what is the meaning of triplicate sampling during process validation and how we get the sample?
Triplicate sampling during blend sampling means, 3 samples taken from one point of blend location in a layer(T,M,B), with triplicate sampling rod, consisting of 3 dies in 3 slots, the 2nd &3rd sample are basically act as backup sample for analysis if any discrepancy observed during analysis of 1st sample, it can be used for analysis and it’s labelled as Ex: T1, T1A,T1B
how to calculate the sample quantity for analysis. & how much sample we take by sample rod.
Sample qty.is generally 1x to 3x of the unit tablet wt.
Ex: Tab wt. 250mg
Blend sampling range: 250 to 750mg.
Also, we need to check the inprocess blend method of that product, how much sample range is specified, we can consider that one.