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

Hello there! Welcome to the Cove!:bigwave:

Essentially, I would consider calibration a subsection of validation. Validation is a bit more of a formal process of verifying suitable use, installation, performance, assessment against functional criteria, etc.

The matter of whether you require a validation would fall more under a regulatory requirement issue and/or a requirement to fulfill any organizational validation guidelines.

But a calibration to assure proper use is definitely a minimal verification.

I am in the process of qualifying the VFD (Variable frequency Drive) associated with the centrifuge.

I also have the same confusion that VFD has to be calibrated or qualified.

Expeted some clarification on this.

Regards / Raghu

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.

Good answer, Ajit. I like the thumbnail definition. As far as the VFD, I would consider it as a functional part of the centrifuge. To me, it would be validated with the centrifuge.

As far as calibration, it's hard to give a definite answer. But in general, I would think it's operation (proper adjustment of the motor speed) would be verified when you calibrate the instruments of the centrifuge.

You calibrate the measuring and monitoring functions of the equipment: e.g. determine whether the equpment meets the accuracy and precision specs.

You validate the equipment against its user requirements: is the centrifuge consistently seggregating all red cells from your plasma (or whatever specification you have defined). In order to meet the use requirement, it needs to be calibrated.

You calibrate the equipment, you validate the process, one does not necessarely exclude the other. Ideally you want to perform both.

One way to view it is that (made up numbers) the calibration verifies the machine used to spin blood spins at 12K rpm +/- 300 rpm.

Validation would verify that spinning actual samples of blood, at that speed, on that machine, actually separates it into a solution 98% +/- 1% pure with maximum 3% loss due to damaged cell structure (it’s a made up specification but the point is that the spec the Customer is looking for is not the 12K rpm, it’s that the blood is separated). The 12K rpm is just an one indicator that the process is still working.

The calibration just verifies it meets the physical requirements while validation tells if it’s doing the job you want it to do which should hopefully match. ie Prove it’s doing the job.