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
The LABS:
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
