FRUITION DESIGNS
Our extensive validation experience has been included in all aspects of the design and manufacture to ensure safe and effective products to the customer. This has included expertise in the following:
Design Validation
• Material Testing: Forgings, mouldings, castings
• Product Testing: All forms of compliance testing suitable for submission
• Coating Testing: Tensile, shear, impurities, impregnation, crystallinity
• Packaging: Transit, stability, oxidization, seal strength
• Electronic: ISO 60601 and EMC
Process Validation
We have experience of the full validation process from the URS to the PQ for either new processes or revalidation. Our experience of processes include the following:
• Surface Treatments: Passivation (nitric and citric) and electropolishing
• Cleaning : Final aqueous clean including water treatment, interim washing and degreasing
• Coating: Plasma spray for titanium and hydroxyapatite, adhesive coatings, antimicrobial
• Machining: Milling and turning
• Marking: Laser marking and etching
• Special Processes: Braiding, heat treatment, assembly, extrusion, laminating, film conversion, ATEX rating, calendering, injection moulding, drying
• Packaging: Pouches, blisters, labelling
• Sterilisation: Gamma, steam and EtO
• Additive Manufacture: 3D printing in plastics and titanium
• Software: Setting up and implementing CSV procedures to 21 CFR Part 11
• Test Equipment: Test method validations to relevant standards