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Installation Qualification Protocol Agilent Capillary Electrophoresis System

Contents
I. Protocol Approval ........................................................................................... 2 II. Document Revision History .......................................................................... 3 III. Scope / Purpose ............................................................................................. 4 IV. Exceptional Conditions ................................................................................ 5 V. Glossary ........................................................................................................... 6 VI. Instrument ...................................................................................................... 7 VII. Certification of Purchase Order Compliance ......................................... 14 VIII. Declaration of Change Control ............................................................... 15 IX. Validation Certificate .................................................................................. 16 X. Certification .................................................................................................. 17 XI. Attachments ................................................................................................. 18

This page will act as final verification that the above listed procedures were completed.

_________________________ Executing Engineers Name (Print Name)

___________________ Signature

_________ Date

Copyright Agilent Technologies 2000

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Protocol Approval

I. Protocol Approval
Protocol Acceptance / Approval by Customer
I agree that the installation procedures in this document are applicable to the equipment defined in Section VI.

_________________________ Customer Name

___________________ Signature

_________ Date

_________________________ Laboratory Supervisor/Manager

___________________ Signature

_________ Date

Protocol Acceptance / Approval by Agilent Technologies

I agree that the installation procedures in this document, assembled by Agilent Technologies Analytical Services, are appropriate for the equipment defined in Section VI. and reflect the current Agilent Technologies specifications for the equipment in Section VI.

_________________________ Executing Engineers Name

___________________ Signature

_________ Date

_________________________ Agilent Technologies Account Manager

___________________ Signature

_________ Date

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Document Revision History

II. Document Revision History

Approval Rev # Date Changes 1st Level 2nd Level Final

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Scope / Purpose

III. Scope / Purpose

This installation qualification protocol will be performed on the equipment specified in Section VI. The equipment specified comprises an Agilent capillary electrophoresis (CE) system. The installation qualification will document the physical placement of the instrument in the laboratory and verify it is properly identified and connected. The installation qualification also ensures the customer is properly familiarized with the installed equipment. This protocol will define the methods and documentation that will be used to evaluate the Agilent CE system for installation in accordance with Agilents specifications and intended use. Successful completion of this protocol will verify that the Agilent CE system has been installed to Agilents specifications. Hardware associated with the system shall be under configuration control. Change control procedures for configuration change shall be in place. The installation qualification will be performed by Agilent Technologies service personnel who are trained and knowledgeable about the equipment.

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Exceptional Conditions

IV. Exceptional Conditions

Any exceptional conditions encountered during the qualification studies will be documented at the time of occurrence and reviewed by Agilent Technologies personnel. Exceptional conditions will be investigated and the appropriate course of action determined, that is, repairs will be completed if instrument and failure are covered contractually, or a course of repair will be agreed upon if no contractual agreement is in force. If a new instrument fails the installation qualification, it may be covered under manufacturers warranty provided the conditions of the warranty have been met.

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Glossary

V. Glossary
Installation Qualification: Documented verification that all key aspects of hardware installation adhere to appropriate codes and approved design intentions and that the recommendations of the manufacturer have been suitably considered.

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Instrument

VI. Instrument
The instrument described on the subsequent pages will be installed in the location specified below: Company name: Location: Building #: Room: Department: Date of installation: Verified by (signature): Date:

Maintenance / Calibration Contracts and Warranties

A warranty statement can be found with the manual for each module. Appropriate calibrations may be performed prior to the execution of the operational qualification testing of this protocol. Instruments will be serviced by trained Agilent Technologies service representatives. Simple maintenance can be performed by a trained analyst using the manuals. Agilent Technologies has trained service representatives who perform maintenance or repairs on an as-called basis. Spare parts are listed in the individual manuals. Some parts are kept with the instrument and/or some are replaced by Agilent Technologies service representatives. Power and environmental requirements are referenced in the Users Guide. Expendables and consumables are found in the Agilent Technologies catalog Capillaries, Reagents and Supplies for Capillary Electrophoresis, publication number 5964-6639E.

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Instrument

Description Manufacturer: Model #: Serial #: Component #: System #: Firmware revision #: Agilent Technologies

Equipment and User Manual:

The Agilent Technologies manual is listed and documented: Product Title Part Number

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Instrument

System Check
This section contains the electrophoresis system check which is used to verify the system has been properly connected for both electronic and liquid operations. What You Will Need Instruments Agilent CE system and Agilent ChemStation.

Capillary Fused silica capillary with 40-cm leff, 50-m id and green alignment interface (provided as part of the Agilent CE hardware startup kit, part number G1600-68706). Chemicals The Agilent CE installation qualification (IQ) chemical kit (part number 5063-6514). This contains buffer (20 mM borate, pH 9.2, 100 ml), test sample (4-hydroxyacetophenone 1 mM, 2 ml) and capillary conditioning solution (1.0 N sodium hydroxide, 100 ml). The Preparing the Agilent CE System and Running the IQ Test following describes how to set up the method and run the IQ test sample. Follow the instructions as defined and compare the resulting electropherogram with that in Figure 1. 1 Follow the installation procedure as defined in the manual. 2 Prepare the instrument as described in the general setup. 3 Install solutions and vials as follows: 4 Select Edit Entire Method from the Method menu. This guides you through all the dialog boxes you need to access when creating a method. Edit Method screen Select the parts of the method you want to edit:

select Method Information select Instrument acquisition select Data analysis deselect Sequence Re-calibration select Run Time Checklist Method Information screen Type comment for the current method: Installation Qualification. Home Values screen Lift Offset: choose default (4 mm) 9 of 20

Installation Qualification Protocol Agilent Capillary Electrophoresis System Instrument

Solution 1-N NaOH Water Buffer Buffer Buffer Test sample Waste

Vial 1 2 4 5 6 7 8

Temperature: 20 C Inlet Home: 4 Outlet Home: 5 Conditioning screen Replenishment (none) Preconditioning: select Use Table and create the following entries Flush 5 minutes inlet 1 (position of 1.0 N NaOH): outlet 8 (waste vial) Wait 5 minutes Flush 20 minutes inlet 6 (buffer wash vial): outlet 8 (waste vial) Postconditioning (none) Injection screen Change injection to Pressure Apply 50 mbar for 4 s Electric screen switch electric: on polarity: positive voltage: 30 kV power: sys limit current: sys limit lower alarm limit: off Timetable screen 10 of 20

Installation Qualification Protocol Agilent Capillary Electrophoresis System Instrument

store data: voltage, current, temperature stoptime: 10 min postime: off timetable: no entries DAD Signals screen select the signals: A: 192,4 Ref: off B: 235,10 Ref: off C: 325,10 Ref: off Spectrum: Store All in peak Range: 190 to 400 nm Threshold: 1.00 mAU Peakwidth: select < 0.01 Autobalance: select Prerun Time table: no entries Stoptime: asHPCE Completing the Method for Data Analysis Signal Details Fraction Collection off Add signals A, B and C to the method Edit Integration Events Set the following integration parameters Initial Peak Area reject: 1.000 Initial Peak Width: 0.010 Initial Shoulders: off Initial Threshold: -1.000 Specify report Select the following report parameters: Destination: Screen and Printer Report style: Electropherogram and short Calculation based on Corrected Areas Setting the Run Time Checklist deselect Prerun macros select Data Acquisition select Standard Data Analysis

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Instrument

deselect Customized Data Analysis select Save GLP Data deselect Postrun macros save Method with Data Saving the Method After you have finished editing the method the system prompts you: Method has changed, do you want to save changes? Answer NO. Select Save method as and enter the file name IQ.M. Checking the Method Select Simulation from the Instrument menu. Start the simulation by selecting the >> button. The data acquisition part will be simulated and shown on the screen. Starting the IQ Test Analysis 1 Select Setup Sample Info from the Run Control menu Enter your name Select manual file naming Select the file name: IQ1 Select the directory: IQ Select file update: manual Select sample vial: 7 Put a comment in the comments line describing the method 2 Select Online Signals in the VIEW menu Add signal A to plot 1 Add signal B to plot 1 Add current to plot 2 3 Starting the run Start the run by selecting Run Method from the Run Control menu, or Start the run by selecting the Start button on the GUI. A typical electropherogram for this analysis is shown in Figure 1. Differences in migration times and areas of the peaks in your electropherogram and the

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Instrument

one shown in Figure 1 might be a result of variations in the concentration of the sample from batch to batch, variations in the quality of the fused silica capillaries from batch to batch and the capillary temperature. The original electropherogram should be printed and entered in the attachment Section XI. of the installation qualification. Figure 1
Absorbance [mAU] (192/4 nm) 4.0

A Typical Electropherogram

3.0

2.0

1.0

0 1.0 2.0 3.0 4.0 5.0 Time [min]

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Certification of Purchase Order Compliance

VII. Certification of Purchase Order Compliance

I certify to the best of my knowledge, the Agilent CE system installed on ______________ , and purchased under PO# _______________ , is in compliance with the specifications of the purchase order. Copies of the purchase order can be found in Section XI.

_________________________ Laboratory Supervisor/Manager

___________________ Date

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Declaration of Change Control

VIII. Declaration of Change Control

Change control procedures are in place in order to maintain the validation process. Any changes to the hardware and software of a computerized system must be clearly specified. A control system will determine the degree of revalidation required according to the extent of the changes. All details of the changes are thoroughly recorded and documented, together with details of completed tests and their results. Software status bulletins describing any known defects and giving recommendations on temporary work-around should be included as an attachment in the installation qualification.

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Validation Certificate

IX. Validation Certificate

Agilent Technologies provides the manufacturer a validation certificate for the Agilent CE system. The certificates can be found in Section XI.

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Certification

X. Certification
Installation Certification Instrument Name: Agilent CE system Certification Type: (Initial or Requalification)__________________________ Attach performance sticker to instrument: (Yes/No) ____________________

_________________________ Executing Engineers Name Analytical Service Dist. (print name)

___________________ Signature

_________ Date

_________________________ Laboratory Supervisor / Manager (print name) NOTE

___________________ Signature

_________ Date

This document provides a protocol to verify and record configuration and operation of analytical laboratory equipment from Agilent Technologies . It has been prepared from documents (and best practices) of Agilent Technologies customers and has been found to be of use to them in satisfying the configuration and operational verification and recording requirements of various laboratory certification programs. However, certification depends upon many factors and use of this protocol alone does not assure certification and Agilent Technologies makes no promises or representations as to its sufficiency for any specific certification program.

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Attachments

XI. Attachments
This section will contain any additional documents not included in the body but referenced in the table of contents. Example: Declaration of Conformity Are attachments referenced in Table of Contents: Yes / No If no, list below. Document name: _________________________________________________________________ _________________________________________________________________ _________________________________________________________________ _________________________________________________________________ _________________________________________________________________

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Attachments

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Installation Qualification Protocol Agilent Capillary Electrophoresis System Attachments

Copyright Agilent Technologies 2000

Printed in Germany Edition 02/00 Part No. G1600-90011