Comments:
PerkinElmer LAS Representative:
Date:
Reviewed By:
Date:
Flexar Analytical / FX-10 UHPLC Pump
IQ/OQ Rev. D June 2009
Test Steps
•
Connect the backpressure regulator to the output of the pump. This device will create the
necessary back pressure on the pump check valves.
•
Purge the pump and fill the line to be used for the test with water.
•
Zero the scale. Weigh the collection vessel on a calibrated scale or balance.
•
Take the collection vessel and go to the pump and set the pump flow for 3 mL/minute.
•
Start the pump. (Direct the initial flow of water off to waste until the pressure stabilizes.
•
When pressure stabilizes, direct the flow of water into the collection vessel and
simultaneously start a stopwatch or other timing device.
•
Let the pump run for 5 minutes.
•
When 5 minutes has elapsed, remove the tube from above the collection vessel and
insert it into the waste.
•
Weigh the collection vessel with the water. Subtract the weight of the collection vessel.
•
The remaining weight of the water should be 15 grams ±
0.15 g (14.85 to 15.15 g)
3 mL/min * 5 min = 15 g (water weighs 1 gram per mL)
•
Divide the weight of the water by 5 to get the volume delivered in a 1 minute interval.
•
Record this number in the Test Result field of Flow Accuracy @ 3 mL/min portion of the
IQOQ Test Certificate. Enter N/A if testing FX-10 UHPLC Pump.
2.4.3 Test Results
Parameter
Specification
Test Result
Pass/Fail
Comments
Analytical Pump (100
µ
µ
µ
µ
L Piston)
Accuracy: 3
mL/min
±
1% of 3mL/min
(2.97ml/min to
3.03ml/min)
2.4.4 FX-10 UHPLC Pump (30
µ
µ
µ
µ
L Piston) Flow Check
@ 0.3 mL/min
Test Conditions
•
Chromatographic Conditions:
100 % H2O
0.3
mL/min
Test Prerequisites
•
It is important that the volume delivered is correct; the pressure during the delivery is not
critical. There is a minimum pressure requirement of 350 psi for the check valves to
operate properly.
