High-End Chemical Analysis

Medical Devices

The GBA Group offers a comprehensive analytics and consulting portfolio for medical devices - tailored to the high regulatory requirements for the safety and quality of medical devices. With state-of-the-art analytics, short delivery times and flexible solutions, we reliably support customers throughout the entire product life cycle.

Chemical characterizations

• Testing of leachables & extractables according to ISO 10993-12/-18
• State-of-the-art testing in accordance with FDA guidance (Draft, September), using validated analytical methods (e.g. GC-MS, LC-MS, ICP-MS)
• Measurement of released alloying elements after simulated extraction

Cleanliness tests

• Cleanliness tests in accordance with ISO 19227, ASTM F2847 and DIN/TS 5343
• Testing for organic, inorganic and particulate residues
• Particle release simulations according to IFU

Material properties

• Verification of the corrosion resistance of stainless steels after passivation in accordance with ASTM A967/A967M (Free Iron Tests)
• Incoming inspections and process validations of polymer materials