Cleaning Validation
The objective of cleaning validation is to ensure that a specific cleaning process will consistently clean to predetermined limits to prevent contaminants (product or cleaning process related) from leaving residues that will adulterate and adversely affect the safety and quality of the next product manufactured. Cleaning validation is documented proof that one can consistently and effectively cleanse a system or equipment item. Pharma solutions has extensive experience in developing meaningful acceptance criteria and ensuring the execution is conducted in an orderly manner. Our experienced staff can provide services in Cleaning validation. Our highly skilled team can ensure that equipment-cleaning procedures are removing residues to predetermined levels of acceptability. These individuals are trained to:
- Understand regulatory requirements, guidelines and expectations
- Select and evaluate effective cleaning methods and processes
- Establish residue limits and calculate sample acceptance criteria
- Select sampling and analytical methods
- Simplify the cleaning validation program.