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19th February 2020, 10:23 PM
#1
Three resin lots required for part qualification
Hi All,
Been running up against some people who like to require three different lots of resin to do a part qualification. Early in my career I spent some time at a medical molder and they used the three lot requirement. Always assumed it was part of the FDA IQ OQ PQ process but searching online I can't find a mention of it being required.
Does anyone know where using 3 lots to qualify comes from? Trying to understand the background so I can attempt to kill the idea here. Current part running into the "we need three lots" wall is non-medical and is molded with HIPS - boggles my mind.
Thanks!
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