Hi everyone,
I was wondering you can help me. I have some question about cleaning validation in 6000 L tanks for oral liquids dosage, and if there is any way to sampling those tanks without need to get inside of them, nowaday we sampling the tanks with a swab to recover residues of API and being analyzed by HPLC.
Is there other way to sampling inside the tank with no need of getting inside?
Rinses taken from the hand valve draining the tank. Also, swab the tank wall and lid.
I second rinse water (Boomer Chemist). Another way is using an extension pole, with a swab tip on the end (the tip is removable and testable). These can be found online. Both rinse and swab on an extension pole have pluses and minuses.
Rinse water will require another method to qualify, and rinse water is considered less accurate and less ideal compared to swab testing (the analogy is “do you look at your sink rinse water to see if your pots are clean, or do you look at your pots?”). Even still rinse water testing is accepted by inspectors. You will need to develop and validate a rinse water test method…
The plus of the swab test is that it is more universally considered reliable. But an argument could be made that using the pole extension makes it super difficult to get repeatable results - believe me I’ve used them, and thought “this is silly” how can this possibly be reliable? But we did it and it was successfully defended too.
The most bullet proof cleaning validation would test using swab and rinsate testing. There is no way an auditor would question the sampling method if you use both. Even if both have limitations, you can correlate the two methods and shows overall that everything is clean.
One last method, and this is kind of the holy grail of cleaning validation - is to go to visual detection only. This takes some very good defense, including lab studies, personnel qualification, risk assessment, etc. Please feel free to contact me with further questions. My linkedin profile can be found googling my username. JaredCroft.
Another thing is to use a chelate and pH buffer in the rinse water like Citric Acid. It might increase the recovery.
If you have a cleaning procedure for the tank you need to validate that procedure. This means you’ll have to take swabs like you’re doing now. But when you have 3 consecutive succesful runs with that procedure and you can show that the procedure works you can drop swapping in the future and just get by testing the last rinsing water.