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