Waters LC/MS

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Systems

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Qualification
Workbook

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Recommended
Procedures for
Operational
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Qualification

Waters 2777
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Sample Manager
Part IV: OQ
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34 Maple Street
Milford, MA 01757

71550277714, Revision A
July 2003
Waters LC/MS Systems Qualification Workbook

NOTICE

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Waters instruments, software, and technical documentation are under revision control. The information
contained in this document is appropriate for the revision level of the specified instruments, software, and
technical documentation. This document is believed to be complete and accurate at the time of publication.

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Waters Corporation assumes no responsibility for any errors that may appear in this document. In no event
shall Waters Corporation be liable for incidental or consequential damages in connection with or arising
from the use of this documentation.

 2003 WATERS CORPORATION. PRINTED IN THE UNITED STATES OF AMERICA. ALL RIGHTS
RESERVED. THE PROTOCOLS AND FORMS IN THIS DOCUMENT HAVE REQUIRED EXTENSIVE
DEVELOPMENT, TESTING, AND REFINEMENT IN ORDER TO PROVIDE A QUALITY PRODUCT

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TO OUR CUSTOMERS. AS SUCH, THIS DOCUMENT IS REGARDED AS INTELLECTUAL
PROPERTY OF WATERS. EXCEPT WHERE INDICATED, THIS DOCUMENT OR PARTS THEREOF
MAY NOT BE REPRODUCED IN ANY FORM WITHOUT THE WRITTEN PERMISSION OF THE

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PUBLISHER.

Waters Service Technicians are not authorized to make entries into unauthorized photocopied documents. To
obtain additional documents, contact your Waters representative.
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Waters is a registered trademark of Waters Corporation.

All other trademarks or registered trademarks are the sole property of their respective owners.
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 Part IV: 2777 Sample Manager Operational Qualification

Table of Contents

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1.1 Introduction ................................................................................................................ 5
1.2 Scope of Operational Qualification............................................................................... 5

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1.3 Preliminary Operational Qualification Procedures ......................................................... 6
1.3.1 Identifying Performers and Reviewers................................................................. 6
1.3.2 Identifying System Components .......................................................................... 7
1.4 Operational Qualification Procedures ........................................................................... 8
1.4.1 Recording Test Equipment Calibration Information ............................................ 8
1.4.2 Verifying Startup Diagnostics and Priming........................................................ 10

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1.4.3 Testing the Tray Positioning............................................................................... 10
1.4.4 Testing the Aspiration Accuracy ........................................................................ 11
1.4.5 Testing the Heater/Cooler................................................................................... 12
1.5 Operational Qualification Log.................................................................................... 16
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Waters LC/MS Systems Qualification Workbook

Forms

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Form 1-1 Identification of Performers and Reviewers ........................................................................6
Form 1-2 Identification of System Components .................................................................................7

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Form 1-3 Test Equipment Calibration Information.............................................................................9
Form 1-4 Initial Operational Qualification Procedure.......................................................................13
Form 1-5 Aspiration Accuracy Test ..................................................................................................14
Form 1-6 Heater/Cooler Test (Optional) ...........................................................................................15
Form 1-7 Operational Qualification Procedures Log ........................................................................16

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 Part IV: 2777 Sample Manager Operational Qualification

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Operational Qualification

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The Waters HPLC Systems Qualification Workbook, Recommended Procedures for Operational Qualification,
Waters 2777 Sample Manager, Part IV: OQ presents the operational qualification process for the Waters® 2777
Sample Manager. Use this workbook to qualify the Waters 2777 Sample Manager in a GLP-, CGMP-, and/or
GALP-regulated environment and/or an ISO 9000-series registered facility.

1.1 Introduction

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This workbook guides a trained and qualified person through the operational qualification of a Waters 2777
Sample Manager.

Recommended Documents

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Use this workbook with the Waters 2777 Sample Manager Operator’s Guide, part number 71500277704*, and
with other referenced documentation to qualify the performance of the Waters 2777 Sample Manager.
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*This document is also available in a PDF file from the Waters Web site at www.waters.com.

Before You Begin

Before you begin the procedures in this workbook (Part IV: OQ), be sure that you have read, understood, and
performed the procedures in the Waters MS Systems Qualification Workbook, System Qualification
Overview, Part I: OV, Part II: IQ (for the Waters 2777 Sample Manager), and in Part III: MP (for the
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Waters 2777 Sample Manager), as applicable.

See the Waters MS Systems Qualification Workbook, System Qualification Overview, Part I: OV for:
• Instructions on completing forms
• Guidelines for requalifying the Waters 2777 Sample Manager
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• Management approval of the system qualification protocols

• Information on using this workbook

After Operational Qualification

After the operational qualification of the 2777 Sample Manager is complete, qualified performers and reviewers
can complete the system qualification by performing the tasks described in the Part V: PQ workbook. Owner’s
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management approves the successful completion of this system qualification by completing the approval form at
the end of the Part V: PQ workbook.
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1.2 Scope of Operational Qualification

Operational qualification involves:
• Verifying startup diagnostics and priming

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 Waters LC/MS Systems Qualification Workbook

• Testing the tray positioning

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• Testing the aspiration accuracy
1 • Testing the heater/cooler (if applicable)
• Completing the operational qualification log

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1.3 Preliminary Operational Qualification Procedures

1.3.1 Identifying Performers and Reviewers

To identify the performers qualified to perform the operational qualification of the Waters 2777 Sample
Manager, and to identify the reviewers qualified to acknowledge the successful completion of the performers’

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tasks, complete Form 1-1.

Form 1-1 Identification of Performers and Reviewers

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The undersigned performers attest that they are trained and qualified to perform the operational qualification of a Waters
2777 Sample Manager.

Performer
Name (print) Signature Initials
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Title Date
(Trained and qualified to perform operational qualification procedures)

Performer
Name (print) Signature Initials
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Title Date
(Trained and qualified to perform operational qualification procedures)

The undersigned reviewers accept that the above performers are trained and qualified to perform the operational qualification
of a Waters 2777 Sample Manager.
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Reviewer
Name (print) Signature Initials

Title Date
(Owner-designated responsible person)

Reviewer
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Name (print) Signature Initials

Title Date
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(Owner-designated responsible person)

 2003 Waters Corporation

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 Part IV: 2777 Sample Manager Operational Qualification

1.3.2 Identifying System Components

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Complete Form 1-2 to identify the system components to be qualified.

Obtaining the Serial Number

Identify the Waters 2777 Sample Manager by locating its Waters serial number on the left side or back of the

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X-Crossrail. Enter the number in Form 1-2.

Obtaining the Firmware Number

To obtain the firmware number:
1. Power on the Waters 2777 Sample Manager. The 2777 Sample Manager Powerup Screen appears
briefly before the Job Queue screen.
2. Obtain the revision number from the Powerup Screen and enter it in Form 1-2.

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Form 1-2 Identification of System Components

Equipment Name Waters 2777 Sample Manager

Manufacturer

Serial Number N
Waters Corporation, 34 Maple Street, Milford, MA 01757 U.S.A.
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Firmware Revision Number

Owner’s Equipment Number

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

Performer Date
Signature

The undersigned reviewer accepts that the above system component information is accurate and complete.
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Reviewer Date
Signature

 2003 Waters Corporation

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 Waters LC/MS Systems Qualification Workbook

1.4 Operational Qualification Procedures

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1 This section provides the procedures you need to verify the operation of the Waters 2777 Sample Manager. If
you require reference material or information on how to perform any of the steps in the following forms, see the
documents appropriate for the Waters 2777 Sample Manager.

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Attention: Before performing the operational qualification procedures in this section, Waters
recommends that all performers and reviewers become familiar with the appropriate document(s)
and any other referenced documentation.

Recommended Materials
• Document(s) appropriate for your Waters 2777 Sample Manager; see Section 1.1, Introduction,
Recommended Documents

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• Waters 2777 Sample Manager, fully assembled
• Analytical balance (capable of accurately weighing 0.0001 g)

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• Calibrated K-type thermocouple with readout device (if optional heater/cooler is installed)
• HPLC-grade water
• Forceps or disposable lint-free gloves
• Seven vials with PTFE septa and caps, or PTFE preslit septa and caps, suitable for the sample tray being
used (microplates cannot be used for operational qualification testing)
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• Syringe, standard 100-µL

1.4.1 Recording Test Equipment Calibration Information

In Form 1-3, record calibration information for the test equipment to be used in the operational qualification
procedures.
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 Part IV: 2777 Sample Manager Operational Qualification

Form 1-3 Test Equipment Calibration Information

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Test/Measurement Device

Serial Number

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Calibration Dates Last Next
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Test/Measurement Device

Serial Number

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Calibration Dates Last Next
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Test/Measurement Device

Serial Number

Calibration Dates Last

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Initials
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Test/Measurement Device

Serial Number

Calibration Dates Last Next

Initials
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Test/Measurement Device

Serial Number
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Calibration Dates Last Next

Initials

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

Performer Date
Signature
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The undersigned reviewer accepts that the above information is accurate and complete.
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Reviewer Date
Signature
 2003 Waters Corporation

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 Waters LC/MS Systems Qualification Workbook

1.4.2 Verifying Startup Diagnostics and Priming

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1 Perform the initial operational qualification procedures as instructed in Form 1-4. If you require reference
material or information on how to perform any of the steps, see the documents appropriate for the 2777 Sample
Manager.

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1.4.3 Testing the Tray Positioning
To perform the tray positioning test:
1. Place six vials suitable for the sample tray being used with unpunctured septa in random locations
throughout the sample tray and mark the locations in Form 1-4.
2. To program one injection from each of the six target vials, press the Menu key (F1).
3. Ensure that Methods is highlighted and press Enter.

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4. Press Insrt Method (F2) and name the method appropriately. Use the scroll knob and the left-right
arrow function keys (F2 and F3) to select among alphanumeric characters and spaces. Method names
can be up to eight characters. Press Enter (F4) to accept the name.

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5. Select LC-Inj for the cycle and press Enter.
6. Enter the parameters listed in Table 1-2.

Note: Ensure no cleaning steps are selected in the method.

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Table 1-1 Injection Accuracy Parameters

Parameter Setting

Sample Volume 10 µ L

Fill Strokes 0
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Inject to None or Waste

7. Press the Home key (F4).

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8. Press the Add Job key (F2).

9. In the Insert Mode field, select Append and press Enter.
10. Select Tray 1 and Count 1. Set the First and Last fields to the desired target vial, and enter the method
name used in step 4.
11. Press the Home key (F4).
12. Repeat step 9 to step 11 for each of the remaining target vials.
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13. Highlight the job and press the Start key (F4).
14. Set the Select Job(s) to Process field to All, and press Enter.
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15. After the injections are complete, verify that the septa of the six target vials were punctured. Record
the results in Form 1-4.

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 Part IV: 2777 Sample Manager Operational Qualification

1.4.4 Testing the Aspiration Accuracy

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Perform the aspiration accuracy test to verify expected operation of the 2777 Sample Manager and to verify that
the 2777 Sample Manager accurately withdraws the selected amounts of sample.

Attention: To ensure the accuracy of this test, use forceps or wear lint-free gloves to handle the vial

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in this test.

Sample Preparation
To prepare for the aspiration accuracy test:
1. Purge the 2777 Sample Manager with degassed HPLC-grade water.
2. Fill a vial suitable for the sample tray being used with HPLC-grade water from the solvent reservoir.

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Note: Microplates cannot be used for this test.

3. Seal the vial with a PTFE (or preslit) septum and cap, if available. If a PTFE (or preslit) septum is not
available, use a cap without a septum. Do not use self-sealing septa (unless preslit) as it will create a
vacuum in the vial during multiple injections.

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4. Zero the analytical balance, then carefully weigh the vial (using forceps or your gloved hand to move
the vial). Record the weight (W1) in Form 1-5.
5. Place the weighed vial in sample position 1 of the sample tray, then place the tray in the 2777 Sample
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Manager.

Test Procedure
To perform the aspiration accuracy test:
1. Drain the outlet line to a waste solvent container.
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2. Press the Menu key (F1).

3. Ensure that Methods is highlighted, and press Enter.
4. Press Insrt Method (F2) and name the method appropriately. Use the scroll knob and the left-right
arrow function keys (F2 and F3) to select among alphanumeric characters and spaces. Method names
can be a maximum of eight characters. Press Enter (F4) to accept the name.
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5. Select LC-Inj for the cycle and press Enter.

6. Enter the parameters listed in Table 1-2.

Note: Ensure no cleaning steps are selected in the method.

Table 1-2 Injection Accuracy Parameters

Parameter Setting
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Sample Volume 50 µ L
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Fill Strokes 1

Inject to Waste

7. Press the Home key (F4) and then press the Add Job key (F2).

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 Waters LC/MS Systems Qualification Workbook

8. In the Insert Mode field, select Append and press Enter.

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9. Select Tray 1, Count 6, and enter the method name used in step 4.
1 10. Press the Home key (F4).
11. Highlight the job and press the Start key (F4).
12. Remove and reweigh the vial in position 1. Record the weight (W2) in Form 1-5.

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13. Use this formula to calculate the average volume of water injected per injection:
[(W1 – W2) / 6] × 1000 = mg of water withdrawn per injection = µL per injection withdrawal

Note: Water is used for this test 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 × 1000 = µ L).

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14. Record the results in Form 1-5, then complete the form.

1.4.5 Testing the Heater/Cooler

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Note: If your 2777 Sample Manager does not include the heater/cooler option, write N/A on the Pass
line of Form 1-6, and sign and date the form.

Note: If laboratory conditions exceed 30 °C ambient temperature or 60% relative humidity, the
heater/cooler may not operate as intended and fail this test.
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If your 2777 Sample Manager includes a heater/cooler option, use this procedure to verify its proper operation:
1. Place a calibrated K-type thermocouple within the autosampler stack. Point the tip of the thermocouple
toward the rear of the stack and ensure that it does not contact any surfaces. Close the stack door.
2. Set any temperature value from 4 to 40 °C, however, do not select a value that is within ±5 °C of
ambient temperature. Record the setpoint in Form 1-6.
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3. Observe that the temperature reading from the thermocouple begins to change toward the new
temperature setpoint entered in step 2.
4. Allow sufficient time for the stack temperature to reach and stabilize at the new setpoint. Record the
observed temperature in Form 1-6.
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Note: The time required to reach the set temperature depends on the ambient temperature, e.g.,
the stack may require up to 90 minutes to reach 4 °C starting from room temperature.

5. Complete Form 1-6.

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 Part IV: 2777 Sample Manager Operational Qualification

Form 1-4 Initial Operational Qualification Procedure

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Waters 2777 Sample Manager Serial Number

Verifying Startup Diagnostics and Priming Completed

1. Power on the 2777 Sample Manager. Verify that it enters the Idle state after all

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diagnostics are complete.
Initials
2. Prime the needle wash pump. Verify that solvent flows from the waste tube.

Tray Positioning Test

Vial Location Punctured
Vial 1 _______________ _______________ (All must be punctured to pass)
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Vial 2 _______________ _______________

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Vial 3 _______________ _______________

Vial 4 _______________ _______________

Vial 5 _______________ _______________

Vial 6 _______________ _______________

NTest Results Pass

Initials
Fail
Initials
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Comments
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Certification

The undersigned performer attests that the operational qualification procedure above was performed and accurately recorded.

Performer Date
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Signature

The undersigned reviewer accepts that the operational qualification procedure above was performed and accurately recorded.

Reviewer Date
Signature

 2003 Waters Corporation

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 Waters LC/MS Systems Qualification Workbook

Form 1-5 Aspiration Accuracy Test

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1 Waters 2777 Sample Manager Serial Number

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Vial Weight Before Six Vial Weight After Six
Withdrawal Injections (W1) = Withdrawal Injections (W2) =

Programmed Withdrawal Calculated Average Volume Acceptable Withdrawal Test Results

Injection Volume [(W1 − W2) / 6] × 1000 Injection Volume Range

50 µL µL 50 µL ±1.5 µL Pass Fail

Initials Initials

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Comments

Certification
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The undersigned performer attests that the above test was performed according to the indicated procedure, and the results
were accurately recorded above.

Performer Date
Signature

The undersigned reviewer accepts that the above test was performed according to the indicated procedure, and the results
were accurately recorded above.
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Reviewer Date
Signature

 2003 Waters Corporation

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 Part IV: 2777 Sample Manager Operational Qualification

Form 1-6 Heater/Cooler Test (Optional)

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Waters 2777 Sample Manager Serial Number

If your 2777 Sample Manager does not have the optional heater/cooler, write N/A on the Pass line and sign and date this form.

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Temperature Values Acceptable Range Test Results

Setpoint Observered ±3 °C of setpoint

Temperature Temperature temperature Pass Fail
Initials Initials

Comments

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Certification

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The undersigned performer attests that the above test was performed according to the indicated procedure, and the results
were accurately recorded above.
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Performer Date
Signature

The undersigned reviewer accepts that the above test was performed according to the indicated procedure, and the results
were accurately recorded above.

Reviewer Date
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Signature

 2003 Waters Corporation

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 Waters LC/MS Systems Qualification Workbook

1.5 Operational Qualification Log

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1 Use Form 1-7 to compile a record of operational qualification procedures performed on the Waters 2777 Sample
Manager, including those performed after scheduled maintenance procedures and corrective servicing.

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Note: Before you enter information on the last page of Form 1-7, make additional copies. Insert them
behind the original.

Form 1-7 Operational Qualification Procedures Log

The undersigned attest and accept that the operational qualification procedures recorded below were performed on the
Waters 2777 Sample Manager, and all approval signatures were obtained where necessary.

Waters 2777 Sample Manager Serial Number

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Service Report
Number

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Procedure

Performer Date
Signature
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Reviewer Date
Signature

Service Report
Number
Procedure
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Performer Date
Signature

Reviewer Date
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Signature

Service Report
Number
Procedure
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Performer Date
Signature
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Reviewer Date
Signature
 2003 Waters Corporation

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Form 1-7 Operational Qualification Procedures Log (Continued)

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The undersigned attest and accept that the operational qualification procedures recorded below were performed on the
Waters 2777 Sample Manager, and all approval signatures were obtained where necessary.

Waters 2777 Sample Manager Serial Number

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Service Report
Number
Procedure

Performer Date
Signature

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Reviewer Date
Signature

Service Report
Number
Procedure

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Performer Date
Signature

Reviewer Date
Signature

Service Report
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Number
Procedure
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Performer Date
Signature

Reviewer Date
Signature

Service Report
Number
Procedure
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Performer Date
Signature

Reviewer Date
Signature
 2003 Waters Corporation

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Form 1-7 Operational Qualification Procedures Log (Continued)

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The undersigned attest and accept that the operational qualification procedures recorded below were performed on the

1 Waters 2777 Sample Manager, and all approval signatures were obtained where necessary.

Waters 2777 Sample Manager Serial Number

Service Report

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Number
Procedure

Performer Date
Signature

Reviewer Date

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Signature

Service Report

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Number
Procedure

Performer Date
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Signature

Reviewer Date
Signature

Service Report
Number
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Procedure

Performer Date
Signature
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Reviewer Date
Signature

Service Report
Number
Procedure
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Performer Date
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Signature

Reviewer Date
Signature
 2003 Waters Corporation
Make extra copies of this form before using the last page.

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