RRay Posted January 10 Share Posted January 10 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. Link to comment Share on other sites More sharing options...
Cliff Posted January 10 Share Posted January 10 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. Link to comment Share on other sites More sharing options...
RRay Posted January 10 Author Share Posted January 10 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 1 Link to comment Share on other sites More sharing options...
Cliff Posted January 10 Share Posted January 10 I believe other manufacturers offer validation kits. Maybe see what Terumo offers? Link to comment Share on other sites More sharing options...
RRay Posted January 10 Author Share Posted January 10 I think I can make the Sebra one work for my needs. Thanks again! jshepherd and Cliff 2 Link to comment Share on other sites More sharing options...
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