I just did an IQ, OQ, PQ on my process. The OQ on the microtome
involved using a dial micrometer. Set the thickness at 5 microns.
Tare or zero the dial micrometer on a point on your sample holder.
Pull the micrometer point back, turn the wheel X number of times and
take your new reading. It should add up to X times 5 microns +/-
your tolerances. The rest of the "validation" process depends on it
being installed properly and that it actually cuts sections suitable
for pathologic interpretation. As we all know, just because the dial
on the microtome says 5, doesn't mean the section is 5 microns.
The point of the Operation Qualification is only to demonstrate that
the machine works like it's supposed to. The dial micrometer needs
to be calibrated/traceable. I got a guy in town to do it for $20.
Of course everything needs to be documented and QA should sign off on
it. Hope it helps.
Twin Cities Histology
I want to know ur comments and thoughts on microtome micron
validation.Is there any method for doing it,please explain
Thanks and Regards
Preclinical safety evaluation
Dr Reddy's Discovery Research
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