The ABC’s of Cleaning Validation: A Simple Primer
What is Cleaning Validation?
Cleaning validation is used to ensure that a cleaning procedure removes all trace soils, cutting fluids, fingerprints, particulates and cleaning agents from surfaces in regulated processes. Any residue must be removed to a predetermined level of cleanliness. Cleaning validation processes protect against the cross-contamination of ingredients from one batch to another, ensure that surfaces or devices are free of residue prior to any further sterilization process, and assist in ensuring product quality.
Cleaning validation is required for use in industries following Good Manufacturing Practices (GMP) as outlined by the US FDA. Manufacturers in the pharmaceutical, medical device and food and beverage industries all use cleaning validation methods to ensure that their equipment is free of waste and that subsequent products manufactured on that equipment are not jeopardized by any remaining soils or soap residue.
FDA guidelines for cleaning validation require specific written procedures detailing how cleaning processes will be validated. These should include:
- Who is responsible for performing and approving the validation
- Acceptance criteria
- When revalidation is required
- Sampling procedures
- Analytical methods to be used
- Documentation of the studies and results
- A final conclusive report stating that all residues have been removed to the predetermined level
If any part of the cleaning process is changed, the cleaning validation process must also be updated.