Cleaning validation is a method to validate cleaning procedures, to remove residues and contaminants and to ensure the effectiveness and uniformity of cleaning in the plant and equipment.
Validation of cleaning procedures is a fundamental prerequisite for pharmaceutical manufacturers to protect patient safety and comply with cGMP rules. Cleaning protocols must be validated to ensure safety, efficacy, quality and regulatory compliance in the production of active ingredients (API, Active Pharmaceutical Ingredient).
The validation of the cleaning has become a necessity for the food sector, too. Food manufacturers must validate their cleaning process to ensure that their products are safe as per current regulations.
Effective cleaning is necessary to achieve suitable hygiene conditions in any food production environment. An insufficient or ineffective cleaning can cause food contamination that may originate from different risk factors:
- Physical contamination from deposits and food residues
- Biological contamination from bacteria and other microorganisms
- Allergenic cross-contamination of proteins in the food chain
- Chemical contamination from residues of detergents and disinfectants that are still present after insufficient rinsing.
Cleaning protocols must be validated to provide documented evidence of cleaning effectiveness and to minimize cross-contamination.
Validation of cleaning processes is necessary for the food sector.
The certification bodies emphasize this concept in the standards to be adopted for food safety –BRC, IFS, etc.
Food sector operators of the EHEDG group (European Hygienic Engineering & Design Group) have drawn up specific and dedicated guidelines “Cleaning Validation in the food industry” to help manufacturers to suitably validate their cleaning process.
Mérieux NutriSciences provides the Cleaning Validation service for the food industries through an integrated approach that meets the needs of the sector:
- Support in defining the cleaning prerequisites according to EHEDG guidelines
- Identification of the most appropriate sampling points
- Validation of sampling techniques
- Selection of analytical methods
- Definition of the cleaning protocol
- Analytical tests to validate the cleaning process
- Drafting of the Cleaning Validation Report
- Monitoring of the validation status
- Customized validation of disinfectants and their use on a specific reference surface
We validate the cleaning process by considering all the different areas of application:
- Cleaning validation - Residues of detergents, disinfectants, fumigants
- Cleaning validation - Allergens
- Cleaning validation - Microbiology
- Validation of disinfectants
- Digital solutions - Enviromap
Click here to visualize our service on Cleaning Validation.