project

Design, project management and CQV for pharmaceutical transfer airlock

Compliance / Security Life Sciences France

Context and challenges

The client, a world leader in the production of insulin, wanted to modify the layout of its transfer airlocks (for staff and materials) spread over 300 square meters of floor space, in order to integrate observations from regulatory inspections and to resolve congestion problems.

The project had to take into account the following requirements:

  • Arrival of AGVs (Automated Guided Vehicles)
  • Creation of Class D transition space, separation of In and Out flows, contamination control
  • Integration of inspection observations and regulatory requirements relating to the flow between classified and non-classified areas

The client called on Assystem to perform the basic and detailed design work for this mission, and to monitor production.

Logo Assystem Care

Project scope

  • Perform basic design work

  • Perform detailed design work

  • Perform tendering, selection and monitoring of suppliers for all project work packages (walls, ceiling, floor, HVAC, furnishings, automated doors and access control, fire protection, sprinkler, electricity, automation, visual management)

  • Conduct acceptance and qualification phases

  • Coordinate the project (meetings, minutes, reporting, scheduling, monitoring budget)
    Total of 800 hours of design work

Requirements: integration of GMP compliance requirements, of simultaneous on-going work of other projects, and of airlock ergonomics. Integration of interfacing issues with the AGV project - flows (staff and materials) and automated arrival of materials on production lines

Results

  • Better overall ergonomics for building (in particular elimination of shoe covers, which were a source of HSE risks), enabling staff to move around more easily and efficiently
  • Reduced costs: major reduction in consumption of production garments and energy
  • Airlocks compliant with GMP (Good Manufacturing Practices)
  • No non-quality events reported since production launch

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