Cleaning validation methodology purpose is to ensure that the cleaning method effectively removes microbial and chemical residues, making the drug production process and processing equipment safe. There are various sources of potential contaminants: API degradation species, detergents and solvents residues, APIs residues and their presence poses risk to patients’ safety and prolonged manufacturing downtimes.
Selvita’s team can support cleaning validation analysis, performed under cGMP certification, including:
- Specific method development/transfer to confirm relevant and effective cleaning process
- Method validation – focused on LOD, LOQ, precision, linearity, selectivity