i’m Marco from Italy, and i’m actually doing a internship (before master graduation) in a big pharma company with the aim of finding new kind of procedure to revalidating equipment as autoclaves, oven, SIP station and so on.
i’m new in the pharma world and i would like to know your opinion and suggestion on a basic issue.
What i can see from available data is that all the tests performed in validation that involve temperature measurement (with TC: kaye, expertlog …) are totally far from the measure i get from the process probes, more randomize, less stable …
so i’m asking my self which is the convenience of perform a validation measuring values that are so far from the ones that normally control the process during production.
is that the same in your companies? do you get reliable data from validation tc measurement of the system?
just two basic example, to let you better understand the problem:
1) tank sterilization:
if i watch to the data i can see:
- in the same run: validation probes measure values with difference of 50% from position to another
- same probes, different run (time), validation probes measure different value, from 5% to 100% difference between two cycle
- process probes VS validation probes: if i look at a validation probe that is close to a process probe, i get difference (in F0) of 50-80%
2) Autoclaves (canister sterilization):
i have evidence that autoclaves is performing well (with thermomapping)
i’m actually monitoring 11 canister over 17, by put a TC and BI inside the loaded canister.
since the probability of failure belong all to the canister assembly, why i should monitor just 11 canister and not all?
moreover, where is the meaning to monitor the canister load when the problem own just to human action (canister assembling) ?
finally, my observation suggests that validation are extremely innacurate because the human hand that put the probes, load the canister, prepare the bi and so on…
where i’m wrong?
thanks and sorry for my bad english!