Allergen Cleaning Validation and Verification

This segment discusses the importance of validation and verification in allergen cleaning regimes.

• Validation ensures that a cleaning process effectively removes allergen soils and meets the cleaning goal. It is done before implementation and revalidated when significant changes occur, such as introducing new allergens, modifying processing steps, or adding new production lines.
• Verification confirms that the validated cleaning regime was correctly performed and remains effective. It is conducted continuously, typically after each allergen clean.

How It's Done

1. Visual Inspections – Essential for both validation and verification. Inspect equipment before and after cleaning, dismantle components, and identify hard-to-clean areas.
2. Analytical Testing – Uses methods such as environmental surface swabs, rinse water analysis, and rapid test kits to detect allergen residues.
3. Worst-Case Validation – Tests the regime against the most stubborn or abundant allergens to ensure effectiveness.
4. Consistency Testing – Conduct at least three consecutive allergen cleaning cycles using the same method and sample type. If allergen residues are consistently removed, the process is considered valid.

Practical Tips

• Develop a cleaning validation plan to streamline the process.
• Focus swabbing on difficult-to-clean areas, not just smooth surfaces.
• Ensure that rapid test kits are suitable for the specific allergen and environment.
• If visible food residues remain post-cleaning, the cleaning regime is ineffective.

Final Note

Validation and ongoing verification are crucial for effective allergen management. Absence of evidence is not evidence of absence, meaning without proof, allergen risks cannot be assumed to be eliminated.