Operational Qualification /

Performance Qualification
for
UltiMate 3000 RSLCnano
Nano, Cap and MIC Systems

Operating Instructions

Version: 1.0
Date: July 2011

P/N 164688

© 2011 DIONEX
OQ and PQ Operating Instructions

All information in this manual is subject to change without notice and does not represent a
commitment on the part of Dionex Corp.
®
CHROMELEON and Ultimate are (registered) trademarks of Dionex Corp. Any other mentioned
trade or company names are subject to the copyright and the property and trademark rights of the
respective companies.
All rights reserved including those for photomechanical reproduction and storage on electronic media.
Without the written permission of Dionex, no part of this publication may be reproduced in any form
(by means of photocopy, microfilm, or any other process) for any purpose or processed, copied,
transmitted, or distributed in any other form, independent from the means, electronic or mechanical,
that is used.

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 OQ and PQ Operating Instructions

Warnings

The Warning sign and the Important sign shown below are included in various locations in this manual
or in the manuals provided with the instruments which are to be tested. These signs provide the
following information:

Warning: Indicates that failure to take note of the accompanying information may
result in personal injury.

Important: Indicates that failure to take note of the accompanying information may
result in damage to the instrument.

Tip: Indicates general information intended to optimize the performance of the

instrument.

Safety Precautions

Warning: The following precautions should be followed to minimize the possibility of

personal injury and/or damage to property.

Tip: Make certain that you are familiar with the contents of this manual and the
operating instructions before working on the system.

The operator should follow all safety precautions, warnings, etc. provided with the instruments, in
addition, please note the items presented below:
All components of the system should be plugged into a common power line that is directly connected
to a true ground.
Repair or replace faulty power cords and all communication cables.
If a leak occurs, turn off power to the instrument and remedy the situation immediately.
If the mobile phase includes volatile or flammable solvents, avoid open flames and sparks.
Many organic solvents and buffers are toxic. Make certain that you know the toxicological properties of
all mobile phases that you are using.
The toxicological properties of many samples may not be well known. If you have any doubt about a
sample, treat it as if it contained a potentially harmful substance.
Wear protective eye goggles when handling mobile phases or operating the instrument. An eye wash
facility and a sink should be close to the unit. If any mobile phase splashes on the eyes or skin, wash
the affected area and seek medical attention.
Dispose of all waste mobile phase in an environmentally safe manner that is consistent with all local
regulations. Do not allow flammable and/or toxic solvents to accumulate. Follow a regulated, approved
waste disposal program. Never dispose flammable and/or toxic solvents through the municipal
sewage system
Wear protective eye goggles when handling fused silica tubing (i.e. installation, cutting etc.)
If a buffer is used as a part of the mobile phase, flush the system with several volumes of a
methanol/water (50/50) solution before it is shut down. This will prevent salt buildup inside the unit.
Do not use the instrument in ways other than those indicated in the instructions given in this manual.

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OQ and PQ Operating Instructions

Warning: The OQ/PQ kit P/N 6720.0098 contains a chemical or chemicals known to the
State of California to cause cancer and/or birth defects or other reproductive
harm. For additional information, consult the product Material Safety Data
Sheet (MSDS).

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 OQ and PQ Operating Instructions

Table of Contents
Warnings ……………………………………………………………………….……….. III

Safety Precautions ………………………………………………………………………. III

1 How to use this Manual ...................................................................................... 3

2 Introduction ......................................................................................................... 4
2.1 Defining the Limits..........................................................................................................................4
2.1.1 Operational Qualification (OQ) ...............................................................................................4
2.1.2 Performance Qualification (PQ) .............................................................................................4
2.1.3 System Suitability Check (SSC; also: System Suitability Test, SST) .....................................4
2.2 Basic Requirements for Successful OQ and PQ .........................................................................5
2.3 Overview of the Checks .................................................................................................................6
2.4 General Notes and Recommendations .........................................................................................7
2.5 For Additional Information .............................................................................................................7

3 Process ................................................................................................................ 8
3.1 Required Materials ..........................................................................................................................8
3.2 Preparations ..................................................................................................................................10
3.2.1 Preparing the UltiMate 3000 System....................................................................................10
3.2.2 Testing Advanced Configurations ........................................................................................12
3.2.3 Preparing Chromeleon .........................................................................................................12
3.3 Performing the Checks ................................................................................................................13
3.4 Repeating Checks .........................................................................................................................13

4 Procedures ........................................................................................................ 14
4.1 Temperature Accuracy of the Column Oven .............................................................................14
4.1.1 Theory ..................................................................................................................................14
4.1.2 Performing the Check ...........................................................................................................14
4.2 Flow Cell Check ............................................................................................................................15
4.3 Wavelength Check ........................................................................................................................16
4.4 Baseline Noise and Drift of the UV Detector ..............................................................................16
4.4.1 Theory ..................................................................................................................................17
4.4.2 Performing and Evaluating the Checks ................................................................................17
4.5 Gradient Composition for the NC and loading pumps: Accuracy, Reproducibility and
Ripple .............................................................................................................................................18
4.5.1 Theory ..................................................................................................................................18
4.5.2 Performing the NC pump Check ..........................................................................................18
4.5.3 Performing the loading pump Check ....................................................................................18
4.5.4 Evaluating the Checks ..........................................................................................................19
4.6 Reproducibility of the Injection Volume .....................................................................................20
4.6.1 Theory ..................................................................................................................................20
4.6.2 Performing the Check ...........................................................................................................20
4.7 Linearity of the UV Detector ........................................................................................................21
4.7.1 Theory ..................................................................................................................................21

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OQ and PQ Operating Instructions

4.7.2 Performing and Evaluating the Check ..................................................................................21

4.8 Linearity of the Injection Volume ................................................................................................22
4.8.1 Theory ..................................................................................................................................22
4.8.2 Performing the Check ...........................................................................................................22
4.9 Carry-over ......................................................................................................................................23
4.9.1 Theory ..................................................................................................................................23
4.9.2 Performing the Check ...........................................................................................................23
4.9.3 Evaluating the Check ...........................................................................................................23

5 Completing and Printing the IQ Report ........................................................... 24

6 Troubleshooting ................................................................................................ 25
6.1 Symptoms and possible causes .................................................................................................25
6.1.1 OQ/PQ failed during the oven test .......................................................................................25
6.1.2 OQ/PQ failed on flow cell check ...........................................................................................25
6.1.3 OQ/PQ failed on noise and drift ...........................................................................................25
6.1.4 OQ/PQ failed on wavelength accuracy ................................................................................25
6.1.5 OQ/PQ failed on reproducibility ............................................................................................25
6.1.6 OQ/PQ failed on linearity......................................................................................................26
6.1.7 OQ/PQ failed on carry-over ..................................................................................................26

7 Example Report ................................................................................................. 27

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1 How to use this Manual

The material included in this manual is provided to assist authorized personnel in performing operation
qualification (OQ) and performance qualification (PQ) on the Dionex UltiMate 3000 Micro (MIC),
Capillary (CAP) and Nano (NAN) HPLC systems. It is assumed that the individual using this manual
has sufficient training in the use of analytical instrumentation and is aware of the potential hazards
including (but not limited to) electrical hazards, chemical solvent hazards, exposure to UV radiation
and the exposure to pressurized solvents.
The layout of this manual is designed to provide quick reference to the sections of interest to the user.
However, we recommend that you review the manual thoroughly before starting Operational or
Performance Qualification in order to obtain full understanding of the procedure.
This manual is provided 'as is'. Every effort has been made to supply complete and accurate
information and all technical specifications and programs have been developed with the utmost care.
However, Dionex assumes no responsibility and cannot be held liable for any errors, omissions,
damage or loss that might result from any use of this manual or the information contained therein. We
appreciate your help in eliminating any errors that may appear in this document.

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OQ and PQ Operating Instructions

2 Introduction
The increasing number of standards and official regulations provide evidence that it is extremely
important to monitor the instruments that are employed for an assay and to make sure that they work
as intended if you want to achieve reliable analytical results. To ensure that the results are valid,
quality management protocols according to ISO 9000 and following are used to monitor and document
the performance of the equipment at different times.

2.1 Defining the Limits

The article “The development and application of guidance on equipment qualification of analytical
instruments” [P. Bedson and M. Sargent, Accred. Qual. Assur. (1996) 1: 265 - 274] presents the basic
definitions of instrument qualification, as described below.

2.1.1 Operational Qualification (OQ)

The purpose of Operational Qualification is to prove and document that an analytical system functions
according to its operating specification when the specific environmental conditions are taken into
account. In this specification, the supplier must therefore define exactly the conditions that must be
observed. With varying conditions, e.g. different ambient temperatures, higher limits must be used.
In most cases, Operational Qualification is performed only when a new device has been installed.

2.1.2 Performance Qualification (PQ)

The purpose of Performance Qualification is to prove and document that an analytical system
functions according to a specification that is suitable for the system's routine operation. As a system is
subject to wear when being operated, it may happen that the supplier's specification is no longer met.
The same procedures are used as in the Operational Qualification but the tolerances used for
Performance Qualification are less restrictive than those used for the Operational Qualification.
Performance Qualification is usually performed after repair or regular system service procedures have
been performed.
Using the same procedures for OQ and PQ simplifies the qualification protocol.

2.1.3 System Suitability Check (SSC; also: System Suitability Test, SST)
The purpose of the SSC is to prove and document that the necessary limits are met for a specific
measuring application. The specific conditions required for that application, e.g., solvents, column
material, and temperature, must be taken into account. Although the System Suitability check can be
developed by the supplier on request, it is not part of the test procedures described below.
Do not use limits that are more restrictive than those used for Performance Qualification.

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 OQ and PQ Operating Instructions

2.2 Basic Requirements for Successful OQ and PQ

As described in section 2.1, OQ and PQ are system-specific procedures. The procedures described
below apply to the following instruments:

TABLE 2-1 List of supported UltiMate 3000 RSLCnano System Components

Instrument Supported Model
UltiMate 3000 Series NCS-3500RS (also contains a loading pump and a thermostated
RSLCnano Pump Modules column oven)
NCP-3200RS
UltiMate 3000 Series VWD-3100RS (one channel)
(a)
UV Detector VWD-3400RS (four channels)
UltiMate 3000 Series Micro WPS-3000PL(RS)
autosampler WPS-3000BPL(RS) (biocompatible version)
WPS-3000TPL(RS) (thermostated version)
WPS-3000TBPL(RS) (thermostated, biocompatible version)
Note: a) If the system does not include a VWD Detector, a standalone VWD detector is required to perform
the OQ/PQ procedures.

Instrument configurations including an UltiMate VWD-3100 or VWD-3400 Variable Wavelength

Detector should be controlled by CHROMELEON 6.8 SR10 or higher.
If a different software package is used to control the instruments (e.g. the Dionex DCMSlink for.
Analyst, HyStar or Xcalibur), programs may need to be prepared manually. Some limitations may
apply due to different or limited control capabilities of these software packages.

Tip: The Dionex DCMSlink can be configured to delete data automatically after
one day. To avoid data loss, make sure to either back-up data or to change
the settings.

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2.3 Overview of the Checks

TABLE 2-2 presents an overview of the parameters to be tested and a short description of the tests. In
addition, it presents the required acceptance limits for OQ and the recommended limits for PQ.

TABLE 2-2 Overview of the OQ and PQ Test Procedures and Limits

Instrument Parameter Comments Limits (a)
OQ PQ
Flow cell The flow cell is installed and filled with
transmittance mobile phase A and B (99:1). The > 15 % of > 15 % of
VWD-3100 transmittance of this flow cell is reference reference
VWD-3400 indicated by the ‘SIG’ value and is intensity intensity
read from the report.
(Note: If the Wavelength
system does not accuracy Is determined by caffeine injections ± 2 nm ± 2 nm
include a VWD
Baseline noise The drift and noise are recorded for < 0.050 mAU < 0.050 mAU
Detector, a
standalone VWD 30 minutes at 254 nm with a flow cell
detector is Baseline Drift filled with mobile phase A and B < 4 mAU/hr < 4 mAU/hr
required to (99:1).
perform the Injections of caffeine standards
OQ/PQ covering the linear range of the UV
procedures) Linearity detector are injected and the peak R ≥ 99.90 % R ≥ 99. 50 %
(b) height is measured. The regression peak height peak height
coefficient of the resulting calibration
curve indicates the linearity.
A step gradient is performed and the
UV trace recorded. The step intensity
indicates the gradient accuracy.
Gradient accuracy, Channel A: water
step gradient ≤3% ≤3%
(b) Channel B: water with 0.5 % acetone
(NAN configuration),
NC_Pump in 0.1 % acetone (CAP/MIC
NCS-3500RS or configuration and for loading pump).
NCP-3200RS
A step gradient is programmed and
Gradient
measured 3 times. ≤1% ≤1%
reproducibility
The reproducibility of the
proportioning is evaluated.

The stability of the UV signal is used

Ripple ≤ 0.500 % ≤ 0.500 %
to estimate the stability of the gradient

An external thermometer is used to

measure the oven temperature. The
Column Oven in Temperature Accuracy Accuracy
oven is tested at 5 different
NCS-3500RS accuracy +/- 1 °C +/- 2 °C
temperatures, 35, 45, 55, 65 and
75 °C respectively

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 OQ and PQ Operating Instructions

Instrument Parameter Description Limits (a)

OQ PQ
Reproducibility of Ten injections of a caffeine standard
injection volume are analyzed. The relative standard Peak Area Peak Area
deviation of the peak areas indicates RSD ≤ 1.5 % RSD ≤ 2.0 %
(b)
the reproducibility of the injection
volume.
Reproducibility of Ten injections of a caffeine standard
retention time Retention time Retention time
WPS-3000(B) are analyzed. The relative standard RSD ≤ 1.0 % RSD ≤ 1.0 %
deviation of the retention time is
WPS-3000T(B) calculated.
Partial Loop injections of a caffeine
Linearity of the standard are performed (from 0.1µL R ≥ 99.90 % R ≥ 99.50 %
injection volume to 0.5µL). The regression coefficient (calculated via (calculated via
of the resulting calibration curve peak area) peak area)
indicates the linearity.
Full Loop injections of caffeine R ≤ 0.05 % R ≤ 0.05 %
standards are performed (10 µg/mL
Carry Over (calculated via (calculated via
and 1 mg/mL followed by 3 injections
of mobile phase A and B (99:1). peak area) peak area)
A step gradient is performed and the
UV trace recorded. The step intensity
indicates the gradient accuracy.
Gradient accuracy, Channel A: water
step gradient ≤3% ≤ 3 %*
(b) Channel B: water with 0.5 % acetone
(NAN configuration),
Loading_Pump 0.1 % acetone (CAP/MIC
NCS-3500RS configuration and for loading pump).
A step gradient is programmed and
Gradient
measured 3 times. ≤1% ≤1%
reproducibility
The reproducibility of the
proportioning is evaluated.
The stability of the UV signal is used
Ripple ≤ 0.500 % ≤ 0.500 %
to estimate the stability of the gradient
Notes: a) OQ limits with optimum measuring conditions, recommended PQ limits.
b) The maximum signal height should not exceed the following limits:
MIC flow cell = 350 mAU, CAP flow cell = 280 mAU and NAN flow cell = 30 mAU.

2.4 General Notes and Recommendations

If the customer ordered a system with two configurations (e.g. a NAN configuration and a CAP
upgrade kit), the OQ/PQ should be performed for the system configuration that the customer will be
using on a routine basis.
After the validation of the different modules, a cytochrome C separation should be performed
according to the Dionex IQ protocol but it is the responsibility of the analyst to perform a validation of
the assay with standards of the compounds of interest.

2.5 For Additional Information

For more detailed information about the operation, maintenance or troubleshooting of the instruments
of the UltiMate 3000 system or how to use the CHROMELEON software package, please refer to the
documentation provided with these products and to the online help of CHROMELEON (F1 key).

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OQ and PQ Operating Instructions

3 Process
3.1 Required Materials
An OQ/PQ kit is available for the UltiMate 3000 RSLCnano system. In addition, parts from the
standard instruments accessory kits and special tools are required. TABLE 3-1 lists all accessories
and standards, which are provided with the OQ/PQ kit.

TABLE 3-1 OQ/PQ Kit for the UltiMate 3000 RSLCnano System (part no. 6720.0098)
Part Description Qty Note
Number
Ultimate 3000 RSLCnano – OQ/PQ Operating
164688 1 Version 1.0
Instructions Manual
Set of 8 caffeine samples (flame sealed amber
6000.0068 1
ampoule)
164697 Brown glas sample vials 1.8 mL, set of 12 1
6826.2401 1 µL sample loop with Viper connections 1
Fused silica tubing I.D. 15 µm ± 3 µm/O.D. 360 µm
164689 1 NAN configuration only
± 10 µm, 3,2 m long with nanoViper on one side
Fused silica tubing I.D. 30 µm ± 3 µm/O.D. 360 µm
164690 1 CAP configuration only
± 10 µm, 2,5 m long with nanoViper on one side
Fused silica tubing I.D. 75µm ± 3 µm/O.D. 360 µm
164691 1 MIC configuration and loading pump
± 10 µm, 5 m long with nanoViper on both side
6720.0074 Microtight Union including 2 fittings and 1 gauge plug 1
Used to connect the restriction
PEEK sleeves (orange) for 280 µm O.D. Fused
6720.0075 1 capillary to the flow cell in NAN and
Silica, 10 pc.
CAP configurations
6720.0076 Sleeves (green) for 365 µm O.D. Fused Silica, 10 pc. 1

The following parts (depending on the configuration) are necessary to perform the OQ/PQ procedure,
however these parts are not included in the OQ/PQ kits.

TABLE 3-2 Required Materials which are not provided with the OQ/PQ kit
Part Description Qty Note
Number
20 µm I.D. x 550 mm, capillary, PEEKsil WPS-3000 to restriction capillary in
6041.5260 1
with nanoViper column oven, NAN configuration
50 µm I.D. x 550 mm, capillary, PEEKsil WPS-3000 to restriction capillary in
6041.5560 1
with nanoViper column oven, CAP configuration
WPS-3000 to restriction capillary in
75 µm I.D. x 550 mm, capillary, PEEKsil
6041.5760 1 column oven, MIC configuration and
with nanoViper
loading pump
20 µm I.D. x 750 mm, capillary, PEEKsil NC pump to WPS-3000, NAN
6041.5280 1
with nanoViper configuration
50 µm I.D. x 750 mm, capillary, PEEKsil NC pump to WPS-3000, CAP
6041.5580 1
with nanoViper configuration
75 µm I.D. x 750 mm, capillary, PEEKsil NC pump to WPS-3000, MIC
6041.5780 1
with nanoViper configuration and loading pump

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 OQ and PQ Operating Instructions

Part Description Qty Note

Number
VWD-3x00 - Flow Cells

UZ-View™ flow cell for VWD 3000, 10 mm path

6074.0270 1 NAN configuration only
length, volume 3 nL
UZ-View™ flow cell for VWD 3000, 10 mm path
6074.0280 1 CAP configuration only
length, volume 45 nL
UZ-View™ flow cell for VWD 3000, 10 mm path MIC configuration and loading
6074.0290 1
length, volume 180 nL pump

Column Oven (if applicable)

5705.0050A Column Thermostat PQ Kit 1

TABLE 3-3 lists the positions of the different samples in the autosampler tray and TABLE 3-4 shows
the required solvents. Samples should be transferred to 1.5mL vials before being positioned in the
autosampler tray.

TABLE 3-3 Sample Positions in the WPS Autosampler Racks

Position Substance Concentration Check(s)
RA1 Caffeine standard 1.0 µg/mL UV linearity
RA2 Caffeine standard 2.5 µg/mL UV linearity
RA3 Caffeine standard 5.0 µg/mL UV linearity
RA4 Caffeine standard 10 µg/mL UV linearity
RA5 Caffeine standard 20 µg/mL UV linearity,
WPS reproducibility,
WPS linearity
RA6, 7 and 8 and RB1 are empty

RB2 Caffeine standard 10 µg/mL WPS carry over, VWD

wavelength check
RB3 Caffeine standard 1 mg/mL WPS carry over
RB4 Mobile phase A: Mobile phase B 99:1 WPS carry over
RB5 Mobile phase A: Mobile phase B 99:1 WPS carry over
RB6 Mobile phase A: Mobile phase B 99:1 WPS carry over

TABLE 3-4 Solvents for the OQ/PQ tests

Solvent Quantity Check(s)
Mobile phase A = 100 % water Approx. 100 mL All tests
Mobile phase B = 100 % water + 0.5 % Approx. 100 mL Gradient accuracy,
acetone (NAN) / 100 % water + 0.1 % acetone gradient reproducibility for
(MIC/CAP, loading pump) NC and loading pumps
WPS wash solvent 50% water 50% Approx. 50 mL
Isopropanol 0.1% TFA

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3.2 Preparations
3.2.1 Preparing the UltiMate 3000 System
While the OQ/PQ procedure is similar for the different system configurations (e.g. whether using the
NAN, CAP or MIC flow selector), there are small but important differences (e.g. flow selector,
restriction capillary, connecting tubing, UV flow cell, acquisition programs, etc.).
Make sure that the system is configured properly. Please refer to the Operating Instructions manual
for more information. According to the current system configuration, the Chromeleon OQ/PQ wizard
will select the correct test programs automatically.
NAN/CAP/MIC: The flow selector that the customer will be using on a routine basis (or the most
frequently) should be installed and the system accordingly configured before the start of the OQ/PQ
procedure. If the system does not include a VWD Detector, a standalone VWD detector is required.

3.2.1.1 VWD/UVD-3x00 UV Detector

Remove the dummy flow cell and replace it with the UV cell matching the flow selector (cf. Table 3-2).
Turn on the detector lamp. Dionex recommends a warm-up time of at least six hours before you start
the check. If a VWD-3100/ VWD-3400 detector is used, only the UV lamp needs to be turned on.

Tip: If the system does not include a VWD-3x00, a standalone VWD Detector is
required to perform the OQ/PQ procedures.

3.2.1.2 NC-3x00 Pump Modules and fluidics

To prepare the NC-3x00 pump modules for the OQ/PQ procedure:
a) Install the flow selector that the customer will be using on a routine basis (or the most frequently).
b) Prepare the solvents as indicated in TABLE 3-4. Purge both blocks for 30 min, purge the
flowmeter for 30 min,
c) Perform the pressure transducer test and the viscosity measurement.
d) Configure the system as required for the chosen application (NAN, CAP or MIC):
Connect the appropriate connecting tubing from the NC pump outlet to the WPS-3000
autosampler.
• Use part no. 6041.5280 for the NAN configuration, part no. 6041.5580 for the CAP
configuration and part no. 6041.5780 for the MIC configuration.
Connect the appropriate connecting tubing from the WPS-3000 autosampler to the switching
valve of the NCS-3500RS column oven (if not applicable, go to step d).
• Use part no. 6041.5260 for the NAN configuration, part no. 6041.5560 for the CAP
configuration and part no. 6041.5760 for the MIC configuration.
Connect the appropriate restriction capillary to the switching valve of the NCS-3500RS column
oven so that the mobile phase flows through the restriction capillary.
• Use part no. 164689 for the NAN configuration, part no. 164690 for the CAP configuration and
part no. 164691 for the MIC configuration.
Secure the restriction capillary in the column oven using clips.
e) Connect the appropriate restriction capillary directly to the injection valve of the WPS-3000
autosampler if qualifying a NCP-3200RS pump or a NCS-3500RS module without switching
valve.
• Use part no. 164689 for the NAN configuration, part no. 164690 for the CAP configuration and
part no. 164691 for the MIC configuration.
f) Use the provided Microtight union and appropriate PEEK sleeves to connect the restriction
capillary (360 µm O.D) to the flow cell inlet (280 µm O.D.) in NAN and CAP configurations
• Use part no. 6720.0076 for the 360 µm O.D. restriction capillary.
• Use part no. 6720.0075 for the 280 µm O.D. flow cell inlet.

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 OQ and PQ Operating Instructions

g) In the case of a NCS-3500RS pump module, the loading pump - also called micro pump -
qualification is performed using a different setup.
• Connect the loading pump to the WPS-3000
WPS 3000 autosampler using the capillary with part no.
6041.5780.
• Connect the WPS-30003000 autosampler to the switching valve of the NCS-3500RS
RS column oven
using the capillary with part no. 6041.5760
• Connect the restriction capillary with part no. 164691 to the switching valve of the NCS-
NCS
3500RS column oven so that the mobile phase flows through the restriction capillary.
• The restriction capillary should be connected to the UV flow cell inlet as described in e).

Tip: Carefully make your connections and flush all the fluidics. Make sure valves
are wetted before being switched.

FIGURE 3-1 Fluidic layouts for OQ setups; P/N for respective tubings are given in the figure.

3.2.1.3 NCS-3500RS Column Oven

To prepare the NCS-3500RS column oven (if applicable) for the OQ/PQ procedure:
a) Connect the e precision thermometer to the data system PC, following the steps described in the
Installation Instructions which are provided with the column thermostat PQ kit.
b) Install the 'Dostmann
Dostmann Thermometer P500/P600' device driver in the Chromeleon Server
Configuration
ation program, device name: 'Thermometer'.
c) On the 'General' tab page, select the COM port to which the thermometer is connected. In
addition, install a virtual channel with the name 'Thermometer'.
'
d) Select the tab 'Signals' and change 'VirtualChannel_01'
' to signal Name 'TemperatureOVEN'
TemperatureOVEN'.
Change 'unit' to '°C' or 'deg C'.
e) Install the temperature probe in the column oven compartment using ing clips as would be done for a
column. Ensure the probe is positioned near the oven temperature sensor.
OQ and PQ Operating Instructions

Tip: Room temperature must be at 25°C (or below) for the column oven to meet
the temperature specifications at 35°C. When room temperature is higher, the
test may fail. Pay attention to environmental conditions as they can greatly
influence the outcome of the OQ/PQ tests.

3.2.1.4 WPS-3000 Autosampler

All tests are performed with the following configuration. Ensure that a 1µL loop, a 2.4 µL needle, a 25
µL syringe and a 50 µL buffer tubing are installed.
Check that the fluidics and the syringe of the WPS autosampler are free of air. Place the standards at
the positions described in TABLE 3-3.

3.2.2 Testing Advanced Configurations

Instrument qualification is performed on a component or modular level. Multiple components can be
used for one test, but qualification is only done for one and the assisting components have been
qualified before their use in independent tests. To support more complex setups with different
modules, e.g. the combination of NCS-3500RS and NCP-3200RS in a single setup, respective tests
have to be repeated after replumbing. In the above example the gradient accuracy test can be
performed on the NCS module first and the NCP module second to qualify the entire system.

Tip: Break down advanced configurations into simpler ones that can be more
easily setup in the server configuration and that can be more easily qualified.

3.2.3 Preparing Chromeleon

The HPLC OQ/PQ templates for the RSLCnano contain all the sequences and programs necessary
for performing the OQ and PQ of FLM- & NC-based systems.

To run the OQ/PQ, perform the following steps:

a) Make the OQ/PQ template for RSLCnano available in the Chromeleon datasource
Note: This can be done by mounting the datasource from the CM_CD or restoring a CMB
file that contains all the templates.
b) Start the OQ/PQ setup wizard
c) Select the Timebase
d) Select the location where the OQ/PQ files are, in this case, the PQ_OQ folder on the CM
datasource.
e) Select the location where the OQ/PQ templates should be stored.
f) Select the OQ/PQ sequences that need to be run in order to create the template
g) Click Finish in the wizard dialog

h) Start the Instrument OQ/PQ wizard

i) Select the Timebase
j) Select the location where the OQ/PQ template is.
k) Select the location where the OQ/PQ results should be stored.
l) Select the OQ/PQ sequences that will be run.
m) Click Finish in the wizard dialog. The OQ/PQ report is opened automatically; fill in the necessary
information under the “specification” tab.
n) Run the sequences after the system is equilibrated and the samples are placed as indicated in
TABLE 3-3.

To ensure that the data is correctly read and processed in the report, print the report as 'Batch Report'
from the Browser:

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 OQ and PQ Operating Instructions

o) Select the sequence for which you want to print the report.
p) Select 'Batch Report' on the 'File' menu and start printing by clicking 'ok'.

3.3 Performing the Checks

The tests to be performed, the order in which they must be performed and the time required for each
individual test are listed inTABLE 3-5. Performing the OQ of an Ultimate 3000 RSLCnano system in a
standard configuration will take approximately 24h.

TABLE 3-5 Tests to be performed and Time required for each test
Check Duration Comment
WARM_UP Irrespective of the presence or absence of
4h
WARM_UP AND OVEN_TEST a thermostated column oven
FLOW CELL CHECK 5 min
NOISE AND DRIFT 25 min
GRADIENT FORMATION TEST 6.0 h
WAVELENGTH CHECK 20 – 40 min
AUTOSAMPLER 1–2h Depending on the configuration (faster for
REPRODUCIBILITY MIC and slower for NAN)
UV LINEARITY
AUTOSAMPLER LINEARITY 45 min - 1.5 h
CARRY OVER TEST
Replumbing required
LOADING PUMP GRADIENT 5.0 h
FORMATION TEST

3.4 Repeating Checks

It may be necessary to repeat one or several checks. In this case, refer to section ‘Troubleshooting’
(Chapter 6) which provides troubleshooting information in relation with the OQ/PQ procedures. More
information about instrument-specific problems is provided in the documentation shipped with the
system and in the service instructions available for the various modules. The OQ/PQ procedures
described in this manual have been optimized for the conditions described in the previous chapters.
When troubleshooting the OQ/PQ results, please control that the experimental setup is used as
described in this manual.
According to GLP, you have to repeat the check that failed and all posterior checks as previous results
are used to validate posterior results and thereby the performances of the system.

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4 Procedures
4.1 Temperature Accuracy of the Column Oven
4.1.1 Theory
Fluctuations in the solvent and/or column temperature may result in considerable variations in
retention times. High temperature stability and accuracy simplify the transfer of an application to a
different system.

4.1.2 Performing the Check

Five different temperatures (35, 45, 55, 65, and 75 C) are used to check the temperature accuracy of
the column oven. The actual temperature is measured with an external, calibrated thermometer and is
compared to the set value. The difference indicates the temperature accuracy. To check the
temperature accuracy of the column oven, use the “WARM_UP AND OVEN_TEST NC” sequence. If
using a NCP-3200RS, the same sequence will be used even though it does not have a column oven.
The test results are displayed in the report under the “Column_Oven” tab (cf. FIGURE 4-1).
OQ_01 WARM_UP AND OVEN_TEST #1 Warm_up and Oven_Test TemperatureOVEN
80,0

70,0

60,0

50,0

40,0
%B: 50,0 %

Flow: 0,500 µl/min

30,0 min
0,0 10,0 20,0 30,0 40,0 50,0 60,0 70,0 80,0 90,0 99,0

FIGURE 4-1 Temperature Trace of the Thermometer

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4.2 Flow Cell Check

The flow needs to be switched on to perform the Flow Cell Check and the “FLOW CELL CHECK VWD
NC” sequence is used. Mobile phase A:Mobile phase B (99:1) is pumped through the flow cell of the
VWD detector at the nominal flow rate of the flow selector, 500 nL/min (NAN), 5 µL/min (CAP) and
25 µL/min (MIC). The UV signal is recorded at 240 nm. The signal limit for the flow cell transmittance
is 15 % of the reference value. The results are shown in the report file under the “Flow_Cell_VWD”
tab.

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4.3 Wavelength Check

The “WAVELENGTH CHECK VWD NC” sequence is used to determine if the detector is still correctly
calibrated. Caffeine (10µg/mL) is injected and the signal is recorded at 270 nm, 272 nm and 274 nm. A
parabola is calculated from the signal heights of the caffeine signals at the three different wavelengths.
The maximum of the parabola is determined and compared to the theoretical value of the spectral
maximum for caffeine (272.5 nm). The results are shown in the report file under the “wavelength
check” tab.

147.7
mAU

145.0

142.5

140.0

137.5

135.5 min
0.833 0.860 0.880 0.900 0.920 0.940 0.960 0.980 1.000 1.020 1.054

FIGURE 4-2 Zoom in on peak tops with caffeine standard injections recorded at three different
wavelengths in capillary mode. Signal intensity depends on wavelength.

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4.4 Baseline Noise and Drift of the UV Detector

4.4.1 Theory
Drift and baseline noise are important parameters when using UV detectors. Increased baseline noise
considerably reduces the sensitivity while increased drift makes integration of the UV signal more
difficult and thereby less accurate.
Baseline noise mainly originates from the lamp. Using an old lamp with low light intensity may result in
a considerable increase in noise. Noise may also increase when air bubbles are present in the
detection cell and if the flow cell is dirty or damaged.
Lamp intensity first decreases when turned on before becoming stable once warm (cf. FIGURE 4-3).
Often turning the lamp on and off will accelerate aging. It is very important that time is allowed for a
lamp to warm up and its signal to stabilize before measurements can be performed. It is even more
important when using a new lamp.
R a u s c h e n _ D r if t _ 3 D F E L D _ M e O H _ U V D 2 # 1 D e t e c t o r n o is e d r if t a n d l a m p in t e n s it y U V _ V IS _ 1
0 ,4 1 R a u s c h e n _ D r if t _ 3 D F E L D _ M e O H _ U V D 2 # 1 2 D e t e c t o r n o is e d r if t a n d l a m p in t e n s it y U V _ V IS _ 1
mAU W V L :2 5 4 n m

0 ,3 0

0 ,2 0

0 ,1 0

0 ,0 0

0 ,1 0

0 ,2 0

0 ,3 0

0 ,4 0

0 ,5 0

0 ,6 0

0 ,7 6 m in
2 ,3 4 3 ,0 0 4 ,0 0 5 ,0 0 6 ,0 0 7 ,0 0 8 ,0 0 9 ,0 0 1 0,0 0 1 1 ,0 0 1 1 ,6 3

FIGURE 4-3 Baseline Drift: Directly after the Lamp has been turned on (bottom trace) and after it
has been lit for six hours (top trace)

4.4.2 Performing and Evaluating the Checks

The flow needs to be switched on to perform the baseline noise and drift check and the “NOISE AND
DRIFT NC” sequence is used. Mobile phase A:Mobile phase B (99:1) is pumped through the flow cell
of the VWD detector at the nominal flow rate of the flow selector, 500 nL/min (NAN), 5 µL/min (CAP)
and 25 µL/min (MIC). The UV signal is recorded at 254 nm. The recorded signal is split into 20
intervals of 1 minute. For each interval, a regression based on measured values is calculated using
the method of least squares. The slope of the curve indicates the drift of the measured signal and the
absolute value of the slope indicates the absolute value of the drift. The noise is the distance between
two parallel lines through the measured minimum and maximum values and the regression line. The
calculated values are averaged for all 20 intervals to establish the final value. The results are shown in
the report file under the “Det_Noise_And_Drift” tab.

Tip: Allow the lamp to warm up for 4-6h before starting with acquiring data. This
is the purpose of the “warm up”. When a new lamp is installed, optimum
performance is obtained after the lamp has been lit for about 24h. When this
test is performed using a new lamp, noise and drift levels may be larger than
the specified values. Do not skip the warm up period. Make sure the system
is not positioned in a draft (e.g. air-conditioning) or directly exposed to
sunlight.

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4.5 Gradient Composition for the NC and loading pumps:

Accuracy, Reproducibility and Ripple
4.5.1 Theory
The gradient composition, both in terms of accuracy and reproducibility, can greatly influence retention
times. To evaluate the quality of gradient formation and delivery, the gradient is tested based on the
ASTM (American Society for Testing & Materials) instructions where different mobile phase
compositions are checked. Because acetone has a large extinction coefficient at λ = 265 nm, the
changes in gradient composition can be followed by recording the UV trace at 265 nm. Different
proportions of acetone are used in mobile phase B depending on the configuration to be tested (cf.
FIGURE 4-4).
1 - OQ_04 GRADIENT FORMATION TEST #2 Gradient formation test_1 UV_VIS_1
2 - OQ_04 GRADIENT FORMATION TEST #3 Gradient formation test_2 UV_VIS_1
3 - OQ_04 GRADIENT FORMATION TEST #4 Gradient formation test_2 UV_VIS_1
10,0
mAU WVL:265 nm
3
2 99,0
1%B: 99,0 %
95,0

-20,0

50,0

-40,0

-60,0
5,0
1,0

Flow: 5,000 µl/min

-80,0 min
0 10 20 30 40 50 60 70 80 90 100

FIGURE 4-4 Set gradient (broken line) and actual gradients (in triplicate) in a CAP setup

4.5.2 Performing the NC pump Check

Gradient composition starts at 99%B, before decreasing by steps down to 95%B, 50%B, 5%B, and
1%B. At the end of the test, the gradient composition is brought back to 99%B. Every gradient
composition is kept stable in order to determine the accuracy of the gradient delivery as well as its
ripple, which is calculated as the signal noise. The “GRADIENT FORMATION TEST NC” sequence is
required to perform this test.

Tip: The maximum absorbance observed should not be greater than the highest
absorption monitored during the linearity test (Section 4.7). Dilute B with
mobile phase A if necessary so that the signal remains on scale when this
test is run.

4.5.3 Performing the loading pump Check

Gradient composition starts at 100%B, before decreasing by steps down to 95%B, 50%B, 5%B and
0%B. At the end of the test, the gradient composition is brought back to 100%B. Every gradient
composition is kept stable in order to determine the accuracy of the gradient delivery as well as its
ripple, which is calculated as the signal noise. The “LOADING PUMP GRADIENT FORMATION TEST
NC” sequence is required to perform this test.
The setup is the same as the one used for testing the gradient composition of the MIC flow selector
with the exception that the loading pump is used instead of the NC pump. Additionally, the flow rate is
set higher at 250 µL/min.
 OQ and PQ Operating Instructions

Tip: Because a change in setup is required before performing the loading pump
gradient test, the flow of the NC pump will stop at the end of the last run
using the NC pump and a message will appear asking to change the
configuration.

4.5.4 Evaluating the Checks

Absorption values are converted and expressed as %B to ease comparison of the gradients. Start and
end composition of the gradient are identical to compensate for the detector drift. These values are the
basis for the regression line that is used to correct the baseline of the entire chromatogram.
Gradient accuracy is calculated by comparing the measured step height to the theoretical height at
each gradient composition. Gradient reproducibility is defined as the standard deviation of the height
of each steps.
Gradient ripple is determined for every gradient step by calculating a regression line, based on the
method of least squares, at the end of each gradient step. The noise, the distance between two
parallel lines passing through the measured minimum and maximum values of each step and the
regression line, gives an indication of the ripple.
The test results are displayed in the report under the “Pump_Gradient” and “Pump_Gradient_Repro”
tabs for the NC pump and under the “Loading_Pump_Gradient” and “Loading_Pump_Gradient_Repro”
tabs for the loading pump.

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4.6 Reproducibility of the Injection Volume

4.6.1 Theory
The reproducibility of the injection volume is mainly influenced by the autosampler. In addition, syringe
movements are decisive to achieve high accuracy and reproducibility of the injection volume. Check
that no air bubbles are present in the syringe, buffer tubing or the sample.

30.0 300
mAU WVL:272 nm mAU WVL:272 nm

25.0 250

20.0 200

15.0 150

10.0 100

5.0 50

6
9
1
2
3
4
5
7
8
10 1
2
3
4
5
6
7
8
9
10
0.0 0

min min
-5.0 -50
0.0 2.0 4.0 6.0 8.0 11.0 0.00 0.50 1.00 1.50 2.00 2.60

FIGURE 4-5 Autosampler reproducibility Overlay of 10 injections of 20 µg/mL caffeine (Left: NAN
setup, Right: CAP setup).

Tip: The flowrate in relation to the injected volume can result in a broad peak
profile. In case of a NAN setup, the injected volume is 2 times higher than the
flowrate per minute. This results in different peak shapes for NAN, CAP, and
MIC setups.

4.6.2 Performing the Check

10 consecutive full-loop injections of a 20.0 µg/mL standard solution of caffeine are performed using
the “AUTOSAMPLER REPRODUCIBILITY NC” sequence. The peak area is used for the calculation of
the injection reproducibility. The retention time is used for the calculation of the retention time
reproducibility. In the case of a NAN setup, peaks are broad as the volume injected is equal to 2 times
the flow rate per minute. The retention time of the peak is determined as “retention time at 50% of
peak area” to accommodate these broad peak profiles. The test results are displayed in the report
under the “Inj_Repro” tab.
 OQ and PQ Operating Instructions

4.7 Linearity of the UV Detector

4.7.1 Theory
The detector linearity mainly depends on the optical and electronic components of the detector.
Electronic components can exhibit non-linearity caused by dark current and dark current drift.
However, dark current measurements can be used to compensate for the influence of these factors.
With decreasing light intensity (either caused by absorption of the solvent or sample or lamp aging)
the influence of the dark current on the linearity increases. Under the OQ/PQ conditions, the influence
of the solvent is insignificant since water does not absorb light at 272 nm. The absorbance of the
sample should thus be the main contributor to a decrease in light intensity and is consequently used to
determine the detector linearity (cf.FIGURE 4-6).
300
mAU WVL:272 nm

200

100

1
2
3
4
5
0

min
-50
0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00

FIGURE 4-6 Linearity of the UV Detector CAP

Tip: Accuracy is only ensured within the linear range of the detector and flowcell.
Ignore the result of the highest concentrations if their absorbance value
exceeds 30 mAU for NAN, 280 mAU for CAP, or 350 mAU for MIC.

4.7.2 Performing and Evaluating the Check

The detector linearity is determined by injecting five different caffeine standards (1; 2.5; 5; 10; 20
µg/mL) and recording the resulting chromatogram at 272 nm using the “UV LINEARITY NC”
sequence. The regression coefficient is then calculated based on peak heights and concentrations,
and qualifies the detector linearity. The test results are displayed in the report under the
“Det_Linearity” tab.
OQ and PQ Operating Instructions

4.8 Linearity of the Injection Volume

4.8.1 Theory
The linearity of the injection volume and its reproducibility are the syringe and associated parameters
(syringe drive, syringe volume-to-injected volume ratio). The linearity may decrease if the syringe is
leaking or when using a syringe that is too large in comparison with the volume injected. Check that no
air bubbles are present in the syringe, buffer tubing or the sample.
220
mAU WVL:272 nm

150

100

50

1
2
3
4
5
6
-20 min
0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60 1.80 2.00 2.20

FIGURE 4-7 Autosampler Linearity CAP, different peak profiles for NAN and MIC setups can be
observed. Area under peak is used in data analysis.

4.8.2 Performing the Check

In the “AUTOSAMPLER LINEARITY NC” sequence, 5 partial loop injections of a 20.0 µg/mL caffeine
solution are performed, from 100 nL to 500 nL injections. Peak areas and injection volumes are plotted
and the regression coefficient is determined, quantifying the autosampler linearity. The test results are
displayed in the report under the “Inj_Linearity” tab.

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4.9 Carry-over
4.9.1 Theory
Sample carry-over is observed when an analyte from one sample is measured in a subsequent
sample.

4.9.2 Performing the Check

In order to investigate the possible carry-over of caffeine from one injection to another, a highly
concentrated sample (1 mg/mL caffeine) is injected followed by the triplicate injections of solvent.
Ideally, no caffeine should be present in the chromatograms corresponding to the injection of solvent.
However, if a caffeine peak/trace sample is detected in one of the “solvent” runs, it indicates carry-over
of caffeine in the autosampler.

4.9.3 Evaluating the Check

Because the concentration of the second sample (1 mg/mL caffeine) is very high, the resulting
caffeine peak lies outside the linear range of the detector. A sample with a lower concentration
(10 µg/mL caffeine) is therefore injected first in order to estimate what the peak area of the 1 mg/mL
caffeine injection should be. The ratio of the signal areas of the mobile phase injections and the
corrected 1 mg/mL caffeine standard indicates the carry-over. The test results are displayed in the
report under the “Inj_Carry_Over” tab.
1 - OQ_09 CARRY OVER TEST #3 Caffeine 10 ug-ml UV_VIS_1
2 - OQ_09 CARRY OVER TEST #4 Caffeine 1 mg-ml UV_VIS_1
3 - OQ_09 CARRY OVER TEST #5 mobile phase A UV_VIS_1
28.0
mAU WVL:272 nm

20.0

15.0

10.0

5.0

3
1
2
-1.0 min
0.00 0.25 0.50 0.75 1.00 1.25 1.50 1.75 2.00 2.25 2.50 2.80

FIGURE 4-8 Autosampler Carry-over MIC

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5 Completing and Printing the IQ Report

Integration of the peaks, analysis of the oven temperature and of the different UV traces (drift,
gradient, etc.) is performed automatically. When integration fails, integration parameters need to be
adjusted.

To that end, open the corresponding run(s) and select in the tool-bar “QNT editor”. In the “Peak Table”
tab, change the retention time and window. It might be necessary to adapt some of the parameters in
the “Detection” tab to improve the quality of the OQ/PQ results (e.g. sensitivity, minimum height, etc.).
When the integration is correct, save the QNT file and open the report. When all peaks are correctly
integrated, the result in the different report tabs will be either “Test Passed” or “Test Failed”. When
peaks are incorrectly integrated, results in the report tabs may be “#DIV/0”.
In the report, many references link to separate data sheets. When lines or columns are inserted or
deleted, the references may get lost and the calculations, hence the results will be false.
To ensure that the data is correctly read and processed in the report, print the report as 'Batch Report'
from the Browser.
a) Right click on the OQ/PQ sequence and select “Batch report”
b) Select the printer of choice and click OK (FIGURE 5-1)
c) Batch report will print the sheets relevant to the sequence you just selected. For example, if right-
clicking on the “loading pump gradient formation test”, the step accuracy and the reproducibility
sheets will be printed.

FIGURE 5-1 Screenshot of Batch Report (Report definition and channel should be “preferred”)

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 OQ and PQ Operating Instructions

6 Troubleshooting

This section provides troubleshooting information in relation with the OQ/PQ procedure. More
information about instrument-specific problems is provided in the documentation shipped with the
system and in the service instructions available for the various modules.
The OQ/PQ procedures described in this manual have been optimized for the conditions shown.
When troubleshooting the OQ/PQ results, please verify that the experimental setup is used as
described in this manual.

6.1 Symptoms and possible causes

6.1.1 OQ/PQ failed during the oven test
The most common causes for an OQ/PQ to fail the oven test are that the system is positioned in a
draft or under the air-conditioning outlet or directly in the sun light. Check external conditions that
could affect the system.

6.1.2 OQ/PQ failed on flow cell check

The most common causes for an OQ/PQ to fail the flow cell check are that the system has not been
purged sufficiently, fluidics are (partially) flushed with the wrong solvent or the flow cell is dirty or
damaged.

6.1.3 OQ/PQ failed on noise and drift

Here is a list of the most commonly-encountered causes when an OQ/PQ does not meet the noise
and drift criteria.
• The lamp is new and has not been switched on long enough. Light intensity decreases when
the lamp is turned on and it may take as long as 24h for the lamp to stabilise when using a
new lamp.
• The system has not been purged sufficiently (or wrong solvent), the flow cell is dirty or
damaged.
• The system is positioned in a draft or under the air-conditioning outlet or directly in the sun
light. Check external conditions that could affect the system.

6.1.4 OQ/PQ failed on wavelength accuracy

Here is a list of the most commonly-encountered causes when an OQ/PQ does not meet the
wavelength accuracy check.
• The lamp is new and has not been switched on long enough. Light intensity decreases when
the lamp is turned on and it may take as long as 24h for the lamp to stabilise when using a
new lamp.
• The system has not been purged sufficiently (or wrong solvent), the flow cell is dirty or
damaged.
• The wrong sample has been used. Concentration is either too high or too low, or the analyte is
not caffeine.

6.1.5 OQ/PQ failed on reproducibility

Here is a list of the most commonly-encountered causes when an OQ/PQ does not meet the
reproducibility criteria. Reproducibility issues can be encountered with respect to retention time, peak
area, pressure, gradient, etc.
• The system has not been sufficiently equilibrated. This particular pump may require more time
to perform reproducibly and achieve stable flow and pressure.
• Viscosity procedure was not performed properly or the A/B canals were not sufficiently purged
prior to running the procedure.

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OQ and PQ Operating Instructions

• Dead volumes could be present in the system. Make sure that all connections are free of dead
volumes.
• Check the integration of the caffeine peaks. It is of special importance when qualifying a NAN
setup.

6.1.6 OQ/PQ failed on linearity

Here is a list of the most commonly encountered causes when an OQ/PQ does not meet the linearity
criterium for either the detector or the autosampler.
• The wrong sample has been used. Concentration is either too high or too low. An error in
labelling or positioning the vials may have occurred.
• The lamp is too old.
• The wrong UV detection cell is used (resulting in too much band broadening or in too short the
detection length).
• There is air in the syringe, or another place of the autosampler fluidics.
• The rotor seal of the autosampler valve is damaged or another part of the injection device is
damaged or blocked.
• Either the detection or integration parameters are not correct.

6.1.7 OQ/PQ failed on carry-over

Here is a list of the most commonly encountered causes when an OQ/PQ does not meet the OQ/PQ
criterium for carry-over.
• The wrong sample (very sticky analyte) has been used.
• The wrong flush solvent is used, or too low a flush volume is being used resulting in poor
flushing of the WPS valve.
• The detection parameters are not correct, check your integration method.

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7 Example Report
For an OQ example report, refer to the following pages.

The report was generated for the following system configuration:

• SRD-3400
• NCS-3500RS with nano flow selector
• VWD-3400RS
• WPS-3000TPL RS

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