Tube sealer Validation

[RRay]

I was finally able to get a new tube sealer!  Been ages since this facility has had one and I can't find any guidance from manufacturer.  Does anyone have a validation protocol for a heat/tube sealer they'd be willing to share?  I can do one from scratch but that's not bandwidth I have at the moment.  Pretty please and thank you.

[Cliff]

I'm surprised the vendor didn't offer support.

Here is an ancient validation plan for a Sebra hand sealer; you can adapt it.

Sebra Hand Held Tube Sealer valid plan.doc

There is also the FDA guidance on the use of the device.

And the decades-old, and since retracted, FDA Memo.

 

[RRay]

Thanks so much!  The only thing offered by the manufacturer is a very basic IQ.  It's the Genesis sealer.  I emailed customer support twice and they only reply with the same user manual with basic IQ.

[Cliff]

I believe other manufacturers offer validation kits.  Maybe see what Terumo offers?

[RRay]

I think I can make the Sebra one work for my needs.  Thanks again!