[Histonet] IHC Validation on new instrument

[Liz Chlipala]

We perform our entire validation process as a new piece of equipment.
Our validation protocols are quite extensive, up to about 85 pages long
on each piece of major equipment, at least that's what it was for our
new prisma stainer and glass coverslipper.  We perform an
installation/operational qualification protocol or an IOQ.  If we move
the instrument we also do the same thing, we already have the protocol
written which takes most of the time we just execute it again.  We are a
GLP lab so we work off a Validation Master Plan that basically tells us
how we are going to validate each piece of equipment in the lab.

Liz

Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC
Manager
Premier Laboratory, LLC
PO Box 18592
Boulder, Colorado 80308
office (303) 682-3949 
fax (303) 682-9060
www.premierlab.com
 
 
Ship to Address:
1567 Skyway Drive, Unit E
Longmont, Colorado 80504

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Laurie
Colbert
Sent: Wednesday, May 19, 2010 9:00 AM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] IHC Validation on new instrument

What do others do when validating a new model of a piece of equipment -
same manufacturer, same basic staining process, but an updated version
of the equipment?

 

I've been told the protocols should be the same and that we only need to
run three controls with three different but similar protocols to
determine what looks best.  Do you all think that is thorough enough, or
would you run actual patient cases and compare old and new equipment?  I
don't see where the CAP checklist refers to new equipment - just new
antibodies and new antibody lots.

 

Laurie Colbert

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