol, process water, air pressure and nitrogen.

New final handling af kvalificering på proces- og forsyningsanlæg

Service and scope of the project

Our service and the scope of the project include:

  • Project management
  • Whiteboard meetings
  • Preparation of URS
  • Preparation of IQ, protocol, test and report
  • Preparation of OQ, protocol, test and report
  • Preparation of PQ protocol