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Manual Operational Qualification

Procedure for the ACQUITY UPLC


Column Manager-A,
Column Manager-Aux,
Column Manager,
Column Heater-A,
Column Heater,
HT Column Heater,
Column Heater/Cooler,
30-cm Column Heater-A, or
30-cm Column Heater/Cooler
 2009 - 2011 Waters Corporation

Complete Form 7 to verify the operational qualification for the ACQUITY UPLC:
• Column manager-A
• Column manager-Aux
• Column manager
• Column heater-A
• Column heater
• HT column heater
• Column heater/cooler
• 30-cm column heater-A
• 30-cm column heater
For information about any steps in this form, see page 4.

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Form 7 ACQUITY UPLC Column Heating/Cooling Device
Temperature Accuracy Test

Owner’s System ID

Complete the applicable sections of this form for the column heating/cooling device(s) in your system.
For column device(s) not in your system, enter N/A on each serial number line.

Temperature Accuracy Test for Column Manager-A

Column Manager-A Serial Number:

Temperature Values Acceptable Range Test Results


(Pass or Fail)

Set-point Observed ±2.0 °C of set-point


temperature temperature temperature

Set-point Observed ±2.0 °C of set-point


temperature temperature temperature

Temperature Accuracy Test for Column Manager-Aux

Column Manager-Aux Serial Number:

Temperature Values Acceptable Range Test Results


(Pass or Fail)

Set-point Observed ±2.0 °C of set-point


temperature temperature temperature

Set-point Observed ±2.0 °C of set-point


temperature temperature temperature

Column Manager-Aux Serial Number:

Temperature Values Acceptable Range Test Results


(Pass or Fail)

Set-point Observed ±2.0 °C of set-point


temperature temperature temperature

Set-point Observed ±2.0 °C of set-point


temperature temperature temperature

 2011 Waters Corporation

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Form 7 ACQUITY UPLC Column Heating/Cooling Device
Temperature Accuracy Test (Continued)

Owner’s System ID

Complete the applicable sections of this form for the column heating/cooling device(s) in your system.
For column device(s) not in your system, enter N/A on each serial number line.

Temperature Accuracy Test for Column Manager, Column Heater-A, Column Heater, HT Column Heater,
Column Heater/Cooler, 30-cm Column Heater-A, or 30-cm Column Heater/Cooler

Serial Number of:


Column Manager,
Column Heater-A,
Column Heater*,
HT Column Heater,
Column Heater/Cooler,
30-cm Column Heater-A, or
30-cm Column Heater/Cooler
(*For the Column Heater use the serial number of the ACQUITY UPLC Sample Manager)

Temperature Values Acceptable Range Test Results


(Pass or Fail)
±2.0 °C of set-point
temperature
Set-point Observed
temperature temperature For the HT Column
Heater only: ±2.0 °C of
set-point temperature
up to 65 °C, or
±3.0 °C of set-point
temperature above
65 °C up to 90 °C.

Comments

Certification
The undersigned performer attests that the test results recorded above are accurate and complete.

Performer Date
Signature

The undersigned reviewer accepts that the test results recorded above are accurate and complete.

Reviewer Date
Signature
 2011 Waters Corporation

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Testing the ACQUITY UPLC Column Manager-A or Column
Manager-Aux Temperature Accuracy

Recommended materials
• Calibrated thermometer probe, with readout device
• Tape, to hold the thermometer probe in place, such as Kapton tape (part number
410001630)

Requirement: Temperature accuracy of the column manager-A or column manager-Aux at the


temperature sensor is ±1.0 °C. To compensate for typical measurement inaccuracy, the
Acceptable Range line in Form 7 specifies a variation tolerance of ±2 °C. When your
measurement device has an inaccuracy greater than ±1 °C, adjust the acceptable range
accordingly. If you do so, record the adjustment in the form’s Comments section.

To test the temperature accuracy of the column manager-A or column manager-Aux:


1. Swing open the front panel of the column manager-A or column manager-Aux.
2. Remove the columns, if installed.
3. Place a calibrated thermometer probe in the upper trough of the column compartment,
positioning it so that it is approximately 1 to 1.5 inches (2.5 to 3.8 cm) to the right of the silver
dot in the column tray.

Column tray (showing silver dot):

4. Ensure that the thermometer probe tip touches the inside of the column compartment.
Requirement: Use tape to hold the tip against the compartment.
5. Close the front panel of the column manager-A or column manager-Aux.
6. In the ACQUITY Console window, specify one set-point value between 4 °C and 90 °C
(inclusive), and record this value in Form 7.
Restriction: Use no value that is within ±5 °C of ambient temperature. Most users choose a
temperature that corresponds to the setting they most frequently set or a temperature at the
extreme end of the range: for example, 4 °C or 90 °C.
7. Allow the column manager-A or column manager-Aux temperature to reach and stabilize at
the set temperature.
8. In Form 7, record the temperature you observe from the thermometer probe.
Tip: The time required to reach the set temperature varies depending on the difference
between the set and ambient temperatures.
9. Repeat step 3 through step 7 for the lower trough in the column manager-A or column
manager-Aux.
10. Return the column manager-A or column manager-Aux temperature to 40 °C.
11. Complete Form 7.

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Testing the ACQUITY UPLC Column Manager or Column
Heater/Cooler Temperature Accuracy

Recommended Materials
• Calibrated thermometer probe, with readout device
• Kapton® tape, (part number 410001630) to hold the thermometer probe in place

Note:

• This procedure is not for the ACQUITY UPLC Column Heater module, which holds only
one column. See “Testing the ACQUITY UPLC Column Heater Temperature Accuracy”
on page 7 if you have the ACQUITY UPLC Column Heater module.
• This procedure is not for the ACQUITY UPLC High Temperature Column Heater
module, which holds only one column. See “Testing the ACQUITY UPLC High
Temperature (HT) Column Heater Temperature Accuracy” on page 8 if you have the
ACQUITY UPLC Column Heater module.

Requirement: The temperature accuracy of the column manager or column heater/cooler at


the temperature sensor is ±1.0 °C. To compensate for typical measurement inaccuracy, the
column manager or column heater/cooler Acceptable Range field in Form 7 specifies a
variation tolerance of ±2 °C. If your measurement device has an inaccuracy of greater than
±1 °C, you can adjust the acceptable range accordingly. If you do so, record the
adjustment in the Comments section.

To test the temperature accuracy of the column manager or column heater/cooler:


1. Swing open the column manager or column heater/cooler’s front panel.
2. Remove the columns, if installed.
3. Place a calibrated thermometer probe in column position 3 of the column compartment.
(Column position 3 is the third column position from the top of the column manager or
column heater/cooler.) Position the thermometer probe so that it is directly over the three
sensor screws.

Column position 3 (showing three sensor screws):

Three sensor screws

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4. Ensure that the thermometer probe tip touches the inside of the column compartment by
using Kapton tape to hold it against the compartment.

Installing the thermometer probe in the column manager or


column heater/cooler:

5. Close the front panel of the column manager or column heater/cooler.


6. Use the ACQUITY Console screen for the column manager or column heater/cooler to
specify a single value between 10 °C and 90 °C (inclusive).
Requirement: Do not use a value that is within ±5 °C of ambient temperature. Most users
choose a temperature that corresponds to the setting that they most frequently set or a
temperature at the extreme end of the range (for example, 10 °C or 90 °C). Record this
set-point value in Form 7.
7. Allow sufficient time for the column manager or column heater/cooler’s temperature to reach
and stabilize at the set temperature. In Form 7, record the temperature you observe from the
thermometer probe.
Tip: The time required to reach the set temperature varies depending on the difference
between the set and ambient temperatures.
8. After completing the column manager or column heater/cooler temperature accuracy test,
return the column manager or column heater/cooler temperature to 40 °C.
9. Complete Form 7.

Testing the ACQUITY UPLC Column Heater-A


Temperature Accuracy

Recommended materials
• Calibrated thermometer probe, with readout device
• Tape to hold the thermometer probe in place, such as Kapton tape (part number
410001630)

Requirement: Temperature accuracy of the column heater-A at the temperature sensor is


±1.0 °C. To compensate for typical measurement inaccuracy, the Acceptable Range line in
Form 7 specifies a variation tolerance of ±2 °C. When your measurement device has an
inaccuracy greater than ±1 °C, adjust the acceptable range accordingly. If you do so, record
the adjustment in the form’s Comments section.

To test the temperature accuracy of the column heater-A:


1. Swing open the front panel of the column heater-A.
2. Remove the column and stabilizer, if installed.

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3. Place a calibrated thermometer probe in the middle of the column tray, positioning it so
that it is approximately 1 to 1.5 inches (2.5 to 3.8 cm) to the right of the silver dot in the
column tray.

Column tray (showing silver dot)

4. Ensure that the thermometer probe tip touches the inside of the column tray.
Requirement: Use tape to hold the tip against the tray.
5. Close the front panel of the column heater-A.
6. In the ACQUITY Console window, specify a set-point value from 5 °C above ambient
temperature to 90 °C, and record this value in Form 7.
7. Allow the column heater-A temperature to reach and stabilize at the set temperature. In
Form 7, record the temperature you observe from the thermometer probe.

Tip: The time required to reach the set temperature varies depending on the difference
between the set and ambient temperatures.

8. Return the column heater-A temperature to 40 °C.


9. Complete Form 7.

Testing the ACQUITY UPLC Column Heater


Temperature Accuracy

Recommended Materials
• Calibrated thermometer probe with readout device
• Kapton tape, (part number 410001630) to hold the thermometer probe in place

Note:

• This procedure is not for the ACQUITY UPLC Column Manager or ACQUITY UPLC
Column Heater/Cooler that holds four columns. See “Testing the ACQUITY UPLC
Column Manager or Column Heater/Cooler Temperature Accuracy” on page 5 if you
have that module.
• This procedure is not for the ACQUITY UPLC High Temperature Column Heater
module, which holds only one column. See “Testing the ACQUITY UPLC High
Temperature (HT) Column Heater Temperature Accuracy” on page 8 if you have the
ACQUITY UPLC Column Heater module.

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Requirement: The temperature accuracy of the column heater at the temperature sensor is
±1.0 °C. To compensate for typical measurement inaccuracy, the column heater Acceptable
Range line in Form 7 specifies a variation tolerance of ±2 °C. If your measurement device has
an inaccuracy of greater than ±1 °C, you can adjust the acceptable range accordingly. If you
do so, record the adjustment in the Comments section.

To test the temperature accuracy of the column heater:


1. Depending on your type of column heater, either remove the column heater’s front panel
(the panel is held by magnets), or swing open the column heater’s front panel.
2. Tilt the column tray downward.
3. Remove the column and stabilizer, if installed.
4. Place a calibrated thermometer probe in the middle of the column tray, positioning the
thermometer probe so that it is approximately 15 cm (6 inches) from the right-hand edge of
the column tray.
Requirement: Ensure that the thermometer probe touches the inside of the column tray by
using Kapton tape to hold it against the tray.

Installing the thermometer probe in the column heater:

5. Tilt the column tray upward to the closed position. Ensure that the wire from the
thermometer probe is routed through the notch on the right-hand side of the column tray.
6. Depending on your type of column heater, refit the front panel or swing it closed.
7. Use the ACQUITY Console screen for the column heater to specify a value from 5 °C above
ambient temperature to 65 °C. Record this set-point value in Form 7.
8. Allow sufficient time for the column heater’s temperature to reach and stabilize at the set
temperature. In Form 7, record the temperature you observe from the thermometer probe.

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

9. After completing the column heater temperature accuracy test, return the column heater
temperature to 40 °C.
10. Complete Form 7.

Testing the ACQUITY UPLC High Temperature (HT)


Column Heater Temperature Accuracy

Recommended Materials
• Calibrated thermometer probe with readout device
• Kapton tape, (part number 410001630) to hold the thermometer probe in place

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Note:

• This procedure is not for the ACQUITY UPLC Column Heater that holds one column and
heats to a maximum of 65 °C. See “Testing the ACQUITY UPLC Column Heater
Temperature Accuracy” on page 7 if you have the ACQUITY UPLC Column Heater
module.
• This procedure is not for the ACQUITY UPLC Column Manager or ACQUITY UPLC
Column Heater/Cooler that holds four columns. See “Testing the ACQUITY UPLC
Column Manager or Column Heater/Cooler Temperature Accuracy” on page 5 if you
have that module.

Requirement: The temperature accuracy of the high temperature (HT) column heater at the
temperature sensor is ±1.0 °C up to 65 °C, and ±2.0 °C above 65 °C up to 90 °C. To
compensate for typical measurement inaccuracy, the HT column heater Acceptable Range
line in Form 7 specifies a variation tolerance of ±2 °C up to 65 °C, and ±3 °C above 65 °C
up to 90 °C. If your measurement device has an inaccuracy of greater than ±1 °C, you can
adjust the acceptable range accordingly. If you do so, record the adjustment in the
Comments section.

To test the temperature accuracy of the HT column heater:


1. Swing open the HT column heater’s front panel.
2. Tilt the column tray downward.
3. Remove the column and stabilizer, if installed.
4. Place a calibrated thermometer probe in the middle of the column tray. Position the
thermometer probe so that it is approximately 15 cm (6 inches) from the right-hand edge
of the column tray.
Requirement: Ensure that the thermometer probe touches the inside of the column tray
by using Kapton tape to hold it against the tray.

Installing the thermometer probe in the HT column heater:

5. Tilt the column tray upward to the closed position.


Requirement: Ensure that the wire from the thermometer probe is routed through the
notch on the right-hand side of the column tray.
6. Close the front panel.
7. In the ACQUITY Console screen for the HT column heater, specify a value from 5 °C
above ambient temperature to 90 °C, and record this set-point value in Form 7.
8. Allow sufficient time for the HT column heater’s temperature to reach and stabilize at the
set temperature.
9. In Form 7, record the temperature you observe from the thermometer probe.

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

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10. After completing the HT column heater temperature accuracy test, return the HT column
heater temperature to 40 °C.
11. Complete Form 7.

Testing the ACQUITY UPLC 30-cm Column Heater-A


Temperature Accuracy

Recommended materials
• Calibrated thermometer probe with readout device
• Tape to hold the thermometer probe in place, such as Kapton tape (part number
410001630)

Requirement: Temperature accuracy of the 30-cm column heater-A at the temperature sensor is
±1.0 °C. To compensate for typical measurement inaccuracy, the Acceptable Range line in
Form 7 specifies a variation tolerance of ±2 °C. When your measurement device has an
inaccuracy greater than ±1 °C, adjust the acceptable range accordingly. If you do so, record
the adjustment in the form’s Comments section.

To test the temperature accuracy of the 30-cm column heater-A:


1. Swing open the door of the 30-cm column heater-A.
2. Place a calibrated thermometer probe in the column tray so that it is approximately 1.5
inches (3.8 cm) above the silver dot in the tray.

Column tray (showing silver dot)

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3. Ensure that the thermometer probe tip touches the inside of the column compartment.
Requirement: Use the tape to hold the tip against the column compartment.

Caution: To prevent damaging the probe wire, ensure it does not catch in the
closing door.

4. Close the column-heater door, being careful to avoid damaging the probe wire.
5. In the ACQUITY Console window, specify one set-point value between 20 °C and 90 °C
(inclusive), and record this set-point value in Form 7.
Restriction: Use no value that is within ±5 °C of the ambient temperature. Most users
choose a temperature that corresponds to the setting they most frequently set or a
temperature at the extreme end of the range: for example, 20 °C or 90 °C.
6. Allow the 30-cm column heater-A temperature to reach and stabilize at the set
temperature. In Form 7, record the temperature you observe from the thermometer
probe.
Tip: The time required to reach the set temperature varies depending on the difference
between the set and ambient temperatures.
7. After completing the temperature accuracy test, return the 30-cm column heater-A
temperature to 40 °C.
8. Complete Form 7.

Testing the ACQUITY UPLC 30-cm Column


Heater/Cooler Temperature Accuracy

Recommended Materials
• Calibrated thermometer probe, with readout device
• Kapton tape, (part number 410001630) to hold the thermometer probe in place

Requirement: For Empower 2 (build 2154) you must have installed feature release 3,
minimum.

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ACQUITY UPLC 30-cm column heater/cooler:

Exposed
Thermocouple
Covered by a
Shroud

If your ACQUITY UPLC System includes the 30-cm column heater/cooler option, use the following
procedure to verify its proper operation.

Requirement: The temperature accuracy of the 30-cm column heater/cooler at the temperature
sensor is ±0.8 °C. To compensate for typical measurement inaccuracy, the device’s
Acceptable Range line in Form 7 specifies a variation tolerance of ±2 °C. If your measurement
device has an inaccuracy of greater than ±1 °C, you can adjust the Acceptable Range
accordingly. If you do so, record the adjustment in the Comments section.

To test the temperature accuracy of the 30-cm column heater/cooler:


1. Place a calibrated thermometer probe as closely as possible to the lower end of the shroud
(see the figure, above), and close the chamber door.
2. In the ACQUITY Console screen for the 30-cm column heater/cooler, specify a single value
between 4 °C and 65 °C (inclusive), and record this set-point value in Form 7.
Requirement: Do not use a value that is within ±5 °C of ambient temperature. Most users
choose a temperature that corresponds to the setting that they most frequently set or a
temperature at the extreme end of the range (for example, 4 °C or 65 °C).
3. Allow sufficient time for the 30-cm column heater/cooler’s temperature to reach and stabilize
at the set temperature.
4. In Form 7, record the temperature you observe from the thermometer probe.
Tip: The time required to reach the set temperature depends on the difference between the
set and ambient temperatures.

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5. After completing the 30-cm column heater/cooler temperature accuracy test, return the
HT column heater/cooler temperature to 40 °C.
6. Complete Form 7.

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