Review and control of the cleaning activity

Apart from the usual evaluations of cleaning procedures such as checks on processing lines to verify that the established processes of cleaning, dragging, etc., have been carried out correctly, allergen control protocols should also be checked frequently to ensure that they continue to be efficient.

Validation of allergen control protocols needs to be performed by a multidisciplinary team. The validation team, if necessary, could bring together not only production operators, but also personnel qualified in allergen management, engineers, hygiene and quality specialists, etc.

It is essential that the team includes operators with specific knowledge of the processes, equipment and cleaning methods involved in the analysis. It is also necessary that before any verification activity is carried out, the cleaning procedures involved are developed and documented in detail.

In order to perform a validation study of allergen control protocols, it is necessary to carry out a physical evaluation of the cleaning, post-cleaning and pre-operation inspection process, and, in addition, a quantitative analysis using verified analytical techniques.

In case the analytical assessment cannot be performed due to lack of evidence, only the physical validation requirements should be followed and then checked for product residues to meet the "visibly clean" standard. Another option that can be followed in this case is to use a marker allergen labeled with the highest percentage in the formulation and test with it.

The first thing to take into account, in order to perform a proper validation of the cleaning procedures, is to identify the major hazards, such as:

• Identify which are the most complicated allergen by-products to eliminate during the cleaning pr