IC System IQ
ICS-3000 System Installation Qualification
© 2006 Dionex Corporation
Document No. 065080 Revision 02
September 2006
Doc. 065080- 02
© 2006, Dionex Corporation
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PRINTING HISTORY
Revision 01, April 2005
Revision 02, September 2006
Doc. 065080- 02 Page 2 of 21
Table of Contents
1 Introduction ....................................................................................................................... 4
2 Installation Qualification (IQ) ...................................................................................................... 5
3 Performing the Installation Qualification................................................................................... 6
3.1 Customer and Shipment Information .......................................................................... 6
3.2 Facility Requirements.................................................................................................. 6
3.3 System Installation ...................................................................................................... 6
3.3.1 Unpacking ...................................................................................................... 6
3.3.2 Placing Modules on Bench ............................................................................ 7
3.3.3 Computer and Software Installation............................................................... 7
3.3.4 Electrical and USB Connections .................................................................... 7
3.3.5 Liquid Line Installation and System Equilibration (Cond. Or Abs detector) ... 8
3.3.5 Liquid Line Installation and System Equilibration (ED detector).................... 8
3.4 General System Function Test ................................................................................... 9
3.5 System Information ................................................................................................... 12
4. IQ Completion ........................................................................................................ 13
4.1 Customer Review...................................................................................................... 13
5 Installation Qualification Worksheets..................................................................................... 14
Section A. Customer and Shipment Information...................................................... 14
Section B. Facility Requirements ............................................................................. 15
Section C. System Installation ................................................................................. 15
Section D. System Information ................................................................................ 16
Section E. IQ Comments ......................................................................................... 21
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1 Introduction
Validation is becoming increasingly important to analytical laboratories. Documented evidence must be
provided to demonstrate the integrity of data collected and validate the results obtained on laboratory
instrumentation.
Many laboratories achieve this by formal quality systems, which are generally implemented in accordance
with one or more of the three internationally recognized quality standards:
ISO 9001
Good Laboratory Practice (GLP)
ISO Guide
These standards are written in broad terms, to make them as widely applicable as possible. All stipulate
general requirements specifying instruments must be fit for purpose, properly maintained, and calibrated
to national or international standards. The procedure used for Dionex IQ is adapted to these standards.
This procedure provides IQ for the ICS-3000 systems and ICS-Series detectors.
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2 Installation Qualification (IQ)
Installation Qualification covers all procedures relating to the installation of instruments in a specific
environment. IQ confirms that the instrument(s) were shipped as ordered and that the environment
where the system is installed is suitable for operating the instrument.
Performing the IQ is required at the initial installation of the instrument or when a new module is added to
an existing instrument.
IQ documents the following items:
That the instruments, including all modules and accessories, were shipped as ordered and were
inspected for shipping damage.
That the required computer hardware and software were supplied.
That the laboratory environment is suitable for the system.
That there is sufficient space to install the instrument and the required materials for the installation
are available.
That the installation of the instrument was performed exclusively according to the manufacturer’s
guidelines.
That the instrument functions as expected when first operated and that any deviations are recorded.
That existing peripheral equipment is connected correctly.
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3 Performing the Installation Qualification
3.1 Customer and Shipment Information
Fill in the customer information located in Section A of the IQ Worksheet. This documents that the
shipment was received according to the actual purchase order placed and all relevant customer
information is documented.
3.2 Facility Requirements
Confirm that the facility requirements located in Section B of the IQ Worksheet are available prior to
performing the installation. Document item availability in the worksheet.
3.3 System Installation
3.3.1 Unpacking
1. Check all shipping boxes for visible damage. If there is any damage, document the details in
Section E of the IQ Worksheet.
2. Place the box on the floor, open it, and remove accessory items.
3. Remove the module.
4. Remove any packing material.
5. Confirm that the module is not damaged. If damage is visible, inform the customer and transport
company immediately. If necessary, take photographs and note names of witnesses to prove the
damage. Document all details in Section E of the IQ Worksheet.
6. Confirm that the module ship kit and all other necessary accessories have been provided.
7. Record all unpacking information in Section C of the IQ Worksheet.
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3.3.2 Placing Modules on Bench
1. Place the base modules on a firm, vibration free surface.
2. Confirm that the bench where the modules are to be installed is not exposed to temperature
fluctuations, high humidity, or direct sunlight.
3. Modules may be stacked one on top of each other as long as it is in accordance with the
customer’s laboratory height requirements. In general, do not stack more than three single stack
modules (i.e., one pump and one EG, or one DC and one VWD or PDA detector, or one TC, one
VWD and one PDA) together.
4. When all modules have been set up on the bench, record this in Section C of the IQ Worksheet.
3.3.3 Computer and Software Installation
1. Install the computer in an appropriate location near the instrument or remotely (at the customer’s
request).
2. If not using a pre-loaded computer with software, install Chromeleon software. and then configure
a timebase for each system being installed.
3. When the computer/software installation is complete, record this in Section C of the IQ
Worksheet.
3.3.4 Electrical and USB Connections
1. Connect all module power cords and plug into laboratory electrical source.
2. Connect all USB cables from the module to the computer or USB hub box (if applicable)
3. Connect any Relay or TTL cables (if applicable).
4. Make all detector cell connections (if applicable).
5. When all module connections have been made, configure a timebase in Chromeleon
6. When all module connections have been made and the timebase has been configured record this
in Section C of the IQ Worksheet.
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3.3.5 Liquid Line Installation and System Equilibration (Conductivity or Absorbance
Detectors)
Note: Do not install columns and suppressors at this time. They will be installed later in the
procedure.
1. Using the tubing provided in the module ship kits, make all appropriate liquid line connections
between the pump, injection valve, autosampler, accessory modules, and detector cell.
2. Confirm that an appropriate waste receptacle is available for system liquid waste.
3. Fill an eluent bottle with 18 megohm deionized, filtered water and connect it to the pump. Prime
the pump for approximately 5 minutes.
4. Select a flow rate of 1.00 mL/min and flush the entire system for approximately 15 minutes.
5. When the system has completed equilibration, record this in Section C of the IQ Worksheet.
3.3.6 Liquid Line Installation and System Equilibration ED (Electrochemical Detector
on ICS-3000 systems only)
Note: Do not install columns at this time. They will be installed later in the procedure.
1. Using the tubing provided in the module ship kits, make all appropriate liquid line connections
between the pump, injection valve, auto sampler, accessory modules, and electrochemistry
detector cell (assembled with disposable gold working electrode).
2. Confirm that an appropriate waste receptacle is available for system liquid waste.
3. Fill an eluent bottle with 50 mM NaOH made from filtered, degassed 18 megaohm deionized water
and connect it to the pump. Prime the pump for approximately 5 minutes.
4. Select a flow rate of 0.25 mL/min and flush the entire system for approximately 30 minutes.
5. Set the Electrochemical cell to Integrated Amperometry Mode. Use one of the following
waveforms:
AAA – AgCl
AAA – pH
Carbohydrate quadruple potential
Carbohydrate triple potential
6. Turn the Electrochemical Cell on.
7. When the system has completed equilibration, record this in Section C of the IQ Worksheet.
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3.4 General System Function Test
3.4.1 General Systems Function Test (Conductivity or Absorbance Detectors)
To perform the general system function test, use the Dionex Quality Installation Solution (For
Conductivity or Absorbance 10 ppm Nitrate, Dionex P/N 052820 included in the pump ship kit. This test
sample is used to confirm system operation and can be used with conductivity and absorbance
detectors. The Quality Installation Solution should not be used as a quantitative standard.
1. Stop the pump flow.
2. Install the yellow PEEK backpressure tubing, included in the Quality Installation Solution packaging,
between the injection valve and the detector cell.
3. Conductivity Detectors or Absorbance Detectors: Turn on the pump flow and select water as
the eluent with a flow rate of 1.00 mL/min.
4. Actuate the injection valve back and forth between LOAD and INJECT to flush the sample loop.
5. Conductivity Detectors. The background conductivity reading should not be higher than 1 µS. If
the background reading is higher, find an alternate water source.
Absorbance Detectors. Turn on the UV lamp and set the wavelength to 210 nm.
6. Check liquid flow paths for leaks, make adjustments where necessary.
7. Allow the system to stabilize, this will take approximately 5 minutes. The system backpressure
should be 1500 to 2500 psi (100 to 170 bar).
8. Inject 15 to 50 µL of the Quality Installation Solution and run data acquisition. The analyte peak will
elute at approximately 0.2 minutes. If the peak does not appear, confirm proper injection valve
operation and that liquid connections are correct, then repeat the injection. Results obtained will be
similar to the example chromatograms in Figure 1.
9. When the general system function test is complete, record this in Section C of the IQ Worksheet.
Doc. 065080- 02 Page 9 of 21
Figure 1. Example Chromatograms
Conductivity Detection
100 µS FS
µS
0.00 5.00
UV Detection
2 AU FS
AU
0.00 5.00
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3.4.2 General System Function Test (Electrochemical Detectors)
To perform the general system function test, use the Dionex MonoStandard (043162 ordered
separately) or equivalent. Follow the directions that are shipped with the standard to make a 0.1 mM
mix of monosaccharide standards. Dilute the 0.1 mM mix 100X to produce a 1 uM mix of
monosaccharide standards, this will be the “Quality Installation Solution”. This test sample is used to
confirm system operation and can be used with electrochemical detectors. This is a mix standard, but
since there is no separation device in the system, it will yield a single peak. The Quality Installation
Solution should not be used as a quantitative standard.
1. Stop the pump flow and turn off the ED cell if it is on.
2. Install the yellow PEEK backpressure tubing, included in the Quality Installation Solution
packaging, between the injection valve and the detector cell.
3. Turn on the pump flow and select 50 mM NaOH as the eluent with a flow rate of 0.25 mL/min.
4. Set the Electrochemical cell to Integrated Amperometry Mode. Use one of the following
waveforms:
AAA – AgCl
AAA – pH
Carbohydrate quadruple potential
Carbohydrate triple potential
5. Turn the Electrochemical Cell on.
6. Actuate the injection valve back and forth between LOAD and INJECT to flush the sample loop.
7. Check liquid flow paths for leaks, make adjustments where necessary.
8. Allow the system to stabilize, this will take approximately 10 minutes. The system backpressure
should be 500 to 1500 psi (35 to 100 bar).
9. Inject 10 to 25 µL of the appropriate Quality Installation Solution and run data acquisition. The
analyte peak will elute at approximately 0.2 minutes. If the peak does not appear, confirm proper
injection valve operation and that liquid connections are correct, then repeat the injection. Results
obtained will be similar to the example chromatograms in Figure 1.
10. When the general system function test is complete, record this in Section C of the IQ Worksheet.
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Figure 1. Example Chromatograms
Electrochemical Detection
200 nC FS
3.5 System Information
Record all computer, software, and module information in Section D of the IQ Worksheet.
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4 IQ Completion
4.1 Customer Review
1. The IQ results should be reviewed by the instrument owner/user. If the qualification is accepted,
both the Customer and the Qualification Executor should sign each page of the IQ Worksheet.
2. Leave the IQ documentation with the customer.
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5 Installation Qualification Worksheets
Note: If the answer to any item is ‘No’, ‘not complete’ or ‘not acceptable,’ an explanation must be
provided in Section E.
Section A. Customer and Shipment Information
A. Customer and Shipment Information
Company Name
Customer Name
Street Address
City, State, Zip
Phone
Customer Purchase
Order
Dionex Order Number
Date of Delivery
Date of Installation
IQ Executor/Company
Do the items on Customer Purchase Order Match Dionex Packing List? Yes No
Are the items on Packing List included with the system shipment? Yes No
Customer Signature _________________________________
Qualification Executor _________________________________ Date _________________
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Section B. Facility Requirements
B. Facility Requirements
Availability (mark N/A if not
Requirement Specification
applicable)
Temperature Range 10° to 40° C Yes No
Humidity Range 5 to 80% Relative Humidity Yes No
Gas Supply (if needed) Nitrogen or Helium as specified Yes No N/A
Outlets available at appropriate country
Power Yes No
voltage
Bench Space 3” of available space behind modules Yes No
Water Quality 18 megaOhm or better Yes No
As specified for application to be
Eluents Yes No N/A
installed
As specified for application to be
Standards Yes No N/A
installed
Section C. System Installation
C. System Installation
Item Status
3.1 Step 1 - Shipping box condition Arrived undamaged Yes No
3.1 Step 5 - Module condition Arrived undamaged Yes No
3.1 Step 6 - Module accessories Included Yes No
3.2 Module setup Complete Yes No
3.3 Electrical and USB connections Complete Yes No
3.4 Computer and software installation Complete Yes No
3.5 Liquid line installation and system equilibration Complete Yes No
3.7 General system function test Complete Yes No
3.8 Application installation Complete Yes No
Customer Signature _________________________________
Qualification Executor _________________________________ Date _________________
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Section D. ICS-3000 System Information
D. ICS-3000 System Information
Name of Timebase
CM CMX Not applicable
(1):
Name of Timebase
(2):
Address Provided. by
Instrument: Model: Serial No.: N/A
(if applicable): Customer:
SP N/A
DP
Pump:
Other:
DC N/A
TC
Compartment
Other:
CD N/A
DC Left Detector
ED
CD N/A
DC Right Detector
ED
EG N/A
Eluent Generation:
Other
AS N/A
AS40
Autosampler: AS-HV
Other:
VWD N/A
PDA
UV Detector: Type:
Other:
RF N/A
2000
Detector 2: Type:
Other:
RI101 N/A
Detector 3: Other: Type:
N/A
UCI: 100
Customer Signature _________________________________
Qualification Executor _________________________________ Date _________________
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D. ICS-3000 Detector Chromatography Module Information
Model: ICS-3000 DC Installed N/A
One Zone Heating
Heating Options
Two Zone Heating
Injection Valve 1 (Left) ports: 6 10 N/A
Lower Compartment
Injection Valve 2 (Right) ports: 6 10 N/A
Detector 1 (Left): CD ED N/A
Middle Compartment
Detector 2 (Right): CD ED N/A
Automation Manager Installed N/A
HP Valve 1: 6 10 N/A
HP Valve 2: 6 10 N/A
Upper Compartment
LP Valve 1: 2 3 N/A
LP Valve 2: 2 3 N/A
RCH-1 Column Heater Installed
Module Serial No:
Firmware Version:
Connection USB
D. ICS-3000 Thermal Compartment Module Information
Model: ICS-3000 TC Installed N/A
Injection Valve 1 (Left) ports: 6 N/A
Injection Valves
Injection Valve 2 (Right) ports: 6 10 N/A
Module Serial No:
Firmware Version:
Connection USB
D. ICS-3000 Pump Module Information
Model: ICS-3000 Pump Installed N/A
Pump Type: SP DP
Pump 1 (Lower) ISO GRAD
Pump 2 (DP Only) GRAD
Second Channel Chromatography
Operational Mode
Auxiliary Dependent
(DP Only):
Auxiliary Independent
Serial No.:
Firmware Version:
Connection: USB
Customer Signature _________________________________
Qualification Executor _________________________________ Date _________________
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D. ICS-3000 Eluent Generator Module Information
Module: ICS-3000 EG Installed N/A
Module Serial No.:
Firmware Version:
Connection: USB
D. ICS-Series Variable Wavelength Detector Module Information
Module: ICS-Series VWD Installed N/A
Channel(s): Single Channel Multiple Channel
Module Serial No.:
Firmware Version:
Connection: USB
D. ICS-Series Photodiode Array Detector Module Information
Module: ICS-3000 PDA Installed N/A
Module Serial No.:
Firmware Version:
Connection: USB
D. ICS-Series Autosampler Module Information
Model: AS AS40 AS-HV Installed N/A
SP ST Simultaneous Kit
Options:
Sequential Kit N/A
Firmware Version:
Module Serial No.:
Connection: USB TTL/RELAY RS-232
Customer Signature _________________________________
Qualification Executor _________________________________ Date _________________
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D. Computer System Information
Item Manufacturer Serial Number Company Asset #
Monitor
CPU
Printer
Customer Signature _________________________________
Qualification Executor _________________________________ Date _________________
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D. System Information – Software
Dongle Serial
Name Version Key Code/License Server
Number
Chromeleon
Installed Features
Server License On Off
Timebase Class 1
Timebase Class 2
Timebase Class 3
Multiple Network Control On Off
MS Control On Off
IC Control SE On Off
3D Data Acquisition On Off
ICS-2000 Gradient Generation On Off
Fraction Collection On Off
Purification On Off
Control Only On Off
DDK Development On Off
Client Features
Client License On Off
Server Control On Off
Concurrent Clients On Off
Report Publisher On Off
GLP Compliance On Off
Virtual Column – Isocratic On Off
Virtual Column – Linear Gradient On Off
Xpress Mode On Off
SDK Features
ASAP On Off
Analyzer On Off
Customer Signature _________________________________
Qualification Executor _________________________________ Date _________________
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Section E. IQ Comments
E. IQ Comments
Section Comment/Action
Customer Signature _________________________________
Qualification Executor _________________________________ Date _________________
Doc. 065080- 02 Page 21 of 21
