Compliance, stability, reproductibility

  • Qualification IQ/OQ/PQ/PPQ of manufacturing  processes
  • Special processes Validation (cleaning, packaging, sterilization)
  • Protocol strategy & writing, support to relevant testing & acceptance criteria definition
  • Identification of applicable guide lines for your process
  • Analysis, results summary and conclusion: final validation & post market survey
  • Risk Management

Our engineers will support you to define:

  • Validation families (geometrical, processes, packaging …)
  • Representative products and Worst Cases for each family
  • Sampling method for each test to perform
  • Sterilization parameters to be followed for a proper validation
  • Manage and execute the tests to challenge and validate the sterile barrier


Micrological laboratory

  • Air and surface microbiologicals control
  • Particles counting
  • Periodical follow up and requalification of our clean rooms by internal & external accredited laboratory (COFRAC)

Testing Laboratory

  • Peeling testing for pouches and blister
  • Compression testing
  • Dye penetration testing

Analysis laboratory

  • SEM/EDX: Scanning Electron Microscope & Energy-dispersive X-ray spectroscopy
  • MicroVu: Non contact measurement machine
  • Surface Tensiometer : Surface Tension (wettability) Measurement
  • Roughometer : Surface Roughness Measurement

Prototyping laboratory

  • Thermoforming machine
  • 3D printing machine