Cleaning validation in the food industry

Cleaning validation is to prove that the equipment is consistently stripped of previous products or cleaning agents to an acceptable level. This is important to avoid possible risk of cross-contamination between products.

Cleaning validation can be applied to any type of cleaning by food processing equipment manufacturers, engineering firms, food manufacturers, and service and chemical suppliers.

Machine manufacturers in the European Union must provide cleaning instructions that specify recommended methods for cleaning, disinfection and rinsing with associated chemicals. This applies to easily accessible areas, but also areas where access is impossible or advisable. The machine manufacturer initially provides general guidelines, because he does not always know the specific use of the installation by the food manufacturer. The food manufacturer is responsible for validating his own cleaning process procedure as he will usually apply this.

There are 2 basic ways of cleaning validation, based on evidence obtained through testing and based on analysis and historical data, also referred to as retrospective validation. If possible, validation by testing is preferred. Retrospective validation is preferred not to be used and is no longer applicable if the production of safe food fails. Validation can also include challenge or worst case testing. These determine the robustness of the cleaning process. If possible, it is recommended to validate the entire processing line.

There must be SOPs (Standard Operating Procedure) that specify exactly how the cleaning process, sampling and analysis methods should be carried out. All procedures described here must be validated.

At least three consecutive uses of the cleaning procedure must be performed and demonstrably successful in order to prove that the method has been validated.

In order to perform validation tasks on time, there must be a suitable system: organizational structure, documentation infrastructure, sufficient personnel and financial resources. Management and personnel responsible for the quality assurance policy must be involved in this. Personnel with the appropriate qualifications and experience are responsible for performing the cleaning validation. If the cleaning activities are outsourced, the operator's personnel must be involved in the validation process.

Before starting the cleaning procedure, it must be established:
Cleaning frequency and non-production times,

• Water quality,
• Cleaning and disinfecting agents,
• Parameters for cleaning process and their registration,
• Responsibilities and qualifications of persons involved,
• Monitoring of the cleaning process incl. Calibration of sensors.

The validation of cleaning and / or disinfection procedures ensures documented evidence that an approved cleaning procedure provides clean equipment for its intended use. The cleaning validation must be described in the cleaning validation protocol that must be formally approved. This protocol covers in detail the entire validation process, summarizes all considerations made, and allows verification that all requirements have been met.