[Histonet] Re: Microtome micron calibration and validation

[Randall Carpenter]

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.

Randy Carpenter
Twin Cities Histology 





Hi,

I want to know ur comments and thoughts on microtome micron calibration and
validation.Is there any method for doing it,please explain


Thanks and Regards
B.Radhika
Junior Scientist
Preclinical safety evaluation
Dr Reddy's Discovery Research