Comments:
PerkinElmer LAS Representative:
Date:
Reviewed By:
Date:
Flexar Analytical / FX-10 UHPLC Pump
IQ/OQ Rev. D June 2009
•
The Pressure Pulsations Test is to verify that the output flow fluctuations are within
specification. The specification for this test to pass is 2 % peak-to-peak of the running
pressure at which the test is run.
Test Prerequisites
•
Start the pump and let the pressure stabilize
Test Steps
•
Connect the pump output to a restrictor coil or 1000 psi backpressure device. Set the
pump flow rate to 1 mL/min. Running pressure for this test must be more than 500 psi.
Adjust tubing length as required to obtain the required back pressure.
•
Monitor the displayed pressure readout for 1 minute. Note the observed maximum and
minimum pressures.
•
Using the numbers obtained determine:
1.
The difference between maximum and minimum (Delta).
2.
The value of the mid-point pressure (MP).
3.
The 2% value of the midpoint pressure. This mid-point value is the pressure used
to compute what the 2 % peak-to-peak error band should be.
Example:
Max
1020 psi,
Min
1003 psi,
Mid Point
(MP Pressure) = 1011 psi.
2 % MP
= MP * 0.02 = 20.22 psi
Observed Delta
= 17 psi
Spec
= Observed Delta <= 2 % MP
2.4.1 Test Results
2.4.2 Analytical Pump (100
µ
µ
µ
µ
L Piston) Flow Check @ 1 mL/min
Test Conditions
•
Chromatographic Conditions:
100 % H2O
1 mL/min
Test Prerequisites
Parameter
Specification
Min Psi
Max Psi
Delta
MP
Pass/Fail
Comments
Pressure Fluctuation
< 2% of MP PSI
