Dear Ade,
My laboratory is accredited to ISO 17025. It follows the requirements
established by A2LA. The facility, like other FDA Field Laboratories,
also has to follow requirements by AOAC.
AOAC previously required calibration of micropipettors on a quarterly
basis. In order to save money, my laboratory decided to have
cGMP-compatible service every six months. In between these service calls
I would use a photometric system to perform quick calibration checks on
the instruments. Due to environmental variables and lack of specialized
equipment, a photometric system was used for these quick checks instead
of gravimetric methods. Note gravimetric calibration requires a moderate
amount of skill, therefore I left it to experts.
AOAC and A2LA now specify micropipettors to be calibrated every six
months. I have found in my experience the instruments need service,
especially O-ring replacement, every six months therefore I have full
service and calibration every six months performed by a contractor. In
between service calls if an instrument fails I send it to Rainin in
California.
My laboratory uses Calibrate, Inc. to have its micropipettors calibrated
every six months. The company has local employees who come to the
laboratory and perform services on-site.
The photometric system I mentioned is from Artel, Inc. The disadvantage
of the system is the cost of the reagents, however the system is
excellent for training and for facilities that need to check their
micropipettors frequently.
Calibrate, Inc.
http://www.pipetpeople.com
Artel USA, Inc.
http://www.artel-usa.com
If you have further questions, you can respond to the list or e-mail me.
Sincerely,
Michael
FDA PRL-NW Micropipettor Monitor
Michael P. Owen, Regulatory Microbiologist
U.S. FDA Pacific Regional Lab Northwest
22201 23rd Drive SE Bothell, WA 98021-4421
Phone: 425-483-4865 E-Mail: michael.owen@fda.hhs.gov
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