pharma/biotech support

Started by OlDave, 04-22-2008 -- 12:46:22

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OlDave

Question for all you people that support either the pharmaceutical or biotech industries.

Piston-operated volumetric apparatus, i.e. pipettes.

Do you calibrate your pipettes in-house. An onsite service provider come in to do them? Send them out to a service provider? How often?

If you calibrate your own, do you do them by the ISO 8655 or the ASTM E1154 methodology? Gravimetric of photometric method?

How about tolerances? Manufacturers tolerance? ISO 8655 specs? Home grown? How did you make that decision?

How about user training? Even if the pipette is perfect, how well can the analyst use it? Have you done any studies to measure the differences between analysts?

I am looking to totally revamp our pipette calibration program here and would like a little feedback from other corporate metrologists in similar settings about what does and doesn't work for your company. How happy are you with your current process? How could it be improved?

We are currently sending our pipettes out for calibration on a 6 month interval. We use the manufacturer's accuracy specification for our pass/fail limits. We are currently concerned with turnaround time and cross-contamination issues from some of our bio labs and looking at all options.

Anybody want to share some of their experiences?

OlDave

bump back to the top of the list....

Does anybody support pipettes?

swampgator

Let me pass this on to my counter-part on the Analytical Met side of the house. He may be able to provide some answers. I'll let you know what he says.

swampgator

I'll cut and paste his response. I'm not sure how much it may help you though.

"We really do not use the autopipettes any more.  There are a couple kicking around.  We perform a gravimetric calibration of our autopipettes every 6 months.  We do 3 replicates at 3 points over the liquid end range with an accuracy and RSD limit.  The accuracy is +/- 2% based on an in-house spec.  The spec is large in that the typical application for the pipette is adding reagents in a color development reaction."

skdykshoorn

Do you calibrate your pipettes in-house.  Calibrate in house, repair as much as able in house, and send out the ones we can't to a service provider.
How often? six month intervals

If you calibrate your own, do you do them by the ISO 8655 or the ASTM E1154 methodology? No, have in house procedure using the Gravimetric  method and Labtronic Pipette Tracker . pipette calibration software

How about tolerances?  Home grown using what will work with the uncontrolled environment that we currently have.

How about user training? For our calibration laboratory technicians, we use Workplace CDs, and on the job training.  For the technicians in the laboratories we support, we bring in different manufacturing representatives to present training.

Even if the pipette is perfect, how well can the analyst use it? Have you done any studies to measure the differences between analysts? Not recently, but probably will in the future. 

For good information, look at the different manufacturer websites.  Also look at Artel, who does photometric method of calibration but has very valuable information and training opportunities. 

SoCalGuy

As a reply to the topic posted regarding the calibration, user training and other general requirements on pipette calibration, I would be happy to talk to you on the phone or on line.  I have over twenty years of pipette calibration, repair and pipette user training experience.  Please visit this link to look at our user training program.
http://www.anmar.com/training.html  Please tell me the method of comunication that you would perfer as I don't have enough time right now to answer your questions, but could this evening or tomorrow afternoon.  Have a nice day and I look forward to talking with you soon to help you reach your goals regarding liquid measurement certainty.