Call +44 (0) 1179 666 761 or email info@besdecon.net to speak to our specialist team

Sealer Validation

Sealers need to meet ISO standard ISO11607-2 and EN868-5.

The maintenance of sterility of sealed instruments is obviously critical, and if instrument pouches are not sealed properly,  the instruments therein are at risk of contamination, and patient safety compromised.  The standards listed above cover the need for a sealer to have calibratable temperature and sealing force  measurement ongoing, so that if one of these process-critical parameters is out of range, the process will be stopped.  The seam must be tested frequently – daily test and documentation process data need to be printed out on a test pouch, and visual inspection included.  (Note: process validation is recommended being done after sterilisation since the strength of the seal drops 20% during sterilisation.)

 

BES Decon's sealers meet these standards. We provide daily, weekly, and annual seal and strength tests along with our sealers. 

To find out more contact BES Decon at info@besdecon.net  or phone +44 (0) 1179666761. Alternatively, you can fill out the enquiry form below.

Benefits

Validation of process

The benefit of testing is that you can validate your sealer and meet the ISO Standard 11607-2 and EN868-5

Your sterile instruments stay sterile

By validating and testing your sealer and the sealing process you can make sure that the sterile instruments pack within seal pouches stay sterile. By using weak seal pouches or a non-acceptable sealer you can put the patient at risk of cross contamination.

Assurance

Testing the sealer and the seal pouches routinely helps give assurance that your equipment is working correctly and meeting the standards.

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