Could you please help explain and confirm my understanding
in the WHO TRS 961, the validation frequency for autoclave is 2 years (no major change/maintenance) but the calibration for the Pt sensor still is not mentioned, my understanding is one year, is it right?
(appendix 4, examples of equipment qualification and monitoring, page 103)
With kind regarsds,
period of requalification for autoclave depends how these equipment is critical. Two years for reqaulification and one year for calibration is too long.
Usually requalification period is one year (somewhere 6 months) for RQ and 6 months (3 months) for re-calibration.
This is because if validation/calibration failed, less number of batches are under investigation.
Dear Zeljko Joksimovic,
Thank you for your comment