Waters HPLC

LY
Systems

ON
Qualification
Workbook

CE
Recommended
Procedures for
EN
Operational
Qualification
ER

Waters 2690/2695
Separations Module
F

Part IV: OQ
RE
R
FO

34 Maple Street
Milford, MA 01757

71550269514, Revision C
February 2003
Waters HPLC Systems Qualification Workbook

NOTICE

LY
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.

ON
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.

 2001–2003 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

CE
QUALITY PRODUCT 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 PUBLISHER.

Waters Service Technicians are not authorized to make entries into unauthorized photocopied documents. To
EN
obtain additional documents, contact your Waters representative.

Alliance, Integrity, Millennium, and Waters are registered trademarks, and Empower is a trademark of
Waters Corporation.
ER

All other trademarks or registered trademarks are the sole property of their respective owners.
F
RE
R
FO

2 of 34
 Part IV: Waters 2690/2695 Separations Module Operational Qualification

Table of Contents

LY
1.1 Introduction ................................................................................................................ 5
1.2 Scope of Operational Qualification............................................................................... 6

ON
1.3 Preliminary Operational Qualification Procedures ......................................................... 7
1.3.1 Identifying Performers and Reviewers................................................................. 7
1.3.2 Identifying System Components .......................................................................... 8
1.4 Operational Qualification Procedures ......................................................................... 10
1.4.1 Recording Test Equipment Calibration Information .......................................... 10
1.4.2 Performing Initial Operational Qualification Procedure .................................... 12

CE
1.4.3 Testing the Flow Rate Accuracy ........................................................................ 13
1.4.4 Testing the Gradient Proportioning Valve .......................................................... 14
1.4.5 Testing the Injection Accuracy........................................................................... 21
1.4.6 Testing the Sample Heater/Cooler Temperature Accuracy ................................ 22
EN
1.4.7 Testing the First Generation Column Heater Temperature Accuracy ................ 23
1.4.8 Testing the Second Generation Column Heater or Column Heater/Cooler
Temperature Accuracy ....................................................................................... 24
1.4.9 Testing the Bar Code Reader.............................................................................. 25
ER

1.5 Operational Qualification Log.................................................................................... 31

F
RE
R
FO

3 of 34
Waters HPLC Systems Qualification Workbook

Forms

LY
Form 1-1 Identification of Performers and Reviewers ........................................................................7
Form 1-2 Identification of System Components .................................................................................9

ON
Form 1-3 Test Equipment Calibration Information...........................................................................11
Form 1-4 Initial Operational Qualification Procedure.......................................................................26
Form 1-5 Flow Rate Accuracy Test...................................................................................................27
Form 1-6 GPV Test ...........................................................................................................................28
Form 1-7 Injection Accuracy Test .....................................................................................................29
Form 1-8 Sample Heater/Cooler, Column Heater, Column Heater/Cooler, and Bar Code

E
Accuracy Tests...................................................................................................................30
Form 1-9 Operational Qualification Procedures Log ........................................................................31

E NC
F ER
RE
R
FO

4 of 34
 Part IV: Waters 2690/2695 Separations Module Operational Qualification

LY
Operational Qualification

ON
The Waters HPLC Systems Qualification Workbook, Recommended Procedures for Operational Qualification,
Waters 2690/2695 Separations Module, Part IV: OQ presents the operational qualification process for the
Waters ® 2690 or 2695 Separations Module. Use this workbook to qualify the Waters 2690 or 2695 Separations
Module in a GLP-, CGMP-, and/or GALP-regulated environment and/or an ISO 9000-series registered facility.

1.1 Introduction

CE
This workbook guides a trained and qualified person through the operational qualification of a Waters 2690 or
2695 Separations Module.

Recommended Documents
EN
Use this workbook with the appropriate documents for your 2690 or 2695 Separations Module, and with other
referenced documentation to qualify the performance of the Waters 2690 or 2695 Separations Module:
• Waters 2690 Separations Module Operator’s Guide, part number WAT553-02*
• Waters 2690 Separations Module Quick Start Guide, part number WAT553-03*
ER
• Waters 2690 Separations Module Documentation Set on a CD, part number 71505530121
• Waters 2690D Alliance Dissolution System Operator’s Guide, part number 71500010302*
• Waters 2695 Separations Module Operator’s Guide, part number 71500269502*
• Waters 2695 Separations Module Quick Start Guide, part number 71500269503*
• Waters 2695 Separations Module Documentation Set on a CD, part number 71500269521
F

• Waters 2695D Alliance Dissolution System Operator’s Guide, part number 71500034302*
• Waters Alliance Series Column Heater and Column Heater/Cooler Operator’s Guide, part number
RE

71500049202*
*This documentation is also available online in PDF files 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 Chromatography Systems Qualification Workbook, Part I: System
Qualification Overview, Part II: IQ (for the Waters 2695 Separations Module), and in Part III: MP (for the
R

Waters 2690/2695 Separations Module), as applicable.

Refer to the Waters Chromatography Systems Qualification Workbook, Part I: System Qualification Overview
FO

for:
• Instructions on completing forms
• Guidelines for requalifying the Waters 2690 or 2695 Separations Module

5 of 34
 Waters HPLC Systems Qualification Workbook

• Management approval of the system qualification protocols

LY
• Information on using this workbook
1 Note: If you are performing an operational qualification of a Waters 2690D or 2695D Separations
Module, follow the procedures in the Waters HPLC Systems Qualifications Workbook, Dissolution
Sample Transfer Module, Part IV: OQ, after completing the procedures in this workbook.

ON
After Operational Qualification
After the operational qualification of the Waters 2690 or 2695 Separations Module is complete, qualified
performers and reviewers can complete the system qualification by performing the tasks described in the
Part V: PQ workbook. Owner’s management approves the successful completion of this system qualification by
completing the approval form at the end of the Part V: PQ workbook.

E
1.2 Scope of Operational Qualification

NC
Operational qualification involves:
• Verifying successful completion of the startup diagnostics
• Testing the carousel
• Testing flow rate accuracy
• Testing the gradient proportioning valve (GPV)
E
• Testing injection accuracy
• Testing the sample heater/cooler module temperature accuracy (if installed)
ER

• Testing the first generation column heater module temperature accuracy (if installed)
• Testing the second generation column heater or column heater/cooler module temperature accuracy (if
installed)
• Testing the bar code reader (if installed).
F
RE
R
FO

6 of 34
 Part IV: Waters 2690/2695 Separations Module Operational Qualification

1.3 Preliminary Operational Qualification Procedures

LY
1.3.1 Identifying Performers and Reviewers
To identify the performers qualified to perform the operational qualification of the Waters 2690 or 2695

ON
Separations Module, and to identify the reviewers qualified to acknowledge the successful completion of the
performers’ tasks, complete Form 1-1.

Form 1-1 Identification of Performers and Reviewers

The undersigned performers attest that they are trained and qualified to perform operational qualification of a Waters 2690 or
2695 Separations Module.

CE
Performer
Name (print) Signature Initials

Title Date
(Trained and qualified to perform operational qualification procedures)

Performer
Name (print)
EN Signature Initials

Title Date
(Trained and qualified to perform operational qualification procedures)
ER

The undersigned reviewers accept that the above performers are trained and qualified to perform operational qualification of
a Waters 2690 or 2695 Separations Module.

Reviewer
Name (print) Signature Initials
F

Title Date
(Owner-designated responsible person)
RE

Reviewer
Name (print) Signature Initials

Title Date
(Owner-designated responsible person)
 2003 Waters Corporation
R
FO

7 of 34
 Waters HPLC Systems Qualification Workbook

1.3.2 Identifying System Components

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

Identifying the Instrument

Identify the Waters 2690 or 2695 Separations Module by locating its serial number inside the syringe

ON
compartment of the Separations Module. Enter the number in Form 1-2.

Obtaining the Firmware Revision Number

To obtain the firmware revision number:
1. Power on the Waters 2690 or 2695 Separations Module.
2. Obtain the revision number from the 2690 or 2695 Separations Module Main screen. Enter the

E
number in Form 1-2.

Identifying the Optional Column Selection Valve

NC
Identify the optional column selection valve by the number of ports:

• The three-column selection valve has 8 ports.

• The column-regeneration valve has 10 ports.
• The six-column selection valve has 14 ports.
E
Indicate the column selection valve type in the space provided in Form 1-2.
F ER
RE
R
FO

8 of 34
 Part IV: Waters 2690/2695 Separations Module Operational Qualification

Form 1-2 Identification of System Components

LY
Equipment Name

Manufacturer Waters Corp., 34 Maple Street, Milford, MA 01757 U.S.A.

ON
Serial Number

Firmware Revision Number

Enter N/A in the Installed column for components that are not applicable to your system.

Options:
Installed

CE
Sample Heater/Cooler
Initials
Column Heater

Column Heater/Cooler

Bar Code Reader EN

Column Selection Valve Option:

Three-Column Selection Valve

Column-Regeneration Selection Valve

ER
Six-Column Selection Valve

Certification

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

Performer Date
Signature
F

The undersigned performer accepts that the system component identification information above is accurate and complete.
RE

Reviewer Date
Signature

 2003 Waters Corporation

R
FO

9 of 34
 Waters HPLC Systems Qualification Workbook

1.4 Operational Qualification Procedures

LY
1 This section provides the procedures you need to verify the operation of the Waters 2690 or 2695 Separations
Module. If you require reference material or information on how to perform any of the steps in the following
forms, refer to the manuals appropriate for the Separations Module.

ON
Attention: Before performing the operational qualification procedures in this section, Waters
recommends that all performers and reviewers become familiar with the appropriate documents
and other referenced documentation and, if applicable, the Millennium32 Help or Empower Help.

Recommended Materials
• Documents appropriate for your 2690 or 2695 Separations Module; refer to Section 1.1, Introduction,
Recommended Documents

E
• Pin plug or cap
• Pressure restriction device capable of producing a backpressure of 500 to 700 psi

NC
• Stainless steel tubing 0.009-in. ID
• 5/16-inch open-end wrenches (two)
• 5/8-inch open-end wrench
• Stopwatch (calibrated)
• Class A volumetric flasks (10-mL, 25-mL, and 5-mL)
E
• Analytical balance (calibrated)
• Strip-chart recorder (calibrated)
ER

• HPLC-grade water
• HPLC-grade methanol
• Waters GPV Test Solution (part number WAT042876)
• Solvent degassing apparatus
• Helium, 50 to 90 psi (if used for sparging)
F

• Forceps or disposable lint-free gloves

• Six 2-mL vials with PTFE septa and caps (part number 186000272), or optionally use 2-mL vials with
RE

PTFE preslit septa and caps (part number 186000307)

• Calibrated K-type thermocouple with readout device (for testing the optional sample heater/cooler,
column heater, and column heater/cooler)
• Five bar code reader labels (if testing the optional bar code reader)

1.4.1 Recording Test Equipment Calibration Information

R

In Form 1-3, record calibration information for the test equipment to be used in the operational qualification
procedures.
FO

10 of 34
 Part IV: Waters 2690/2695 Separations Module Operational Qualification

Form 1-3 Test Equipment Calibration Information

LY
Test/Measurement Device

Serial Number

ON
Calibration Dates Last Next
Initials

Test/Measurement Device

Serial Number

CE
Calibration Dates Last Next
Initials

Test/Measurement Device

Serial Number

Calibration Dates Last

EN Next
Initials

Test/Measurement Device
ER
Serial Number

Calibration Dates Last Next

Initials

Test/Measurement Device
F

Serial Number
RE

Calibration Dates Last Next

Initials

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

Performer Date
Signature
R

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

Reviewer Date
Signature
 2003 Waters Corporation

11 of 34
 Waters HPLC Systems Qualification Workbook

1.4.2 Performing Initial Operational Qualification Procedure

LY
1 Initial Procedure
Perform the procedure in Form 1-4, then perform the following carousel test. Enter N/A in the Completed
column for each step not required for your Separations Module.

ON
Carousel Test
To perform the carousel test:
1. Install one vial with unused septa in each carousel.

Note: The use of optional preslit septa in this test may not easily indicate when it has been
punctured. If you use preslit septa, secure a piece of aluminum foil over the vial to better indicate
when the septa has been punctured.

E
2. Record the location of the vial for each carousel in Form 1-4.

NC
3. Press the Direct Function screen key.
4. Select Inject Samples. The Inject Samples screen appears.
5. Enter the location of the vial in the first carousel in the Vial Range field, then enter the other
parameters listed in Table 1-1.

Table 1-1 Inject Samples Parameters for the Carousel Test

E
Parameter Setting

Vial Range Position of vial

ER

Injects per Vial 1

Run Time 0.1

Inject Volume 0.0

F

6. Press the OK screen key to start the run. When the run is complete, the status in the banner area of
RE

the screen changes to Idle.

7. Repeat step 3 through step 6 for each carousel.
8. Verify that the septa of the vials in each carousel were punctured. Record the results and complete
Form 1-4.
R
FO

12 of 34
 Part IV: Waters 2690/2695 Separations Module Operational Qualification

1.4.3 Testing the Flow Rate Accuracy

LY
Your HPLC system configuration determines which flow rates and flask sizes you use to test flow rate accuracy.
Run the flow rate accuracy test at each flow rate that applies to your system as listed in Table 1-2. Write N/A in
the Pass field of Form 1-5 for the flow rate not used by your system.

ON
Table 1-2 Flow Rate and Flask Size Requirements

5.0-mL/min 1.0-mL/min 0.5-mL/min 0.25-mL/min

System Flow Rate Flow Rate Flow Rate Flow Rate
(25-mL Flask) (10-mL Flask) (10-mL Flask) (5-mL Flask)

Waters HPLC X X X
Alliance® systems
except LC/MS

CE
systems

LC/MS systems X X X
only

EN
Caution: 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. Refer to the Material Safety Data Sheet for each solvent and test solution in use.

Attention: Never change directly between immiscible eluents or between buffered solutions and
organic eluents. Immiscible eluents form emulsions in the flow path. Buffered solutions and organic
ER
eluents in combination may result in salt precipitation in the gradient proportioning valves, pump
heads, check valves, or other parts of the system.

Confirm that all fluids in the system are miscible with methanol. If you need additional information about
priming your system, refer to the manuals appropriate for your 2690 or 2695 Separations Module; see
Section 1.1, Introduction, Recommended Documents.
F

5.000-mL/min Flow Rate Test

To test the flow rate accuracy of the solvent management system at 5.000 mL/min:
RE

1. Obtain a 25-mL Class A volumetric flask and ensure that it is thoroughly dry.
2. Prime solvent line A with fully degassed methanol. Set the vacuum degasser (if installed) to run
continuously, or set the sparge rate to 100% A.
3. Prepare the stopwatch to begin timing.
4. Enter 5.000 in the Flow Rate field in the Status screen, then press Enter.
R

Note: If you receive a maximum flow rate error for the current stroke volume, change the stroke
volume to 130 µL.
FO

5. When the flow and pressure are stable, simultaneously insert the red outlet tubing into the volumetric
flask and start the stopwatch.
6. Stop the stopwatch when the bottom of the meniscus reaches the 25-mL mark on the flask.
7. Record the elapsed time in seconds and the observed system pressure in Form 1-5.

13 of 34
 Waters HPLC Systems Qualification Workbook

8. Calculate the flow rate using the following equation:

LY
1 Calculated flow rate = volume of flask / (measured time in seconds / 60)
9. Record the calculated flow rate in the appropriate line of Form 1-5.

Note: The flow rate accuracy specification is ±1% or 10 µL/min, whichever is greater. The

ON
acceptable flow rate value in Form 1-5 includes the Class A flask accuracy and operator error of
±0.2%.

1.000-mL/min, 0.500-mL/min, and 0.250-mL/min Flow Rate Tests

To test the flow rate accuracy of the solvent management system at 1.000 mL/min, 0.500 mL/min, and 0.250
mL/min:
1. Attach a length of stainless steel tubing or other restriction device to the red outlet line to produce

E
backpressure of 500 to 700 psi (31.25 and 43.75 bar) at 1.000 mL/min.
2. Obtain a 10-mL Class A volumetric flask and ensure that it is thoroughly dry.

NC
3. Prime solvent line A with fully degassed methanol. Set the vacuum degasser (if installed) to run
continuously, or set the sparge rate to 100% A.
4. Prepare the stopwatch to begin timing.
5. Enter 1.000 in the Flow Rate field in the Status screen, then press Enter.
6. When the flow and pressure are stable, simultaneously insert the outlet tubing into the volumetric
flask and start the stopwatch.
E
7. Stop the stopwatch when the bottom of the meniscus reaches the 10-mL mark on the flask.
8. Record the elapsed time in seconds and the observed system pressure in Form 1-5.
ER

9. Calculate the flow rate using the following equation:

Calculated flow rate = volume of flask / (measured time in seconds / 60)

10. Record the calculated flow rate in the appropriate line of Form 1-5.

Note: The acceptable flow rate value in Form 1-5 includes the Class A flask accuracy and
F

operator error of ±0.2%.

RE

11. Repeat step 2 through step 10 using a flow rate of 0.500 mL/min. Adjust the restriction device to
produce backpressure of 500 to 700 psi (31.25 and 43.75 bar) at a flow rate of 0.500 mL/min.
12. When finished, repeat step 3 through step 10 using a thoroughly dry 5-mL Class A volumetric flask
and a flow rate of 0.250 mL/min (if applicable to your system). Adjust the restriction device to
produce backpressure of 500 to 700 psi (31.25 and 43.75 bar) at a flow rate of 0.250 mL/min (if
applicable to your system).

Note: The acceptable flow rate value in Form 1-5 for the 0.250-mL/min flow rate includes the
R

Class A flask accuracy and operator error of ±0.4%.

13. Complete Form 1-5.

FO

1.4.4 Testing the Gradient Proportioning Valve

Test the gradient proportioning valve (GPV) using one of the following methods:
• An absorbance detector and Millennium ®32 or Empower

14 of 34
 Part IV: Waters 2690/2695 Separations Module Operational Qualification

• An absorbance detector and a strip-chart recorder

LY
• Graduated cylinders (only if an absorbance detector is not available)

Note: Waters recommends using either the absorbance detector and Millennium32 or Empower
method or the absorbance detector and strip-chart recorder method because it tests the gradient
proportioning valves to ±0.5% accuracy. However, when no absorbance detector is available, you can

ON
use the alternate graduated cylinder method, which tests to ±4.5% accuracy. Choose the method that
best suits your installation. Document the results for all versions of the test in Form 1-6.

Using an Absorbance Detector and a Millennium³² or Empower Data Station

Perform the following procedures to test the gradient proportioning valve (GPV) using an absorbance
detector and a Millennium32 or Empower data station.

CE
Note: If using Empower, you must use the Pro interface. Empower does not support the 2690
Separations Module.

Preparing for the GPV Test

To prepare for the GPV test:
EN
1. Connect a UV detector (such as the Waters 486 Tunable Absorbance Detector, the Waters 2487 Dual λ
Detector, the Waters 2996 Photodiode Array Detector, or the Waters 996 Photodiode Array Detector) to
the outlet of the inline filter using an appropriate length of 0.009-inch ID tubing.
2. Fill the reservoir for the A and B lines with solvent 1 (100% methanol).
3. Fill the reservoir for the C and D lines with 500 mL of methanol containing 5.6 mg/L propylparaben
(1 ampule of Waters GPV Test Solution, Waters part number WAT042876, per 500 mL of methanol).
ER

4. Prime the pump.

5. Run the inline degasser for 10 minutes, or, optionally, use appropriate sparge or sonication methods.

Entering the Gradient Table

To enter the Gradient table:
F

1. Create an instrument method in Millennium32 or Empower using the parameters listed in Table 1-3.
2. Set the detector to 254 nm with 1 pt/sec with a 1-second filter. If you are using a 2996 or 996
RE

Detector, also set the parameters listed in Table 1-4.

3. Save the method with a name such as GPV_IM.
4. Create a new method set that includes the instrument method created in step 1.

Table 1-3 Gradient Table Parameters when Using an Absorbance Detector

Time Flow %A %B %C %D Curve

R

INIT 2.000 50 50 0 0

2.00 2.000 0 0 50 50 11
FO

6.00 2.000 50 50 0 0 11

10.00 2.000 45 45 10 0 11

12.00 2.000 50 50 0 0 11

15 of 34
 Waters HPLC Systems Qualification Workbook

Table 1-3 Gradient Table Parameters when Using an Absorbance Detector (Continued)

LY
1 Time

14.00
Flow

2.000
%A

45
%B

45
%C

0
%D

10
Curve

11

16.00 2.000 50 50 0 0 11

ON
18.00 0.000 50 50 0 0 11

Table 1-4 Parameters for the 2996 or 996 Detector

Parameter Setting

E
For the 2996 only: For the 2996 only:
3D Data Collection Selected

NC
Wavelength range (Start/End) 230 to 260 nm

Sampling Rate 1.0 spectra/sec, minimum

Resolution 1.2 nm

Monitoring wavelength 254 nm (default)

E
(Set in Run Samples)

Auto Exposure Yes

ER

Filter Response 1 sec (For the 2996 Detector also

ensure the Digital Filter is selected)

Running the GPV Test

F

To run the GPV test:

1. Run single injection with an 18-minute run time using the above created method set and the Prepare and
Inject icons. Select Run Only from the Run Samples window. The resultant printout will be similar to
RE

Figure 1-1.
R
FO

16 of 34
 Part IV: Waters 2690/2695 Separations Module Operational Qualification

LY
0.60

Fu l lS c a le - 6 .1 8 8
0.50

ON
0.40

0.30
AU

A / B /C - 1 2 . 0 7 9

A /B / D - 1 6 .0 8 4
0.20

CE
0.10

0.00

2 .0 0 4 .0 0 6 .0 0 8.00 1 0 .0 0 1 2 .0 0 1 4 .0 0 1 6 .0 0 1 8 .0 0
EN
Figure 1-1 Printout from a Successful GPV Test
Mi n u te s

Processing the Results

To process the results:
ER
1. Bring the channel into Review.
2. If you are using a Waters 2996 or 996 Photodiode Array Detector, extract a 254-nm chromatogram.
3. Click the Processing Method Wizard icon.
4. Follow the wizard steps. Be sure the wizard uses a large Peak Width (approximately 200) and
Threshold (approximately 100).
F

5. Rename the peaks as FullScale, A/B/C, and A/B/D in that order. There should only be three peaks.
6. After the wizard is completed, go to the Window-Processing Method and add an integration event in
the table. The start time should be 2.00 minutes, the event should be Force Baseline by Time, and the
RE

stop time should be 18.00 minutes. Also go into the Component table and increase the Retention
Time Window to 2.00 minutes. Save the Processing Method.
7. Once the Processing Method is created, you need to make a custom field in the project. In
Configuration Manager, go to the properties of the project. Click Custom Fields, then click New.
Follow the steps of the wizard and create a Peak custom field with the following formula:
(Height/FullScale[Height])*100
R

Use the default width and a precision of 1. Call it GPVPercent.

8. Process the GPV run with the previously made processing method to obtain the percent of the full
scale peak and save the result. If you are using a Waters 2996 or 996 Photodiode Array Detector,
FO

process the GPV run with a method set that contains both a derived channel of 254 nm and the previously
made processing method. Using the following steps, you can generate a report method that gives the
GPV percent. It should be 10% ±0.5. Check that the peak height is based on the average height along
the flat area at the top of the peak. If not, adjust as necessary.

17 of 34
 Waters HPLC Systems Qualification Workbook

Printing Results

LY
To print your results:
1 1. In the project window, click the Results tab. Right-click on the GPV result that was saved previously and
select Preview/Publisher.
2. In the Open Report Method window, select Use a report method that was generated to be

ON
appropriate for the selected data, and click OK.
3. In the Preview window, click Close. The Report Publisher window appears.
4. Right-click the Peak Results table and select Table Properties. Delete columns Area, Amount, and
Units by highlighting the column and pressing the Delete key on your keyboard.
5. Click the Peak Fields icon on the left of the window. Drag the GPVPercent field into the table.
6. Save the method with a name such as GPVResults.

E
7. Click the Preview icon and verify that the GPV Percent field was populated.
8. Click Print to print the report.

NC
Interpreting Results
The result table gives the calculated percent for the relative height of the peak. This result should be 10% ±0.5.
Record the results on the Observed GPV Percent lines in Form 1-6.

Using an Absorbance Detector and a Strip-Chart Recorder

Follow the procedures below to test the gradient proportioning valve (GPV) using an absorbance detector
E
and a strip-chart recorder.
ER
Note: Testing the GPV using this procedure is not supported for versions 3.0 and 3.1 of the 2996
Detector firmware.

Preparing for the GPV Test

To prepare for the GPV test:
1. Connect a UV detector (such as the Waters 486 Tunable Absorbance Detector, the Waters 2487 Dual λ
F

Detector, or the Waters 996 Photodiode Array Detector) to the outlet of the inline filter using an
appropriate length of 0.009-inch ID tubing.
RE

2. Connect a strip-chart recorder to the integration output of the detector.

3. Set the detector to 254 nm. Set the integration output of the detector to 1 V = 1 AU.

Note: When using a 2487 Detector, set the AUFS to 2.0 to get a 1 V = 1 AU output.

Note: If you are using a 996 Detector, you must set up an instrument method in Millennium32 or
Empower with only the 996 Detector that has the channel 1 analog out enable for 254 nm. Then
in Run Samples, click Monitor to monitor the baseline and to start the output.
R

4. Fill the reservoir for the A and B lines with 500 mL of methanol.
5. Fill the reservoir for the C and D lines with 500 mL of methanol containing 5.6 mg/L propylparaben
FO

(1 ampule of Waters GPV Test Solution, part number WAT042876, per 500 mL of methanol).
6. Prime the pump.
7. Run the inline degasser for 10 minutes, or, optionally, use appropriate sparge or sonication methods.
8. Set the solvent composition to 25% A, 25% B, 25% C, and 25% D.

18 of 34
 Part IV: Waters 2690/2695 Separations Module Operational Qualification

9. Set the flow rate to 2.000 mL/min and allow the solvent to flow for a minimum of 2 minutes to

LY
exercise the valves.

Adjusting the Recorder

To adjust the zero and full-scale settings of the recorder:

ON
1. Set the chart speed to 1.0 cm/min and the sensitivity to 500 mV.
2. Set the solvent management system to deliver 50% A and 50% B at a flow rate of 2 mL/min.
3. After the detector stabilizes, adjust the recorder for zero deflection using the zero adjust control.
4. Set the solvent management system to deliver 50% C and 50% D at a flow rate of 2 mL/min.
5. After the detector stabilizes, adjust the recorder to full-scale deflection using the variable full-scale
control.

CE
Entering the Gradient Table
Create a gradient method in the 2690 or 2695 Separations Module using Table 1-3.

Running the GPV Test

To run the GPV test:
1. Set the composition to 50% A and 50% B and the flow rate to 2.000 mL/min.
EN
2. When the baseline is stable at zero:
• Switch the recorder to the 100 mV scale.
• Adjust the baseline of the recorder to 10% full scale using the zero adjustment (a positive 10%
offset).
ER
3. On the 2690 or 2695 Separations Module Status Page, select the gradient method that you created using
Table 1-3.
4. Press Direct Function.
5. Select Condition Column, then enter a time of 18 minutes.
6. Press OK to execute the gradient table.
F

Note: The Full Scale peak (50% C and 50% D) will go completely off the scale of the strip-chart
recorder during the test because the strip-chart recorder scale was changed from 500 to 100 mV
RE

in step 2. This peak is not used for calculations.

Analyzing the GPV Test Results

To analyze the GPV test results:
1. Locate and label the portions of the trace where the composition was 50% A and 50% B.
2. Locate the peak where the composition was 50% C and 50% D and label it Full Scale.
R

3. Locate the peak where the composition was 10% C and label it A/B/C.
4. Locate the peak where the composition was 10% D and label it A/B/D.
5. Draw a line that represents the average height of the A/B/C and A/B/D peaks.
FO

6. Measure the height of the average line for each peak as a percentage of the recorder scale, and write
this value above each peak. Enter these values on the Observed Chart Recorder Percent lines in
Form 1-6.

19 of 34
 Waters HPLC Systems Qualification Workbook

Attention: In this recorder-based test, do not measure from peak to baseline. Obtain the value

LY
for observed chart recorder percent from the recorder scale (i.e., 0% to 100%). The assumption

1 is that the baseline remains stable throughout the test. If the baseline is not stable, rerun the
test.

Note: The mobile phase compositional accuracy specification for this product is ±0.5%. Based

ON
on the detector sensitivity and recorder attenuation settings for this test, each small division on
the chart represents a compositional range of 0.2% (recorder full scale = 20% compositional
change).

If you use sparging, spikes may occur in the readout when you switch reservoirs during the test.
These spikes are caused by gas seeping back into the idle eluent lines. If you are using the inline
degasser, the baseline may temporarily drift due to the increased degassing of unused eluent
lines.

E
7. Record the serial number of the 2690 or 2695 Separations Module on the recorder trace, sign and date
the recorder trace, then file the recorder trace behind Form 1-6.

NC
Using Graduated Cylinders

Note: This method of testing the 2690 or 2695 Separations Module GPV is not as accurate as
either the absorbance detector and Millennium32 or Empower method or the absorbance detector
and strip-chart recorder method. Use this method only when an absorbance detector and
Millennium32 or Empower or a strip-chart recorder are not available. This test checks the gradient
E
proportioning valves to within 4.5% gradient proportioning accuracy. In comparison, the
absorbance detector method checks the valves to 0.5% accuracy.

To test the 2690 or 2695 Separations Module GPV using the graduated cylinders method:
ER

1. Obtain two matched 50-mL graduated cylinders (TC or TD), each with an accuracy of 0.5%.
2. Place the primed Solvent A and Solvent B lines from the 2690 or 2695 Separations Module into the
two graduated cylinders.
3. Fill the cylinders to the 50-mL mark with 100% methanol.
F

4. Set the flow rate to 5 mL/min with 50% A and 50% B.

5. When the solvent in the A cylinder reaches the 25-mL mark, stop the flow.
RE

6. In Form 1-6, record the values for the volumes in each cylinder (A and B).
7. Remove the Solvent A and B lines from the cylinders.
8. Place the primed Solvent C and Solvent D lines in the graduated cylinders.
9. Refill the cylinders to the 50-mL mark.
10. Set the flow rate to 5 mL/min with 50% C and 50% D.
11. When the solvent in the C cylinder reaches the 25-mL mark, stop the flow.
R

12. In Form 1-6, record the values for the volumes in each cylinder (C and D).
To pass the test, the difference in volume between a pair of cylinders must be less than 2 mL. A 2-mL
FO

difference (±0.5% cylinder error) is equal to or less than a 4.5% change in composition.
13. Initial the appropriate Pass/Fail line in Form 1-6.

20 of 34
 Part IV: Waters 2690/2695 Separations Module Operational Qualification

1.4.5 Testing the Injection Accuracy

LY
Perform the injection accuracy test to verify that the sample management system in the Waters 2690 or 2695
Separations Module accurately withdraws the selected amount of sample within the injection volume range
normally used in analytical laboratories.

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

Sample Preparation
To prepare for the injection accuracy test:
1. Fill a standard 2-mL vial with 1.5 mL of degassed HPLC-grade water.

CE
2. 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.
3. 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 1-7.
4. Place the weighed vial in position 1 of the A carousel, then place the carousel in the sample
EN
compartment.
5. Fill reservoir A with degassed 100% HPLC-grade methanol, then prime the solvent delivery system.

Test Procedure
To perform the injection accuracy test:
ER

1. Press the Menu/Status key to display the Status screen.

2. Set the flow rate to 1.0 mL/min of degassed 100% HPLC-grade methanol.
3. Press the Direct Function screen key.
4. Select Inject Samples. The Inject Samples screen appears.
F

5. Enter the values listed in Table 1-5.

Table 1-5 Inject Samples Parameters for the Injection Accuracy Test
RE

Value When Using a Value When Using a

Parameter
250-µL Syringe 25-µL Syringe

Vial Range 1 1

Injects per Vial 6 16

Run Time 0.1 0.1

R

Inject Volume 50.0 12.0

FO

6. Press the OK screen key (Auto Page screen key for Integrity ® LC/MS systems) to start the run. At
the completion of the run, the status in the banner area of the screen changes to Idle (the Menu:
Main page for Integrity LC/MS systems).
7. Remove and reweigh the vial. Record the weight (W2) in Form 1-7.

21 of 34
 Waters HPLC Systems Qualification Workbook

8. Use one of the following formulas to calculate the average volume of water injected per injection:

LY
For 250-µL syringe systems:
1 [(W1– W2) / 6] × 1000 = mg of water withdrawn per injection = µL per injection

For 25-µL syringe systems:

[(W1– W2) / 16] × 1000 = mg of water withdrawn per injection = µL per injection

ON
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).

9. Record the results in Form 1-7, then complete the form.

1.4.6 Testing the Sample Heater/Cooler Temperature Accuracy

E
If your 2690 or 2695 Separations Module includes the sample heater/cooler option, use the procedure in this
section to verify proper operation.

NC
Note: The temperature accuracy of the sample heater/cooler is ±3 °C. To compensate for typical
measurement inaccuracy, the heater/cooler Acceptable Range field in Form 1-8 is set to ±4 °C. If
your measurement device has an inaccuracy of greater than ±1° C, you may adjust the Acceptable
Range accordingly. If you do so, record the adjustment in the Comments section.
E
To test the temperature accuracy of the sample heater/cooler:
1. Place a calibrated K-type thermocouple in the autosampler chamber over the center of the carousel, as
shown in Figure 1-2. Ensure that the thermocouple does not contact any surfaces. Close the chamber door.
ER

Thermocouple Lead
F
RE

Figure 1-2 Installing the Thermocouple

2. Press the Menu/Status key to display the Status screen.

3. Select the Sample Set field, then enter any value from 4 to 40 °C that is at least 5 °C above or below
R

ambient temperature. Record this set point value in Form 1-8.

4. Allow sufficient time for the chamber temperature to reach and stabilize at the set temperature. In
Form 1-8, record the temperature you observe from the thermocouple.
FO

Note: The time required to reach the set temperature depends upon the difference between the
set and ambient temperatures. For example, the chamber may require up to 90 minutes to reach
4 °C starting from room temperature.

22 of 34
 Part IV: Waters 2690/2695 Separations Module Operational Qualification

1.4.7 Testing the First Generation Column Heater Temperature Accuracy

LY
Note: The first generation column heater has two independent doors. See Figure 1-3.

ON
CE
EN Two
Independent
Doors
ER

TP01632
F

Figure 1-3 First Generation Column Heater (with an Optional Column Selection Valve)
RE

If your 2690 or 2695 Separations Module includes the first generation column heater option, use the procedure in
this section to verify proper operation.

Note: The temperature accuracy of the column heater is ±0.8 °C. To compensate for typical
measurement inaccuracy, the column heater Acceptable Range field in Form 1-8 is set to ±2 °C. If
your measurement device has an inaccuracy of greater than ±1 °C, you may adjust the Acceptable
Range accordingly. If you do so, record the adjustment in the Comments section.
R

To test the temperature accuracy of the column heater:

1. Place a calibrated K-type thermocouple inside the column heater chamber, near the top of the chamber.
Ensure that the thermocouple does not contact any surfaces. Close the chamber door.
FO

2. Press the Menu/Status key to display the Status screen.

3. Select the Column Set field and enter any value from 5 °C above ambient temperature to 60 °C.
Record this set point value in Form 1-8.

23 of 34
 Waters HPLC Systems Qualification Workbook

4. Allow sufficient time for the chamber temperature to reach and stabilize at the set temperature. In

LY
Form 1-8, record the temperature you observe from the thermocouple.

1 Note: The time required to reach the set temperature depends on the difference between the set
and ambient temperatures.

ON
5. Complete Form 1-8.

1.4.8 Testing the Second Generation Column Heater or Column Heater/Cooler

Temperature Accuracy
Note: The second generation column heater or column heater/cooler has one integrated door. See
Figure 1-4. The second generation column heater or column heater/cooler is only for the 2695
Separations Module and requires firmware version 2.02 or higher.

E
Temperature Port
E NC
One
ER

Integrated
Door
F
RE

Selection Valve
(Optional)
R

Figure 1-4 Second Generation Column Heater or Column Heater/Cooler (with an Optional Column Selection
Valve)
FO

If your 2690 or 2695 Separations Module includes the second generation column heater or column heater/cooler
option, use the procedure in this section to verify proper operation.

24 of 34
 Part IV: Waters 2690/2695 Separations Module Operational Qualification

Note: The temperature accuracy of the column heater or column heater/cooler is ±0.8 °C. To

LY
compensate for typical measurement inaccuracy, the column heater or column heater/cooler
Acceptable Range field in Form 1-8 is set to ±2 °C. If your measurement device has an inaccuracy
of greater than ±1 °C, you may adjust the Acceptable Range accordingly. If you do so, record the
adjustment in the Comments section.

ON
To test the temperature accuracy of the second generation column heater or column heater/cooler:
1. Insert a calibrated K-type thermocouple approximately 1.5 inches through the temperature port in the
column mounting plate inside the chamber of the column heater or column heater/cooler, near the top of
the chamber. (See Figure 1-4.) Close the chamber door.
2. Press the Menu/Status key to display the Status screen.
3. If you are testing the second generation column heater, select the Column Set field and enter any
value from 5 °C above ambient temperature to 65 °C. Record this set point value in Form 1-8.

CE
If you are testing the column heater/cooler, select the Column Set field and enter any value from
15 °C below ambient temperature or 4 °C (whichever temperature is greater) to 65 °C, however do
not use a value that is within ±5 °C of ambient temperature. Record this set point value in Form 1-8.
4. Allow sufficient time for the chamber temperature to reach and stabilize at the set temperature. In
Form 1-8, record the temperature you observe from the thermocouple.
EN
Note: The time required to reach the set temperature depends on the difference between the set
and ambient temperatures.

5. Complete Form 1-8.

1.4.9 Testing the Bar Code Reader

ER

If your 2690 or 2695 Separations Module includes the bar code reader option, use this procedure to verify proper
operation.

To test the bar code reader:

1. Place a bar code label on five 2-mL vials. In the next steps, you place each vial in a separate Carousel
(Carousels A to E).
F

2. Write the 6-digit bar code label number (for the vial to be placed in Carousel A) in the Bar Code
Label Number column in Form 1-8.
RE

3. Place the vial in a vial position in Carousel A, then write the vial position in the Vial Position column
in Form 1-8. Load the carousel into the 2690 or 2695 Separations Module.
4. Repeat step 2 and step 3 for the remaining vials, placing a single vial in Carousels B through E.
5. From the Diagnostics screen, press the Other Tests screen key, then select Carousel Test from the
list.
6. In the New Vial field of the Carousel Test, enter the vial position for the labeled vial in Carousel A,
R

then press the Go to Vial screen key. When the vial is accessed, the bar code label number appears in
the Bar Code field. Record this number in the Bar Code Displayed column in Form 1-8.
7. Initial the appropriate pass/fail result in the Test Results column in Form 1-8.
FO

8. Repeat step 6 and step 7 for the labeled vials in Carousels B through E.

25 of 34
 Waters HPLC Systems Qualification Workbook

Form 1-4 Initial Operational Qualification Procedure

LY
1 Waters Separations Module Serial Number

Procedure Completed
1. Power on the 2690 or 2695 Separations Module. Verify that all items in the Startup

ON
Diagnostics screen are OK and that the Separations Module enters the Idle state after
all diagnostics are complete.
Initials
2. Prime the needle wash pump. Verify that needle wash solvent flows from the waste tube.

3. Prime the plunger seal wash pump. Verify that seal wash solvent flows from the waste
tube.

4. In the Status screen, set the sparge rate to 100% for each reservoir one at a time. Verify
that bubbles emerge from the appropriate sparge line when the line is installed in a
reservoir.

E
Carousel Test Carousel A Carousel B Carousel C Carousel D Carousel E

NC
Location of Vial
Number Number Number Number Number

Vial Punctured
Initials Initials Initials Initials Initials
E
Pass Fail
Initials Initials
ER

Comments
F

Certification

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

Performer Date
Signature

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

Reviewer Date
R

Signature

 2003 Waters Corporation

FO

26 of 34
 Part IV: Waters 2690/2695 Separations Module Operational Qualification

Form 1-5 Flow Rate Accuracy Test

LY
Waters Separations Module Serial Number

Flow Rate Accuracy Results

ON
Set Observed System Observed Calculated Acceptable
Flow Rate Pressure Elapsed Time Flow Rate Flow Rate Test Results

5.000 mL/min psi/bar sec mL/min 4.94 to 5.06 Pass Fail

mL/min Initials Initials

1.000 mL/min psi/bar sec mL/min 0.988 to 1.012 Pass Fail

mL/min

CE
0.500 mL/min psi/bar sec mL/min 0.489 to 0.511 Pass Fail
mL/min

0.250 mL/min psi/bar sec mL/min 0.239 to 0.261 Pass Fail

mL/min

Comments
EN
Certification

The undersigned performer attests that the above test was performed according to the indicated procedure, and the results were
ER

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.
F

Reviewer Date
Signature
RE

 2003 Waters Corporation

R
FO

27 of 34
 Waters HPLC Systems Qualification Workbook

Form 1-6 GPV Test

LY
1 Waters Separations Module Serial Number

Complete the form for the GPV test method used, then write the method used and the test results.

ON
Waters GPV Test Solution
Lot Number Expiration Date

A. Absorbance Detector and Millennium³² or Empower Software Method

Observed GPV Percent
When using the absorbance detector and Millennium32 or
Valves A, B, & C Valves A, B, & D Empower method, the printed values on the report must be
from 9.5% to 10.5%.

E
B. Absorbance Detector and Strip-Chart Recorder Method

NC
Observed Chart Recorder Percent

Valves A/B/C When using the absorbance detector and strip-chart

recorder method, the charted peak height values must be
from 57.5% to 62.5% (including the positive 10% offset).
Valves A/B/D
E
C. Graduated Cylinders Method
ER
To pass, Solvent B must equal the A cylinder volume ±2 mL
Solvent A Solvent B
mL mL and Solvent D must equal the C cylinder volume ±2 mL =
±4.5% compositional accuracy.
Solvent C Solvent D
mL mL

Method Used Test Results

F

Pass Fail
A, B, or C Initials Initials
RE

Comments

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

Performer Date
Signature
FO

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

Reviewer Date
Signature
 2003 Waters Corporation

28 of 34
 Part IV: Waters 2690/2695 Separations Module Operational Qualification

Form 1-7 Injection Accuracy Test

LY
Waters Separations Module Serial Number

Injection Accuracy Test Results

ON
Vial Weight Before Vial Weight After
Injection (W1) = Six Injections (W2) =
(16 injections when using
a 25-µL syringe)

Programmed Calculated Average Acceptable Injection Test Results

Injection Volume Volume Volume Range

CE
50 µL µL 50 µL ±1.0 µL Pass Fail
(12 µL when using (12 µL ±1.0 µL when Initials Initials
a 25-µL syringe) using a 25-µL syringe)

Comments EN
Certification
ER

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
F

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

Reviewer Date
Signature

 2003 Waters Corporation

R
FO

29 of 34
 Waters HPLC Systems Qualification Workbook

Form 1-8 Sample Heater/Cooler, Column Heater, Column Heater/Cooler, and Bar

LY
Code Accuracy Tests
1 Waters Separations Module Serial Number

Sample Heater/Cooler Sample Heater/Cooler

ON
Temperature Accuracy Test Not Installed
Initials
Temperature Values Acceptable Range Test Results

Set Point Observed ±4.0 °C of

Temperature Temperature set point temperature Pass Fail
Initials Initials

Column Heater or Column Heater/Cooler Column Heater Not Installed

E
Temperature Accuracy Test Initials

Column Heater/Cooler Not Installed

NC
Temperature Values Acceptable Range Test Results

Set Point Observed ±2.0 °C of

Temperature Temperature set point temperature Pass Fail
Initials Initials
E
Bar Code Reader Test Bar Code Reader
Not Installed
Initials
Bar Code Label Number Vial Position Bar Code Displayed Test Results
ER

Carousel A ______________________ _______________ ______________________ Pass _________ Fail _________

Initials Initials
Carousel B ______________________ _______________ ______________________ Pass _________ Fail _________

Carousel C ______________________ _______________ ______________________ Pass _________ Fail _________

F

Carousel D ______________________ _______________ ______________________ Pass _________ Fail _________

Carousel E ______________________ _______________ ______________________ Pass _________ Fail _________

RE

Comments

Certification
The undersigned performer attests that the above tests were performed according to the indicated procedures, and the
R

results were accurately recorded above.

Performer Date
Signature
FO

The undersigned reviewer accepts that the above tests were performed according to the indicated procedures, and the
results were accurately recorded above.

Reviewer Date
Signature
 2003 Waters Corporation

30 of 34
 Part IV: Waters 2690/2695 Separations Module Operational Qualification

1.5 Operational Qualification Log

LY
Use Form 1-9 to compile a record of operational qualification procedures performed on the Waters 2690 or 2695
Separations Module, including those performed after scheduled maintenance procedures and corrective
servicing.

ON
Note: Before you enter information on the last page of Form 1-9, make additional copies of the form.
Insert the copies behind the original.

Form 1-9 Operational Qualification Procedures Log

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

CE
Waters 2690 or 2695 Separations Module Serial Number

Service Report
Number
Procedure

EN
Performer Date
Signature

Reviewer Date
Signature
ER

Service Report
Number
Procedure
F

Performer Date
Signature
RE

Reviewer Date
Signature

Service Report
Number
Procedure
R
FO

Performer Date
Signature

Reviewer Date
Signature
 2003 Waters Corporation

31 of 34
 Waters HPLC Systems Qualification Workbook

Form 1-9 Operational Qualification Procedures Log (Continued)

LY
1 The undersigned attest and accept that the operational qualification procedures recorded below were performed on the
Waters 2690 or 2695 Separations Module, and all approval signatures were obtained where necessary.

Waters 2690 or 2695 Separations Module Serial Number

ON
Service Report
Number
Procedure

Performer Date
Signature

E
Reviewer Date
Signature

NC
Service Report
Number
Procedure
E
Performer Date
Signature

Reviewer Date
ER

Signature

Service Report
Number
Procedure
F
RE

Performer Date
Signature

Reviewer Date
Signature

Service Report
Number
Procedure
R
FO

Performer Date
Signature

Reviewer Date
Signature
 2003 Waters Corporation

32 of 34
 Part IV: Waters 2690/2695 Separations Module Operational Qualification

Form 1-9 Operational Qualification Procedures Log (Continued)

LY
The undersigned attest and accept that the operational qualification procedures recorded below were performed on the
Waters 2690 or 2695 Separations Module, and all approval signatures were obtained where necessary.

Waters 2690 or 2695 Separations Module Serial Number

ON
Service Report
Number
Procedure

Performer Date
Signature

CE
Reviewer Date
Signature

Service Report
Number
Procedure
EN
Performer Date
Signature
ER
Reviewer Date
Signature

Service Report
Number
Procedure
F
RE

Performer Date
Signature

Reviewer Date
Signature

Service Report
Number
R

Procedure
FO

Performer Date
Signature

Reviewer Date
Signature
 2003 Waters Corporation

33 of 34
 Waters HPLC Systems Qualification Workbook

Form 1-9 Operational Qualification Procedures Log (Continued)

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

1 Waters 2690 or 2695 Separations Module, and all approval signatures were obtained where necessary.

Waters 2690 or 2695 Separations Module Serial Number

Service Report

ON
Number
Procedure

Performer Date
Signature

E
Reviewer Date
Signature

Service Report

NC
Number
Procedure

Performer Date
E
Signature

Reviewer Date
Signature
ER

Service Report
Number
Procedure
F

Performer Date
RE

Signature

Reviewer Date
Signature

Service Report
Number
Procedure
R

Performer Date
FO

Signature

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

34 of 34