I've read up on the Calibration vs Validation FAQ, but it didn't clarify my question. In my previous job, which was in the blood banking sector, they validated our centrifuges. They were separating the red cells from the plasma. At my current employment, medical device world, we only calibrate our centrifuges. The centrifuges are used to separate one component from another. A validation has never been performed on the centrifuges. Is calibration of speed acceptable in this case or would it need to be validated? Thanks in advance for your assistance.
G
QA Manager
Hi KingQA,
Both the terms viz. Validation and Calibration are applicable at different stages.
If you go with the definition of Validation, it says, " A documented evidence that provides a high level of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality". Therefore, The Validation (which includes the Equipment Qualification for Installation Qualification (IQ), Operational Qualification (OQ)and Performance Qualification (PQ) are performed before putting the equipment into use. In case of exisiting equipment, a retrospective Qualification / Validation can be performed to have consistency in operations. Validation (besides Calibration of any indicators) shall include various aspects like Imbalance detector accuracy, Speed, Safety features like automatic lid lock, Imbalance detector etc.
While, Calibration is performed on measuring or monitoring systems like gages etc. If there is a rpm (revolutions per minute) indicator, that shall be calibrated.
Thus calibration is a subset in the "umbrella" of validation.
Hope it clarifies.