Products and Packaging Validation

Analysis for heavy metals

Testing method with ICPOES has been established in order to analyze and to identify the toxic heavy metals such as Arsenic (As), Cadmium (Cd), Mercury (Hg) and Lead (Pb).

The testing of heavy metals trace in medical devices is critical to determine the toxicity of biomaterials and to predict its interactions with other compounds.

Quality Guidelines Overview – Metal Impurities :

• Guideline on the Specification Limits for Residues of Metal Catalysts or Metal Reagents, EMA
• ICH Q3D, Draft Guideline
• Ph. Eur. 2.4.8, Heavy Metals
• USP Guideline <231> Heavy Metals
• USP Draft Guideline <232> Elemental Impurities – Limits
• USP Draft Guideline <233> Elemental Impurities – Procedures

These tests are conducted both on raw materials and finished products.