Thermo Scientific UltiMate, Протоколы и инструкции по квалификации установки и эксплуатационной квалификации

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Requirements for a Successful OQ/PQ
Page 10 of 60
M1393R0
OQ/PQ Operating Instructions
2.2 Checks and Acceptance Limits
TABLE 2-2 lists all OQ/PQ test procedures that are to be performed in the order they must
be performed. In most instances, it is necessary that a test is passed before the next test
in the overall is attempted. As an example, if the ‘Linearity of the UV Detector’ test is
failed (Section 4.7), the result of the ‘Gradient Accuracy’ test will be questionable (Section
4.10).
TABLE 2-2 List of OQ and PQ Test Procedures to be performed
Test Procedure Performed Section
Lamp Intensity of the UV Detector
Manually
4.2
Wavelength Check
CM Sequence
4.3
Flow Cell Check
Manually
4.4
UltiMate Fluid Path Test
Manually
4.5
Baseline Noise and Drift Test of the UV Detector
CM Sequence
4.6
Linearity of the UV Detector
CM Sequence
4.7
Reproducibility of the Injection Volume
CM Sequence
4.8
Linearity of the injection
CM Sequence
4.9
Gradient Accuracy
CM Sequence
4.10
Switchos Fluid Path Check
Manually
4.11
Switchos Flow Rate and Pressure Stability Test
CM Sequence
4.12
Switchos Valve Position Check
Manually
4.13
Note: According to GLP, a test procedure that failed needs to be repeated and all test
procedures following the one that failed must be repeated.
TABLE 2-3 presents an overview of the parameters to be tested and a short description of
the tests. In addition, it presents the required acceptance limits for OQ and the
recommended limits for PQ.
TABLE 2-3 Overview of the OQ and PQ Test Procedures and Limits
Limits (a) Instrument Parameter Description
OQ PQ
Wavelength
accuracy External holmium filter is required. ± 2 nm ± 2 nm
Lamp Intensity
(Section 4.2) The dummy flow cell is installed
and the lamp intensity is read
from the detector SIGNALS
screen. 0.4 < SIG < 0.9
0.1
<
REF
<
0.9
0.4 < SIG < 0.9
0.1
<
REF
<
0.9
Flow cell
transmittance
(Section 4.4)
(b) The flow cell is installed and filled
with water. The transmittance of
this flow cell is indicated by the
‘SIG’ value and is read from the
detector SIGNALS screen. > 15%
of reference
intensity > 15%
of reference
intensity
Baseline drift
(Section 4.6)
< 4000
µ
AU/hr < 4000
µ
AU/hr
Baseline noise
(Section 4.6)
The drift and noise are recorded
for 21 minutes at 254 nm with a
flow cell (filled with mobile phase
A).
< 50 µ AU < 50 µ AU
UltiMate
UV Detector
(Note:
If the
system does
not include an
UltiMate UV
Detector, a
standalone
UltiMate UV
Detector is
required to
perform the
OQ/PQ test
procedures
).
Oven test
(Section 4.6)
(d) An external thermometer is used
to measure the oven temperature. Accuracy
+/- 1°C Accuracy
+/- 1°C