Thermo Scientific UltiMate, Installation Qualification/Operational Qualification Protocols And Instructions

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Process
OQ/PQ Operating Instructions
M1393R0
Page 21 of 60
3.3 Performing the Checks
The OQ/PQ tests that need to be performed depend on the UltiMate system configuration.
For a complete system (e.g. UltiMate, FAMOS and Switchos) all test procedures
4.2
to
4.13
must be performed. For different system configurations refer to TABLE 3-6.
TABLE 3-6 Tests to be performed for the different System Configurations
System Configuration Test
No. Description Duration
(approx.)
UltiM
ate, FAMOS
UltiM
ate, FAMOS,
Switchos UltiMate without UV Detector (a) UltiM
ate Dual
Gradient (a) UltiM
ate with
Manual Injector (c)
UltiMate and FAMOS tests
4.2 Lamp Intensity of the UV
Detector
10 min • • • • •
4.3 Wavelength Check 10 min
• • • • •
4.4 Flow Cell Check 10 min
• • • • •
4.5 UltiMate Fluid Path Test 15 min • • • • •
4.6 Baseline Noise and Drift
Test of the UV Detector (d)
4 h • • • • •
Oven accuracy (e) (•) (•) (•) (•) (•)
4.7 Linearity of the UV
Detector
NAN: 64 min
CAP: 32 min
• • • • •
4.8 Reproducibility of the
Injection Volume NAN: 72 min
CAP: 36 min • • • •
4.9 Linearity of the injection NAN: 56 min
CAP: 28 min • • • •
4.10 Gradient Accuracy NAN: 4.5 h
CAP: 3 h • • • • •
(b)
•
Switchos Tests (if applicable)
4.11 Switchos Fluid Path Check 15 min • • •
4.12 Switchos Flow Rate and
Pressure Stability Test
15 min • • •
4.13 Switchos Valve Position
Check 10 min • • •
Notes (a) Additional UV detector required.
(b) The ‘Gradient Accuracy Test’ must be performed for both gradient pumps. Depending on the
configuration, an additional CAP flow is required.
(c) No FAMOS Microautosampler and no Switchos Unit included in the system configuration.
(d) Includes a wash cycle of the FAMOS injection valve.
(e) If included in the configuration.
TABLE 3-6 indicates the tests for the OQ and PQ procedure for different UltiMate system
configurations. The time required to complete a test procedure is also indicated. The total
time required for checking an entire system (e.g. UltiMate, FAMOS and Switchos) is
approximately 13 hours. UltiMate Dual Gradient systems require that the test 4.10 must
be performed for both gradient pumps. For the UltiMate Dual Gradient system the entire
OQ/PQ requires approximately 17 hours.
For the OQ and PQ of UltiMate system configurations which does not include an UV
detector or for the UltiMate Dual Gradient system, a standalone UV detector is required
and all UV Detector related tests must be performed on this unit as described in this
manual.