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.

 

  Title
Using Swabs for Cleaning Validation
Validation (Part 2): Cleaning validation
Cleaning Validation. Official requirements
Validatability of cleaning procedures
Cleaning validation master plan
Establishing the scope of validation
Acceptance criteria and limit calculation
Sampling procedures
Analytical procedures
Documentation
Maintenance of the validated status
Cleaning validation documentation (example)
Prevention of cross-contamination
CIP & SIP
Books and presentations