Seeking help in validating a cleaning process.

[Davidngqk88]

Hi there!

I need some advice. I have a cleaning process where a medical device is cleaned in an ultrasonic bath inside a Biological Safety Cabinet, then left to air dry.

I'm writing the IOPQ for these equipment now, and I'm wondering the following:

- I have a final testing criterion that the cleaning process needs to meet. Since the Ultrasonic bath and the BSC work in conjunction to meet that, could I not do performance qualification of the ultrasonic bath, the BSC, AND the validation of the cleaning process in one study?

 

[planB]

Doing all qualification/validation work in one study may be doable, but builds up complexity.

You may want to reduce complexity by breaking down your overall set-up into smaller chunks, such as

- qualification of your ultrasonic bath
- qualification of your biological safety cabinet
- validation of the cleaning process in the ultrasonic bath
- validation of the drying process in the cabinet

HTH,

 

[Davidngqk88]

Forgot to add- the cleaning process uses Two ultrasonic baths- one for the main cleaning and one for the final rinse.

So the process looks like this- wash in Bath 1 - rinse in Bath 2 - dry in BSC.

Ok, question then:

- given that I only have the specifications required for the full cleaning process, how would I then do the performance qualification for the ultrasonic bath?

Say for example the final specification for the cleaning is that I need to meet total organic extractables to be below a certain level. But there's no requirement for the intermediate Step. How would one go about doing PQ for this?

 

[yodon]

Have you looked at the "FDA Guidance on Reprocessing Medical Devices..."? It wasn't clear if you fall under FDA jurisdiction but it's an 'interesting' read, anyway.

Unless I'm not following (and that's a distinct possibility), the qualification of the ultrasonic bath would be separate from your cleaning (and disinfection?) validation. You do need to do that to show the equipment is suitably qualified, though.

 

[indubioush]

given that I only have the specifications required for the full cleaning process, how would I then do the performance qualification for the ultrasonic bath?

Performance qualification is for the process, not just the equipment. Typically, the equipment undergoes installation qualification and operational qualification, and then after that, the process is qualified using the qualified equipment. Pretty sure this is what Yodon said too in a different way. Reading this document may help as well: https://www.imdrf.org/sites/default...g3-n99-10-2004-qms-process-guidance-04010.pdf

 

[Apoorva]

I agree with what Yodon and Indubiosh said along with that follow the guidance documents given by FDA, it may help you with understanding the validation of cleaning process.