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Projects Management

Process & Design Engineering:

Our expert project management & dedicated project teams will work together with you to deploy innovative solutions.

Our documentation and quality assurance vision is to provide unequaled customer service through the detailed documentation of customer specifications and specialized testing. We ensure the highest standards of quality products along with the technical and quality testing required.

Each decontamination unit is operated and fully tested at our manufacturing facilities, located in France and the United States.

Biopharmaceutical processing: Design 3D Modellinbiowast Decontaiation System Biopharmaceutical processing : Manifacturing and FAT Biopharmaceutical processing : Installation, Tests and Validation on Site

Design

  • Preliminary study: delivery of the simplified functional analysis, equipment dimensioning, preliminary layout, structure of the automation for validation.
  • Detailed study: delivery of the manufacturing drawings, nomenclature, materials data sheet, and detailed functional analysis for validation.
  • Design in accordance with the cGMP and CFR guidelines


Manufacturing and FAT

  • Scheduling and production scheme in compliance with the "Quality Plan Project"
  • Manufacturing & Assembly
  • Finalization of the documentary file
  • Delivery of the FAT protocols
  • Complete FAT before shipment


Commissioning, tests and validation on site

  • Site installation
  • Preliminary tests
  • SAT
  • Assistance to the IQ and OQ qualifications
  • Training & ongoing service and support


Maintenance