Process Support

Compliance Solutions

    Thermal Validation

    The purpose of thermal validation and revalidation is to demonstrate that similar sterilisation processes are subject to control and that they comply with regulations, eg. DS/EN/ISO17665 (applicable to autoclaves).

    By carrying out trend analyses on the validations, it is possible to determine any deviations between the validations on a year-on-year basis.

    The trend analysis may provide an indication of a any unintended changes to the process, the environment or the handling, variations in utility or a mechanical fault.

    Process Support also provides thermal validation of cooling, freezing and warehouse facilities and incubation processes.

    Process Support is experienced in the following consultancy services:


    • Preparing protocols


    • Carrying out thermal validation using the Kaye Validator® or Ellab, E-VAL FLEX and TRACKSENSE®


    • Validation reports


    All work can be carried out according to customer specific requirements using the customers document templates. If Process Support is required to carry out thermal validation according to our in-house specifications, we will provide our own protocol and report templates with associated SOPs.

    Process Support would be glad to assist during ensuing inspections.