Performance Maintenance Protocol

WAT053374 Rev. 12

Performance Maintenance Protocol

2690/2695/e2695 Separations Module

Performance maintenance

Goal

This performance maintenance protocol is a guide to performing maintenance tasks on your system. Packaged as part of the performance maintenance kit, it is intended to ensure optimum performance and an uninterrupted period of trouble-free operation.

Schedule

Waters recommends that performance maintenance visits be performed once a year. Systems under heavy use or using aggressive solvents will need more frequent maintenance. For detailed maintenance schedules, refer to the appropriateoperator’s guide(s) located on the Waters web site. Failure to follow the maintenance schedules as described in the operator’s guides may result in unreliable operation and inaccurate laboratory results.For some protocols, optional tests can be performed by Waters field service engineers for added confidence and reliability.

Safety considerations

Some protocols may involve removing instrument covers, exposing the performer to high voltages, high currents, and moving parts. This presents risks of electric shock and/or damage to the instrument. To reduce these risks, Waters recommends that these protocols be conducted by certified Waters field service engineers, who have access to the latest information on Waters products. Waters does not advise and is not responsible for an unqualified performer initiating actions that they do not understand. If there is any doubt on the part of the performer, a Waters certified field service engineer should conduct the performance maintenance activity.

Waters Quality Parts

Waters designs and manufactures Waters Quality Parts® to the same strict regulatory standards as your high-performance Waters systems.Waters recommends using Waters Quality Parts for all maintenance activities.Failure to use Waters Quality Parts may compromise laboratory results and reliability.

Customer education

Waters offers several operation and maintenance courses for ACQUITY® UPLC®, Alliance®HPLC and MS systems as well as courses designed to help you maintain professional competency and further your knowledge in Chromatography, UPLC, Informatics and Mass Spectrometry. For more information on available training courses from Waters Educational Services please visit the Waters web site.

Compliance services

Waters Compliance Services help you achieve and maintain the regulatory compliance of your LC and MS instruments and software with a combination of expertise, compliant-ready systems and software, and a portfolio of services to ensure that you have quality data, consistently. To learn more about these services, please visit the Waters web site.

General tasks

Use the following guidelines when conducting performance maintenance visits. This information is intended to be a guide only. For example:

• If a particular module has been recently serviced, it may need only testing and replacement of fewer parts.
• Not all procedures apply to all instruments (specify NA in the Comments section if the procedure does not apply).
• If the instrument fails to perform adequately during pre-performance maintenance checks, further service may be required beyond the scope of this protocol. Such service may incur additional parts and labor charges.

The following table lists the general tasks to be performed during a performance maintenance visit. Perform and confirm the steps listed for each procedure and record any comments that you have about the results at the end of each section.

For detailed instructions and a list of the necessary tools, refer to the Operator’s Guide located on the Waters website.

1 Optional tests performed by Waters field service engineers as part of a Total Assurance with Calibration Plan.For those without the plan,the tests can be performed for an additional charge. Some of these tests may require additional chemistry kits that are not supplied in the performance maintenance kit.

2Firmware upgrades, if required, should be performed by a Waters field service engineer prior to beginning performance maintenance. Firmware upgrades may require re-qualification of the upgraded instrument if it is in a regulated environment.

3Batteries are replaced by Waters field service engineers only.

Inspect

Firmware version

Confirm which firmware versionis installed and note it on the cover page. Update the firmware if required.

Firmware check complete.

Yes No N/A

Comments:

Fan

To inspect the fan:

1. Observe the fan on the rear of the instrument.
2. Ensure that the fan grate is clear of debris and dust. The fan should be blowing outward.
3. Clean if necessary.

Fan inspection complete.

Yes No N/A

Comments:

Valves

Prime/vent valve inspection complete.

Yes No N/A

High pressure valves 1 and 2 inspection complete.

Yes No N/A

Low pressure valve 3 inspection complete.

Yes No N/A

Gradient proportioning valve inspection complete.

Yes No N/A

Comments:

Carousel drive mechanism

Carousel drive mechanism inspection complete.

Yes No N/A

Comments:

PerformancePlusdegasser

PerformancePlus degasser inspection complete.

Yes No N/A

Comments:

Seal wash system

Seal wash systeminspection complete.

Yes No N/A

Comments:

Fittings and tubing leak inspection

Fittings and tubing leak inspection complete.

Yes No N/A

Comments:

Error logs

Error log review complete.

Yes No N/A

Comments:

Maintenance tasks

The following procedures are routinely performed as part of the performance maintenance. Waters Quality Parts® have been used to replace/rebuild all parts.

• Filters
• Solvent management components
• Sample management components
• Lithium battery

NOTE:Batteries are replaced by Waters field service engineers only.

Yes No N/A

Comments:

Post-performance maintenance checks

Perform the post-performance maintenance checks in the order listed.

Initialization diagnostics

Turn on power, allow instrument to complete and pass the on-board software checks.

Initialization diagnostics check complete.

Yes No N/A

Comments:

Static leak test

1. Prime the system.
2. Energize the seals.
3. Test the accumulator and primary pump heads.

Static leak test check complete.

Yes No N/A

Comments:

Compression check

1. Prime the system.
2. Purge the injector.
3. Perform the compression check.

Compression check complete.

Yes No N/A

Comments:

Performance maintenance confirmation

Optional calibration tests

Optional calibration tests are performed by Waters field service engineers as part of a Total Assurance with Calibration Plan. For customers without this plan, these tests can be performed for an additional charge. Some of these tests may require additional chemistry kits that are not supplied in the performance maintenance kit.

Optional calibration tests

1. Testing the flow rate accuracy.
2. Testing gradient proportioning.
3. Testing the injection accuracy.

Tools/materials required

• Graduated cylinder,10 mL

• (2) Graduated cylinders, 50 mL or 100 mL

• Stopwatch (calibrated)

• 100% HPLC – grade Methanol

• 100% HPLC -grade water

• 2 mL vial

• Analytical balance (calibrated)

WARNING: Always observe safe laboratory practices when you use this equipment and when you work with solvents and test solutions. Know the chemical and physical properties of the solvents and test solutions you use. See the Material Safety Data Sheet for each solvent and test solution in use.

CAUTION: Never change directly between immiscible solvents or between buffered solutions and organic solvents. Immiscible solvents form emulsions in the fluid pathways. Buffered solutions and organic solvents in combination can result in salt precipitation in the gradient proportioning valves, pump heads, check valves, and other parts of the system. Confirm that all fluids in the system are miscible with methanol.

Testing the flow rate accuracy

1. Obtain a 10 mL graduated cylinder or similar container.

NOTE: Ensure that the graduated cylinder is thoroughly dry.

1. Prime the system with fully degassed methanol or water. Set the vacuum degasser (if installed) to run continuously, or set the sparge rate to 100% A.
2. Prepare the stopwatch to begin timing.
3. Enter the test flow of 1.0 mL/min.
4. When the flow and pressure are stable, insert the outlet tubing into the graduated cylinder.
5. When the meniscus reaches the 1.0 mL mark of the graduated cylinder, start the stopwatch.
6. Stop the timer when the bottom of the meniscus reaches the 4 mL mark on the graduated cylinder.
7. Record the time required to reach the 4 mL mark.

NOTE: Ifthe time is not within the acceptable range, other service adjustments may be necessary for an additional charge.

Flow rate accuracy test complete.

Yes No N/A

Stop watch
serial #:

Calibration
date:

Comments:

Testing gradient proportioning

1. Place the primed solvent A and B lines from the separations module into two identical 50 or 100 mL graduated cylinders.
2. Fill the cylinders to the 50 mL mark.
3. Set the flow rate to 5 mL/min with 50% solvent A, and 50% solvent B.
4. When the solvent in the A cylinder reaches the 25 mL mark, stop the flow.
5. Record the values for the volumes in each cylinder(Table 2).

NOTE: Expected Result: B cylinder volume = A cylinder volume ± 3 mL.

NOTE: If the volume is not within the acceptable range, other service adjustments may be necessary for an additional charge.

Gradient proportioning test complete.

Yes No N/A

Comments:

Injection accuracy test

CAUTION: To ensure the accuracy of test results use forceps, or wear lint-free gloves to handle the vial used in this test.

Preparing the sample for the injection accuracy test

1. Fill a standard 2 mL vial with degassed HPLC-grade methanol (Method A) or degassed HPLC-grade water (Method B).
2. Seal the vial with a PTFE (or pre-slit) septum and cap, if available.

NOTE: If a PTFE (or pre-slit) septum is not available, use a septum-free cap. Do not use self-sealing septa (unless pre-slit), as they create a vacuum in the vial during multiple injections.

1. Zero the analytical balance, and then carefully weigh the vial (using forceps or your gloved hand to move the vial).
2. Record the weight in grams(W1).
3. Place the weighed vial in position 1 of carousel A, and then place the carousel in the sample compartment.

Performing the injection accuracy test

1. Program the system to make the appropriate volume and number of injections from the vial. Use the shortest possible runtime.

1. Remove and reweigh the vial.
2. Record the weight in grams(W2).
3. Use one of the following formulas to calculate the average amount injected per injection:

•For a 250 µL syringe systems (Method A methanol): [(W1– W2)/6] x 1.268 x 1000 = mg of methanol withdrawn per injection = µL per injection

•For a 25 µL syringe systems (Method A methanol): [(W1– W2)/16] x 1.268 x 1000 = mg of methanol withdrawn per injection = µL per injection

•For a 250 µL syringe systems (Method B water): [(W1– W2)/6] x 1.0x 1000 = mg of water withdrawn per injection = µL per injection

•For a 25 µL syringe systems (Method B water): [(W1– W2)/16] x 1.0 x 1000 = mg of water withdrawn per injection = µL per injection

1. Record the results.

NOTE: If the result is not within the acceptable range, other service adjustments may be necessary for an additional charge.

Balance
serial #:

Calibration
date:

Comments:

Calibration confirmation

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