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Validation studies for equipment, processes, ingredients and products

A tool that has become essential in order to demonstrate compliance with regulatory/clients requirements

Carry out a validation study… where to start?

Validation studies are necessary to demonstrate that the hazards identified in a process are effectively controlled according to the applicable compliance requirements. It will happen in certain specific cases such as for example the installation of a new process, a new machine, the use of a new antimicrobial additive, etc.; that the validation study should/would need to be redone and/or at least revised.

It is possible that antimicrobial equipment, processes, machinery or ingredients, etc. be used elsewhere by other companies or in other countries. The validation study which will then be necessary will therefore consist in demonstrating that you are operating under the same or similar conditions which make it possible to control the same hazard (s) identified to an acceptable level. The same situation will arise if there are technological , scientific or other changes that call into question the effectiveness of equipment, processes, machines, antimicrobial ingredients, products, etc. that you use.

What is important to include in a validation study

  • A hazard analysis that ensures that everything that could occur under the worst-case scenario is properly identified and that the control measures are provided with the limits to be observed as well as all the other regulatory documents required according to the program applied.

  • Scientific and technical data that will serve as beacons to justify the use of your control measures , even if there is no regulatory or legislative basis yet.

  • A plan or strategy for implementing your process, machine or new substance with supporting documents on the harmlessness of materials, chemicals, cleaning methods, disassembly, etc.

  • A test or test plan with objectively measurable parameters that demonstrate that you are in control and that the process, machine or antimicrobial, etc. produce the expected results or effect accompanied by a full report with the conclusions that demonstrate that the hazards are controlled to an acceptable level.

We are able to help you to carry out validation studies so that you are able to meet regulatory and normative compliance requirements and those of your clients (including those stipulated in the GFSI standards). It will also simplify/streamline your approach to improve your level of compliance by achieving better scores during regulatory and customer audits, save time/money, facilitate training of your staff and continue to improve your productivity.

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