Medical Expertise

Process Validation

Compliance, stability, reproducibility

Qualification IQ/OQ/PQ/PPQ of manufacturing  processes
Special process Validation (cleaning, packaging, sterilization)
Protocol writing, support to relevant testing & acceptance criteria definition
Identification of applicable guide lines for your process

Analysis, resulst summary and conclusion : final validation

Our engineers will support you to :

  • Define validation families (gemoetrical, processes, packaging …)
  • Define representaitve products for each family
  • Define sampling method for each test to perform
  • Define sterilization parameters to follow to achive proper validation
  • Manage and realize testing to evaluate and demonstrate sterile barrier efficiency

The laboratory

In our microbiological laboratory, our engineers and technicians monitor and follow the bateria managment our clean room  (ISO5 & ISO7) :

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

In addition to characterize the materials behaviour and our process management, we also achive in our laboratory :

  • Peeling / compression testing
  • Integrity challenge (Dye test / Vaccum etc…)
  • Labo 1
  • Labo 2
  • Banc test