Validation

The process of autoclave validation is a critical component in ensuring that sterilisation equipment operates according to predefined criteria to achieve effective and reproducible sterilisation.

The process involves a series of tests to confirm that the autoclave performs as expected, and that it consistently delivers a specified level of sterilisation efficacy. Temperature, pressure, and time are the three parametric elements measured as part of a validation.

The validation of autoclaves is mandated under various guidelines, including BS-EN ISO:13060:2014, BS-EN ISO:15883:1, and HTM 01-05. These standards require that autoclaves undergo periodic validations—typically on a quarterly or annual basis, or as recommended by the manufacturer—to ensure their continued compliance and proper functioning.

GP and Dental practices are required to have their Autoclaves validated annually as a minimum, and practices are regularly audited by the HSE, HSA, and Dental council to ensure compliance.

This validation process, should be performed by a competent person, and ensures the autoclave is functioning correctly and achieving the required sterilization conditions.

The Autoclaves should also undergo Re-Qualification or re-validation again after any major repairs, or break down, i.e. when vacuum or water pumps are repaired or replaced.