Packaging Re-Validation - Sealer machine broke down or was changed to a new one

Ajit Basrur

Staff member
Admin
#11
Hi!

You discussed the situation when a new sealer is installed. I performed the IQ, OQ and PQ for one sealer, but there are other two on the site. They are the same brand and model. Could you please advise: Should I perform the same tests as for the first sealer?
Is it possible to shorten the qualification process of the other two sealers? Do I have to perform all OQ tests again?

Thank you.
Welcome to the Cove :bigwave:

If you shorten the qualification procedure for the similar sealer, how can you demonstrate and assure that the second and third sealer behave identical as first one ?
 
Elsmar Forum Sponsor
Y

Yarocin

#12
The other sealers are the same brand and model. They are identical and they are used for sealing of the same type of materials. I assume that in this case I can give just a good rationale for shortened qualification.
 
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