Leading to competitiveness through innovation in medical devices, biomaterials, and processes.

Cleaning Validation

Type of pollution Researched elements Acceptance Analysis method and references
Total hydrocarbons (THC) Hydrocarbon ≤ 0,5 mg/implant Gas chromatography (NF ISO 9377-2)
Total Organic Carbon (TOC) TOC ≤ 0,5 mg/implant TOCmeter (NF EN 1484)

These tests are conducted to determine the absence of manufacturing oil, polishing grease, lubricant, etc. on orthopedic implants.