Physical validation requirements

Develop a flow chart: A flow chart should be made to show all the equipment in the production plant involved in food processing. Those implements that come into contact with allergenic substances such as raw materials or finished products should be highlighted in the diagram.

Components where allergenic residues can accumulate, such as vacuum filters in pneumatic conveying systems, should also appear in the diagram, even if neither ingredients nor products flow through them.

High-risk contamination areas should be subjected to thorough allergen sanitization and subsequent visual assessment, and in those areas that are difficult to access, where cleaning and visual verification is difficult, cleaning should be performed in combination with dry cleaning.

The flow chart can be used to verify the production line during cleaning to ensure the integrity of the cleaning process. This verification is recommended to be carried out in conjunction with operators who are familiar with the plant's cleaning and manufacturing procedures. Cleaning of areas and equipment that are difficult to access: Equipment that requires special treatment during cleaning, either because it is difficult to access or because it must be disassembled, must be identified and recorded, and it must also be specified where samples will be taken for validation analysis.

Allergen transfer procedures should contain the specific actions and requirements needed for proper cleaning of the production line.

Photos of identified areas that are difficult to clean or difficult to access can be used for staff training purposes and, if deemed necessary, can be added to the cleaning program.

In complex facilities such as closed circuits, where it is not possible to perform periodic evaluations of equipment and areas after sanitization, compliance should be verified after the completion of each cleaning process. Documentation: With the information gathered in the steps mentioned above, all documentation should be kept up to date, such as:

• Cleaning schedules, including specifications for disassembly of equipment with poorly accessible areas and other relevant parameters to be taken into account during the cleaning process, such as, for example: caustic wash at 2 % v/v, at 75°c, for 10 minutes.

• Pre-operation measurement checklists.

• Checklists of risk analysis and control measure