Blank Procedure



Performance Maintenance Protocol

2707 Autosampler

|Serial Number/ |      |

|Firmware Version: | |

|Date: |      |

|Performer: |      |

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 appropriate operator’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 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®, ACQUITY® Arc™, 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 Compliance 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, additional service beyond the scope of this protocol may be required. 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 .

|Inspect |Maintenance tasks |Post-performance |Optional calibration tests1 |

| | |maintenance checks | |

|Firmware version2 |Air needle |Initialization diagnostics |Sample aspiration accuracy |

|Fan |Sample needle3 |Calibrate syringe plunger4 | |

|Tubing and fittings |Wash station |Calibrate needle axes4 | |

|Error logs |Syringe dispenser valve |Calibrate wash position4 | |

| |Syringe | | |

| |Rotor seal | | |

| |Buffer tubing | | |

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.

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

3 If needed, use the Adjust Needle Position function to fine-tune the x-y injection position.

4 Calibrate syringe plunger, needle axes, and wash position are only performed by a Waters Field Service Engineer.

Inspect

Firmware version

Confirm what firmware versions are installed. Update if required.

NOTE: Refer to Downloads on for the latest firmware and driver pack release notes. These release notes detail software and data system requirements, and installation notes.

1. Click the Launch Instrument Console icon from the 2707 Autosampler Contol Panel located at the bottom of the Run Samples window in Empower.

2. From the Console, click Configure > View module information. In the 2707 Autosampler Module Information window, note the firmware version and serial number on the front page.

Firmware check complete.

Yes No N/A

Comments:      

| |

     

| |

     

| |

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:      

| |

     

| |

     

| |

Tubing and fittings

Check tubing and fittings for leaks.

Tubing and fittings inspection complete.

Yes No N/A

Comments:      

| |

     

| |

     

| |

Error logs

1. Power-on the module.

2. Start the chromatographic data system software.

3. Click the Launch Instrument Console icon located in the 2707 Control Panel at the bottom of the Run Samples window in Empower.

4. Click on Instruments in the System tree.

5. Click on Logs to review the error logs.

Review error logs complete.

Yes No N/A

Comments:      

| |

     

| |

     

| |

Maintenance tasks

The following components are replaced/rebuilt as part of the performance maintenance. Waters Quality Parts have been used to replace/rebuild all parts.

• Air needle

• Sample needle

• Wash station

• Syringe dispenser valve

• Syringe

• Rotor seal

• Buffer tubing

Yes No N/A

Comments:      

| |

     

| |

     

| |

Post-performance maintenance checks

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

Initialization diagnostics

Power-on the instrument, and allow it to complete and pass on-board software checks.

Initialization diagnostics check complete.

Yes No N/A

Comments:      

| |

     

| |

     

| |

Calibrate syringe plunger

Calibrate syringe plunger complete.

Yes No N/A

Comments:      

| |

     

| |

     

| |

Calibrate needle axes

Calibrate needle axes complete.

Yes No N/A

Comments:      

| |

     

| |

     

| |

Calibrate wash position

Calibrate wash position complete.

Yes No N/A

Comments:      

| |

     

| |

     

| |

Performance maintenance confirmation

|I confirm on behalf of | |      | |

| |Company Name |

|that this performance maintenance |      |

|procedure has been satisfactorily completed on: | |

| | | | |

| | |Serial No. |

| Signed: | | Date:       |

| | | | | | |

|Customer | |

|      | |

| | | | | | |

|Type Name | |

|I certify that the maintenance procedure has been successfully completed. | |

| Signed: | | Date:       |

| | | | | | |

|Waters Engineer | |

|      | |

| | | | | | |

|Type Name | |

|Comments:      |

| | | |

|      |

| | | |

| | |

|Waters Corporation |[pic] |

|34 Maple Street | |

|Milford, Massachusetts | |

|01757 USA | |

|Waters, MassLynx, The Science of What’s Possible and Waters Quality Parts are registered trademarks of Waters Corporation. All other trademarks are |

|property of their respective owners. |

|©2016 Waters Corporation. Printed in the U.S.A. |

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.

Tools/materials required

* LC/MS-grade water

* LC/MS-methanol

* Sample vials

* Forceps

* Calibrated balance

* Powder-free nitrile gloves and safety glasses

[pic] 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.

Sample aspiration accuracy

Testing the sample aspiration accuracy confirms that the autosampler accurately withdraws a specified amount of sample.

[pic] Caution: To ensure test results are accurate, use forceps or wear lint-free gloves when handling the vials in this test.

Procedure

The procedure to test sample aspiration accuracy consists of two sections:

1. Preparation

2. Testing the sample aspiration accuracy

Preparation

1. Depending on the autosampler’s configuration, fill a sample vial with degassed

LC/MS-grade water.

|Configuration type |Vial type |

|Analytical |2-mL |

|Preparative |10-mL |

[pic] Caution: When a PTFE preslit septum is not available, use a septum-free cap. Do not use self-sealing septa (unless preslit), because they create a vacuum in the vial during multiple injections.

2. Seal the vial with a PTFE preslit septum and cap.

[pic] Caution: Use forceps or your gloved hand to move the vial.

3. Zero the analytical balance, and then carefully weigh the vial.

4. Record the weight (W1).

[pic] Caution: If the 2707 Autosampler is configured for preparative operation, ensure that you have defined the custom plate type in Empower.

5. Place the weighed vial in position 1:A of the applicable vial tray, and then place the tray in the left-hand side of the autosampler’s sample compartment.

6. Fill the mobile phase pump reservoir with filtered, degassed, 100% LC/MS-grade methanol.

7. Fill the 2707 Autosampler wash solvent reservoir with filtered, degassed, 100% LC/MS-grade water.

8. Create an instrument method using these parameters:

|Instrument method parameters |

|Configuration type |Sample loop option |Overfill flush volume (µL) |Overfill flush volume (µL) for ICS |

| | | |v1.30 only |

|Analytical |Partial |N/A |N/A |

|Preparative |Partial loop with needle |60 |N/A |

| |overfill | | |

9. Create a sample set using these parameters:

|Sample set parameters |

|Configuration type |Plate/well |Injection volume (µL) |# of injections |Function |Run time (min) |

|Preparative |1:A, 1 |1000 |6 |Inject sample |1.0 |

Testing the sample aspiration accuracy

[pic] Caution: Ensure that both the pump and the autosampler are properly primed before proceeding.

1. Set the pump flow rate for 100% methanol to 1.0 mL/minute.

2. Connect a length of tubing or another restriction device to the outlet line of the autosampler to create a backpressure of 600 to 1000 psi (41 to 69 bar, 4136 to 6894 kPa).

3. Run the sample set.

4. When the sample set completes, remove and reweigh the vial, and record the weight (W2).

5. Calculate the average volume of water injected per injection using one of the following formulas:

• Analytical configuration:

[(W1-W2) / 12] x 1000 = mg of water withdrawn per injection = µL per injection

• Preparative configuration for ICS v1.30 only:

[(W1-W2) / 6] x 1000 = mg of water withdrawn per injection = µL per injection

• Preparative configuration for ICS v1.20 and lower:

{[(W1-W2) / 6] x 1000} – 60 = mg of water withdrawn per injection = µL per injection

* This test requires you to use water because its density, 0.99823 g/mL at 20 C and 0.99707 g/mL at 25 C, introduces less than 0.3% error when volume is assumed equal to weight (grams water x 1000 = µL). When using the preparative configuration, a constant 60-µL volume is used to flush the needle. Hence, 60 µL is subtracted in the calculation to compensate for the additional volume introduced.

6. Record the results.

|Analytical configuration sample aspiration test results |

|Vial weight before |Vial weight after twelve |Programmed injection |Calculated average |Acceptable injection |Results |

|injection (W1) |injections (W2) |volume |volume (µL) |volume range | |

|Preparative configuration sample aspiration test results |

|Vial weight before |Vial weight after six |Programmed injection |Calculated average |Acceptable injection volume|Results |

|injection (W1) |injections (W2) |volume |volume (µL) |range | |

|Balance |

|Serial/ID number |      |

|Calibration date |      |

Sample aspiration accuracy test complete.

Yes No N/A

Comments:      

| |

     

| |

     

| |

Calibration confirmation

|I confirm on behalf of | |      | |

| |Company Name |

|that the calibration has been satisfactorily completed on: |      |

| | | | |

| | |Serial No. |

| Signed: | | Date:       |

| | | | | | |

|Customer | |

|      | |

| | | | | | |

|Type Name | |

|I certify that the calibration has been successfully completed. | |

| Signed: | | Date:       |

| | | | | | |

|Waters Engineer | |

|      | |

| | | | | | |

|Type Name | |

|Comments:       |

| | | |

|      |

| | | |

| | |

|Waters Corporation |[pic] |

|34 Maple Street | |

|Milford, Massachusetts | |

|01757 USA | |

|Waters, MassLynx, The Science of What’s Possible and Waters Quality Parts are registered trademarks of Waters Corporation. All other trademarks are |

|property of their respective owners. |

|©2016 Waters Corporation. Printed in the U.S.A. |

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