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Qualification of Sonicator

Posted: Sat Dec 31, 2005 6:17 am
by Sunjay
Dear All,

Recently one auditor asked about the performance qualification of the sonicator. He told us that we can do it by keepning sugar in water and checking the time to dissolve it.

Do any one know about the exact procedure i.e how much sugar/Water/Sugar crystal size and acceptance criteria etc?

Plase share.

Thanks in advance.

Warm regards..........

Posted: Wed Jan 04, 2006 1:16 am
by Sallybeetle
Are you in a GMP regulated lab? I have worked in cGMP regulated labs for twenty years and have never heard of sonicator qualification. We have calibrated the timer against and NIST traceable device, but never the sonication ability.

This is very interesting.

Posted: Wed Jan 04, 2006 10:38 am
by Rafael Chust
I think your auditor is either crazy or has consumed some drug of abuse before speaking with you...

It is the craziest thing I have ever heard!

Posted: Wed Jan 04, 2006 4:46 pm
by AA
That is a strange request. The next time you get that kind of thing, make sure to press the auditor for a procedure or a reference for a procedure. This time, I would think you should be able to go back to the auditors report, get thier name and press them for more information. If that auditors concern never got written down in the report, it never happened.