Using equivalence between each autoclave's performance to justify reduced
validation of the other is not acceptable. Each machine has to be treated
independently and validated separately. The fact that they have similar
performances is great but is not enough to "double up" on required
validations.
However, if I understand you correctly, you will still be performing an
annual revalidation on each autoclave by doing bi-annual validation on
each machine. As long as you validate your current load(s) in each autoclave
annually, this approach should be acceptable.
Philip Gammell
philip.gammell@eircom.net
|