Hi ALL,

Can you please comment on the OQ/PQ validation tests for the pump module in a HPLC system. The tests followed currently are Flow accuracy, pressure hold test and.. I need to know what all other tests to be incorporated in the OQ documents.

thanks

if the pump is used to mix, the accuracy off the mixing....

noise: you should regist the evolution signal/noise evolution in a isocratic system

It depends on how you use the pump. If you have use online mixing you should test the proportioning accuracy. If you run gradients you should perform a gradient proportioning test. I recommend using a digital flow meter and you can test for both flow accuracy and precision. If you are going to be performing a gradient proporting test anyway you might as well configure it to give you dwell volume data as well. Good Luck.

I conduct instrument validation for laboratories that need to be in compliance with regulations. For Pumps I usually run a Leak Test(this is a Diagnostic Test),Pressure Test,Flow Accuracy Test, Noise Test,Gradient Linearity, Gradient Step Accuracy and etc...For more information call me at BIOMATIC TECHNOLOGIES INC. 781-341-1444.
I will be happy to answer any of your validation questions
Michael Collins- Manager of Validation and Chemistry

How the flow accuracy test has to be done? Is it with the column on the line or without it?

Flow accuracy is best measured by timing how long it takes to fill a 10 mL volumetric flask to the mark with water at 1 mL/min. If you want 2% accuracy, it should take 9.8-10.2 minutes. As pumps work best under pressure, you need some form of back pressure device. You can leave the column in (assuming it's an RP column), but I like to use a 2m length of 0.005" id tubing. This gives about 450 psi at 1 mL/min of water. It might also be a good idea to try different solvents, to see how solvent compressibility affects the accuracy.

Considering the accuracy of some of today's pumps, you can use then to calibrate your graduate!!!