project

Industrial organisation audit and design for quality control pharmaceutical laboratories

Design / Consulting Life Sciences Switzerland

Context and challenges

This client is a fully integrated pharmaceutical company, with a production site in Switzerland. This site includes several quality control laboratories: physico-chemistry, microbiology, analytical development, pharmaceutical development and biological process. Regulatory authorities have made comments to improve processes and activities, as space lay out of these laboratories was not optimal as located on several floors.

The client has launched a project which aims at:

  • Rationalizing the flows of the different laboratories
  • Relocating lab activities to optimize the space of existing buildings
  • Introducing molecular biology laboratories for upcoming projects
  • Improving compliance linked to regulatory requirements, especially FDA (Food and Drug Administration) requirements

The client has appointed Assystem Care to audit the facilities, working methods and redesign laboratories (detailed design), to take into account new regulatory requirements and optimise activities.

Project scope

  • Analysis focusing on processes and flows related to:
    • Samples, consumables and dirty versus clean glassware
    • Time and distance of walking of employees
  • Organisation of workshops to enhance processes and workflows (new layout)

These analysis and workshops followed a bottom-up approach:

  • Definition of the different labs’ needs and the new labs’ design
  • Recommendations to improve compliance (regulatory, safety, biosafety) and integration in the new layout
  • Proposition of relocation plan (timing and phasing) taking into account technical constraints, continuity of operations and compliance
  • Risk analysis for projected implementation phase

Two senior Assystem Care experts (BE, CH) were dedicated to the project.

Results

  • Reduction in walking time by 37% with new laboratory design
  • Enhanced compliance with regulatory requirements, e.g. by moving non-lab activities such as administrative work outside the microbiology labs
  • Improved efficiency, focusing on regrouping activities in a logical way, in order to optimise flows and minimise transportation of materials
  • Hand-over of proposed design to the engineering provider for execution

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