3 channels on the FCA are leaking during the maintenance script. I have replaced some of the inline filters previously and all channels are passing the daily inline filter test.
I have swapped the diti adapter and plunger assembly out with non-leaking channels, and the original channels still leak. I tried to wipe any debris from all accessible seals with a dry cloth. Any advice for next steps to clean/lubricate upper seals?
What does your data tell you? Are you using an ARTEL to qualify it?
We are preparing to start the qualification process in the coming weeks, so we do not have any data yet.
There are water droplets forming from the 3 of the tips in the leakage test during the weekly maintenance.
Did you swap the entire channel (part on top that does the actual pipetting) or just the tip adapter/plunger assembly (at bottom)? You may need to swap the entire channel.
If the problem persists, I would consider disabling the inline filter check tbh.
My understanding of the leakage test is that droplets are okay as long as they don’t drop to the deck (feels bit subjective.)
I’ve only swapped the lower assembly thus far and I definitely have one channel that is releasing a drop withing the 1 minute test.
I think your FSE pulled a fast one on you
I ran the same Tecan leak test 6-7 times in a row. After 2-3 failed runs the pressure held on all channels for several minutes passed the 1 minute script hold.
I don’t think that is related to the channels being cold since I’ve run >5 inline filter tests each time beforehand. Any thoughts on why it would start working after several failures? Maybe a seal/gasket that needed to be pressed into place multiple times. This process repeated the next morning as well. 3-6 failed leak tests followed by passing results.
My concern is that when I release the system into a validated environment, I will need to document how many failed tests can occur before the system must be taken out of service, and I would like to have a good argument for saying 6 when 2 failures is the default max.