This story reminded me of an experience calibrating pipettes: Former Theranos Lab Employee Interview
My first job in validation was mostly qualifying CTUs and laboratory equipment. I had four years of GMP lab experience at this point. I was used to pre-approved acceptance criteria and protocols and writing deviations for changes to such. This validation company I was working for mostly did biotech and R&D validation, so non-GMP. Most clients didn't even see the protocol until it was sent to them for final post-approval.
My boss had an ongoing client that mostly had CTUs to qualify. It was a laboratory doing HIV research. They needed pipettes calibrated and my boss said we could do it even though I don't think he had any experience doing it. So my boss bought a balance and some pipette calibration tracking software. The catch was that since these pipettes were used in a BSL-2, they didn't want to have to decontaminate them and take them out of the area. There was no live virus in the area. This was not a GMP facility.
These were small pipettes, 1mL and under. Talking about some dispensed amounts as small as a nanoliter for ELISA and other analyses. I had just attended a lecture by a calibration lab about calibrating pipettes, so I knew our setup was impossible to use. Even worse, the lab bench I was to use was next to a running biosafety cabinet. Worse yet, I had no instructions on even how to adjust these pipettes if they were out. This was circa 2007 a lot less was online that is now.
"4_365"by cam_rich345 is licensed under CC BY-SA 2.0
So I get in the lab and start pipetting water. Of course, half the pipettes are failing based upon the default acceptance criteria given by the pipette calibration software. I have no idea what to do, so I go outside to and call the boss. He tells me to widen the acceptance criteria. I asked how we were going to justify that. I don't remember his response. I then go inside widen the acceptance criteria. Pipettes are still failing. Go outside, call the boss. He tells me to widen the acceptance criteria more. I go inside and run pipettes again. Still failing. I finally decided to pack up my stuff and figure out a better way to approach this instead of not doing my due diligence for the client.
Thankfully the client called me later and said they were going to find somebody else to calibrate the pipettes. I recommended the calibration company that gave the lecture to us, Alpha and Omega.
We lost that client later because they finally figured out that they didn't need to totally requalify every CTU every year!
My first job in validation was mostly qualifying CTUs and laboratory equipment. I had four years of GMP lab experience at this point. I was used to pre-approved acceptance criteria and protocols and writing deviations for changes to such. This validation company I was working for mostly did biotech and R&D validation, so non-GMP. Most clients didn't even see the protocol until it was sent to them for final post-approval.
My boss had an ongoing client that mostly had CTUs to qualify. It was a laboratory doing HIV research. They needed pipettes calibrated and my boss said we could do it even though I don't think he had any experience doing it. So my boss bought a balance and some pipette calibration tracking software. The catch was that since these pipettes were used in a BSL-2, they didn't want to have to decontaminate them and take them out of the area. There was no live virus in the area. This was not a GMP facility.
"4_365"by cam_rich345 is licensed under CC BY-SA 2.0
So I get in the lab and start pipetting water. Of course, half the pipettes are failing based upon the default acceptance criteria given by the pipette calibration software. I have no idea what to do, so I go outside to and call the boss. He tells me to widen the acceptance criteria. I asked how we were going to justify that. I don't remember his response. I then go inside widen the acceptance criteria. Pipettes are still failing. Go outside, call the boss. He tells me to widen the acceptance criteria more. I go inside and run pipettes again. Still failing. I finally decided to pack up my stuff and figure out a better way to approach this instead of not doing my due diligence for the client.
Thankfully the client called me later and said they were going to find somebody else to calibrate the pipettes. I recommended the calibration company that gave the lecture to us, Alpha and Omega.
We lost that client later because they finally figured out that they didn't need to totally requalify every CTU every year!
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