Posted January 10, 20241 yr comment_87605 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.
January 10, 20241 yr comment_87606 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.
January 10, 20241 yr Author comment_87608 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.
January 10, 20241 yr comment_87609 I believe other manufacturers offer validation kits. Maybe see what Terumo offers?
January 10, 20241 yr Author comment_87610 I think I can make the Sebra one work for my needs. Thanks again!
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