OQ/PQ for ACQUITY UHPLC/HPLC Arc Systems with PDA/UV Detectors

3 Operational/Performance
Qualification Preparation
This section provides the procedures for confirming operation and performance of the
ACQUITY UHPLC Arc System.

3.1 Recommended materials

Project
Using “SQT_E_rQSM_rFTN_2xxx” (2998 for PDA and 2489 for UV detector).
Column
• C18 column, 4.6 mm × 50 mm, 2.7 μm (for Acquity UHPLC Arc Systems)
• C18 column, 4.6 mm × 50 mm, 3.5 μm (for Acquity HPLC Arc Systems)
Test solution kits
• Caffeine Standard
Chemicals
• HPLC-grade water
• HPLC-grade acetonitrile
Detector flow cells
• ACQUITY UV flow cell:
− Analytical flow cell, 10-mm path length.
• ACQUITY PDA flow cell:
− Analytical flow cell, 10-mm path length.
Lab ware
• Membrane filters, nylon, 0.20 μm or similar
• Vial holder plate, 48-well, 2-mL, included in sample manager-FTN-R's startup
kit
• 2-mL vials (20), with preslit silicone/PTFE septa and caps to prevent a vacuum in the
vial during injections
• Graduated cylinders, 100-mL and 1000-mL
• Reservoir bottles (2), 1-L and (1) 100-mL
• Class A volumetric flask, 10-mL
Tools
• Pressure restriction device capable of producing backpressure of 500 to 700 psi
• Calibrated stopwatch
• Calibrated thermometer probe with readout device (for testing the sample
manager-FTN-R heater/cooler and column heater)
• Tape, to hold the thermometer probe for the sample manager-FTN-R
heater/cooler and column heater temperature accuracy test

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3.2 Recording test solutions and test equipment calibration

information
In Form 3-1, record test solution and calibration information for the test equipment to
be used in the OQ/PQ procedures.
Form 3-1 Test solutions and test equipment calibration information

Owner’s System ID

Caffeine Stardard

Expiration Date

Lot No.
Initials

Test/Measurement Device

Serial Number

Calibration Dates Last Next

Initials

Test/Measurement Device

Serial Number

Calibration Dates Last Next

Initials

Test/Measurement Device

Serial Number

Calibration Dates Last Next

Initials

The undersigned performer attests that the information above is accurate and complete.

Performer Date
Signature

The undersigned reviewer accepts that the information above is accurate and complete.

Reviewer Date
Signature

© 2015 Waters Corporation

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