Hi,all.
We have to perform full qualification of our mixing tanks.I understand what is IQ and OQ for them.How to perform PQ(performance qualification) of mixing tanks.What reference documents or guidelines are for it.Or any ideas?
The PQ of mixing tank depends on 3 parameters.
a) Mixing speed
b) Mixing time
c) Assay or homogeneity result.
The acceptance criteria of assay result have to be met during PQ.
Can we perform homogenity test for one drug?
You can, but your PQ will be approved only for that drug. That’s why you have to perform for every drug otherwise you have to select your drug (worst) by risk assessment.
As per wrost case it is difficult to dissolved in water or practical insoluble water molecules to be marked for pq of mixing vessel .
So for example in our mixing vessel we have to go for the pirixicam mokecule for pq
you can go with sodium chloride salt .
Sodium chloride is easily available
Add sodium chloride in PW containing in mixing tank and the start mixer and collect sample for different time and then check for assay at respective time sample for complete dissolution of Nacl, prior to that there must be analytical method validated for analysis of Nacl assay.