Cleaning Validation

Cleaning validation is a relevant GMP activity to prevent contamination of biopharmaceutical products by ensuring that the processing equipment is suitable for following manufacturing processes. Potential contaminants include residues of the active pharmaceutical ingredients or their related substances, and residues from the products used during the cleaning process such as solvents or detergents. This is particullary important for highly-sensitizing compounds such as antibiotics, hormones and cytotoxics and in the case of parenteral drug products.

Full suport:

We can assist you in the different steps of cleaning validation:

• Evaluation of critical risks and calculation of allowed residue levels on manufacturing equipment
• Design of cleaning protocols and reports
• Development and validation of analytical methods
• Wide range of techniques available: ICP-MS, GC, HPLC, HPLC-MS, TOC
• Analysis of validation samples (direct surface samples and rinse samples)
• Method transfer to the manufacturer for routine testing

TOC Analyzer HACH ANATEL PAT700