View More Resources at Chomatography.

co

Agilent 1200 Series

Qualification Workbook

Agilent Technologies
Notices
© Agilent Technologies, Inc. 2006 Warranty defined in FAR 52.227-19(c)(1-2) (June
1987). U.S. Government users will receive
No part of this manual may be reproduced in The material contained in this docu-
any form or by any means (including elec- no greater than Limited Rights as defined in
ment is provided “as is,” and is sub- FAR 52.227-14 (June 1987) or DFAR
tronic storage and retrieval or translation ject to being changed, without notice, 252.227-7015 (b)(2) (November 1995), as
into a foreign language) without prior agree- in future editions. Further, to the max-
ment and written consent from Agilent applicable in any technical data.
imum extent permitted by applicable
Technologies, Inc. as governed by United law, Agilent disclaims all warranties,
States and international copyright laws. Safety Notices
either express or implied, with regard
to this manual and any information
Manual Part Number contained herein, including but not
limited to the implied warranties of
CAUTION
G1310-90300
merchantability and fitness for a par-
ticular purpose. Agilent shall not be A CAUTION notice denotes a haz-
Edition
liable for errors or for incidental or ard. It calls attention to an operat-
02/06 consequential damages in connec- ing procedure, practice, or the like
Printed in Germany tion with the furnishing, use, or per- that, if not correctly performed or
formance of this document or of any
Agilent Technologies information contained herein. Should adhered to, could result in damage
Hewlett-Packard-Strasse 8 Agilent and the user have a separate to the product or loss of important
76337 Waldbronn, Germany written agreement with warranty data. Do not proceed beyond a
Microsoft ® is a U.S. registered trademark terms covering the material in this
document that conflict with these
CAUTION notice until the indicated
of Microsoft Corporation.
terms, the warranty terms in the sep- conditions are fully understood and
arate agreement shall control. met.
Technology Licenses
The hardware and/or software described in
this document are furnished under a license
WA R N I N G
and may be used or copied only in accor-
dance with the terms of such license. A WARNING notice denotes a
hazard. It calls attention to an
Restricted Rights Legend operating procedure, practice, or
If software is for use in the performance of a the like that, if not correctly per-
U.S. Government prime contract or subcon- formed or adhered to, could result
tract, Software is delivered and licensed as in personal injury or death. Do not
“Commercial computer software” as
defined in DFAR 252.227-7014 (June 1995), proceed beyond a WARNING
or as a “commercial item” as defined in FAR notice until the indicated condi-
2.101(a) or as “Restricted computer soft- tions are fully understood and
ware” as defined in FAR 52.227-19 (June met.
1987) or any equivalent agency regulation or
contract clause. Use, duplication or disclo-
sure of Software is subject to Agilent Tech-
nologies’ standard commercial license
terms, and non-DOD Departments and
Agencies of the U.S. Government will
receive no greater than Restricted Rights as

Agilent 1200 Series Qualification Workbook

About this Book…
This Qualification Workbook for the AGILENT TECHNOLOGIES
1200 Series systems and modules for LC contains documents of
the 4 phases of the entire instrument life in a user's laboratory:
• Design Qualification (DQ),
• Installation Qualification (IQ),
• Operational Qualification (OQ),
• Performance Qualification (PQ).

The book will help to demonstrate, e.g. in case of an audit or

inspection, that the instrument is qualified independent of its
age. For this purpose the workbook needs to be updated
regularly.
The documents in the chapter Design Qualification (DQ) Phase
demonstrate the qualification of the vendor and the
instrument's functional and performance specifications.
Because system qualification is not a one-time event Agilent
Technologies has set-up processes to enable qualification during
the entire product life. Therefore the workbook contains
examples for qualification documents of the other phases of the
instrument's lifetime. The user must replace them with the
originals at appropriate time. The user should feel free to add
further documents whenever he/she thinks this is
appropriate(1).
The AGILENT TECHNOLOGIES 1200 Series Qualification
Workbook contains documents for a 1200 Series system
containing at least one of the following 1200 Series modules.

Please printout this document and put it in a binder. You can add your own material to this
NOTE Qualification Workbook.

Module
• isocratic pump
• binary pump
• binary pump SL
• capillary pump
• nanoflow pump
• quaternary pump

Agilent 1200 Series Qualification Workbook

 • vacuum degasser
• micro vacuum degasser
• manual injector
• autosampler
• high performance autosampler
• high performance autosampler SL
• thermostatted autosampler
• thermostatted high performance autosampler
• thermostatted column compartment
• thermostatted column compartment SL
• variable wavelength detector
• variable wavelength detector SL
• diode array detector
• diode array detector SL
• fluorescence detector
• LC/MSD module
• handheld controller Instant Pilot
• AGILENT TECHNOLOGIES ChemStation for LC Systems

1 Overview

2 Design Qualification (DQ) Phase

3 Installation Qualification (IQ) Phase

4 Operational Qualification (OQ) Phase

5 Performance Qualification (PQ) Phase

Agilent 1200 Series Qualification Workbook

 Contents

1 Overview
Introduction
Design Qualification (DQ) Phase
Installation Qualification (IQ) Phase
Operational Qualification (OQ) Phase
Performance Qualification (PQ) Phase
Agilent´s line of proven qualification products and services

2 Design Qualification (DQ) Phase

Iso 90001: Valid June 2006 Certificate
Pump Specifications
G1310A Isocratic Pump
G1311A Quaternary Pump
G1312A Binary Pump
G1312B Binary Pump SL
G1361A Preparative Pump
G1376A Capillary Pump
G2226A Nano Pump
Injection Systems Specifications
G1329A Autosampler 100 µl metering head
G1329A Autosampler 900 µl metering head
G2260A Preparative Autosampler
G1367B High Performance Autosampler and
G1367C High Performance Autosampler SL
G1377A Micro Well plate Sampler
Detectors Specifications
G1314B Variable Wavelenght Detector and
G1314C Variable Wavelenght Detector SL
G1315B Diode Array Detector
G1365B Multible Wavelength Detector

Agilent 1200 Series Qualification Workbook

Contents

G1315C Diode Array Detector SL

G1365C Multible Wavelength Detector SL
G1362A Refractive Index Detector
Fraction Collectors Specifications
G1364B Fraction Collector preparative scale
G1364C ANALYTICAL SCALE Fraction Collector
G1364D Micro Collector/Spotter
Valves Specifications
G1157A Agilent 1200 Series 2 position / 10 port valve
G1158A Agilent 1200 Series 2 position / 6 port valve
G1159A Agilent 1200 Series 6 position selection valve
G1160A Agilent 1200 Series 12 position/ 13 port selection valve
G1162A Agilent 1200 Series 2 position/ 6 port micro valve
G1163A Agilent 1200 Series 2 position/ 10 port micro valve
Miscellaneous Specifications
G1322A Vacuum Degasser
G1379B Micro Vacuum Degasser
G1316A Thermostatted Column Compartment
G1316B Thermostatted Column Compartment
G1330A Autosampler Thermostat
Agilent ChemStation Specifications
Agilent ChemStation Plus Specifications
Compliance
Customer contributed documents

3 Installation Qualification (IQ) Phase

Side Preparation Specification Checklist
Agilent 1200 Series Liquid Chromatograph Hardware Site Preparation
Specification
Agilent 1200 Series LC/MSD G1956A/B, G2908BA, G3218AA, G3218BA Site
Preparation Specification

Agilent 1200 Series Qualification Workbook

 Contents

Agilent ChemStation Software Modules G2070BA, G2071BA, G2072BA,

G2170BA, G2171BA, G2180BA Software Site Preparation Specification
B.02.01
Agilent ChemStation Software Modules G2070BA, G2071BA, G2072BA,
G2073BA, G2170BA, G2171BA, G2180BA, G2090BA, G2710BA, G1601BA,
G2201BA B.02.01 Upgrade Site Preparation Checklist
Installation Qualification
Agilent 1200 Series Liquid Chromatograph Hardware and Software Installation
Checklist
Agilent LC and CE ChemStation Software G2170BA, G2171BA, G2175BA,
G2180BA, G2185BA,G211601BA, G2172BA, G2205BA Software Installation
Checklist B.02.0x
Familiarization Checklist
Agilent 1200 Series Liquid Chromatograph Famliarization Checklist
Agilent 1200 Series Liquid Chromatograph Scorp of Work Installation and
Famliarization
Declaration of Conformity and System Validation
Declaration of Conformity According to ISO/IEC Guide 22 and CEN/CENELEC
EN 45014
Declaration of Conformity to mannufacturing Specifications
ChemStation Declaration of System Validation
ChemStation Installation Verification Report
Customer contributed documents

4 Operational Qualification (OQ) Phase

OQ/PV Protocols
Agilent ChemStation Verification Test Report
Certificates showing tracebility of:
Standard: Caffeine Kit
Holmium Oxid Glass Filter (Type Hoya HY-1)
Customer contributed material

Agilent 1200 Series Qualification Workbook

Contents

5 Performance Qualification (PQ) Phase

Preventive Maintenance Checklist
Agilent 1200 Series Liquid Chromatograph Preventive Maintenance Checklist
Agilent 1200 Series Liquid Chromatograph Scorp of Work Preventive
Maintenance
Agilent 1100/1200 Series LC/MSD Quad Major Preventive Maintenance
Checklist
Agilent 1100/1200 Series LC/MSD Quad Major Interim Preventive
Maintenance Checklist
System performance and noise
Customer contributed material

Agilent 1200 Series Qualification Workbook

System Description

This book is dedicated to the HPLC system below.

System #

Manufacturer

Module Model #

Serial # Firmware Revision # System #

Module Model #

Serial # Firmware Revision # System #

Module Model #

Serial # Firmware Revision # System #

Module Model #

Serial # Firmware Revision # System #

Module Model #

Serial # Firmware Revision # System #

Module Model #

Serial # Firmware Revision # System #

Module Model #

Serial # Firmware Revision # System #

Module Model #

Serial # Firmware Revision # System #

 Agilent 1200 SERIES HPLC SYSTEM CHANGE CONTROL DOCUMENT

System # Location

Date Details of Change Reason for Change Change Details of Reason for Results of Approved
made By Qualification Qualification Qualification for Use By

Change Control Document Number [ ]

Effective 02/03/2006 1-1 Revision A.01.01

 Agilent 1200 Agilent 1200 Series
Qualification Workbook

1
Overview
Introduction
Agilent´s line of proven qualification products and services

This chapter gives you a short introduction to this workbook

Agilent Technologies
1 Overview
Introduction

Introduction

Proper functioning and performance of equipment plays a major role in

obtaining consistency, reliability and accuracy of analytical data. Therefore,
equipment qualification should be part of any good analytical practice (1).
The term qualification, as previously applied for qualification of computer
systems by the U.S. Pharmaceutical Manufactures Association, has been
broken down by Freeman and coworkers (2) into four areas, which describe
the entire life of the equipment:
• Design qualification (DQ) for setting functional and performance
specifications (operational specifications),
• Installation qualification (IQ) for performing and documenting the
installation in the selected user environment,
• Operational qualification (OQ) for testing the equipment in the selected
user environment to ensure that it meets the previously defined functional
and performance specifications,
• Performance qualification (PQ) for testing that the system consistently
performs as intended for the selected application

Agilent 1200 Series Qualification Workbook

 Overview 1
Introduction

Qualifications Time Line

Design Install Prepare Start-up Operate

Design Installation Operational

qualification Performance
qualification qualification
(DQ) qualification
(IQ) (OQ/PV)
(PQ)
Calibrations Calibrations
DQ OQ PQ
IQ
Phase Phase Phase
Phase

Equipment qualification

User's responsibility

Vendor assistance

Documentation Personal support/SOPs/Software Software

Figure 1 Qualifications time line

Agilent 1200 Series Qualification Workbook

1 Overview
Introduction

Design Qualification (DQ) Phase

Definition and frequency
Design qualification defines the functional and operational specifications of
the equipment and details the conscious decisions in the selection of the
supplier (3). The DQ phase is finished with the purchase of the equipment.

Who performs design qualification

The user always should perform DQ. The instrument's functional and
performance specifications from the vendor can be used as a source for
information

The AGILENT TECHNOLOGIES 1200 Series concept

All Agilent Technologies liquid chromatography systems are developed and
produced in compliance with the International Organization for
Standardization quality standards ISO 9001 (refer to ISO 9001 certificate in
chapter Design Qualification (DQ) Phase), and in accordance with the
specifications of AGILENT TECHNOLOGIES' Life Science and Chemical
Analysis Group life-cycle document.
The life-cycle concept for product development and validation is common in
many engineering and manufacturing fields and was proposed by the
American National Standards Institute (ANSI), the Pharmaceutical
Manufacturers Association (PMA) , the US Environmental Protection Agency
(EPA) and the International Organization for Standardization (ISO). Software
products are in addition developed and produced in compliance with ISO
9000-3 as a guide (refer to itqs certificate in chapter Design Qualification (DQ)
Phase).
Prior to shipment to the customer, each AGILENT TECHNOLOGIES 1200
Series hardware module is verified in the factory and is shipped together with
a
• Declaration of Conformity, figure 2, which declares that the instrument has
successfully passed all production quality tests
• Declaration of Conformity according to ISO/IEC Guide 22 and EN 45014.
This document states that the product conforms to the safety and
electromagnetic conductivity specifications and carries the CE marking.

Agilent 1200 Series Qualification Workbook

 Overview 1
Introduction

Figure 2 Declaration of Conformity

Every AGILENT TECHNOLOGIES ChemStation is shipped with the

• Declaration of System Validation, figure 3. The document declares that the
AGILENT TECHNOLOGIES ChemStation software was developed, tested
and successfully validated according to the Software Life Cycles, and
Quality Manuals followed by the solution units of the AGILENT
TECHNOLOGIES Life Science and Chemical Analysis Group.

Agilent 1200 Series Qualification Workbook

1 Overview
Introduction

Although the declarations belong to the DO phase we have added an example

copy of each to the chapter Installation Qualification (IQ) Phase, because the
installing customer engineer will attach the originals to the Installation
Qualification Protocol to demonstrate that he/she has installed factory
verified equipment.

Figure 3 Declaration of System Validation

Contribution of the Qualification Workbook

The chapter Design Qualification (DQ) phase contains documents on the
qualification of the vendor and on the design qualification of the equipment.
The user has to add further documents, e.g. detailing his conscious decisions
in the selection of the supplier (1).

Agilent 1200 Series Qualification Workbook

 Overview 1
Introduction

Installation Qualification (IQ) Phase

Definition and frequency
Installation qualification (IQ) establishes that the instrument is received as
designed and specified, that it is properly installed in the selected
environment, and that this environment is suitable for the operation of the
instrument (3). The IQ phase is finished after the successful installation and
the signing of the Installation Qualification Protocols by a trained
representative of AGILENT TECHNOLOGIES and the customer.

Who performs installation qualification?

IQ for large, complex instruments as liquid chromatographs should be
performed by vendors. Only for small, low-cost instruments such as pH meters
IQ can be performed by users.

The AGILENT TECHNOLOGIES 1200 Series concept

The process is broken into
• Installation Qualification for Hardware
The installation follows a documented procedure. The equipment is checked
for completeness and proper function after installation. AGILENT
TECHNOLOGIES provides field proven protocols for Installation Qualification
(IQ) which is followed, filled out and signed by a trained AGILENT
TECHNOLOGIES representative during an installation. For a system that
consists of several modules, IQ includes an injection and qualitative
evaluation of the isocratic standard sample, which verifies the correct
installation of all fluid and electrical tubing and cables.
• Installation Qualification for software and computer systems

The installation of software follows a documented procedure. Installation of

software on a computer is checked for integrity. AGILENT TECHNOLOGIES
provides installation qualification software for integrity check of the
AGILENT TECHNOLOGIES ChemStation software, which is executed
during installation.

Agilent 1200 Series Qualification Workbook

1 Overview
Introduction

Contribution of the Qualification Workbook

The chapter Installation Qualification (IQ) Phase contains documents showing
current installation qualification. The chapter must be updated by the user if a
change happens to the system, e.g. when a new software revision is installed.

Operational Qualification (OQ) Phase

Definition and frequency
Operational qualification is the process of demonstrating that an instrument
will function according to the operational specification in the selected
environment (3). This process is called
Operational Qualification (OQ) in the Pharmaceutical/FDA environment and
Performance Verification (PV) in the ISO/EN/Accreditation environment.
The tests have to be performed by the user on a regular basis. In general, users
should select time intervals between the tests so the probability is high that all
parameters still are within the operational specifications. Typically the
respective tests should be performed:
• After installation,
• After a change to the system,
• After a major repair
• At defined time intervals. For AGILENT TECHNOLOGIESLC equipment the
interval is typically one year.

Who performs operational qualification/performance verification?

OQ can be performed either by vendors or users. Business or economics needs
rather than technical concerns determine this choice. The decision mainly
depends on the resources available at the user's site and on the vendor's
capability to offer the service with high quality.

Agilent 1200 Series Qualification Workbook

 Overview 1
Introduction

The AGILENT TECHNOLOGIES 1200 Series concept

Automated OQ/PV of equipment hardware and complete systems. OQ/PV tests

include rigorous performance testing of the instruments on-site. A report is
generated with acceptance criteria, actual results and pass/fail comments that
are acceptable to investigators/auditors.

Automated OQ/PV of AGILENT TECHNOLOGIES ChemStation The correct

function of the AGILENT TECHNOLOGIES ChemStation should be checked
prior to routine use, after module and system updates, for example, after
changing a processor board on the computer or after software updates. The
AGILENT TECHNOLOGIES ChemStation's OQ/PV software checks key
functions of the software, such as data acquisition, peak integration,
quantitation, file storage and retrieval. It checks any influence from the
environment, e.g., motors, high frequency lamps, on data transfer.
Results generated during the AGILENT TECHNOLOGIES ChemStation
verification are compared to known, prerecorded values. The same principle
may be applied to data files and methods generated by the user. A report is
printed that is acceptable to investigators/auditors.

Contribution of the Qualification Workbook

The chapter Operational Qualification (OQ) phase contains examples of
documents as the OQ/PV reports on the AGILENT TECHNOLOGIES 1200
modules and the AGILENT TECHNOLOGIES ChemStation, which demonstrate
that the equipment functions according to operational specifications.
The documents must be updated by the user whenever tests have been
performed.

Performance Qualification (PQ) Phase

Definition and frequency
Performance qualification is the process of demonstrating that an instrument
consistently performs according to a specification appropriate for its routine
use (3).

Agilent 1200 Series Qualification Workbook

1 Overview
Introduction

The test frequency - every day, every month or whenever the instrument is
used - is much higher than for OQ. It depends not only on the stability of the
equipment but on everything in the system that may contribute to the
analytical results, e.g. column and detector lamp. The test criteria and
frequency should be determined during the development and validation of the
AGILENT TECHNOLOGIESLC method.
Another difference is that PQ always should be performed under conditions
that are the same or similar to routine sample analysis.

Who does performance qualification?

PQ always should be performed by users because it is application specific, and
vendors may be unfamiliar with the applications.

The AGILENT TECHNOLOGIES 1200 Series concept

Intelligent system suitability check

The AGILENT TECHNOLOGIES ChemStation includes intelligent system

suitability testing in which users measure and compare critical key system
performance characteristics with documented, preset limits.
For example, users could inject a well characterized standard five or six times
and then compare the standard deviation of the amounts with a predefined
value. If the limits of detection and quantitation are critical, users should test
the lamp's intensity profile or the baseline noise.
Maintenance Checklists, Early Maintenance Feedback and Maintenance
Logbooks.
Users of equipment are required to develop an ongoing maintenance and
calibration program. The idea of the preventive maintenance is to avoid
instrument failures.
If in FDA regulated pharmaceutical quality control laboratories a specific
analysis is out of specification, for any reason, it is no longer acceptable to just
adjust a few parameters, to repeat the analysis and average the results. For
each out of specification analysis, a failure investigation has to be done (4).
Therefore laboratories do their utmost to maintain instruments such that false
results are avoided.

Agilent 1200 Series Qualification Workbook

 Overview 1
Introduction

The AGILENT TECHNOLOGIES 1200 Early Maintenance Feedback (EMF)

system informs the user when actual usage level have exceeded their user
specified limits. Examples are:
• usage of detector lamps,
• mobile phase usage and wear counts,
• number of injections.
In addition maintenance activities can be performed by trained customer
engineers on a timely basis. The maintenance activities should be documented
in the electronic loogbook.

Contribution of the Qualification Workbook

The chapter Performance Qualification (PQ) phase contains examples of
documents to demonstrate that the equipment performs according to a
specification for its routine use. It also contains documents to show that it is
well maintained. Typical examples are:
• System suitability reports
• Copies of maintenance logbooks
• Maintenance checklists
System suitability reports have to be updated by the user depending on the
frequency determined during method development and validation of the
method. The other documents need to be updated based on EMF information
and whenever Planned/Preventive Maintenance is performed.
Heinz Goetz, Ph.D.
1200 Series Worldwide Product Manager
AGILENT TECHNOLOGIES R&D and Marketing GmbH & Co. KG
Ger-76337 Waldbronn

Agilent 1200 Series Qualification Workbook

1 Overview
Introduction

References:
(1) L. Huber, LC?GC 16(2), 149-156
(2) M. Freeman, M. Leng, D. Morrison, and R.P. Morrison,
Pharm. Techn0l. Eur. 7(10), 40-46 (1995)
(3) P. Bedson, M. Sargent, Accredidation and Quality Assurance 1 (6), 265-274
(1996)
(4) United States FDA, Guide to Inspection of Pharmaceutical Quality Control
Laboratories, Final Rule, USA FDA, Rockville, 1993

© Copyright Agilent Technologies Company 2006

All rights reserved. Reproduction, adaption, or translation without prior

written permission is prohibited, except as allowed under the copyright laws.

The information contained in this document is subject to change without

WA R N I N G notice.Agilent Technologies makes no warranty of any kind with regard to this
material, including, but not limited to, the implied warranties or
merchantability and fitness for a particular purpose.Agilent Technologies
shall not be liable for errors contained herein or for incidental or
consequential damages in connection with the furnishing, performance, or use
of this material.

Agilent 1200 Series Qualification Workbook

 Overview 1
Agilent´s line of proven qualification products and services

Agilent´s line of proven qualification products and services

Agilent has been a worldwide Compliance leader for two decades. The
unmatched experience of our experts goes into each of our compliance
services. Agilent can provide you with the compliance tools, knowledge,
service and support necessary to keep your lab operatiing smoothly and
efficiently. For an overview refer to the brochure "
Can you take the heat - Don´t get burned by compliance". On the next pages
you find the brochure.

Agilent 1200 Series Qualification Workbook

5988_6910EN.QXD 7/3/02 11:19 AM Page 1

Can you take the heat

Don’t get burned by compliance
5988_6910EN.QXD 7/3/02 11:19 AM Page 3

Agilent’s line of proven qualification products and

services takes the heat off you…and your lab

The one-source solution for

qualification and validation
Compliance is a necessary and demanding Agilent provides the most complete line of
load on a lab’s resources. If not well compliance products and services available
managed and implemented it can become – allowing labs to select service for Agilent
a growing inferno, which can lead to severe instruments, Agilent software and even
penalties and financial consequences. products from other manufacturers.
In addition, compliance standards are Agilent offers a complete compliance
constantly evolving and therefore create program that enables lab managers to make
a “moving target” and a significant source one call for any or all of their needs – no
Overall benefits: of stress for those involved in the process. matter what the brand, no matter what the
• Provide evidence to satisfy requirements Let Agilent remove the stress of compliance service. Agilent offers customer-focused
of monitoring agencies and and take the heat off you and your lab – products and services for all stages of an
organizations. once and for all. Then, your lab can focus instrument’s life cycle. From installation and
• Save time and money by eliminating on analytical results, not extinguishing the upgrade to operation and repair – Agilent
the need to write your own operating flames of non-compliance. provides the resources and tools necessary
procedures or monographs and training to ensure compliance is not a burning issue.
your staff.
• Ensure that all equipment is performing
to manufacturers’ standards.
• Receive uniform documentation that
provides consistent, traceable results
among all locations – worldwide.
• Decrease risk of financial loss due to
noncompliance.
• Reduce complexity of scheduling
multiple vendors.
• Allow scientists and staff to focus on
research, not compliance.

2
5988_6910EN.QXD 7/3/02 11:19 AM Page 4

When compliance heats up, Agilent keeps you cool

Compliance products and services Operational Qualification (OQ) Performance Qualification (PQ)
for Agilent instruments ensures basic accuracy from maximizes uptime and productivity
An investment in Agilent instruments the beginning PQ is a method for a lab to perform ongo-
ensures maximum productivity. To maintain After IQ, OQ is performed to verify and ing self-validation and is an excellent way
the highest level of operation, a suite of document an Agilent instrument’s ability to to head off potential problems before they
products and services is available. meet specified performance criteria after it occur. Small problems can be identified
These products and services take into is installed. OQ involves a comprehensive and remedied, before they become costly.
account the various phases of an test of the complete system using In addition, consistent PQ allows formal
instrument’s life cycle and allow the lab established conditions and known sample compliance procedures to move much
to customize a compliance program based characteristics. A key benefit to this more rapidly because there are traceable
on specific needs. From installation procedure is to ensure the basic accuracy paths of documentation demonstrating
to ongoing support, Agilent has and precision of the instrument or system prior inspections and service.
compliance covered. and to uncover any potential problems
before they occur. Agilent recommends To support a lab’s PQ program, Agilent
Installation Qualification (IQ) preventive maintenance for OQ. offers preventive maintenance services
provides validation upon delivery to ensure maximum instrument uptime
IQ ensures that new Agilent hardware Recommended times for OQ and extended life. Agilent’s service
and software is installed correctly from • Installing hardware or software professionals can perform a documented
the moment it is unpacked to the point it • Repairing a major piece of hardware list of maintenance procedures on your
is ready for operation – documenting the • Any software change that affect instrument prior to performing a qualifica-
completeness of shipping, the operating system security, data integrity or tion procedure. Preventive maintenance
environment and the components of administrative controls can be scheduled to coincide with PQ
the system. to minimize instrument downtime.
Repair Qualification (RQ) restores
Recommended times for IQ equipment validation A lab’s validation plan or change control
• Moving an instrument to another RQ is a must for any service or program should define when it needs to
laboratory maintenance performed on Agilent qualify instruments and software to ensure
• Adding components to an instrument instruments. RQ provides documented compliance with quality and regulatory
• Installing hardware or software evidence that proper techniques and requirements.
• Installing a software patch, procedures are utilized. This is
update or other application accomplished through ISO trained
technicians who use traceable,
documented tools and equipment
to ensure that the work they do
meets all facets of compliance.

3
5988_6910EN.QXD 7/3/02 11:19 AM Page 5

Compliance solutions for all Agilent software

Accurate data management is critical Design Qualification (DQ) is a step ChemStation Plus NDS –
in the right direction Modular software for more control
to a lab’s total compliance agenda. The first step in any compliance program is and more productivity
Design Qualification. This process requires The ChemStation family provides a
Agilent offers a range of products to the lab to document user requirements modular approach to instrument control,
and Agilent instrument functional/opera- data acquisition and data management,
help facilitate information handling tional specifications. The instrument ven- allowing a lab to choose a system that
dor also has to be qualified for appropriate meets current and future needs.
and security. This variety allows a software development processes. To assist To accomodate these changing needs,
the lab in this process, Agilent utilizes an the scalable solution starts with
lab to maintain compliance from the
extensive list of functional specifications ChemStation base software and
for computer systems that allows applica- add-on software modules that cover
day software is installed, through
ble functions and specifications to be security and compliance to expand the
everyday use, and into upgrade and qualified for their intended uses. Agilent system's capabilities.
also provides documented evidence that
service – providing continued software and computer systems have
been developed and validated according
productivity with minimal downtime. to standardized procedures such as
ISO 9001.

ChemStation Plus
Incorporates the ChemStation base
software, plus allows the addition of
any of the available add-on modules.

ChemAccess
Provides the ability to control and
ChemStation monitor Agilent instruments from
Start with the ChemStation base anywhere on the network.
software for control of LC, LC/MS,
GC, CE and CE/MS instruments, Security Pack
then expand the sytem’s power with Add Security Pack to accelerate review
add-on modules for data organization and approval of results as well as provide
and storage remote control and monitoring, support of regulatory requirements such
compliance with regulator guidelines and as the FDA’s ruling on electronic records
for validation of analytical methods. and signatures, 21 CFR Part 11.

Built-in user administration allows only authorized users to

connect to the database.

Level-4 instrument control provides for diagnostics that

enable a lab to interpret instrument systems and perform
repairs on-site.

Electronic signatures for full support of 21 CFR Part 11.

4
5988_6910EN.QXD 7/3/02 11:19 AM Page 6

Method Validation (MV) qualifies the Cerity Networked Data Systems –

process to make your work easier Lab-specific software for
If the analytical method isn’t validated, smoother workflow
then qualified instruments don’t matter. The Cerity NDS family provides lab-specific
Method Validation is yet another critical software applications that model the way
component in the compliance process. analysts work, making every step of the
Methods must be validated after their lab’s workflow more efficient. For regulat-
development and prior to routine use. ed environments, the Cerity NDS for
And if any parameter is changed signifi- Pharmaceutical QA/QC provides a secure
cantly, the method must be validated data management system where
again. Agilent’s MV products will ensure procedures must be followed according to
that processes meet the standards of compliance requirements such as 21 CFR
such organizations as United States Part 11. Version control, inherent data
Pharmacopoeia (USP) and the International integrity and security, and an automatic,
Conference on Harmonization (ICH). One fully traceable audit trail ensure no records
such product is the Method Validation Pack can be overwritten.
available for the Agilent ChemStation Plus
software package and is just one of many
software solutions for all validation needs.

Cerity NDS for

Pharmaceutical QA/QC
Specifically designed to meet the unique and
Method Validation Pack wide-ranging requirements of QA/QC labs in
Add Method Validation Pack to support the val- the pharmaceutical industry.
idation of analytical methods according to ICH
and Pharmacopoeia requirements as well as 21
CFR Part 11.

Level-4 control of networked

instruments means reliable,
trustworthy and traceable data.

Validation planning according to USP, EP, ICH and

FDA guidelines.

A complete test suite meets the major industry method Built-in spreadsheet eliminates manual data transcription,
validation guidelines. lowering validation costs. 5
5988_6910EN.QXD 7/3/02 11:19 AM Page 7

Agilent can train you and your staff to

avoid compliance flare ups
Agilent offers broad-scope training courses For convenience, standardized courses
for regulatory compliance to ensure are offered in select locations worldwide.
research methods are up to date and Or, on-site courses can be tailored to
suitable for specific purposes. In addition, specific needs and time frames. For the
training will enable lab staff to create ultimate in convenience, Agilent offers
traceable chains that provide the complete e-seminars as a way to advance
records required by regulatory agencies to knowledge and improve lab skills on
demonstrate proper laboratory analyses. a specific subject. Each seminar lasts
between 60 and 90 minutes and enables
Agilent has a comprehensive training researchers to gather usable information
curriculum dedicated to the needs of the from their desktops – eliminating
pharmaceutical industry. These courses expensive and time-consuming travel.
offer basic and advanced training in liquid Agilent e-seminars keep scientists up to
chromatography techniques, chemical date on pertinent qualification techniques
analysis hardware and software operation and procedures, troubleshooting and
as well as data analysis and reporting. system optimization techniques.
These courses allow the pharmaceutical
laboratory to use chemical analysis instru- Featuring a user-friendly internet
ments at their most productive levels – conferencing system that allows you
giving greater return on investment for all to interact with the speaker, e-seminars
lab resources. In addition, courses cover enable the attendee to participate from
methods to improve the quality of data the office, home or out of town using a
Training courses for regulatory and how to improve troubleshooting skills. basic internet connection and a browser
compliance in the pharmaceutical such as Microsoft® Internet Explorer or
industry Netscape Navigator. You can find a
Instrumentation Qualification – This IQ/OQ complete listing of compliance related
course covers the basic principles of e-seminars at:
chromatography instrument operation, www.agilent.com/chem/eseminars.
focusing on design qualification (DQ), installation
qualification (IQ), and operational qualification
(OQ) for liquid chromatographs, UV-Vis
spectrophotometers, infrared spectrometers
and automated workstations.

Method Validation – This course covers why

an analytical method should be validated
and which parameters must be validated
for pharmaceutical applications. in addition,
this course reviews current techniques of
method validation, shows the steps for
validating a method, describes how data
is obtained, and explains how to
ensure that a method is appropriate
for the purpose. It uses practical
pharmaceutical examples to
demonstrate how method
validation works within ISO
and GMP/GLP environments.

6
5988_6910EN.QXD 7/3/02 11:19 AM Page 8

Multi-Vendor Validation Program* Multi-Vendor Validation

offers a single solution Program benefits
Compliance offers enough challenges on • A single master plan that is simplified
its own – then consider that many labs uti- for ease of use.
lize many different brands of instruments. • Harmonization of protocols to reduce
The task can be daunting. Agilent offers a effort of instrument validation.
solution based on a single set of protocols • Coverage of all instruments, regardless
applicable across a variety of instruments, of manufacturer, from a single vendor.
regardless of manufacturer. Laboratories • Unique, metrology-based technique
that are seeking methods to streamline made possible by the GLP-100, a
experiments and increase productivity proprietary test-box tool that measures
can rely on the Multi-Vendor Validation the basic physical parameters of your For more information regarding
Program. It allows a lab manager to make instruments. a successful compliance program
one call, schedule one vendor, and keep • A customizable program with qualifica- Go to www.agilent.com/chem and look
disruption to an absolute minimum. tions performed under test conditions up our online brochure, “5-Step Concept to
This program can be applied to many and parameter ranges you design. Successful Compliance.”
instruments, including the following: #5988-7026EN
• UV Spectrophotometer International protocol acceptance
• Liquid Chromatograph (LC) There are a variety of national and interna-
• LC/MS tional regulatory and quality standards that Expert advice from the expert himself
• Gas Chromatograph (GC) require laboratory equipment be validated To facilitate international compliance
• GC/MS upon installation and after upgrade or programs, products and services, Agilent
• Dissolution Tester repair. Agilent qualification protocols have employs experts like Ludwig Huber, Ph.D
• Capillary Electrophoresis a proven record of success in satisfying (Worldwide Product Marketing Manager for
these requirements. Agilent protocols have HPLC products and pharmaceutical industry
*Not available in all areas. gone unchallenged in numerous audits solutions at Agilent Technologies). Dr. Huber
worldwide. serves as a consultant for industry and
regulatory agencies on laboratory compliance
Agilent’s protocols have been designed issues like the US PDA task force on 21 CFR
to comply with regulations and standards Part 11 and on the GAMP Special Interest
such as: Group for Laboratory Equipment. He is also
• GMP of US FDA and other agencies on the advisory board for the European
• GLP of US FDA, OECD and other Compliance Academy.
agencies
• 21 CFR Part 11 on e-records/signatures It is this sort of expertise that drives our
• ISO 17025 (replaces EN 45000/45001) compliance programs and enables them
• ISO 9000 series to deliver the results your lab demands. This
level of experience and wealth of knowledge
is available online, by registering for one of
the many e-seminars, by contacting the
Agilent compliance team directly at
www.agilent.com/chem
“It is our goal to allow
or by contacting Dr. Huber directly at
Agilent customers to [email protected] or via
telephone at +49 7243 602209.
comply at the lowest
cost and with the
highest confidence.”
– Dr. Ludwig Huber
7
5988_6910EN.QXD 7/3/02 11:19 AM Page 2

For more information visit us at: www.agilent.com/chem

Confidence is knowing you’ll never

be burned by compliance
Confidence begins with knowing that
Agilent’s internal procedures are as exact
and traceable as the procedures we
employ at laboratories worldwide.
We utilize exact documentation paths to
create, test and review the products and
services we offer. Our service professionals
arrive at your site trained and certified
under a factory program registered to
ISO 9001 – with training records for our
service professionals available upon
request. Each service professional carries
calibrated and traceable tools, testing
equipment and standards for the rigorous
tests needed to verify instrument
performance. For these reasons, Agilent
is recognized as the premier supplier of
compliance products and services around
the world. It is a reputation that has been
earned audit after audit – lab after lab.

Agilent can provide your lab with the tools,

knowledge, service and support necessary
to keep it operating smoothly and
efficiently. It’s our mission to keep you
on your mission – and to keep you cool
when things heat up. Agilent can’t
eliminate the need for compliance,
but our blanket of support can help
smother any potential fires.

To obtain detailed information about Agilent’s

qualification and support services, please call
1-800-227-9770 in the U.S. and Canada.
In other regions of the world, please contact your
Agilent Technologies sales office and ask for a
chemical analysis representative.

© Agilent Technologies, Inc. 2002

The information in this publication is subject to change

without notice.

All rights reserved. Reproduction, adaptation or transla-

tion without prior written permission is prohibited,
except as allowed under the copyright laws.

Microsoft is a U.S. registered trademark of

Microsoft Corporation.
Printed in the USA June 21, 2002

5988-6910EN
1 Overview
Agilent´s line of proven qualification products and services

Agilent 1200 Series Qualification Workbook

 Agilent 1200 Agilent 1200 Series
Qualification Workbook

2
Design Qualification (DQ) Phase
Iso 90001: Valid June 2006 Certificate
Specifications
Pump Specifications
Injection Systems Specifications
Detectors Specifications
Fraction Collectors Specifications
Valves Specifications
Miscellaneous Specifications
Agilent ChemStation Specifications
Agilent ChemStation Plus Specifications
Compliance
Customer contributed documents

The user should feel free to add further documents, e.g. not supplied by
Agilent Technologies whenever he thinks this is appropriate.

Agilent Technologies
2 Design Qualification (DQ) Phase
Iso 90001: Valid June 2006 Certificate

Iso 90001: Valid June 2006 Certificate

Agilent 1200 Series Qualification Workbook

Affiliate with the N.V. KEMA in the Netherlands
A member of the International Network for Quality System Assessment and Certification “IQNet”

CERTIFICATE
Certificate Number: 510014.045
With two page addendum

The Quality System of:

Agilent Technologies, Inc.

Life Sciences and Chemical Analysis Group
Americas, Europe and Asia Pacific

Including its implementation, meets the requirements of the standard:

ISO 9001:2000
Scope:
Design, development, manufacture, marketing, distribution and support of analytical
instrumentation, systems and microarray systems including related software, services,
chromatography columns, packing, reagents, and consumables.

This Certificate is valid until: June 1, 2006

This Certificate is valid as of: February 10, 2006
Certified for the first time: February 1, 1994

H. Pierre Sallé
President
KEMA-Registered Quality

The method of operation for quality certification is defined in the KEMA General Terms
And Conditions For Quality And Environmental Management Systems Certifications.
Integral publication of this certificate is allowed.

KEMA-Registered Quality, Inc. Accredited By:

4377 County Line Road ANAB
Chalfont, PA 18914
Ph: (215)997-4519
Fax: (215)997-3809
CRT 001 073004
Affiliate with the N.V. KEMA in the Netherlands
A member of the International Network for Quality System Assessment and Certification “IQNet”

ADDENDUM
To Certificate Number: 510014.045 (ISO 9001:2000) of February 1, 1994
Valid as of: October 27, 2005
Valid until: June 1, 2006
Page one of two

The Quality System of:

Agilent Technologies, Inc.
Life Sciences and Chemical Analysis Group
Waldbronn Analytical Division Hewlett-Packard-Strasse 8 Waldbronn, Germany 76337
Yokogawa Analytical Systems Inc. 9-1 Takakura-Cho, Hachioji-Shi Tokyo, Japan
(initial certification date December 28, 1994)
Agilent Technologies Shanghai No. 412 Ying Lun Road Shanghai, PRC
Little Falls Site 2850 Centerville Road Wilmington, Delaware
Newport Site 101 First State Blvd. Newport, Delaware
Folsom Site 91 Blue Ravine Road Folsom, CA
Santa Clara Site 5301 Stevens Creek Blvd. Santa Clara, CA
Chemical Analysis Logistics Center - Americas Twin Spans Industrial Park, 500 Ships
Landing Way New Castle, DE 19720
Pleasanton Site - 6612 Owens Drive, Pleasanton, CA

H. Pierre Sallé
President
KEMA-Registered Quality

The method of operation for quality certification is defined in the KEMA General Terms
And Conditions For Quality And Environmental Management Systems Certifications.
Integral publication of this certificate is allowed.

KEMA-Registered Quality, Inc. Accredited By:

4377 County Line Road ANAB
Chalfont, PA 18914
Ph: (215)997-4519
Fax: (215)997-3809
CRT 001 073004
Affiliate with the N.V. KEMA in the Netherlands
A member of the International Network for Quality System Assessment and Certification “IQNet”

ADDENDUM
To Certificate Number: 510014.045 (ISO 9001:2000) of February 1, 1994
Valid as of: February 10, 2006
Valid until: June 1, 2006
Page two of two

The Quality System of:

Agilent Technologies, Inc. Life Sciences and
Chemical Analysis Group
Customer Support activities including Compliance Services, Installation, Repair and
Onsite maintenance of analytical test equipment in Chromatography, Spectrometry,
Laboratory Automation and Laboratory Information Technology equipment, project
consultancy and user training in the Austria, Belgium, Brazil, Canada, Denmark, Finland,
France, Germany, Ireland, Italy, Luxemburg, the Netherlands, Sweden, Spain,
Switzerland, the United Kingdom, and the United States.
Customer Sales and Support activities including Sale of equipment, Compliance
Services, Installation, Repair and Onsite maintenance of analytical test equipment in
Chromatography, Spectrometry, Laboratory Automation and Laboratory Information
Technology equipment, project consultancy and user Training in Australia.
Centralized Support from the following: Analytical Response Center - Europe
(Amstelveen) – United States (Little Falls, DE); Central Call management, Customer
Engineer training and the provision of Software Support (internal and to customers)
Field Support Centers located in Germany (EFSC - Waldbronn) and the United States
(AFSC – Little Falls, DE); Brazil and Mexico, Call management, CE-Assist for Hardware,
products, escalation management, Customer Engineer training
Field Repair Centers located in Germany (ERC - Waldbronn) and the United States (ERC
Little Falls, DE); and Mexico, Centralized Bench Repair Services and Instrument
Exchange program
Business Centers located in Spain (Barcelona) and the United States (Little Falls, DE);
Order fulfillment of standard and supplied products and services concerning analytical
test equipment in Chromatography, Spectrometry, Laboratory Automation and Laboratory
Information technology equipment.

H. Pierre Sallé
President
KEMA-Registered Quality

The method of operation for quality certification is defined in the KEMA General Terms
And Conditions For Quality And Environmental Management Systems Certifications.
Integral publication of this certificate is allowed.

KEMA-Registered Quality, Inc. Accredited By:

4377 County Line Road ANAB
Chalfont, PA 18914
Ph: (215)997-4519
Fax: (215)997-3809
CRT 001 073004
 Design Qualification (DQ) Phase 2
Pump Specifications

Pump Specifications

G1310A Isocratic Pump

Performance Specifications

Table 1 Performance Specification Agilent 1200 Isocratic Pump

Type Specification

Hydraulic system Dual piston in series pump with proprietary servo-controlled variable
stroke drive, floating pistons and active inlet valve

Setable flow range 0.001 – 10 ml/min, in 0.001 ml/min increments

Flow range 0.2 – 10.0 ml/min

Flow precision ≤0.07% RSD, or ≤0.02 min SD whatever is greater, based on retention
time at constant room temperature

Flow accuracy ±1% or 10µl/min whatever is greater

Pressure Operating range 0 – 40 MPa (0 – 400 bar, 0 – 5880 psi) up to 5 ml/min

Operating range 0 – 20 MPa (0 – 200 bar, 0 – 2950 psi) up to 10 ml/min

Pressure pulsation < 2 %amplitude (typically < 1 %), at 1 ml/min isopropanol,

at all pressures > 10 bar (147 psi)

Compressibility User-selectable, based on mobile phase compressibility

compensation
Recommended pH 1.0 – 12.5, solvents with pH < 2.3 should not contain acids which attack
range stainless steel

Control and data Agilent ChemStation for LC

evaluation

Analog output For pressure monitoring, 2 mV/bar, one output

Communications Controller-area network (CAN), GPIB, RS-232C, APG Remote: ready,

start, stop and shut-down signals, LAN optional

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Pump Specifications

Table 1 Performance Specification Agilent 1200 Isocratic Pump(continued)

Safety and maintenance Extensive diagnostics, error detection and display (through control
module and Agilent ChemStation), leak detection, safe leak handling,
leak output signal for shutdown of pumping system. Low voltages in
major maintenance areas.

GLP features Early maintenance feedback (EMF) for continuous tracking of

instrument usage in terms of seal wear and volume of pumped mobile
phase with user-settable limits and feedback messages. Electronic
records of maintenance and errors.

Housing All materials recyclable.

For use with flow rates below 500 µl/min a vacuum degasser is required.
NOTE

Physical Specifications

Table 2 Physical Specifications

Type Specification Comments

Weight 11 kg (25 lbs)

Dimensions 140 × 345 × 435 mm

(height × weight × depth) (5.5 × 13.5 × 17 inches)

Line voltage 100 – 120 or 220 – 240 VAC, Wide-ranging

± 10 % capability

Line frequency 50 or 60 Hz, ± 5 %

Power consumption 220 VA Maximum

Ambient operating temperature 4 – 55 °C (41 – 131 °F)

Ambient non-operating -40 – 70 °C (-4 – 158 °F)
temperature

Humidity < 95 %, at 25 – 40 °C (77 – 104 °F) Non-condensing

Operating Altitude Up to 2000 m (6500 ft)

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Pump Specifications

Table 2 Physical Specifications(continued)

Non-operating altitude Up to 4600 m (14950 ft) For storing the isocratic

pump

Safety standards: IEC, CSA, UL Installation Category II, Pollution

Degree 2

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Pump Specifications

G1311A Quaternary Pump

Performance Specifications

Table 3 Performance Specification Agilent 1200 Quaternary Pump

Type Specification

Hydraulic system Dual plunger in series pump with proprietary servo-controlled variable
stroke drive, floating plungers and active inlet valve

Setable flow range 0.001 – 10 ml/min, in 0.001 ml/min increments

Flow range 0.2 – 10.0 ml/min

Flow precision ≤0.07% RSD, or ≤0.02 min SD whatever is greater, based on retention
time at constant room temperature

Flow accuracy ±1% or 10µl/min whatever is greater

Pressure Operating range 0 – 40 MPa (0 – 400 bar, 0 – 5880 psi) up to 5 ml/min

Operating range 0 – 20 MPa (0 – 200 bar, 0 – 2950 psi) up to 10 ml/min

Pressure pulsation < 2 %amplitude (typically < 1 %), at 1 ml/min isopropanol,

at all pressures > 1 MPa (10bar)

Compressibility User-selectable, based on mobile phase compressibility

compensation

Recommended pH 1.0 – 12.5, solvents with pH < 2.3 should not contain acids which attack
range stainless steel

Gradient formation Low pressure quaternary mixing/gradient capability using proprietary

high-speed proportioning valve
Delay volume 800 – 1100 µl, dependent on back pressure
Composition Range 0 – 95 % or 5 – 100 %, user selectable

Composition Precision < 0.2 % RSD, at 0.2 and 1 ml/min

Control and data Agilent ChemStation for LC

evaluation

Analog output For pressure monitoring, 2 mV/bar, one output

Communications Controller-area network (CAN), GPIB, RS-232C, APG Remote: ready,

start, stop and shut-down signals, LAN optional

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Pump Specifications

Table 3 Performance Specification Agilent 1200 Quaternary Pump(continued)

Safety and maintenance Extensive diagnostics, error detection and display (through control
module and Agilent ChemStation), leak detection, safe leak handling,
leak output signal for shutdown of pumping system. Low voltages in
major maintenance areas.

GLP features Early maintenance feedback (EMF) for continuous tracking of

instrument usage in terms of seal wear and volume of pumped mobile
phase with user-settable limits and feedback messages. Electronic
records of maintenance and errors.

Housing All materials recyclable.

Physical Specifications

Table 4 Physical Specifications

Type Specification Comments

Weight 11 kg (25 lbs)

Dimensions 140 × 345 × 435 mm

(height × weight × depth) (5.5 × 13.5 × 17 inches)

Line voltage 100–120 or 220–240 VAC, ± 10% Wide-ranging capability

Line frequency 50 or 60 Hz, ± 5%

Power consumption 220 VA Maximum

Ambient operating temperature 4–55 °C (41–131 °F)

Ambient non-operating -40–70 °C (-4–158 °F)

temperature

Humidity < 95%, at 25–40 °C (77–104 °F) Non-condensing

Operating Altitude Up to 2000 m (6500 ft)

Non-operating altitude Up to 4600 m (14950 ft) For storing the

quaternary pump

Safety standards: IEC, CSA, UL Installation Category II, Pollution

Degree 2

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Pump Specifications

G1312A Binary Pump

Performance Specifications

Table 5 Performance Specification Agilent 1200 Binary Pump

Type Specification

Hydraulic system Two dual piston in series pumps with proprietary servo-controlled
variable stroke drive, floating piston design and active inlet valve

Setable flow range Setpoints 0.001 – 5 ml/min, in 0.001 ml/min increments

Flow range 0.1 – 5.0 ml/min

Flow precision ≤0.07% RSD, or ≤0.02 min SD whatever is greater, based on retention
time at constant room temperature

Flow accuracy ±1% or 10µl/min whatever is greater

Pressure Operating range 0 400 bar (0 – 5880 psi) up to 5 ml/min

Pressure pulsation < 2 % amplitude (typically < 1 %), at 1 ml/min isopropanol,

at all pressures > 1 MPa

Compressibility User-selectable, based on mobile phase compressibility

compensation

Recommended pH 1.0 – 12.5, solvents with pH < 2.3 should not contain acids which attack
range stainless steel

Gradient formation High-pressure binary mixing, delay volume 180 – 480 µl without mixer,
600 – 900 µl with mixer, dependent on back pressure

Composition range 1 – 99 % or 5 µl/min per channel, whatever is greater

Composition precision ≤0.5% absolute

Composition accuracy ±0.15% RSD, at 1 ml/min

Control and data Agilent ChemStation for LC

evaluation

Analog output For pressure monitoring, 2 mV/bar, one output

Communications Controller-area network (CAN), GPIB, RS-232C, APG Remote: ready,

start, stop and shut-down signals, LAN optional

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Pump Specifications

Table 5 Performance Specification Agilent 1200 Binary Pump(continued)

Safety and maintenance Extensive diagnostics, error detection and display (through handheld
controllers G4208A, G1323B and Agilent ChemStation), leak detection,
safe leak handling, leak output signal for shutdown of pumping system.
Low voltages in major maintenance areas.

GLP features Early maintenance feedback (EMF) for continuous tracking of

instrument usage in terms of seal wear and volume of pumped mobile
phase with user-settable limits and feedback messages. Electronic
records of maintenance and errors.

Housing All materials recyclable.

For use with flow rates below 500 µl/min a vacuum degasser is required.
NOTE

Physical Specifications

Table 6 Physical Specifications

Type Specification Comments

Weight 15.5 kg (34 lbs)

Dimensions 180 × 345 × 435 mm

(height × weight × depth) (7 × 13.5 × 17 inches)
Line voltage 100 – 120 or 220 – 240 VAC, ± 10 % Wide-ranging
capability
Line frequency 50 or 60 Hz, ± 5 %
Power consumption 220 VA Maximum

Ambient operating temperature 4 – 55 °C (41 – 131 °F)

Ambient non-operating -40 – 70 °C (-4 – 158 °F)

temperature

Humidity < 95 %, at 25 – 40 °C (77 – 104 °F) Non-condensing

Operating Altitude Up to 2000 m (6500 ft)

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Pump Specifications

Table 6 Physical Specifications(continued)

Non-operating altitude Up to 4600 m (14950 ft) For storing the binary

pump

Safety standards: IEC, CSA, UL Installation Category II, Pollution

Degree 2

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Pump Specifications

G1312B Binary Pump SL

Performance Specifications

Table 7 Performance Specifications of the Agilent 1200 Series Binary Pump SL

Type Specification Comments

Hydraulic system Two dual piston in series pumps with

proprietary servo-controlled variable
stroke drive, floating piston design and
active inlet valve

Setable flow range Setpoints 0.001 – 5 mL/min, in 0.001

mL/min increments

Flow range 0.05 – 5.0 mL/min

Flow precision ≤0.07% RSD or ≤0.02 min SD, whatever based on retention time at
is greater constant room temperature

Flow accuracy ± 1% or 10 µL/min, what ever is measured with water

greater

Pressure Operating range 0 – 600 bar (0 – 7800

psi) up to 5 ml/min

Pressure pulsation Standard delay volume configuration: at 1 mL/min water,

< 2% amplitude (typically < 1%) at all pressures > 1 MPa
Low delay volume configuration:
< 5% amplitude (typically < 2%)
Compressibility Automatic, pre-defined, based on
compensation mobile phase compressibility

Recommended pH 1.0 – 12.5 Solvents with pH < 2.3 should

range not contain acids which attack
stainless steel.

Gradient formation High-pressure binary mixing

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Pump Specifications

Table 7 Performance Specifications of the Agilent 1200 Series Binary Pump

SL(continued)

Type Specification Comments

Delay volume Standard delay volume configuration: measured with water

600-800 µl, dependent on back
pressure (includes 400 µl mixer)
Low delay volume configuration:
120 µl

Composition range settable range: 0 – 100%

recommended range: 1 – 99 % or 5
µl/min per channel, whatever is
greater

Composition precision < 0.15 % RSD at 1mL/min

Composition accuracy ± 0.35% absolute (water/caffeine tracer)

Control Agilent ChemStation for LC (32-bit) Revision B.02.00 or above

G4208A Handheld Controller
EZ Chrom Elite

Analog output For pressure monitoring, 1.33 mV/bar,

one output

Communications Controller-area network (CAN),

RS-232C, APG Remote: ready, start,
stop and shut-down signals, LAN
optional

Safety and maintenance Extensive diagnostics, error detection

and display (through Agilent LC
Diagnostics), leak detection, safe leak
handling, leak output signal for
shutdown of pumping system. Low
voltages in major maintenance areas.

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Pump Specifications

Table 7 Performance Specifications of the Agilent 1200 Series Binary Pump

SL(continued)

Type Specification Comments

GLP features Early maintenance feedback (EMF) for

continuous tracking of instrument
usage in terms of seal wear and
volume of pumped mobile phase with
pre-defined and user-settable limits
and feedback messages. Electronic
records of maintenance and errors.

Housing All materials recyclable.

For use with flow rates below 500 µl/min or for use without damper and mixer a vacuum
NOTE degasser is required.
All specification measurements are done with degassed solvents.

Physical Specifications

Table 8 Physical Specifications

Type Specification Comments

Weight 15.5 kg (34 lbs)

Dimensions 180 × 345 × 435 mm

(width × depth × height) (7 × 13.5 × 17 inches)

Line voltage 100 – 240 VAC, ± 10 % Wide-ranging capability

Line frequency 50 or 60 Hz ± 5 %

Power consumption (G1312B) 160 VA Maximum

Ambient operating temperature 0 – 55 °C (32 – 131 °F) .

Ambient non-operating -40 – 70 °C (-4 – 158 °F)

temperature

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Pump Specifications

Table 8 Physical Specifications(continued)

Humidity < 95%, at 25 – 40 °C Non-condensing

(77 – 104 °F)
Operating altitude Up to 2000 m (6500 ft)

Non-operating altitude Up to 4600 m (14950 ft) storage conditions

Safety standards: IEC, CSA, UL, Installation category II,

EN pollution degree 2

G1361A Preparative Pump

Performance Specifications

Table 9 Performance Specification Agilent 1200 Series Preparative Pump

Type Specification

Hydraulic system Dual pistons in parallel

Settable flow range 0.001 – 100 ml/min

Flow precision < 0.5 % RSD

Pressure range 20 to 400 bar (5880 psi) system pressure

Compressibility User-selectable, based on mobile phase compressibility

compensation

Recommended pH 1.0 – 12.5, solvents with pH < 2.3 should not contain acids which attack
range stainless steel.

Control and data Agilent ChemStation for LC

evaluation

Communications Controller-area network (CAN), RS-232, APG Remote: ready, start, stop
and shut-down signals, CAN-DC OUT, LAN optional

Safety and maintenance Extensive diagnostics, error detection and display (through control
module and Agilent ChemStation), leak detection, safe leak handling,
leak output signal for shutdown of pumping system. Low voltages in
major maintenance areas.

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Pump Specifications

Table 9 Performance Specification Agilent 1200 Series Preparative Pump(continued)

GLP features Early maintenance feedback (EMF) for continuous tracking of

instrument usage in terms of seal wear and volume of pumped mobile
phase with user-settable limits and feedback messages. Electronic
records of maintenance and errors.

Housing All materials recyclable.

Physical Specifications

Table 10 Physical Specifications - Preparative Pump

Type Specification Comments

Weight 15.0 kg

Dimensions 200 × 345 × 440 mm

(height × width × depth) (8 × 13.5 × 18 inches)

Line voltage 100 – 240 VAC, ± 10 % Wide-ranging capability

Line frequency 50 – 60 Hz, ± 5 %

Power consumption 250 VA Maximum

Ambient operating temperature 4 – 40 °C (41 – 104 °F)

Ambient non-operating -40 – 70 °C (-4 – 158 °F)

temperature

Humidity < 95 %, at 25 – 40 °C (77 – 104 °F) Non-condensing

Operating Altitude Up to 2000 m (6500 ft

Non-operating altitude Up to 4600 m (14950 ft) For storing the

preparative pump

Safety standards: IEC, CSA, UL Installation Category II, Pollution for indoor use only!
Degree 2

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Pump Specifications

G1376A Capillary Pump

Performance Specifications

Table 11 Performance Specification Agilent 1200 Series Capillary Pump

Type Specification

Hydraulic system Two dual piston in series, with proprietary servo-controlled variable
stroke drive, floating piston, active inlet valve, solvent selection valve
and electronic flow control for flow rates up to 100 µl/min

Settable column flow 0.01 – 20 µl/min

range 0.01 – 100 µl/min (with the extended flow range kit)
0.001 – 2.5 µl/min (with the electronic flow control bypassed)

Recommended column 1 – 20 µl/min

flow range 10 – 100 µl/min (with extended flow range kit)
0.1 – 2.5 ml/min (with the electronic flow sensor bypassed)
Column flow precision < 0.7 % RSD or 0.03 % SD (typically 0.4 % RSD or 0.02 % SD), at
10 µl/min and 50 µl/min column flow (based on RT, default setting)

Optimum composition 1 to 99% or 5 µl/min per channel (primary flow), whatever is greater
range

Composition precision < 0.2 % SD, at 10 µl/min (20 µl flow sensor), 50 µl/min (100 µl flow
sensor) and 1 ml/min (normal mode) default setting

Delay volume Typically 3 µl from the electronic flow control to the pump outlet for flow
rates up to 20 µl/min.
Typically 12 µl from the electronic flow control to the pump outlet for
flow rates up to 100 µl.
for flow rates up to 100 µl/min and electronic flow control active:
primary flow path 180 - 480 µl without mixer, 600 - 900 µl with mixer
(system pressure dependant)
Typically 180 to 480 µl (system pressure dependent) without mixer for
flow rates up to 2.5 ml/min. (Mixer delay volume 420 µl)

Pressure range 20 to 400 bar (5880 psi) system pressure

Compressibility User-selectable, based on mobile phase compressibility

compensation

Recommended pH 1.0 – 8.5, solvents with pH < 2.3 should not contain acids which attack
range stainless steel. Upper pH range is limited by fused silica capillaries.

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Pump Specifications

Table 11 Performance Specification Agilent 1200 Series Capillary Pump(continued)

Control and data Agilent ChemStation for LC

evaluation

Analog output For pressure monitoring, 2 mV/bar, one output

Communications Controller-area network (CAN), GPIB, RS-232C, APG Remote: ready,

start, stop and shut-down signals, LAN optional

Safety and maintenance Extensive diagnostics, error detection and display (through instant pilot
and Agilent ChemStation), leak detection, safe leak handling, leak
output signal for shutdown of pumping system. Low voltages in major
maintenance areas.

GLP features Early maintenance feedback (EMF) for continuous tracking of

instrument usage in terms of seal wear and volume of pumped mobile
phase with user-settable limits and feedback messages. Electronic
records of maintenance and errors.

Housing All materials recyclable.

Physical Specifications

Table 12 Physical Specifications

Type Specification Comments

Weight 17 kg (39 lbs)

Dimensions 180 × 345 × 435 mm

(height × weight × depth) (7 × 13.5 × 17 inches)

Line voltage 100 – 120 or 220 – 240 VAC, ± 10 % Wide-ranging capability

Line frequency 50 or 60 Hz, ± 5 %

Power consumption 220 VA Maximum

Ambient operating 4 to 55 °C (41 to 131 °F)

temperature

Ambient non-operating -40 to 70 °C (-4 to 158 °F)

temperature

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Pump Specifications

Table 12 Physical Specifications(continued)

Humidity < 95 %, at 25 to 40 °C (77 to 104 °F) Non-condensing

Operating Altitude Up to 2000 m (6500 ft)

Non-operating altitude Up to 4600 m (14950 ft) For storing the

autosampler

Safety standards: IEC, CSA, UL Installation Category II, Pollution

Degree 2

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Pump Specifications

G2226A Nano Pump

Performance Specifications

Table 13 Performance Specification Agilent 1200 Series Nano Pump

Type Specification

Hydraulic system Two dual piston in series, with proprietary servo-controlled variable
stroke drive, floating piston, active inlet valve, solvent selection valve
and electronic flow control for flow rates from 0.1 to 1 µl/min

Settable column flow 0.01 – 4 µl/min

range 1 – 2500 µl/min (with the electronic flow control bypassed)

Recommended column 0.1 – 1 µl/min

flow range 200 – 2500 µl/min (with the electronic flow sensor bypassed)

Optimum composition 1 to 99% or 5 µl/min per channel (primary flow), whatever is greater
range
Composition precision < 0.2 % SD, at 500 nl/min (default settings),
Minimum primary flow/pump channel is 5 µl/min

Delay volume Typically 300 nl from the electronic flow control to the pump outlet for
flow rates up to 4 µl/min. For flow rates up to 4 µl/min and electronic
flow control active: primary flow path 180 - 480 µl; system pressure
dependent (default settings; calculated volume)
Typically 180 to 480 µl (system pressure dependent) for flow rates up to
2.5 ml/min. (default settings; calculated volume)

Pressure range 20 to 400 bar (5880 psi) system pressure

Compressibility User-selectable, based on mobile phase compressibility

compensation

Recommended pH 1.0 – 8.5, solvents with pH < 2.3 should not contain acids which attack
range stainless steel. Upper pH range is limited by fused silica capillaries.

Control and data Agilent ChemStation for LC

evaluation

Analog output For pressure monitoring, 2 mV/bar, one output

Communications Controller-area network (CAN), GPIB, RS-232C, APG Remote: ready,

start, stop and shut-down signals, LAN optional

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Pump Specifications

Table 13 Performance Specification Agilent 1200 Series Nano Pump(continued)

Safety and maintenance Extensive diagnostics, error detection and display (through control
module and Agilent ChemStation), leak detection, safe leak handling,
leak output signal for shutdown of pumping system. Low voltages in
major maintenance areas.

GLP features Early maintenance feedback (EMF) for continuous tracking of

instrument usage in terms of seal wear and volume of pumped mobile
phase with user-settable limits and feedback messages. Electronic
records of maintenance and errors.

Housing All materials recyclable.

Physical Specifications

Table 14 Physical Specifications

Type Specification Comments

Weight 17 kg (39 lbs)

Dimensions 180 × 345 × 435 mm

(height × weight × depth) (7 × 13.5 × 17 inches)

Line voltage 100 – 120 or 220 – 240 VAC, ± 10 % Wide-ranging capability

Line frequency 50 or 60 Hz, ± 5 %

Power consumption 220 VA Maximum

(apparent power) 75 W Maximum
Power consumption (active
power)

Ambient operating 4 – 55 °C (41 – 131 °F)

temperature

Ambient non-operating -40 – 70 °C (-4 – 158 °F)

temperature

Humidity < 95 %, at 25 – 40 °C (77 – 104 °F) Non-condensing

Operating Altitude Up to 2000 m (6500 ft)

Non-operating altitude Up to 4600 m (14950 ft) For storing the binary pump
Safety standards: IEC, CSA, Installation Category II, Pollution
UL Degree 2

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Injection Systems Specifications

Injection Systems Specifications

G1329A Autosampler 100 µl metering head

Performance Specifications

Table 15 Performance Specifications Agilent 1200 Autosampler (G1329A). Valid when

standard 100 µl metering head installed.

Type Specification

GLP features Early maintenance feedback (EMF), electronic records of

maintenance and errors

Communications Controller-area network (CAN). GPIB (IEEE-448), RS232C,

APG-remote standard, optional four external contact closures and
BCD vial number output

Safety features Leak detection and safe leak handling, low voltages in maintenance
areas, error detection and display

Injection range 0.1 – 100 µl in 0.1 µl increments

Up to 1500 µl with multiple draw (hardware modification required)

Replicate injections 1 – 99 from one vial

Precision < 0.25 % RSD from 5 – 100 µl,

< 1 % RSD 1 – 5 µl
variable volume

Minimum sample volume 1 µl from 5 µl sample in 100 µl microvial, or 1 µl from 10 µl sample in

300 µl microvial

Carryover Typically < 0.1 %, < 0.05 % with external needle cleaning

Sample viscosity range 0.2 – 50 cp

Replicate injections per vial 1 – 99

Sample capacity 100 × 2-ml vials in 1 tray

40 × 2-ml vials in ½ tray
15 × 6-ml vials in ½ tray (Agilent vials only)

Injection cycle time Typically 50 s depending on draw speed and injection volume

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Injection Systems Specifications

Physical Specifications

Table 16 Physical Specifications - Autosampler (G1329A / G2260A)

Type Specification Comments

Weight 14.2 kg (31.3 lbs)

Dimensions 200 × 345 × 435 mm

(height × width × depth) (8 × 13.5 × 17 inches)

Line voltage 100 – 120 or 220 – 240 VAC, ± 10 % Wide-ranging capability

Line frequency 50 or 60 Hz, ± 5 %

Power consumption (apparent 300 VA Maximum

power) 200 W Maximum
Power consumption (active
power)

Ambient operating 4 – 55 °C (41 – 131 °F) see User Manual

temperature
Ambient non-operating -40 to 70 °C (-4 to 158 °F)
temperature
Humidity < 95 %, at 25 – 40 °C (77 – 104 °F) Non-condensing

Operating Altitude Up to 2000 m (6500 ft)

Non-operating altitude Up to 4600 m (14950 ft) For storing the

autosampler

Safety standards: IEC, CSA, UL Installation Category II, Pollution

Degree 2
For inddor use only

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Injection Systems Specifications

G1329A Autosampler 900 µl metering head

Performance Specifications

Table 17 Performance Specifications Agilent 1200 standard autosampler (G1329A).

Valid when standard 900 µl metering head installed.

Type Specification

Pressure Operating range 0-20 MPa (0-200 bar, 0-2950 psi)

GLP features Early maintenance feedback (EMF), electronic records of

maintenance and errors

Communications Controller-area network (CAN). GPIB (IEEE-448), RS232C,

APG-remote standard, optional four external contact closures and
BCD vial number output

Safety features Leak detection and safe leak handling, low voltages in maintenance
areas, error detection and display

Injection range 0.1 – 900 µl in 0.1 µl increments (recommended 1 µl increments)

Up to 1800 µl with multiple draw (hardware modification required)

Replicate injections 1 – 99 from one vial

Precision Typically < 0.5 % RSD of peak areas from 5 – 2000 µl,
Typically < 1 % RSD of peak areas from 2000 – 5000 µl,
Typically < 3 % RSD of peak areas from 1 – 5 µl

Minimum sample volume 1 µl from 5 µl sample in 100 µl microvial, or 1 µl from 10 µl sample in

300 µl microvial

Carryover Typically < 0.1 %, < 0.05 % with external needle cleaning

Sample viscosity range 0.2 – 50 cp

Sample capacity 100 × 2-ml vials in 1 tray

40 × 2-ml vials in ½ tray
15 × 6-ml vials in ½ tray (Agilent vials only)

Injection cycle time Typically 50 s,

depending on draw speed and injection volume

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Injection Systems Specifications

Physical Specifications

Table 18 Physical Specifications - Autosampler (G1329A / G2260A)

Type Specification Comments

Weight 14.2 kg (31.3 lbs)

Dimensions 200 × 345 × 435 mm

(height × width × depth) (8 × 13.5 × 17 inches)

Line voltage 100 – 120 or 220 – 240 VAC, ± 10 % Wide-ranging capability

Line frequency 50 or 60 Hz, ± 5 %

Power consumption (apparent 300 VA Maximum

power) 200 W Maximum
Power consumption (active
power)

Ambient operating 4 – 55 °C (41 – 131 °F) see User Manual

temperature
Ambient non-operating -40 to 70 °C (-4 to 158 °F)
temperature

Humidity < 95 %, at 25 – 40 °C (77 – 104 °F) Non-condensing

Operating Altitude Up to 2000 m (6500 ft)

Non-operating altitude Up to 4600 m (14950 ft) For storing the

autosampler

Safety standards: IEC, CSA, UL Installation Category II, Pollution

Degree 2
For inddor use only

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Injection Systems Specifications

G2260A Preparative Autosampler

Performance Specifications

Table 19 Performance Specifications Agilent 1200 Preparative Autosampler (G2260A)

Type Specification

Pressure Operating range 0-40 MPa (0-400 bar, 0-5800psi)

GLP features Early maintenance feedback (EMF), electronic records of

maintenance and errors

Communications Controller-area network (CAN). GPIB (IEEE-448), RS232C,

APG-remote standard, optional four external contact closures and
BCD vial number output

Safety features Leak detection and safe leak handling, low voltages in maintenance
areas, error detection and display

Injection range 0.1 – 900 µl in 0.1 µl increments (recommended 1 µl increments)

Up to 1800 µl with multiple draw (hardware modification required)
Up to 5000 µl with multiple draw (hardware modification required)

Replicate injections 1 – 99 from one vial

Precision Typically < 0.5 % RSD of peak areas from 5 – 2000 µl,
Typically < 1 % RSD of peak areas from 2000 – 5000 µl,
Typically < 3 % RSD of peak areas from 1 – 5 µl

Minimum sample volume 1 µl from 5 µl sample in 100 µl microvial, or 1 µl from 10 µl sample in

300 µl microvial
Carryover Typically < 0.1 %, < 0.05 % with external needle cleaning
Sample viscosity range 0.2 – 50 cp

Sample capacity 100 × 2-ml vials in 1 tray

15 × 6-ml vials in ½ tray (Agilent vials only)

Injection cycle time Typically 50 s,

depending on draw speed and injection volume

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Injection Systems Specifications

G1367B High Performance Autosampler and

G1367C High Performance Autosampler SL
Performance Specifications

Table 20 Performance specifications Agilent 1200 Series High Performance Autosampler

and Agilent 1200 Series High Performance Autosampler SL

Type Specification

GLP features Early maintenance feedback (EMF), electronic records of

maintenance and errors

Communications Controller-area network (CAN). RS232C, APG-remote standard,

optional four external contact closures and BCD vial number output

Safety features Leak detection and safe leak handling, low voltages in maintenance
areas, error detection and display

Injection range 0.1 – 100 µl in 0.1 µl increments

Up to 1500 µl with multiple draw (hardware modification required)

Precision Typically < 0.25 % RSD from 5 – 100 µl,

Typically < 1 % RSD from 1 – 5 µl variable volume

Pressure range G1367B: up to 400 bar (5880 psi)

G1367C: up to 600 bar (8700 psi)

Sample viscosity range 0.2 – 5 cp

Sample capacity 2 × well plates (MTP) + 10 × 2 ml vials

108 x 2-mL vials in2 x 54 vial plate plus 10 additional 2 mL vials
30 x 6-mL vials in 2 x 15 vial plate plus 10 additional 2 mL vials
54 Eppendorf tubes (0.5/1.5/2.0mL) in 2 x 27 Eppendorf tube plate

Also compatible with the Agilent 1200 Series sample capacity

extension for further expansion of the sample capacity

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Injection Systems Specifications

Table 20 Performance specifications Agilent 1200 Series High Performance Autosampler

and Agilent 1200 Series High Performance Autosampler SL(continued)

Injection cycle time Typically < 30 s using following standard conditions:

Default draw speed: 200 µl/min
Default eject speed: 200 µl/min
Injection volume: 5 µl

Carry-over Typically < 0.01 % using the following conditions:

Column: 125 x 4 mm Hypersil ODS, 5 µm
Mobile phase: Water/Acetonitrile = 80/20
Flow rate: 1 ml/min
Injection volume: 1 µl caffeine (1 mg/ml), 5 µl water to test carryover
Outside wash of needle before injection: 20 sec with water using
flush port

Physical Specifications

Table 21 Physical Specifications - sampler (G1367B/C / G1377A)

Type Specification Comments

Weight 15.5 kg (34.2 lbs)

Dimensions 200 × 345 × 440 mm

(height × width × depth) (8 × 13.5 × 17 inches)

Line voltage 100 – 240 VAC, ±10 % Wide-ranging capability

Line frequency 50 or 60 Hz, ±5 %

Power consumption (apparent 300 VA Maximum

power)

Power consumption (active 200 W Maximum

power)

Ambient operating temperature 4 to 55 °C (41 to 131 °F)

Ambient non-operating -40 to 70 °C (-4 to 158 °F)

temperature

Humidity < 95 %, at 25 to 40 °C Non-condensing

(77 to 104 °F)

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Injection Systems Specifications

Table 21 Physical Specifications - sampler (G1367B/C / G1377A)(continued)

Type Specification Comments

Operating Altitude Up to 2000 m (6500 ft)

Non-operating altitude Up to 4600 m (14950 ft) For storing the

autosampler

Safety standards: IEC, CSA, UL Installation Category II, Pollution

Degree 2

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Injection Systems Specifications

G1377A Micro Well plate Sampler

Performance Specifications

Table 22 Performance Specifications Agilent 1200 Series Micro Well plate sampler

Type Specification

GLP features Early maintenance feedback (EMF), electronic records of

maintenance and errors

Communications Controller-area network (CAN). RS232C, APG-remote standard,

optional four external contact closures and BCD vial number output

Safety features Leak detection and safe leak handling, low voltages in maintenance
areas, error detection and display

Injection range 0.01– 8 µl in 0.01 µl increments with the small loop capillary
0.01– 40 µl in 0.01 µl increments with the extended loop capillary

Precision Typically < 0.5 % RSD of peak areas from 5 – 40 µl,

Typically < 1 % RSD from 1 – 5 µl
Typically < 3 % RSD from 0.2 – 1 µl

Pressure range up to 400 bar (5880 psi)

Sample viscosity range 0.2 – 5 cp

Sample capacity 2 × well-plates (MTP) + 10 × 2 ml vials

108 x 2-mL vials in 2 x 54 vial plate plus 10 additional 2 mL vials
30 x 6-mL vials in 2 x 15 vial plate plus 10 additional 2 mL vials
54 Eppendorf tubes (0.5/1.5/2.0mL) in 2 x 27 Eppendorf tube plate
Injection cycle time Typically < 30 s using following standard conditions:
Default draw speed: 4 µl/min
Default eject speed: 10 µl/min
Injection volume: 0.1 µl

Carry-over Typically < 0.05 % using the following conditions:

Column: 150 x 0.5 mm Hypersil ODS, 3 µm
Mobile phase: Water/Acetonitrile = 85/15
Column Flow rate: 13 µl/min
Injection volume: 1 µl caffeine (=25ng caffeine), 1 µl water to test
carryover
Outside wash of needle before injection: 20 sec with water using
flush port

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Detectors Specifications

Detectors Specifications

G1314B Variable Wavelenght Detector and

G1314C Variable Wavelenght Detector SL
Performance Specifications

Table 23 Performance Specifications Agilent 1200 Series Variable Wavelength Detector

Type Specification Comments

Detection type Double-beam photometer

Light source Deuterium lamp

Wavelength range 190–600 nm

Short term noise ± 0.75 × 10-5 AU at 254 nm See NOTE on page 31.
(ASTM)

Drift 3 × 10-4 AU/hr at 254 nm See NOTE on page 31

Linearity > 2 AU (5%) upper limit See NOTE on page 31

Wavelength ± 1 nm Self-calibration with deuterium

accuracy lines, verification with holmium
oxide filter

Band width 6.5 nm typical

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Detectors Specifications

Table 23 Performance Specifications Agilent 1200 Series Variable Wavelength Detector

(continued)

Type Specification Comments

Flow cells Standard: 14-µl volume, 10-mm cell path Can be repaired on component
length and 40 bar (588 psi) pressure level
maximum
High pressure: 14-µl volume,
10-mm cell path length and 400 bar
(5880 psi) pressure maximum
Micro: 1-µl volume, 5-mm cell path
length and 40 bar (588 psi) pressure
maximum
Semi-micro: 5-µl volume, 6-mm cell path
length and 40 bar (588 psi) pressure
maximum

Control and data Agilent ChemStation for LC

evaluation

Analog outputs Recorder/integrator: 100 mV or 1 V,

output range 0.001 – 2 AU, one output

Communications Controller-area network (CAN), GPIB, GPIB for G1314B only

RS-232C, APG Remote: ready, start, stop
and shut-down signals, LAN optional

Safety and Extensive diagnostics, error detection

maintenance and display (through control module and
Agilent ChemStation), leak detection,
safe leak handling, leak output signal for
shutdown of pumping system. Low
voltages in major maintenance areas.

GLP features Early maintenance feedback (EMF) for

continuous tracking of instrument usage
in terms of lamp burn time with
user-settable limits and feedback
messages. Electronic records of
maintenance and errors. Verification of
wavelength accuracy with built-in
holmium oxide filter.

Housing All materials recyclable.

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Detectors Specifications

ASTM: “Standard Practice for Variable Wavelength Photometric Detectors Used in Liquid
NOTE Chromatography”.

Reference conditions: cell path length 10 mm, response time 2 s, flow 1 ml/min LC-grade
methanol.

Linearity measured with caffeine at 265 nm.

Physical Specifications

Table 24 Physical Specifications

Type Specification Comments

Weight 11 kg
25 lbs

Dimensions 140 × 345 × 435 mm

(height × width × depth) 5.5 × 13.5 × 17 inches

Line voltage 100 – 240 VAC, ± 10% Wide-ranging capability

Line frequency 50 or 60 Hz, ± 5%

Power consumption 220 VA, 85 W / 290 BTU Maximum

Ambient operating temperature 0–55 °C (32–131 °F)

Ambient non-operating -40–70 °C (-4–158 °F)

temperature

Humidity < 95%, at 25–40 °C Non-condensing

(77–104 °F)
Operating altitude Up to 2000 m (6500 ft)

Non-operating altitude Up to 4600 m (14950 ft) For storing the instrument

Safety standards: IEC, CSA, UL, Installation Category II,

EN Pollution Degree 2.
For indoor use only.

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Detectors Specifications

G1315B Diode Array Detector

G1365B Multible Wavelength Detector
Performance Specifications

Table 25 Performance Specifications Agilent 1200 Series DAD and MWD

Type Specification Comments

Detection type 1024-element photodiode array

Light source Deuterium and tungsten lamps

Wavelength range 190 – 950 nm

Short term noise (ASTM) ± 1 × 10-5 AU at 254 and 750 nm See on page 52
Single and Multi-Wavelengt

Drift 2 × 10-3 AU/hr at 254 nm See on page 52

Linear absorbance range > 2 AU (upper limit) See on page 52

Wavelength accuracy ± 1 nm Self-calibration with

deuterium lines,
verification with
holmium oxide filter

Wavelength bunching 1 – 400 nm Programmable in

steps of 1 nm

Slit width 1, 2, 4 , 8, 16 nm Programmable slit

Diode width < 1 nm

Flow cells Standard: 13 µl volume, 10 mm cell path length See “Optimization

and 120 bar (1760 psi) pressure maximum Overview”.
Semi-Micro: 5 µl volume, 6 mm cell path length
and 120 bar (1760 psi) pressure maximum
Micro: 2 µl volume, 3 mm cell path length and
120 bar (1760 psi) pressure maximum
High pressure: 1.7 µl volume, 6 mm cell path
length and 400 bar (5880 psi) pressure
maximum
80 nano: 0.08 µl volume, 10 mm cell path length
and 50 bar (725 psi) pressure maximum
500 nano: 0.5 µl volume, 10 mm cell path length
and 50 bar (725 psi) pressure maximum

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Detectors Specifications

Table 25 Performance Specifications Agilent 1200 Series DAD and MWD(continued)

Type Specification Comments

Control and data evaluation Agilent ChemStation for LC

Analog outputs Recorder/integrator: 100 mV or 1 V, output

range 0.001 – 2 AU, two outputs

Communications Controller-area network (CAN), GPIB, RS-232C,

APG Remote: ready, start, stop and shut-down
signals, LAN optional
Safety and maintenance Extensive diagnostics, error detection and
display (through control module and
ChemStation), leak detection, safe leak
handling, leak output signal for shutdown of
pumping system. Low voltages in major
maintenance areas.

GLP features Early maintenance feedback (EMF) for

continuous tracking of instrument usage in
terms of lamp burn time with user-settable
limits and feedback messages. Electronic
records of maintenance and errors. Verification
of wavelength accuracy with built-in holmium
oxide filter.

Housing All materials recyclable.

ASTM: “Standard Practice for Variable Wavelength Photometric Detectors Used in Liquid
NOTE Chromatography”.

Reference conditions: cell path length 10 mm, response time 2 s, flow 1 ml/min LC-grade
Methanol, slit width 4 nm.

Linearity measured with caffeine at 265 nm.

For environmental conditions refer to “Environment” in the User Manual.

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Detectors Specifications

Physical Specifications

Table 26 Physical Specifications

Type Specification Comments

Weight 11.5 kg (26 lbs)

Dimensions 345 × 435 × 140 mm

(width × depth × height) (13.5 × 17 × 5.5 inches)

Line voltage 100 – 240 VAC, ± 10 % Wide-ranging capability

Line frequency 50 or 60 Hz ± 5 %

Power consumption 300 VA / 125 W / 427 BTU Maximum

(G1315B/65B)

Ambient operating temperature 0 – 55 °C (32 – 131 °F) .

Ambient non-operating -40 – 70 °C (-4 – 158 °F)

temperature

Humidity < 95%, at 25 – 40 °C (77 – 104 °F) Non-condensing

Operating altitude Up to 2000 m (6500 ft)

Non-operating altitude Up to 4600 m (14950 ft) For storing the detector

Safety standards: IEC, CSA, UL, Installation category II, pollution

EN degree 2.
For indoor use only.

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Detectors Specifications

G1315C Diode Array Detector SL

G1365C Multible Wavelength Detector SL
Performance Specifications

Table 27 Performance Specifications Agilent 1200 Series DAD and MWD

Type Specification Comments

Detection type 1024-element photodiode array

Light source Deuterium and tungsten lamps The UV-lamp is equipped with I.D. tag
that holds lamp typical information.

Wavelength range 190 – 950 nm

Short term noise ± 0.8 × 10-5 AU at 254 and 750 nm See note on page 31
(ASTM)
Single and
Multi-Wavelength
Drift 0.9 × 10-3 AU/hr at 254 nm See note on page 31

Linear absorbance > 2 AU (upper limit) See note on page 31

range

Wavelength accuracy ± 1 nm Self-calibration with deuterium lines,

verification with holmium oxide filter

Wavelength bunching 1 – 400 nm Programmable in steps of 1 nm

Slit width 1, 2, 4 , 8, 16 nm Programmable slit

Diode width < 1 nm

Flow cells Standard: 13 µl volume, 10 mm cell path length See “Optimization Overview” in the
and 120 bar (1760 psi) pressure maximum manual
Semi-Micro: 5 µl volume, 6 mm cell path length All flow cells are equipped with I.D.
and 120 bar (1760 psi) pressure maximum tags that hold cell typical
Micro: 2 µl volume, 3 mm cell path length and information.
120 bar (1760 psi) pressure maximum
High pressure: 1.7 µl volume, 6 mm cell path
length and 400 bar (5880 psi) pressure maximum
500 nano: 0.5 µl volume, 10 mm cell path length
and 50 bar (725 psi) pressure maximum
80 nano: 0.5 µl volume, 10 mm cell path length
and 50 bar (725 psi) pressure maximum

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Detectors Specifications

Table 27 Performance Specifications Agilent 1200 Series DAD and MWD(continued)

Type Specification Comments

Control and data Agilent ChemStation for LC (32-bit) Revision B.01.03 or above
evaluation

Analog outputs Recorder/integrator: 100 mV or 1 V, output range

0.001 – 2 AU, two outputs

Communications Controller-area network (CAN), RS-232C, APG

Remote: ready, start, stop and shut-down signals,
LAN

Safety and Extensive diagnostics, error detection and display

maintenance (through control module and ChemStation), leak
detection, safe leak handling, leak output signal
for shutdown of pumping system. Low voltages
in major maintenance areas.

GLP features Early maintenance feedback (EMF) for

continuous tracking of instrument usage in terms
of lamp burn time with user-setable limits and
feedback messages. Electronic records of
maintenance and errors. Verification of
wavelength accuracy with built-in holmium oxide
filter.

Housing All materials recyclable.

ASTM: “Standard Practice for Variable Wavelength Photometric Detectors Used in Liquid
NOTE Chromatography”.

Reference conditions: cell path length 10 mm, response time 2 s, flow 1 ml/min LC-grade
Methanol, slit width 4 nm.

Linearity measured with caffeine at 265 nm.

For environmental conditions refer to “Environment” in the manual.

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Detectors Specifications

Physical Specifications

Table 28 Physical Specifications

Type Specification Comments

Weight 11.5 kg (26 lbs)

Dimensions 345 × 435 × 140 mm

(width × depth × height) (13.5 × 17 × 5.5 inches)

Line voltage 100 – 240 VAC, ± 10 % Wide-ranging capability

Line frequency 50 or 60 Hz ± 5 %

Power consumption 160 VA /160 W / 546 BTU Maximum

(G1315C/G1365C)

Ambient operating temperature 0 – 55 °C (32 – 131 °F) .

Ambient non-operating -40 – 70 °C (-4 – 158 °F)

temperature

Humidity < 95%, at 25 – 40 °C Non-condensing

(77 – 104 °F)
Operating altitude Up to 2000 m (6500 ft)

Non-operating altitude Up to 4600 m (14950 ft) For storing the detector

Safety standards: IEC, CSA, UL, Installation category II, pollution

EN degree 2.
For indoor use only.

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Detectors Specifications

G1362A Refractive Index Detector

Performance Specifications

Table 29 Performance Specifications Agilent 1200 Series Refractive Index Detector

Type Specification Comments

Detection type Refractive Index

Refractive index range 1.00 - 1.75 RIU, calibrated

Measurement range +/- 600 x 10-6 RIU

Optical zeroing via set screw

Optics temperature 5 ° C above ambient to 55 ° C

control

Sample cell volume 8uL

maximum pressure
5 bar (0.5Mpa)
maximum flow rate
5mL/minute

Valves Automatic purge and automatic

solvent recycle

Volumes Inlet port to sample cell 62uL,

inlet port to outlet port 590uL

Liquid contact materials 316 stainless steel, teflon

and quartz glass

pH range 2.3 - 9.5

Performance Short term noise see note below this table

specifications < +/- 2.5 x 10-9 RIU
Drift
< 200 x 10-9 RIU/hour
Time programmable polarity, peak width
parameters

Detector zero automatic zero before analysis

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Detectors Specifications

Table 29 Performance Specifications Agilent 1200 Series Refractive Index Detector

(continued)

Type Specification Comments

Control and data Parameter entry, signal display,

evaluation on-line help and diagnostics
with the Agilent 1200 Series
Control Module. Optional
PCMCIA card for method,
sequence and logbook storage
and transfer. Agilent
ChemStation for LC PC based
software for control and data
evaluation.

Analog outputs Recorder/integrator: 100 mV or

1 V, output range selectable,
one output

Communications Controller-area network (CAN),

GPIB, RS-232C, LAN, APG
Remote: ready, start, stop and
shut-down signals

Safety and maintenance Extensive diagnostics, error

detection and display (through
control module and
ChemStation), leak detection,
safe leak handling, leak output
signal for shutdown of pumping
system. Low voltages in major
maintenance areas.

GLP features Early maintenance feedback

(EMF) for continuous tracking
of instrument usage with
user-selectable limits and
feedback messages. Electronic
records of maintenance and
errors. Automated operational
qualification/performance
verification (OQ/PV).

Housing All materials recyclable.

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Detectors Specifications

Table 29 Performance Specifications Agilent 1200 Series Refractive Index Detector

(continued)

Type Specification Comments

Environment: 0 to 55 ° C constant
temperature at <95% humidity
(non-condensing)

Dimensions: 180 mm x 345 mm x 435 mm

(7 x 13.5 x 17 inches)
(height x width x depth)
Weight 17 kg (38 lbs)

Based on ASTM method E-1303-95 “Practice for Refractive Index Detectors used in Liquid
NOTE Chromatography”.Reference conditions; optics temperature 35 ° C, response time 4 s, flow
1.0 mL/min LC-grade Water, restriction capillary, column compartment temperature 35 ° C,
Agilent 1200 Series on-line vacuum degasser, pump and thermostatted column
compartment. Instrument equilibrated for 2 hours.

Physical Specifications

Table 30 Physical Specifications Agilent 1200 Series Refractive Index Detector

Type Specification Comments

Weight 17 kg (38 lbs)

Dimensions 345 × 435 × 180 mm

(width × depth × height) (13.5 × 17 × 7 inches)

Line voltage 100 – 240 VAC, ± 10 % Wide-ranging capability

Line frequency 50 or 60 Hz ± 5 %

Power consumption 160 VA Maximum

Ambient operating temperature 0 – 55 ° C (32 – 131 ° F)

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Detectors Specifications

Table 30 Physical Specifications Agilent 1200 Series Refractive Index

Detector(continued)

Ambient non-operating -40 – 70 ° C (-4 – 158 ° F)

temperature

Rel. Humidity < 95%, at 25 – 40 ° C Non-condensing

(77 – 104 ° F)

Operating altitude Up to 2000 m (6500 ft.)

Non-operating altitude Up to 4600 m (14950 ft.) For storing the detector

Safety standards: IEC, CSA, UL, Installation category II, pollution For indoor use only
EN degree 2

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Fraction Collectors Specifications

Fraction Collectors Specifications

G1364B Fraction Collector preparative scale

Performance Specifications

Table 31 performance Specifications Agilent 1200 Series PREPARATIVE SCALE

Autosampler (G1364B)

Type Specification

trigger modes Time slices,

Peak (threshold, up- / downslope),
Timetable (combination of time intervals and peak) and
Manual trigger (supported only with G1323B Control Module)
Agilent 1200 Series DAD/MWD detectors (G1315A/B/C, G1365 A/B/C),
the Agilent 1200 Series fluorescence detector and the Agilent G1946C/D,
G1956A/B LC-MSD are fully supported other detectors can be used but are
not supported for fraction collection.

operating modes Discrete fractions: default mode for all vessels. The flow is diverted to
waste, while moving from one vessel position to the next vessel position
Continuous flow: optional, available only when using well plates. It is
possible to move from one well plate position to the next one without
diverting the flow into the well plate to waste

Fraction capacities 4 x well-plates full tray (MTP)* (for use with deep well plates, only)
and trays 2 × well-plates std. tray (MTP) (for use with deep well plates, only)
+ 10 × 2 ml vials* (+ 1 half tray)
100 x 2 ml in std. tray (+ 1 half tray)*
3 x 40 x 2 ml in half tray*
3 x 15 x 6 ml in half tray*
Full tray with 40 test tubes (30 mm OD, max. height 100 mm, ~45 ml / tube)
Full tray with 60 test tubes (25 mm OD, max. height 100 mm, ~25 ml / tube)
Full tray with 126 test tubes (16 mm OD, max. height 100 mm, ~12 ml /
tube)
Full tray with 215 test tubes (12 mm OD, max. height 100 mm, ~7 ml / tube)
Installed trays are automatically detected and identified.
For the with uncapped vials, tests tubes and well plates, only!

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Fraction Collectors Specifications

Table 31 performance Specifications Agilent 1200 Series PREPARATIVE SCALE

Autosampler (G1364B)(continued)

Type Specification

test tube / plate Minimum 48 mm to 100 mm maximum

sizes

Maximum tube ca. 45 ml

volume

Maximum flow rate 100 ml / min (depending on viscosity and generated back pressure, max.
6 bar at the diverter valve)

Delay volumes [μl] Fraction collector inlet to diverter valve: ~500 (typical, depends on length of
the tubing)
Diverter valve: ~15
Diverter valve to needle: ~110
Needle: ~5

Delay calibration Single wavelength absorbance detector working at 654 nm, consisting of a
sensor LED and a photo diode

Diverter valve 3/2 Diverter valve with low internal volume (15 μl), switching time
< 100 ms, maximum operating pressure 6 bar

cooling Optional (with additional G1330B), performance depending on ambient

conditions and the volume of collected fractions

maximum capacity 3 fraction collectors in parallel plus one recovery fraction collector
connected via 12-Position, 13-Port Selector valve (PN G1160A)
GLP features Early maintenance feedback (EMF), electronic records of maintenance and
errors

Interfaces Controller-area network (CAN).

optional; LAN or external contacts interface
RS232C,
APG-remote (for remote start / stop signals to / from other modules)
Interface to G1330A Thermostat
CAN-DC-out for operation of Agilent
approved external devices like valves

Safety features Leak detection and safe leak handling, error detection and display, exhaust
fan for fume extraction of hazardous vapors

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Fraction Collectors Specifications

* Vials can be used as recommended by Agilent Technologies (see “List of Recommended Vials and
Caps” in the manual and “List of Recommended Plates and Closing Mats” in the manual) but must
be uncapped. Only the 96 deep well-plates can be used (without closing mats, see “List of Recom-
mended Plates and Closing Mats” in the manual)

Only one type of well-plates can be used at a time in one tray.

NOTE

Physical Specifications

Table 32 Physical Specifications - Autosamplers (G1364B, G1364C)

Type Specification Comments

Weight 13.5 kg (29.8 lbs)

Dimensions 200 × 345 × 440 mm

(height × width × depth) (8 × 13.5 × 17 inches)

Line voltage 100 – 240 VAC, ±10 % Wide-ranging capability

Line frequency 50 or 60 Hz, ±5 %

Power consumption (apparent 200 VA Maximum

power)

Power consumption (active 180 W Maximum

power)

Ambient operating temperature 4 – 55 °C (41 – 131 °F)

Ambient non-operating -40 – 70 °C (-4 – 158 °F)
temperature

Humidity < 95 %, at 25 – 40 °C Non-condensing

(77 – 104 °F)
Operating Altitude Up to 2000 m (6500 ft)

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Fraction Collectors Specifications

Table 32 Physical Specifications - Autosamplers (G1364B, G1364C)(continued)

Type Specification Comments

Non-operating altitude Up to 4600 m (14950 ft) For storing the

autosampler

Safety standards: IEC, CSA, UL Installation Category II, Pollution

Degree 2.
For indoor use only.

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Fraction Collectors Specifications

G1364C ANALYTICAL SCALE Fraction Collector

Table 33 Performance Specifications Agilent 1200 Series ANALYTICAL SCALE
Autosampler (G1364C)

Type Specification

trigger modes Time slices, Peak (threshold, up- / downslope), Timetable (combination of
time intervals and peak) and Manual trigger (supported only with G1323B
Control Module)
Agilent 1200 Series DAD/MWD detectors (G1315A/B/C, G1365 A/B/C),
the Agilent 1200 Series fluorescence detector and the Agilent G1946C/D,
G1956A/B LC-MSD are fully supported other detectors can be used but
are not supported for fraction collection.

operating modes Discrete fractions: default mode for all vessels. The flow is diverted to
waste, while moving from one vessel position to the next vessel position
Continuous flow: optional, available only when using the deep well plates.
It is possible to move from one well plate position to the next one without
diverting the flow into the well plate to waste
Needle into location: Needle pushes into the vessel as deep as specified,
for the use with capped vials and test tubes and well plates with closing
mats
Droplet setup mode: The tip of the fraction collector needle will initially
move down to the bottom of the well. Then it will slowly move upwards
while the fraction is collected. The droplet setup mode enables the fraction
collector to collect small fractions without bubbles.

fraction vessel • 4 x well-plates full tray (MTP)*

capacities and trays • 2 x well-plates std. tray + 10 funnels with external containers* (+ 1 half
tray)
• 2 × well-plates std. tray (MTP) + 10 × 2 ml vials* (+ 1 half tray)
• 100 x 2 ml in std. tray (+ 1 half tray)*
• 3 x 40 x 2 ml in half tray*
• 3 x 40 funnels in half tray
• 3 x 15 x 6 ml in half tray*
• Full tray with 40 test tubes (30 mm OD, max. height 48 mm, ~20 ml vol.)
• Full tray with 60 test tubes (25 mm OD, max. height 48 mm)
• Full tray with 126 test tubes (16 mm OD, max. height 48 mm)
• Full tray with 215 test tubes (12 mm OD, max. height 48 mm)
Installed trays are automatically detected and identified. Installed plates
and vials can be detected when operating in the needle into location mode
* max. height can be extended by using the short needle assembly
G1364-87202

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Fraction Collectors Specifications

Table 33 Performance Specifications Agilent 1200 Series ANALYTICAL SCALE

Autosampler (G1364C)(continued)

Type Specification

maximum tube / 48 mm with long needle assembly G1367-87200

plate height 75 mm with short needle assembly G1364-87202

Maximum tube ca. 20 ml with 48 mm test tubes, ca. 30 ml with 75 mm test tubes or
volume unlimited, if funnels are used with external containers.

Maximum flow rate 10 ml / min (depending on viscosity and generated back pressure, max.
6 bar at the diverter valve). The analytical scale fraction collector can be
modified for flow rates > 10 ml/min.

delay volumes [μl] Fraction collector inlet to diverter valve: ~50 (typical, depends on the
length of the tubing)
Diverter valve: ~15
Diverter valve to needle: ~10
Needle: ~4

delay calibration Single wavelength absorbance detector working at 654 nm, consisting of a
sensor LED and a photo diode

diverter valve 3/2 Diverter valve with low internal volume (15 μl), switching time
< 100 ms, maximum operating pressure 6 bar

cooling Optional (with additional G1330B), performance depending on ambient

conditions and the volume of collected fractions

maximum capacity 3 fraction collectors in parallel plus one recovery fraction collector
connected via 12-Position, 13-Port Selector valve (PN G1160A)

GLP features Early maintenance feedback (EMF), electronic records of maintenance and
errors
interfaces - Controller-area network (CAN).
- optional; LAN or external contacts interface
- RS232C,
- APG-remote (for remote start / stop signals to / from other modules)
- Interface to G1330A Thermostat
- CAN-DC-out for operation of Agilent approved external devices like
valves

safety features Leak detection and safe leak handling, error detection and display, exhaust
fan for fume extraction of hazardous vapors

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Fraction Collectors Specifications

* Vials and well-plates and capped vials and well plates with closing mats can be used as recom-
mended by Agilent Technologies (see “List of Recommended Vials and Caps” in the manual and
“List of Recommended Plates and Closing Mats” in the manual)

Only one type of well-plates can be used at a time in one tray.

NOTE

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Fraction Collectors Specifications

G1364D Micro Collector/Spotter

Performance Specifications

Table 34 Performance Specifications Agilent 1200 Series Micro Autosampler (G1364D)

Type Specification

trigger modes Time slices,

Peak (threshold, up- /downslope),
Timetable (combination of time intervals and peak) and
Agilent 1200 UV-Vis detectors DAD G1315A/B, MWD G1365 A/B are
fully supported. Other detectors with appropriate delay volumes can
be connected through UIB interface.

operating modes Above location

Into location
Liquid Contact Control: The tip of the fraction collector capillary will
initially move down to the bottom of the well. Then it will slowly
move upwards while the fraction is collected. The contact control
mode enables the micro collector/spotter to collect fractions down
to 2 μl in well plates or MALDI spots down to 100 nl

fraction vessel capacities • 4 well-plates full tray (MTP)

and trays with: 384 or 96-well plates (standard and conical shape) or 4 x 27,
Eppendorf tubes (0.5, 1.5, 2.0 ml), MALDI Target Plates.
• 2 × well-plates std. tray (MTP) + 10 × 2 ml vials (+ 1 half tray)
with: 384 or 96-well plates (standard and conical shape) or 2x 27
eppendorf tubes (0.5, 1.5, 2.0 ml),

MALDI Spotting plates • 96 Agilent plate for AP-MALDI

(pre-configured) • 100 Applied Biosystems, 2x96 Applied Biosystems, 192 Applied
Biosystems, 400 Perseptive Biosystems
• Micromass 80/96 spots
• Bruker Anchor Chips 384/1536 spots

MALDI Plate Capacity 4 (3 for Bruker Anchor Chip 1536)

Minimum fraction volume Typically 2 μl (depending on the fraction collection container)

MALDI spot size 100-5000 nl (depending on the MALDI plate)

maximum spotting rate 20 spots/min (1spot/3s)

Maximum flow rate 100 μl/min

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Fraction Collectors Specifications

Table 34 Performance Specifications Agilent 1200 Series Micro Autosampler

(G1364D)(continued)

Type Specification

delay volumes [μl] 25 μm ID fraction collector capillary: ~0.25

50 μm ID fraction collector capillary: ~1
100 μm ID fraction collector capillary: ~5

cooling Recommended (with additional G1330B)

maximum capacity 2 micro collector/spotter connected via 2-Position, 6-Port micro

valve (G1162A)

GLP features Early maintenance feedback (EMF), electronic records of

maintenance and errors

interfaces - Controller-area network (CAN).

- optional; LAN or external contacts interface
- RS232C,
- APG-remote (for remote start / stop signals to / from other
modules)
- Interface to G1330A Thermostat
- CAN-DC-out for operation of Agilent
approved external devices like valves

Only one type of well plate or MALDI plate can be used at a time in one tray.
NOTE

Physical Specifications

Table 35 Physical Specifications - micro collector/spotter G1364D

Type Specification Comments

Weight 13.5 kg (29.8 lbs)

Dimensions 200 × 345 × 440 mm

(height × width × depth) (8 × 13.5 × 17 inches)

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Fraction Collectors Specifications

Table 35 Physical Specifications - micro collector/spotter G1364D(continued)(continued)

Type Specification Comments

Line voltage 100 – 240 VAC, ±10 % Wide-ranging capability

Line frequency 50 or 60 Hz, ±5 %

Power consumption (apparent 200 VA Maximum

power)

Power consumption (active 180 W Maximum

power)

Ambient operating 4 – 55 °C (41 – 131 °F)

temperature
Ambient non-operating -40 – 70 °C (-4 – 158 °F)
temperature

Humidity < 95 %, at 25 – 40 °C (77 – 104 °F) Non-condensing

Operating Altitude Up to 2000 m (6500 ft)

Non-operating altitude Up to 4600 m (14950 ft) For storing the

autosampler

Safety standards: IEC, CSA, UL Installation Category II, Pollution

Degree 2.
For indoor use only.

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Valves Specifications

Valves Specifications

G1157A Agilent 1200 Series 2 position / 10 port valve

Performance Specifications

Table 36 2 position / 10 port valve

Liquid contacts Stainless Steel and PEEK

Port size: Accepts 10-32 male threaded fittings

Flow passage diameters: Stator and stator face assembly 0.6-mm (0.024”), rotor seal 0.6-mm
(0.024”)

Volume in flow passage: Stator (includes stator face seal) 2.1 µl/hole, rotor seal 0.7
µl/groove

Maximum pressure: 41 MPa (408 bar, 6000 psi)

Recommended flow range: 0.2 - 100 ml/min

Physical Spesificarions for all Valves

Table 37 Physical Spesificarions for Agilent 1200 Series Valves

Type Specification

• Weight 1.9 Kg (4.2 lbs)

• Dimensions 92 x 84 x 200 mm
• (height x width x depth) (9.2 x 3.3 x 8.0 inches)

• Power supply 24 Volts DC (1.7 amps)

• Ambient operating temperature 4 to 55°C (39 to 131°F)

• Humidity < 95%, non-condensing

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Valves Specifications

Table 37 Physical Spesificarions for Agilent 1200 Series Valves(continued)

Type Specification

• Safety Standards IEC, CSA, UL, EN

Installation category II,
pollution degree 2
For indoor use only

Revision

• Agilent 1200 Firmware A.05.04 and higher

• Control Module Firmware G1323B B.03.11 and higher

• Agilent ChemStation Software A.09.03 and higher

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Valves Specifications

G1158A Agilent 1200 Series 2 position / 6 port valve

Performance Specifications

Table 38 2 position / 6 port valve

Liquid contacts: Stainless steel, PEEK, and alumina ceramic

Port size: Accepts 10-32 male threaded fittings

Flow passage diameters: Stator and stator face assembly 0.4-mm (0.015”), rotor seal 0.5-mm
(0.018”)

Volume in flow passage: Stator (includes stator face seal) 0.7 µl/hole, rotor seal 0.3
µl/groove

Maximum pressure: 41 MPa (408 bar, 6000 psi)

Recommended flow range: 0.2 - 100 ml/min

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Valves Specifications

G1159A Agilent 1200 Series 6 position selection valve

Table 39 6 position selection valve

Liquid contacts: Stainless steel and PEEK

Port size: Accepts 10-32 male threaded fittings

Flow passage diameters: Stator 0.6-mm (0.024”), stator face assembly and rotor seal 0.4-mm
(0.015”)

Volume in flow passage Angled ports 1, 2, 5 (15.6 µl)

Radial ports 2, 4, 6 (18,8 µl)

Maximum pressure: 35 MPa (345 bar, 5000 psi)

Recommended flow range: 0.3 - 40 ml/min*

* The G1159A Agilent 1200 Series 6 positions selection valve can be used at flow rates up to 100
ml/min, but without valve switching. In most cases e.g. column selection the valve switches during
the postrun or prerun, when the flow can be reduced.

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Valves Specifications

G1160A Agilent 1200 Series 12 position/ 13 port selection valve

Table 40 12 position/ 13 port selection valve

Liquid contacts: Stainless steel and PEEK

Port size: Accepts 10-32 male threaded fittings

Flow passage diameters: 1.0-mm (0.040”)

Volume in flow passage: Stator (includes stator face seal) 6.4 µl/hole, rotor seal 4.0
µl/groove

Maximum pressure: 21 MPa (207 bar, 3000 psi)

Recommended flow range: 0.2 - 100 ml/min (at high pressures, after the pump)
0.2 - 10 ml/min (at low pressures, in front of the pump)

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Valves Specifications

G1162A Agilent 1200 Series 2 position/ 6 port micro valve

Table 41 2 position/ 6 port micro valve

Liquid contacts: DuraLife processed stainless steel (stator) and vespel (rotor seal)

Port size: Accepts M4 male threaded fittings

Flow passage diameters: 0.20 mm (0.008")

Volume in flow passages: 70 nl port to port

Maximum pressure: 41 MPa (408 bar, 6000 psi)

Recommended flow range: 0.1 - 100 μl

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Valves Specifications

G1163A Agilent 1200 Series 2 position/ 10 port micro valve(continued)

Table 42 2 position/ 10 port micro valve

Liquid contacts: DuraLife processed stainless steel (stator) and vespel (rotor seal)

Port size: Accepts M4 male threaded fittings

Flow passage diameters: 0.20 mm (0.008")

Volume in flow passages: Stator (20° ports)27.2 nl, (45° ports) 30.5 nl, rotor seal 25.0
nl/groove

Maximum pressure: 41 MPa (408 bar, 6000 psi)

Recommended flow range: 0.1 - 100 μl

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Miscellaneous Specifications

Miscellaneous Specifications

G1322A Vacuum Degasser

Performance Specifications

Table 43 Performance Specifications Agilent 1200 Series Vacuum Degasser

Type Specification

Maximum flow rate 10 ml/min per channel

Number of channels 4

Internal volume per channel Typically 12 ml per channel

Materials in contact with solvent PTFE, PEEK

pH range 1 – 14

Analog output (AUX) For pressure monitoring, range 0 – 3 V

The G1322 Vacuum Degasser has been tested for evaporation of solvents into the
NOTE atmosphere by an independent institute with approved methods. The tests were performed
with Methanol (BIA Nr. 7810) and Acetonitrile (NIOSH, Nr. 1606). Evaporation of these
solvents into the atmosphere when operating the degasser was below the limits of
detection.

Physical Spesificarions

Table 44 Physical Specifications

Type Specification Comments

Weight 7 kg (15.4 lbs)

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Miscellaneous Specifications

Table 44 Physical Specifications(continued)

Dimensions 345 × 435 × 80 mm

(width × depth × height) (13.5 × 17 × 3.1 inches)

Line Voltage 100 – 120 or 220 – 240 VAC, Wide-ranging capability

± 10 %
Line Frequency 50 or 60 Hz, ± 5 %

Power consumption 30 W Maximum

Ambient Operating Temperature 0 – 55 °C (32 – 131 °F)* see User manual

Ambient Non-operating -40 – 70 °C (-4 – 158 °F)

Temperature

Humidity < 95 %, at 25 – 40 °C (77 – 104 °F) Non-condensing

Operating Altitude Up to 2000 m (6500 ft)

Non-operating Altitude Up to 4600 m (14950 ft) For storing the instrument

Safety Standards: IEC, CSA, UL Installation Category II, Pollution

Degree 2

* This temperature range represents the technical specifications for this instrument. The mentioned
temperatures may not be suitable for all applications and all types of solvents.

Never operate your instrumentation under conditions other than specified by the
WA R N I N G
vendor. Operating the instrumentation under conditions other than their intended
use might result in a potential safety hazard or might damage the instrumentation.

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Miscellaneous Specifications

G1379B Micro Vacuum Degasser

Performance Specifications

Table 45 Performance Specifications Agilent 1200 Micro Vacuum Degasser

Type Specification

Maximum flow rate 0 - 5 ml/min per channel

Number of channels 4

Internal volume per channel Typically 1 ml per channel

Materials in contact with solvent PTFE, FEP,PEEK

pH range 1 – 14

RS-232 output For diagnostic purposes

The Agilent 1200 Series micro vacuum degasser has been tested for evaporation of
NOTE solvents into the atmosphere by an independent institute with approved methods. The
tests were performed with Methanol (BIA Nr. 7810) and Acetonitrile (NIOSH, Nr. 1606).
Evaporation of these solvents into the atmosphere when operating the degasser was below
the limits of detection.

Physical Spesificarions

Table 46 Physical Specifications

Type Specification Comments

Weight 7 kg (15.4 lbs)

Dimensions 345 × 435 × 80 mm

(width × depth × height) (13.5 × 17 × 3.1 inches)

Line Voltage 100 – 120 or 220 – 240 VAC, ± 10 % Wide-ranging capability

Line Frequency 50 or 60 Hz, ± 5 %

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Miscellaneous Specifications

Table 46 Physical Specifications(continued)

Power consumption 30 W Maximum

Ambient Operating 0 – 45 °C (32 – 113 °F)* see User manual

Temperature

Ambient Non-operating -40 – 70 °C (-4 – 158 °F)

Temperature

Humidity < 95 %, at 25 – 40 °C (77 – 104 °F) Non-condensing

Operating Altitude Up to 2000 m (6500 ft)

Non-operating Altitude Up to 4600 m (14950 ft) For storing the instrument

Safety Standards: IEC, CSA, Installation Category II, Pollution for indoor use only!
UL Degree 2

* This temperature range represents the technical specifications for this instrument. The mentioned
temperatures may not be suitable for all applications and all types of solvents.

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Miscellaneous Specifications

G1316A Thermostatted Column Compartment

G1316B Thermostatted Column Compartment

Performance Specifications

Table 47 Performance Specifications Agilent 1200 Series Thermostatted Column

Compartment G1316A/G1316B

Type Specification Comments

Temperature range 10 degrees below ambient to 80 °C G1316A

10 degrees below ambient to 100 °C G1316B (SL)

up to 80 °C: flow rates up to 5 ml/min G1316A / G1316B (SL)

up to 100 °C: flow rates up to 2.5 ml/min G1316B (SL)

Temperature stability ± 0.15 °C G1316A

± 0.05 °C G1316B (SL)

Temperature accuracy ± 0.8 °C

± 0.5 °C With calibration

Column capacity Three 30 cm

Warm-up/cool-down 5 minutes from ambient to 40 °C

time 10 minutes from 40 – 20 °C

Dead volume 3 µl left heat exchanger i.d. 0.17 mm

6 µl right heat exchanger

Dimensions 140 × 410 × 435 mm

(h × w × d) (5.5 × 16 × 17 inches)

Weight 10.2 kg (22.5 lbs)

Communications Controller-area network (CAN), GPIB, no GPIB on G1316B SL

RS-232C, APG Remote: ready, start, stop
and shut-down signals, LAN via other
1200 series module

Safety and maintenance Extensive diagnostics, error detection and

display (through control module and
Agilent ChemStation), leak detection, safe
leak handling, leak output signal for
shutdown of pumping system. Low
voltages in major maintenance areas.

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Miscellaneous Specifications

Table 47 Performance Specifications Agilent 1200 Series Thermostatted Column

Compartment G1316A/G1316B(continued)

Type Specification Comments

GLP features Column-identification module for GLP

documentation of column type, see
“Column-Identification System” in the
manual

Housing All materials recyclable.

All specifications are valid for distilled water at ambient temperature (25 °C), set point at
NOTE 40 °C and a flow range from 0.2–5 ml/min.

Physical Specifications

Table 48 Physical Specifications

Type Specification Comments

Weight 10.2 kg (22.5 lbs)

Dimensions 410 × 435 × 140 mm

(width × depth × height) (16.1 × 17 × 5.5 inches)

Line Voltage 100 – 240 VAC, ± 10 % Wide-ranging

capability

Line frequency 50 or 60 Hz, ± 5 %

Power consumption 320 VA / 150 W / 512 BTU Maximum

Ambient operating temperature 0 – 55 °C (32 – 131 °F)

Ambient non-operating -40 – 70 °C (-4 – 158 °F)
temperature

Humidity <95 %, at 25 – 40 °C (77 – 104 °F) Non-condensing

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Miscellaneous Specifications

Table 48 Physical Specifications(continued)

Operating altitude Up to 2000 m (6500 ft.)

Non-operating altitude Up to 4600 m (14950 ft.) For storing the

instrument

Safety standards: IEC, CSA, UL, Installation Category II, Pollution

EN Degree 2
For indoor use only.

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Miscellaneous Specifications

G1330A Autosampler Thermostat

Performance Specifications

Table 49 Performance Specifications Agilent 1200 autosampler thermostat

Type Specification

Temperature range: setable from 4°C to 40°C in 1° increments

Temperature accuracy at ambient -1°C to +4°C at a setpoint of 4°C

temperatures < 25°C and humidity < 50%

Temperature accuracy at ambient -1°C to +5°C at a setpoint of 4°C

temperatures > 25°C and/or humidity > 50%

Physical Specifications

Table 50 Physical Specifications - Thermostatted Autosampler

Type Specification Comments

Thermostat
Weight 20.7 kg (45.6 lbs)

Dimensions 140 × 345 × 435 mm

(height × width × depth) (5.5 × 13.5 × 17 inches)

Line voltage 100 – 120 or 220 – 240 VAC, ± 10 % Automatic selection

Line frequency 50 or 60 Hz, ± 5 %

Power consumption Autosampler: 300 VA Maximum

ALS Thermostat: 260 VA Maximum

Ambient operating 4 – 40 °C (41 – 131 °F) see User manual

temperature
Ambient non-operating -40 – 70 °C (-4 – 158 °F)
temperature
Humidity < 95 %, at 25 – 40 °C (77 – 104 °F) Non-condensing;

Operating Altitude Up to 2000 m (6500 ft)

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Miscellaneous Specifications

Table 50 Physical Specifications(continued)- Thermostatted Autosampler(continued)

Type Specification Comments

Non-operating altitude Up to 4600 m (14950 ft) For storing the

autosampler

Safety standards: IEC, CSA, Installation Category II, Pollution

UL, EN Degree 2

Agilent 1200 Series Qualification Workbook

 Design Qualification (DQ) Phase 2
Agilent ChemStation Specifications

Agilent ChemStation Specifications

Agilent 1200 Series Qualification Workbook

 Agilent ChemStation for
GC, LC, LC/MSD, CE, and A/D Systems
- Rev. B.02.01

Specifications
May 2006

What’s New in Rev. B.02.01

Revision B.02.01 is the next step The following new features are specific signal options to
in active development of the included in Revision B.02.01: improve data review
Agilent ChemStation. Its new • Possibility to save manual inte-
User Interface addresses cus- • New and improved gration events in Data Analysis
tomer's growing needs for faster ChemStation User Interface method along with newly
acquisition and review of data. A design acquired sequence data files
modern tree view along with a • New tree- and table based navi- • Online help integrated
new navigation table allows easy gation providing fast and flexi- ChemStation tutorial, to enable
finding, sorting and review of ble Data Handling within vari- learning the software while
multiple sample data. It adopts ous ChemStation views working on your own methods
new Microsoft technologies while • Improved data review and and data
maintaining well known reprocessing capabilities using • Enhanced utilization of high
ChemStation concepts to avoiding the Data Analysis Navigation resolution monitor and avail-
need of re-training. Table able screen real estate
• Flexible storage locations for
Note: Rev. B.02.01 Agilent data, methods, and sequences For users of the Agilent 1100
ChemStation software release • New packaging concept for /1200 Series LC systems and LC
does not relate to UV-VIS or sequence data guaranties con- software:
GC/MSD instrumentation. These sistency of all methods and • Support for the GPC Add-on
instruments are controlled and results within a sequence software G2182BA
supported by separate Agilent • Additional signal options give • Direct software link to new
ChemStation software products. possibility to assign method Agilent LC Diagnostics
• Interface for 3rd party LC
detector drivers
Introduction and full support of For users of the GC systems
the new Agilent 1200 Series LC, and GC software
including the new Agilent 1200 • With B.02.01, a GC column data-
Series Rapid Resolution LC system base utility is available to trans-
with the following new hardware fer user-defined GC columns
modules: after an upgrade from G2070AA
• Agilent 1200 Series binary pump to G2070BA ChemStation. The
SL (G1312B) utility is available on the
• Agilent 1200 Series high perfor- ChemStation CD-ROM in the
mance autosampler SL (G1367C) Support directory.
• Agilent 1200 Series thermostat- • 732 J&W GC columns have
ted column compartment SL been added to the B.02.01 GC
(G1316B) ChemStation column catalog.
• Agilent 1200 Series variable
wavelength detector SL (G1314C)
• improved diode-array detector
SL (G1315C)
• improved Agilent 1200 Series
mutliple wavelength detector SL
(G1365C)

Important firmware information

for Agilent 1200/1100 Series sys-
tems:
• For Agilent 1200/1100 Series
modules the minimum firmware
revision is A.06.02
• The new G1315C/G1356C DAD-
SL/MWD-SL require firmware
B.01.02.
• Firmware Rev. A.06.02 and
B.01.02 are not compatible with
6.01 resp. B.01.01 or earlier.

2
Table of Contents

What’s New in B.02.01 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1

General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Computer Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Minimum PC Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
Maximum Number of Supported Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
Maximum Number of Supported Modules Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
IEEE-488 GP-IB Support Matrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
USB/GP-IB Interface Support Matrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
LAN-MIO Support Matrix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Printers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Operating System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Methods and Sequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
System Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Data Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Software User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Data Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Data Analysis - Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Data Analysis - Integration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Data Analysis - Quantification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15
Data Analysis - Standard Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Data Analysis - Specialized Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Utilies and Compatibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
XML Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Customization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Automation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Good Laboratory Practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Instrument Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Agilent ChemStation for GC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
Agilent ChemStation for LC Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Agilent ChemStation for LC/MSD Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
Agilent ChemStation for A/D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Additional Data Evaluation Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
High Throughput Purification Software Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
Agilent ChemStore C/S Database Client Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
Agilent ChemStation Plus Security Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
Networking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

3
General Description

The Agilent 32-Bit ChemStations automation and customization for additional instrument control soft-
for GC, LC, LC/MSD, CE and A/D a single analytical instrument. A ware. It is possible to configure
systems are instrument control, single instrument may collect data up to four chromatography instru-
data acquisition and data evalua- from a number of different detec- ments per ChemStation PC. The
tion systems for: tors simultaneously. The fivecore four additional instrument control
2D software products are: software products are:
• Agilent 6890N, 6890 Plus and
6890A gas chromatographs, • Agilent 32-Bit ChemStation for • Additional LC Instrument
• Agilent 6850 gas chromato- 2D Liquid Chromatography (LC) Control and Data Acquisition
graph, systems (G2170BA) software, (G2171BA)
• Agilent 5890 Series II and 4890D • Agilent 32-Bit ChemStation for • Additional GC Instrument
gas chromatographs, Gas Chromatography (GC) sys- Control and Data Acquisition
• Agilent 1200 Series modules tems (G2070BA) software (G2071BA)
and systems for HPLC, includ- • Agilent 32-Bit ChemStation for • Additional LC/MS Instrument
ing the Agilent 1200 Series Liquid Chromatography / Mass Control, Data Acquisition and
LC/MSD, Selective Detector (LC/MSD) data evaluation software,
• Agilent 1100 Series modules systems (G2710BA) (G2715BA)
and systems for HPLC, includ- • Agilent 32-Bit ChemStation for • Additional CE Instrument
ing the Agilent 1100 Series Capillary Electrophoresis (CE) Control, Data Acquisition and
LC/MSD, systems (G1601BA) data evaluation module
• HP 1090 Series liquid chro- • Agilent 32-Bit ChemStation for (G2172BA)
matographs, 35900E Analog to Digital • CE/MS Add-on software
• Agilent 35900E dual channel Converter (A/D) systems, (G2201BA) for G1946X
analog-to-digital interface, and (G2072BA) • Additional 35900E Analog to
• Agilent capillary electrophore- Digital Converter (A/D)
sis systems. ChemStation 3D Software Instrument Control and Data
Module Acquisition software (G2073BA)
The software is designed to run on
IBM compatible personal comput- The capabilities of the core 2D LC ChemStation License to use
ers with a PCI interface under software may be expanded to software on another PC
Microsoft Windows operating allow for 3D data through the pur-
environments. chase of the additional LC 3D Once an initial core ChemStation
Spectral Module (G2180BA). software product has been pur-
Core ChemStation 2D chased it is possible to purchase
Software ChemStation Additional licenses to use that software on
Instrument Control Software another PC. The available license
Five core 32-Bit ChemStation 2D products are:
software products are available. The instrument control capabili-
Each core software product pro- ties of the core Agilent • License to use 2D LC
vides data acquisition, instrument ChemStation software may be ChemStation software on
control, data analysis (integration, extended to allow for multiple another PC (G2175BA)
quantification and reporting), instrument systems by purchasing

4
• License to use 3D LC figurations right through to dis- • Retention Time Locking
ChemStation software on tributed, multi-technique configu- (G2080BA)
another PC (G2185BA) rations and client-server function- Retention Time Locking soft-
• License to use GC ChemStation ality. Users, instruments and ware for the G2070BA GC
software on another PC applications can be added with- ChemStation.
(G2075BA) out disruption.
• License to use CE ChemStation Note: Some combinations • Integrated Headspace Con-
software on another PC (marked with*) require trol Software (G2924AA)
(G2205BA) ChemStation B.02.01 SR1. Requires G2070BA GC
• License to use A/D ChemStation software.
ChemStation software on • Agilent ChemStore,
another PC (G2077BA) Standalone/Client* • Analyst Software
(G2181BA) ChemStore (G2731AA)
ChemStation Data Analysis Server* (G1410A) For LC/MSD data analysis.
Only Software ChemStore provides central- Requires LC/MSD ChemStation
ized data organization and stor- software.
There are three data analysis only age, custom calculations,
ChemStation software products. review and approval as well as • Peptide Tools (G2720AA)
These products are designed for powerful report generation LC/MSD Deconvolution &
data evaluation only purposes, for capabilities such as control Bioanalysis SW. For determi-
example in an office environment, charting. It is available as nation of molecular weight
and should not have instruments either a Standalone or from multiply charged API-ES
configured. The three data analy- Client/Server configuration. mass spectra & for evaluation
sis only software products are: of MS data from proteins/ pep-
• Agilent ChemStation Plus tides/ oligonucleotides.
• ChemStation Data Analysis Security Pack, (G2183AA) Requires G2710BA LC/MSD
software for LC (G2190BA) Compliance with regulatory ChemStation Software or
• ChemStation Data Analysis guidelines such as the FDA's 21 G2715BA LC/MSD Add-on
software for GC (G2090BA) CFR Part 11 Software module to operate.
• ChemStation Data Analysis
software for LC/MSD Dedicated Solutions for • TOF Software (G3300AA)
(G2730BA) Specific Applications For CE-MS TOF.

ChemStation Plus Add-On • High Throughput

Software Modules Purification (Purify) soft-
ware modules*
Agilent provides a range of add-on Advanced, high-capacity
software modules which extend preparative LC for large num-
the capabilities of the Chem- bers of samples.
Station base software. The modu-
lar architecture ensures that you • Agilent ChemStation
can control your enhanced system Companion
from the same, familiar user inter- Provides a simple single-screen
face. ChemStation Plus is a fully user interface for GC routine
scaleable solution that enables analysis. Automatically
you to expand your data system installed with ChemStation GC
from single PC to instrument con- software.

5
Computer Hardware

The 32-Bit ChemStation consists for time critical events such as of the GPIB interface, for
of Hewlett-Packard personal com- injection. instance, may conflict with the
puter hardware and ChemStation memory configuration of a
software. The hardware is an IBM Non HP / Compaq Computers non-HP /Compaq computer.
compatible personal computer The Agilent ChemStation has Additional accessory interface
with an ISA or PCI interface bus. been designed to successfully run boards may cause conflicts of
on a wide range of compatible hardware related resources
The personal computer is inter- personal computers equipped (I/O ports, interrupt settings,
faced to the analytical instruments with accessories and peripherals DMA channels). For a non-HP/
through a LAN card, a GP-IB inter- that adhere to the programming Compaq computer, use the setup
nal card, a USB/GP-IB interface, standards for the Intel PC plat- utility program supplied by the
or a combination of one GP-IB form and Microsoft Windows manufacturer to configure your
card and a LAN card. All cards operating systems. Agilent computer and check the supplied
plug directly into the computer’s Technologies has tested the documentation to eliminate
PCI or interface. Third-Party Agilent ChemStation software resource conflicts in your PC's
instruments can be connected via mainly on Hewlett Packard/ setup, especially regarding the
the Agilent 35900E A/D-Converter Compaq equipment. All configura- configuration of the GPIB inter-
interface. The separate hardware tion information listed in this face. Although the software is
components that comprise a par- manual applies to Hewlett- also designed to be run on other
ticular instrument configuration, Packard/Compaq Kayak, Vectra compatible hardware Agilent
including third party instrumenta- and EVO computers and may not Technologies will not necessarily
tion, may need to be coordinated be optimized for other vendor's accept responsibility for defects
through a remote cabling system PCs. The standard configuration solely observed and reported on
third party hardware.

Minimum PC Configuration

Windows XP and Windows 2000 • MS Windows compatible Minimum memory specifica-

based systems: pointing device tions:
• Hewlett-Packard / Compaq PC • ATAPI CD, CD-RW or DVD • 512 MB RAM
with Pentium V, 1.5 GHz drive
• SXGA display (1280x1024 • 10/100 baseT LAN interface * Agilent supports the use of hyperthread-
ing on Pentium IV or higher PC's running
resolution) card.
Windows® XP.
• 40 GB hard disk

6
Maximum Number of Supported Instruments

A maximum of four instruments • A maximum of three instru- instrument) may be configured

may be configured per Agilent ments are supported per PC on the same PC. No additional
ChemStation PC. The following when ChemStore is installed. instruments are supported on
instrument/module specific limita- • A maximum of three instru- the CE/MS ChemStation sys-
tions exist: ments are supported per PC tem.
• A maximum of two diode-array when spectroscopy instruments • CE ChemStation can co-reside
detector instruments may be are configured. with a second system (either LC
configured per PC. • An Agilent 1200/1100 Series or CE ChemStation), however
• A maximum of one variable LC/MSD system only allows one coexecution of the software is
wavelength detector (VWD), additional Agilent 1200/1100 or not supported.
one pump module, one 1090 Series II HPLC instrument
autosampler module and one to be configured.
thermostated column compart- • Only one CE instrument may be
ment (TCC) module are allowed configured per PC.
per instrument on a PC with • A maximum of one CE/MS
four instruments configured. (including the DAD on the

Maximum Number of Supported Modules Guidelines

The guideline for the maximum Out of these 18 modules up to six

number of modules that may be CAN-slave modules can also be
configured per Agilent Chem- configured, e.g. values or UIB
Station PC is 18. Approximately 12 interfaces. For correct configura-
analytical modules can be config- tion of specific instruments and
ured but this depends on the exact modules please contact your
configuration. Agilent Technologies representa-
tive. The ChemStation Plus
Note: Please contact your Agilent Ordering Guide provides additional
Technologies representative to details on supported configura-
confirm whether configurations tions.
approaching this 12 module limit
are possible.

7
IEEE-488 GP-IB Support Matrix

Instruments Supported on 82350A/B GP-IB Interface cards a PCI slot is required on the
GP-IB Cards PC. The Agilent 82350 is a PCI
Agilent 6890 Gas Chromatograph Analytical instruments can com- GPIB interface card and no addi-
Agilent 5890 Gas Chromatograph municate with the Agilent tional settings such as changing
Agilent 1090 Series LC systems ChemStation via GPIB using a the I/O base address are required.
Agilent Capillary Electrophoresis GPIB board installed in the com- Please note that GPIB communi-
(CE) puter. Agilent 82350A or 82350B cation requires installation of the
Agilent Capillary Electrophoresis PCI high-performance GPIB inter- SICL I/O library version M.01.01.
Mass Spectrometry (CE/MS) face cards can be used on Please ask your local Agilent
HP 1046 FLD Windows 2000 and Windows XP Technologies representative for
HP 1049 ECD Professional systems. For both additional details.
HP 1090 LC

USB/GP-IB Interface Support Matrix

Instruments supported on USB/GP-IB Interface CE PC bundle (G1602BA Option

USB/GP-IB (USB port on PC is A USB/GPIB interface (82357A) 720) or as an internal support part
used): allows you to directly connect (G1680-63200) from the Support
• Agilent Capillary from the USB port on your PC to Organisation. Please ask your
Electrophoresis (CE) GPIB instruments. The interface local Agilent Technologies repre-
• Agilent Capillary is small, portable, flexible, uses sentative for additional details.
Electrophoresis Mass industry standards and is easy to
Spectrometry (CE/MS) connect. The interface can be Note: USB/GPIB interfaces are
• HP 1046 FLD used on both Windows 2000 and only supported with legacy LC
• HP1049 ECD Windows XP Professional sys- and CE instruments.
• HP 1090 LC tems. The USB/GPIB cable is
available as an option against the

8
LAN-MIO Support Matrix
G1369A Agilent LAN Interface revision of B.01.02. A new Communication Protocols
Card LAN/RS-232 Firmware Update Instruments are controlled over
The firmware of the card must be Tool 2.1 is available for updat- LAN using industry standard
revision A.01.05 or higher. For ing firmware quickly and easily. TCP/IP (Transmission Control
non-LC systems (35900E ADC, Please ask your local Agilent Protocol / Internet Protocol). It is
6890 GC and 6850 GC) a minimum Technologies representative for necessary to verify correct com-
Firmware Revision of C.03.00 is details. munication between the PC and
required. Please refer to Service Note: Firmware Rev. A.06.02 analytical instruments connected
Note G1369-003. & B.01.02 are NOT compatible over the LAN. The Microsoft
with Rev. A.06.02 & B.02.01 TCP/IP protocol needs to be
J2552B/C JetDirect Internal or earlier. installed and configured as a net-
Printer Servers (MIO) work protocol on the PC.
The firmware of the JetDirect card Instruments / Modules
has to be revision A.08.32 or high- Supported on LAN The boot strap protocol is used to
er. Agilent 1200/1100 Series LC sys- configure the JetDirect or G1369A
tems LAN card. The Boot strap proto-
J4100A JetDirect N Internal Agilent 6890 Gas Chromatograph col requires a BootP service
Printer Servers (MIO) Agilent 6850 Gas Chromatograph (refer to the readme). Agilent no
The firmware of the JetDirect card Agilent 1200/1100 Series LC/MS longer supports the Bootp
has to be revision K.08.32 or high- systems Service. The Agilent BootP
er. Agilent 35900E A/D systems Service Program uses the LAN
Agilent 1200 Chip Cube interface communication parameters speci-
Note: (G4240A for Ion Trap systems) fied in the Configuration Editor to
• The 6890N requires firmware establish communication. The
revision N.05.04 or higher and G1369A LAN Interface Card Agilent BootP Service Program
LAN board firmware revision LAN interface cards are used to can be used for central adminis-
04.7B3. LAN communication connect analytical instruments to tration and distribution of IP
with the Agilent 6890A requires the LAN. Jet Direct or G1369A addresses and settings.
firmware revision A.03.08 or LAN cards are required. The mini-
higher. This is available in an mum firmware required for LC Fixed IP Addresses for
electronic chip format from systems used with the G1369A Communication
Agilent Technologies (Please LAN card is Rev. A.01.05 or higher. IP addresses can be stored in the
ask your local Agilent For non-LC systems (35900E ADC, non-volatile RAM of the module's
Technologies representative for 6890 GC and 6850 GC) a minimum LAN card. Depending on the LAN
details). Firmware Revision of C.03.00 is card it is possible to assign a fixed
• LAN communication with the required. Additional details are IP address to the Agilent
Agilent 1100 Series requires a available in the Agilent G1369A 1200/1100 Series modules, using
minimum firmware revision of LAN Interface manual. either a handheld control module,
A.06.02. The G1315C DAD-SL a mode selecting a predefined
and G1356C MWD-SL detectors address by DIP switch or Telnet to
require a minimum firmware assign IP addresses. It is possible
to assign a fixed IP address to the
6890N and 6850 using the front
display.

9
Additional Hardware Required er with an Agilent G2402A 8- LAN Transmission Rates
for LAN Instrument Control port 10/100 auto sensing switch Traffic on the LAN from each
An industry standard LAN PC card for the ability to connect one or instrument is approximately
is shipped with all Agilent more instrument to a PC. 100KB per second for a 2D instru-
ChemStation 32-Bit PC bundles. A twisted pair 'crossover' cable ment at maximum data rate.
can be used to make a single
An instrument LAN card can also connection from one PC to one
be ordered from Agilent instrument. This configuration
Technologies as an option to the is only suitable for single instru-
instrument or as an individual ment configurations. This con-
part. Please ask your Agilent figuration is not supported on
Technologies representative for Agilent 1200/1100 Series
details. LC/MSD systems.
• BaseT coaxial cabling with the
Industry standard LAN cabling appropriate tee connectors and
using twisted pair or coaxial terminators can also be used to
cabling: configure single and multi-
• Twisted pair –10/100 baseT instrument systems.
twisted pair cabling with RJ45
connectors can be used togeth-

Printers

The Agilent ChemStation has Networked printers must be Recommended color printers are
been designed to work with print- shared by a network server run- the HP LaserJet 2500TN, OfficeJet
ers that are compatible with the ning a network protocol support- Pro K550DTWN or an HP DeskJet
operating system. The software ed by the Microsoft operating family printer.
operates with any Microsoft system.
Windows compatible printer Agilent Technologies has not test-
capable of interpreting an escape Recommended black and white ed all printer and printer driver
code language (e.g. PCL) or page printers are the HP LaserJet combinations that are supported
description language (e.g. family using PCL 5e or 6. For in the Windows environment.
PostScript). The printer may be lower performance applications it Print performance and results
directly connected to the comput- is possible to use the HP DeskJet may vary on other manufacturer's
er through a parallel or serial family. Please note that the HP printers and appropriate drivers.
interface or connected through a DeskJet printer family is not rec- Please note that host-based print-
Local Area Network. Serial port ommended for high throughput ers (e.g. GDI or PPA printers)
printers are supported by the applications. impose more processing tasks on
operating system but may exhibit the CPU and are not recommend-
speed performance limitations. ed for use with the Agilent
ChemStation on-line sessions.

10
Operating System

The Agilent 32-Bit ChemStation or Windows XP Professional with

requires Microsoft Windows 2000 Service Pack 2.
Professional with Service Pack 4

Methods and Sequences

The Agilent ChemStation analyti- integration, quantification and individual sample information, as
cal method fully describes how a reporting. The system may be set well as references to the appropri-
particular separation is performed. up to acquire data from a number ate methods, user for data acquisi-
It contains all the parameters for of samples by different methods. tion, data analysis and automatic
instrument control, data acquisi- The control file for this operation recalibration specifications.
tion and evaluation, including is called a sequence and holds the

System Configuration

The configuration of the instru- It allows users to define their data, sequences and methods, and
ment system is done through the instruments, GP-IB addresses, IP the color definition for the
configuration editor program. LAN addresses, the directories for ChemStation software.

Data Model

The ChemStation software is have their own header with infor- tion for different purposes. As
designed around a data model mation about the analytical mea- well as analytical data, the regis-
based on a memory structure surement such as the data file ter data model is used for holding
called a register. Registers are name, injection date and time, configuration information and
multi-purpose structures that sample name, and tables. Tables analytical methods. They may be
can hold analytical data and are used to hold different types of saved as files on non-volatile stor-
information for both two dimen- data as one block of information. age and reloaded into the
sional (e.g., time/intensity) and For example, the quantification ChemStation memory, printed and
three dimensional (e.g. time/inten- process in a calibrated method plotted to the screen or a hard-
sity/wavelength) analyses. constructs a quantification table copy device. Their binary format
that contains peak numbers, com- means they are not editable out-
The ChemStation provides, com- pound names, compound amounts side the ChemStation and each
mands and functions to construct, and retention times. data item may also be protected
expand, extract and, where it by assigning access attributes to it
does not alter primary data, edit Like other parts of the registers, when it is created.
registers. tables may be user-defined and
Registers hold information about have the functionality of database Their design fits extremely well to
their contents in register headers. tables with the additional benefit modern database technology
The registers are further subdivid- of being directly associated with enabling systems to be developed
ed into one or more objects. the base piece of analytical infor- to map analytical results or data
Typically an object holds data mation from which they were directly to a relational database
that describes an analytical mea- derived. system.
surement, such as a chromatogra-
phy signal. Each of these objects Each register may hold informa-

11
Software User Interface

The Agilent ChemStation user The standard toolbar provides

interface consists of a navigation rapid access to the common sys-
pane containing the ChemStation tem specification information
explorer plus navigation buttons such as methods and sequences.
and a navigation table. Both frame
the Views that group software The Method and Run Control
functionality according to typical view additionally incorporates a
analytical tasks. The ChemStation system status bar, a sample infor-
explorer provides means to select mation area, that may be config-
data or actions meaningful to the ured for single runs or automated
actual view, e.g. loading a runs, and a schematic instrument
sequence or method. Three stan- interface diagram for GC, LC,
dard views are present in all soft- LC/MSD, CE and CE/MSD configu-
ware configurations: rations. The schematic instrument
• The Method and Run Control interface diagram uses hot spots
view for controlling and acqui- to allow rapid access to instru-
ing data from the instrument. ment parameters and an animated
• The Data Analysis view for graphical overview of the status of
reviewing and re-evaluating each analysis as it proceeds. The
data that has been acquired. schematic instrument diagram
may be turned off if it is not
• The Report Layout view for
required, to save memory and
designing specific report lay-
other Windows resources.
outs.
The configurable navigation but- The Data Analysis view is headed
tons allow for fast switching of by the navigation table to sort,
views. Additional views are pre- group and review data of the sam-
sent if additional data evaluation ples selected here. The toolbar
modules have been installed or for below extends to specific data
certain instrument configurations analysis tasks including integra-
that support instrument diagnos- tion, calibration, reporting, repro-
tics and verification procedures. cessing, annotation, signal com-
The ChemStation Companion view parison and additional specialized
offers an easy to use interface tasks if the appropriate modules
specifically designed for the pro- are installed. Each of these sepa-
duction operator and routine labs. rate data analysis modes are sup-
Instrument operators can run sam- ported with a task-specific toolbar
ples from an easy to use, precon- of its own.
figured table.
The Report Layout view allows
Each view consists of a set of the user to graphically define the
standard user elements including layout of a specific report style in
menus and toolbars. a graphical object orientated fash-
ion. It too uses a set of toolbars
specific to this task.

12
Data Acquisition

The status of the instrument is preferred settings as the instru-

continually monitored and up- ment default. The window has
dated on the display, along with zoom capability and the cursor
the elapsed run time of the analy- may be used to display a specific
sis, both when the software is a signal’s response at any point in
visible window and when it is time.
iconized. The transactions that
occur during the analysis, includ- The complete functionality of the
ing any errors and the instrument ChemStation can be used during
conditions at the start and the end an analysis with an off-line copy
of the analysis, are recorded in of the software.
the system's logbook, an extract
of which is stored with every data A snapshot command is available
file. in a reprocessing copy of
ChemStation for users who wish
The instrument conditions, such to start processing data before the
as flow, temperature, pressure and analysis is completed.
solvent composition for liquid
chromatographs may be recorded The layout of the signal and status
and stored with each data file. information windows, including
These instrument parameters can the components of the schematic
be displayed and plotted to testify instrument interface diagram, is
to the quality of each analysis. saved automatically.
The exact nature of the parame-
ters recorded depends both on the
technique and the capabilities of
the configured instrument.

One or more display windows

may be used to monitor the data
being acquired by the instrument
in real time. The data are dis-
played in real measurement units
such as mAU, Volts, degrees or
bar. The windows may each show
multiple overlaid chromatograph-
ic signals or instrument parame-
ters, such as pressure. The display
default settings may be adjusted
and are remembered by the sys-
tem so users can set their own

13
Data Analysis - Display

The data analysis view extends the font for the RT and com-
the standard tool bar with task- pound labels, adjust the size
grouped data analysis functions and orientation of the display,
including integration, calibration, select the display as overlaid or
reporting, annotation and signal separated and select scaling
comparison toolsets. Together factors.
with the navigation table they • The chromatogram display may
form a fast and powerful means include graphical overlays of
for data review and reprocessing. instrument parameters depend-
The following key graphical opera- ing on the capability of the con-
tions are possible: figured instrument.
• Single or multi-signal displays
• User defined annotations may
selectable when loading the
be interactively added to the
chromatogram.
display, with the selection of
• Overlays of chromatograms font, size, text rotation and
from different samples. color. Once defined, the annota-
• Subtraction of one chromato- tions may be graphically
gram from another. moved, edited or deleted.
• Graphical vertical and horizon- • Copy the display to the
tal alignment of signals to help Windows clipboard in both
visual comparison. metafile and bitmap format.
• Signal inversion or mirroring to • A Pick Mode function to display
help visual comparison. the values of individual data
• Graphical zoom and scrolling points in detector units.
functions. • Export of time/intensity digi-
• Adjustment of display attributes tized points to the Microsoft
including selection of tick Windows clipboard.
marks, baselines, axes, reten- • Display of fraction results in
tion times and compound graphics and table format
names. The user can also select

14
Data Analysis - Integration

The Chem32 integration algorithm matograms requiring human • tangent skim processing
used in the 32-Bit ChemStation is interpretation (these events including solvent peak defini-
the second revision of a new gen- may also be recorded in the tion commands,
eration integrator offering method and used as part of the • the ability to define individual
improved ruggedness, reliability automated operation), front/tail tangent skim calcula-
and ease-of-use. • display and printing of tions event tables for all chro-
integration results, matographic signals,
Integrator Capabilities • the ability to integrate at least • the ability to use baseline cor-
The integrator algorithms include 1000 peaks per chromatogram. rection parameters (non signal
the following key capabilities: • integrator parameter definitions related),
• an autointegrate capability used to set or modify the basic inte- • integrator control commands
to set up initial integrator para- grator settings for area rejec- defining retention time ranges
meters, tion, height rejection, peak for the integrator operation.
• the ability to define individual width and slope sensitivity, • peak shoulder allocation
integration event tables for • baseline control parameters, through the use of second
each chromatographic signal if such as force baseline, hold derivative or degree of curva-
multiple signals or more than baseline, baseline at all valleys, ture calculations, and
one detector is used, baseline at the next valley, fit • improved sampling of non-
• interactive definition of integra- baseline backwards from the equidistant data points for bet-
tion events that allows users to end of the current peak, ter performance with DAD LC
graphically select event times, • area summation control, data files that are reconstructed
• graphical manual or rubber- • negative peak recognition, from DAD spectra
band integration of chro-

Data Analysis - Quantification

The Agilent ChemStation calibra- are automatically reflected in all The following calibration point
tion mode of the data analysis the others. This mode allows weighting options are available:
view allows simultaneous graphical selection and modifica-
display of tions of the calibration data. Equal – All calibration points
• the signal or signals being cali- have equal weight in the curve.
brated with an indication of the Quantification is based on %,
current compound’s retention Normalized %, External standard,
Linear (Amnt) – A calibration
time window, External standard %, Internal
point with the amount x has the
• the calibration table whose dis- standard and Internal standard %
weighting 1/x normalized to the
play may be configured from a calculations calculated on either
smallest amount so that the
comprehensive selection of cal- peak area or height. Calibrations
largest weight factor is 1.
ibration parameters, and may be multilevel and include
Normalization is done by multiply-
multiple internal standard defini-
• the calibration curve for the ing the weight with the smallest
tions. Calibration histories are
compound being calibrated. amount. For example the weight
automatically saved and can be
All the calibration mode windows of a calibration point with the
used to weight the recalibration
are linked so that changes in one amount x is (1/x) x a where a is
calculations.
the smallest amount of the cali-

15
brated compound prepared in the response. For example the weight are indicated on the appropriate
calibration standards. If the origin of a calibration point with the analysis report. They may be used
is included it is assigned the mean response y is (1/y2) x b2 where b in conjunction with the control
of the weightings of the other cali- is the response corresponding to samples that can be defined as
bration points. the smallest amount of the cali- part of the automation setup, to
brated compound prepared in the verify the performance of the sys-
Linear (Resp) – A calibration calibration standards. tem running automatically.
point with the response y has the The ChemStation can calibrate
weighting 1/y normalized to the # Calibrations – A calibration methods with up to 1000 peaks
smallest response so that the point is weighted according to the and 2000 calibration points. This
largest weight factor is 1. number of recalibrations of the means, for example, with 1000 cal-
Normalization is done by multiply- point. No normalization is done. ibrated peaks only two calibration
ing the weight with the smallest levels may be defined for each
response. For example the weight The origin of the calibration curve peak. With fewer peaks more lev-
of a calibration point with the may be specified as els may be defined in proportion
amount y is (1/y) x b where b is • ignored — the origin (0,0) is not to these limits (for example, 100
the response corresponding to the used in the curve calculations, compounds could have 20 levels
smallest amount of the calibrated each).
• included — the origin is used as
compound prepared in the calibra-
one of the calibration points,
tion standards. If the origin is The group calibration capability
included it is assigned the mean of • forced — the curve is forced allows the user to group calibrat-
the weightings of the other cali- through the origin, and ed peaks into a named group and
bration points. • connected — the linear segment report quantitative results for both
is constructed between the ori- the individual group members and
Quadratic (Amnt) – A calibra- gin and lowest calibration point the group itself.
tion point with the amount x has on the curve.
the weighting 1/x2 normalized to
the smallest amount so that the Compound identification may be
largest weight factor is 1. refined by defining individual
Normalization is done by multiply- retention time windows’ parame-
ing the weight with the smallest ter limits and qualifier peaks.
amount. For example the weight Qualifier peaks are usually the
of a calibration point with the same compound detected on a dif-
amount x is (1/x2) x a2 where a is ferent signal with a predictable
the smallest amount of the cali- response ratio. They are used as a
brated compound prepared in the further check on peak identifica-
calibration standards. tion rather than just relying on
retention times.
Quadratic (Resp) — A calibra-
tion point with the response y has Each calibrated compound may
the weighting 1/y2 normalized to have individual absolute limits for
the smallest response so that the the amount, peak area, peak
largest weight factor is 1. height, symmetry, efficiency in
Normalization is done by multiply- plates, resolution and k’. Results
ing the weight with the smallest lying outside any defined limits

16
Data Analysis - Standard Reporting

A standard set of user definable may also select the annotation Microsoft Excel. Independent
report styles for sample reporting fonts, graphical orientation, size from the report style selected,
are selectable from the report and whether the graphics are only the information contained in
specification screen. Every stan- overlaid or separated. If the the report style Short will be
dard report type contains standard ChemStation is connected to saved.
information groups and a series of instruments that can record .CSV – The report is in Comma
optional information groups. instrument parameters as a sig- Separated Values (CSV) format.
nal, such as temperature, flow This is a very simple format for
The standard groups include and pressure, the user may also tabular data that is accepted by
• A header with the originating select to include these graphics many spreadsheet programs and
data file and sample name. in the report. databases. Independent from the
• A footer with the instrument • Calibration table and calibration report style selected, only the
name, operator name, print graphics. information contained in the
time and page number in ‘page Reports may be output to either report style "Short" will be saved.
x of y’ format. the screen, printer or file. There can be several .DIF and
• A sample information block that .CSV files for a single report. For
includes sample name, vial If the screen is selected as the each report block, the first file, for
number, method and sequence report destination,, the report example, REPORT00.CSV, con-
information, operator and together with graphics will be dis- tains the report header informa-
instrument name and sample played in the Report Preview win- tion. Subsequent files contain the
information text. down from which it can be print- tabular results. If the results are
• A quantification results table ed. sorted by retention time, only one
containing retention times and file is required for the complete
the integration or quantification Report File Formats table, for example,
table depending on the calcula- A report can be saved in six differ- REPORT01.CSV. If the results are
tion scheme chosen. This table ent formats. Each format has a sorted by signal, a separate table
can be formatted either by specific extension. It is possible to is required for each signal. In this
retention time or by signal. select more than one format for a case, the files are named
report. Report01.CSV through
Users may select from a series of .TXT – The report text is printed ReportNN.CSV, where NN is the
optional information groups by as a UNICODE text file. number of the signal.
specifying a particular style for .EMF – Each report graphic (sig- .XLS – The report is exported to a
the analytical report. These groups nal or calibration curve) is saved Microsoft Excel spreadsheet in
include in a Microsoft Windows metafile (XLS) format. The data generally
• A front page that can include (EMF). Several .EMF files for one requires additional processing.
user-defined text. report are possible. The generated .HTML – Results are saved in
• Repetition of the sample infor- file format adheres to the Hypertext markup language for
mation block on every page. Microsoft enhanced metafile for- viewing in web browsers.
• Instrument conditions. mat as defined in the Windows
software development documenta- The Agilent ChemStation for CE
• The analytical column for LC has an additional mobility report
tion. These files are compatible
and LC/MSD systems. that uses the voltage signal and
with the Aldus Placeable Metafile
• The run logbook. (APM) format used by a number the electropherogram to compen-
• The chromatogram with annota- of proprietary software packages. sate for the velocity of the com-
tion options that include selec- .DIF – The tabular report data is pounds migrating through the
tion from peak retention times, saved in Data Interchange Format detector cell.
compound names, tick marks, (DIF). This format is accepted by
baselines and axes. The user spreadsheet programs such as

17
Data Analysis - Specialized Reporting

Advanced reporting capabilities The noise parameters are reported detailed graphical repeatability or
are also included in the 32-Bit as a signal-to-noise ratio for each trend analysis of user-selectable
ChemStation for users who peak or calibrated compound and parameters between different
require a more specialized set of a noise table for each signal. Each samples analyzed by the same
reports. These include statistics noise table includes noise calcu- method. The reports are built up
on separation quality, reports that lated by the six times standard from nine optional categories of
include trend analyses between deviation, peak to peak and ASTM information:
samples and user-defined report methods as well as the wander • a header page that may be user
layouts. and drift. defined,
• the instrument configuration
System Suitability Reports The Extended Performance style including revision numbers and
System suitability reports enable adds plots of each individual peak analytical column or capillary
users to report system perfor- showing graphically the peak start specifications for LC, CE and
mance parameters for individual and stop times, half width and LC/MSD systems,
analyses. There are three varia- baseline. This style includes the • the list of samples scheduled for
tions, or styles of these reports. following parameters in addition analysis,
to the ones reported by the stan- • the logbook printout which
The Standard Performance report dard performance reports: states what was analyzed and
prints parameters for uncalibrated • area, height and amount, documents the data acquisition
methods that include • skew, and processing steps as well as
• retention time, • excess, any unexpected events,
• capacity factor, k’, • USP tailing factor, • a printout of the analytical
• peak area, • time interval between data methods,
• peak height, points and number of data • individual sample reports,
• symmetry, points over the peak, • statistics on calibration samples,
• true peak width at half height, • statistical moments (M0 to M4), • statistics on unknown samples,
• efficiency in plates, • peak width at half height calcu- and
• resolution, and lated by the true, five sigma, • a summary page that may be
• selectivity. tangent and tailing methods, either a sample summary, one
and line of information per analysis,
For calibrated methods the com- • plate/column and plates/meter or a compound summary with a
pound name and amount replace calculated by the peak width at short compound summary table
the peak area, height and selectivi- half height, five sigma, tangent in addition to the sample sum-
ty columns. and statistical methods. mary.
Users may define their own noise
The report header includes the evaluation ranges and acceptable The statistical reports may be
standard header and footer, sam- limits for these performance crite- selected as standard or extended
ple information block, the analyti- ria. Values lying outside the user- styles. The Standard Style is text-
cal column parameters and defined acceptable limits are indi- based and includes the mean,
optionally a plot of the chro- cated on the report. standard deviation (SD), relative
matogram. standard deviation (RSD) and
Sequence Summary Reports standard error for the following
The Performance and Noise style Sequence summary reports are parameters tabulated by com-
adds an evaluation of the signal produced at the end of a series of pound:
noise, in up to seven user-defined automated analyses. Their range • retention time,
evaluation ranges, to the data of application is from a brief sum- • area,
from the performance report style. mary of the samples analyzed to a • height,

18
• peak width, and • spectral library comparison fac- The user may define headers and
• peak symmetry. tor (with the diode-array spec- footers to appear on every page,
tral evaluation module only). time stamps for the report and
The Extended Style includes page numbering in the ‘page x of
graphical trend analyses based on The report includes a separate y’ format. The information includ-
a selection of parameters for sta- graphical trend analysis for each ed in the report may be any
tistical evaluation. The parameters selected parameter. Sequence ChemStation or user-defined para-
that can be selected include summary reports may be output to meter.
• retention time, the printer, to file or both. The
• area, user may select to either print or Once the report has been designed
• height, suppress individual analysis it may be associated with a partic-
• amount, reports together with the ular method to make it the default
• peak width at half height, by the sequence summary. report format for that particular
sigma, tangent and tailing meth- type of analysis.
ods, Customized Reports
• peak symmetry, A customized reporting design Customized reports may be output
• tailing factor, view is included in the Chem- to the screen, a printer or a file.
• capacity factor, k’, Station for users who want to Reports to the screen include
• theoretical plates by the peak define the exact content of their graphics.
width at half height, sigma, tan- own reports. The user graphically
gent and statistic methods , defines a report layout which may Control Chart Reports
• resolution by the peak width at include general sample informa- A Control Chart feature is includ-
half height, sigma, tangent and tion, signal, integration and quanti- ed with the ChemStation software.
statistic methods, tative analytical result informa- Once this feature is installed and
• selectivity, tion. The user may define individ- selected, the user may automati-
• skew, and ual elements, such as text, tables cally track a selected parameter of
• excess. and graphics, organize them in a compound each time a method
sections and graphically adjust the is run. These parameters include:
Technique specific parameters for relative position, size and orienta- Amount, Response Factor,
liquid chromatography include: tion of each defined element. The Retention Time, and Area.
• peak purity evaluation factors individual sections may be added,
(with the diode-array spectral deleted, re-ordered and nested.
evaluation module only), and

Utilities and Compatibilities

General pliance level one (sample informa- (DDE) standard of the Microsoft
The ChemStation can import and tion and signal data) and data Windows platform as both a DDE
export data files in the ANDI export at compliance level two client and a DDE server. The com-
(Analytical Data Interchange) (sample information, signal data mand set includes commands to
chromatography format of the and integration results). establish and terminate connec-
Analytical Instrument Association tions, transfer information in both
(AIA), revision 1.0, copyright 1992. The ChemStation includes com- directions and execute remote
Data import is supported at com- mands and functions to support functions.
the Dynamic Data Exchange

19
Data Analysis - Integration is not compatible for use with nal Rev. A.xx.xx file or B.01.0x..
All files (data files, methods, older Rev. A.xx.xx or B.01.0x sys- This preserves the original Rev.
sequences, log files etc) created tems. The system will warn users A.xx.xx file which can continue to
on previous ChemStation Rev. to save files with a new name be used with ChemStation Rev.
A.xx.xx systems can be loaded when performing the one-time A.xx.xx or B.01.0x systems if
and used in the new 32-Bit Rev. conversion from Rev. A.xx.xx in desired.
B.01.0x ChemStation. The Rev. the new system. To maintain
B.01.0x system converts Rev. backwards compatibility it is rec-
A.xx.xx files to a new structure ommended to save converted files
during saving. The new structure with a name different to the origi-

XML Interface
XML (eXtensible Markup To connect the ChemStation to a interface allows manual or fully
Language) is a protocol for struc- Laboratory Information automated export of sample and
turing data in pure text format; the Management System (LIMS) or result information. The XML
XML file contains data with Knowledge Management System schema files provided with the
embedded structural information (KMS) the ChemStation offers an software allow an easy adaptation
and, being pure text, it can be edit- interface based on the standard- of the interface for a specific
ed with a simple editor like ized XML format. The interface LIMS or knowledge Management
Notepad. XML has become a very allows manual import of sample system. More information is avail-
flexible and portable format espe- data into the ChemStation able in the Agilent ChemStation
cially for exchanging data between sequence. This process can be XML interface users guide
different systems. automated using the ChemStation (G2170-90223).
macro language. In addition the

Customization

The ChemStation can be custom- user interaction, nest their

ized using a powerful command macros and schedule and
set . These commands may be exchange data with other MS-
grouped to automatically execute DOS or Microsoft Windows appli-
a specific function; such a group cations.
is called a macro. Users writing
macros may define their own vari- More information on customiza-
ables, build in conditional or loop- tion is available in the Macro
ing constructs, perform physical Programming Guide within the
I/O including file handling and Agilent ChemStation online help.

20
Automation

The ChemStation can execute the sequence table. The user can unknowns. In bracketing a series
multi-method sequences. configure the columns to be dis- of unknown samples are analyzed
played in the sequence table as between two calibration sets. The
All data generated during a well as the individual column quantitative reports for the
sequence is stored in a unique widths. The user can jump unknown samples are then calcu-
sequence container along with the between individual cells in the lated using a calibration table
actually used methods. The pat- table and copy, cut or paste indi- averaged between the two calibra-
tern used for naming of the vidual cells or entire rows or tion sets.
sequence container can be config- series of rows in order to build
ured to contain a combination of sequences efficiently and quickly. When re-evaluating data already
for example, date, time, operator, A sequence table can easily be acquired users can specify
instrument, PC or sequence name. created or changed using the fill- whether reprocessing uses the
down wizard function. The original sample quantification data
The sequence parameter set may sequence import wizard allows the or new data entered in the
be defined to use automatically import of sequences from any sequence's sample table.
named data files or sequentially kind of delimited text file.
numbered ones with a user- Sequences may be paused to run
defined prefix of up to fifteen Samples may be identified in the single injection priority samples
characters. The user may select to sequence table as unknowns, cali- by another method then restarted
run full analyses or data repro- bration or control sample types. without disrupting the automation.
cessing only sequences and can The sample type determines any Samples can be added to the
also select one of a series of tech- special data evaluation treatment sequence table while the sequence
nique specific shutdown com- of the sample: is executing.
mands or a user-defined shutdown
macro that runs when the • Unknown samples are evaluat- Both the sequence and partial
sequence terminates either by ed and reported according to sequence tables may be printed.
error or after all the analyses are the method specification,
completed. • Calibration samples are used to Stepping (even automatically)
recalibrate the quantification through the navigation table in
The sequence table, or list of component of the method as Data Analysis View also allows for
analyses to run, is built in a described below, and a fast review of samples.
spreadsheet-like user interface • Control samples are evaluated
that allows users to specify vial against the limits for each com- Batch Review is an additional
numbers and sample names, ponent defined in the method. mode of data analysis that pro-
analysis methods, sample quantifi- If the results lie outside any vides automation by allowing a
cation parameters including sam- specified parameter range the fast and easy first-pass review of a
ple amount, a multiplier and dilu- execution of the sequence will batch of samples. The batch con-
tion factor, calibration specifica- be halted. sists of all or a selection of runs
tion, a data exchange parameter from a sequence. You can check
(LIMSID) and the number of Calibration samples may be the calibration accuracy and the
repeat injections. Depending on defined as simple, cyclic or brack- individual integrations before
the configured instruments and eted. Simple recalibrations mean a approving the results. All chro-
modules, additional fields will recalibration occurs each time a matogram-specific modified inte-
accessible. For example if an calibration sample is defined in gration parameters can be saved
Agilent 1200/1100 LC system the sequence. Cyclic recalibra- for data traceability. Once data is
includes a fraction collector the tions occur at defined intervals accepted the entire batch can be
"Fract. Start" colum will appear in during analysis of a series of reprocessed to generate reports
with one keystroke.

21
Good Laboratory Practice

The 32-Bit ChemStation is devel- change history log. The change Method Robustness
oped to internationally recognized history log is automatically
design and development standards stored as part of the method. To Sequence summary reports (see
and has a number of features prevent unauthorized access to section “Data Analysis -
specifically to help users operat- the records it is protected by Specialized Reporting”) provide a
ing in a regulated environment. the user access scheme, means to test methods for robust-
These features help users validate described below. The change ness. The extended format reports
and specify methods, verify that history log may be viewed and for user-selected criteria are
methods are fit for their intended printed. reported as trend charts and may
use, verify system performance • Limits may be assigned on a be used to determine the realistic
and operation and ensure the compound-by-compound basis operation limits. These limits can
traceability, integrity and security in each method for a number of then be incorporated in the
of the data. chromatographic and system method to ensure, through the
performance parameters, as analysis of control samples, that
Development Process described in the data analysis the method is operating within
quantification section. Results specifications.
The Agilent Certificate of exceeding these parameter
Validation shipped with each soft- ranges are used to control the System Operation
ware package documents the soft- execution of automated
ware development and testing sequences as described in the The ChemStation software verifi-
steps executed as part of the automation section. They are cation kit, that is part of the stan-
development cycle. The develop- indicated on the appropriate dard software, automatically
ment process is registered to the analysis report. checks for the correct operation
ISO 9001 quality standard. It is • System performance or suitabili- of the data evaluation parts of the
documented together with on-site ty reports (see ‘Reporting’ sec- software by comparing results
revalidation protocols in the tions ) provide detailed analysis generated when a test is executed
Validation CD-ROM. of the separation quality. against pre-recorded known val-
ues. The verification test allows
Method Specification and Use • The ChemStation may be config-
users to define their own data files
ured for restricted access
and methods to be the basis of the
through two user access levels,
• Global methods — the complete test.
an operator and manager level.
instrument and data analysis The manager level may be pass-
specification is stored in one Data Traceability, Integrity and
word protected and allows
place. Methods include individ- Security
access to the complete Chem-
ual compound range specifica- Station functionality. The opera-
tions to check that quantifica- • The run-time logbook provides a
tor level restricts the user to
tion results are not applied out- transaction log of the complete
key functionality and to execut-
side the calibrated range. system. It also records any
ing defined analytical methods.
• The method change history log unusual events (such as errors
The operator level is intended
allows users of a validated or parameter changes made
for use in routine laboratories
method to automatically record during a run), as well as the
and specifically prevents users
how and when a method was instrument conditions before
from modifying and creating
changed. Users may add a rea- and after each analysis. A copy
new methods.
son for the change to the of the relevant logbook extract
is saved with each data file.

22
• The actual instrument condi- data and the run logbook in one
tions, such as pressure, flow, checksum protected binary file.
and temperature, that occurred This is an uneditable binary for-
during each analysis are also mat that ensures the integrity of
recorded if the configured the results. The file includes a
instrument supports this capa- revisioning scheme that indi-
bility. This data can be subse- cates if data has been
quently displayed graphically reprocessed.
with the chromatogram to show • Control sample types may be
the actual instrument condi- defined in the sequence table
tions during that particular and used to automatically
analysis. These graphics may be check the instrument perfor-
included on each report. mance against quality control
sample results when the instru-
• Methods saved with the data file ment is running unattended.
record the actual method at the Results that are outside the
time of the analysis and allow user-specified acceptable range
the complete reconstruction of will stop the automatic execu-
the reported data at a later tion of the instrument.
date. The method is saved at • Data security is achieved in the
the completion of all the analyt- PC environment through pass-
ical steps. word protected PCs, software
locks built into both Microsoft
operating systems and secure
• All reports have time stamps
(password-protected) networks.
and traceable page numbering
(‘page x of y’ style). The user
may select the level of detail in
each report ranging from simple
summary reports to complete
system details (see Reporting
section).
• GLP save register files, specified
as part of the method configura-
tion, save all the original data
including sample information,
data analysis method, chro-
matographic signals, instrument
conditions, integration and
quantification results, report

23
Instrument Control

The instrument control capabili- modules to allow multiple instru- following sections, each relating
ties of the Agilent ChemStation ment, mixed technique configura- to a specific technique.
may be expanded through the pur- tions. The instrument control
chase of additional instrument capabilities are documented in the

Agilent ChemStation for GC

Instrument Control and Data In addition to GC control the fol-
Acquisition with the Agilent lowing features are noted: Sampling
ChemStation for GC • Graphical user interface for
(G2070BA) and the Additional easy access to all method areas The Agilent 7673C and Agilent
GC Instrument Module for all Agilent GCs 7683 Series automatic samplers
(G2071BA) • Table driven system scheduler allow for complete automation of
which permits clock time pro- sample introduction in single
The Agilent ChemStation for GC gramming for all Agilent GCs. front, single rear or dual-injector
combines instrument control, data Quick Method allows the configurations.
acquisition, and data analysis soft- Agilent Series 6890 and Agilent
ware for the Agilent 6890, 6850, 6850 GC user to enter a limited Dual-injector configurations
5890 Series II, and 4890D gas number of setpoints from (Agilent 6890 Series, 5890 II, and
chromatographs and the Agilent which the Agilent ChemStation 4890D GCs) allow individual or
35900E A/D converter. will create a method. synchronous injections. Each
• Method resolution in the automatic sampler allows a 3-vial
The Agilent ChemStation is inter- Agilent ChemStation turret, 8-vial turret, or 100-vial
faced to the GC via LAN or GPIB Agilent 6890 and Agilent 6850 access if a sample tray is fitted.
and collects full range digital data Series only) will verify and alert (6890 and 5890 Series only). The
from detectors. Depending on the the operator of potential 6850 GC also supports the
detector type, data can be problems if a method was G2880A 22/27 positions tray. The
acquired at rates up to 20 Hz from created on a different GC Agilent ChemStation allows ran-
the Agilent 5890 and Agilent system or if the configuration dom sample access and priority
4890D Series and up to 200 Hz has changed. sample injection.
from the Agilent 6890 and Agilent • Capillary columns can be
6850 Series. calibrated from the Chem- The following autosampler para-
Station meters may be controlled:
When interfaced to an Agilent gas • number of syringe pumps
chromatograph, the Agilent The Agilent ChemStation can dis- • number of syringe washes
ChemStation can control GC play graphically the oven tempera- • the injection volume
parameters for heated zones, ture, inlet temperature, inlet pres- • the bottle number for each
oven temperatures, detectors, sure, auxiliary channel pressure injection
inlets, cryogenic cooling, signals, and column flow programs. The • a viscosity delay
electronic pressure and flow con- Agilent ChemStation also can con- • on-column injection setup
trol, and cool on-column tempera- trol, through a timetable, a maxi- • syringe size
ture programming. mum of eight valves or relays. • depth of needle penetration

24
• multiple injections per run in Agilent GC ChemStation (“original”) method, the method
cooperation with PTV for large Companion and its associated RTL calibration
volume injection can be transferred to another
• For the Agilent 7683 Series, The Agilent ChemStation instrument with the same column
plunger speed may be Companion provides the user with type and carrier gas type. RTL
controlled from a maximum a simple single-screen user inter- software in Agilent ChemStations
of 100 µl/sec to a minimum of face for GC routine analysis. In assists with the process of deter-
5 µl/sec when using a 10 µl the Companion View, the user is mining and using RTL calibrations.
syringe. limited to selecting pre-pro-
• For the Agilent 7683B, larger grammed samples, methods, vial To lock a new system to the origi-
turret for 2x increase in solvent numbers, and run control. Users nal system, carrier gas head pres-
and waste capacity (6890, 6850 cannot modify or create any meth- sure is adjusted using the RTL cali-
only). ods or run any methods or sam- bration curve. The retention time
• For the Agilent 7683B, solvent ples not assigned to them by their of a target compound (same one
saver made for 4x increase in lab manager. The Agilent used to generate the RTL calibra-
solvent usage (6890, 6850 only). ChemStation Companion is tion) can be locked onto the
• For large volume injections a installed automatically during the desired retention time value. All
100-µl syringe can be used with GC ChemStation installation. other analyte retention times will
the Agilent 7683 Series. then also match those of the
Retention Time Locking original.
The Agilent ChemStation allows Software
the user to optionally display a RTL software also provides the
Sampling Diagram window con- Retention Time Locking (RTL) capability to search retention
taining a graphical display of the software, (G2080BA) is an add-on timetables. Searching unknowns is
one hundred vial tray, indicating to the G2070BA. based primarily on retention times
which samples have already run, and may also include element
which sample is currently running, Retention Time Locking is a use- information (such as one might get
and which samples will be run. ful technique developed by Agilent from selective detectors) to nar-
Technologies to match analyte row search results further. Users
The G1926A bar code reader retention times between and can create, edit, import and export
attachment is supported in the among Agilent GC systems. RTL RTL libraries.
100-vial tray configuration of the is essentially based on void-time
autosampler. The bar code reader matching through an empirically The RTL Pesticide Library, prod-
can be used to help build automa- determined pressure-retention uct number G2081AA, includes the
tion sequences and verify that the time calibration curve. RTL cali- retention times for pesticides and
identity of the injected sample bration curves are specific to the suspected endocrine disrupters.
matches the name in the sequence analyte chosen (pick one analyte To use this library, the RTL soft-
table at injection time. in your standard, the best choice ware product G2080BA must be
is a peak well separated from installed. Peak identification is
The new G2615A bar code reader other peaks and in the middle por- performed by comparing the reten-
is used with the 7683 automatic tion of the chromatogram), type of tion time of the unknown peak
liquid sampler tray. column used (stationary phase with that of a standard included in
type, phase ratio, and column the library table.
The Agilent ChemStation can dimensions), carrier gas type, and
acquire a third and fourth signal oven temperature program used in
from external detectors in a single the method. Once the calibration
run by adding the 35900E A/D has been done for an initial
converter.

25
Agilent ChemStation for LC Systems

Instrument Control and Data offset from the sample, a numbe- • Agilent thermostat option
Acquisition with the Agilent red vial/well, waste and air. (G1330A /B)
ChemStation for LC Systems • Agilent fraction collectors
(G2170BA) and the Additional The Agilent bar code reader (G1364A /B/ C/D)
LC Instrument Module (G2256A) is available for selected • Agilent 1200/1100 Series
(G2171BA). autosampler configurations. It can barcode reader (G2256A) for
be used to help build automation the sample capacity extension
The Agilent ChemStation for LC sequences and verify the identity (G2257A)
and additional LC instrument of the injected sample matches the
module controls and acquires data name in the sequence table at Solvent Delivery Systems
from the Agilent 1200/1100 Series injection time. In LC configura-
modules and systems for LC, the tions it can also be used to mix liq- All the solvent delivery systems
HP 1090 Series liquid chromatog- uid samples as a step in an injec- have a set of initial parameters,
raphy systems with either the fil- tion program. including pressure limits, initial
ter photometric detector (FPD) or flow and composition, that are
built-in diode-array detector The following Agilent 1200/1100 complemented by a time-table for
(DAD), the stand-alone HP 1040 injection systems are supported: programming changes in flow,
diode-array detector (DAD), the composition and pressure limits.
HP 1046A fluorescence detector • Standard autosampler These parameters can be viewed
(FLD), the HP 1049A electrochem- (G1313A / G1329A thermo- graphically. Users can define a
ical detector (ECD) and the stattable with illumination) postrun time for column equilibra-
Agilent 35900E dual channel inter- • Thermostatted standard tion.
faces. All the sampling, pumping autosampler (G1327A)
and detector options of the • High performance autosampler The following Agilent 1200/1100
Agilent 1200/1100 Series modules SL (G1367C high pressure com- solvent delivery systems are sup-
and systems for LC, and the patible with illumination) ported:
HP 1090 Series liquid chro- • High performance autosampler • Isocratic pump (G1310A)
matographs can be controlled. (G1367B) • Binary pump (G1312A)
• Well-plate autosampler (G1367A) • Binary pump SL (G1312B)
Sampling Systems • Thermostatted well-plate • Quaternary pump
autosampler (G1368A) (G1354A / G1311A)
The injection systems may be • Micro well-plate autosampler • Preparative pump (G1361A /
manual or automated with an (G1377A with illumination) G1391A with gradient
autosampler or well-plate auto- • Thermostatted micro well-plate extension)
sampler. All automatic injectors sampler (G1378A) • Capillary pump
may be programmed for different • Thermostatted micro autosam- (G1376A pump only / G1382A
injection volumes, the speed of pler (G1387A) with degasser)
injection and the injector wash • Preparative autosampler • Agilent 1200/1100 nanoflow
procedure. The user may also spe- (G2260A with illumination) pump (G2226A pump only,
cify a complete injector program • Thermostatted preparative G2225A with degasser)
for sample dilution, standard addi- sampler (G2261A)
tion or sample derivatization. The • Agilent sample capacity Column Compartments
commands available for the injec- extension (G2257A) for the 1100
tor program include draw, eject, Series well-plate sampler The Agilent 1200 Series ther-
mix, wait, inject, sampler valve G1367A and micro well-plate mostatted column compartment
and column switch control. These sampler G1377A SL (G1316B) can be set between
can be defined in conjunction • Agilent dual loop autosampler 10 °C and 100 °C and provides
with the sample, a vial/well-plate (G2258A with illumination) post column cooling capability.

26
The Agilent 1100 Series ther- • 2-position/6-port valve option The ChemStation software can
mostatted column compartment (G1316B# 055) up to 600bar simultaneously acquire five chro-
can be set between 10 °C below • 2-position/6-port micro valve matographic and reference signals
ambient and 80 °C. The tempera- option (G1316B # 056) up to each with an independent band-
ture is programmable during the 600bar width from the Agilent 1100
run through a timetable. The • 2-position/10-port valve option Series diode-array detector
HP 1090 column oven temperature (G1316B # 057) up to 600bar (G1315A or G1315B).
can be set to a constant tempera- • 2-position/6-port valve option
ture (20 °C above ambient to 100 (G1316A# 055) The system can simultaneously
°C without external cooling). • 2-position/6-port micro valve acquire up to a total of eight chro-
Column switching valves are pro- option (G1316A # 056) matographic and reference signals
grammable from the software. • 2-position/10-port valve option from the HP 1090 with an inde-
(G1316A # 057) pendent bandwidth.
Valves
The maximum number of external The detectors have a graphical test
The Agilent ChemStation supports valves connected to one Agilent for signal intensity and wavelength
external valves as well as ther- 1200/1100 Series HPLC system is calibration. All DADs may have the
mostatted valves built into the col- limited to 5 or less, depending on initial parameters changed during
umn compartment. the system configuration. For a run by a time-based program.
details please contact your Agilent Users can program wavelength
The following external Agilent representative. and spectral acquisition mode
valves are supported: changes in the time table.
• Agilent 1200/1100 Series 6-posi- Detectors
tion/ Initial parameters that may be
7-port valve (G1156A) Spectral data from all diode-array set for the DADs include signal
• Agilent 1200/1100 Series 2-pos- detectors may be acquired in a peak- wavelengths and reference
tion/10-port valve (G1157A) controlled or full acquisition mode. wavelengths, spectral acquisition
• Agilent 1200 Series 2-positon/ 6- mode, signal sampling rate and
port valve SL (G1158B) The Agilent 1200 Series diode- autobalance.
• Agilent 1200/1100 Series 2-posi- array detector (DAD-SL), G1315C,
ton/6-port (standard) valve and the Agilent 1200 Series multi- The HP 1090 filter photometric
(G1158A) ple wavelength detector (MWD- detector (FPD) may be pro-
• Agilent 1200/1100 Series 6-posi- SL), G1365C, support 80 Hz full grammed with parameters to set
tion selection valve (G1159A) spectral data acquisition. The the lamp current, response time
• Agilent 1200/1100 Series 12-posi- G1315C and G1365C support up to and the filter. The filter may be
tion/13-port selection valve 80 Hz data acquisition of up to 8 changed during an analysis
(G1160A) signals, additional instrument through events in the detector's
• Agilent 1200/1100 Series 2-posi- curves and offer data buffering on time table. The ChemStation
tion/6-port (micro) valve a built-in Compact Flash Card to includes a diagnosis screen for
(G1162A) provide 'data never lost' insur- testing the reference and sample
• Agilent 1100 Series ance. The cells and UV lamp uti- photo diode light paths in the
2-position/10-port (micro) valve lize RFID tags to capture and detector. The FPD is interfaced to
(G1163A) store lamp and cell information. the ChemStation through the digi-
The improved Temperature tal GP-IB interface for control and
The following thermostatted Management System provides through a dual channel A/D inter-
valves built into the column com- ambient rejection and stable cell face for the data acquisition.
partment are supported: temperature.

27
The excitation and emission wave- The Agilent 1200/1100 Series The optical unit temperature of
lengths of the HP 1046A variable wavelength detector the Agilent 1200/1100 Series
Fluorescence Detector (FLD) can (VWD) may be programmed with refractive index detector (RID)
be set from 190 to 800nm, in steps a single detection wavelength. can be set between 20 and 55ºC.
of 1nm. Gain, response time, gate, Data acquisition rates may be pro- The signal acquisition rate may be
delay and lamp frequency may grammed for peak widths from adjusted for peak widths from
also be set. Gain and changes in <0.12 up to 8.00 seconds. The <0.12 up to 8 seconds. During the
the emission and excitation wave- VWD can be programmed with a course of an analysis the RID can
length may be time-programmed. timetable to change the wave- be programmed with a timetable
The excitation and emission wave- length and perform wavelength to change Polarity and Peakwidth
lengths may be optimized by ana- scans during the course of an ana- of the acquired chromatographic
lyzing scans. The range and speed lysis. signal. For diagnostic and troubles-
may be specified for each scan hooting purposes, it is possible to
during the optimization process. The Agilent 1200 Series multiple store Diode Signal 1, Diode Signal
The scans taken during an analy- wavelength detector (MWD-SL), 2, Optical Unit Temperature,
sis are stored in a ChemStation G1365C, can simultaneously acqui- Polarity and the Balance Signal in
spectral file format that allows re up to 8 signals at an 80 Hz data addition to the chromatographic
them to be displayed and used in a acquisition rate. Data Buffering is signal.
spectral library. possible on a built-in Compact
Flash Card providing 'data never The Agilent 1100 Series fluores-
The HP 1049A Electrochemical lost' insurance. The cells and UV cence detector (FLD) may be pro-
Detector (ECD) may be used in lamp utilize RFID tags to capture grammed for single wavelength or
amperometry, pre-treatment, and store lamp and cell informati- simultaneous multiple wavelength
sweep, pulse and differential on. The improved Temperature detection and spectra aquisition.
mode. The voltage potential and Management System provides Up to four signals at different exi-
limits may be defined between - ambient rejection and stable cell tation or different emission wave-
2.0V and +2.0V in steps of 0.001V. temperature. lengths may be obained. Within a
A voltage potential increment timetable initial exitation or emis-
between analysis may be defined The Agilent 1200/1100 Series sion wavelengths, response time,
from -2.0V and +2.0V in steps of multiple wavelength detector PMT Gain and baseline behaviour
0.001V and the number of repeat (MWD) (G1365A or G1365B) can as well as spectral parameters
analyses at a given increment may simultaneously acquire up to five may be changed. Exitation or
be set. Drift limits for the detec- chromatographic signals each emission spectra can be watched
tor not ready condition may be with independent reference wave- online and stored and analyzed as
specified from 0.1 nA to 500 nA in lengths and bandwidths. The sig- described for DAD spectra. For a
steps of 0.1 nA. The user may also nal acquisition rate may be set for single compound trapped in the
specify auto-zero control, based peak widths between 0.1 and 16 flow cell, complete information on
on the prepare or stop signal or a seconds. During the course of an exitation and emission spectra is
user defined drift value, full scale analysis the MWD can be pro- available in a single task with the
detector output at 0.05 mA or grammed with a timetable to fluorescence scan and can be
500 mA, the signal polarity and the change wavelengths, bandwidths watched as an iso-plot or as 3D-
temperature of the solvent ther- and peak-widths for all five wave- graphics.
mostat (20 to 60°C). lengths.

28
The Agilent 35900E dual channel Depending on the system configu- The diagnosis view is designed to
interface allow the system to ration up to two Purification sys- help users identify instrument
acquire data from detectors that tems can be controlled from single malfunctions starting from a par-
are not interfaced for data acquisi- ChemStation system (without ticular symptom. A failure of a
tion through GP-IB or LAN, such purification related software add particular instrument verification
as the FPD, the HP 1047A refrac- on). Optional add-on software, e.g. test will automatically identify the
tive index detector or a third party High/Throughput Purification soft- appropriate symptom for the user
detector. One or two analog sig- ware (G2262AA, G2263AA, or the user may select the symp-
nals per instrument may be config- G2265AA) or Easy Access tom interactively.
ured; if only one is used the other (G2725AA) provides advanced
is available for use with another functionalities. One or more possible causes is
instrument. Data rates up to 100 listed for each symptom. Each
Hz per signal may be defined. The Agilent 1200/1100 Series possible cause is associated with a
user may also define the units for Instrument Verification series of diagnostic measure-
acquisition and their relationship ments, with limits, and a series of
to the voltage signal (units/volt). The Agilent ChemStation for LC diagnostic tests. Users observe the
includes an instrument opera- measurements and carry out the
The Agilent 35900E interfaces tional qualification and perfor- tests in order to confirm or dis-
offer external event control mance verification (OQ/PV) view miss the possible cause of the
through digital TTL (transistor- in which users of the Agilent instrument malfunction.
transistor logic) signals, each of 1200/1100 Series of modules and
which are given specific state systems may select a series of Once identified, the cause of the
(high and low) names, that may be semi or fully-automated tests to instrument malfunction may be
time-programmed before, during test the operational suitability of repaired by using the repair proce-
and after an analysis. The Agilent the LC instrument. dures given on the Agilent
35900E can be configured for up 1200/1100 Series Maintenance and
to eight signals for each indepen- To perform instrument verification Repair CD-ROM. The repair proce-
dent channel. it is first necessary to purchase dures include parts and materials
the relevant service from Agilent breakdowns and clear animated
Fraction Collectors Technologies. The required step-by-step graphics or video
method and sequence files will be with a sound track for each repair
All different versions of the installed at the time of service procedure. The procedures are
Agilent 1200/1100 Series fraction delivery by an authorised Agilent called directly from the Agilent
collectors (G1364A, G1364B, service provider. Please contact ChemStation diagnostics view.
G1364C, G1364D) can be fully con- you local Agilent Technologies
trolled from Agilent ChemStation. representative for more details.
Fraction data can be reviewed in
the fraction task of the data analy- Agilent 1200/1100 Series
sis screen. The maximum number Diagnostics
of fraction collectors connected to
one Agilent 1100 Series Purifi- The Agilent 1200/1100 Series of
cation system is limited to 3 (with systems and modules for LC have
the possibility for one additional an additional ChemStation diagno-
recovery fraction collector). sis view.

29
Agilent ChemStation for LC/MSD Systems

Instrument Control, Data LC/MSD System Control the Agilent 1200/1100 Series
Acquisition, and Data LC/MSD system can be pro-
Evaluation with the Agilent The software provides digital con- grammed to make multiple injec-
ChemStation for LC/MSD trol of the LC/MSD API ion source tions from a single or multiple
Systems (G2710BA) and the and ion optics, dynamic ramping sample vials, storing all data in a
LC/MSD ChemStation Add-on of ion optics element voltages, and single datafile. Up to two LC/MSD
Module (G2715BA) control for spraying and drying method parameters can be pro-
gases. Method-specific LC/MSD grammatically varied with each
The Agilent ChemStation for parameters include spectral acqui- injection.
LC/MSD systems (G2710BA) and sition mode (scan/SIM), signal
the LC/MSD ChemStation Add-on sampling rate, LC/MSD tune file, The system includes the ability to
module (G2715BA) provide con- ionization mode (APCI, APPI or do fast scanning of up to 5250
trol, data acquisition, and data API-ES mode) and polarity (posi- amu/sec and includes autotune for
evaluation capabilities for Agilent tive or negative ion detection). fast scanning. Also included is
1200/1100 Series LC/MSD systems. Within a LC/MSD method, support of the Agilent Analog
The G2710BA and G2715BA LC/MSD-timed events include Output Accessory which provides
LC/MS software includes the mass range, SIM ion groups, mass up to 12 SIM signals directly to a
G2170BA LC ChemStation and analyzer stepsize, fragmentor volt- customer LIMS system.
G2180AA diode-array detector age, electron multiplier gain, MS
(DAD) spectral evaluation module. on/off, and API ion source para- LC/MSD Tuning
Add-on module. Together, these meters. Fragmentor voltage set-
software components provide tings may be dynamically ramped The Agilent ChemStation for
integrated control with a common within a scan to optimize response LC/MSD systems includes a
graphical user interface for all of for various m/z values. LC/MSD LC/MSD tune view in which users
the Agilent 1200/1100 Series LC operating parameters such as frag- of the Agilent 1200/1100 Series
modules and systems, including mentor voltage, drying gas temper- LC/MSD may select to either auto-
the Agilent 1200 Series DAD as ature, and EMV gain can be matically, or manually tune the
well as the Agilent 1200 Series acquired and saved with a data instrument. The Agilent 1200/1100
LC/MSD. In addition to the file. These instrument parameters Series LC/MSD integrated cali-
Agilent 1200 Series family of mod- can be displayed and plotted as a brant delivery system is software-
ules and systems, the HP 1090 record of the exact values associ- controlled, and together with the
Series II liquid chromatography ated with the acquired data. software autotune provides fully
system, as well as the Agilent automated tuning of the Agilent
35900E A/D interface can be con- In addition to the standard 1200/1100 Series LC/MSD for API-
trolled by G2710BA as part of ChemStation automation capabili- electrospray (API-ES), atmospher-
LC/MSD systems. The Agilent ties for single run methods and ic pressure chemical ionization
ChemStation for LC/MSD system mutiple method sequences, an FIA (APCI) and atmospheric pressure
supports a single Agilent (Flow Injection Analysis) Series photo ionization (APPI) modes of
1200/1100 Series LC/MSD system. automation mode is available operation. An extensive set of
through software selection. In this manual tune capabilities is also
mode, which requires the Agilent provided for users who wish to
1200/1100 Series LC autosampler, manually tune the Agilent
1200/1100 Series LC/MSD.

30
Agilent 1200/ 1100 Series Series LC/MSD can be called Interactive Data Processing
LC/MSD Instrument directly within the diagnosis view
Verification from the Agilent 1200/1100 Series The data from the mass selective
LC/MSD Maintenance and Repair detector may be displayed in a
Computer-aided operational quali- CD-ROM. The procedures include number of ways. The total ion
fication and performance verifica- parts and materials breakdowns chromatogram (TIC) is the sum-
tion (OQ/PV) tests and procedures and clear animated step-by-step mation of all mass signals (m/z
can be used to verify that system graphics and multimedia clips for values) over the entire acquired
performance is acceptable on an each repair procedure. data range. An extracted ion chro-
ongoing basis. Early maintenance matogram (EIC) displays the sig-
feedback (EMF) tracks the status Early Maintenance Feedback nals of individual ions (m/z val-
of system maintenance items and (EMF) automatically notifies the ues) or a range of m/z values.
provides notification when a pre- user when maintenance is
ventive maintenance procedure is required for key system compo-
The mass selective detector sig-
due. On-line diagnostics enable nents such as rough pumps, cali-
nals (TIC and /or EICs) may be
system troubleshooting using inte- brant delivery system, spray
displayed along with those from
grated tests. System logbooks pro- chamber, and electron multiplier.
other LC detectors. The software
vide date- and time-stamped
permits peak alignment for chro-
records of runs, errors, and main- LC/MSD Data Evaluation
matograms from different detec-
tenance events.
tors connected in series. Full,
The LC/MSD ChemStation
comparative mass and UV-visible
To perform instrument verification includes all of the data evaluation
spectra manipulation are available
it is first necessary to purchase capabilities of the Agilent 3D
including selection of spectra by:
the relevant service from Agilent Chem-Station for LC, including
Technologies. The required data evaluation for UV-visible • individual spectrum,
method and sequence files will be spectra acquired from a supported • peak apex spectrum,
installed at the time of service diode-array detector (DAD). In
• average spectrum over a graphi-
delivery by an authorised Agilent addition, the LC/MSD Chem-
cally defined retention time
service provider. Please contact Station includes capabilities for
range
you local Agilent Technologies evaluation of mass spectral data
representative for more details. acquired from the Agilent 1100 • range of spectra, and
Series LC/MSD module. • all spectra over a peak.
Diagnostics/Early Maintenance
Feedback Both UV-visible and LC/MSD data The user may also select how the
can be viewed, compared, and spectra are processed when they
The Agilent 1200/1100 Series printed. Chromatograms from the are displayed. The available
LC/MSD software extends the separate detectors may be simul- options include:
diagnosis view of the existing LC taneously displayed, aligned, and
ChemStation to include tests for resized to correlate peaks from • background subtracted spectra,
the Agilent 1200/1100 Series one chromatogram to the other. • limiting the m/z range,
LC/MSD. The diagnosis view is Mass spectra and UV-visible • smoothing,
designed to help users identify spectra can be simultaneously • normalization, and
instrument malfunctions starting reviewed using a common spec-
• continuous curves or histogram
from a particular symptom. tral toolset. Reports can include
mode.
Maintenance and repair proce- either UV-visible or mass spectral
dures for the Agilent 1200/1100 data, or both.

31
Quantification In interactive operation, the Acquired mass spectra can also be
LC/MSD peak purity function displayed as a three dimensional
All of the standard ChemStation examines the most significant ions plot of m/z against retention time
quantification capabilities are across a user-selected chromato- and abundance. The display can
available for use with mass spec- graphic peak to determine if more be graphically adjusted by the
tral data. TIC or EIC signals can than one compound is present. user in the time, m/z, and intensity
be used for quantification. For tar- The software automatically over- domains. The resolution of the
get compound analysis, retention lays extracted ion chromatograms plot is selectable, and the orienta-
time windows, quantification ion for the selected peak, with each tion of the plot can be adjusted
signals, and qualifier ion signals/ extracted ion chromatogram dis- graphically. The plot may be print-
ratios can be defined on a per- played in a separate color. A table ed, and the color scheme adjusted.
compound basis. of the number of components
located and the two most signifi- Agilent 1200 Chip Cube
Peak Purity cant ions used to resolve each Interface (G4240A)
component is displayed. The
The LC/MSD ChemStation next/previous peak or the next/ The Agilent 1200 Chip Cube inter-
includes all the UV-visible peak previous impure peak can be face is designed for LC systems
purity data evaluation capabilities selected by simple mouse actions. using an Agilent Ion Trap MSD as
of the Agilent diode-array detector A purity report that includes peak detector and Bruker Software for
(DAD) spectral evaluation module. purity assessment for all peaks in Data Analysis. The ChemStation
Capability for peak purity determi- a chromatogram can also be provides software support for this
nation using LC/MSD mass spec- specified and displayed/printed. interface.
tral data is also included. Peak
purity may be determined inter- Iso-abundance Plot and Three
actively on either a peak by peak Dimensional Plot
basis, for all the peaks from a cer-
tain data file, or automatically at In addition to iso-absorbance and
the end of an analysis as part of three dimensional plots for UV-vis-
the method. ible spectral data, the LC/MSD
ChemStation also provides equiva-
The user can select to interactive- lent capabilities for mass spectral
ly evaluate peak purity for data data.
sets that include both DAD spec-
tral data and LC/MSD spectral The MS iso-abundance plot dis-
data in either a single or dual plays acquired mass spectra as a
mode. In single mode, the soft- color-contoured map of m/z
ware configures the purity user against retention time together
interface for evaluation of data with areas for display of m/z sig-
from either one of the two data nals and mass spectra defined by
types at a time. The user can the position of cross-hairs on the
toggle between the data types if iso-abundance plot. In the iso-
desired. The dual mode user inter- abundance plot, a color scale is
face permits simultaneous evalua- used to represent signal intensity.
tion of spectral purity using both Users can define the contour color
DAD and LC/MSD data. schemes and retention time and
m/z ranges for the display.

32
Agilent ChemStation for A/D

Acquisition with the Agilent The user may also define the units
ChemStation for A/D for acquisition and their relation-
(G2072BA) and the Additional ship to the voltage signal
A/D Instrument Module (units/volt). The Agilent 35900E
(G2073BA) interfaces offer external event
control through digital TTL
The A/D ChemStation and addi- (transistor-transistor logic) signals,
tional A/D interface acquisition each of which are given specific
module controls and acquires data state (high and low) names, that
from Agilent 35900E dual channel may be time-programmed before,
interface. These interfaces allow during and after an analysis. The
the ChemStation to acquire data Agilent 35900E can be configured
from instruments that are not for up to eight TTL signals for
capable of being interfaced for each independent channel.
data acquisition through the GP-IB
system or LAN. One or two analog
signals per instrument may be
configured; if only one is used the
other is available for use with
another instrument running on
another timebase. Data may be
acquired at up to 100 Hz per signal.

33
Additional Data Evaluation Modules

The data processing capability of • average spectrum over a graphi- The purity components are calcu-
the ChemStation may also be cally defined retention time lated and displayed. These include
expanded through the purchase of range, the spectra, the spectral differ-
additional data processing mod- • range of spectra, and ences, the signals, a signals-based
ules for specific applications: • all spectra over a peak ratiogram, similarity and threshold
curves.
• LC diode-array detector (DAD) The user may also select how the
Similarity curves give the most
spectral evaluation module spectra are processed when they
detailed information about a
(G2180BA) are extracted. The available
peak’s purity. User selected or
options include:
• Agilent ChemStore sample orga- average spectra are compared
• setting the subtracted reference
nization and results database with all the other spectra acquired
spectrum or spectra,
module (G2181BA) during the peak's elution and the
• limiting the extracted wave- resulting spectral comparison fac-
length range, tors are plotted as the similarity
LC Diode-Array Detector
(DAD) Spectral Evaluation • customizing the spectral and curve. For a perfectly pure peak
Module (G2180BA) reference display, and the similarity curve will be a
• setting the spectral processing. straight line corresponding to a
UV-visible spectra, acquired using Options include setting a theoretically pure compound.
a diode-array detector, may be smoothing and splining factor, Impurities will cause a deviation
graphically selected from a chro- logarithmic processing and from this ideal line. The similarity
matogram signal for visual inspec- derivative order. curves are plotted with reference
tion and comparison or may be to the theoretically pure line and
used for peak purity determina- the user-defined purity threshold.
Peak Purity Determinations
tions, wavelength optimization The similarity curve gives the best
and component identification indication of any impurities that
Peak purity may be determined
through spectral libraries. The occurred in the peak as it eluted.
interactively on a peak by peak
spectral library functionality can The deviation of the similarity
basis, for all the peaks from a cer-
be extended to automatic identifi- curve from the ideal theoretically
tain data file, or automatically at
cation of components in up to pure value is influenced by both
the end of each analysis as part of
four user-defined spectral libraries compound impurities and spectral
the method. Users may optimize
based on peak or target com- noise. The user-defined purity
peak purity processing for accura-
pound identification. threshold may be replaced by a
cy or performance by setting pref-
system calculated threshold curve
erences relating to:
Interactive Spectral Processing based on the signal-to-noise ratio
• the number of spectra used over
of the peak in question. The noise
a peak,
Users may graphically select spec- sample may be user selected and,
• the wavelength range used for if truly representative of the spec-
tra from a chromatographic signal the purity determination,
for visual inspection and printing. tral noise when the peak eluted,
The spectra are displayed in a sep- • the reference spectra, compensates for any deviation of
arate spectral window and may be • the purity threshold, the similarity curve, from the theo-
overlaid for comparisons. The retically pure value, attributable to
• spectral processing including
user can select spectra in the fol- spectral noise.
logarithmic, smoothing and
lowing modes: splining factors and derivative
• individual spectrum, order.
• peak apex spectrum,

34
Wavelength Optimization using The iso-absorbance plot is typical- can manage an unlimited number
the Iso-absorbance Plot ly used during method develop- of spectral libraries each with up
ment to explore the sample’s to as many entries as there is
UV-visible spectra, acquired con- response at different UV-visible available system memory (typical-
tinuously during an analysis, can wavelengths in order to determine ly hundreds of entries). Libraries
be used to determine the optimum the optimal detection wavelengths may be loaded and searched by
signal wavelengths and band- and bandwidths through experi- selecting individual spectra from a
widths for routine detection by a mentation with the integration and chromatogram and searching the
signal-based method. The iso- quantification processes. library for the best matches. The
absorbance plot displays the library search may be constrained
acquired spectra as a color-con- Users can define the contour color by specifying a search template
toured map of wavelength against schemes and retention time and that allows the user to define a
retention time together with areas wavelength ranges for display. retention time window and
for the display of both signals and include the informational data
spectra defined by the position of Three Dimensional Plot associated with each library entry.
the cross-hairs on the iso- For example, the applicable reten-
absorbance plot. UV-visible spectra acquired contin- tion time can be constrained to ±
The iso-absorbance map can be uously during an analysis, can be 5 % of the library retention time
used in four modes: displayed as a three-dimensional and the entry names must start
plot. The display may be graphi- with the letter ‘B’. The search
• Quick view mode allows users cally adjusted by the users in the results may be displayed on the
to view and compare spectra time, intensity and wavelength screen and printed.
and signals by moving a cross- domains. The resolution of the
hair over the area of the con- plot is selectable. Users may build their own
tour map. Spectra and signals • The orientation of the plot can libraries by analyzing known sub-
are continuously extracted and be adjusted graphically. The ori- stances under defined analytical
updated in the display areas. entation of the display is not conditions, creating a new library
The extracted spectra and sig- restricted in any dimension. and entering the individual spectra
nals may be frozen in the dis- • The plot may be printed. and the information fields to
play areas for comparison pur- describe the entry into the library.
poses. • The color scheme used in the
Library entries may be added,
plot may be selected from a
• Zoom mode allows users to deleted, edited, viewed or printed.
number of choices.
zoom into areas of interest on Details of each spectrum in a
the iso-absorbance map. library including absorbance and
Spectral Libraries wavelength data may be exam-
• Signals mode allows users to
ined.
extract a particular signal, with
a graphically determined band- Spectral libraries allow users to
positively identify compounds by Automated Spectral Library
width, into the chromatograph-
comparing the spectra of peaks in Search Reports
ic window for routine data pro-
cessing such as integration and the sample to libraries of spectra
derived from analytical standards. Automated spectral library search
quantification.
reports allow users to automati-
• Spectral mode allows users to cally identify and quantify
extract spectra into the spectral The ChemStation allows users to
window for further processing. use libraries both interactively and unknown samples based on the
automatically. The ChemStation positive identification from up to

35
four separate spectral libraries. The calculation of the peak purity
Search criteria may be specified factor may be included as part of
for each library separately through the library search.
a library search template that
allows users to constrain the Report styles can be selected to
search both in the retention time produce simple library search
and library entry identification reports or a combination of library
parameters. search and standard performance
reports described above.
One of three search modes may be
selected : Spectral Data Import and
• Standard search mode identifies Export
each integrated peak in the
chromatogram from the library. The ChemStation spectral module
• Target analysis from the calibra- can import spectra stored in
tion table limits the library Agilent’s .WAV format files, from
search to those library entries the HP 8452 and
identically named in the calibra- Agilent 8453 spectrophotometers,
tion table. Identification may be and industry standard JCAMP
further constrained through the spectrum files.
use of the library template to
restrict other search criteria The ChemStation is data file com-
such as the retention time win- patible with Agilent’s ChemStation
dow. After positive identifica- for UV-visible spectroscopy run-
tion, quantification proceeds ning in the Windows environment.
according to the data in the cal- Both DAD and UV-visible spectra
ibration table may be exchanged between the
two systems either as Chem-
• Target analysis from the library
Station register files or through
uses the library entries to iden-
the Windows clipboard.
tify peaks in the chromatogram
that are within the RT window
specified for the particular
library entry. This mode differs
from the standard search mode
in that it excludes peaks whose
retention times are not covered
by library entry time windows.
Consequently it is typically faster
than the Standard search, espe-
cially if there are many more
peaks in the sample than there are
entries in the library. After posi-
tive identification, quantification
proceeds according to the data in
the calibration table.

36
High Throughput Purification Software Module (Purify)

The High Throughput/Purification In addition, the MS-based fraction

software module (G2262AA) is collection add on software pack-
designed for the needs of prepara- age G2263AA allows fraction trig-
tive HPLC. It offers utmost flexi- gering based on up to 16 masses.
bility for purification of large And/Or fraction logic on UV and
numbers of samples. For efficient MS or other signal offers highest
data review the graphical user flexibility for complex purification
interface provides an easy way for tasks.
sample and fraction tracking.
Sophisticated import and export Note: This module requires
functionality allows smooth inte- ChemStation B.2.01 SR1
gration of the system in the purifi-
cation workflow.

Agilent ChemStore C/S Database Client Software

The Agilent ChemStore C/S

database client software G2181BA
may be added to any Agilent
ChemStation configuration. The
specifications for this product
may be found in the dedicated
“Agilent ChemStation Plus
Specifications” document.

Note: This module requires

ChemStation B.2.01 SR1

37
Agilent Chemstation Plus Security Pack

The ChemStation Plus Security supporting the requirements

Pack (G2183AA) is a module of for electronic records and elec-
the Agilent Plus Series designed tronic signature. The specificati-
to support the requirements of 21 ons for this product can be
CFR Part 11. In the Agilent found in the "Agilent Chem-
ChemStation the ChemStation Station Plus Specifications".
Plus Security Pack modifies data
analysis and provides advanced Note: This module requires
data management with regard to ChemStation B.2.01 SR1

Networking

The software has been successful- The Agilent ChemStation

ly tested for compatibility with the software may be installed on a
standard networking components suitable network server and
of the Windows environment. The downloaded onto the client PCs
software will run at the same time as required. Each client specific
as other network software and configuration ensures a suitable
computer applications written for, environment for different tech-
and adhering to, the recommend- niques and individual users while
ed programming practices of the the centralized software installa-
Microsoft Windows operating tion relieves the burden of man-
environments. aging many copies of the same
Agilent ChemStation installation
These products enable the in one work environment.
ChemStation to share physical
devices such as plotters and
printers with other laboratory
computers as well as sharing infor-
mation such as data files and
methods.

38
Documentation

The documentation set has spe- Using ChemStation, or who want to

cific components designed for: build in additional features, may
• installing the Agilent Two additional categories of on- do so by writing macros using the
ChemStation software, line information are designed for command set.
• using the Agilent ChemStation the routine user.
software, The Commands Help file,
The ChemStation includes com- accessed directly from the
• understanding the principles of
prehensive, Windows-style, con- ChemStation’s Help menu or the
how the software works, and
text sensitive and indexed on-line Show command dialog box, is the
• customizing the Agilent help. This system gives detailed programmer’s function reference.
ChemStation. explanations of every screen and It includes syntax and parameter
• interfacing the Agilent the meaning of the parameters on explanations with example
ChemStation with LIMS that screen. The detailed explana- macros illustrating the use of
• upgrading from previous ver- tions are backed up by graphics many of the commands. By virtue
sions of ChemStation where appropriate, and may be of being on-line, the users can
copied to the Windows clipboard copy the examples and command
for incorporation in the users own syntax directly into their own
Installing and Learning
documentation, or printed. An macro source files.
integrated tutorial provides a
Each Agilent ChemStation soft-
ChemStation Tour and explains Interfacing
ware product comes with an
the basic concepts and major
installation manual that includes
views to accomplish regular tasks. The Agilent ChemStation Plus
details of the key steps in PC
hardware and software require- XML Connectivity Guide (G2170-
The online help also includes 90225) includes installation and
ments, instrument interface instal-
check lists to help less frequent reference information for imple-
lation, Agilent ChemStation instal-
users to deal with error conditions menting an XML interface
lation and installation qualifica-
and set up the system correctly. between the Agilent ChemStation
tion. The installation manual is
These checklists are directly and a LIMS (Laboratory
specific to the purchased configu-
linked to the detailed on-line help Information Management System).
ration and includes troubleshoot-
information. The guide contains examples of
ing, system records and system
maintenance advice. the XML files and the schemas
Understanding used to generate them. XML
Each Agilent ChemStation (eXtensible Markup Language) is a
The Understanding Your protocol for structuring data in
includes a task-based tutorial that
ChemStation manual documents pure text format. XML is a highly
is built into the help. This tutorial
the principals of the software flexible and portable format for
is the primary learning aid and is
operation and the algorithms used exchanging data between different
designed to let users learn what
in the data manipulations. systems.
they want at their own pace. Each
analytical task is divided into a
Customization
number of clear, guided steps each
of which the users may see exe-
Sophisticated users who wish to
cuted automatically by the soft-
customize the operation of the
ware and then practice them-
selves.

39
www.agilent.com/chem/cds

Windows, Windows 2000 and Windows XP are

registered trademarks of Microsoft
Corporation.

The information in this publication is subject to

change without prior notice.

Copyright © 1995-2006 Agilent Technologies

All Rights Reserved. Reproduction, adaptation
or translation without prior written permission
is prohibited, except as allowed under the
copyright laws.

Published May 1, 2006

Publication Number 5989-5055EN
2 Design Qualification (DQ) Phase
Agilent ChemStation Plus Specifications

Agilent ChemStation Plus Specifications

Agilent 1200 Series Qualification Workbook

 Agilent ChemStation Plus

July 2004
Specifications

General Description The Agilent ChemStation Plus Agilent ChemStation Plus

software package currently con- Security Pack—designed to sup-
sists of the modules below. port the requirements of 21 CFR
This document provides specifica-
Part 11. It uses a relational data-
tions for Agilent ChemStore C/S,
Agilent ChemStation for base based on the ChemStore C/S
Agilent ChemStation Plus Security
GC, LC, LC/MSD, CE, UV-visible database for secure result data
Pack, Agilent ChemAccess C/S
and A/D systems—instrument storage, data review and elec-
Agilent ChemStation Plus Method
control, data evaluation systems. tronically signing off runs (pages
Validation Pack, which are part of
Detailed specifications are avail- 24–38).
the Agilent ChemStation Plus family.
able in the Agilent ChemStation
With the Agilent ChemStation Plus
Specifications (Agilent publication Agilent ChemStation Plus
family you need to purchase only
number 5988-9925EN). Method Validation Pack—
the features you require. This can
advanced statistics module to cal-
be the fully featured software
Agilent ChemStore C/S— culate the quality of analytical
package for the most advanced
data organizing and storage mod- results including configuration,
capabilities, or you can exclude
ule that provides a scalable in- design and execution of method
features that you may not want
process chromatographic data development and method valida-
now, and add them later as your
organization system for Agilent tion experiments. It provides an
needs change.
ChemStations (pages 2–20). automated printout of a complete
method validation report as
Agilent ChemAccess C/S— requested by ICH and Pharma-
remote access module that pro- copoeia guidelines. All validation
vides a laboratory-wide remote data are stored with versions in a
status and control client/server built-in relational database for full
data system for networked Agilent data security and data integrity
ChemStations (pages 21–23). and to support FDA’s 21 CFR
Part 11 (pages 39–67).
1. Agilent ChemStore C/S

What’s New? • Optional peak performance cal- satisfies the requirements for
culation per-run or sequence data handling in a regulated
With the latest revision users can
line (see ChemStore C/S – environment including the detailed
benefit of new functionality in
Reporting on page 14) requirements of the U.S. food and
many areas as listed below.
drug administration for electronic
Open system connectivity records and electronic signatures,
Workflow • File-less LIMS interface known as 21 CFR Part 11.
• Up to three configurable levels (see ChemStore C/S – LIMS
of approval linked to separate Connectivity on page 18)
user privileges (see Agilent Agilent ChemStore C/S is available
ChemStation Plus Security in two different configurations:
Administration
Pack – Electronic signatures • Email notification enhancements
and password settings on • Agilent ChemStore C/S
(see Agilent ChemStation Plus standalone database
page 33) Security Pack — E-Mail
• Optional locking of runs after This provides a low cost, easy-
Notification on page 37) to-use, entry-level database
approval to prevent them from • Configurable command line
further modification (see Agilent module which integrates with a
access (see ChemStation Plus single Agilent ChemStation
ChemStation Plus Security Pack Security Pack — User
– Electronic signatures and workstation.Very limited main-
Management and Application tenance support is required and
password settings on page 33) Security on page 28)
• New chromatogram viewer any user with advanced know-
• Support for Windows XP ledge of the Windows XP or
providing dynamic zooming Professional Workstation
and rescaling capabilities (see Windows 2000 operation system
• Drop of support for Windows NT functionality for backup and
Agilent ChemStore C/S – User Workstation
Interface on page 15) administration can maintain it.
• Support for Oracle 9i This entry-level database module
• Direct Read-access to
ChemStation Method (see allows for storage of all raw
Agilent ChemStation Plus Product Description and meta data in single data-
Security Pack – Audit Trails base file to ensure full data
Agilent ChemStore C/S is a scal- integrity. The file format adheres
and Change Documentation able in-process chromatographic
on page 36) to a common standard, which
database for Agilent ChemStations. is used by many other applica-
• Variables in advanced queries It provides a means to easily
for operator names and dates tions, for example, MS Access.
organize, review and approve
(see Agilent ChemStore C/S – analytical data based on study
Working with Agilent ChemStore • Agilent ChemStore C/S
and sample information. Agilent server Oracle® database
C/S on page 10) ChemStore C/S supports the users'
• New database field for area% client/server system
data review process offering This client/server system is
results from ChemStation statistically result summaries, based on an Oracle database
flexible control charts, cross- running on a Windows 2000
Reporting sample reports and documented
• Powerful custom calculator for server together with multiple
data archiving and restoring. Agilent ChemStations and/or
advanced calculations, reporting These services also aid users in
and charting of calculation Agilent ChemStore C/S review
doing on-going system suitability clients. It provides enhanced
results, based on fully versioned testing. The Agilent ChemStore
calculation templates (see data security and data integrity,
C/S server database can be used distributed processing, as well
ChemStore C/S – Working with as a single place for data storage
Agilent ChemStore C/S, Custom as the ability to store raw data,
for all analytical data including methods and sequence files
calculations on page 12) methods, sequences and the within the database. This
raw data. This data storage also configuration reflects best the

2
 regulatory needs for electronic datafile is detected, the user • Data from non-Agilent chroma-
records and ensures full data receives an error message and tography systems may be
integrity and traceability. the file is no longer available included via the Agilent Chem-
for modifications. Station AIA import capability.
Based on standard database • Approve or reject runs after • Agilent ChemStore C/S offers
features, Agilent ChemStore C/S reviewing, following the rules the possibility to start with an
offers functionality which focuses for electronic signature. entry level solution, and to then
on the user’s needs for fast, secure • Ability to flag an arbitary upgrade when the data process-
and traceable handling of chro- set of samples for reprocessing, ing needs increase.
matographic data: and to initiate batch reprocess- Laboratories can easily upgrade
ing of those samples on any from one or more entry-level
• User-defined or automated Agilent ChemStation in a C/S standalone systems to an
transfer of selected data from network. Agilent ChemStore C/S server
the Agilent ChemStation into • Custom fields—User specified Oracle database client/server
the Agilent ChemStore C/S data- additional information fields system. Previously stored data
base. with each set of results (“run”) in the entry-level databases can
• Define, edit and manage to hold values not measured by be easily migrated to the new
“studies” as the underlying data the Agilent ChemStation (for server database. The user inter-
storage format. example, weights, pH, etc.) that face does not change, except
• Manage or restrict data access can be used for later queries, that some additional items are
in studies by assigning study reports or charts. available for administrators.
access only to authorized users. • Flexibility in scaling and • A built-in archive/delete tool
• Create database queries labeling control chart data. allows for easy data transfer to
graphically without the need for • Simple user-defined other disks and or media to free
any knowledge of the SQL lan- calculations for control charts up database space while keep-
guage. and reports. ing a complete audit-trail of all
• Review entire sets of data • User-controlled fast and easy archiving and delete
across instruments and studies, data export to other applica- operations.
that several sequences in a fast tions such as MS Excel®. • Automatic archiving
and easy manner. • Powerful and intuitive based on a set of configurable
• Create additional filters and report generator based on MS archive queries for easy data-
selection criteria to produce Access runtime including most base maintenance and adminis-
adequate subsets of the study in commonly used report tem- tration.
order to best sort the data and plates. • Open system connectivity
optimize the performance. • Architecture allows for off-line using XML (Extensible Markup
• Complete audit traceability by review. Can be installed as a Language) for easy data
individual log-ins and complete data review client running on a exchange with other applica-
documentation within the data- separate PC without needing tions.
base including authorization the Agilent ChemStation soft- • Advanced email notification
failures. ware. feature (C/S only). See page 37
• Security check of all files that for details.
have been transferred over the
network from the ChemStation
application to the ChemStore
database application and back.
Whenever a corruption of the

3
Agilent ChemStore C/S—System Requirements

1. Agilent ChemStore C/S Service Pack 1a

standalone • Agilent ChemStation revision Typical runs use approximately
A.10.01 or later 10 KB for a short report with four
• Microsoft Internet Explorer peaks, and use up to 300 KB per
Hardware requirements 5.5 or later run for an extended performance
The following list shows the mini- • Microsoft data access compo- report with 20 peaks. Table 1
mum hardware requirements for nents (MDAC) 2.8 will be helps calculate the amount of
this application: installed on your system. If you hard disk space requirements.
• 600-MHz Pentium III (Pentium IV already use a later version of Additional information on this
recommend) MDAC, or for compatibility topic may be found in the Agilent
• 4 GByte of free hard disk space reasons require a previous ver ChemStore C/S Installation man-
• 128 MB RAM for single Chem- sion, please contact your ual and the Concepts Guide.
Station instrument. 256 MB is Agilent support representative
recommended for best perfor- for compatibility information. Note:
mance, for Windows XP the • A local or network printer must The standalone database size is
minimum requirement is 256 MB. be installed and configured. limited to 800 MB due to some
• 256 MB RAM for two Chem- strict size limitations in the under-
Station instruments (512 MB or Hardware considerations lying file format. To ensure opti-
more is recommended for best mum performance for later data
Disk space requirements depend
performance) review Agilent strongly recom-
on several factors, such as:
• Display: 1024 ∞ 768, small • number of runs and compounds,
mends not to exceed this data-
fonts, 65-thousand col- base size limit. If a larger single
• technique (3D data requires
ors database is required, Agilent
more disk space than 2D data)
recommends that the client/server
• Agilent ChemStation report
Software requirements version of the product be pur-
style
chased. The client/server database
The following list shows the • the “Store in Addition” settings
uses Oracle, which allows for a
minimum software requirements of the study to which the run is
much larger database. Additional
for this application: assigned, (see table 4 on page 7),
standalone databases can be cre-
• Windows 2000 Professional and
ated via the Agilent ChemStore
with Service Pack 4 or • use of custom fields
C/S utility.
Windows XP Professional • database backup requirements

Number of peaks Agilent ChemStation report style Run length Approximate size
(minutes) per run (KB)

4 short 6 10
4 short 30 40
4 extended performance 6 80
20 short 6 190
20 extended performance 6 300
Table 1
Client storage requirements for result only data storage

4
2. Agilent ChemStore C/S server Server hardware requirements recommended to use a high speed
dual processor system with suffi-
Oracle® database system Agilent has optimized the perfor-
cient RAM.
mance of a ChemStation Plus
client/server system to an average
Client hardware requirements of 30 “concurrent” Agilent
The minimum requirements for the
The following list shows the mini- server in a Client/Server installa-
ChemStation/Agilent ChemStore
mum requirements for the client tion are the following:
Review clients, where concurrent
in a client/server installation. • 600-MHz Pentium III processor
clients are defined as clients con-
• 600-MHz Pentium III (Pentium IV • 512 MB RAM
nected to the central ChemStore
recommend) • RAID SCSI controller
C/S data organization system, that
• 4 GByte of free hard disk space • 6 disk drives - 9 GB or larger–
actively either spool data to the
• 128 MB RAM for single Chem- 2 drives configured as a mirror
database or perform interactive
Station instrument. 256 MB is set and 4 drives configured as a
queries (review client). Due to the
recommended for best perfor- RAID-5 array
nature of the application the
mance, for Windows XP the • Tape Device
impact of data retrieval is higher as
minimum requirement is 128 MB. • Uninterruptable Powersupply
this requires direct access to the
• 256 MB RAM for two Chem- (UPS)
database, while during acquisition
Station instruments (512 MB or Note:
the spooler is able to buffer data,
more is recommended for best The drive configuration yields one
thus ensuring a secure transfer in
performance) mirrored partition for the operat-
case of a network failure, for exam-
• Display: 1024 × 768; small fonts; ing system and application soft-
ple. So the optimum number of
65-thousand colors ware, and one large array for the
concurrent clients might vary
database files.
depending on the work practice in
Client software requirements the laboratory. Depending on the
• Windows 2000 Professional with combination of 2D/3D instruments, Server hardware
Service Pack 4 or Windows XP a typical high-end configuration considerations
Profession Service Pack 1a can thus grow to approximately 30 The hardware requirements of the
• Microsoft TCP/IP protocol acquisition clients with a maximum Agilent ChemStore C/S server will
• Microsoft Internet Explorer of 90 instruments. It is therefore
5.5 or later
• Microsoft data access compo-
nents (MDAC) 2.8 will be Entry level Standard level Highend level
installed on your system. If you No. of concurrent review clients 1-5 1-15 > 15
already use a later version of Processor speed (GHz) 1 1 1
MDAC, or require for compati- Number of processors 1 1 2
bility reasons a previous ver- RAM (MB) 512 1024 2048
sion, please contact your Number of RAID controllers 1 2 2
Agilent support representative Disks for operating system 2 × 18 GB RAID 1 2 × 18 GB RAID 1 2 × 18 GB RAID 1
for compatibility information. (Controller 1) (Controller 1)
• Oracle 9i client version 9.2.0.3.0. Disks for Oracle database 3 × 18 GB RAID 5 5 × 18 GB RAID 5 5 × 36 GB RAID 5, (Oracle
(included with the ChemStore RAID 5 (Controller 2) Data, Contoller 2)
2 × 18 GB RAID 1 (Index
C/S server software) Log Files, Rollback Seg-
• Agilent ChemStation version ments, Controller 1)
A.10.01 or higher (optional) Hot swappable drives yes yes yes
• A local or network printer must Backup device DAT/DLT tape drive DAT/DLT tape drive DAT/DLT tape drive
be installed and configured. UPS yes yes yes
Table 2
Recommended server configurations for Agilent ChemStore C/S

5
vary based on the size of the data-
base selected at installation time
and the number of concurrent
connections (the number of active
instruments acquiring samples to
the database and Agilent Chem-
Store C/S review clients) and the
backup requirements for the serv-
er database. Table 2 shows three
recommended server configura-
tions. In a very small networked
installation with less than three
clients and no need for advanced
security using RAID, the Chem-
store C/S Oracle database can also
run on a high-end PC using
Microsoft Windows 2000 server
software as operating system.
Figure 1
Note: Study setup for full data integrity in the server database
Planning the server disk configu-
ration is very important:
configuration of the server, please Database size
12 GByte (for small database) to
refer to the Agilent ChemStore
54 GByte (for large database) The database size is selected at
C/S Installation manual.
hard disk, RAID 5 configuration installation time and should be
is recommended. Using a RAID 5 given careful consideration as this
hard disk configuration (redun- Server software requirements will affect the total number of
dancy and striping) yields less free runs which can be accessed online
hard disk space than RAID 0 (no • Windows 2000 Server with
and the frequency of
redundancy). For example, 3 disks Service Pack 4
archive/dearchive operations.
of 9 GByte each using RAID 5 • Microsoft TCP/IP network
Archive with delete (to recover
yields 18 GBytes while using protocol
run space in the database) or
RAID 0 yields 27 GByte. RAID 5 • Microsoft Internet Explorer 5.5
dearchive operations (to access
is recommended for maximum or later (for admin client only)
run data online). At installation
performance and protection of • Internet Information Server
time you can either select from
your data. For backup operation version 3 or greater (IIS is
the preconfigured databases con-
of the database, the required disk integrated into Windows 2000
figurations listed in table 3, or
space must be duplicated, that is a Server
have a customized configuration.
54 GByte RAID 5 configuration • Oracle 9i Standard Edition
should have an additional 54 GByte version 9.2.0.3.0 (included with
ChemStore C/S server software) Database Approx. Database
of disk space available for database configuration no. of runs size
backup. When calculating server
small ≤ 7500 4 GByte
memory requirements, calculate
medium ≤ 25000 10 GByte
8 MB of additional memory for
large > 25000 40 GByte
each Agilent ChemStore C/S client.
For more details on setup and Table 3
Database configurations

6
Note: The custom database con- The actual amount of space con- • Retention time locking
figuration must be planned as a sumed by each run in an Agilent software, add-on module for
project with Agilent database con- ChemStore C/S database will vary Agilent ChemStation for gas
sulting specialists prior to system depending on: chromatography,
installation. The size of the • the Store in Addition • Agilent ChemStation for liquid
Agilent ChemStore C/S database to Result settings of the study chromatography, revision
is based on an Agilent ChemStore to which the run is assigned A.10.01 or later,
C/S system which has an average (table 4), and • Gel permeation chromatogra-
distribution of all Agilent • the technique and complexity phy software add-on module
ChemStation 2D and 3D tech- (numbers of peaks, Agilent for the Agilent ChemStation for
niques. Also, all Store in Addition ChemStation reports, custom LC,
checkboxes are fields, and so on) of your chro- • Agilent ChemStation for
enabled for all studies, as shown matography for that run. capillary electrophoresis, revi-
in figure 1. The space require- • For details on the size of sion A.10.01 or later,
ments for runs stored in the raw data files by technique, • Agilent ChemStation for liquid
Agilent ChemStore C/S database please refer to table 5. chromatography mass selective
will vary depending on your envi- detection, revision A.10.01 or
ronment. A run is defined as a sin- Supported Agilent Chem- later.
gle set of results produced from a • Agilent ChemStation for analog
Station software
single sample acquisition or signal acquisition, revision
Agilent ChemStore C/S can be
reprocessed by an Agilent A.10.01 or later,
used with the following Agilent
ChemStation which has been • Agilent ChemStation for
ChemStation software:
transferred and stored in the capillary electrophoresis mass
Agilent ChemStore C/S database. • Agilent ChemStation for gas selective detection, revision
chromatography, revision A.10.01 or later,
A.10.01 or later, • Agilent ChemAccess C/S
remote instrument control revi-
Store in Addition Description sion A.02.01, and
• Agilent ChemStation Plus
Chromatograms Stores all available chromatograms (from each detector and/or signal) Method Validation Pack A.02.01.
Spectra for quantified Stores spectra from all peaks that have been identified and quanti
peaks fied as compounds in the calibration table.

Raw data Stores the acquired data in addition to the calculated result. Technique Average file size (kB)
Note:
This setting has a significant effect on the amount of storage space 2D GC/LC 50
required for each run in the ChemStore C/S database. For example 3D LC 60
ChemStation data which is created from 3D techniques such as a
liquid chromatography diode array detector will require more 3D LC/MS 750
storage space than a 2D technique such as gas chromatography. 3D CE 600

Sequence Stores the ChemStation sequence. Table 5

Average raw data file size by technique
Method Stores the ChemStation method
Table 4
Store in Addition study settings

7
Agilent ChemStore C/S — Working with Agilent ChemStore C/S

1. Data transfer

The Agilent ChemStation Plus

concept consists of different soft-
ware components designed for the
various tasks in the chromato-
graphic laboratory. The Agilent
ChemStation manages data acqui-
sition and data analysis, and the
Agilent ChemStore C/S database
offers advanced data and result
management along with additional
sample information management
such as data organization, advanced
result calculations, result approval,
and archiving. This concept allows
a clear separation of result rework
and advanced result review and
offers unmatched data integrity
and traceability by tracking the
data history — Results in
ChemStore can only be under
Figure 2
review or after review completion, Data transfer setup screen in the Agilent ChemStation
locked and pending for archival,
while results in ChemStation are Interactive mode created, together with an entry
under rework. It is therefore very Users perform the transfer manu- in the audit trail of the Agilent
important to have a secure and ally from the Agilent ChemStation ChemStore C/S database, thus
documented data transfer menu item in “Data Analysis View” ensuring a full history of the
between the software application. or use the batch review interface injection.
The specifications will offer a of the Agilent ChemStation. This
detailed outline of the data transfer mode of operation is useful for File security during data
including security measures for analysts who wish to perform a transfer
both directions. To further manifest first pass data review from the Each file that is transferred over
this separation between rework Agilent ChemStation data analysis the network from the Chem-
and review, results can be locked view before transferring the Station to the ChemStore data-
from further modification when approved results to the database. base or back is protected with a
giving an approval. hash value. The application soft-
Automated mode ware automatically calculates the
From Agilent ChemStation to Results are transferred automati- hash value prior to any data trans-
ChemStore database cally to the database at the end of fer using a 24 character value
each run. This mode ensures that based on the RSA Data Security,
Agilent ChemStore C/S offers two all analytical data are transferred Inc, MD 5™ message digest algo-
modes of data transfer from the into the Agilent ChemStore C/S rithm. The hash value is stored
Agilent ChemStation into the server database and are protected with the data file. Whenever this
Agilent ChemStore C/S database – from unauthorized modification. data file is transferred over the
• interactive mode and If the same sample injection is network, e.g. for a reanalysis
• automated mode. reanalyzed and then transferred, a cycle, the same message algo-
Figure 2 shows the interactive new version of the result data is rithm calculates the hash value of
mode.

8
the current file and compares it be executed. Custom fields can or a default value as well upper
with the stored value. Any differ- also be used in later queries for and lower limits can be specified.
ence is reported as an error and reports, custom calculations or
the data transfer is interrupted. charts. Custom field values are entered
before the single sample or
Assignment of studies and Study and custom field sequence acquisition:
custom field information configuration • Single sample/manual
Runs are stored in studies which A custom field and its type are operation: Study and custom
form the top level hierarchical ele- defined globally per database as field values are entered by a
ment of the Agilent ChemStore shown in figure 3. The available “single run” Agilent Chem-
C/S database similar to a drawer field types are: Station menu item (figure 4).
in a cabinet. Study access is • True/False selection • Sequence operation: Study
restricted to users that were • Configurable selection list and custom field values are
explicitly granted the permission • Integer value specified per sequence line and
to access the data inside this • Real value and stored with the sequence.
study. Users must be assigned to a • Text field
study in order to review study • Date or Date/Time Using Agilent ChemStore C/S data
data or spool data into the study. review capabilities, the lab manager
The amount of result and meta Custom fields need to be assigned or a quality control person can
data that is stored in the Agilent to a study to activate them for use. review data generated on multiple
ChemStore C/S database is defined As part of the study setup the user instruments throughout the lab.
on a per study basis. For example, defines how the custom field is Samples can be approved, rejected,
the transfer of a set of results may populated and whether it is a excluded or assigned for rework
also include chromatograms and mandatory field or not. A custom by the Agilent Chem-Station (see
spectra, and the raw data, methods field can be filled by a ChemStation below From database to the
and sequence file used to produce function or manually. Manual Agilent ChemStation).
those results. fields can be flagged as “required”
ChemStore spooler – Managing
Custom fields allow additional data transfer from Agilent
information or result fields to be ChemStation to Agilent
linked to each set of results (“run”). ChemStore C/S
They are used to store additional To ensure optimum performance
information that is not accessible of the Agilent ChemStation, a
from the Agilent ChemStation background spooler takes care of
method or results, that is, informa- a secure result transfer from the
tion which may reflect other mea- Agilent ChemStation data into the
surements (for example, Figure 3 Agilent ChemStore C/S database.
Creating a custom field
LIMS ID, sample pH, patient weight,
dosage, and so on) or may be used
to organize the data (for example,
the identification code of the test
patient from whom a serum sam-
ple was obtained). These custom
fields may be configured as
“required” or “optional”. For the
former, a value must be specified
before results can be transferred Figure 4
to the database or a sequence can Data transfer setup screen in the Agilent ChemStation

9
This approach has several advan-
tages, including
• releasing the Agilent Chem-
Station to go on with other
tasks quickly while the transfer
continues in the background
and
• guarding against data loss in
case the database insert opera-
tion fails or the network is
down.

From database to the

Agilent ChemStation
Runs which require further
rework, for example manual
integration, can be transferred
from the database to the Agilent
ChemStation. Agilent ChemStore
C/S creates an Agilent ChemStation
batch to ensure a consistent ease
of operation. The setup for this
batch submission is a two-step
approach:
Figure 5
1. Create the batch request from Batch setup for data transfer from database to the Agilent ChemStation
the Agilent ChemStore C/S
review client by marking the menu item to select the desired data review - the sample-centric
runs for transfer in the user batch from the pool of pending Sample view and the compound-
interface. An authorized user Agilent ChemStore C/S batches centric Compound view. Both
configures the transfer details to download the runs to the views are further subdivided into
in an interactive pop-up window Agilent ChemStation. The a tabular display, with or without
(figure 5). These include operator then reviews the data chromatograms and/or spectra,
• assigning the run data to one in the ChemStation batch and a chart display for plotting
or, in case of several runs, to review and makes the necessary sample- or compound-related data.
more than one user for reanaly- changes. After completion of the
sis on a per run basis, review the modifications can be The task flow of Agilent
• optionally transferring the transferred to the database as ChemStore C/S is designed to
method with the data (including new result versions. support the laboratory’s workflow
the choice between all versions and can be outlined as follows:
of the method), and 2. Task flow in the review
• entering a comment with each 1. Select the database that
client
run transfer that will be dis- contains the data you want to
played to the Agilent work with.
ChemStation operator. Retrieve and review sample 2. Extract the set of results you
data will work with. This is done via
2. Use the Agilent ChemStation The ChemStore C/S review client a database query and the
Load Batch from ChemStore provides two user interfaces for results become the “current set

10
 of data”. ments for electronic signatures.
3. Perform any of the following The standard query builder of In addition, Regression Statistics
tasks, in any order: ChemStore C/S provides fast can also be used to calculate
• Review the results “by sample” access to the commonly used curves and statistics of two
or “by compound”. While database fields for fast and easy numerical columns. Curve types
reviewing the results, you may data retrieval. For more sophisti- include:
switch between any of several cated queries the advanced query • linear
different data presentations builder provides for access to • quadratic
(for example, a table, a chart, or all database fields, conditional • cubic
plots of the chromatograms and query capabilities as well as the • logarithmic
or spectra). In addition, you use of variables for the operator • exponential
may specify additional statistical name (“currently logged on user”) • power
computations to be done on and the date (for example “not
the results and included in the older than 2 days”). The curve parameters for the
tabular or graphical presenta- curves and the residuals will be
tions. Performing statistics calculated and displayed. Residual
• Generate a report on the and curves can also be displayed
calculations
data in the set of data. Any of a in a chart.
set of report templates may be The user may optionally select to
used, and you may customize have statistical calculations per-
Custom expressions
those templates according to formed on the (numerical) data
which is being reviewed, as shown Simple Mathematical calculations
your needs or create new ones.
in figure 6. This can be achieved may be performed on results using
• Export selected data. Data may
using summary statistics that cal- the built-in expression definition
be sent to an Excel 5.0 “*.xls”
culates statistical values based on interface (figure 7).
file or to an application that
supports cut-and-paste of the a single column of numerical val-
ues. The calculated values are: This offers the basic expression
appropriate format.
• number functions (addition, subtraction,
• Execute custom calculations
• minimum division and multiplication) plus
such as cross-run or cross-com-
• maximum the following functions:
pound calculations or advanced
• sum • exponential
statistical calculations. Pre-
• mean • natural logarithm
defined templates can be
• variance • logarithm
modified or new ones can be
• standard deviation • square
created. Modifications are
• relative standard deviation • square root
stored as new template version.
Calculation tables and charts
of calculated values can be
integrated into the report.
• Set up a “batch” by marking
runs whose data and method
are to be transferred back to
the Agilent ChemStation for re-
analysis.
• Filter or exclude any run in the
current data set.
• Approve or reject runs based
on your result review. Both Figure 6
steps follow the FDA require- Summary statistics

11
Custom calculations
The ChemStore C/S custom calcu-
lator provides all means to develop
custom calculations that cannot
be done with the simple expression
builder. The custom calculator
user interface for development of
calculation templates is shown in
figure 8. Calculation templates are Figure 7
Setup of custom expressions
fully versioned. The modification
of an existing calculation template
is stored as a new template version.
Only users with the appropriate
permission have access to the
custom calculator.

For a fast and easy template

development the custom calculator
is equipped with eight wizards:
• Create Table defines the data
items for the calculation
• Create Subtable defines a sub-set
of data
• Insert Column allows to define
columns that are populated
with calculation results and can
be used in further calculations
• Define Variable allows to
specify variables (fixed values
or calculation results) that can
be used in further calculations
• IF condition defines conditional
values, for example for limit
checking, resulting in a con-
figurable result output, such • Group allows to group by a – minimum value,
as “pass” or “fail”. specific data item and do – relative standard deviation,
• Format defines the number statistical group calculations, – standard deviation,
format and precision of data such as – sum, and
items for reporting – number of values (“count”), – variance.
• Transpose allows to transpose a – maximum value,
table or subtable – mean value,

12
The expression wizard (figure 9)
is used for defining a calculation,
which can be either an expression
or condition. Calculations can be
defined for all available columns
or variables. It provides a set
of arithmetical and statistical
functions that can be used in
conditions or expressions, these
include:
• addition
• subtraction
• multiplication
• division
• absolute value
• count
• exponential
• logarithm
• natural logarithm
• mean value
• minimum Figure 9
• maximum The expression builder of the custom calculator
• relative standard deviation
• square
• square root stored in any other database field information. Optionally it can be
• standard deviation including custom fields. Groups of included in the report to fully
• sum data can be used in statistical cal- document the calculation.
• variance culations, where the results may
serve as a data source for further Any part of the calculation or the
Multiple calculations can be calculations. The IF condition wiz- complete template can be tested
defined within a single template ard integrates with the expression on sample data obtained by a
based on any table or subtable. builder and can filter result data database query. Any error or
based on virtually any condition. inconsistency is identified and
All calculations are strictly column- The output can be reported documented in the error window.
based operations and easily allow according to the specific laboratory The related calculation piece is
any kind of cross-compound or regulatory requirements, for highlighted in the protocol for
calculation, for example for the example for limit checking – a convenient and simple trou-
determination of relative retention sample result lying outside of a bleshooting.
times as required in some regula- specified interval can be flagged as
tory methods for confirmation of “out of spec.”. Calculation result tables as well as
a successful identification or for charted calculation results can be
calculating relative responses. The During the development the custom integrated into ChemStore reports.
transpose wizard converts a table calculation is documented in a The user may choose whether to
for doing cross-run calculations scripting window as shown in base a report on the latest version
such as the comparison of results figure 8. This protocol is stored in of a calculation or any earlier one.
to a reference run. The group wiz- the database as the calculation The reporting capabilities of
ard provides for the ability of template. Each new version of a ChemStore C/S are outlined in the
grouping a set of results by criteria template is stored with version following section.

13
Agilent ChemStore C/S — Reporting

Agilent ChemStore C/S offers a The following are key customizable The ChemStore C/S application
powerful report generator features of the reporting offers an additional functionality to
enabling users to easily create and • display of the selection criteria print the current view. This func-
generate final summary reports. of the query, tion gives access to an immediate
The preview function helps to • display of all custom calculations printout of the actual screen
interactively develop the desired that have been used in the data including all graphics without any
report without requiring test print- section of the report formatting or configuration tasks.
outs. Agilent ChemStore C/S • an overall report header
comes with a set of built-in tem- displayed on each page that For system suitability reports the
plates to cover the most common allows to include graphic items calculation of system suitability
needs for summary reporting. such as a company logo, parameters can be triggered
These templates can be used as a • table information, independently of the ChemStation
starting point to build your own • configurable table contents and method during sample or sequence
customized reports. table header. setup by enabling the “Calculate
• fonts and font attributes, Peak Performance” checkmark
Following is a list of built-in • individual sections with additi- per run or sequence line (see
reports onal individual headers contain- figure 2).
• Analysis Results reports. ing data tables, chromatogram
• Audit Trails reports and spectra (if available from a
• Compound Amounts reports diode array detector) or data
for individual results. charts,
• Instrument and Run reports • individual page breaks,
• Peak Details reports • additional sorting criteria within
• Kinetic Decay reports. one data section to group data
• Sample Summary reports with logically, for example, around a
numeric tables of the result vial number, a sample type or
information. any other item that the user
• Sequence summary report— requires,
a complete report for GMP • restriction capabilities to focus
requirements including summa- on an adequate subset of the
ry statistics, graphics of chro- data, that is, one peak within a
matograms and spectra and chromatogram, and
result charts with control limits • statistical calculations selected
for each compound type interactively at any time during
grouped by the sample type. the data review from the
• System Suitability summary ChemStore C/S user interface.
reports including statistics over • inclusion of custom calculation
replicate injections. result tables, charts of calculated
values and full documentation
of the custom calculations,
including calculation formula
and calculation errors.

14
Agilent ChemStore C/S — Data Export into Other Applications

Agilent ChemStore C/S allows an

easy export of selected database
information (selection by records
and data fields) to third party
applications (notably MS Excel).
The user has control over which
fields are included and in which
order. This can be done based on
queries or reports exporting data
Figure 10
into the native file format. Agilent Interactive data export from Agilent ChemStore C/S into other applications
ChemStore C/S also offers clipboard
cut-and-paste for both tabular and
graphical data (figure 10). Report ChemStore C/S allows printing in • CSV format for spreadsheet
outputs can be in a file format the following file formats: applications
allowing convenient publishing of • HTML format for review with • XML format as generic file-
reports, for example, HTML for an Internet browser (excluding interface (excluding graphics)
internet and intranet publishing. graphics).

Agilent ChemStore C/S — User Interface

The Agilent ChemStore C/S review detailed inspection of the baseline summary or regression statistics
client offers the user two main to judge whether any rework of are in use. If regression statistics
“toolkits”: data review and database the integration is required. are being calculated, the regres-
administration. The latter will be sion chart and residual chart pre-
described in the next section. General chart presentation sentations replace it. Figure 11 is
an example of a chart contained
In the chart layout view the chart
Sample and compound review in the display area.
presentation is available only if no
Within the data review toolkit, the
user has a choice of whether to see
data organized by analysis (also
referred to as “run” or “sample”)
or by compound. In the table
layout view data is displayed in
configurable tables, either sample-
or compound-centric.

Chromatogram/spectrum
presentation
In the review layout view, the
display area can contain both
graphics and a table. The details
differ for sample and compound
review. The chromatogram viewer Figure 11
provides for dynamic zooming and Chart for retention time reproducibility with warning and
critical limits
rescaling capabilities, allowing a

15
Agilent ChemStore C/S — Security

Data acquisition, data analysis and Agilent ChemStore C/S database. Minimum length is the minimum
data review are password-protected. Users and their permissions can acceptable length (in characters)
Each user must have a valid user-id be imported from an existing of a password. Password validity
and a password to log on to the database during creation of a is the length of time (in days) over
application, as shown in figure 12. new standalone database. In a which the password remains valid.
To be able to transfer data to the client/server environment users Minimum password recycle is the
database the user must be logged are centrally managed in the minimum number of new, unique
on to the database. User validation Oracle database. passwords that a user must use
is done on a per database level and before a password can be used
always requires to enter a user again.
name and a password. Permissions Electronic signatures and
for several tasks like approval or password security
archival of runs, creation of custom Agilent ChemStore C/S uses elec-
fields, report templates, calculation tronic signatures based on the
templates or studies can be assigned application User-ID/password
to each individual user. Four user combination to uniquely identify
group templates for permission the users and their signatures. In
rights are supplied with the review order to keep the password
client. They can be used as a unique to the individual user an
starting point for the assignment additional security function is
of the permissions. Note that users implemented to periodically check
Figure 12
and their security permissions are and revise passwords, and apply Password protection of the application
configured separately for each the company's password policy. software

Agilent ChemStore C/S — Database Administration, Backup and Recovery

Database administration • Assign studies to users, • Schedule archive, dearchive

• Email notification for example and delete operations.
The review client provides the
on security violations (server- • Modify scheduled operations.
graphical user interface (GUI)
only). • View reports detailing pending
through which the user can accom-
operations.
plish the following administrative
The client/server version offers • Review archive and dearchive
tasks. Although the capabilities of
supplementary tools for administra- history.
the entry-level and client/server
tors in the Admin Client to per- • View information about
versions are to some extent differ-
form proper maintenance of the archives, runs and other
ent, the GUI is identical.
server database, archive/dearchive objects, including a list of all
• Create a new database–(entry
or archive/delete functions and runs in the archive unit.
level database only),
other setup tasks. The Agilent • Execute archive, dearchive and
• Compact (defragment) a data
ChemStore C/S Admin Client is a delete operations immediately.
base–(entry level database only),
web-based application that can be • Keep an audit trail of all archive
• Create or modify a study or
run from any PC on the network. and archive delete operations.
custom fields,
The Admin Client performs the • Add and modify database con-
• Administer system settings,
following main tasks on the server nections to offer connection to
• Administer users and security,
database using a service running a second Oracle database.
• Manual or automatic archive,
on the server.
delete and de-archive data
(server-only),

16
Database backup and recovery ing and testing a ChemStore C/S administrator Agilent provides a
One of the most important IT Server Backup and Restore strategy. consulting service to plan and
routines is the implementation of This strategy should ideally be implement the right backup and
a Backup and Restore concept. planned before the implementation recovery strategy for your business.
Backups and – equally as important but Agilent offers both, a service
– the ability to restore a backup prior to the installation as well as With a working knowledge of
are important tasks in order to a post implementation service. implementing solutions Agilent
protect business data and labo- uses software from Veritas called
ratory investments. For this purpose a ChemStore C/S Veritas Backup Exec™ for
Backup & Recovery strategy paper Windows 2000, Backup Exec Agent
Agilent Technologies can provide has been developed. With this for Oracle™ and Backup Exec
assistance in creating, implement- strategy paper and by working Intelligent Disaster Recovery.
with a customer’s ChemStore C/S

Agilent ChemStore C/S — Archiving Data

The client-server version provides name, operator name, sequence including wildcards and relative
for manual or automatic archiving name, method name, study name, values (for example, runs “older
of runs present in the database to custom field values, approval status than x days”). For performance
a separate file on disk or tape. and so on (figure 13). The available reasons the number of clauses
operands depend on the data cate- that can be defined for automated
Manual archiving gory (text, numeric values, date) archival is restricted to 10.
Manual archiving is done from the
“Archive/Delete” view in the
ChemStore C/S review client and
is based on the selected data set.
Manual archiving requires the user
to have the permission for archival.
Individual runs or the whole set of
runs are marked interactively for
archival. These runs are then
scheduled for the next archival
operation on the server.

Automatic archival
An administrator with archival
permission can set up a list of
individual archive queries for
automatic archiving, which are
executed at predefined time inter-
vals. Each custom query is put
together from a set of criteria,
including for example, injection Figure 13
time, sample name, instrument Setup of automatic archive queries

17
Each archive query is stored filename for the automatic archive A checksum-protected archive
under a unique user-defined name file is appended with the archival catalog file in XML format is gen-
and can be executed based on a date, resulting in a file name format erated with each archive unit,
configurable time interval (per “<filename>-yyyy-mm-dd”. Each which contains detailed informa-
query), for example, daily, weekly, archive query can be disabled when tion about the content of the
monthly or in conjunction with a not required permanently. After binary archive file. A generic
counter such as every x days. A successful completion of the archive interface provides a clos-
test functions allows the user to archive the data can be automati- er linkage to other applications
obtain information on the number cally deleted to create free space for enhanced archive manage-
of runs that the query returns at in the database. ment (for example, archive man-
the moment with the given query Both manual and automatic agement or hierarchical storage
condition. For each archive query archival require re-identification management systems).
the name and path for the archive with user-ID and password.
unit have to be specified. The

Agilent ChemStore C/S — LIMS Connectivity

ChemStation Plus can be easily The sample list must contain a approval of data as shown in
connected to a Laboratory LIMS ID for each sample. This figure 14. The administrator may
Information Management System LIMS ID is mandatory for sample decide which approval level is
(LIMS). For this purpose the tracking from and result transfer appropriate to initiate the LIMS
Agilent ChemStation provides for to the LIMS. Optionally additional transfer. In addition the LIMS
a sample list import function to two fields can be populated with can acknowledge data that was
conveniently translate a work list LIMS-specific data. successfully transferred to LIMS
from the LIMS into a ChemStation to exclude it from future updates.
sequence. An instant, file-less Result update to LIMS
result transfer back to the LIMS Workflow
ChemStore C/S provides for
from the ChemStore C/S database
file-less access to all result data The workflow can be divided
(server only) is achieved through
stored in the database as LIMS into five sequential activities
the integrated ChemStore C/S
data (identified by the LIMS ID). shown below:
LIMS interface.
This is achieved through a 1 The sample list is generated
combination of read-access to all by the LIMS system in an XML
Sample list import from LIMS result data in the database as well format
The sample list generated by as a controlled write-access for 2 It is imported by the Agilent
the LIMS can be imported to the LIMS. Prerequisite for results ChemStation and translated
the Agilent ChemStation as a to be accessible by LIMS is the into a ChemStation sequence
ChemStation sequence in XML-file existence of a LIMS ID which is 3 Samples are analyzed, results
format. XML is a very portable assigned per sequence line. In are calculated and stored in
and flexible protocol for inter- addition a LIMS notification may the ChemStore C/S relational
connectivity between systems. be used, which is tied to the Oracle database

18
4 Information typically required
by LIMS systems are instantly
made accessible in the
ChemStore C/S database (tied
to the existence of the LIMS ID)
5 If enabled on the system or
for a specific study, a LIMS
notification is triggered
upon the approval of data (as
configured in the approval
configuration console)
6 A program from the LIMS
systems can scan a table in the
database for a specific update
flag to see if any new records
are available for processing,
and can amend the flag so
that it is not scanned during
subsequent scans.
Figure 14
Configuration of approval levels and LIMS transfer

Agilent ChemStore C/S — Installation and Upgrading

The standalone version of Agilent • ChemStation Plus CD-ROM, and • Migrate Agilent ChemStore C/S
ChemStore C/S is user-installable • ChemStore C/S client software B.03.01 data to Agilent
from the ChemStore C/S CD-ROM (on ChemStation Plus CD-ROM). ChemStore C/S server data.
and can be added to an existing If you are currently running
ChemStation installation (Agilent Agilent ChemStore C/S data- Agilent ChemStore A.01.03 on
ChemStation software family CD- base migration your system, and you wish to
ROM version A.10.01 or higher). migrate your data to the Agilent
The Agilent ChemStore C/S sys- ChemStore C/S server Oracle data-
The Agilent ChemStore C/S Oracle tem includes a migration utility base, you will need to migrate in
client/server version includes : which enables you to migrate your two steps. First migrate to the
• ChemStore C/S server Agilent ChemStore C/S data in the B.03.01 Agilent ChemStore C/S
software (included on the following ways: standalone database, then migrate
ChemStation Plus CD-ROM), • Migrate Agilent ChemStore from there to the Oracle database.
• Oracle 9i standard edition A.01.03 or B.0x.0x data (stand-
version 9.2.0.3.0 (included in alone) to Agilent ChemStore
ChemStore C/S server software C/S B.03.01 (standalone).
on a set of separate CD-ROMs),

19
Agilent ChemStore C/S — Product Options and Configurations

Standalone version Description Product No.

The complete Agilent ChemStore Software module to add Agilent ChemStore C/S to an existing
C/S standalone software is provid- ChemStation for GC, LC, LC/MSD, CE, CE/MSD or A/D. G2181BA
ed on the Agilent ChemStation
Plus CD-ROM as described in License to use the ChemStore C/S database module on another computer. G2186BA
Must either be on the same order as G2181BA or the customer must supply
table 6a. the license number for the original software. Does not require ChemStation.

Agilent ChemStore C/S server ChemStation Plus client upgrade software, upgrades a single ChemStation G1657A
Plus client to the latest software revision.
The Agilent ChemStore C/S server Requires valid software licenses and ChemStation upgrade software G1656A.
product includes the ChemStation
Plus CD-ROM and Oracle 9i revi- Table 6a
Agilent ChemStore C/S standalone version
sion 9.2.0.3.0 software on a sepa-
rate CD-ROM offering one Oracle
standard edition license. In addi-
Description Product No.
tion an application-specific full
user license is required and sold ChemStore C/S client/server version. Includes ChemStore C/S server software G1410A
from Agilent for each additional Oracle standard editions, 5 Oracle application-specific named user licenses. Qty: 1 per server
user running a ChemStore review Oracle named user license for Agilent NDS G1411A
client. Five application-specific Required for each additional named user Qty: (number of
named user licenses are already of the ChemStore C/S server database. named users) –5
included with the Agilent
Software module to add Agilent ChemStore C/S to an existing G2181BA
ChemStore C/S server software. ChemStation for GC, LC, LC/MSD, CE, CE/MSD or A/D. Qty: 1 per server
Refer to table 6b for details.
Licence to use the ChemStore C/S review client on another computer. G2186BA
Includes one online ChemStore license for use with an online data acqui- Qty: (number of
sition ChemStation plus an additional offline ChemStore license for clients connected
offline data review to the server) –1

ChemStation Plus client upgrade software, upgrades a single ChemStation G1657A

Plus client to the latest software revision.
Requires valid software licenses and ChemStation upgrade software G1656A.

ChemStation Plus server upgrade software G1655BA

Upgrades ChemStation Plus server software to the latest revision.
Includes G1656A ChemStation software upgrade. Requires valid software license.

Table 6b
Agilent ChemStore C/S client/server version

20
 Agilent ChemAccess C/S

Product description HP 1090 Series and 1050 Series, matically and securely stored
Agilent 1100 Series, Agilent CE onto the Agilent ChemAccess
Agilent ChemAccess C/S is a
system, Agilent 5890, 6850, 6890 C/S server. This functionality is
client/server application which
GC systems, Agilent 5972, largely superceded when com-
facilitates the secure and con-
5973A and 5973N GC/MSD bining or adding Agilent
trolled integration of Agilent
system, Agilent 1100 LC/MSD ChemStore C/S to a Agilent
ChemStations into a networked
system, Agilent 35900 A/D ChemAccess C/S system.
environment by enabling users to:
converter
• provides flexible centralized An Agilent ChemAccess C/S data
• monitor and control instru-
data organization features system contains Agilent
ments from any client on the
which allows Agilent ChemStation clients, the Agilent
network, for the following
ChemStation files to be auto- ChemAccess C/S software and a
instrument modules:
Microsoft Windows NT server.
Agilent ChemAccess C/S is com-
patible with both the multi-tech-
nique Agilent ChemStation and
data analysis versions, enabling
flexible and cost effective remote
status monitoring control and
review from locations which are
situated away from the laborato-
ries instrumentation.

Remote status and monitoring

and control
From any Agilent ChemAccess C/S
client an authorized user can
remotely perform the following
tasks on a remote instrument:

• Start and stop the method or

sequence currently running.
• Assign a method or sequence
• Real time plot of the
instrument signals.
• Execute a remote Agilent
ChemStation command.
• Monitor the status of the
Figure 15 remote PC's resources (disk
Agilent ChemAccess C/S remote status and control user interface space, memory and software
revisions).
• Monitor the status of the
Agilent ChemStation and
instrument modules. Details
are shown in figure 15.

21
Working with Agilent ChemAccess C/S

Data storage and organization view of the Agilent ChemStation.

Agilent ChemAccess C/S enables If the same results are retrans-
the Agilent ChemStation results ferred to the server, Agilent
(raw data, methods and ChemAccess C/S employs data
sequences) to be securely stored versioning to ensure that an entire
on the Agilent ChemAccess record of the analysis is recorded.
Windows NT server. The results
can be transferred automatically
at the end of each run or interac-
tively through the data analysis

Agilent ChemAccess C/S — System Requirements

Client hardware requirements • Agilent ChemStation for gas Each Agilent ChemStation that is
chromatograhpy mass selective integrated in an Agilent Chem-
Agilent ChemStation and detection revision C.00.xx, Access C/S system should con-
ChemAccess C/S • Agilent ChemStation for gas form to the following Agilent
The PC client should conform to chromatography, revision ChemStation and Windows soft-
the requirements as specified in A.08.04. to A.10.0x, ware revisions:
Agilent ChemStation Specifications • Retention time locking
(Agilent publication number software, add-on module for • ChemStation for GC, LC,
5988-9925EN). In addition to Agilent ChemStation for gas LC/MSD, CE and A/D revision
these requirements further 8 MB chromatography, A.08.04 to A.10.0x, on Windows
memory is required for network • Agilent ChemStation for liquid NT 4.0 Service Pack 6a or
connectivity software and Agilent chromatography, revision Windows 2000 Service Pack 2-4
ChemAccess C/S software. A.08.04. to A.10.0x, • GC/MSD ChemStation revision
• Gel permeation chromatography C.00.xx on Windows NT 4.0
Agilent ChemStation, software add-on module for the Service Pack 6a.
Agilent ChemStation for LC • GC/MSD ChemStation revision
ChemAccess and ChemStore C/S
• Agilent ChemStation for D.00.xx on Windows NT 4.0
Configure the client using the capillary electrophoresis, Service Pack 6a or Windows
Agilent ChemStore C/S client revision A.08.04. or later, 2000 Service Pack 2.
hardware requirements specified • Agilent ChemStation for liquid
in this document. chromatography mass selective Note:
detection, revision A.08.04. to Agilent ChemAccess C/S currently
Client software requirements A.10.0x, does not support the Agilent
The ChemAccess C/S client module • Agilent ChemStation for analog ChemStation for UV-visible
can be added to the Agilent signal acquisition, revision systems.
ChemStation. The ChemAccess A.08.04. to A.10.0x, and
C/S module is supported with the • Agilent ChemStation for
following ChemStation software capillary electrophoresis mass
packages: selective detection, revision
A.08.04. or later.

22
Server hardware requirements Server software requirements
Agilent ChemAccess C/S supports • Windows NT 4.0 with Service
up to 15 “concurrent” Agilent Pack 6a or Windows 2000
ChemAccess clients, where con- Service Pack 2
current is defined as a client con- • Microsoft TCP/IP networking
nected to the Agilent ChemAccess (supplied with Windows NT and
C/S server which either transfers Windows 2000).
result data from the Agilent
ChemStation to the server for data
storage or performs remote real Entry level Hi-end
time plot. Recommended server
Number of clients supported 1-10 1-15
configurations are listed in table 7.
Agilent NetServer model or equivalient LC2000 LH3000
Processor speed (MHz) 933 1 GHz
Note:
Number of processors 1 1
For a ChemStation Plus server
RAM 384 MB 512 MB
system which has both Agilent
Disk (number and size) 3 x 18 GB 2 x 18 GB, 3 × 18 GB
ChemAccess and Agilent
Raid level five one and five
ChemStore modules, use the
Hot swappable drives yes yes
Agilent ChemStore C/S server
Network interface card 1 1
requirements. Disk configurations
may need to be customized to fit Table 7
to your laboratories online and to Recommended server configurations for Agilent ChemAccess C/S
long term storage needs.

Agilent ChemAccess C/S — Product Options and Configurations

The complete Agilent ChemAccess Description Product No.

C/S software is provided on the
Agilent ChemStation Plus CD- ChemAccess server software for remote status, G1494A
ROM. This includes the software monitoring and control of 16-bit ChemStation.
listed in table 8. Includes 10-user licenses for 3D data analysis software
and a 2-user license for the GC/MS data analysis software

ChemAccess client software, 5-user license G1495A

remote status, monitoring and control client
software for 16-bit ChemStation.

ChemStation Plus server upgrade software. G1655BA

Upgrades ChemStation Plus server software to the latest revision. Includes
G1656A 16-bit ChemStation software upgrade. Requires valid software license.

Table 8
Agilent ChemAccess C/S software

23
3. Agilent ChemStation Plus Security Pack

What's new? and 5989-0848EN, respectively. database. This database (determi-

The ChemStation Plus Security nation of the database connection
Please refer to the section on new
Pack is available as a standalone requires the log-on to the Windows
features in ChemStore C/S on page 2.
solution or in a fully integrated operating system with a Windows
client server network connected administrator account) will store
Product Description to the ChemStore C/S server all raw, meta and result data. In
The ChemStation Plus Security Oracle database. It provides full addition, any recalculation of
Pack is a module of the Agilent support of 21 CFR Part 11 by results in the ChemStation will
ChemStation Plus Series designed offering advanced data security, automatically be recognized as a
to support the requirements of data integrity and full change new result version and will be
21 CFR Part 11. In the Agilent documentation in audit-trails. transferred to the database as a
ChemStation the ChemStation Specifications of the ChemStore new version. This versioning
Plus Security Pack modifies data C/S database module are available assures that no data is ever lost or
analysis and provides advanced in the ChemStore C/S section of overwritten and that a complete
data management with regard to this document. chain of events is documented. If
supporting the requirements for a new result version is generated
electronic records. It also offers a To achieve data security, the interactively, the user is forced to
procedure to sign off runs with an ChemStation Security Pack utilizes enter a mandatory comment,
electronic signature. To support a combination of Windows user which is written to the audit trail.
the typical approval workflow in a accounts and file permissions and
regulated laboratory the Security auditing. In addition, it utilizes an To achieve data traceability, the
Pack optionally provides for three application-related second layer of ChemStation Plus Security Pack
levels of approval which can be data security based on standard utilizes logbooks and audit trails
combined with run locking. It database security features. The that document who did what, when
offers an easy upgrade for an application-related security and why. These logbooks and audit
existing ChemStation installation. requires a valid ChemStation Plus trails are user-independent and
user account allowing the log-on cannot be modified or deleted.
The Agilent ChemStation Plus to the application. A user with
Security Pack is compatible with the administrative priviledges can All data is in electronic format
following ChemStation modules: assign appropriate user permis- and capable of long-term storage
• Agilent ChemStation for GC, sions to other users within the through archive/restore as well as
LC, A/D, CE, CE/MS and LC/MS ChemStation Plus software. viewing and printing in human
for instrument control and data readable format.
analysis The ChemStation Plus Security
• Agilent ChemAccess C/S Pack software allows to match user Key product features of the
remote instrument control tasks in the laboratory with user ChemStation Plus Security Pack
• Agilent ChemStore C/S data roles in the software. It modifies include storage of all chromato-
organization and data storage the ChemStation operator rights, graphic data in a relational data-
module allowing to routinely operate the base, secured through
• Agilent ChemStation Plus ChemStation application in the • password protection to access
Method Validation Pack operator mode. For proper use and the data,
to achieve the best data security • full data protection using
The UV-Vis as well as GC/MS capabilities all users except those Windows security and data-
ChemStation offer separate solutions with administrative functions base security features,
for 21 CFR Part 11. Please refer should utilize the ChemStation • application protection with a
to the specifications of the UV operator mode. mandatory log-in, consisting of
ChemStation Security Pack and the both identification components
MSD Security ChemStation included To achieve data integrity, all users - user-id and password,
in publication number 5980-0337E are required to log on to a single

24
• user management with individual • A completely revised • Complete change control
user profiles and privileges for ChemStation operator access documentation for methods
the application – independent level which allows operating and manual integration
of the user privileges assigned the entire application as changes.
for the operating system, ChemStation operator. • Four levels of audit-trails for
• an application-specific session • A configurable access to the data acquisition, data analysis
lock allowing to explicity lock ChemStation commandline application tasks and security
one ChemStation session while independent of the ChemStation violations.
leaving a second instance user level, thus also preventing • Electronic signatures for each
running on the same PC, and access for ChemStation result version following the
• a configurable time-based managers. guidelines of 21 CFR Part 11.
application lock to lock the • A modified batch review • Three configurable levels of
current ChemStation or interface providing an automat- approval.
ChemStore session after a ed user-independent data ver- • Optionally locking of runs upon
specified time of inactivity and sioning with detailed audit- the approval to prevent them
thus avoids any unauthorized trails for all modifications. from further modification.
access to the application.

ChemStation Plus Security Pack — System Requirements

Client hardware requirements • Windows 2000 Professional with strict size limitations in the under-
Service Pack 4 or Windows XP lying file format. To ensure opti-
The following list shows the mini-
Profession Service Pack 1a mum performance for later data
mum hardware requirements for
• Agilent ChemStation revision review Agilent strongly recom-
this application:
A.10.01 or later mends not to exceed this database
• 600-MHz Pentium III (Pentium IV
• Microsoft Internet Explorer size limit. A configurable size-
recommend)
5.5 or later checking tool automatically
• 4 GByte of free hard disk space
• Microsoft data access components launches a warning message when
• 128 MB RAM for single Chem-
(MDAC) 2.8 will be installed on the specified size limit is reached.
Station instrument. 256 MB is
your system. If you already use
recommended for best perfor-
a later version of MDAC, or If a larger single database is
mance, for Windows XP minimum
require for compatibility reasons required, Agilent recommends that
requirement is 256 MB.
a previous version, please the client/server version of the
• 256 MB RAM for two Chem-
contact your Agilent support product be purchased. The client/
Station instruments (512 MB or
representative for compatibility server database uses Oracle,
more is recommended for best
information. which allows for a much larger
performance)
• A local or network printer must database. Table 9 gives some data
• Display: 1024 ∞ 768; small fonts;
be installed and configured. on the time required for down-
65-thousand colors
• The hard disk partition that is loading data from the standalone
used for installation of Security database into the active memory
Client software requirements Pack must be formatted with of the client. The time mainly
The following list shows the mini- NTFS. depends on the size of the stand-
mum software requirements for The standalone database size is alone database, the number of
this application: limited to 800 MB due to some runs marked for download and

25
the performance charactistics of Database Size No. of peaks No. of runs No. of runs loaded from database Time [s]
the computer. All runs were stored
with raw data, methods, sequences, 93986 2137 240 100 17
192048 4642 410 100 17
and all result versions. The PC 445826 22621 868 100 13
used for the test was below the 683 76
recommended configuration 1048472 36710 2203 100 13
(Kayak PIII, 450 MHz, 128 MB, and 683 59
no data acquisition running in the Table 9
background). Run download time depending on the number of runs selected for download and
the database size.

Working with ChemStation Plus Security Pack

Result management Data protection In client-server installations of

ChemStation Plus Security Pack
The ChemStation Plus Security Using the Security Pack in the
direct, uncontrolled access to data
Pack is designed to store standalone version, all data is
in the Oracle database without
ChemStation data in a relational stored in a single database file. The
using the ChemStore user interface
database by transferring it as a subdirectory storing the database
is virtually impossible. This is
post-data analysis spooling job to files is protected with Windows
because users must have a valid
the database. Depending on the file security permissions and only
Oracle user account and they
laboratory workflow the data allows write access for members
must have access to the data dic-
analysis can also be separated of the Windows user group.
tionary describing the meaning
from the acquisition. In this case
and contents of the Oracle tables
only raw and meta data are The application denies access to
and table columns. The dictionary
automatically spooled to the data without a valid ChemStation
is only available from Agilent
database, without a first set of data Plus user-id and password. Any
Technologies against a written
analysis results (data is acquired attempt to access the data in the
Confidentiality Agreement and
in acquisition-only mode). The standalone database directly with
should not be available for appli-
ChemStore C/S ODBC spooler is another application such as MS
cation users. Overall the attempt
a proprietary tool managing the Access fails as it requires a pass-
to falsify or delete data requires
transfer and protecting data word/user-id combination that is
the collaboration of the user and
against loss, modification or strictly confidential and only
the database administrator that
damage in case of transfer known by Agilent. It is not known
provides the direct database
problems or network errors. by or given to any Agilent customer
access. Sufficient security
or user of this product.
constraints need to be imposed
within the organisation to prevent
any uncontrolled modifications.

26
Data storage the database). From then on, the group Administrators or Power
data security mechanisms of the Users to access the configuration
By default the the database stores
database itself secure the data. of the ChemStation Plus Security
the following data:
The temporary directory where Pack. It restricts access to all data
• calculation results of the
the database spooler stores inter- directories on the local PC with
ChemStation,
mediate data is protected using important information using the
• contents of the ChemStation data
Windows NTFS file and folder Windows users group privileges.
directories; the *.d directories
security. The default configuration automat-
including the chromatographic
ically sets all directory permis-
raw data files,
If a first pass review in the sions and access limitations as
• current method used for data
ChemStore review client results part of the installation using the
acquisition and data analysis,
in the need for some reanalysis Windows groups “Users”, “Power
• current sequence, if a sequence
work, for example reintegration, Users” or “Administrators”. Each
was run to acquire or reprocess
the data is submitted as a batch ChemStation user has to be mem-
data,
to ChemStation. This requires ber of either one of the groups.
• sequence, run and method
restoring data files to a temporary
logbooks,
subdirectory. The Security Pack Note:
• detector channel chromato-
protects this subdirectory Normal users must not be
grams as images according to
hpchem/x/data/chemstor where x members of the Windows
the report configuration of the
is the instrument session number Administrators nor Power Users
method, and
with read-only access for members groups. The membership to these
• apex spectra of all identified
of the Windows users group thus groups should be dedicated for
peaks in a chromatogram, when
denying unauthorized access for system administrators.
using a 3D detector.
operators.
• Optionally all peak performance
Table 10 gives an overview of the
parameters independent of the
Configuration and data permission rights that are limited
ChemStation method.
to members of the Windows
protection using Windows Adminstrators and Power Users
Protection of temporary data security features groups.
files For security reasons, a user must
The ChemStation uses a given be a member of the Windows user
data directory structure to store
acquisition and result data. The
ChemStation Plus Security Pack
also protects this data. After com- User task Granted to members of Granted to member of Power
Windows User group Users or Administrators group
pletion of data acquisition and a
first result calculation, by default Create a new MS Access database no yes
the data transfer is immediately Configure database Alias no yes
Access the ChemStore ODBC spooler to resume
initialized through the ChemStore interrupted data transfer yes yes
spooler and the *.d directory with Access to the selection list of available databases no yes
all its contents is deleted from the Table 10
local hard disk (these default Tasks requiring membership in the Windows Administrators or Power Users group
settings can only be modified by a
user with administrative rights in

27
Local directories storing relevant File path Permission Permission Windows Directory/file Data directory
chromatographic data are also Windows Administrators owner contents
protected with Windows file and Users or Power Users
directory permissions. Table 11 \hpchem\chemstor (W)(full) (full)(RWXD), All members of Contains
gives an overview of the Windows \database local Admini- database *.mdb file
permission rights on the data strators or Power storing all raw and
Users group meta data
directories and files on the local
hard disk. The first item in brack- \hpchem\chemstor (WX)(full) (full)(RWXD) All members of Spooler jobs and
ets displays the permission rights \spool local Admini- data files
strators or Power
on the folder; the second item Users group
displays the individual file
permission rights. \hpchem\chemstor none (full) All members of Access to ChemStore
\hputil00.exe local Admini- utility tool to create/
strators or Power copy and manage
Note: Users group local database files
Windows file security does not
\hpchem\X (instru- (WX)(Full) (full)(RWXD) All members of Stores data files re-
give any access to a folder or ment session num- local Admini- loaded from Chem-
directory for users that do not ber)\data\chemstor strators or Power Store database to
have access rights to the folder, Users group ChemStation batch
review
even if the user has control over
the files in the folder. Table 11
Directory and file permissions [(directory)(file)] set by the ChemStation Plus
Security Pack [W=write, R=read, X=execute, D=delete, full=all permissions]

ChemStation Plus Security Pack — User Management and Application Security

User management and privileges compared to the standard assigned individually and is not
ChemStation Plus Security ChemStation for data acquisition. tied to any ChemStation user
The ChemStation Manager always level (see figure 16). A detailed
Pack user access rights has access to all tasks within the documentation of the data review
Security Pack provides a fully ChemStation with the exception user privileges in the ChemStore
integrated user management that of access to the ChemStation C/S database is in the ChemStore
is independent of the Windows command line. Unlike the standard C/S concept guide.
operating system. The user ChemStation this privilege can be
management covers both the
ChemStation Plus data acquisition User privilege Security pack operator ChemStation operator
and data analysis tasks and the
ChemStore C/S database data Save acquisition method no no
review privileges. The entire user Save data analysis method yes no
Load/run/save sequence yes yes
administration itself is a user-
Modify acquisition parameter yes yes
privilege granted to administrators Re-Integrate chromatograms manually only in batch review no
in the ChemStore C/S database. The Change integration events only in batch review no
ChemStation Plus Security Pack Recalibrate overview and peak summing only in batch review no
includes a modified ChemStation Recalibrate other no no
Apply method to data and print report yes yes
operator level allowing operators to
User-independent automated result versioning yes no
perform all important acquisition Access to tasks with manual result versioning no no
and data analysis tasks for daily
Table 12
operations. Table 12 shows the Comparison of user privileges in the ChemStation Plus Security Pack and the
most important changes in user standalone ChemStation

28
Application security
The Security Pack only allows users
with a given user-ID to log on to
the ChemStation Plus application,
as shown in figure 12. Users need
to be set up by the administrator
to gain access. At initial login, users
must specify their initial password
in order to keep it unique to each
user. Protecting the application
software from unauthorized access
during operation is possible with a
separate session lock (figure 17).
This lock function offers
• an interactive session lock which
should be enabled manually
before leaving the computer
unattended, e.g. during a break
or shift change, and
• for enhanced security a time-
based automated lock of the
session for other periods of
short-term absence from the Figure 16
computer. User Management in ChemStation Plus Security Pack

The time-based session lock is

configured centrally through users
with administrative rights in the
ChemStore C/S database, and
is automatically applied on all
connected ChemStation Plus
clients. The session lock allows
to lock each instrument session
individually and independently, so
users sharing computers with two
or more instruments connected to
one computer can operate with a
clear user distinction and unique
user identification. The name of
the current user and the instrument Figure 17
Instrument session lock
session are always shown in the
title bar. The instrument sessions
can be locked either
• privately, allowing only the user base to unlock the session, for
who locked the session or an example during shift changes
administrator to unlock it, or (figure 17). If a dialog is still
• non-privately allowing all users open the application will
with a valid user-ID in the data- automatically lock privately.

29
ChemStation Plus Security Pack — Data Integrity, Automated Result Versioning
and Data Reanalysis

Data integrity In addition, ChemStation Plus command to create a new result

The Security Pack maintains full managers can perform manual version:
data integrity by storing all results result manipulation interactively • drawing a manual baseline,
along with the raw and meta data in the Data Analysis view without • deleting a peak,
in a relational database as shown using the batch review user • tangent skimming of one peak,
in figure 18. interface. The user-independent • splitting a peak, and
revision management does not • integrating manually with a
Result revision management cover the manual reanalysis of negative baseline.
Daily work in the analytical labo- results in the standard ChemStation Access to tasks with a user-
ratory often requires sample data analysis view. The user creates dependent creation of new results
reanalysis. The ChemStation Plus new result versions in this review is the only difference in the
Security Pack includes a result function using the manual Transfer result management between
versioning that stores all recalcu- Data to Database command the ChemStation Security Pack
lation results from one original (figure 19). manager level and the ChemStation
injection as result versions. In Security Pack operator level.
addition, the application software The following manual tasks in The new result version in the
includes a tool that automatically the Data Analysis view, outside database is the same for both
detects new results during the of batch review, require a user automated and user-dependent
reanalysis process. This applica- selected Transfer Data to Database data transfer.
tion-controlled automated process
does not require any user interac-
tion such as Save Results or a
similar action. It is completely
user-independent and covers the
following reanalysis steps:
• All functions in the batch review
that calculate or change results
such as reintegration, recalibra-
tion, method modifications (for
example changing compound
names) execution of predefined
methods including manual
reintegration
• In the data analysis view:
Integrating, printing reports and
recalibration excluding manual
reintegration Figure 18
Default configuration of data storage in
Sequence reprocessing as well as database
all initial review tasks (loading a
batch from disk, initial loading of
a run into the interactive data
analysis view) always create new
result versions. These reanalysis
tasks cover all activities of the
ChemStation operator thus ensur-
ing that all reanalysis steps at the
ChemStation operator level include Figure 19
a user-independent versioning. Manual revision management

30
User-independent, automated
result version management
The data storage includes an
application controlled version
management that is based on the
creation of a result reference file.
Prior to reprocessing, the applica-
tion software creates a binary
result registry file called
save_sec.reg for each file. This
save_sec register is stored along
with the raw data. It includes all
numeric results of the current
result revision in a binary format,
such as amount, compound reten-
tion time and so on. Whenever a
new result is calculated, the soft-
ware automatically compares the
new run result with the original Figure 20
result in the register file. If the Text file documenting result changes for the actual run revision
results changed, the software
detects the difference between the
most recent and the current result
and creates a new result version.

For proper documentation of the

changes, the application software
creates a second file in a human
readable format that stores the
results of the comparison and
documents the changes. The file is
named sec_trac.txt and is stored
along with the raw data in the *.d
subdirectory, as shown in figure 20.
Both the registry and the text file
are also stored in the database
along with the raw data and they
can be restored to disk with the
data file, if necessary. These
changes including manual
integration events are also docu- Figure 21
mented in the Manual Integration Manual integration events documented in ChemStore run audit-trail
Events section of the ChemStore
audit-trail as shown in figure 21. example in an audit situation available under a confidentiality
The audit trail as well as the (see also the application note agreement).
sec_trac.txt can be used in order “Handling of Electronic records
to regenerate the result from raw with ChemStation Plus” publication
and meta data at any time, for number 5988-9643EN, which is

31
ChemStation Plus Security Pack—Graphical Result Review and Calculation

Summary of version manage- the database. Each data transfer

of new results creates a new ver-
ment in the ChemStation Plus
sion entry in the database so that
Security Pack no data is ever overwritten. The
Each time a new result is calculat- versioning also assures that no
ed in the ChemStation, the appli- “data” is lost and that a complete
cation compares the values with “chain of events” is documented.
the result values of the last This ensures full data integrity and
reprocessed result copy. If it traceability.
detects a difference, it automati-
cally initializes the data storage in

Agilent ChemStation Plus Security Pack—Graphical Result Review and Calculation

The graphical result review for calculation section. The applica- to calculate the results with the
example inspecting the baseline tion allows a graphical rework of new settings by moving to the
of the chromatogram or zooming the chromatogram for each run next run or starting an automated
in to check the integration, is that was included in the batch. result recalculation (figure 22). As
done in the ChemStore review This is done by setting new soon as new results are created,
client. If any further rework is integration events and applying the result transfer to the database
required the data is submitted to manual events such as baseline is performed either for the single
the ChemStation batch review drawings and others without an run, or if starting an automated
user interface for data reanalysis. immediate transfer to the data- result recalculation, for all
In batch review the ChemStation base. The transfer is initiated reprocessed runs. During the
Plus Security Pack allows splitting automatically as soon as the user transfer of manually integrated
the review into a working and a has finished his work and decides data the user is prompted for a
mandatory comment that is written
to the results audit trail. The
comment can be either a selection
from a set of predefined comments
or a free text or a combination of
both. After finishing the data
reanalysis and closing the batch
review interface, the temporary
files will be deleted from the local
hard disk.

Figure 22
Result calculation and automated versioning

32
ChemStation Plus Security Pack—Electronic Signatures and Password Security

21 CFR Part 11 permits the use of

electronic signatures if the appli-
cation ensures data integrity, data
security and full audit-trail docu-
mentation. If an electronic signa-
ture is supposed to be equivalent
to a handwritten signature it must
contain at least two distinct identi-
fication components such as an
identification code and a password.

Approval of results
The ChemStation Plus Security
Pack protects all activities that
create, modify or delete electronic
records with user privileges and
electronic signatures. Signing for
approval is a privilege that must
be configured and granted by the
Figure 23
system administrator and is there- Signing off results requires reentry of user-ID with password confirmation and a
fore limited to certain users. mandatory comment
Signing runs for approval or
rejection always prompts for a
re-identification and password
confirmation of the signer for each
run, plus a mandatory comment for
the sign off, as shown in figure 23.
The signer has to be the currently
logged-on user.

ChemStation Plus provides three

levels of approval tied to two
separate user permissions to
support the typical approval work-
flow in an analytical laboratory. It
can be configured on a study level
whether multiple approval levels
should be applied or not. The
approval configuration is part
of the study settings. For new
studies the settings from the global
approval configuration template are
copied to the study. The approval
configuration is shown in figure 24.
Figure 24
Global approval configuration template

33
The operator will typically give or change the free-text comment. valid range between 1 and 32000.
the first level approval when The approval comments are • Password uniqueness is the
reviewing his results. To allow for defined by the administrator in the minimum number of new,
peer reviews the application sup- global approval configuration tem- unique passwords that a user
ports multiple first level plate. must use before a password can
approvals. The second level be re-used. The default is 12,
approval lies in the responsibility All other sensitive actions (for which means that a user must
of the laboratory manager when example, changing run-related change the password at least 12
signing off the results and pre- custom field values such as the times before re-using the original
vents a signed run from further batch ID) and the archival or password. The range is between
first level approvals, unless the deletion of runs follow the same 0 and 32000.
run is rejected. The third level process as described above and • Account lockout after ‘x’
approval (equals a 2nd second are tied to distinct user permissions. attempts (where ‘x’ is the
level approval) can serve as the All electronic signatures are noted number of failed log-on attempts)
final sign-off by the quality control in the individual sample audit-trail is the maximum number of
department. It requires the signing and in the database logbook. consecutive unsuccessful
user to have the second level attempts that a user can enter
approval permission. After the The ChemStation Security Pack before ChemStore rejects the
third level approval no more sig- uses electronic signatures based on user. The default is three with
natures can be applied unless the the application User-ID/password a valid range between 0 and
run is rejected. Optionally runs combination to uniquely identify 32000. If the maximum number
can be locked from reanalysis the user and his or her signature. of re-entries is reached, the
after the approval (see figure 24). In order to keep the password current user is invalidated and
Which level finally locks the run is unique to the individual user an must be reactivated by a user
configurable. The administrator additional security function is with the required permission.
assigns the permissions for the implemented to periodically check
different approval levels to the and revise passwords, and apply
users. the company's password policy
(figure 25). The administrator
Preconfigured approval can specify the values for these
comments conditions.
The ChemStation Plus Security
• Minimum length is the minimum
Pack provides the ability to globally
acceptable length (in characters)
define approval comments.
of a password. Passwords
These comments consist of two
shorter than the minimum
components - a short fixed text that Figure 25
length are invalid and rejected Password policy
cannot be modified nor deleted by
by ChemStore C/S. The default
the signer and a pre-defined
is eight characters with a valid
default text that can be changed
range between 0 and 30.
during the signing. These two
• Password expiry date is the
components appear during the
number of days over which the
approval. The signer has to
password remains valid. The
choose a fixed comment from the
password expires after the
dropdown list box containing the
specified validity, and a new
pre-configured comments as shown
password must be provided.
in figure 23 and can optionally enter
The default is 90 days with a

34
ChemStation Plus Security Pack — Audit-trails and change documentation

The Agilent ChemStation Plus • all run versions, All reanalysis events and result
Security Pack includes four audit- • all user comments during versions are documented in the
trails: reanalysis cycles, and sample audit-trail. The sample
• run logbooks, • a detailed change documentation audit-trail creates for each result
• method revision history data, of manual integration events. change one new line in the audit-
• sample audit-trail, and • all approval events including trail table. It displays both the
• database logbook. the name of the approver, date interactive manual changes and
& timestamp, approval com- the system generated entries each
Run and sequence logbook ment and the level of approval. in a separate line. Examples for
During data acquisition, all events
are documented in the sequence
and run logbooks with date and
time stamp (figure 26). The
sequence and run logbook
documents all data acquisition
events such as
• start and execution of methods Figure 26
• the actual sequence line in the Run and sequence logbook
sequence table,
• any failure during method
execution, and
• any modification of method
parameters during the analysis,
such as manually extending the
run time
• initialization of data spooling to
the ChemStore C/S database. Figure 27
Method change audit-trail
Method changes
The method changes are stored
with each current method version
including a mandatory user
comment for the change (figure 27).
The method audit-trail stores
• the time of change and the
operator who performed the
change
• the current method revision in
the database, and
• a mandatory comment of at
least five characters each time
the method was changed.

Sample audit trail

Figure 28
The sample-related audit-trail, Audit-trail table with manual change documentation in the comment field
shown in figure 28 documents
• all changes and modifications,
on one sample,

35
manual interactive changes are: Review of method parameters • the associated result version,
• change of custom field values • method name,
Each result version is associated
• manual reintegration during • method modification date,
with its ChemStation method that is
reanalysis, • study name,
stored in the relational ChemStore
• approval, rejection and retransfer • database name,
database. To inspect the differences
to batch, • sample name,
in method parameters between
• reloading data to disk, • injection date and
result revisions or to review a
• archiving and dearchiving, and • acquisition instrument.
method that was used to generate
• re-opening of read-only runs. a specific result the application
Changes to method parameters can
provides direct access to the
The automated entries in the only be applied in the ChemStation.
method information from the
sample audit-trail are created when For this purpose the method has
ChemStore user interface. All
• a run is transferred to the to be restored from the database.
method parameters, including
database New result versions generated
acquisition parameters, data
• a new result version is created with the modified method are
analysis parameters and calibration
• a run is reloaded in the spooled to the database along
information can be reviewed in
ChemStation batch review with the method.
read-only mode as well as printed.
interface for reanalysis. The method report header con-
tains information on
Database logbook
The database logbook (figure 29)
stores all application related activ-
ities such as:
• log-on/log-off events and failed
logon attempts,
• archive/delete/reopen activities,
• session locks and unlocks,
• approval and rejection of runs,
• modification of custom fields
and custom field values,
• changes in user administration,
• modification of user
permissions,
• password resets and password
clearance, and
• database migration from
Access to Oracle.
• Account lockout events.
Figure 29
Database logbook

36
Agilent ChemStation Plus Security Pack — E-Mail Notification

The email notification feature

(client-server only) allows to send
an email to a configurable list of
recipients on the event of
• account lockout
• batch submission
• user permission change
• user creation

For each event the recipients can

be defined separately as well as a
user-defined message text and
subject.

This function requires an e-Mail

server to be running in the network.
The e-mail message can be trans-
ferred to the e-mail server through
Simple Mail Transfer Protocol
(SMTP). For example this can
serve for the purpose of instant
notification on unauthorized
attempts to access the database.
An e-mail message can be triggered
by account lockout events in the
ChemStore C/S database logbook.
(figure 30).

Figure 30
Setup of e-mail notification

37
ChemStation Plus Security Pack—Product Options and Configuration

Standalone version Description Product No.

The standalone version provides
ChemStation Plus Security Pack. G2183AA
the ChemStation CD-ROM revision Adds the secure ChemStore C/S relational database add-on software 1 per PC
A.10.01 or higher and the module to the ChemStation Plus SW for A/D, GC, CE, LC and CE/LC-MSD. 1 per laboratory
ChemStation Plus CD-ROM Supports 21 CFR Part 11. Includes user documentation, licenses and media.
revision B.03.01 or higher as
described in the table next to License to use G2183AA on another PC. G2187AA
Includes license and user information only. Supports 21 CFR Part 11. Must 1 per PC be in the
this text. be on same order as G2183AA or requires a valid license for G2183AA. same laboratory

ChemStation Plus client upgrade software. G1657A

Upgrades a single ChemStation Plus client to the latest software revision.
Requires valid software licenses and ChemStation upgrade software G1656A.

Description Product No.

Client/server version
The client server/version of the ChemStore C/S server application software. G1410A
product consists of a set of Includes:1 x ChemStore C/S and Oracle 9i standard edition software, Qty: 1 per server
components that are required to 5 Oracle application-specific named user licenses are included.
implement ChemStation Plus Oracle named user license for Agilent NDS G1411A
Security Pack in a client/server Required for each named user of the ChemStore C/S server database. Qty: (number of
version. The product number are clients connected
listed in the table next to this text to server) – 5
along with the required quantities.
ChemStation Plus Security Pack. G2183AA
Adds the secure ChemStore relational database add-on software Qty: 1 per server
module to the ChemStation Plus client server SW for A/D, GC, CE, LC and
CE/LC-MSD. Supports 21 CFR Part 11.

ChemStation Plus ChemStore client license. G2186BA

Includes one online ChemStation Plus license for online data acquisition Qty: (number of
and one ChemStore C/S offline data review license. clients connected
Includes license and user information only. to server – 1
Requires but does not include ChemStation Plus software media.

License to use G2183AA on another PC. G2187AA

Can be used as additonal copy for standalone installations or 1 per PC in the
as additional Security Pack client in ChemStation Plus Security Pack C/S same laboratory.
installations. Includes manual, 1 license for either online or offline use
and media. Supports 21 CFR Part 11 Must be on the same order as
G2183AA or requires a valid license for G2183AA.

ChemStation Plus client upgrade software. G1657A

Upgrades a single ChemStation Plus client to the latest software revision.
Requires valid software licenses and ChemStation upgrade software G1656A.

ChemStation Plus server upgrade software.

upgrades ChemStation Plus server software to the latest revision. G1655BA
Includes G1656A ChemStation software upgrade. Requires valid software license.

38
 Agilent ChemStation Plus Method Validation Pack
4.

Introduction 1. The definition of general good configure the method validation

quality criteria for a method to according to the guideline under
A comprehensive understanding
address the qualitative require- consideration. The ICH has also
of the functionality of Agilent
ments, and published a guidance on “Stability
ChemStation Plus Method
2. The definition of specific Testing in New Drug Substances
Validation Pack requires a brief
requirements for the individual and Products” to define the
introduction to the general
analytical problem to address required amount of information
aspects of method validation.
the quantitative question. and procedures for the submittal
Eventually it requires an answer in a registration application for
The goal of method validation is
to the question “does this method products (ICH Topic Q1A). The
“to provide documented evidence
provide good results based on purpose of stability testing is to
that a specific process will consis-
independent requirements?” provide evidence on how the
tently provide results meeting the
quality of a substance varies with
predetermined specifications.”
For step 1, ICH and FDA used the time under the influence of a
This definition is taken from one
definition of general good quality variety of environmental factors
of the FDA's method validation
criteria (along with many other such as temperature, humidity,
guidance documents. In other words
contributors). These organizations and light, and to establish a re-test
method validation is the process
defined a number of criteria that a period for the substance, and
of evaluating and documenting the
separation method must fulfill to recommended storage conditions.
performance of an analytical
be classified as “good quality.” Method Validation Pack does
method to ensure that the method
These criteria are include tests for short-term and
is suitable for its intended use by
• accuracy long-term stability testing according
ensuring compliance with product
• precision to the ICH guideline.
or method requirements. The
• robustness/ruggedness
outcome should provide sufficient
• selectivity Based on these test criteria, step 2
confidence in the result produced
• limit of detection/quantification can be executed. This is an indi-
with a particular method.
• linearity vidual definition of requirements
• calibration function (quantitative limits) for the
The analytical purpose of the
statistical results of the tests by
method validation experiments is
Based on the compound type, all the responsible validation person.
to provide a master method with a
or a subset of these criteria must This step must be repeated for
master chromatogram for all con-
be met. Most common compound each new validation and will
secutive separations of this partic-
types are require different limits for each
ular sample. Method validation
• main compound validation experiment. Method
testing must compare results of
• side compound Validation Pack maps this step
multiple runs (it is inter-chromato-
• known impurities with a set of advanced statistical
graphic) in order to answer the
• unknown impurities calculations. The calculations
question “is this method suitable
offer simple summary statistics
for the separation task?” The com-
It is obvious that it is not necessary (RSD, %RSD and linear regression
parison must give a qualitative and
to determine the limit of detection statistics) as well as a set of
quantitative answer to this question
for the main compound as the advanced calculations for outlier
based on the analytical results. A
amount of the main compound will detection, trend tests and many
comparison typically involves a
always be closer to saturation than more. For each criterion, a different
human judgement, so how can a
to limit of detection. A detailed list set of statistical calculations on
comparison provide a user-inde-
of compound types and appropriate the result values is performed
pendent and quantitative result?
test criteria can be found in ICH based on the test requirement. The
This is the most difficult task in
and USP literature. Method administrative user defines the
the method validation process,
Validation Pack uses built-in tem- calculation limits, transferring
because proper execution requires:
plates to automatically analytical requirements into

39
quantitative result criteria. Method Validation Pack — Level 3: compound it allows to define a set
Validation Pack offers tests such Checkpoint planning on page 49) of tests (checkpoints) according
as Neumann trend tests and • Partial execution of validation to ICH, Pharmacopoeia or DIN
Outlier tests (e.g. according to sequences (see ChemStation guidelines. By default each test
Dixon) and many more to provide Plus Method Validation Pack requires results of at least six
and document an assessment of the — Interaction with other repetitive injections in order to use
quality of analytical separations. ChemStation Plus modules statistics for a quantitative result
on page 58) evaluation. In some areas less than
Method validation is an iterative
Validation report six values can be used, but then
process. Through the course of the
• Calculation formula documented some statistical evaluation methods
validation it might turn out that
in the report are omitted. The statistical results
some acceptance criteria need to
• One-page summary report can visualize whether the analytical
be revised or even that the whole
• Optionally color-coded test results meet their specifications or
method of analysis is not suitable
results in the reports show any deviation. When all tests
for solving the analytical problem.
• Manual integration indicator in are passed, the compound meets the
To support this approach Method
the report requirements. When all compounds
Validation Pack allows to generate
• Optional inclusion of audit trail meet the requirements the method
and manage multiple versions of
information in validation reports can be seen as applicable or “vali-
the same validation.
• Development validations carry a dated” according to its well-defined
Step 3 is to construct the overall marker in the report purpose and with the specified
validation report including the (see Working with limits. At this stage, the validation
validation data, results and ChemStation Plus Method can be locked, the full validation is
statistics, graphics and additional Validation Pack — Level 1: printed and the validation study for
information such as required Reporting on page 51) this method can be archived.
standard operating procedures for Export
Method Validation Pack provides
sampling, analysis etc. Method • Export of validation reports in
all required statistical functions
Validation Pack includes a variety pdf-Format (see ChemStation
and calculations, stores all results
of different reporting functions. Plus Method Validation Pack —
with their raw and meta data,
Data Security on page 62) displays the statistical results
What’s New? Administration graphically, and captures all actions
With the latest revision users can • Unlocking of locked validations in automatic user-independent audit-
benefit from new functionality in with an electronic signature trails. Further, it allows to map the
many areas as listed below. (see ChemStation Plus Method key steps in validation experi-
Validation planning Validation Pack — Data ments - planning and definition of
• Solution stability calculations Security on page 65) expected results, experiment exe-
for short-term as well as User documentation cution and result evaluation - as
long-term stability studies • Revised Method Validation Pack separate tasks tied to different
(see ChemStation Method User’s Guide and Online Help user permissions. All steps are
Validation Pack — Checkpoint documented in audit-trails and are
Planning on page 52) Product description fully traceable. Method Validation
• Enhanced handling of selectivity Agilent ChemStation Plus Method Pack is equipped with a fully fea-
data and calculation Validation Pack is a data tured document management sys-
(see ChemStation Method management system for all method tem (DMS), that is used to retain
Validation Pack — Checkpoint validation data. It includes advanced and manage all versions of a vali-
Planning on page 57) statistical calculations and result dation (including all attachments).
Validation execution management in a relational database. The DMS provides a powerful
• Submission of custom validation Method Validation Pack offers a search engine, further complement-
sequences (see Working with compound-centric design. For each ed by the ability to tag validations
ChemStation Plus Method with additional keywords.

40
Agilent ChemStation Plus Method Validation Pack — Work Flow

Configuration
The configuration of validation
experiments is hierarchical (figure
31). The top level represents the
complete validation experiment.
This level may include standard
operating procedures (SOP) for
sampling, sample preparation,
description of quality and grades
of solvents, testing materials, a
description of the analytical method
and so on. Such information can
be directly added as validation
comments or enclosed as document
attachments to the validation.
The next level introduces a
compound-centric view of the
validation in the form of compo- Figure 31
nents. This enables individual Hierarchical structure of a validation
calculations and validations for
each compound or peak in an
analytical separation. For further
structuring the validation, it is even
possible to define multiple compo-
nents for the same compound or
peak (for example if different
matrix effects are investigated).
For each component, additional
sub-levels offer a list of check-
points such as robustness, linearity
and others as defined in the various
regulatory guidelines. The planning
of checkpoints is the lowest level
because each checkpoint can have
a different planning configuration.
Within the planning dialog,
data is configured such as the
determination method, the
applicability of multiple injections,
or multiple determinations for one
result data point as well as the
number of result values and test
specifications such as nominal Figure 32
Options for generation of Method Validation sequence
(expected) values or limits.
ChemStation Plus system. Method method validation sequences
Test execution Validation Pack transfers the theo- (MVS). The user has three options
Having completed the validation retical validation planning into a during sequence generation.
configuration, the experiments list of analytical runs by creating As shown in figure 32 the validation
can be executed on an Agilent one or multiple ChemStation
41
can be transferred into
• a single sequence for the
complete validation
• one sequence per component
• or a set of user-defined
custom sequences.
The custom sequence option allows
to define as many sequences as
required in any combination of the
invididual checkpoints. During the
submission the sequence can be
assigned to a specific owner or
made available to all users.
To minimize the amount of
necessary data and analysis time
some checkpoints can share, if
suitable, the same result data. Figure 33
This function can be enabled in Wizard for multiple usage of checkpoint results
the MVS export options (figure 32).
For the ease of use Method
Validation Pack provides a wizard
that proposes which result data is due to an instrument error base whereas the validation results
suitable for sharing. The user may towards the end, it can be loaded are contained in Method Validation
decide per checkpoint whether or into ChemStation and modified Pack. Traceability of results is
not to share the result data as accordingly. achieved with unique run-IDs in
shown in figure 33. Method ChemStore for each result version.
Validation Pack transfers these The ChemStore run-IDs are also
sequences to the ChemStation for
Result data entry and statistical
calculations transferred and displayed along
data acquisition and data analysis. with the analytical results in the
The sequences can load into an After completion of the analytical Method Validation Pack.
Agilent Method Validation Pack experiments the results can be
ChemStation system and run uploaded from the ChemStore When all result data is imported, the
similar to other sequences in the database into Method Validation validation report can be printed.
Agilent ChemStation. The results Pack. The upload from ChemStore This report displays all data related
of the method validation sequences is an automated direct database to the validation as defined in the
are stored automatically in the data access invoked by the user. top-level validation configuration.
ChemStore database. Each The transfer is executed as This includes the components, their
validation corresponds to a defined in the planning of the planning and result data as well as
separate ChemStore study. If a validation experiments. The data the calculation results, statistical
validation sequence failed it can wizard helps to find and complete data and conclusions, for example,
be resubmitted and rerun. Or if data sections, that require manual “outliers [not] detected” along with
only parts of a validation sequence entries. The analytical results are a graphical representation of the
need to be repeated, for example contained in the ChemStore data- results in charts.

42
Data management and audit- database as a new version of the entry-level system each validation
trails existing validation. All changes is stored in a separate validation
and modifications are documented database on the local hard disk
All configuration and result data either in the program audit-trail (file extension .VDB).
along with the MVS files and vali- (for program related events such
dation reports form the “valida- as logon) or in the validation
tion”. It is stored in a relational audit-trail. In a server-based instal-
database for full data integrity and lation all validation data is stored
to ensure data security. Every vali- in additional Oracle tables of the
dation modification or configura- same database instance as used by
tion change is stored in the DMS the ChemStore database. In the

ChemStation Plus Method Validation — System Requirements

Compatibility with Pack. Method Validation Pack is • 128 MB RAM for single Chem-
ChemStation Plus modules available in a standalone PC-based Station instrument. 256 MB is
version or as full client-server recommended for best perfor-
Agilent ChemStation Plus Method application. The standalone data- mance, for Windows XP the
Validation Pack A.02.01 is base file format adheres to a minimum requirement is 256 MB.
compatible with the following common standard, which is used • 256 MB RAM for two Chem-
ChemStation Plus modules: by many other applications, for Station instruments (512 MB or
example, MS Access. The client- more is recommended for best
• Agilent ChemStation for GC, server version is based on an performance)
LC, A/D, CE, CE/MS and LC/MS Oracle relational database. • Display: 1024 ∞ 768, small
for instrument control and data fonts, 65-thousand col-
analysis ors
• Agilent ChemAccess remote
Hardware requirements
access and module The following list shows the mini-
Method Validation Pack installs and
• Agilent ChemStore data organi- mum hardware requirements for
runs on the same instance of the
zation and data storage module the client application:
Oracle database as ChemStore C/S
and thus does not require a separate
For result management in a rela- • 600-MHz Pentium III (Pentium IV
Oracle licence. For server hard-
tional database, Method Validation recommend)
ware requirements, please refer to
Pack requires the ChemStore data- • 4 GByte of free hard disk space
the server hardware requirements
base or ChemStation Plus Security

43
for ChemStore on page 5. paragraph. versions; changes to one VDB file
Software requirements Client-server installation are stored as a new version, new
VDB files create a new entry in the
• Windows 2000 Professional with The client-server version of
DMS system. The required space
Service Pack 4 or Windows XP Method Validation Pack is based
for an individual VDB file was
Professional Service Pack 1a on an Oracle relational database.
discussed in the previous section.
• Agilent ChemStation revision The application supplies three
A.10.01 or later pre-defined schemes for the data-
Database parameter have been
• Agilent ChemStore C/S B.03.01 base installation: small, medium
chosen for unattended operation;
or higher and large. The databases are
tablespaces and datafiles extend
• Microsoft Internet Explorer 5.5 separated into multiple tablespaces
automatically until their maximum
or later for better performance and
file size has been reached.
• Microsoft data access administration. In particular, the
Nevertheless, you should keep
components (MDAC) 2.8 will be tables storing the validation data
in mind that frequent database
installed on your system. If you (comments can contain large
maintenance and administration is
already use a later version of graphics) and those reserved for
necessary to ensure optimum
MDAC, or require for compati- the document management system
performance and correct and
bility reasons a previous version, (DMS) reside in larger tablespaces,
secure operation (backup tasks,
please contact your Agilent optimized for the management of
size checks etc.). Your database
support representative for BLOB data (binary large objects).
administrator may manually
compatibility information. Table 13 shows the database sizes
expand your database if necessary.
• A printer must be installed and according to the configuration.
There is no known database size
configured in Windows. VDB files are validation data files,
limitation in Method Validation
• The hard disk partition the DMS stores all VDB file
Pack.
that is used for installation of
Method Validation Pack must
be formatted with NTFS. Small Medium Large

VDB data Database MB Database MB Database MB

Hard disk space Initial size 30 Initial size 600 Initial size 1200
Maximal size 300 Maximal size 1200 Maximal size 2400
File growth 15 File growth 30 File growth 60
Standalone installation Comments Comments Comments
Method Validation Pack needs Initial size 100 Initial size 1400 Initial size 2800
approximately 40 MB hard disk Maximal size 700 Maximal size 2800 Maximal size 5600
space for the installation files. The File growth 40 File growth 70 File growth 140
validation database files (VDB) DMS data Database MB Database MB Database MB
typically require 250–1000 KB Initial size 20 Initial size 500 Initial size 2000
each. The exact size strongly Maximal size 200 Maximal size 1000 Maximal size 4000
depends on the size of embedded File growth 5 File growth 25 File growth 100
graphics. If possible, use vector BLOBS BLOBS
Initial size 180 Initial size 4500 Initial size 18000
graphics (WMF-format) rather Maximal size 1800 Maximal size 9000 Maximal size 36000
than bitmap graphics (BMP) to File growth 45 File growth 225 File growth 900
reduce the validation file size.
Table 13
Using large bitmap graphics in Preconfigured database sizes for Method Validation Pack in a client-server
validation comments also has an configuration using an Oracle relational database
impact on the DMS size. Hard disk
requirements for the Oracle data-
base are discussed in the following

44
Working with ChemStation Plus Method Validation Pack

General software operation • report settings (output has an integrated data completion
formats, etc.), and wizard. As long as a checkpoint
• security settings is not complete, the related report
Compatibility with Microsoft cannot be generated and is flagged
functionality Ease of operation incomplete with an invalid-data
Method Validation Pack is a entry in the table of contents.
All important tasks in Method
Microsoft Windows program and The Data Wizard points the user
Validation Pack are accompanied
can be operated via mouse and to all incomplete checkpoints
by wizards to make it easier for
keyboard in accordance with the prompting him for completion.
the novice user to become familar
Microsoft Windows standard. Users Double-clicking it opens the data
with the main tasks.
of Microsoft Windows programs input grids. Input fields with a
should easily become familiar with dark background are locked and
Validation assistant supposed to be automatically
operating Method Validation Pack.
Method Validation Pack comes with populated with data from the
an additional validation assistant ChemStore study. Input fields with
Context menu
that helps to configure and setup normal background color require
When working with Method Method Validation Pack function- manual entries.
Validation Pack, the right mouse ality. An administrator can configure
button opens the context menu the assistant to automatically start
displaying your current program Application structure
after each user logon. In addition,
options. The context menu can ChemStation Plus Method
the wizard can be started inter-
consist of functions concerning Validation Pack translates the
actively at any time. The assistant
a selected component, or the validation requirements into a
helps speeding up the operation of
attributes of a graphic or a report. structured workflow following a
the software, and offers a quick
All functions of the context menu stepwise approach to analytical
and easy way to resume your
are also accessible via the main method validation. It requires the
work. The assistant offers the fol-
menu bar. user to thoroughly configure and
lowing options when started
plan a validation before executing
• Creation of a new Validation
User interface settings the actual experiment. By design it
• Opening an existing Validation
forces the user to separate method
All settings that are changed in the • Opening the last Validation
validation testing into three steps:
menus or tool bars are recorded (per user)
• planning and design,
for the user and saved at the end
• test execution (run samples), and
of a session. They are automatically The validation assistant guides the
• result calculation based on the
loaded during the users next login. user through all configuration and
experimental result data.
planning steps in Method Validation
All of these tasks are managed
Navigation bar Pack. It can be used either to
within ChemStation Plus. All
create a new validation or to add
On the left side of the screen, the ChemStation Plus modules support
a new component to an existing
navigation bar presents the most data security, data integrity and
validation. It is accessible from
important top-level functions of audit-trails for comprehensive
the validation or help menu or via
Method Validation Pack. You can support of FDA's requirements for
the context as described earlier.
use this bar for directly selecting the electronic records and electronic
• program, default validation or signatures (21 CFR Part 11). The
current validation audit Data completion wizard combination of audit-trails in all
• Document Management System Some checkpoint information ChemStation Plus modules with the
(DMS), (such as the concentrations for advanced data security features built
• export dialog, linearity) can only be added after into the relational database offers
• import wizard for templates, data acquisition. It is not available full traceability and complete
• new validation wizard, during checkpoint planning. documentation of all steps during
• planning wizard, Method Validation Pack therefore the method validation experiments.

45
Method Validation Pack • Automatic translation of the 5) Creating the method
validation into one or more validation report
hierarchy
system-generated ChemStation (User level 1)
The Method Validation Pack soft- sequences based on the vali- • After data completion, the
ware structure is strictly hierarchical, dation configuration and method validation report is
divided into five levels. These levels • Submission of the sequence(s) compiled according to the
also correspond to user-access to the ChemStation for data report configuration in step 1
levels. The list below outlines acquisition (style and level of detail, for
the step-by-step execution of the example charts, statistical
method validation experiments details, calculation formula)
After acquisition – the validation
with the hierarchical structure
and the user access levels. report
Figure 34 again illustrates the steps
4) Data completion and result outlined above. All configuration
Before acquisition – creating a calculation (User level 2) and transfer steps are fully auto-
• Review of the data, that was
validation template mated and integrated with the
acquired and stored in the other ChemStation Plus modules.
1) Setup and configuration corresponding study in the
(User levels 5 and 4) All data transfers are automatic
ChemStore database, and documented in audit trails thus
Overall validation planning, • Loading of the result data
definition of program defaults avoiding any accidental transfer or
from the database into the transcription error.
and component configuration Method Validation Pack, and
in the Method Validation Pack • Completing the necessary
software manual entries with the data
completion wizard.
2) Checkpoint planning
(User level 3)
Each checkpoint can use
different calculation methods
depending on the applied
guidelines. The checkpoint
configuration step is either
repeated for each checkpoint
or it is copied from another
component using drag and
drop functionality.

Data acquisition – the validation

experiment
3) Experiment preparation,
data management and
execution (User level 3)
This step consists of: Figure 34
• Creation of new or update of Interaction of ChemStation Plus software modules and their mapping of the
key steps of method validation experiments
existing ChemStore study for
the analytical result data

46
User levels

Top-level (Level 4 and 5):

Validation setup and configu-
ration
Setup
Method Validation Pack organizes
data in method validation databases.
A method validation database is the
top-level container for all data that
relate to one validation. All settings
are linked to one validation data-
base. For new validations the soft-
ware offers a master validation
template that allows building new
validations based on the template.
The following settings or properties
are configured per validation
(figure 35) and can be preconfigured
in a template:
• validation configuration,
• output settings,
• default reporting header data,
• storage of external documents Figure 35
and, Validation properties menu for validation setup and configuration
• storage of method in text format.
For non-Part 11 validations For text elements the output
Validation configuration (“development validation”), the settings define:
The validation configuration user may also specify the audit- • the report title page,
defines the parameters for the level in the configuration. • an additional general report
statistical calculations in the report. comment page,
Each checkpoint offers different Output settings • the report header
calculation options and is config- The method validation output • additional footer text, and
ured individually. For example the settings define the output format • default comments for
user may decide which level of and content of the validation validation planning and
significance should be applied for report. For each checkpoint the validation configuration
the t-values for the t-test as part of extent of statistical information
the selectivity checkpoint (default contained in the report can be In addition, the text configuration
is “5% two-sided”). In addition, the configured separately. For details defines the checkpoint table head-
configuration task defines overall on the checkpoint content, please ers. Each checkpoint can have up
calculations that are common for see the checkpoint section lateron. to ten freely configurable header
all checkpoints. These include Further, output settings define the data items with different user-
outlier tests, trend test, homogeneity decimal precision for the result defined content. The header infor-
tests and systematic error detection. data shown in the report as well mation is used to describe general
Other settings allow specifying the as graphic settings, text elements, validation information that is
minimum sample size for each and whether or not to document the necessary to uniquely identify and
test, handling of zero as input value configuration values in the report characterize the method validation
and handling of missing values. or include audit trail information. experiment. Examples for useful

47
table header are the product individual checkpoint if the actual Store method
name, the analytical equipment, information are different from the Store method allows adding
QS or internal ID number, test preconfigured header data. Using the method as a text file to the
method and others. Default entries default header data speeds up the validation database. The method
for the header data can be defined checkpoint configuration as it must be in file format and can not
when selecting the default header allows skipping multiple data be a folder or anything else that
data button in the validation entries for the checkpoint headers. can not be opened with a standard
properties. Figure 36 shows table One example that might outline editor.
headers and default header data. the usage of default data for the
checkpoint header is the definition Level 4: Component configuration
of the analytical system as check- and checkpoint configuration
point header. The system will
remain the same for all check- The next level under the top-level
points except for the ruggedness is the component level. The
testing where another system component typically relates
from a different vendor might be to a peak (or in ChemStation
used. The user now enters the terminology to a compound) in a
analytical system by default in the separation but it allows having
default header data and applies multiple components for one peak
this to all checkpoints. For the e.g. to perform result comparison
Figure 36
ruggedness checkpoint the default or result copies. Usage of multiple
Default headers (grey) and header data components per peak is mainly
header data for the instrument
will be manually overwritten, for used during method development.
Table headers can only be changed all other checkpoints the default During component configuration
or overwritten by changing the header data are copied and do not the user may specify a unique
complete validation configuration need a manual entry. name for the component along
while the default header data can with the checkpoints that will be
be overwritten for every checkpoint. Storage of external documents executed for this component.
Users can store any external Checkpoints are either created
The graphics section defines the document with the validation. The according to a user selection or
checkpoints that will have graphic document must be available as a can be based on predefined
result visualization in the final file with an extension that allows templates. The templates include:
report. direct read-out and data display. • Complete range (all check
This is particularly useful for points will be selected),
Default (checkpoint) header data adding master methods, sample • Trace method (selecting preci-
This section defines the header preparation and other method sion, calibration function and
data section of the checkpoint related information to the limit of detection/quantification),
report as defined in the output set- validation. During printing all • Trace method with demand
tings. It provides a single entry external documents can be (above plus lab capability)
point for common data for all integrated into the final validation • Non-trace method (precision
checkpoints e.g. the method name report. The storage capability of only), and
or an internal code for the tests. external documents in the method • Non-trace method with demand
All data that are entered as default validation database allows using (above plus lab capability)
reporting header data are copied the Method Validation Pack soft-
to all checkpoint headers. The ware as a container for all method Each component typically
default checkpoint header data validation related data (see also the includes one or multiple check-
can be manually modified for each section on the DMS on page 62). points from the following list:

48
• Precision - used to monitor • Number of samples and y-unit • ChemStation Plus Method
random errors Defines the number of Validation Pack – Planning
• Robustness/Ruggedness independent samples used for In this planning area the user
• Lab capability (mainly used in calculations (Note: By default, configures the ChemStation
non-pharmaceutical applications) minimum number must be six result data type for the check-
• Calibration function and the system will show missing point calculations. For example
• Limit of detection/quantification values either as Zero or as MV for precision data the calculation
• Accuracy in case the configuration allows can be either based on peak area
• Selectivity 0 as valid data input). Each or peak height as determined
• Ring experiment (used to com- sample translates into a by the ChemStation. Additional
pare results among multiple lab- separate sequence line and header information can be
oratories) thus sample vial. imported from ChemStore
• Linearity • Multiple injections or along with the result values.
determinations Available result values are peak
The checkpoint configuration will “Multiple injections” means area, peak height, peak width,
typically depend on the compound repetitive injections from the retention time, and amount.
type, and hardly any component same vial and averaging the For the selectivity checkpoint,
requires execution of all check- results before applying statistics; resolution data is obtained with
points. The system therefore the number of injections can different calculation methods as
requires running the checkpoint vary between 2 and 10. “Multiple provided by the ChemStation
configuration for each component determinations” allow using data (tangent method according
individually. from two or more different vials to USP/EP/ASTM, halfwidth
for the same checkpoint. Number method, sigma method, statistical
Level 3: Checkpoint planning of multiple determinations method). Additional header
allows for values from 2 to 10 information can be:
Each checkpoint must be config-
ured. The configuration defines
the test and calculation methods,
data sources and data types for
x- and y values (e.g. for linearity
x-value is amount in mg/mL and
the y-value is peak height). A typi-
cal planning dialog, in this case for
accuracy is shown in figure 37.
The following sections are
configurable for all checkpoints:
• Headers
These data sections will show
the default data if configured in
the validation properties and
allow individual data entry for
each header line
• Planning data
Selects the calculation method
from a pool of possible calcula-
tions available for this check-
point
Figure 37
Checkpoint planning window (example for accuracy) with sections for check-
point header data, test planning data, number of results y-units and multiple
determination.

49
 • study name, component can be validated in a Level 2: Data input
• method name, separate sequence either on the
After checkpoint configuration
• method text, same or a different instrument,
and planning is completed, users
• instrument name, sequences can be submitted per
can start with the data entry.
• instrument module with component. Method Validation
This is the first step involving
serial numbers, Pack then creates a sequence for
experimental result data and
• run Ids (database Ids), every component.
following the planning phase.
• run Id with version number, Depending on the number of
• run Ids and approval status, compounds and the extent of
Method Validation Pack offers
• run Ids and raw data file validation it might be useful to
three types of data input:
path, and define your own set of validation
1. Automated data upload from
• all custom fields with data sequences. For this purpose the
the ChemStore database. Users
entries. custom sequence submission
select to load study data from
The system allows a maximum of provides the user with the
the ChemStore study created
5 additional header items providing capability to freely combine
for the validation and all data
information from the ChemStore tests into as many sequences as
are automatically imported as
database. required. For this purpose all
configured in the planning
tests are displayed in a tree-like
phase and described in the
After the planning phase is structure, where checkpoints that
previous section
completed the planned validation include several data series are
2. Data import for all result data
procedure can be automatically already divided into separate
that is not created by the
translated into one or more sub-items. The user can choose
ChemStation and managed in
ChemStation sequences. Method from the tree, which tests are to
the ChemStore database e.g.
Validation Pack provides the be combined in a sequence and
data from non-Agilent instru-
ability to submit a sequence submit the sequence. To make it
ments generated during rugged-
• per validation, transparent to the user, which
ness testing. The system comes
• per component, or checkpoints were already
with an import filter function
• as a number of custom submitted, these are immediately
allowing for an automated data
sequences highlighted in green.
import. For details see the
to the ChemStation. separate section on data import
When choosing to create a The number of necessary
below
sequence per validation, the experiments can be further
3. Manual data entry - for all data
software generates a single reduced by the ability to share
that are not created on a
sequence containing all necessary data between checkpoints, for
computer system, e.g. pH
sequence lines to complete all example by using the same data
values, the system allows for a
tests in one sequence. This will set for more that one test, like
manual data entry
be the most suitable and efficient for example reusing linearity data
way in case the method will for the calibration function check-
Data import
not be transferred between point. Data sharing is defined
Data import uses an import assis-
instruments and thus no during sequence submission,
tant, which helps users to import
ruggedness testing is required, where the software automatically
data from external result summary
or if no time-consuming tests are offers all available choices that
files, typically in spreadsheet
involved such as long-term stability. would allow data sharing due to
formats. It imports various file
If a validation is structured per the same data structure.
formats such as CSV, TXT, Microsoft
component in a way that each Excel and any other ASCII formats

50
where the file extension has to be The validation report includes the Both reports can be compiled in
specified if it differs from ASC or following parts: two different styles:
TXT. The import assistant displays • Page header and page • Classic report - standard report
a definition dialog enabling Method footer (Footer includes printed look
Validation Pack to automatically user name, date, page # of # and • Modern report - different
load this summary data to its a signature placeholder for appearance using color-coded
data input grids. The following manual report sign-off.) results (passed/fail)
definitions can be made: • Report title page
• name and description of the • Default comment page Finally the software offers a
import mask, • Table of contents with page concise summary report providing
• source type (file extension) and numbers a one-page summary of the
path, • Checkpoint sections for each complete validation results. It
• field separator (delimiter), checkpoint consisting of header contains only the checkpoint
• row options, data, planning comment, names and the test result (passed/
• data positions allowing to experimental results, graphics fail statements).
exclude header and text data and statistical results, execution
(with optional transposition of comment and revision informa- Report customization
the data), and tion from the document The following elements can be
• column information (X-Y data, management system. configured within the Method
information for multiple injec- • Optional inclusion of the Validation Pack application:
tions and determinations). calculation formula for each • report language: German or
The import settings can be saved checkpoint with a short English,
as import mask and applied at any explanatory text and a complete • report fonts and sizes,
later time to import data. The legend of the variables and • graphics section: line style,
system can handle multiple data symbols. This function is enabled background color for data,
import masks allowing to quickly on a global level via the report color of axis and display of
import results from various data options as part of the program limits, axis annotations, and
sources. options. • text sections: title page,
• validation audit trail (optionally) validation comment page,
Level 1: Reporting • a flag in the footer of the report report header and default
indicating that the validation planning and execution
Method Validation Pack software
was done with a reduced level comment. All text sections can
offers multiple reports. Users can
of audit trail (development vali- also include graphics such as
have
dation, see page 47) company logos.
• planning reports–print all
data from the planning dialog,
Available report styles Method Validation Pack uses a
• graphics report for each
Method Validation Pack offers two Microsoft-Word-based reporting
checkpoint–prints only results
report types: engine. If further customization is
in graphic representation,
• Normal report - standard report required it allows to open the
• complete reports on check-
containing detailed information entire method validation report as
point level, component level,
• Short report - compact report a MS Word document. This allows
and
containing only the most for easy data export of the
• complete validation reports
important sections and omitting complete validation report and easy
with all validation settings and
for example statistical details modification and customization of
all component and checkpoint
the report document.
results.

51
ChemStation Method Validation Pack — Checkpoint Planning

This section lists all checkpoints interval) are entered. For long- • Error of result
with their planning options and a term stability a minimum storage • Trend test according to
short explanation of their meaning. duration as acceptance period is Neumann
additionally specified. Precision • Outlier test according to
Precision can be performed with multiple Dixon/Grubbs
injections as well as multiple • Normality check
Precision describes the extent of
determinations. Figure 38 shows (Sharpiro-Wilk-Test)
conformity between results
the planning dialog for checkpoint • Method standard deviation
obtained during repeated use of a
“precision”. • Mean value
set analytical method under recur-
• Correlation coefficient
rent and comparable conditions.
Planning data
Monitoring the precision records
• Determination method: Robustness/Ruggedness
random errors. Precision can be
• Precision
planned as precision in the true Robustness is defined as the inde-
• System precision from
sense, or as repeatability from pendence of an analytical result
linearity
linearity. In both cases, the nominal from changes in other parameters,
• Stability test
(expected) values of the variation which could influence the result.
• Other data
coefficient can be entered. Further Ruggedness of an analytical
• Number of values ( change
precision can be used to determine method is given if the deviation
default)
the stability according to ICH Q1A of laboratory mean values is not
• Y-units
and Q2B. The purpose of stability significantly different from the
• Multiple injection possible
testing is to provide evidence on deviation of all measured values.
Output settings
how the quality of a substance Ruggedness should show the
• Repeatability limit
varies with time under the influence reliability of an analysis with
• T-value
of a variety of environmental factors respect to the influence of
• Confidence interval
such as temperature, humidity, transferring a method to another
and light, and to establish a re-test
period for the substance and
recommended storage conditions.
Stability according to Q1A is used
for proving long-term stability,
i.e. that an analytical substance
is stable within a given range,
normally for a period of 12-35
months. To do so, a linear regression
is calculated and the extrapolated
regression values as well as the
extrapolated values of the
confidence interval are compared
against the acceptance period.
Stability according to Q2B is used
for proving short-term stability,
i.e. stability of the analytical
substance (typically 24-48 hours).
In both cases the study duration,
the initial value (initial amount or
response of a freshly prepared
standard) and the specification Figure 38
limit in percent (acceptance Planning dialog for checkpoint “Precision”

52
instrument. Sometimes both
terms, robustness and ruggedness,
are used interchangeable. Whether
or not a method is considered as
robust/rugged is distinguished by
the fact that a change of parameters
(method setpoints, environmental
conditions, instrument etc.) within a
reasonable range has no significant
influence on the result. The F-test
and the t-test can be applied as
statistical criteria for the evaluation.
As a measure for ruggedness,
the comparative standard
deviation is calculated and listed.
Figure 39 shows the planning
dialog of the checkpoint
“ruggedness/robustness”.

Planning data
• Determination method: Figure 39
• Comparison of results Planning dialog of checkpoint “Robustness/Ruggedness”
• Comparison with reference
• Other data:
• Number of series ( from 2-50)
• Y-units
• Multiple injections possible
• Nominal value for the standard
deviation

Output settings for calculations

• Comparison of results
• Neumann trend test
• Dixon or Grubbs test for
outliers
• Variance homogeneity
• Repeatability limit
• Reproducibility limit
• Error of result
• Range of confidence
(repeatability conditions)
• Range of confidence
(reproducibility conditions)
• Test for robustness Figure 40
Planning dialog of checkpoint “Lab Capability”
• Comparison with reference
• Apply t-test
• Apply F-test

53
The following results are always Linearity For proportionality the following
calculated for robustness/ entries need to be specified: the
Linearity calculates a linear
ruggedness testing: nominal value d, which describes
regression using the least square
• standard statistics such as mean the maximum deviation of the
error for the model y = a + bx.
value, RSD, repeatbility and one-point calibration from the
Linearity calculations can be
reproducibility along with linear regression, the niveau
carried out for multiple injections
confidence intervals for repeata- specification limit g, which is the
and multiple determinations.
bility and reproducibility, and minimum concentration where
Figure 41 shows the planning
• variance homogenity according the one-point calibration has
dialog of the checkpoint “linearity”.
to Bartlett. to be valid, and the number of
Planning data
measurements to be executed at
• Determination method:
Lab capability the limit g. Calculated parameters
• Regression weighting:
are:
Knowledge of lab capability is unweighted, weighted 1/x,
• Sum of the x- and y values
necessary for accurate estimates of weighted 1/x2 or
• Slope
process capability (see DIN 55350 • Proportionality ( test for
• y-intercept
parts 33 and 11). Lab capability is validity of one point
• Linear equation
not required by the FDA nor ICH. calibrations)
• Residual standard deviation
It checks for the ratio of result • Other data:
• Absolute method standard
dispersion versus specifications. • Number of levels
deviation
Lab capability occupies a special • Y-units
• Relative method standard
position among Validation concepts • Multiple injections possible
deviation
because it does not exclusively • Multiple determinations
• Confidence interval of the slope
refer to the analytical method. possible
and y-intercept
Figure 40 shows the planning Output settings for calculations
• Coefficient of correlation (r)
dialog of checkpoint “linearity” • Residual standard deviation
• Method standard deviation • Coefficient of determination (r2)
Planning data
• Number of samples
• Y-units
• Lower specification
• Upper specification
• Calculation of Xb, where Xb is
the reference value (expected
analytical result value)
• Multiple injections possible

Output settings for calculations

No output settings can be
configured by the user. For lab
capability, the lab capability index
Cm and lab performance index
Pm are determined, as well as the
corrected values Cmk and Pmk.
The result includes all indices
along with the specification limits
and a judgement if lab capability
is low, medium or high.
Figure 41
Planning dialog of checkpoint “Linearity”

54
 is higher than the detection limit. a calculation of LOD and LOQ
Calibration function The relative error of results based on the standard deviation of
is requied to calculate the the signal and the calibration curve
The calibration function is the
quantitation limit. Both the d (slope). This is referred to as
correlation between the expected
etection limit and the quantitation “according to ICH” in the planning
value of the test characteristic,
limit can be calculated by the dialog. Finally LOD and LOQ
e.g. the UV absorbance (see DIN
standard deviation of blank values can be determined by “visual
55350 part 13), and the content,
(blank value method) or the inspection” based on the signal-to-
e.g. a concentration. The user can
residual standard deviation of noise-ratio. In this case no
specify the maximum degree of
regression data (calibration curve calculations are performed and
curve fit for the calibration curve.
method). Only one of the two the chromatogram is attached to
1st order is standard and 3rd order
methods may be suitable for the validation as a bitmap (BMP
is the maximum (cubic curve).
practical purposes. Both methods, format) or windows meta file
Figure 42 shows the planning dialog
however, are almost equal with (WMF format) and included in
of the checkpoint “calibration
respect to the detection limit. The the overall report. Figure 43 shows
function”
calibration curve method is suited the planning dialog of the check-
Planning data
to determine the quantitation limit. point “limit of detection/quantifi-
• Number of levels
For this method the concentration cation”
• Unit of values
and the slope values need to be Planning data
• Curve fit display 1-3
entered during data entry. If the • Determination method:
• Multiple injections possible
blank value method is chosen, the • Blank value method
• Multiple determinations
user must enter or import the according ICH
possible
measured values and the value of • Calibration line method
the slope of the calibration function. according to ICH
Output settings for calculations
Further the ICH-guideline describes • ICH method
• Vector y=ax+b - curve equation
in the case of linearity
• Square sum of the residuals
(only calibration function)
• Residual standard deviation
• Mean value and standard
deviation of y
• Multiple correlation coefficient
• Results of F- and t-tests
• Method standard deviation

Limit of detection and limit of

quantitation
The detection limit (LOD) is the
smallest amount of substance that
can be detected qualitatively
during one analysis with a defined
statistical certainty. The quantitation
limit (LOQ) is the smallest amount
of a substance that can be detected
quantitatively during one analysis Figure 42
with a statistical certainty to be Planning dialog of checkpoint “Calibration Function”
determined. The quantitation limit

55
 • Signal/noise ratio according
to ICH
• Other data
• Nominal values for the
detection limit d and
quantitation limit q
• Number of samples
• Y-units
• Multiple injections possible

Output settings for calculations

• Standard deviation
• Procedure standard deviation
• Critical value yk
• Residual standard deviation
(additional for calibration curve
method)

Accuracy
Accuracy is a qualitative
measure describing the extent
Figure 43
of correspondence between Planning dialog of checkpoint “Limit of Detection/Quantification”
the expected value and the
conventional value. Accuracy is
influenced by systematic errors.
The systematic error is divided
into a constant systematic error
and a proportional systematic error.
A constant systematic error is not
influenced by the concentration of
the substance to be determined. If
the error is influenced by the
concentration, it is a proportional
systematic error. A qualitative
measure for accuracy of a result is
its systematic deviation. Figure 44
shows the planning dialog of the
checkpoint “accuracy”. Method
Validation Pack provides a set of
different determination methods,
some involving a comparison with a
second method. The standard addition
method is used in trace analysis and
determines the matrix influence. The
extended spiking method allows
constant and proportional systematic Figure 44
errors to be determined, even when Planning dialog for checkpoint “Accuracy”
there are no samples with known

56
content. It is suitable for • Recovery point “selectivity”. The selectivity
analytical methods which consist of • Standard deviation for a, b is determined from the resolution
weighing, diluting and measuring • Residual standard deviation values calculated by the
steps. For the recovery method • Method standard deviation ChemStation. Available calculation
linearity must be given for a number • Test quantities ta and tb methods are tangent (according
of samples with different content. • t-distribution to USP, EP and ASTM), sigma,
A nominal value for the variation • Method comparison halfwidth and statistical.
coefficient VC can be entered for • comparison of mean values
method comparison and for accuracy Planning data
by recovery. Selectivity/Specificity • Number of values
• Y-units
Selectivity means that an analytical
Planning data • Nominal value for the
method can distinguish the
• Determination method: resolution R
substance to be determined from
• Comparison with nominal • Add chromatogram bitmap
other substances in the sample.
value µ for the t-test • Multiple injections possible
Specificity is a synonym for selec-
• Method comparison with tivity, selectivity in chromatography
joined samples (two sample Output settings
describes the separation capability
sets determined with two All available data including the
of the chromatographic system for
different methods) obtained resolution values are
two components. Figure 45 shows
• Method comparison with a shown.
the planning dialog of the check-
validated method (according
to ICH)
• Standard addition
• Extended spiking method
• Recovery
• Accuracy by recovery
(according to ICH)
• Other data:
• Number of samples
• Y-units
• Multiple injections possible

Output settings for calculations

• General:
Result t-Test
• Joined samples:
• Difference of value pairs
• Mean value and standard
deviation of differences
• Nominal value comparison:
• Result of Wilcoxon test Figure 45
(additional for nominal value Planning dialog of checkpoint “Selectivity”
comparison)
• Extended spiking method:
• Test quantity for a and b
• Threshold quantity t division
• Standard additional method:
• Result F-test
• Result t-test

57
Ring experiment
Ring experiments are used to
prove that a method can be
successfully transferred to an
entirely different location (other
site, company etc.) and that it
delivers appropriate results. A ring
experiment can be seen as a more
general ruggedness test. Figure 46
shows the planning dialog of the
checkpoint “Ring experiment”.

Planning data
• Number of rows ( one row for
one lab)
• Y-units
• Checkmark for same number of
values per lab
• Multiple injections possible
Figure 46
Output settings Planning dialog of checkpoint “Ring Experiment”.
• Neumann trend test
• Dixon or Grubbs test for • Error of result All output settings are preconfigured
outliers • Range of confidence during installation to useful defaults.
• Variance homogeneity (repeatability conditions) As long as you do not have the
• Repeatability limit • Range of confidence need to enable special settings,
• Reproducibility limit (reproducibility conditions) there is no need to change anything.

ChemStation Plus Method Validation Pack — Interaction with other ChemStation

Plus modules

As described in previous sections tion sequences. It includes two method validation sequence import
Method Validation Pack interacts additional Method Validation menu menu. The import window displays
with ChemStation for data acquisi- items in the ChemStore menu a list of all pending method
tion and ChemStore for result and (figure 47), as well as new buttons validation sequences (MVS files)
data management. in the graphical user interface. The the user should have access to.
first button switches ChemStation The list includes status information
Interaction with ChemStation into method validation mode and and user assignment of the MVS
for data acquisition back to the standard mode. The files. In a client-server installation
second button opens the sequence the list of method validation
If Method Validation Pack is import dialog. sequences is accessible from any
installed in a ChemStation Plus ChemStation in the cluster that has
data system ChemStation will If method validation mode is Method Validation Pack installed.
offer additional functionality to enabled, the user has access to the This means that validation planning
run and execute method valida-

58
and data acquistion do not need to sequence template is stored as a robustness testing. A convenient
be done on the same system. Users text document with the validation way to quickly fill in the method
can now select the MVS files they in the Document Management name is the sequence filldown
want to download from the list of System (DMS) of the Method wizard of the ChemStation.
pending files. An MVS file has an Validation Pack software. Each Additional information is stored
assignment to one specific user or injection translates into one line in protected custom fields. This
it has no user assignment and is in the sequence table; repetitive information displays the check-
thereby an all-user job for all injections of the same sample point name, the component name
users with a valid logon an the receive only one sequence line but and a unique run-ID for easy
appropriate access privileges to write the number of injections in identification in the sample
Method Validation Pack. As soon the related sequence column. The information text dialog. These
as a user has loaded a pending MVS files automatically include fields can only be configured and
validation sequence for execution information on the sample type, edited by the Method Validation
in the ChemStation, it is blocked number of injections and sample Pack software.
for other users. Before running name. The sample name references
the sequence the user can add the related checkpoint, the sample To run MVS sequences the opera-
additional sequences lines, for comment contains more detailed tor only fills in the vial position
example calibration runs, blank information. By default the method for the samples and starts the
runs or system suitability checks. name in the method column of the sequence. For further details on
Partially completed MVS sequences sequence table is populated with ChemStation functionality, please
can be set to Finalize which skips the validation name. It will have to refer to ChemStation specifica-
the remaining acquisition runs and be replaced with the real name - tions, Agilent Technologies publi-
deletes the file from the list of especially when several methods cation number 5988-5314EN.
pending MVS files. The missing are required, for example during
runs can be executed at a later
point in time by submitted them
again in a custom sequence.
Alternatively partially executed
and not finalized MVS sequences
can be reloaded and re-run after
the already executed sequence
lines have been manually deleted.
Finalizing a MVS sequence will also
lock the validation and prevent
it from further modification.
A validation can only be unlocked
by an authorized user and requires
an electronic signature.

MVS sequences are created with a

specific command (Create Study
and MVS for ChemStation Plus)
in the Method Validation Pack
software. They are automatically
built according to the validation
configuration in the Method
Figure 47
Validation Pack software - no user Additional Method Validation menu item in the Data Acquisition ChemStation
interaction is required. The MVS software module

59
Agilent ChemStation Plus Method Validation Pack — Interaction with other
ChemStation Plus modules

Data management • MV_runID - storing a unique base and the change is document-
run identifier that allows full ed in the run-related audit trail.
ChemStore manages the analytical traceability from method
results along with the raw and meta validation pack results to The user decides if the validation
data of the samples in a relational ChemStation Plus result man- is a development validation or a
database. This also includes all agement. This is particularly final validation that must run under
analytical data of the method useful for example, if you full 21 CFR Part 11 conditions.
validation sequences that have notice outliers in your method In the former case, users with
been acquired in the ChemStation. validation. In order to check the administrative rights can configure
The method validation data are integration and decide whether the level of audit trail for the
stored in method validation-specific to reanalyze this run, you only validation and the study settings
studies. Method validation studies have to query for the run-ID of the ChemStore study. This is
are similar to standard ChemStore to immediately obtain the run done within the Method Validation
studies except that they can only be that is under investigation with Pack and is similar to the study
created and modified through the its result. configuration in ChemStore. They
Method Validation Pack software. can select to
All method validation study data Data review • Save raw data with results
are visible in ChemStore, but they • Delete raw data on the local
A first pass review of the data is
can not be changed or modified hard disk after transfer to the
done in the ChemStore review
except for reanalysis. As part of database
client. Here the user can inspect
the data transfer from Method • Save method and sequence
the results and the quality of the
Validation Pack to ChemStation the along with results
integration. The graphical result
Method Validation Pack software • Save chromatogram and spectra
review such as inspecting the
creates and, when revising data, pictures with the result
baseline of the chromatogram or
updates a method validation study zooming in to check the integration
in ChemStore. The study name In a 21 CFR Part 11 validation, all
is done in the chromatogram view
corresponds to the validation name. these functions are enabled for
of the review client. If any rework
It is recommended to use short the data management options and
is required the data can be sub-
validation names as a study name cannot be disabled. The validation
mitted to the ChemStation batch
is limited to 12 characters. Method report includes a marker which
review user interface for graphical
Validation studies have three clearly indicates whether the
rework and data reanalysis as
custom fields automatically validation was a carried out unter
described in the section Agilent
configured with the studies. These 21 CFR Part 11 conditions or,
ChemStation Plus Security Pack -
fields are under less stringent conditions,
Graphical Result Review and
• MV_checkpoint - storing the as a development validation.
Calculation. These steps generate
Method Validation Pack check If the decision was made to run a
a new result version that is then
point information (which test validation in development status
used for the validation instead of
was used with this run) in order to reduce the amount of
the initial version. If a result was
• MV_component - the name of information stored in the database
obtained by applying manual inte-
the Method Validation Pack and logged in audit trails, this
gration events it will be marked as
component in the validation - decision cannot be revised at
such in the validation report. The
comparable to the ChemStation a later stage. A development
result is transferred to the data-
Plus compound. validation cannot be promoted
to a 21 CFR Part 11 validation.

60
ChemStation Plus Method Validation Pack — User Management and Access Rights

Based on the hierarchical struc- The user levels are part of the
ture of the Method Validation ChemStation Plus user administra-
Pack software, the system has five tion as shown in figure 48. They
user levels. They are: are centrally configured and
administered in the ChemStore
1) Reporting: Logging into the database. All users have two
system with a name and a pass- identification components, user ID
word of level 1 (reporting) gives and password. One user ID is valid
the user access to report output for all ChemStation Plus modules,
only. At this level, data changes so a user only has to remember
are impossible. one password for all tasks he is
2) Data input: Logging into the assigned to in ChemStation Plus.
system with a name and a pass-
word of level 2 (data input)
gives the user access to all level 1
tasks and validation data input
(loading study data, manual input,
import) and the configuration
of the graphics/report output.
3) Planning: Logging into the
system with a name and a pass-
word of level 3 (planning) gives
the user access to all level 1
and level 2 tasks plus checkpoint
planning.
4) Configuration: level 4
(configuration) gives the user
access to configuration rights
and all level 1-3 tasks. The user
may change the configuration
on a validation level only.
5) Administration: Logging into
the system with a name and a
password of administrator
level 5 gives the user access Figure 48
to all functions of Method Central user administration for ChemStation Plus including Method Validation
Pack user administration and user levels
Validation Pack including the
program configuration (global
settings such as the default
validation settings for new vali-
dations).

61
Agilent ChemStation Plus Method Validation Pack — Data Security

User authorization • MVS section for method for review. All DMS entries are
validation sequences—all displayed in a hierarchical list.
As mentioned under “User
ChemStation method validation Entries can be selected to view all
management”, only users with a
sequences that have been created properties which are displayed on
valid ChemStation Plus user ID
from the validation database. the right window pane of the DMS.
and password can log on to the
• DOC section for reports—all Additional information that is
Method Validation Pack software.
reports are stored as doc files stored with each revision includes:
The user management includes a
that have been printed for the • name of entry,
password policy for regular pass-
validation database. • original path,
word renewal and user account
• PDF section for reports in pdf- • label,
lockout after a specified number of
format—all reports exported in • purpose of entry (manual
unsuccessful password entries. For
pdf-format for this validation revision, automatic revision),
details, please refer to ChemStation
are stored in this section. • version,
Plus Security Pack specifications.
• document type,
Each section offers a full • size,
Document management system revisioning of the data. Whenever • checksum,
Method Validation Pack comes a new entry in the DMS is made, • status (normal, checked-out
with a fully featured document a new revision is created. The and finalized),
management system (DMS) storing revision is uniquely identified • login of user, user domain and
all data in a relational Oracle through continuous version user computer,
database. For standalone systems, numbers, the timestamp of creation • real name of user (display name),
all data are stored in a VDB file, along with the user name, the • reason for check-in,
a database file that adheres to a database name and the PC host • check-in date, and
common file format as used by MS name. Each revision of each file • date of parent entry (i.e. base
Access. The DMS is automatically can be recreated and reopened node entry).
started with Method Validation
Pack and runs in the background.
It is used to store and maintain
validation data by providing full
versioning of validations and
storage of all important related
data such as configuration and
planning information, document
attachments, copies of reports and
validation sequences that were
generated for full traceability. It
stores all data under the validation
name as the highest hierarchical
element called “document”. It is
subdivided into four subsections
as shown in figure 49:
• VDB section for validation data
base—all data from planning,
configuration, setup and Figure 49
analytical results. Method Validation Pack document management system DMS

62
A click in the checkbox of a
section offers review of any
document revision. Clicking a
version child node once displays Figure 50
Selection dropdown window for database connection
its properties. Double-clicking a
validation (VDB-file), or clicking
on its selection field, will restore selects the validation from the list folder permissions. It offers write-
the selected version. Documents with a simple click on the actual only access to all authenticated
and MVS files can be displayed in validation. If users open older users and only an administrative
a review window, allowing to revisions of a validation the user has full access to the DMS
zoom, print, export or copy the validation is opened in a locked directory. Understanding and using
selected document. The actions status as read-only. Only saving it file security is particularly important
depend on the type of entry: docu- as the latest revision removes the in standalone installations where
ments are displayed in a review read-only lock. all data is stored in the local data-
window, validations are stored in base. In a client-server installation,
the file system. File security for the standalone the default storage location should
database be the Oracle database that is stored
DMS with standalone systems on a separate server and that is not
Standalone systems will typically The local validation database must accessible to any software operator.
require managing multiple data- be protected from unauthorized
bases. The system will prompt the access for example through
Explorer or MS-DOS. Method
Permanent display of current
user to create a new DMS database user
file after the size limit of 800 MB Validation Pack software uses file
is exceeded. A DMS or validation security settings to protect the Method Validation Pack always
that has passed its size limit can database file. All Method Validation displays the current user in the
still be selected for review. If the Pack data is stored under the title bar. The system displays the
system has more than one DMS Method Validation Pack root current user name and the database
database, the user is automatically directory on the PC hard drive. information. The database is either
connected to the current DMS as The Document Management displayed as local login for a
shown in figure 50. If there is a System is located in a separate standalone database connection or
need to review old data the user subfolder of the Method Validation as the Oracle database alias if the
has to select the DMS database Pack program directory. The folder system is connected to an Oracle
from the dropdown list of available name is DMS. This folder is database, as shown in figure 51.
database to connect to it. The DMS protected with Windows file and
databases are sorted and named
by date.

DMS for client/server systems

Client/Server system using an Oracle
relational database will store all
validations in the same database.
A list of all available validations Figure 51
displays when selecting to open Permanent display of current user name, and database connection with
an existing validation. The user Method Validation Pack software

63
Agilent ChemStation Plus Method Validation Pack — Audit trails and change
documentation

Audit-trails
The Method Validation Pack audit-
trail tracks all actions that users
execute during program operation.
The audit-trail is user-independent,
can not be modified nor deleted and
it is completely system-generated.
Method Validation Pack has three
different audit-trail levels, as
Figure 52
shown in figure 52: Three levels of audit-trail with Method Validation Pack software
• program audit-trail,
• default validation audit-trail,
and
• validation audit-trail.

The default display size of the

audit-trail can be configured in the
audit-trail window. The number of
entries for display must be between
25 and 30000. All audit trails can be
printed to a printer. The validation
audit trail can also be included in
the overall validation report. This
is a global setting and has to be
enabled for generating the report.

For easier searching through the

audit trail, users can group the
audit-trail entries. All audit-trail
column headers are available as
grouping criteria. The grouping
functionality uses a simple drag-
Figure 53
and-drop functionality to enable Grouping of audit-trails, in this example grouped by user
or disable grouping. The user only
drags the column header into the
grouping section and receives a Audit-trail details • Level of action (e.g. level 4 for
sorting of the complete audit-trail configuration changes)
The validation and default validation
according to the column entries. • Status of the change ( saved
audit-trails display all actions that
As an example, the audit-trail or unsaved
are related to a validation or the
should be arranged by user name. • Affected component
default validation template which
The system displays all user name • Modified checkpoint
is applied when creating new
entries as parent nodes. A simple • Action (the audit-trail lists the
validations.
click on the node expands the menu if the user did only open
audit trail to now display all audit- the menu without changes and
Both audit-trails offer the following
trail entries for the selected user it lists any parameter change
information where each item dis-
as shown in figure 53. with the old and the new value)
plays its data in a separate column:
• Display name of the signer and
• Date and time of action
signature comment
• Printed user name

64
The program audit trail will be Validation locking and DMS system. Only users with an
described in more detail in the electronic signatures access level 3 (planning) or
following section. higher have access to the locking
After completion of a single check- functionality. Each locking action
point, an entire component or a requires an electronic signature.
Default validation audit-trail complete validation, a validation The electronic signature uses the
The default validation audit-trail can be locked to the same extent password/ user ID combination as
refers to the general configuration to prevent further modification. defined by the FDA (figure 54).
of validations. It covers all To avoid locking of incomplete The sign-off dialog comes with a
changes that are not related to a items, the application software time limit of 45 seconds. If the
specific validation database but will display a warning message signature was not executed during
apply to the validation template and close the lock dialog without this period, the dialog will close
that all new validations are based changes if the locking procedure and the validation status remains
on upon creation. These settings was not completed by giving an unchanged.
are new validation properties and electronic signature. If an item was locked by mistake
new validation output settings. Partial validation locking allows or has to be modified due to late
Changes to these settings are locking a single checkpoint or a changes in the test specifications
displayed in the default validation complete component. After locking the lock status can be removed by
audit-trail. the item, no changes are possible a user with sufficient privileges
to this particular item anymore, (level 3 or higher). For unlocking
Validation audit-trail unless it is explicitely unlocked. It a validation, component or
The Validation audit-trail tracks all is in a review-only mode allowing checkpoint the same procedure is
actions on the actual validation. only printing reports and reviewing followed as for locking. The user
the graphics. Every locking action has to give an electronic signature
automatically creates a new
Program audit-trail to initiate unlocking.
revision of the validation in the
The program audit-trail is designed
to track all actions that relate to
the general program operation
such as save and logon actions.
The program audit-trail table
items are:
• Date and time
• User ID
• Validation name
• Storage location of the actual
validation snapshot copy
• Action (Program start and stop,
user logon and logoff, IQ
execution, validation opening,
use of import mask for data
entry, and program options)

Figure 54
Executing electronic signatures with Method Validation Pack

65
Agilent ChemStation Plus Method Validation Pack — Installation

Prerequisites Non-Agilent software Client-server installation

• MDAC 2.8 (Microsoft Data
Method Validation Pack can The client-server installation must
Access Components 2.8)
operate both PC-based in a include for the server
(installed by ChemStore)
standalone installation or in a • installation of Oracle 9i server
• Adobe Acrobat Reader 5.0 (part
networked system installation with software (version 9.2.0.3.0) ,
of standard bundle)
full client-server functionality. In • installation of ChemStore
• Microsoft Internet Explorer 6.0
both scenarios, some prerequisites server software,
must be met: • creation of the Oracle database
The Microsoft Data Access
• installation of Method
Components install a layer to
Validation Pack software, and
Software access local databases or central
• creation of Method Validation
ChemStation Plus standalone – database servers. Method
Pack tablespaces in ChemStore
For a fully integrated installation Validation Pack uses Microsoft
Oracle instance (alias “HPCS”)
of Method Validation Pack it is JET database to save local data
required to have the following (i.e. Microsoft Access format).
On every client the procedure
software installed: Adobe Acrobat Reader 5.0 is
includes the installation of
• ChemStore standalone rev. required to display the online
• Oracle 9i client software ver-
B.03.01 or higher or Security manual.
sion 9.2.0.3.0
Pack rev. B.03.01 or higher and • ChemStation software for data
• Agilent ChemStation for GC, Standalone installation acquisition
LC, A/D, CE, CE-MS and LC-MS • ChemStore or Security Pack
The standalone installation is
rev. A.10.01 or higher for data software for data management
user installable from the Method
acquisition • Method Validation Pack software
Validation Pack (rev. A02.01 or
higher) software CD-ROM. All
ChemStation Plus Please note that Method Validation
other ChemStation Plus modules
If the system should operate in Pack software does not necessarily
as outlined above are also user
client-server mode, ChemStore need to be installed on every client
installable for advanced users.
with Oracle 9i (version 9.2.0.3.0) in a client-server system. If method
However, Agilent recommends the
must be installed on the system. validation is carried out on a subset
installation of the ChemStation
In the client-server installation, all of all networked ChemStation
Plus modules through an Agilent-
ChemStation Plus modules can Plus clients, only those clients
certified service engineer to
operate from different PCs. participating in the process of
prevent from any potential
Their installation is completely validating analytical methods
installation problems and for
independent and the system is must have the software installed.
inclusion of software familiarization
fully functional as long as all
upon installation.
required modules (see above) are Agilent offers the complete portfolio
installed within this cluster and of installation, validation and
they can connect with each other. training through its project services
organization. This will be handled
as one project where the complete
service delivery is managed
centrally based on the individual
customer requirements.

66
ChemStation Plus Method Validation Pack — Product Options and Configurations

Standalone version Description Product No.

The standalone version of Method ChemStation Plus Method Validation Pack G2184AA
Validation Pack requires the Requires but does not include ChemStore C/S or Security Pack. Allows
additional installation of the for method validation according to DIN/ICH/USP and EP guidelines.
ChemStation for data acquisition Supports 21 CFR Part 11(only in conjunction with ChemStation Plus Security Pack).
and the ChemStation Plus database Software module to add Agilent ChemStore C/S to an existing G2181BA
module for data management of ChemStation for GC, LC, LC/MSD, CE or A/D.
analytical data. The database can
be ordered as G2181BA ChemStore ChemStation Plus Security Pack. G2183AA
Adds the secure ChemStore C/S relational database add-on software
database or as G2183AA Security module to the ChemStation Plus SW for A/D, GC, CE, LC and CE/LC-MSD.
Pack for full support of 21 CFR Supports 21 CFR Part 11.
Part 11. The installation only
requires one of these products.

Client/server version Description Product No.

Method Validation Pack ChemStation Plus Method Validation Pack G2184AA
client/server installation runs on Requires but does not include ChemStore C/S or Security Pack. Allows Oty: number of method
Oracle 9i Rev. 9.2.0.3.0. A complete for method validation according to DIN/ICH/USP and EP guidelines. validation systems in
system configuration requires Supports 21 CFR Part 11. ChemStation Plus C/S
Must have one copy of G2186BA or G2181BA per PC running Method networked data
ChemStore C/S server software Validation Pack software. For full support of 21 CFR part 11 replace systems
(G1410A) for each server plus G2181BA with G2183AA per server
Agilent NDS Oracle user licenses NOTE: The number of Method Validation clients can be smaller than
(G1411A) for each named database the number of ChemStation plus clients in case method validation
will only execute on a subset of all networked ChemStation Plus clients
user, one full use copy of the
ChemStore client software (G2181BA) ChemStore C/S server application software G1410A
and a ChemStation Plus client Includes ChemStore C/S server software, Oracle 8i standard edition Qty: one per server
license (G2186BA) for each software, 5 Oracle application-specific named user licenses
connected client as well as Oracle named user license for Agilent NDS G1411A
copies of G2184AA for all Method Required for each named user of the ChemStore C/S Qty: (Required for each
Validation Pack clients. For full server database named user in the
support of FDA's 21 CFR Part 11, ChemStation Plus
networked data
replace G2181BA with G2183AA. system) -5
Agilent provides all Agilent
ChemStation Plus software and ChemStore C/S client application software G2181BA
Oracle 9i software on Agilent Software module to add Agilent ChemStore C/S to an existing Qty: one per server
ChemStation for GC, LC, LC/MSD, CE, CE/MSD or A/D.
CD-Rom media.
ChemStation Plus ChemStore client license G2186BA
Includes one online ChemStation Plus license for online data acquisition Oty: Number of clients
and one ChemStore C/S offline data review license. Includes -1
license and user information only. Requires but does not include
ChemStation Plus software client media.

ChemStation Plus Security Pack. G2183AA

Adds the secure ChemStore C/S relational database add-on software Qty: one per server
module to the ChemStation Plus software for A/D, GC, CE, LC and Replaces G2181BA
CE/LC-MSD. Supports 21 CFR Part 11.

67
Installation, Qualification Services and Training

Installation and familiarization Training

Agilent Technologies’ installation Agilent’s ISO-registered trainings
and familiarization service ensures can save you time, help keep your
that the Agilent ChemStation Plus laboratory operating costs low,
is installed correctly and in the broaden your capabilities, and
right environment. ensure that your laboratory
complies fully with regulatory
In addition, Agilent offers a range and quality requirements.
of on-going support services to For your convenience, standardized
help: courses are offered in selected
• get your system up and running locations worldwide. Onsite
fast, courses can be tailored to your
• resolve problems quickly, specific needs.
• keep productivity high,
• extend instrument life, and
• comply with regulatory quality
requirements.

Qualification services
• Agilent Technologies offers a www.agilent.com/chem/cds
full range of qualification
services to provide the evidence
you need to satisfy the
requirements from agencies The information in this publication is subject to
such as the U.S. Food and change without notice.
Drug Administration (FDA), the
U.S Environmental Protection Microsoft®, and Microsoft Windows® are U.S.
registered trademarks of Microsoft Corp.
Agency (EPA), the International
MDS™ is a trademark of RSA Data Security, Inc.
Standardization Organization Oracle® is a U.S. registered trademark of Oracle
(ISO), and the Organization for Corp.
Economic Cooperation and
Development (OECD).
© Copyright 1999-2004 Agilent Technologies Inc.
• Installation qualification (IQ)
service All Rights Reserved. Reproduction, adaptation or
• Operational qualification/ translation without prior written permission is
performance verification prohibited, except as allowed under
(OQ/PV) service the copyright laws.

Published in Germany, July 1, 2004

Publication Number 5989-1390EN
 Design Qualification (DQ) Phase 2
Compliance

Compliance

Agilent has been a worldwide Compliance leader for two decades. The
unmatched experience of our experts goes into each of our compliance
services. Agilent can provide you with the compliance tools, knowledge,
service and support necessary to keep your lab operatiing smoothly and
efficiently. For an overview refer to the brochure "
Can you take the heat - Don´t get burned by compliance", see “Agilent´s line of
proven qualification products and services” in Chapter 1, “Overview”.

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Customer contributed documents

Customer contributed documents

Agilent 1200 Series Qualification Workbook

2 Design Qualification (DQ) Phase
Customer contributed documents

Agilent 1200 Series Qualification Workbook

Agilent 1200 Agilent 1200 Series
Qualification Workbook

3
Installation Qualification (IQ) Phase
Side Preparation Specification Checklist
Agilent 1200 Series Liquid Chromatograph Hardware Site Preparation
Specification
Agilent 1200 Series LC/MSD G1956A/B, G2908BA, G3218AA,
G3218BA Site Preparation Specification
Agilent ChemStation Software Modules G2070BA, G2071BA,
G2072BA, G2170BA, G2171BA, G2180BA Software Site Preparation
Specification B.02.01
Agilent ChemStation Software Modules G2070BA, G2071BA,
G2072BA, G2073BA, G2170BA, G2171BA, G2180BA, G2090BA,
G2710BA, G1601BA, G2201BA B.02.01 Upgrade Site Preparation
Checklist
Installation Qualification
Agilent 1200 Series Liquid Chromatograph Hardware and Software
Installation Checklist
Agilent LC and CE ChemStation Software G2170BA, G2171BA,
G2175BA, G2180BA, G2185BA,G211601BA, G2172BA, G2205BA
Software Installation Checklist B.02.0x
Familiarization Checklist
Agilent 1200 Series Liquid Chromatograph Famliarization Checklist
Agilent 1200 Series Liquid Chromatograph Scorp of Work Installation
and Famliarization
Declaration of Conformity and System Validation
Declaration of Conformity According to ISO/IEC Guide 22 and
CEN/CENELEC EN 45014
Declaration of Conformity to mannufacturing Specifications
ChemStation Declaration of System Validation
ChemStation Installation Verification Report
Customer contributed documents

Agilent Technologies
3 Installation Qualification (IQ) Phase

For the items marked with a * example pages are added. It is the
responsibility of the user to replace these with the originals. The user should
feel free to add further documents, e.g. not supplied by Agilent Technologies
whenever he thinks this is appropriate.

Agilent 1200 Series Qualification Workbook

 Installation Qualification (IQ) Phase 3
Side Preparation Specification Checklist

Side Preparation Specification Checklist

Agilent 1200 Series Qualification Workbook

3 Installation Qualification (IQ) Phase
Side Preparation Specification Checklist

Agilent 1200 Series Liquid Chromatograph Hardware Site

Preparation Specification

Agilent 1200 Series Qualification Workbook

Agilent 1200 Series
Liquid Chromatograph

Hardware Site Preparation Specification

Purpose of Procedure
Your site must meet this specification or set of requirements to assure a successful and timely installation of your Agilent
instrumentation. This document is designed to prevent delays during installation, familiarization, and the initial use of the system in
your application. This document outlines the supplies, consumables, space and utility requirements for a 1200 LC. It also
recommends tools and consumables that may help you get started. Use this document along with the 1200 Installation
documentation and Consumable Catalog. This information is also available from Agilent Technologies, Inc.’s website
(http://www.agilent.com).

Customer Responsibilities
Make sure your site meets this specification, including: the necessary space, electric outlets, gases, tubing, operating supplies,
consumables and other usage dependent items such as columns, vials, syringes and solvents (HPLC Grade Isopropanol, Acetonitrile
and water) required for the successful installation of instruments and systems. If Agilent is delivering installation and
familiarization services, users of the instrument should be present throughout these services; otherwise, they will miss important
operational, maintenance and safety information.

Important Information
If you have problems in providing anything described as a Customer Responsibility, please contact your local Agilent Technologies
office for assistance. Assistance with user specific applications may be provided but should be contracted separately.

PLEASE NOTE:
Some of the instrumentation, you have ordered, may not appear on the following tables, because some of the individual modules that
generate a system are not sold as individual parts.
For example, if you ordered a:
- G1354A, you will receive a G1311A (Quat. Pump) and a G1322A (Micro Vacuum Degasser)
- G1382A, you will receive a G1376A (Capillary Pump) and a G1379B (Micro Degasser)
- G2225A, you will receive a G2226A (Nano Pump) and a G1379B (Micro Degasser)

If you have ordered a bundled system or if you have problems in identifying the individual modules that are part of your system,
please contact your sales representative for information about the individual modules that generate this system.

Issued: Feb 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies 1 WAD Product Support Page 1 of 8
Agilent 1200 Series
Liquid Chromatograph

Hardware Site Preparation Specification

Dimensions and Weight □

Select the laboratory bench space before your system arrives. Pay special attention to the total height requirements. Avoid bench
space with overhanging shelves. Pay special attention to the total weight of the modules you have ordered. Make sure that your
laboratory bench can support this weight.

Module Weight Height Depth Width

G1310A/G1311A Iso. / Quat. 11 kg 25 lbs. 14 cm 5.5 in 43.5 cm 17 in 34.5 cm 13.5 in
Pumps
G1312A Binary Pump 15.5 kg 34 lbs. 18 cm 7 in 43.5 cm 17 in 34.5 cm 13.5 in
G1376A Capillary Pump 17 kg 39 lbs. 18 cm 7 in 43.5 cm 17 in 34.5 cm 13.5 in
G2226A Nano Pump
G1322A / G1379B Degassers 7.5 kg 16.5 lbs. 8 cm 3 in 43.5 cm 17 in 34.5 cm 13.5 in
G1361A Preparative Pump 15 kg 32.9 lbs. 20 cm 8 in 43.5 cm 17 in 34.5 cm 13.5 in
G2258A Dual Loop 14.0 kg 29.8 lbs. 20 cm 8 in 43.5 cm 17 in 34.5 cm 13.5 in
Autosampler
G1329A/G2260A Autosamplers 14.2 kg 31.3 lbs. 20 cm 8 in 43.5 cm 17 in 34.5 cm 13.5 in
G1367B/G1377A High 15.5 kg 34.2 lbs 20 cm 8 in 43.5 cm 17 in 34.5 cm 13.5 in
Performance Autosamplers
G1330B ALS Thermostats 18.5 kg 40.7 lbs. 14.4 cm 5.5 in 43.5 cm 17 in 34.5 cm 13.5 in
G1316A Thermostatted Column 10.2 kg 22.5 lbs. 14 cm 5.5 in 43.5 cm 17 in 41 cm 16 in
Compartment
G1314B/C Variable Wavelength 11 kg 25 lbs. 14 cm 5.5 in 43.5 cm 17 in 34.5 cm 13.5 in
Detectors
G1315B/C Diode-Array 11.5 kg 26 lbs. 14 cm 5.5 in 43.5 cm 17 in 34.5 cm 13.5 in
Detectors
G1365B/C Multiple Wavelength 11.5 kg 26 lbs. 14 cm 5.5 in 43.5 cm 17 in 34.5 cm 13.5 in
Detectors
G1321A Fluorescence Detector 11.5 kg 25.4 lbs 14 cm 5.5 in 43.5 cm 17 in 34.5 cm 13.5 in
G1362A Refractive Index 17 kg 38 lbs. 18 cm 7 in 43.5 cm 17 in 34.5 cm 13.5 in
Detector
G1364B/C/D Fraction 17 kg 38 lbs. 18 cm 7 in 43.5 cm 17 in 34.5 cm 13.5 in
Collectors

Issued: Feb 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies 2 WAD Product Support Page 2 of 8
Agilent 1200 Series
Liquid Chromatograph

Hardware Site Preparation Specification

Environmental Conditions □
Operating the LC System within the recommended temperature ranges insures optimum instrument performance and lifetime.
Performance can be affected by sources of heat and cold from heating, air conditioning systems, or drafts.
Please Note:
The site’s ambient temperature conditions must be stable for optimum performance of the system’s modules (as specified in the
“Performance Specifications” section of each module’s Reference Manual). Temperature changes of 2°C / hour or less (as defined
by ASTM conditions) are required to achieve best possible baseline stability. Higher variations will definitely result in higher signal
drift and wander of the baseline.

Module Operating temp range Operating humidity range

G1314B/C, G1315B/C, G1316A, G1322A, 0 to 55°C (32 to 131°F), constant temperature. < 95%, non-condensing
G1365B/C, G1362A
G1379B 0 to 45°C (32 to 113°F) < 95%, non-condensing
G1330B, G1361A, G1364B/C/D, G2258A 4 to 40°C (39 to 104°F) < 95%, non-condensing
G1321A 0 to 40°C (32 to 104°F), constant temperature < 95%, non-condensing
All other modules 4 to 55°C (39 to 131°F), constant temperature. < 95%, non-condensing

Power Consumption □
PLEASE NOTE:
An AC power outlet is required for EACH module, in addition to the Computer System (if applicable)
All Agilent 1200 modules have automatic line sensing, wide ranging power supplies. All modules operate with line voltages in the
range of 100-240 VAC, +/- 10%

Maximum Power Maximum Power BTU

Module Consumption [VA] Consumption [W]
G1310/11A Iso. / Quat. Pumps 180 VA 55 W 188
G1312A Binary Pump 220 VA 74 W 253
G1376A Capillary Pump 220 VA 75 W 256
G2226A Nano Pump
G1361A Prep Pump 250 VA 210 W 717
G1379B Micro Degasser 30 VA 30 W 102
G1322A Degasser 30 VA 30 W 102
G1329A, G2260A ALS 300 VA 200 W 683
G1367B/G1377A High 300 VA 200 W 683
Performance Autosamplers
G2258A Dual Loop Autsampler 260 VA 210 W 717
G1330B Sample Thermostat 260 VA 210 W 717
G1316A Therm Column Comp 320 VA 150 W 512
G1314B VWD 220 VA 85 W 290
G1315B DAD 300 VA 125 W 427
G1315C DAD 160 VA 130 W 546
G1365B MWD 300 VA 125 W 427
G1365C MWD 160 VA 130 W 546
G1362A RID 160 VA 65 W 222
G1321A FLD 180 VA 70 W 239
G1364B/C/D Fraction Collectors 200 VA 180 W 614

Issued: Feb 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies 3 WAD Product Support Page 3 of 8
Agilent 1200 Series
Liquid Chromatograph

Hardware Site Preparation Specification

Other considerations □
Module Stacking
Bench Space:

The modular dimensions and weight allow the instrument to be placed on almost any laboratory bench. The instrument requires a
space of at least 2.5 cm (1.0 inch) on both sides, and approximately 8 cm (3.1 inches) at the rear for the circulation of air and room
for electrical connections.

If the bench is to support a complete Agilent Technologies 1200 Series system, make sure that the bench is designed to carry the
total weight of all the modules.

Ensure that all 1200 series modules are installed and operated in a horizontal position. Operating a module on its side will
defeat the leak detection system of the module and possibly cause a hardware failure within the module.

Recommended Stacking Configurations:

A single-stack configuration may be considered only if:

* The height of the stack does not result in a safety problem.
* The system does not include a G1330B thermostat module.

A multiple stack configuration must be used if:

* The stack of 1200 modules is too high, resulting in a safety problem.
* The system includes a thermostatted sampler or fraction collector.

PLEASE NOTE:
The thermostatted version of all samplers and the fraction collector include the G1330B thermostat module. The thermostat module
must be placed directly under the sampler or the fraction collector to be thermostatted. It is recommended that the thermostat module
is positioned as the bottom module of the stack, directly on the laboratory bench. Any stack containing a G1330B thermostat module
needs at least 25 cm (10 inches) of space on either side to guarantee proper ventilation.

PLEASE NOTE:
Try to avoid stacking configurations that result in excessive volumes between sampler and column, and between column and
detector(s) to avoid potential problems related to excessive delay volume or peak broadening.

Please refer to figures 1, 2, 3 and 4 for recommended stacking configurations. The figures just show a selected number of
recommended configurations. Other module setups might be possible, but may require additional connecting capillaries.

Issued: Feb 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies 4 WAD Product Support Page 4 of 8
Agilent 1200 Series
Liquid Chromatograph

Hardware Site Preparation Specification

Figure 1
Recommended 1-Stack Configuration

Solvent cabinet

Vacuum degasser

Pump Instant
Pilot

Autosampler or
Micro Autosampler or
Preparative Autosampler

Column compartment

Detector

Issued: Feb 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies 5 WAD Product Support Page 5 of 8
Agilent 1200 Series
Liquid Chromatograph

Hardware Site Preparation Specification

Figure 2
Recommended 2-Stack Configuration (with Thermostat)

Detector

Column
compartment

Solvent cabinet
Autosampler
Vacuum degasser

Thermost Pump
t

Issued: Feb 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies 6 WAD Product Support Page 6 of 8
Agilent 1200 Series
Liquid Chromatograph

Hardware Site Preparation Specification

Figure 3
Recommended 2-Stack Configuration with Fraction Collector (Analytical Scale System)

I. Solvent bottles

II. Degasser (optional, VII. Fraction

for all pumps except the collector
Quat. Pump (G1311))
III. Pump

VI. UV-Vis
Detector

IV. Sampling device

V. Column
compartment

Issued: Feb 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies 7 WAD Product Support Page 7 of 8
Agilent 1200 Series
Liquid Chromatograph

Hardware Site Preparation Specification

Figure 4
Recommended 2-Stack Configuration with Fraction Collector (Preparative Scale System)

Solvent bottles

Prep. Pump A
Column organizer

Prep. Pump B

Fraction
collector

Injection device
UV-Vis
Detector

Issued: Feb 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies 8 WAD Product Support Page 8 of 8
 Installation Qualification (IQ) Phase 3
Side Preparation Specification Checklist

Agilent 1200 Series LC/MSD G1956A/B, G2908BA, G3218AA,

G3218BA Site Preparation Specification

Agilent 1200 Series Qualification Workbook

Agilent 1200 Series LC/MSD G1956A\B, G2908AA, G2908BA, G3218AA, G3218BA

Site Preparation Specification

Purpose of Procedure Procedure Checklist

To ensure that the installation site is
properly evaluated and prepared with Agilent G1956A/B Mainframe: Tick Boxes
the appropriate utilities, consumables footprint:*
and supplies for the successful Depth: 62.3 cm Width: 64.0 cm
installation of Agilent instruments 24.5 in 25.2 in ‰
and systems.
maximum cabinet dimensions:**
Customer Responsibilities Weight: 63.1 kg Height: 57.5 cm
Customers should ensure that all 138.75 lb 22.6 in
necessary operating supplies, Depth: 68.83 cm Width: 73.0 cm
consumables and usage dependent 27.1 in 28.75 in ‰
items such as columns, vials,
syringes, solvents and buffers E1M18 Mechanical Pump:
required for the successful Weight: 32.0 kg Height: 23 cm
installation of instruments and 70.4 lb 9.2 in
systems are available. Installation Depth: 51.0 cm Width: 17.0 cm
sites should be prepared in 20.4 in 6.8 in ‰
accordance with the following
specifications. An Agilent customer Agilent G1947A APCI Source:
engineer will call approximately 2 Weight: 1.7 kg Height: 23 cm
weeks prior to installation to confirm 3.75 lb 9.2 in
site readiness. Depth: 13.0 cm Width: 18 cm
5.1 in 7.1 in ‰

Important Information Agilent G1948A API-ES Source:

This checklist is designed to be used Weight: 1.7 kg Height: 17 cm
in conjunction with the Agilent 1200 3.75 lb 6.8 in
Series LC/MSD Site Preparation Depth: 9.5 cm Width: 18.0 cm
Manual. If you have problems 3.7 in 7.1 in ‰
providing any of the following,
please contact your local Agilent Agilent G1971A APPI Source:
sales office for assistance. Weight: 1.7 kg Height: 23 cm
Assistance with user specific 3.75 lb 9.2 in
applications may be provided but Depth: 13.0 cm Width: 18.0 cm
should be contracted separately. 5.1 in 7.1 in ‰
Users of the instrument should be
present throughout the installation Agilent G1978A Multimode Source:
and familiarization otherwise Weight: 2.29 kg Height: 23 cm
important operational, maintenance 5.05 lb 9.2 in
and safety information may be Depth: 13.0 cm Width: 18.0 cm
missed. 5.1 in 7.1 in ‰
* The footprint dimensions represent the minimum dimensions of the
supporting surface. This surface must also be relatively vibration
free and capable of supporting at least 65 kg (143 lbs).

** Maximum cabinet dimensions are for an Agilent G1956A/B with an

Agilent G1947A APCI, G1971A APPI, or G1978A Multimode
source installed. At least 30 cm (1 ft) to the left of the cabinet and at
least 55 cm (1.8 ft) above the cabinet must be added to these
dimensions to provide adequate instrument access.

Issued: Feb 2006 – Rev. 2.0 Copyright © 2005 Agilent Technologies LC/MS Technical Marketing Page 1 of 3
Agilent 1200 Series LC/MSD G1956A\B, G2908AA, G2908BA, G3218AA, G3218BA

Site Preparation Specification

Environmental Conditions
Temperature: 15 to 35 °C (59 to 95 °F) Tick Boxes
at constant temperature (variations < 3 °C/hr).
Humidity: < 95% relative, non-condensing ‰

Power
Americas & Japan: 200 to 220 VAC; 1100 VA max1
Europe & Asia Pac: 220 to 264 VAC; 1500 VA max1
G1971A APPI Source: 110 - 240 VAC; 15 VA max2
‰
G1978A MM Source: 110 - 240 VAC; 15 VA max2

N2 Generator: 90-110 VAC; 15 VA max3

108-132 VAC; 15 VA max3
207-253 VAC; 15 VA max3
All power: 50/60 Hz +/- 5%
1
Single outlet for LC/MSD. See LC/MSD Site Preparation
Manual, G1956-90098 for power cord configurations.
2
Single outlet for G1971A APPI Source power supply.
3
Single outlet for G1978A MM Source power supply.
4
Single outlet for LC/MS N2 Generator w/ compressor

Heat Dissipation ‰
Output: 2000 Watts (6800 BTU / hour)1
1
Approximately 600 Watts are removed with the
source exhaust.

Nitrogen Gas Supply

Purity: 99.5% or better - Gas Cylinder ‰
98.0% or better - N2 gas generator or
liquid N2 Dewar.
Balance of impurity should consist of oxygen and/or
argon. Gas must be hydrocarbon free (< 0.1 ppm).
Outlet Pressure: 80-100 psi. A 1/4" Swagelok outlet
(male) fitting is required to connect the LC/MSD.
Volume: Up to 15 liters/min.

Laboratory Supply Requirements

Mobile Phases: Water, Methanol, Isopropanol,
Acetonitrile1 ‰
Purity: HPLC-grade or better
Buffers: Ammonium Formate2
Acids: Acetic or Formic Acid3
Purity: Ammonium formate, 97% or better
Acetic acid, 99.7% or better
Formic acid, 96% or better
1
Methanol/water required for G1956B installation.
Organic/water required for G1956A installation.
2
Required for G1956B installation.
3
Optional for G1956A installation.

Issued: Feb 2006 – Rev. 2.0 Copyright © 2005 Agilent Technologies LC/MS Technical Marketing Page 2 of 3
Agilent 1200 Series LC/MSD G1956A\B, G2908AA, G2908BA, G3218AA, G3218BA

Site Preparation Specification

Exhaust Venting Requirements Tick Boxes

Capacity: Up to 15 liters/min. total.
Connections: Separate 1/2" hose barbs required for
rough pump and ion source (ES, APCI, APPI or ‰
MM).
1
A 20ft. length of 1/2 inch i.d. Tygon™ tubing is included
for venting source exhaust (drain bottle) and rough pump.
(Sufficient for two 10 foot lengths.)

Remote Diagnostics
Phone: One analog phone line is recommended to ‰
provide remote diagnostics capability for the LC/MSD.
A second phone line is also strongly recommended for
communication with the system operator.

Issued: Feb 2006 – Rev. 2.0 Copyright © 2005 Agilent Technologies LC/MS Technical Marketing Page 3 of 3
3 Installation Qualification (IQ) Phase
Side Preparation Specification Checklist

Agilent ChemStation Software Modules G2070BA, G2071BA,

G2072BA, G2170BA, G2171BA, G2180BA Software Site Preparation
Specification B.02.01

Agilent 1200 Series Qualification Workbook

Agilent ChemStation Software Modules
G2070BA/G2071BA/G2072BA/G2170BA/G2171BA/G2180BA
Software Site Preparation Specification B.02.01

Purpose of Procedure Procedure Checklist: ‰ A printer supported by the current

version of the ChemStation. For
To assure that the installation of further information please contact
Software Requirements
Agilent instruments and systems can your local service representative.
be completed successfully by careful
preparation and evaluation of the ‰ Windows 2000 SP4 or
‰ The voltage setting of the computer
installation site and by ensuring the Windows XP Professional SP2 *
system and the power cables have to
availability of appropriate utilities, ‰ Administrator logon required to the
be correct.
consumables and supplies. ChemStation PC.
‰ TEMP variable points to an existing
directory (e.g. TEMP=C:\TEMP)
Customer Responsibilities ‰ Check if a printer driver is installed
Customers should ensure that all on the system
necessary operating supplies, ‰ Verify that the regional settings are *Detailed information on how to set up
consumables and usage dependent set to English-US Windows XP Professional for optimal
items such as columns, vials, ChemStation usage is located on the
syringes and solvents required for Hardware Requirements ChemStation CD-ROM under the
the successful installation of manuals\installation\Configure and
instruments and systems are ‰ All PC hardware needs to be listed Maintain your Agilent Computer
available. Installation sites should respectively in the Windows 2000 or directory.
be prepared in accordance with the Windows XP Professional Hardware
following specifications. Compatibility List
(see www.microsoft.com ) **Please verify if the instrument
supports GPIB connection.
Important Information
‰ Microsoft Windows compatible
If you have problems in providing
pointing device
any of the following, please contact
your local Agilent office for
‰ Pentium IV processor operating at
assistance. Assistance with user
1.5 GHz or higher
specific applications may be
provided but should be contracted
‰ at least 512 MB of RAM for a single
separately. Users of the instrument
should be present throughout the instrument 2D or 3D configuration
installation and familiarization
‰ CD-ROM drive
otherwise important operational,
maintenance and safety information
may be missed. ‰ hard-disk with at least 40 GB free
capacity

‰ SVGA or better graphics adapter

and monitor (recommended
resolution 1280 x 1024), True Color

‰ 82350A/B GP-IB card available

with one free IRQ on the PC and
one free PCI slot ** or

‰ LAN interface with TCP/IP protocol

installed and LAN card (J4100A
JetDirect card or G1369A LAN
card) for instrument available.

Issued: Feb 2006– Rev 6.0 Copyright © 1995 Agilent Technologies WAD Product Support Page 1 of 1
 Installation Qualification (IQ) Phase 3
Side Preparation Specification Checklist

Agilent ChemStation Software Modules G2070BA, G2071BA,

G2072BA, G2073BA, G2170BA, G2171BA, G2180BA, G2090BA,
G2710BA, G1601BA, G2201BA B.02.01 Upgrade Site Preparation
Checklist

Agilent 1200 Series Qualification Workbook

Agilent ChemStation Software Modules
G2070BA/G2071BA/G2072BA/G2073BA/G2170BA/G2171BA/G2171BA/G2180BA/G2090BA/
G2710BA/G1601BA/G2201BA

B.02.01 Upgrade Site Prep Checklist

Purpose of Procedure Procedure Checklist: ‰ Available LAN interface with

TCP/IP protocol installed and a
To assure that the upgrade of LAN card (J4100A JetDirect card,
Software Requirements
Agilent instruments and systems can G1369A LAN card or equivalent)
be completed successfully by careful ‰ Windows 2000 Professional SP4 or
for the instrument, if needed.
preparation and evaluation of the Windows XP Professional SP2 *
installation site and by ensuring the ‰ Administrator logon required to the
‰ A printer supported by the current
availability of appropriate utilities, ChemStation PC
version of the ChemStation. For
consumables and supplies. ‰ TEMP variable points to an existing
further information please contact
directory (e.g. TEMP=C:\TEMP)
your local service representative or
‰ Check if a printer driver is installed
Customer Responsibilities the ChemStation installation manual
on the system
of your appropriate technique.
Customers should ensure that all ‰ Verify that the regional settings are
necessary operating supplies, set to English-US
‰ The voltage setting of the computer
consumables and usage dependent
system and the power cables has to
items such as columns, vials, PC Hardware Requirements be correct.
syringes and solvents required for
the successful installation of ‰ All PC hardware needs to be listed
instruments and systems are respectively in the Windows 2000 or
available. Installation sites should Windows XP Professional Hardware *Detailed information on how to set up
be prepared in accordance with the Compatibility List Windows XP Professional for optimal
following specifications. (see www.microsoft.com ) ChemStation usage is located on the
ChemStation CD-ROM under the
Important Information ‰ Microsoft Windows compatible manuals\installation\Configure and
pointing device Maintain you Agilent PC directory.
If you have problems in providing
any of the following, please contact *Please verify if your instruments
‰ Pentium IV processor operating at
your local Agilent office for support GPIB connection.
1.5 MHz or higher for LC, LC/MS
assistance. Assistance with user
and GC systems
specific applications may be
provided but should be contracted
separately. Users of the instrument ‰ At least 512 MB of RAM for
should be present throughout the - 2D instrument configuration
installation and familiarization - 3D instrument configuration
otherwise important operational, - LC/MS instrument configuration
maintenance and safety information - instrument configuration with
may be missed. ChemStore C/S

‰ CD-ROM / DVD-ROM drive

Additional Information
For detailed steps to perform an ‰ Hard-disk with at least 40 GB free
upgrade installation refer to the capacity
“Upgrade Preparation Guide for
Rev. B.02.01 ChemStation” (P/N ‰ 1280x1024 recommended resolution
G2170-90226). or better graphics adapter and
monitor, True Colors

‰ 82350A/B GP-IB card available

with one free IRQ on the PC and
one free PCI slot **.

Issued: Feb 2006– Rev 1.0 Copyright © 2006 Agilent Technologies WAD Product Support Page 1 of 3
Agilent ChemStation Software Modules
G2070BA/G2071BA/G2072BA/G2073BA/G2170BA/G2171BA/G2171BA/G2180BA/G2090BA/
G2710BA/G1601BA/G2201BA

B.02.01 Upgrade Site Prep Checklist

Instrument Hardware
Requirements LC, GC and For GC systems only:
Instrument Minimum Firmware
LC/MS GC Column Catalog: A GC Column Revision
Database Utility is available to transfer 6890N GC Firmware >= N.05.05
‰ Check if Firmware revisions of
user-defined GC columns from System LAN assembly
instruments and modules are
G2070AA to G2070BA ChemStation. 04.7B3
appropriate for ChemStation
B.02.01. 6890Plus, Firmware >= A.03.08
User-defined column entries in the GC 6890A
Column catalog are not transferred 6850 GC Firmware >= A.05.04
For LC systems only: automatically during an upgrade from serial# >= LAN assembly
G2070AA to G2070BA ChemStation. US10243001 04.7B3
‰ If Firmware is not current, ask The GC Column Database Utility can be
customer to upgrade to minimum 6850 GC Firmware >= A.03.03
used after the upgrade to transfer the serial# <=
Firmware A.06.02/B.01.02 required user-defined GC Columns.
with Rev. B.02.01 ChemStation. US00003200
Please use the record outlined in the Agilent 6850 Firmware >= A.05.04
The Utility is available on the Handheld
“1100/1200 IQ Attachment Form”. ChemStation CD-ROM under the
This document is available from the Controller
Support directory. (G2629A)
EPI Warehouse @
http://whadmin.cos.agilent.com/sear 35900E Firmware >= E.01.02
ch/AdvPubForm.asp by searching ‰ If the firmware is not current, ask 5890 Series II Firmware >= A.03.02
for “1100/1200 PM Checklist”. The the customer to upgrade to the 4890D Firmware >= A.06.00
1100/1200 IQ Attachment Form minimum firmware. For previously ‰ The GC Firmware Update Utility is
AND the 1100/1200 PM Checklist qualified systems, please use the GC provided on the ChemStation
will be retrieved. The 1100/1200 IQ IQ Attachment form to record the B.02.0x CD-ROM under the
Attachment Form is to be used only change. This document is available Support directory. Please check the
once. from the EPI Warehouse @ Agilent Technologies website for
http://whadmin.cos.agilent.com/sear the latest firmware:
‰ The FW upgrade process is ch/AdvPubForm.asp by searching http://www.chem.agilent.com/script
described in the manual coming for “GC IQ Attachment”. s/cag_firmware.asp
with the FW upgrade tool, placed on
the ChemStation CD-ROM. ‰ It is recommended to upgrade to the
minimum firmware listed in the For CE systems only:
For LC/MS systems only: table using the GC Firmware Update
Utility:
‰ If the firmware is not current, ask
‰ Update the LC/MSD firmware by the customer to upgrade to the
running the executable minimum firmware:
c:\Chem32\MS\FIRMWARE\ Mainframe: 2.3
msupdate.exe while connected to the DAD: 1.2
LC/MSD.

‰ Before upgrading the LC/MSD

ChemStation to revision B.02.01,
perform a dual polarity Autotune to
verify instrument tune performance
and to generate a record of current
tune parameters.

Issued: Feb 2006– Rev 1.0 Copyright © 2006 Agilent Technologies WAD Product Support Page 2 of 3
Agilent ChemStation Software Modules
G2070BA/G2071BA/G2072BA/G2073BA/G2170BA/G2171BA/G2171BA/G2180BA/G2090BA/
G2710BA/G1601BA/G2201BA

B.02.01 Upgrade Site Prep Checklist

ChemStation Solutions
For GC systems only: Additional Familiarization Upgrades
Check for installed Add-On Solutions.
from Rev. A to Rev. B ChemStation
‰ Companion
Before installing the Add-On solution,
‰ Explain the modified ChemStation
verify the correct revision of the Add-On ‰ Retention Time Locking
Solution Products for ChemStation structure (e.g. ChemStation.ini)
B.02.01 using the using the link to the ‰ HeadSpace
LSM Marketing Homepage for the ‰ Outline the new integrator features
compatibility matrix/Product Support ‰ Other: _________________
Plan: ‰ Outline the integrator changes and
http://lsbu.marketing.agilent.com/article/ inform about the available
ashow.asp?article_id=710 documentation *
ChemStation System Customization ‰ Outline the change for the “old”
Rev. A/Rev. B. Upgrades: Check for customized solutions:
All Add-On Products need to be spectra tool and inform about the
uninstalled BEFORE upgrading to the available documentation*.
‰ Check if “User.mac” is present in
B.02.01 ChemStation: xx:/hpchem/core directory or *Detailed information regarding the
xx:/chem32/core directory integration/spectra update, macro
General:
changes etc. can be found in the
‰ Ask customer if any customization “Upgrade Preparation Guide for
‰ ChemStore has been done and back up all Rev. B.02.01 ChemStation, Pub
customized macro files. number G2170-90226”.
‰ ChemAccess
‰ For Rev. A Upgrades only:
‰ ChemStation Plus Security Pack Regarding impact on customized
macros due to the upgraded
‰ Other: _________________ ChemStation structure point
customer to the available
documentation *.
For LC, LC/MS systems only:
‰ Purify Software

‰ Active Splitter

‰ G1979A Multi-Signal Output

Accessory (Side Box)

‰ Analyst

‰ Easy-Access

‰ Data Browser

‰ Other: _________________

Issued: Feb 2006– Rev 1.0 Copyright © 2006 Agilent Technologies WAD Product Support Page 3 of 3
3 Installation Qualification (IQ) Phase
Installation Qualification

Installation Qualification

Agilent 1200 Series Qualification Workbook

 Installation Qualification (IQ) Phase 3
Installation Qualification

Agilent 1200 Series Liquid Chromatograph Hardware and Software

Installation Checklist

Agilent 1200 Series Qualification Workbook

Agilent 1200 Series
Liquid Chromatograph

Hardware and Software Installation Checklist

Hardware / Software Unpacking and inspection of G1322A/79B– Degasser

shipped materials ‰ Section NOT Applicable
Installation Note: Shipping containers should
not be opened until an Agilent 1. SN/FW#_____________________
Purpose: To ensure that instruments
Technologies representative is
and systems are correctly installed 2. SN/FW#_____________________
present
and functioning as designed, in the
‰ Unpack all boxes and place
customer's facility. Correct ‰ Set up the degasser(s)
equipment on bench. To
installation is the first step in { solvent inlet/outlet
prevent injury, get lifting
ensuring that instruments and ‰ Priming each channel with
assistance if needed.
systems operate reliably over an Isopropanol from solvent bottle
‰ Retain shipping containers and
extended lifetime. to pump inlet
material until installation is
complete and performance is
Customer Responsibilities G1310A/11A/12A – Pump
verified
The customer should ensure that the ‰ Section NOT Applicable
‰ Notify order fulfillment of any
installation site is prepared in
discrepancies
accordance with the specifications 1. SN/FW#_____________________
‰ Unpack and verify condition
contained in the relevant site
and completeness of shipment
preparation document and that the 2. SN/FW#_____________________
‰ Check serial numbers and fill in
necessary operating supplies,
installation documentation S/N 3. SN/FW#_____________________
consumables and usage dependent
fields if necessary
items such as vials, paper, solvents,
‰ Verify that power cords are ‰ Set up the pump(s)
etc. are available. A customer
correct (must mate with power { solvent inlet/outlet
representative should be present at
sockets) and are plugged into { waste drain
all times during the installation.
power receptacle { remote control (if used)
‰ When applicable, install { relay contacts (if installed)
Note: Typical installation time is
computer system and connect all { seal wash tubing
1.5 hours for a system and 30
power interconnect cables (if installed)
minutes for a module.
‰ Check for the Agilent LC { CAN
Diagnostic CD-ROM and install { Agilent LAN (see note*)
If installation time was not sold for
this software component. ‰ Priming the pump
any section, check that section as
not applicable. { prepare solvents
{ turn on
{ purge
Installation Checklist
{ purge mobile phase
{ monitor the pressure
‰ Section NOT Applicable

Note: G1382A/G1376A Capillary Pump

If one section contains multiple G1379B Micro Degasser
choices for installed Hardware
G2225A/G2226A Nano pump
please encircle all modules that are
G1379B Micro Degasser
part of the system and fill in the
corresponding Serial Number.
‰ Section NOT Applicable

Issued: Feb, 2006 – Rev. 6.0 Copyright © 1995 Agilent Technologies WAD Product Support Page 1 of 6
Agilent 1200 Series
Liquid Chromatograph

Hardware and Software Installation Checklist

1. SN/FW#_____________________ electronically switch the { Agilent LAN (see note*)

EMPV to waste
2. SN/FW#_____________________ { Manually suck the solvent The following section applies if a
into and trough the pump G1330B - ALS Thermostat
‰ Set up the pump { Pump at least 0.5 liter of IPA is installed together with any of the
{solvent inlet/outlet through the pump well-plate-, autosamplers or fraction
{ waste drain collectors to generate a:
{ remote control (if used) G1328B – Manual Injector or G1329A + G1330B - Thermostat.
{ relay contacts (if installed) 5065-9922 Prep. Manual Injector ALS
{ CAN ‰ Section NOT Applicable G1364B/C/D + G1330B Therm.
{ Agilent LAN (see note*) Fraction Collector
{ set up the degasser SN/FW#________________________ G1367B + G1330B - Thermostat.
{ solvent inlet/outlet High Performance Autosampler
{ priming each channel with ‰ Setup the injector G1377A + G1330B - Thermostat.
Isopropanol from solvent { start/stop cable to pump Micro WPS
bottle to pump inlet { base plate & mounting pole G2260A + G1330B - Thermostat.
‰ Priming the pump { position valve Preparative ALS
{ prepare solvents { inlet/outlet connected
{ turn on { sample loop G1330B - ALS Thermostat
{ purge { vent tubes ‰ Section NOT Applicable
{ purge mobile phase
{ monitor the pressure G1329A – Autosampler 1. SN/FW#_____________________
G1367B – High Performance
G1361A – Prep. Pump Autosampler 2. SN/FW#_____________________
‰ Section NOT Applicable G1377A - Micro WPS
G2258A – Dual Loop ALS 3. SN/FW#_____________________
1. SN/FW#_____________________ G2260A - Preparative ALS
‰ Section NOT Applicable ‰ Setup the ALS Thermostat(s)
2. SN/FW#_____________________ underneath the module(s) that
1. SN/FW#_____________________ has (have) to be thermostatted.
‰ Set up the pump(s)
{ solvent inlet/outlet 2. SN/FW#_____________________ WARNING: Do not connect the
{ waste drain ALS thermostat cable while the line
{ remote control (if used) 3. SN/FW#_____________________ power is connected to the any
{ relay contacts (if installed) of the modules. This would damage
{ seal wash tubing ‰ Setup the autosampler(s) the sampler or fraction collector and
{ CAN { solvent inlet/outlet the thermostat electronics.
{ Agilent LAN (see note*) { waste drain (must be in a { air channel adapter and plate
straight line down, no { ALS thermostat cable
‰ Priming a prep pump bends, kinks or curves { ALS thermostat waste drain
{ Prime each pump individually { large volume tube
{ Use the syringe + adapter + (if installed) G1316A - Column Compartment
tubing and connect to the { BCD output (if installed) ‰ Section NOT Applicable
waste outlet of the pump`s { remote control (if used)
EMPV { relay contacts (if installed) SN/FW#________________________
{ Turn ON the pump and { CAN

Issued: Feb, 2006 – Rev. 6.0 Copyright © 1995 Agilent Technologies WAD Product Support Page 2 of 6
Agilent 1200 Series
Liquid Chromatograph

Hardware and Software Installation Checklist

‰ Setup the TCC { waste drain

{ solvent inlet/outlet { remote control (if used) SN/FW#________________________
{ column { analog output (if used)
{ waste drain { relay contacts (if installed) ‰ Set up the detector
{ remote control (if used) { CAN { solvent inlet/outlet
{ CAN { Agilent LAN (see note*) { waste drain
‰ Verify the operation of the { remote control (if used)
G1157A/58A/59A/60A/62A/63A detector { analog output (if used)
Valves { CAN
‰ Section NOT Applicable Lamp Pass/Fail { Agilent LAN (see note*)
Intensity
1. SN/FW#_____________________ Zero-order ‰ Verify the operation of the
WL Deviation detector
2. SN/FW#_____________________ calibration 656nm
Deviation Lamp Pass/Fail
3. SN/FW#_____________________ Intensity
G1315B/C-DAD / G1365B/C- Excitation
‰ Setup the Valves WL Deviation
‰ Setup the 1200 Series Valve MWD
‰ Section NOT Applicable
verification Emission
{ solvent inlet/outlet Deviation
{ CAN
1. SN/FW#_____________________
{ CAN-DC-In from other 1200 G1362A – RID
Module (e.g. G1367B 2. SN/FW#_____________________ ‰ Section NOT Applicable
Autosampler, G1364B/C/D
Fraction Collector or G1361A ‰ Set up the detector(s) SN/FW#________________________
Prep. Pump) { deuterium lamp
(if not installed) ‰ Set up the detector
G1383A Column Organizer { solvent inlet/outlet WARNING: Make sure that all
‰ Section NOT Applicable { waste drain plugs are removed from the ports
{ remote control (if used) and the appropriate capillaries
SN/FW#________________________ { analog output (if used) (inlet/outlet/recycling) are
{ relay contacts (if installed) connected (maximum backpressure
‰ Setup the column organizer of 5 bar for flow cell).
{ CAN
{ base plate and organizer plate { solvent inlet/outlet
{ Agilent LAN (see note*)
{ rods { solvent recycle
‰ Verify the operation of the
{ traverses { waste drain
detector
{ additional holders (if used) { remote control (if used)
Lamp 1. Pass/Fail
Intensity 2. { analog output (if used)
G1314B/C – VWD { CAN
1. Alpha
‰ Section NOT Applicable { Agilent LAN (see note*)
WL 2. Deviation
SN/FW#________________________ calibration 1. Beta
2. Deviation ‰ Verify the operation of the
detector
‰ Set up the detector
G1321A – FLD Diode
{ flow cell
‰ Section NOT Applicable Balance Value
{ solvent inlet/outlet

Issued: Feb, 2006 – Rev. 6.0 Copyright © 1995 Agilent Technologies WAD Product Support Page 3 of 6
Agilent 1200 Series
Liquid Chromatograph

Hardware and Software Installation Checklist

G1364B/C/D – Fraction Collector

‰ Section NOT Applicable

1. SN/FW#_____________________

2. SN/FW#_____________________

3. SN/FW#_____________________

4. SN/FW#_____________________

‰ Setup the fraction collector(s)

{ solvent inlet/outlet
{ waste drain
{ remote control (if used)
{ relay contacts (if installed)
{ CAN
{ Agilent LAN (see note*)

G1390A – Universal Interface Box

(UIB)
‰ Section NOT Applicable

SN/FW#________________________

‰ Setup the universal interface

box
{ CAN
{ Analog In (if used)
{ GPIO / Analog In (if used)
{ Relay Contacts (if used)

Note: Agilent LAN connection is

made between one (1) of the
Agilent 1200 Series System
modules and the Agilent
ChemStation PC. If a detector is
installed connect the LAN to this
module.

Issued: Feb, 2006 – Rev. 6.0 Copyright © 1995 Agilent Technologies WAD Product Support Page 4 of 6
Agilent 1200 Series
Liquid Chromatograph

Hardware and Software Installation Checklist

G2408 Instant Pilot Software Installation (Un- 1200 LC Checkout

‰ Section NOT Applicable Bundled) ‰ Start a run
‰ Section NOT Applicable ‰ Prepare:
SN/FW#________________________ 1. pump(s)
Software 2. online degasser (s)
‰ Set up the control module Product:_________________________ (if present)
{ Connect via CAN to 3. injection device(s)
available instrument module Software
4. column compartment
Revision:_____________________
5. detector(s)
Software Installation (Bundled) 6. fraction collector(s)
‰ Section NOT Applicable ‰ Start Windows
(if present)
‰ Install ChemStation using the
7. Valve(s) (if present)
Software ChemStation Installation guide
8. recording device
Product:_________________________ for reference.
‰ Attach results to installation
‰ Check if a printer driver is
Software documentation
installed on the system
Revision:________________________ ‰ Fill out instrument logbook
‰ Verify that the regional settings
‰ Verify connection to the Agilent
are set to English-US
‰ Start Windows LC Diagnostic Tool.
‰ Install and Configure TCP/IP if
‰ Start ChemStations -> Add the instrument will be connected
Licenses and add the license using LAN.
numbers. You find these ‰ If necessary install and
numbers in the 'Software Configure IO Libraries
Certificate and Registration (LC/MS).
Packet' envelopes. ‰ If necessary install and
‰ Configure TCP/IP if the configure AGILENT Bootp
instrument will be connected Service if the instrument will be
using LAN. connected using LAN
‰ If necessary install and ‰ Use the Configuration Editor
Configure IO Libraries and configure your instruments.
(LC/MS) ‰ Install the Agilent LC
‰ If necessary install and Diagnostic software.
configure Agilent Bootp Service
for LAN connection.
‰ Use the Configuration Editor
and configure your instruments.
‰ Install and Configure Software
Add-Ons (if applicable)
‰ If present, install the PC Image
software and create a backup
using the Backup Solution User
Guide as reference.
‰ If present, install the Agilent LC
Diagnostic software.

Issued: Feb, 2006 – Rev. 6.0 Copyright © 1995 Agilent Technologies WAD Product Support Page 5 of 6
Agilent 1200 Series
Liquid Chromatograph

Hardware and Software Installation Checklist

Service Review Note: Password is the Registration

‰ Affix any reports generated to number for the software
this Checklist
‰ Record in the instrument ‰ Sales Order Number
logbook date and time install _________________________
was completed
‰ Explain Agilent warranty for ‰ Service Order (SO) Number
Hardware, Software and return __________________________
policy for the Instrument
Service Center ‰ Date completed
‰ Explain how to log an __________________________
instrument service call
‰ Explain support services ‰ Customer Signature
‰ Explain how to use manuals __________________________
‰ Advise customer of additional
training options ‰ Support Provider Signature
‰ Advise the customer of the __________________________
following useful Agilent web
sites:

e.g. 1200 Series Firmware

(Downloads/patches)
Exclusive offers:
www.agilent.com/chem/exclusiveoffers

Library -
http://www.agilent.com/chem/library

Education -
www.agilent.com/chem/education

eSeminars -
www.agilent.com/chem/eseminars

Software Status Bulletins and Patches -

www.agilent.com/chem/techsupport

Supplies - www.agilent.com/chem/supplies

Tech Support -
www.agilent.com/chem/techsupp

Issued: Feb, 2006 – Rev. 6.0 Copyright © 1995 Agilent Technologies WAD Product Support Page 6 of 6
3 Installation Qualification (IQ) Phase
Installation Qualification

Agilent LC and CE ChemStation Software G2170BA, G2171BA,

G2175BA, G2180BA, G2185BA,G211601BA, G2172BA, G2205BA
Software Installation Checklist B.02.0x

Agilent 1200 Series Qualification Workbook

Agilent LC and CE ChemStation Software
G2170BA, G2171BA, G2175BA, G2180BA, G2185BA, G1601BA, G2172BA, G2205BA

Software Installation Checklist B.02.0x

Purpose of Installation 1. Installation Checklist generic 2b. Installation Checklist

To ensure that instruments and systems Non-Bundle system (if applicable)
‰ Unpack and verify condition and
are correctly installed and functioning
completeness of shipment. ‰ Install the IO libraries if the
as designed, in the customer's facility.
Correct installation is the first step in instrument will be connected using
ensuring that instruments and systems ‰ Check license numbers and fill in GP-IB or
operate reliably over an extended installation documentation S/N
lifetime. fields if necessary. You find these ‰ Install the Agilent BootP Service
numbers in the 'Software Certificate program (if necessary ) for LAN
and Registration Packet' envelopes. communication
Customer Responsibilities
The customer should ensure that the Note: The license registration
installation site is prepared in numbers consist of 10 ‰ Start the ChemStation installation
accordance with the specifications alphanumeric characters. This by starting setup.exe from the
contained in the site preparation and number is proof of purchase and Agilent ChemStation CD-ROM.
installation manual and that the needed in case of a reinstall. Point Note: A previously installed
necessary operating supplies, out to the customer that he must ChemStation will be updated.
consumables and usage dependent store this number in a secure place.
items such as paper, pens, etc. are ‰ Choose the installation directory.
available. A customer representative ‰ Point the support directory out to The default is C:\CHEM32.
should be present at all times during the customer. Explain the Software
the installation. Status Bulletin (SSB). ‰ Select the instrument number to be
installed, the desired software for
2a. Installation Checklist this instrument and type in the
Bundle system (if applicable) license number.

‰ Start Windows ‰ If you need to install more than one

instrument, repeat the preceding
‰ Start ChemStation -> Add Licenses step.
and add the license numbers. You
find these numbers in the 'Software ‰ Use the Configuration Editor and
Certificate and Registration Packet' configure your instruments.
envelopes.
‰ Install Agilent LC Diagnostic Tool
‰ Install the Agilent BootP Service
program if the instrument (if ‰ Close all Windows applications,
necessary ) for LAN connection or close Windows and restart the
computer.
‰ Install the IO libraries if the
instrument will be connected using
GP-IB

‰ Use the Configuration Editor and

configure your instruments.

‰ Install Agilent LC Diagnostic Tool

Issued: Feb 2006 - Rev.5.0 Copyright © 1995 Agilent Technologies WAD Product Support Page 1 of 2
Agilent LC and CE ChemStation Software
G2170BA, G2171BA, G2175BA, G2180BA, G2185BA, G1601BA, G2172BA, G2205BA

Software Installation Checklist B.02.0x

3. Installation Checklist generic

‰ Start ChemStation -> Installation

Qualification to ensure correct
installation.

‰ If there is an online instrument,

start the appropriate Online
Instrument ChemStation.

‰ If there is no online instrument,

start the appropriate Offline
Instrument ChemStation.

‰ Start the Agilent LC Diagnostic

Tool and verify connection

4. If Familiarization is not to be
performed:

‰ Explain how to use the manuals

(refer customer to operational
maintenance section). Show the
sample methods and data files
installed with the software.

‰ Explain Agilent Support services

and how to obtain help, note if
customer requires further
information.

Issued: Feb 2006 - Rev.5.0 Copyright © 1995 Agilent Technologies WAD Product Support Page 2 of 2
 Installation Qualification (IQ) Phase 3
Familiarization Checklist

Familiarization Checklist

Agilent 1200 Series Qualification Workbook

3 Installation Qualification (IQ) Phase
Familiarization Checklist

Agilent 1200 Series Liquid Chromatograph Famliarization Checklist

Agilent 1200 Series Qualification Workbook

Agilent 1200 Series
Liquid Chromatograph

Familiarization Checklist

Hardware / Software Hardware Familiarization Module Screens for the 1200”

section from the appropriate
Familiarization Module Reference Manual as
‰ Section Not Applicable
guidance. Review the following
Purpose of Procedure
System Overview and Hardware Screens:
To demonstrate the steps required to
perform a basic analysis using a Familiarization
‰ Power on each module and 1. Views
standard sample or internal data file, 2. Diagnostics and Tests
evaluate the resulting data and describe the various states of the
status indicators. Screen
perform routine operational
‰ Indicate the installed modules in
maintenance. Maintenance/Diagnostics
Familiarization is intended to give the following list that will be
covered as part of the ‰ Review common maintenance
operators a basic overview of the procedures by reviewing the
operation and maintenance of new familiarization:-
“Simple Repairs” section in the
instruments, systems and application appropriate Reference Manual
software and is not designed to ‰ G4208- Instant Pilot
substitute for a full operator-training ‰ G1310A/11A/12A /61A/76A/
G2226A – Pump ∗ For Systems that do not have
course. a Control Module, detailed
‰ G1322A/79B- Degasser
‰ G1328B – Manual Injector Familiarization of the 1200 set
Customer Responsibilities points will be covered in the
The customer should ensure that ‰ 5065-9922 – Prep. Manual Inj.
‰ G1329A or G2260A – EDIT METHOD and
necessary operating supplies, DIAGNOSTIC portions of the
consumables and usage dependent Autosampler
‰ G1367B/77A – Autosampler Software Familiarization.
items such as vials, syringes and
solvents are available. Users of the ‰ G2258A – Dual Loop Sampler
instrument should be present at all ‰ G1316A - Column
times during the familiarization, Compartment
otherwise important information on ‰ G1157A/58A/59A/60A/62A/63
operation and maintenance may be A – Valves
missed. The manuals delivered with ‰ G1314B/C – VWD
the instrument will be used as a ‰ G1315B/C–DAD /
guide during familiarization and G1365B/C–MWD
should be available. ‰ G1321A – FLD
‰ G1362A – RID
Note: Typical familiarization ‰ G1364B/C/D – Fraction
times for a Bundled LC System Collectors
are: ‰ G1330B – Thermostat for
2D System –approx. 6.5 Hours Samplers or Fraction Collectors
3D System – approx. 8.5 Hours
‰ Below Item Not Applicable
(see note*)
If customer did not purchase
familiarization time for the 1200, ‰ Demonstrate stand-alone
check that section as not operation for each installed
applicable. Module using the Control
Module. Use the “Control

Issued: Feb, 2006 – Rev. 4.0 Copyright © 1995 Agilent Technologies WAD Product Support Page 1 of 3
Agilent 1200 Series
Liquid Chromatograph

Familiarization Checklist

Software Familiarization collection order and mode, Data Analysis

needle movement ‰ Demonstrate use of the
‰ Section Not Applicable navigation pane
Edit Method ‰ Explain navigation table and
System Startup ‰ Prepare a method using the demonstrate table options
‰ Demonstrate switching on “Edit Entire Method” menu item ‰ Demonstrate the various ways to
instruments, PC and peripherals to analyze the checkout sample load a signal and how to get
‰ Demonstrate starting Windows ‰ Don’t forget to explain signal specific information
operating system, logon parameters under the “More and ‰ Load data file ISOCRA.D found
password Auxiliary”- Buttons or Menus in X:\CHEM32\1\DATA\DEMO\…
‰ Demonstrate starting LC ‰ If the Spectral Software ‰ Manipulate graphics windows
ChemStation software (G2180BA) is loaded, select (Zoom, print window, etc.)
‰ Describe ChemStation acquisition of all spectra ‰ Integrate signal (Automated and
Configuration Editor ‰ Save the method as ISO_1.M Manual)
‰ Describe Online and Offline ‰ Explain the difference between ‰ Setup report using “Specify
session the method in memory and in Report” menu
the instrument ‰ Print an area percent report
General Familiarization ‰ Demonstrate “reviewing” and
‰ Describe software manuals Run Method “reprocessing” of data files
‰ Demonstrate Online help and ‰ Prepare the Isocratic Checkout using the navigation table in
Tutorial sample Data Analysis
‰ Demonstrate the ChemStation ‰ Load ISO-1.M
layout ‰ Setup the run through the Quantification
‰ Explain use of the various “Sample Info” menu and ‰ Load method DEF_LC.M
analyze the sample ‰ Load data file ISOCRA.D
Views and the usage of the
‰ Demonstrate status monitors ‰ Demonstrate the steps in
Navigation Pane
‰ Explain ChemStation Explorer and on-line signal display creating a single level
‰ Explain Packaging Concept of
calibration
Edit Sequence ‰ Demonstrate generating a
ChemStation Data
‰ Demonstrate mouse actions in ‰ Load sequence DEF_LC.S External Standards report
the various tables and graphic ‰ Explain usage of the sequence
items preferences Spectral Data Evaluation
‰ Explain Full/Short menu and ‰ Explain how to create sequence ‰ Section Not Applicable
view structures templates and demonstrate the
‰ Explain the user access levels data storage based on this ‰ Demonstrate display of spectra
definition and reference spectra
Configure Instruments ‰ Demonstrate preparation of a ‰ Demonstrate display of a 3D
Where necessary (e.g. for samplers sequence using the “Sequence plot
and fraction collectors: used trays Parameters” and “Sequence ‰ Demonstrate display of an Iso-
and vessels) Table” menus absorbance plot
‰ Configure wellplates and test ‰ Run a single injection sequence ‰ Demonstrate the creation of a
tubes (if applicable) using the checkout sample. Spectral Library
‰ Demonstrate “Partial sequence” ‰ Demonstrate creation of an
For fraction collectors, only: and “Sequence Save” Automated Library Search
‰ Configure delay volume, Report

Issued: Feb, 2006 – Rev. 4.0 Copyright © 1995 Agilent Technologies WAD Product Support Page 2 of 3
Agilent 1200 Series
Liquid Chromatograph

Familiarization Checklist

‰ Demonstrate Peak Purity Diagnostic e.g. 1200 Series Firmware

‰ Explain file management and (Downloads/patches)
Purification and Fraction other software utilities
Collection ‰ Describe the importance of data Library
http://www.chem.agilent.com/Scripts/Li
‰ Section Not Applicable back-up, disk checks, disk de-
brary.asp
fragmentation, archiving and
‰ Demonstrate, how to reset the master disk storage Education
tray fill information ‰ Discuss the importance of http://www.chem.agilent.com/Scripts/ca
‰ Demonstrate, how to perform a disabling power management g_countrysites.asp?pf=T
delay calibration options and utilities that run
‰ Demonstrate fraction collection automatically E-seminars
in the time based and peak ‰ In Agilent LC Diagnostic http://webshop.chem.agilent.com/iccdoc
based mode describe Status Report and how s/seminarList.shtml
‰ Demonstrate the use of the to edit a report as PDF or as
Fraction Preview printable file Supplies
‰ Demonstrate the Fraction ‰ In Agilent LC Diagnostic http://www.chem.agilent.com/Scripts/P
Col.asp?lPage=572
collection in a single run describe the guided diagnostic.
(method) using the “Sample
Software Status Bulletins and Patches
Info” for specifying a Fraction http://www.chem.agilent.com/scripts/ca
Start Location Service Review g_checkreg.asp
‰ Generate and run a Fraction ‰ Register the customer for
Collection Sequence with a complimentary software Note: Password is the Registration
Fraction Start position in the support. number for the software
Sequence Parameters and in the ‰ Affix any reports generated to
Sequence Table this Checklist ‰ Sales Order Number
‰ Demonstrate, how to do Pooling ‰ Record in the instrument ____________________________
‰ Demonstrate, how to do Sample logbook date and time install
Recovery (if applicable, was completed
appropriate trays and ‰ Explain Agilent warranty for ‰ Service Order (SO) Number
configuration must be available) Hardware, Software and return ____________________________
‰ Demonstrate, how to generate a policy for the Instrument
report including Fraction Service Center
Tickmarks and Fraction Table ‰ Explain how to log an ‰ Date completed
instrument service call ____________________________
Maintenance/Diagnostics ‰ Explain support services
‰ Introduce the diagnostic tools in ‰ Explain how to use manuals
ChemStation and Agilent LC ‰ Advise customer of additional ‰ Customer Signature
Diagnostic training options ____________________________
‰ Describe EMF Utilities and how ‰ Give the customer a tour of the
to set limits in following useful Agilent web
ChemStation /Agilent LC sites: ‰ Support Provider Signature
Diagnostic ____________________________
‰ Demonstrate troubleshooting Technical Support
using diagnostics in http://www.chem.agilent.com/Script
ChemStation / Agilent LC s/cag_techsupport.asp

Issued: Feb, 2006 – Rev. 4.0 Copyright © 1995 Agilent Technologies WAD Product Support Page 3 of 3
 Installation Qualification (IQ) Phase 3
Familiarization Checklist

Agilent 1200 Series Liquid Chromatograph Scorp of Work

Installation and Famliarization

Agilent 1200 Series Qualification Workbook

Agilent 1200
Liquid Chromatograph

Scope of Work ---- Installation and Familiarization

Scope of Work
Installation and Familiarization for the 1200
Series Liquid Chromatograph
1. Scope
This document provides details of the procedures necessary for the successful Installation and Familiarization
(I&F) of a 1200 Series LC and the associated recording device. It clarifies expectations and responsibilities and
assures uniform delivery of the service. Only Support Providers trained and certified by Agilent Technologies
will provide the service. Support Providers are Agilent Customer Engineers (CE’s) and/or Agilent
Authorized Support Providers (ASPs). References to other documents are included to supply additional
information or to provide clarity. Delivery time for the completion of the Installation and Familiarization is
dependent upon the type of recording device to be used (ChemStation or Integrator). Time starts when the
Support Provider arrives at the Customer site and ends when he/she leaves the site. Installation and
Familiarization is comprised of the following parts:
Installation Familiarization
1. Setup 1. Familiarization
2. Checkout 2. Service Review
3. Service Review
Note: This document is to be used by Agilent Employees and non-Agilent ASPs, and is not to be provided to
customers.

2. Applicable Models
This document applies to the following models. This document and the associated install and familiarization times
do not apply to the install/configuration of a non-bundled PC or of the GPIB or LAN board or connection of the
PC to an existing LAN. Extra time must be quoted for these configurations.
Table 2-1. Applicable Models
System Component Product Number Description
Degassing G1322A/79B Agilent 1200 Series Online Vacuum Degassers for pumps
G1310A Agilent 1200 Series Isocratic Pump
Pumps G1311A Agilent 1100 Series Quaternary Pump
G1312A Agilent 1200 Series Binary Pump
G1376A Agilent 1200 Series Capillary Pump
G2226A Agilent 1200 Series Nano Pump
G1361A Agilent 1200 Series Isocratic/Binary Preparative Pump
G1328B/5065-9922 Agilent 1200 Series (Prep.)Manual Injector
Sample Introduction G1329A Agilent 1200 Series Thermostatted Autosampler
G2260A Agilent 1200 Series Preparative Autosampler
G1367B Agilent 1200 Series High Performance Autosampler
G1377A Agilent 1200 Series Micro Well Plate Autosampler
G2258A Agilent 1200 Series Dual Loop Autosampler
G1330B Agilent 1200 Series Thermostat for Autosamplers or Fraction Collectors
Oven/Heater G1316A Agilent 1200 Series Thermostatted Column Compartment
Detectors G1314B/C Agilent 1200 Series Variable Wavelength Detector

Issued: Feb 2006 – Revision 4.0 Agilent Restricted WAD Product Support Page 1 of 12
Agilent 1200
Liquid Chromatograph

Scope of Work ---- Installation and Familiarization

G1315B/C Agilent 1200 Series Diode Array Detector

G1321A Agilent 1200 Series Fluorescence Detector
G1362A Agilent 1200 Series Refractive Index Detector
G1365B/C Agilent 1200 Series Multiple Wavelength Detector
Fraction Collectors G1364B/C/D Agilent 1200 Series Fraction Collectors
Valves G1157A/58A/59A/50A/62A Agilent 1200 Series Valves
/63A
Control G4208A Agilent 1200 Series Instant Pilot plus CAN cable
Single Instrument LC 2D ChemStation
G1317BA
Includes HP/Compaq PC, Monitor,
With PC/SW
HP LaserJet printer, LC 2D software and Windows XP.
Single Instrument LC 3D ChemStation
G1319BA
BUNDLES Includes HP/Compaq PC, Monitor,
With PC/SW
(I&F time included with purchase HP LaserJet printer, LC 3D software and Windows XP.
and H1172A included with HPLC 2D ChemStation S/W License Bundle
G2215BA Includes HP/Compaq PC, Monitor, HP LaserJet printer,
purchase
With PC/SW LC 2D License SW and Windows XP. Does not include installation.

3. Time Required
Time required is dependent upon the LC modules sold and the type of recording device present. For an 1200 2D
LC bundled with ChemStation, typical Installation and Familiarization time is 6.5 hours. Typical time required for
an 1200 3D LC bundled with ChemStation is 8.5 hours.

Table 3.1 Typical time required for I&F of a Standalone 1200 LC Module
Time Model Description
0.5 hour I&F G1379B Agilent 1200 Series Vacuum Degasser/Micro Vacuum Degasser
I hour I&F G1322A Agilent 1200 Series Vacuum Degasser/Micro Vacuum Degasser
1 hour I&F G1310A Agilent 1200 Series Isocratic Pump
1 hour I&F G1311A Agilent 1200 Series Quaternary Pump
1 hour I&F G1312A Agilent 1200 Series Binary Pump
1 hour I&F G1376A Agilent 1200 Series Capillary Pump
1 hour I&F G2226A Agilent 1200 Series Nano Pump
1 hour I&F G1361A Agilent 1200 Isocratic/Binary Preparative Pump
0.5 hour I G1328B/5065-
Agilent 1200 Series Manual Injector, preparative scale Manual Injector
9922
1.hour I&F G1329A Agilent 1200 Series Thermostatted Autosampler
1 hour I&F G1387A Agilent 1200 Series Micro Autosampler
1 hour I&F G2260A Agilent 1200 Series Preparative Autosampler
1 hour I&F G1367B Agilent 1200 Series High Performance Autosampler
1 hour I&F G1377A Agilent 1200 Series Micro Well Plate Autosampler
1.5 hour I&F G2258A Agilent 1200 Series Dual Loop Autosampler
0.6 hour I&F G1330B Agilent 1200 Series Thermostat for Autosampler or Fraction Collector
0.5 hour I G1316A Agilent 1200 Series Thermostatted Column Compartment
1 hour I&F G1314B/C Agilent 1200 Series Variable Wavelength Detector
1 hour I&F G1315B/C Agilent 1200 Series Diode Array Detector
1 hour I&F G1321A Agilent 1200 Series Fluorescence Detector
1 hour I&F G1362A Agilent 1200 Series Refractive Index Detector
1 hour I&F G1365B/C Agilent 1200 Series Multiple Wavelength Detector
1 hour I&F 1364B/C Agilent 1200 Series Fraction Collectors
1.5 hour I&F 1364D Agilent 1200 Series Fraction Collectors
0.5 hour I&F G1157A/58A/59A Agilent 1200 Series Valves
/60A/62A/63A
For most current information please refer to http://services-cag.scs.agilent.com/marketing/main.htm

Issued: Feb 2006 – Revision 4.0 Agilent Restricted WAD Product Support Page 2 of 12
Agilent 1200
Liquid Chromatograph

Scope of Work ---- Installation and Familiarization

Table 3.2 Typical time required for I&F of a Standalone LC System (with Control Module)
Time Tasks Customer Comments
Present
Approx.3 Pre-install Discussion 9 A Customer Representative should provide assistance in placement of the LC onto the bench.
hours
(depending
System Setup 9 The customer should be present due to the short I&F time. This is a good opportunity to
demonstrate to the customer the installation of the tubing, flow cell, and column.
on the
installed Instrument Checkout 9 LC checkout conditions using the control module.
modules) LC Familiarization 9 LC Hardware Familiarization Checklists.

Table 3.3 Typical time required for I&F of a 2D/3D LC with ChemStation
Time Tasks Customer Comments
Present
Approx. Pre-install Discussion 9 A Customer Representative should provide assistance in placement of the LC onto the bench.
6.5hrs System Setup Although the Customer is not required to be present during setup, this is a good opportunity to
(2D-Value demonstrate to the customer the installation of the tubing, flow cell, and column.
System)
Instrument Checkout LC checkout conditions.
or LC Familiarization 9 LC Hardware Familiarization Checklists
ChemStation Familiarization Checklist and ChemStation Tutorial
8.5 hrs(3D) Familiarization 9 Additional 2 hour familiarization of Spectral software for 3D system
Maintenance 9 Instrument and PC
(depending
on the
Service Review 9
installed
modules)

Table 3.4 Typical time required for H1172A Image Solution

Time Tasks Customer Comments
Present
1 hour Create Image, H1172 The customer should be present due to the short I&F time. This is a good opportunity to
Backup Solution explain the customer the need of backup solutions and PC maintenance

Table 3.5 Typical time required for Agilent LC Diagnostic

Time Tasks Customer Comments
Present
25 minutes Install LC Diagnostic, For 1200 Series Rapid Resolution SL Hardware Systems:
Establish Connection , The customer should be present due to the short I&F time. This is a good opportunity to
Familiarization demonstrate the use of this tool and the associated documentation.

(10 minutes) For 1200 Series Hardware Systems:

Describe only Describe Guided Diagnostic, Status Report and generate PDF report

4. Customer Responsibilities
In preparation for the Installation, the Call Initiator (see below for a definition of the Call Initiator) verifies with
the Customer that they have complied with the Site Preparation Checklist. Specific Site Preparation
information (dimensions, weights, solvents, environmental, and electrical specifications) can be found in the
1200 Site Preparation Specification.

• Customer should have available HPLC grade Isopropanol, Acetonitrile and Water

Issued: Feb 2006 – Revision 4.0 Agilent Restricted WAD Product Support Page 3 of 12
Agilent 1200
Liquid Chromatograph

Scope of Work ---- Installation and Familiarization

• The site is well ventilated and free of corrosive materials and overhanging obstacles.
• Site temperature is within the recommended range of 0 to 55°C for the G1314B/C, G1315B/C, G1316A,
G1322A, G1365B/C, G1362A, 4 to 45°C for the G1379B, 4 to 40°C for the G1330B, G1361A, G1364B/C/D,
G2258A, 0 to 40°C for the G1321A and all other modules 4 to 55°C.
• The sites ambient temperature conditions must be stable, 2°C/hour or less is required to meet Agilent
Technology’s published drift specification. The greater the temperature fluctuation in the lab the greater
baseline instability of the LC System. Take care in placement of the system, trying to avoid placement near
heating and air conditioning vents to insure optimum performance.
• Site humidity is within the recommended range of <95%, non-condensing.
• Bench space is adequate and can support the weight of the Agilent 1200 system, including all LC modules and
the ChemStation PC. Additionally the instrument requires 2.5 cm (1.0 inch) of space on either side and 8cm
(3.1inch) at the rear for circulation of air and room for electrical connections. The TCC requires 25cm (10
inches) of space on either side.
• An AC outlet is required for each module, in addition to the Computer System.

5. Agilent Responsibilities
5.1. Scheduling—The Call Initiator
The Installation call begins with a call to the Customer by the “Call Initiator.” The Call Initiator may be the
Support Provider, a workload administrator, or a dispatcher, depending on local processes. The Call
Initiator:
• Calls the Customer, schedules the date and time for I&F, and confirms Customer preparation.
• Reminds Customer not to open/unpack boxes until an Agilent representative is present.
• Discusses possible problem areas before Support Provider goes on site.

5.2. Support Provider Responsibilities

All Support Providers shall be Agilent trained and certified to install and familiarize a customer on the 1200
LC. Support Providers shall take necessary Electro-Static Discharge (ESD) precautions (see appropriate
Hardware Manual) when working on or near printed circuit boards or other sensitive assemblies.

5.2.1. Delivery
• Brings all necessary tools for LC system installation including the Isocratic Checkout sample,
part number - 01080-68704 (Service Note 01200-048)
• Complete all steps in the I&F Checklist that are applicable to the instrument. Note that the
I&F Checklist is a separate document.
• Brings the prep. Checkout column for a Prep. Scale Purification System - 846975-202 (if
applicable)

5.2.2. Documentation
• Asks the Customer to sign the I&F Checklist acknowledging the completion of service.

Issued: Feb 2006 – Revision 4.0 Agilent Restricted WAD Product Support Page 4 of 12
Agilent 1200
Liquid Chromatograph

Scope of Work ---- Installation and Familiarization

• Affix all data generated to the Checklist and give to the customer for addition to the instrument
logbook for future reference.

6. Installation and Familiarization Task Details

6.1. Discussion Before Install
• Review with the Customer the information listed in Table 3.1, 3.2, 3.3, making sure that the Customer
will be present for the tasks that require the Customer to be present.
• Arrange to have assistance placing the LC system on the bench.
• Check that the site preparation requirements have been fulfilled and verify where the Customer would
like the 1200 system installed.
• Ask Customer where to store additional consumables, software, and manuals.
• Coordinate with Customer where to place empty boxes and packing material, as the instrument is
unboxed.

6.2. Setup
The following table summarizes the steps involved in setting up the 1200 system. More details can be
found in the Installation section of the Module Reference Manual.

Table 6-2 Setup Details

Step Comments
Unpack • Remove all equipment from the boxes and place on the bench in the location specified by the customer.
Keep the shipping containers until the Checkout has been completed.
• Store the consumables, software, and manuals in the location specified by the customer.
Check for Completion of Shipment and • Check the items for signs of damage. Any damage or missing in shipment should be reported to Agilent
Signs of Damage Technologies Order Fulfillment or follow local processes as determined by field management.
• Check all items received against the packing list. Any discrepancies should be immediately reported to
the Customer and Order Fulfillment.
• Record all Serial Numbers on the Installation Checklist.
Electrical/Plumbing • Install LC Modules in the 2 stack configuration found in the Site Preparation Specification.
• Install CAN cables from module to module. Install LAN the cable from PC to Detector module, if more
than one detector, install LAN cable to 3D detector.
• Install Autosampler – Thermostat cable if applicable. Note-Do not connect power to this module unless
this cable has been installed. Failure to do so can result in damage to the electronics of this module.
• Connect power cables to each module, install remote cable from Degasser Module, to closest available
remote port.
• Connect capillary from module to module as specified in the module Reference Manual.
• Install waste drains routing outlet to waste reservoir. Note- Ensure the outlet of the detector module is
attached to large bore tubing to prevent excessive back-pressure on the flow cell.
• Install Control Module if applicable.
LC ChemStation Install • For LAN-Configure ChemStation, TCP/IP, if necessary install BOOTP Service software, turn on LC
(if applicable) detector to get MAC address, configure BOOTP manager.
• Install the ChemStation (if applicable) using the appropriate ChemStation Installation guide for reference.
• Establish communication with the 1200 LC.

Issued: Feb 2006 – Revision 4.0 Agilent Restricted WAD Product Support Page 5 of 12
Agilent 1200
Liquid Chromatograph

Scope of Work ---- Installation and Familiarization

LC Diagnostic Install • Set up LAN-Connection on PC

(if applicable) • Install the LC Diagnostic
• If ChemStation is present, verify communication to the LC Diagnostic
• If no ChemStation is present, configure LC Diagnostic
• Establish communication with the 1200 LC.
Checkout Preparation • For isocratic pump, fill the solvent bottle with 35% HPLC grade Water and 65% HPLC grade
Acetonitrile. For all other pumps, fill solvent bottle A with HPLC grade Water. Fill solvent bottle B with
HPLC grade Acetonitrile. If installed, purge each channel of the on-line degasser using the supplied
syringe as specified in the Degasser Reference Manual.
• Open Pump Purge Valve, and purge each channel at the maximum flow rate possible. For the binary
pump, 5ml/min, for the isocratic and quaternary pump 10ml/min. Purging each channel for 5 minutes
should be sufficient to remove air in the system.
• Install the supplied checkout column (993967-906 or 846975-202 for PS systems) into the Column
Compartment if applicable.

6.3. Checkout
The following conditions apply to the checkout of an 1200 LC system.

• Checkout of a 1200 detector is applicable only to the models listed in Table 2-1. Table 6-3 defines
checkout specifications with ChemStation or Control Module control using the methods and conditions
listed in the Table 6-3 or from the Detector Reference manual. Autosampler and detector combinations
not listed in Table 6-3 or use of conditions other than those specified do not have specific limits. In those
cases, generation of a chromatogram similar to that specified in Table 6-2 will act as the final checkout.
• Checkout of a 1200 system with a third party detector will be limited to generation of a chromatogram.
No specific limits will apply. In addition, communication to a third party data system is not an Agilent
responsibility and must be handled by the Customer.
• Flush flow-cell with HPLC grade Water for 5 minutes then run the Wavelength Calibration and Intensity
Test where applicable. For an RID detector, perform the Diode balance at this time.
• Allow system to equilibrate at the below checkout conditions for 10 minutes. Prepare a vial of the
Isocratic Checkout sample*, part number - 01080-68704. Start a run using the conditions in Table 6.3.
• Special Systems, such as prep. Scale and Purification Systems may require a special checkout procedure.
Please perform these procedures according to the documentation supplied for these systems

Issued: Feb 2006 – Revision 4.0 Agilent Restricted WAD Product Support Page 6 of 12
 Agilent 1200
Liquid Chromatograph

Scope of Work ---- Installation and Familiarization

Table 6.3 Detector Checkout Specifications

Detector Method Checkout Specifications

• For Isocratic pump, fill the solvent bottle with 35% HPLC grade Water and 65% • See Below
HPLC grade Acetonitrile. For all other pumps, fill solvent bottle A with HPLC
grade Water. Fill solvent bottle B with HPLC grade Acetonitrile
All 1200 Detectors • 1.5 ml/min flow-rate of 35% A and 65% B
• Inject Isocratic Checkout sample*, part number – 01080-68704
• Column – Zorbax Eclipse XDB-C8, 4.6 x 150mm, 5μm, part number – 993967-
906
• Column Compartment 25°C • 4 peaks visible in chromatogram
• Injection volume 1μl • Intensity Test – Pass
VWD/DAD/ MWD • Stop Time = 6 minutes • Wavelength Calibration ± 1nm
• 254nm for VWD, S:254,4 and R:500,100 slit width of 4 for the DAD
• Save method as ISO-1.M
• Injection volume 1μl **Make a 1:10 dilution of the Isocratic Sample in MeOH or • Chromatogram as seen in FLD
ACN Reference Manual
• Stop time = 4 Minutes • Intensity Test – Pass
FLD • Column compartment temperature = 30°C • Wavelength Calibration ± 3nm
• FLD EX=246nm, EM=317nm
• PMT Gain=10
• FLD Response Time = 4 seconds
• Save method as ISO-1.M
• Stop time = 10 minutes • Diode Balance - ±0.5
• Injection volume = 20μl • 4 peaks visible in chromatogram
RID • Column compartment and optical unit temperature = 35°C
• Save method as ISO-1.M
* The Isocratic sample does not ship with the 1200 system. The support provider must bring this sample with them to perform the checkout.

6.4. Familiarization
Familiarization is intended to give operators a basic overview of the operation and maintenance of new
instruments, systems, and software and is not designed to substitute for a full operator trainer course. The
customer must know how to operate a computer and be familiar with the operating system. Familiarization
does not include training on the PC, Windows, or networking.

Table 6.4.1 1200 ChemStation Bundle Familiarization

Tasks Task Details Time Notes and Objectives

1) System • Review with the customer what equipment they have and indicate the • For Systems that do not
Overview and modules that familiarization will be provided on. have a Control Module,
Hardware • Point out each Module Reference Manual. Describe the Status Indicators detailed Familiarization
Familiarization using the Status Indicators section of the Module Reference Manual. of the 1200 set points
• Using the Agilent 1200 Series Liquid Chromatograph Familiarization 45 will be covered in the
checklist, the appropriate Module Reference Manual, and the Control EDIT METHOD and
Minutes DIAGNOSTIC
Module, give an overview of the available parameters for the installed
module(s). For this task, go to the chapter titled “Control Module portions of the
Screens…”. The Customer should use the Control Module to step through ChemStation
the screens in this chapter while the Support Provider follows along in the Familiarization.
Reference Manual while providing additional details as needed.

Issued: Feb 2006 – Revision 4.0 Agilent Restricted WAD Product Support Page 7 of 12
Agilent 1200
Liquid Chromatograph

Scope of Work ---- Installation and Familiarization

2) System Startup • Demonstrate how to turn on PC and Peripherals. Demonstrate how to log in • Understand
into the operating system and demonstrate how to change the login ChemStation File
password. Structure
• Using Windows Explorer (or another windows explorer), show the location • Configure instruments
of the Agilent ChemStation Software. Show where the instrument(s) • How to start
directories, default data, method and sequence directories are located. ChemStation
• Demonstrate the use of the ChemStation Configuration editor.
• Explain the difference between the Online and Offline Instrument sessions.
• Start up an Online session.
3) General • Describe the resources available (software manuals, on-line help, software • Demonstrate Online
Familiarization support) including the support information on the CD-ROM such as the SSB Help and reference
and SRB. 1.5 Hour installation and
• Demonstrate how to use the on-line help and the tutorial. operator guides
• Explain the software layout and how to navigate between the different views • Refer to the Tutorial
using the Navigation Pane for first time users
• Explain use of the various Views
• Demonstrate how to change between the short/full menus.
• Explain ChemStation Explorer
• Explain Data Organization, particular the single/sequence data file container
• Demonstrate mouse actions in the various tables and graphic items
• Explain the user access levels.
4) Edit Method • Configure Instruments: • Editing/Saving a
Where necessary (e.g. for samplers and fraction collectors: Configure well method using checkout
plates and test tubes (if applicable) specs from table 6.3
For fraction collectors, only: Configure delay volume, collection order and
mode, needle movement
• Load ISO-1.M checkout method used in Section 6.3.
• Select “Edit the Entire Method” from the ChemStation menu.
• Explain the available method parameters using the on-line help and 1200
operators’ manuals for guidance.
• Don’t forget the parameters, that can be entered under the “More” and the
“Auxiliary” Settings
• If the Spectral Software (G2180BA) is loaded, select acquisition of all
spectra using the full spectral range of 190-950 and peak width that
corresponds to one spectra every 0.1 seconds.
• Save the method as ISO-1.M
5) Run Method • Place the Checkout sample prepared in Section 6.3, into vial location 1 of • Demonstrate loading
Autosampler. If an Autosampler is not available introduce the sample using and running a method.
the Manual Injection valve.
• Load ISO-1.M.
• Select Sample Info and define a data file name. Enter in the appropriate 30 min
sample information including the vial location.
• Select Run Method.
• As data is being acquired, demonstrate the use of the instrument status
monitors and on-line signal displays available in the View menu.
6) Edit Sequence • Describe the difference between a method and a sequence. • Demonstrate edit and
• Load Sequence DEF_LC.S. sequence execution
• Explain usage of the sequence preferences
• Explain how to create sequence templates and demonstrate the data storage
based on this definition
• Select SEQUENCE PARAMETERS and describe the various fields
including the REPROCESSING ONLY mode. 20 min
• Select SEQUENCE TABLE and describe the various fields.
• Demonstrate how to save a sequence.
• Load Sequence INSTPERF.S
• Select SEQUENCE, PARTIAL SEQUENCE and describe how to run a
partial sequence.
•

Issued: Feb 2006 – Revision 4.0 Agilent Restricted WAD Product Support Page 8 of 12
Agilent 1200
Liquid Chromatograph

Scope of Work ---- Installation and Familiarization

7) Data Analysis • Select VIEW, DATA ANALYSIS. • Demonstrate

• Load data file C:\CHEM32\1\DATA\DEMO\ISOCRA.D Integration and Reports
• Demonstrate use of the ChemStation Explorer
• Explain Navigation Table and demonstrate table options
• Demonstrate the various ways to load a signal and how to get signal specific
information
• Load data file C:\CHEM32\1\DATA\DEMO\ISOCRA.D
• Demonstrate the Autointegrate feature.
• Demonstrate Graphic manipulation by selecting GRAPHICS, SIGNAL
OPTIONS. Under RANGES, select USE RANGES and enter 1.5 in the
minimum time range. 45
• Demonstrate Integration Events by selecting INTEGRATION,
INTEGRATION EVENTS. Demonstrate how to make changes to the two
Minutes
tables and save the changes to an integration events file. Exit out of the
Integration Events table.
• Demonstrate Manual Integration by selecting INTEGRATION, DRAW
BASELINES.
• Generate an Area Percent Report by selecting REPORT and selecting the
QUALITATIVE options PERCENT, AREA, and SIGNAL. Select the
DESTINATION to be the PRINTER. Select REPORT, PRINT REPORT
• Demonstrate “reviewing” and “reprocessing” of data files using the
navigation table in Data Analysis
.
8) Quantification • Demonstrate the creation of simple Calibration by using the following steps; • Create Multi-Point
• Load method DEF_LC.M. Load data file ISOCRA.D. Select VWD1A only Calibration using
for this demonstration. AUTOINTEGRATE the file. stored data
• Open the INTEGRATION EVENTS TABLE and add 2 lines to the table. • Generate a Report
At TIME 0 INTEGRATION OFF. At TIME 3.5 INTEGRATION ON. Exit
and save the Integration events to the method.
• Select CALIBRATION, NEW CALIBRATION TABLE. Use Automatic
Setup to add LEVEL 1, DEFAULT AMOUNT 1. In COMPOUND NAME
of the calibration table, name this Test Peak.
45
• Select GRAPHICS, SIGNAL OPTIONS. Under RANGES, select USE Minutes
RANGES and enter 3.5 in the minimum time.
• Save the method as TEST by selecting FILE, SAVE METHOD. Enter
TEST as the method name.
• Demonstrate the creation of an ESTD quantification report by selecting
REPORT, SPECIFY REPORT. Under QUANTATIVE RESULTS, select
Calculate ESTD, Based on AREA, Sorted by SIGNAL. Select Destination
PRINTER. Select REPORT, PRINT REPORT.

Issued: Feb 2006 – Revision 4.0 Agilent Restricted WAD Product Support Page 9 of 12
Agilent 1200
Liquid Chromatograph

Scope of Work ---- Installation and Familiarization

9) Spectral Data • In Data Analysis, load the Checkout data file from step 5. • Explain the detailed
Evaluation (if • Demonstrate selection of Spectra. Select the Spectral Task Icon. Using training on Spectral
applicable) either the Spectra Tool Icons or the drop down menus from the menu Evaluation is available
SPECTRA, demonstrate how to select a spectrum and reference spectrum. from Agilent. This
• Demonstrate how to display a 3D plot. Make sure that FULL MENU option 1.5 Hour will be covered in the
is selected. Under SPECTRA, select 3D PLOT. Demonstrate the Rotate Service Review
functions. Exit the 3D plot. Select NO when asked to unload the spectral Section.
data from memory.
• Demonstrate an Isoabsorbance plot. Select SPECTRA, ISOABSORBANCE
PLOT. Move the crosshairs around to demonstrate the change to the
chromatogram and spectra windows. Exit the Isoabsorbance Plot.
• Demonstrate the creation of a Spectral Library. Load method DEF_LC.M.
Load data file ISOCRA.D or load the Checkout datafile from step 5. Select
SPECTRA, LIBRARY, NEW LIBRARY. Name the library DEMO.uvl and
type in DEMO LIBRARY in the information category. Select SPECTRA,
SELECT SPECTRA, and click on the first peak. Select SPECTRA,
LIBRARY, ADD ENTRIES. Type in PEAK1 for the name. Repeat the last
3 steps for the remaining 3 peaks using PEAK2, PEAK3, PEAK4 for the
entry names. Select SPECTRA, LIBRARY, SAVE LIBRARY.
• Demonstrate the creation of an Automated library search report. Select
REPORT, AUTOMATED LIBRARY REPORT. Use the Spectral Library
File X:\CHEM32\SPECLIBS\DEMO.uvl. Select REPORT, SPECIFY
REPORT. Choose the destination PRINTER and style LIBRARY
SEARCH. Select REPORT, PRINT REPORT. Review the resulting report.
• Demonstrate Peak Purity. Load the Checkout datafile from step 5 or use
DEMODADN.D. Select SPECTRA, SELECT PEAK PURITY and click on
a peak to obtain its purity information. When prompted to update to the new
spectra/purity options click “YES”. Highlight that this decision has to be
made once per method. Use SPECTRA, SEARCH PEAKS AND PRINT to
show the automatic purity check. Explain the purity setpoints in SPECTRA,
SPECTRA OPTIONS.
10) Preparative and • Demonstrate, how to reset the tray fill information 1.5 hours • These instructions are
Purification • Demonstrate, how to perform a delay calibration valid only for systems
Systems (if • Demonstrate fraction collection in the time based and peak based mode operated with the
applicable) • Demonstrate the use of the Fraction Preview ChemStation, only
• Demonstrate the Fraction collection in a single run (method) using the • Systems with the
“Sample Info” for specifying a Fraction Start Location PURIFICATION Add-
• Generate and run a Fraction Collection Sequence with a Fraction Start On SW require a
position in the Sequence Parameters and in the Sequence Table special familiarization
• Demonstrate, how to do Pooling for the Add-On SW
• Demonstrate, how to do Sample Recovery (if applicable, appropriate trays
and configuration must be available)
• Demonstrate, how to generate a report including Fraction Tickmarks and
Fraction Table

Issued: Feb 2006 – Revision 4.0 Agilent Restricted WAD Product Support Page 10 of 12
Agilent 1200
Liquid Chromatograph

Scope of Work ---- Installation and Familiarization

11) Maintenance/ ChemStation: • Cover all Maintenance

Diagnostics • Discuss Computer maintenance issues including file cleanup, defrag and issues including file
scandisk clean up, defrag and
Use for • Discuss the importance of regular backups. 25 scandisk.
1200 Series LC • Specify to customer all consumables needed to run the instrument using the Minutes
Modules. consumable catalogs for guidance.
• Using each installed Module Reference Manual, point out the “Simple
See section 12 for SL Repair” section in each manual.
modules ♦ For Pumps, review replacement of valves, frits, and seals, filters and
seal wash parts (if applicable)
♦ For Autosamplers, review replacement of needle and needle seat, rotor,
plunger seal (+ sample loop and wash port parts, where applicable)
♦ For detectors, review replacement of lamps, cleaning and flushing of
flow cell
♦ For fraction collectors review replacement of tubings
♦ For valves review replacement of rotor and rotor seal (if applicable)
• Select VIEW, DIAGNOSIS. Select DIAGNOSIS, TESTS. Review the
available tests. Select CLOSE to exit.

LC Diagnostic:
• Describe Guided Diagnostic
• Describe Status Report and how to generate a report as PDF or as a printable
file

12) LC Diagnostic • Describe Guided Diagnostic • Cover all Maintenance

• Describe Status Report and how to generate a report as PDF or as a printable issues.
file
Use for • Overview about existing diagnostic tasks
25
1200 Series • Calibration procedures Minutes
Rapid Resolution SL • Additional maintenance procedures, e.g. injector steps
LC Systems • EMF editor including parameter limits

13) Service Review • Refer to Section 7.0 of this Document 30

Minutes

Table 6.4.2 1200 Standalone Module/Bundle Familiarization

Tasks Task Details Time Notes and Objectives

1) System • Review with the customer what equipment they have and point out each • The Module Reference
Overview and Module Reference Manual. Describe the Status Indicators using the Status Manuals will be needed
Hardware Indicators section of the Module Reference Manual. for the Familiarization.
Familiarization • Using the Agilent 1200 Series Liquid Chromatograph Familiarization
checklist, the appropriate Module Reference Manual, and the Control 45
Module, give an overview of the available parameters for the installed
module(s). For this task, go to the chapter titled “Control Module
Minutes
Screens…”. The Customer should use the Control Module to step through
the screens in this chapter while the Support Provider follows along in the
Reference Manual while providing additional details as needed.

Issued: Feb 2006 – Revision 4.0 Agilent Restricted WAD Product Support Page 11 of 12
Agilent 1200
Liquid Chromatograph

Scope of Work ---- Installation and Familiarization

2) Maintenance • Specify to customer all consumables needed to run the instrument using the •
consumable catalogs for guidance.
• Using each installed Module Reference Manual, point out the “Simple
Repair” section in each manual. 15
♦ For Pumps, review replacement of valves, frits, and seals, filters and Minutes
seal wash parts (if applicable)
♦ For Autosamplers, review replacement of needle and needle seat, rotor,
plunger seal (+ sample loop and wash port parts, where applicable)
♦ For detectors, review replacement of lamps, cleaning and flushing of
flow cell
♦ For fraction collectors review replacement of tubings
♦ For valves review replacement of rotor and rotor seal (if applicable)

3) Service Review • Refer to Section 7.0 of this Document 30 •

Minutes

7. Service Review
Review with the customer all bullet items listed. Typical time required for service review takes 30 minutes.
• If applicable enroll the customer for 1 year Software Support.
• Attach all reports, chromatograms to the Checklist for future reference.
• If available, record in a Customer provided instrument logbook the date and time installation is completed.
• Explain the importance of license numbers to the customer and that he/she must store them securely.
• Explain hardware warranty, software warranty and return policy for Agilent Instrument Service Center.
• Describe how to create a Service Call
• Provide customer with a schedule of CAG Support Services. Reference Publication number 5980-0281EE.
• Briefly explain the use of all Operator and Reference Manuals.
• Inform customer of additional training classes.
• If the customer has an Internet connection, offer to show these Agilent Technologies external web-sites.

Technical Support
http://www.chem.agilent.com/Scripts/cag_techsupport.asp

Library
http://www.chem.agilent.com/Scripts/Library.asp

Education
http://www.chem.agilent.com/Scripts/cag_countrysites.asp?pf=T

E-seminars
http://webshop.chem.agilent.com/iccdocs/seminarList.shtml

Supplies
http://www.chem.agilent.com/chem/go

Software Status Bulletins and Patches

http://www.chem.agilent.com/chem/go

• Complete Sales Order, CSO Number, Date, Customer signature and Support Provider signature

Issued: Feb 2006 – Revision 4.0 Agilent Restricted WAD Product Support Page 12 of 12
3 Installation Qualification (IQ) Phase
Declaration of Conformity and System Validation

Declaration of Conformity and System Validation

Agilent 1200 Series Qualification Workbook

 Installation Qualification (IQ) Phase 3
Declaration of Conformity and System Validation

Declaration of Conformity According to ISO/IEC Guide 22 and

CEN/CENELEC EN 45014

Agilent 1200 Series Qualification Workbook

 A DECLARATION OF CONFORMITY
According to ISO/IEC Guide 22 and CEN/CENELEC EN 45014

Manufacturer’s Name: Agilent Technologies International sarl

Manufacturer’s Address: Rue de la Gare 29
Supplier’s Address: CH – 1110 Morges
Switzerland

Declares under sole responsibility that the product as originally delivered

Product Name: 1200 Series Isocratic Pump, 1200 Series Quaternary Pump

Model Number: G1310A, G1311A

Product Options: This declaration covers all options of the above products

complies with the essential requirements of the following applicable European Directives, and
carries the CE marking accordingly:

Low Voltage Directive 73/23/EEC, amended by 93/68/EEC

EMC Directive 89/336/EEC, amended by 93/68/EEC

and conforms with the following product standards:

EMC Standard Limit

IEC 61326-1:1997+A1:1998 / EN 61326-1:1997+A1:1998

CISPR 11:1997 / EN 55011:1998 Group 1 Class B
[1]
CISPR 11:1997 / EN 55011:1998 Group 1 Class A
IEC 61000-3-2:1998 / EN61000-3-2:1995+A1/2:1998
IEC 61000-3-3:1994 / EN61000-3-3:1995
IEC 61000-4-2:1999 / EN 61000-4-2:1995+A1:1998 4kV CD, 8kV AD
IEC 61000-4-3:1999 / EN 61000-4-3:1996+A1:1998 3 V/m, 80-1000 MHz
IEC 61000-4-4:1995 / EN 61000-4-4:1995 0.5kV signal lines, 1kV power lines
IEC 61000-4-5:1995 / EN 61000-4-5:1995 0.5 kV line-line, 1 kV line-ground
IEC 61000-4-6:1996 / EN 61000-4-6:1996 3V, 0.15-80 MHz
IEC 61000-4-11:1994 / EN 61000-4-11:1994 I cycle (20ms), 100%

Australia/New Zealand: AS/NZS 2064.1

Canada ICES / NMB-001:1998

The product was tested in a typical configuration with Agilent Technologies test systems.
[1]
1200 Series module with LAN Communication Interface attached.

Safety IEC 61010-1:2001 / EN 61010-1:2001

Canada: CSA C22.2 No. 1010.1:1992+A2:1997
USA: UL3101.1

Supplementary Information:
This ISM device complies with Canadian ICES-001. Cet appareil ISM est conforme à la norme NMB-001 du Canada.

This DoC applies to above-listed products placed on the EU market after:

December 19, 2005

Date Wolfgang Wilde, Quality Manager

For further information, please contact your local Agilent Technologies sales office, agent or distributor,
or Agilent Technologies Deutschland GmbH, Herrenberger Straße 130, D 71034 Böblingen, Germany.

Revision: A Document No. G1311-90510

*G1311-90510*
3 Installation Qualification (IQ) Phase
Declaration of Conformity and System Validation

Declaration of Conformity to mannufacturing Specifications

Agilent 1200 Series Qualification Workbook

Declaration of Conformity
to manufacturing specifications

We herewith inform you that the product

G1311A with serial number:

DE60555268

has successfully passed all our production

quality tests.

During final instrument performance verification

the following functional characteristics were
individually tested for conformance with our
internal specifications:

Leak Sensor Function

Leak Test

Gradient Precision Test

Operational Test

February 20, 2006

Signature: ______________________________
Test Technician: Sven Buggermann

G1311A

DE60555268
 Installation Qualification (IQ) Phase 3
ChemStation Declaration of System Validation

ChemStation Declaration of System Validation

Agilent 1200 Series Qualification Workbook

 Declaration of System Validation

We herewith inform you that the software product/system

Product Name Product Number Revision Number

ChemStation for GC G2070BA, G2071BA, G2075BA, B.02.0x
G2090BA (where x ranges from 0 to 9)
ChemStation for LC G2170BA, 2171BA, G2175BA, B.02.0x
G2180BA, G2185BA, G2190BA (where x ranges from 0 to 9)
ChemStation for A/D G2072BA, G2073BA, G2077BA B.02.0x
(where x ranges from 0 to 9)
ChemStation for CE G1601BA, G2172BA, G2205BA B.02.0x
(where x ranges from 0 to 9)
ChemStation for CE/MS G2201BA B.02.0x
(where x ranges from 0 to 9)
ChemStation for LC/MS G2710BA, G2715BA, G2720BA, B.02.0x
G2730BA, G2731AA (where x ranges from 0 to 9)
Software Revision updates G1656B Not applicable

was developed according to the quality process and software life cycle followed by the Life Sciences and
Chemical Analysis divisions of Agilent Technologies. Life cycle check-point details were reviewed and
approved by management. The product was found to meet its functional and performance specifications,
and release criteria at release to shipment.
In order to fulfill the validation requirements of the users of this product according to current regulations
and quality standards including, but not limited to, 21 CFR 210 (Good Manufacturing Practice for Drugs),
21 CFR 211 (current Good Manufacturing Practice for finished pharmaceuticals), 21 CFR 58 (Good
Laboratory Practice), Agilent Technologies will make the source code and the documents referenced on page
2 of this declaration available to an authorized governmental or regulatory agency for inspection at its
Pharmaceutical Solutions Unit, Waldbronn, Germany (terms and conditions to be negotiated).
Agilent Technologies will maintain possession of all documents and their reproductions and may require a
confidential disclosure agreement to be provided by those requiring access to these documents.

Date: February 2006

Engineering manager:
(PHS) (CAS)

Quality manager:
(PHS) (CAS)
 Product description
Specifications

Lifecycle Phase Transition Approvals

Proposal
Investigation
Design
Implementation
Test
Manufacturing Release

Software Quality Assurance

Quality Plan
Release criteria
Software Test Plan
Test procedures and acceptance criteria
Definition of expected test results
Test cases, test suites, test results
System change request tracking and reporting

Documentation and Change Management

Requirements Management
Software Configuration Management
Change Management Process
Coding Standards

Source Code

Part Number: G2170-90523 © Agilent Technologies, Inc. 2006

*G2170-90523*
*G2170-90523*
G2170-90523 Edition 02 / 2006 Agilent Technologies
Printed in Germany Hewlett-Packard-Strasse 8
76337 Waldbronn, Germany
3 Installation Qualification (IQ) Phase
ChemStation Installation Verification Report

ChemStation Installation Verification Report

Agilent 1200 Series Qualification Workbook

ChemStation Installation Verification Report
 Installation Qualification (IQ) Phase 3
Customer contributed documents

Customer contributed documents

Agilent 1200 Series Qualification Workbook

 Agilent 1200 Agilent 1200 Series
Qualification Workbook

4
Operational Qualification (OQ) Phase
OQ/PV Protocols
Agilent ChemStation Verification Test Report
Certificates showing tracebility of:
Standard: Caffeine Kit
Holmium Oxid Glass Filter (Type Hoya HY-1)
Customer contributed material

For the items marked with a * example pages are added. It is the
responsibility of the user to replace these with the originals. Documents for
calibrated test equipment are handcarried by the Agilent Technologies
customer engineer who performs for example the OQ/PV procedure. Copies of
these documents should be added to the present binder. The user should feel
free to add further documents, e.g. not supplied by Agilent Technologies
whenever he thinks this is appropriate.

Agilent Technologies
4 Operational Qualification (OQ) Phase
OQ/PV Protocols

OQ/PV Protocols

• Agilent 1200 Series modules

• Agilent ChemStation Plus
Add here the protocols as handed over by a certified Agilent service engineer
after an Operational Qualification (OQ).
Recommended times for OQ
• Installing hardware or software
• Repairing a mayor piece of hardware
• Any software change that affect system security, data integrity or
administrative controls

Agilent 1200 Series Qualification Workbook

 Operational Qualification (OQ) Phase 4
Agilent ChemStation Verification Test Report

Agilent ChemStation Verification Test Report

Agilent 1200 Series Qualification Workbook

Test Name C:\CHEM32\1\VERIFY\LCAREA.VAL

--------------------------------------------------------------
ChemStation Verification Test Report
--------------------------------------------------------------

Tested Configuration:

Component Revision
---------------------------------------------------------------------
ChemStation for LC 3D systemsRev. B.02.01 [241]
Microsoft Windows Microsoft Windows 2000
Processor Intel Pentium Pro
CoProcessor yes

ChemStation Verification Test Details:

Test Name : C:\CHEM32\1\VERIFY\LCAREA.VAL

Data File : C:\CHEM32\1\VERIFY\LCAREA.VAL\ASIGLC01.D
Method : C:\CHEM32\1\VERIFY\LCAREA.VAL\AREALC.M
Original Datafile : ASIGLC01.D
Original Aquisition Method: OQLLC35D.M
Original Operator : SSO Development
Original Injection Date: 14-Jan-98, 06:12:44
Original Sample Name : A LCSignal

Signals Tested:
Signal 1 : ADC1 A, ADC1 CHANNEL A of ASIGLC01.D

ChemStation Verification Test Results:

Test Module Selected For Test Test Result

------------------------------------------------------------

Digital electronics test No N/A

Integration test Yes Pass
Quantification test Yes Pass
Print Analytical Report Yes N/A

ChemStation Verification Test Overall Results: Pass

Instrument 1 06-Mar-06 11:07:18 AM Page 1 of 1

4 Operational Qualification (OQ) Phase
Certificates showing tracebility of:

Certificates showing tracebility of:

Agilent 1200 Series Qualification Workbook

 Operational Qualification (OQ) Phase 4
Certificates showing tracebility of:

Standard: Caffeine Kit

Agilent 1200 Series Qualification Workbook

 Certificate of Analysis

Caffeine Standards Kit

Part No 8500-6762 Lot No OC367446

Concentrations:
Caffeine in water:

Nominal value Effective value determined by UV-

spectroscopy using the absorption
maximum at 273 nm
500 µg/ml 480.6 µg/ml + 1,5 %
250 µg/ml 241.3 µg/ml + 1,5 %
125 µg/ml 120.6 µg/ml + 1,5 %
25 µg/ml 24.5 µg/ml + 2 %
5 µg/ml 4.85 µg/ml + 5 %

Purity grades:

Caffeine: extra pure, acc. to Ph. Eur.

Concentration (acid. titration): 98.5 – 101.5 %
Heavy metals (as Pb): < 0.001%
Loss on drying (105°C): < 0.5%
Water: 18.2 MO x cm

The standards in this kit have been produced gravimetrically using ISO 9000 quality procedures.
Balances used are calibrated regulary against PTB (Physikalisch Technische Bundesanstalt [Federal
Physical-Technical Institute] – Braunschweig – Germany) traceable weight sets.

The standards have been analysed on a high-performance UV/VIS/NIR spectrophotometer. The

spectrophotometer is regularly validated for accuracy and reproducibility of absorbance and wavelength
as well as for linearity, baseline drift, stray light and spectral resolution power using the following testing
materials:

Absorbance: NIST SRM 1930 and double aperture method

Wavelength: NIST SRM 2034, emission lines of D2-, Hg- and Ar-lamps
Stray light: NIST SRM 2032
Spectral resolution power: Half width value of D2 emission lines for checking the effective optical
bandwidth
UV/VIS Spectrum Caffeine in water [concentration: 125 µg/ml]

2,0 Wavelength Absorbance

1,8

1,6 (205 nm) (maximum)

1,4
(245 nm) (minimum)
(273 nm) (maximum)
Absorbance

1,2

1,0

0,8

0,6

0,4

0,2

0,0
2 0 0 2 2 5 2 5 0 2 7 5 3 0 0

W a v e l e n g t h [ n m ]

Date of release: 03.12.2002

Expiration date: 31.12.2004 Wolfgang Gernand

Analytical manager
4 Operational Qualification (OQ) Phase
Certificates showing tracebility of:

Holmium Oxid Glass Filter (Type Hoya HY-1)

Agilent 1200 Series Qualification Workbook

 Declaration of Conformity

We herewith inform you that the

Holmium Oxide Glass Filter (Type Hoya HY-1)

(Part No. 79880-22711)

meets the following specification of absorbance maxima positions:

Product Series Measured Wavelength Optical

Number Wavelength * Accuracy Bandwidth
79883A 1090 361.0 nm +/- 1 nm 2 nm
79854A 1050 418.9 nm
G1306A 1050 453.7 nm
G1315A 1100 536.7 nm
G1315B/C 1100 / 1200
G1600
79853C 1050 360.8nm +/- 2 nm 6 nm
418.5nm
536.4nm
G1314A/B/C 1100 / 1200 360.8nm +/- 1 nm 6 nm
418.5nm
536.4nm

*) The variation in Measured Wavelength depends on the different Optical Bandwidth.

Agilent Technologies guarantees the traceability of the specified absorbance maxima to a National Institute of
Standards & Technology (NIST) Holmium Oxide Solution Standard with a lot-to-lot tolerance of ± 0.3 nm.

The wavelength calibration filter built into the Agilent Technologies UV-VIS detectors is made of this
material and meets these specifications. It is, therefore, suitable for wavelength calibration of these detectors
within the specified wavelength accuracy of the respective detector over its wavelength range.

January 13, 2006

---------------------------------
(Date)

-------------------------------------- --------------------------------------
(Engineering Manager) (Quality Manager)

P/N 89550-90501
*89550-90501*
Revision: E
Effective by: Jan 13, 2006 A
 Operational Qualification (OQ) Phase 4
Customer contributed material

Customer contributed material

Agilent 1200 Series Qualification Workbook

4 Operational Qualification (OQ) Phase
Customer contributed material

Agilent 1200 Series Qualification Workbook

 Agilent 1200 Agilent 1200 Series
Qualification Workbook

5
Performance Qualification (PQ) Phase
Preventive Maintenance Checklist
Agilent 1200 Series Liquid Chromatograph Preventive Maintenance
Checklist
Agilent 1200 Series Liquid Chromatograph Scorp of Work Preventive
Maintenance
Agilent 1100/1200 Series LC/MSD Quad Major Preventive
Maintenance Checklist
Agilent 1100/1200 Series LC/MSD Quad Major Interim Preventive
Maintenance Checklist
System performance and noise
Customer contributed material

For the items marked with a * example pages are added. It is the
responsibility of the user to replace these with the originals. The user should
feel free to add further documents, e.g. not supplied by Agilent Technologies
whenever he thinks this is appropriate.

Agilent Technologies
5 Performance Qualification (PQ) Phase
Preventive Maintenance Checklist

Preventive Maintenance Checklist

Agilent 1200 Series Qualification Workbook

 Performance Qualification (PQ) Phase 5
Preventive Maintenance Checklist

Agilent 1200 Series Liquid Chromatograph Preventive Maintenance

Checklist

Agilent 1200 Series Qualification Workbook

Agilent 1200 Series
Liquid Chromatograph

Preventive Maintenance Checklist

Purpose of Procedure ‰ Check for proper mounting and ‰ Replace PTFE Frit, gold seal, and
functionality of all leak sensors. plastic cap in purge valve.
Preventive Maintenance is an Agilent ‰ Wash deposits from each leak ‰ Replace the sieve, gold seal, and
Technologies recommended procedure sensor. plastic cap in the outlet ball valve
designed to reduce the likelihood of (2x for G1312A).
electro-mechanical failures. Failure to ‰ Open purge valve and attach
perform preventive maintenance may
PUMPS restriction capillary to purge valve.
reduce the long-term reliability of Prime applicable channel into a
certain instruments and systems. G1310A/11A/12A – Pump suitable container with IPA for 10
minutes. For a Binary pump, prime
Customer Responsibilities ‰ 1. Record model number Channel A. For a Binary pump
with a solvent selection valve,
Customers should ensure that all __________________________ prime Channel A2. For a
necessary operating supplies, Quaternary pump, prime Channel
consumables and usage dependent items ‰ 1. Record serial number D. While purging, begin
such as paper, pens, solvents (HPLC maintenance on the sampler (or
grade water, 2-propanol) are available. __________________________ manual injection valve) and
Analytical columns should be removed Column Compartment if installed.
from the column compartment, the ‰ 2. Record model number ‰ Close purge valve.
system should be flushed with HPLC- ‰ Perform built-in leak test.
grade water and all samples removed __________________________
from the autosampler. A Customer 1. Result
Representative should be available ‰ 2. Record serial number Pass/Fail
while performing the preventive 2. Result
maintenance procedure. __________________________ Pass/Fail
3. Result
LC System ‰ 3. Record model number Pass/Fail
Note – Complete the PM Checklist __________________________
in the order given. G1376A Capillary Pump
G2226A Nano Pump
‰ 3. Record serial number
‰ Ask Customers if they would like
‰ Record serial number
the module(s) firmware updated. If __________________________
firmware is to be updated, the
__________________________
Firmware IQ attachment form must ‰ Remove and disassemble pump
be filled out and appended to the head(s). ‰ Remove and disassemble pump
instrument IQ. ‰ Remove and clean plungers. heads.
‰ Clean support rings. ‰ Remove and clean plungers.
Firmware Updated? ______YES ‰ Remove old seals, clean piston ‰ Clean support rings.
______NO chambers, and replace seals. ‰ Remove old seals, clean piston
‰ If the seal wash option is installed, chambers, and replace seals.
‰ Check instrument logbook and remove and replace wash seals and ‰ Reassemble pump-heads and install
exclude maintenance on recently gaskets. Replace the seal wash on metering drive.
serviced items. pump cassette, if the NEW active ‰ Go to the “Normal Mode” and
‰ Perform general inspection of each seal wash is installed. perform a seal wear-in procedure
LC module. ‰ Reassemble pump-head(s) and for standard seals ONLY.
‰ Check that each waste tray and install on metering drive. ‰ Replace PTFE Frit, gold seal, and
interface is properly mounted. ‰ Perform seal wear-in procedure for plastic cap in purge valve (if the
standard seals ONLY.

Issued: Feb, 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies WAD Product Support Page 1 of 11
Agilent 1200 Series
Liquid Chromatograph

Preventive Maintenance Checklist

pump is used in Normal Mode) ‰ Remove and disassemble pump

‰ Replace the sieve, gold seal, and head. __________________________
plastic cap in the outlet ball valve ‰ Remove and clean plungers. ‰ Replace rotor seal.
(2x). ‰ Clean support rings. ‰ Replace the needle and the needle
‰ Change the frit located in the filter ‰ Remove old seals, clean piston seat assembly.
in front of the EMPV. chambers, and replace seals. ‰ Clean the transport unit rods, using
‰ Perform the EMPV test procedure. ‰ Reassemble pump-head and install a lint free cloth and IPA. DON’T
on metering drive. use any lubricant for the transport
‰ Replace the filter cup in the Multi unit rods!
Result Pass/Fail Assy. ‰ Check that the ALS Thermostat
‰ Pump 200 ml of IPA through the unit drain tube is positioned
pump. correctly (if applicable).
‰ Perform built-in pressure test.
‰ Replace the SST filter assembly. ‰ Purge Autosampler and Column
‰ Replace the seal wash pump Compartment with IPA for 5
cartridge and tubings. minutes.
Result Pass/Fail ‰ Perform the EMPV cleaning ‰ If the Column Compartment
procedure. contains a Column Switching
• If the system is used in micro Valve, Cap outlet of ALS with
mode, perform the “Micro mode 1. Result blank nut. Otherwise, Cap outlet of
pressure test”: Pass/Fail Column Compartment with
2. Result blanking nut.
‰ Perform built-in pressure test
Pressure Pass/Fail Pass/Fail
value
Flow Pass/Fail
‰ Prime system with IPA.
‰ Perform built-in leak test. 1. Result Pass/Fail
• If the system is used in normal 2. Result Pass/Fail
mode, perform the “Normal mode 1. Result Pass/Fail
pressure test”:
2. Result Pass/Fail G1328B Manual Injector
Slope of Pass/Fail 5065-9922 Prep. Manual Injector
Pressure ramp
Pressure Pass/Fail SAMPLERS ‰ 1. Record model number
value
Final Pass/Fail G1329A - Autosampler __________________________
Pressure drop G2260A Prep. Autosampler
‰ 1. Record serial number
G1361A Preparative Pump ‰ 1. Record model number
For a binary setup perform these steps __________________________
for both pumps __________________________
‰ Replace rotor seal.
‰ 1. Record serial number. ‰ 1. Record serial number ‰ Purge Injector and Column
Compartment with IPA for 5
__________________________ __________________________
minutes.
‰ If the Column Compartment
‰ 2. Record model number contains a Column Switching
‰ 2. Record serial number. Valve, Cap outlet of Injector with
__________________________
blank nut. Otherwise, Cap outlet of
__________________________ Column Compartment with
‰ 2. Record serial number

Issued: Feb, 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies WAD Product Support Page 2 of 11
Agilent 1200 Series
Liquid Chromatograph

Preventive Maintenance Checklist

blanking nut. Column Compartment with __________________________

‰ Perform built-in pressure test blanking nut.
‰ Perform Pressure Test ‰ 2. Record model number
Result Pass/Fail
__________________________
G1367B High Performance 1. Result Pass/Fail
Autosampler
G1377A Micro Well Pl. Sampler 2. Result Pass/Fail ‰ 2. Record serial number
G2258A Dual Loop Autosampler
__________________________
‰ 1. Record model number
COLUMN
‰ 3. Record model number
COMPARTMENT
__________________________
G1316A Column Compartment __________________________
‰ 1. Record serial number
‰ 3. Record serial number
‰ Record serial number
__________________________
__________________________
__________________________
‰ 2. Record model number ‰ Replace Column Switching Valve
Rotor Seal if installed. G1157A, G1158A G1159A,
‰ If Column Switching Valve Rotor G1160A
__________________________ ‰ Replace rotor seal and stator face.
Seal has been replaced, purge
Column Compartment with IPA for ‰ Inspect valve fittings and capillaries
‰ 2. Record serial number
5 minutes. Then Cap outlet of for leaks.
__________________________ Column Compartment with
blanking nut and perform a built-in G1162A, G1163A
‰ Replace rotor seal.
pressure test. ‰ Replace rotor seal.
‰ Replace the needle and the needle ‰ Inspect valve fittings and capillaries
seat assembly (for all samplers for leaks.
except for the G2258A DLA. For
the DLA, this only has to be Result Pass/Fail
performed, if the needle is bent or DETECTORS
needle/needle seat are leaky. Must ‰ Perform thermostat test.
be billed separately as a repair).
‰ Inspect G2258A DLA capillaries G1314B/C – VWD
and tubings for kinks and damages Result Pass/Fail ‰ Record serial number
and replace, if necessary, must be
billed separately as a repair. ‰ Purge LC System with HPLC –
‰ Replace the peristaltic pump __________________________
grade water for 10 minutes. ‰ Inspect flow cell for leaks.
cartridge
‰ Check that the ALS thermostat unit ‰ Perform Holmium Oxide Test.
drain tube is positioned correctly (if VALVES ’
applicable) Result Pass/Fail
‰ Purge Autosampler and Column ‰ 1. Record model number ’ If test fails perform Wavelength
Compartment with IPA for 5 min. Calibration.
‰ If the Column Compartment __________________________ ‰ Perform intensity test.
contains a Column Switching
Valve, Cap outlet of ALS with ‰ 1. Record serial number Result Pass/Fail
blank nut. Otherwise, Cap outlet of

Issued: Feb, 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies WAD Product Support Page 3 of 11
Agilent 1200 Series
Liquid Chromatograph

Preventive Maintenance Checklist

G1315B/C – DAD
G1365B/C – MWD ‰ Perform intensity test.
FRACTION
‰ 1. Record model number COLLECTORS
1. Result Pass/Fail
__________________________ G1364B/C/D – Fraction Collector
2. Result Pass/Fail
‰ 1. Record serial number ‰ 1. Record model number
3. Result Pass/Fail
__________________________ __________________________
G1321A FLD
‰ 2. Record model number ‰ 1. Record serial number
‰ Record serial number
__________________________ __________________________
__________________________
‰ 2. Record serial number ‰ 2. Record model number
‰ Inspect flow cell for leaks.
__________________________ __________________________
‰ Verify the operation of the detector.
‰ Perform the Lamp Intensity Test
‰ Inspect flow cell for leaks. ‰ 2. Record serial number
‰ Perform the Wavelength
‰ Perform filter test and attach results ’ Verification Test using the Raman
to checklist band. __________________________
‰ Perform dark current test.
Lamp Pass ‰ 3. Record model number
Intensity Fail
1. Result Pass/Fail WL Excitation __________________________
Verif. Deviation
2. Result Pass/Fail WL Emission ‰ 3. Record serial number
Verif. Deviation
3. Result Pass/Fail ’ If test fails perform Wavelength
__________________________
Calibration.
‰ Perform Holmium Oxide Test. ‰ 4. Record model number
G1362A – RID
’ __________________________
1. Result Pass/Fail ‰ Record serial number
’ ‰ 4. Record serial number
2. Result Pass/Fail __________________________
’ ‰ Check diode balance with pure
__________________________
3. Result Pass/Fail water in both, the reference and the
sample cell, instrument stable as ‰ 1) Replace the inlet / waste
’ If test fails perform Wavelength
specified tubings
Calibration. ‰ 2) Replace the valve to needle
tubings
‰ Check that the ALS Thermostat
Result Value
unit drain tube is positioned
correctly (if applicable).
‰ Adjust optical balance if value >
+/- 0.2

Issued: Feb, 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies WAD Product Support Page 4 of 11
Agilent 1200 Series
Liquid Chromatograph

Preventive Maintenance Checklist

SERVICE REVIEW handling of hazardous mobile phase

is a Customer responsibility.
‰ If a ChemStation is the Instrument ‰ Record in Instrument Logbook that ‰ Service Order (SO) Number
Controller, attach printouts of all a PM was performed.
‰ Update customer logbooks and
_____________________________
tests completed to this Preventive
Maintenance Checklist. EMF sections. ‰ Date completed
‰ If the Instrument Firmware was ‰ Affix the PM Sticker to the 1200 _____________________________
updated, complete the IQ system or Instrument Logbook as
attachment protocol and append it specified by the Customer. ‰ Customer Signature
to the instrument IQ. * If the PM is being performed in
‰ Make a test injection of a dilute test advance of an OQPV, use the _____________________________
mixture (1 drop of Acetone in a protocol as guide for Checkout and
2ml vial of water) with no column. Setup. ‰ Support Provider Signature
* Use the DETECTOR conditions
specified in method OQGRAD.M.
‰ Prime system with Customer’s
_____________________________
mobile phase. * Note – Special

Issued: Feb, 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies WAD Product Support Page 5 of 11
Agilent 1200 Series
Liquid Chromatograph

Preventive Maintenance Checklist

Parts Requirements

Please Note: Any parts, not included in the parts lists given below, are not part of the
recommended Preventive Maintenance Procedure, nor are they included in the price of this service.
If a system has a special setup/configuration that requires the use of additional or special parts for the
instrument service, then these parts must be ordered separately and billed as a repair.
If a customer demands additional service that is not listed in the procedures described above to be
performed at his/her instrumentation, then the additional service must be ordered separately and billed
as a repair as well as any additional parts consumed.

G1310A/11A/12A – Pump

This maintenance procedure requires the following consumables.

G1310A/11A Isocratic / Quarternary Pumps kit G1310-68730, consists of:

2x Seals 5063-6589 Standard (Pack of 2)
Purge-Valve Assembly
1x PFTE Frit 01018-22707 (pack of 5)
1x Outlet Gold seal 5001-3707
1x Outlet Cap 5042-1346
Outlet Ball Valve Assembly
1x Outlet Gold seal 5001-3707
1x Outlet Cap 5042-1346

Issued: Feb, 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies WAD Product Support Page 6 of 11
Agilent 1200 Series
Liquid Chromatograph

Preventive Maintenance Checklist

G1312A Binary Pump kit G1312-68730, consists of:

4x Seals 2x 5063-6589 Standard (Pack of 2)
Purge-Valve Assembly
1x PFTE Frit 01018-22707 (pack of 5)
1x Outlet Gold seal 5001-3707
1x Outlet Cap 5042-1346
Outlet Ball Valve Assembly
2x Outlet Gold seal 5001-3707
2x Outlet Cap 5042-1346
2x Sieve 5063-6505 (pack of 10, needed for binary pump, only)

G1310A/11A/12A Isocratic / Quarternary / Binary Pumps kit for SEALWASH G1310-68731,

consists of:
2x Wash Seal 0905-1175 and
2x Wash Seal Gasket 5062-2484 (pack of 6),

Seal wash items are needed only, if the seal wash option is installed.
The kit above is needed twice for a G1312A binary pump.

G1361A – Preparative Pump

This maintenance procedure requires the following consumables for each pump (the parts are all
included in the G1361-68710 Prep. Pump PM kit):

Pump Head Assembly

4x Prep Flange Seals 5022-2188
Multi-Assy
1x Filter cup 3150-0942
1x SST Filter Assy 5022-2192
Seal wash pump
1x Cartridge 5042-8507
1x Tubing 0890-1764
2x Fittings 5042-6422

Issued: Feb, 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies WAD Product Support Page 7 of 11
Agilent 1200 Series
Liquid Chromatograph

Preventive Maintenance Checklist

G1376A – Capillary Pump or G2226A – Nano Pump

This maintenance procedure requires the following consumables:

Pump Head Assembly

2x Seals 5063-6589 Standard (Pack of 2) or
Purge-Valve Assembly (if pump is to be used in Normal mode)
1x PFTE Frit 01018-22707 (pack of 5)
1x Outlet Gold seal 5001-3707
1x Outlet Cap 5062-2485 (pack of 4)
Outlet Ball Valve Assembly
2x Sieve 5063-6506 (pack of 10)
2x Outlet Gold seal 5001-3707
2x Outlet Cap 5062-2485 (pack of 4)
Filter Assembly
1x Frit 5022-2185

Issued: Feb, 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies WAD Product Support Page 8 of 11
Agilent 1200 Series
Liquid Chromatograph

Preventive Maintenance Checklist

G1329A – Autosampler and G2260A Preparative Autosampler

This maintenance procedure requires the following consumables:

For G1329A (these parts are all included in the G1313-68730 Autosampler PM kit):
1x Rotor seal 0100-1853 (Vespel®)
1x Needle Seat G1313-87101 with 0.17mm ID capillary (std.)
1x Needle G1313-87201 (for 100 micro-liter head)

For G2260A
1x Rotor Seal and Stator Face kit 0101-1268 (PEEK®)
1x Needle Seat G2260-87101 with 0.50mm ID capillary
1x Needle G2260-87201

Issued: Feb, 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies WAD Product Support Page 9 of 11
Agilent 1200 Series
Liquid Chromatograph

Preventive Maintenance Checklist

G1367B Well Plate Sampler, G1377A Micro Well Plate Sampler and G2258A Dual
Loop Autosampler
This maintenance procedure requires the following consumables:

For G1367B (these parts are all included in the G1367-68730 Wellplate Autosampler PM kit):
1x Rotor seal 0100-1853 (Vespel®)
1x Needle seat G1367-87101
1x Needle G1367-87201
1x Peristaltic pump cartridge 5065-4445
1x nut for sample loop fitting 0100-2086

For G1377A
1x Rotor seal 0100-2088 (Vespel®)
1x Needle seat G1377-87101
1x Needle G1377-87201
1x Peristaltic pump cartridge 5065-4445

For G2258A
1x Rotor seal 0100-2415 (Vespel®)
1x Peristaltic pump cartridge 5065-4445 (with Pharmed tubing)
Note: If the following parts replacements are necessary because the needle is deformed or if
needle/seat are leaking these are not covered by the PM and they MUST be BILLED
SEPARATELY as a REPAIR:
1x Needle seat G2258-87102
1x Needle G2258-87306
1x Fitting kit 2mm 5065-9950
Note: After a needle has been replaced several times, the buffer loop capillary will become too
short and will also have to be replaced:
1x buffer loop capillary G2258-87300

G1328B – Manual Injection Valve and 5065-9922 Prep. Manual Injection Valve
This maintenance procedure requires the following consumables:

1x Rotor seal 0101-0623 (Vespel®) for analytical scale manual injection valve (G1328A/B) or
1x Rotor seal 0101-1233 (PEEK®)
for preparative scale manual injection valve 5065-9922.

Issued: Feb, 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies WAD Product Support Page 10 of 11
Agilent 1200 Series
Liquid Chromatograph

Preventive Maintenance Checklist

G1316A – Column Compartment

This maintenance procedure requires the following consumables only if a column-switching valve is
installed (G1316A #055 1200 Series 2PS/6PT or G1316A #057 1200 Series 2PS/10PT Valve options):

1x Rotor seal 0100-1854 (Tefzel®) for valve opt. #055 or

1x Rebuild Kit 0101-1359 (Rotor Seal and Stator Face) for valve option #057.

G1157A, G1158A, G1159A, G1160A, G1162A, G1163A - 1200 Series Valves

This maintenance procedure requires the following consumables:

1x Rebuild kit 0101-1359 (Rotor seal and Stator Face) for G1157A
1x Rebuild kit 0101-1358 (Rotor seal and Stator Face) for G1158A
1x Rebuild kit 0101-1290 (Rotor seal and Stator Face) for G1159A
1x Rebuild kit 0101-1288 (Rotor seal and Stator Face) for G1160A
1x Rotor seal 0100-2087 for G1162A
1x Rotor seal 0101-1361 for G1163A

Detectors: G1314B/C VWD, G1315B/C DAD and G1365B/C MWD, G1321A FLD
and G1362A RID
The maintenance procedure requires NO consumables.

G1364B/C/D – Fraction Collector

This maintenance procedure requires the following consumables.

Inlet/waste tubing and valve to needle tubing kit

G1364-68712 for AS fraction collectors G1364A #050 and G1364C or G1364-68711
for PS fraction collectors G1364A or G1364B).
Capillary assembly for G1364D Micro Fraction collector
G1364-87304 (25 micro-m ID) or
G1364-87305 (50 micro-m ID) or
G1364-87306 (100 micro-m ID).

Issued: Feb, 2006 – Rev. 1.0 Copyright © 2006 Agilent Technologies WAD Product Support Page 11 of 11
5 Performance Qualification (PQ) Phase
Preventive Maintenance Checklist

Agilent 1200 Series Liquid Chromatograph Scorp of Work

Preventive Maintenance

Agilent 1200 Series Qualification Workbook

Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

Scope of Work
Preventive Maintenance for the 1200 Series
Liquid Chromatograph
SCOPE OF WORK

Preventive Maintenance for the Agilent 1200 Series Liquid Chromatograph

1. SCOPE
This document provides details of the procedures necessary for the successful completion of a Preventive
Maintenance (PM) service call for the 1200 Series Liquid Chromatograph. It clarifies responsibilities
and assures uniform delivery of the service. Only Support Providers trained and certified by Agilent
Technologies will provide the service. Support Providers are Agilent Customer Engineers (CE’s)
and/or Agilent Authorized Support Providers (ASPs). Services to other documents are included to
supply additional information (such as part numbers) or to provide clarity.

Delivery time for completion of the PM call is approximately 4.0 hours for a system comprising a pump,
degasser, column compartment, autosampler or manual injector, and a detector. One hour should be
added for each additional detector. Time starts when the Support Provider arrives at the Customer site
and ends when he/she leaves the site. The PM Checklist (a separate document) details the steps
necessary for completion.

NOTE: This document is to be used by Agilent Employees and Agilent ASPs, and is not to be
provided to Customers.

2. CUSTOMER RESPONSIBILITIES
In preparation for the service call, the Call Initiator (see section 3.1 below for a definition of the Call
Initiator) verifies with the Customer that the Support Provider has:

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 1 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

• Access to the liquid chromatograph scheduled for PM and adequate downtime to complete the
procedure.

• Adequate working space around the liquid chromatograph, with all supplies nearby.

• A representative (for example, the operator) present at all times when Support Provider is
performing this service.

• The system flushed with HPLC grade water, samples removed from the Autosampler (ALS), and
analytical columns removed from the column compartment.

• Normal operating supplies available including consumables and usage-dependent items such as
paper, pens, and solvents (HPLC grade water, isopropanol, methanol, acetone).

• Failure to provide the above may reduce applicable tests performed in the PM (that is, pressure test,
test injection).

3. AGILENT RESPONSIBILITIES
3.1 Scheduling—The Call Initiator
The service call begins with a call to the Customer by the “Call Initiator.” The Call Initiator may be the
Support Provider, a workload administrator, or a dispatcher, depending on local processes. The Call
Initiator:

1. Calls the Customer, schedules the date and time for service, and confirms Customer preparation.

2. Discusses possible problem areas before the Support Provider goes on site.

3. Asks the Customer to log a service call, if the instrument is not functional.

3.2 Support Provider Responsibilities

All Support Providers shall be Agilent trained and certified to work on 1200 Series Liquid
Chromatographs and the applicable detectors. Support Providers shall take necessary Electro-Static
Discharge (ESD) precautions (see appropriate Hardware Manual) when working on or near printed
circuit boards or other sensitive assemblies.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 2 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

3.2.1 Delivery

1. Brings all necessary tools, supplies and parts to complete the procedure (see 1200 Series
Service/Service Manuals for list of tools, supplies and parts) including:

− Restriction capillary (5022-2159) for seal wear-in procedure

− Blank nut (01080-83202) for pressure/leak test

2. Has access to the latest 1200 Firmware @ http://www.chem.agilent.com/scripts/cag_firmware.asp

3. Supplies consumables used during the PM. See sections 4.1.4 through 4.1.11 and 4.1.16 of this
document for a list of included consumables.

4. Completes all steps in the PM Checklist applicable to the instrument.

NOTE: The PM Checklist is a separate document.

3.2.2 Documentation

1. Writes the date service was completed on the PM sticker.

2. Applies PM sticker to the instrument or instrument logbook.

3. Completes Firmware IQ Attachment Form if 1200 firmware was updated.

4. Asks the Customer to sign the PM Checklist acknowledging the completion of service.

5. Signs the PM Checklist.

6. Affixes all data generated to the PM Checklist and gives it to the Customer for addition to the
instrument logbook.

4. PM CHECKLIST
Refer to the 1200 Series PM Checklist.

Support Provider completes the Checklist whether or not the instrument is fully operational.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 3 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

4.1 PM Task Details

4.1.1 Customer responsibilities

1. Customer has system flushed with HPLC grade water, all samples removed from the ALS, and
analytical columns removed from the column compartment.

2. Customer has isopropanol (IPA) and HPLC grade water in the appropriate mobile phase containers
available for the procedure.

3. Customer saves all methods and sequence files prior to PM start.

4.1.2 PM checklist

1. Verify that the Customer has removed analytical column. If still present, remove it now.

2. Verify with the Customer that system was flushed with HPLC grade water. If not, flush system
now.

3. If 1200 firmware is to be updated, verify that Customer has backed-up all methods.

4. Complete the PM Checklist in the order given.

5. If any module fails a test, record the results in the Test Results box and complete the rest of the
PM Checklist.

NOTE: In the event of any test failure, the Support Provider will log a service call, if the
Customer has a service contract. If the Customer does not have a service contract, the
Support Provider will inform the Customer of the failure (leak, inoperable sensor, test,
etc.), and offer to log a Time and Material service call for the Customer.

4.1.3 Liquid chromatograph system

1. Check firmware revisions of modules to be serviced:

− For systems with a Control Module, select VIEWS>SYSTEM>RECORDS.

− For systems with ChemStation, select METHOD AND RUN CONTROL and ensure that FULL
MENU is selected. Select INSTRUMENT>REVISIONS AND SERIAL #S.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 4 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

− If firmware is not current, ask Customer if they would like the firmware updated. If the
Customer chooses to have the firmware updated, update the firmware following the procedure in
the 1200 IQ Attachment Form. This document is available from the EPI Warehouse @
http://whadmin.pal.agilent.com/SrchAdv.asp by searching for “1200 PM Checklist.” The 1200
IQ Attachment Form AND the 1200 PM Checklist will be retrieved. The 1200 IQ Attachment
Form is to be used only once.

− If the firmware is updated again at a later date, an additional 1200 IQ Attachment Form must be
used after obtaining the required Customer approval.

2. Record the module model number and serial number on the PM Checklist. If the model/serial
number is not included in the 1200 system, record N/A (not applicable) in this area and N/A in the
module Tests Result box.

3. Check the instrument logbook for recently serviced items. Exclude maintenance on items that were
replaced within 90 days of the current PM.

4. Perform a general inspection of each LC module. Alert the Customer to any potential safety issues
(waste container full, frayed wiring, drain tubes blocked, etc.).

5. Check that all waste trays/interfaces are properly mounted as per the 1200 Series Installation Guide.

6. Check for proper mounting and functionality of all leak sensors. Wash off each sensor with water.
If the sensor is functioning, the LC module indicator light will change to red indicating a leak. Dry
off sensor using a tissue or paper towel.

7. For tests performed, attach printed results to the PM Checklist.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 5 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

4.1.4 G1310A/11A/12A Isocratic / Quaternary / Binary Pumps

1. This maintenance procedure requires the consumables found in the parts list at the end of this
document.

2. Switch off power to the pump.

3. Remove and disassemble the pump head following the procedure in the 1200 Pump Service Manual.

4. Clean the plungers with methanol or toothpaste. If toothpaste is used, take care to wash off any
residual toothpaste with water or methanol.

5. Clean the support rings and springs in the pump housing with water or methanol. A toothbrush can
be used to help remove stubborn deposits.

6. Exchange the pump seals following the procedure in the 1200 Pump Service Manual.

7. If the seal wash option is installed remove and replace wash seal and gasket as specified in
1200 Pump Service Manual.

8. Reassemble the pump head assembly following the procedure in the 1200 Pump Service Manual.

9. Prepare a bottle of isopropanol and perform the seal wear-in procedure as defined in the 1200 Pump
Service Manual. The use of a restriction capillary (5022-2159) is required.

NOTE: This procedure is required for standard seals only (5063-6589). Performing this
procedure on the normal phase application seals (0905-1420) will damage them.

10. Replace the purge valve frit, gold seal, and plastic cap following the procedure in the 1200 Pump
Service Manual.

11. Replace the outlet ball valve sieve (binary pump), gold seal, and plastic cap as described in the 1200
Pump Service Manual.

12. Using the same bottle of isopropanol, immerse solvent filter into the solvent and attach restriction
capillary to purge valve.

13. Prime appropriate channel at 3mL/min (lower flow rate may be needed to avoid overpressure) for
10 minutes with the purge closed. For a binary pump, purge Channel A. For a binary pump with a

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 6 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

solvent selection valve, purge Channel A2. For a quaternary pump, purge Channel D. This will
require >30mL of isopropanol.

14. While purging, begin maintenance on the Sampler or Manual Injector and Column Compartment, if
installed.

15. Close purge valve.

16. Cap the outlet of the pump with a blanking nut (01080-83202). Perform the built-in leak test
following the procedure in the 1200 Pump Service Manual.

17. If the test fails, reprime the system for an additional 5 minutes and rerun the test. Continued failure
may indicate an improperly assembled pump or a loose fitting.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 7 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

4.1.5 G1361A Preparative Pumps

1. This maintenance procedure requires the consumables found in the parts list at the end of this
document.

2. Switch off power to the pump.

3. Remove and disassemble the pump head following the procedure in the 1200 Prep Pump Service
Manual.

4. Clean the plungers with methanol or toothpaste. If toothpaste is used, take care to wash off any
residual toothpaste with water or methanol.

5. Exchange the pump seals (front and rear, left and right) following the procedure in the 1200 Prep
Pump Service Manual.

6. Reassemble the pump head assembly following the procedure in the 1200 Prep Pump Service
Manual.

7. Replace the filter cup in the multi assembly following the procedure in the 1200 Prep Pump Service
Manual.

8. Pump 200 mL of IPA through the pump before replacing the SST filter assembly.

9. Replace the SST filter assembly following the procedure in the 1200 Prep Pump Service Manual.

10. Replace the seal wash pump cartridge following the procedure in the 1200 Prep Pump Service
Manual.

11. Perform the EMPV cleaning procedure as described in the 1200 Prep Pump Service Manual.

12. Perform the built-in leak test following the procedure in the 1200 Prep Pump Service Manual.

13. If the test fails, reprime the system for an additional 5 minutes and rerun the test. Continued failure
may indicate an improperly assembled pump or a loose fitting.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 8 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

4.1.6 G1376A Capillary Pumps and G2226A Nano Pumps

1. This maintenance procedure requires the consumables found in the parts list at the end of this
document.

2. Switch off power to the pump.

3. Remove and disassemble the pump head following the procedure in the 1200 Capillary or Nano
Pump Service Manual.

4. Clean the plungers with methanol or toothpaste. If toothpaste is used, take care to wash off any
residual toothpaste with water or methanol.

5. Exchange the pump seals following the procedure in the 1200 Capillary or Nano Pump Service
Manual.

6. Reassemble the pump head assembly following the procedure in the 1200 Capillary or Nano Pump
Service Manual.

7. Replace the purge valve frit, gold seal, and plastic cap following the procedure in the 1200 Capillary
or Nano Pump Service Manual (that is if the pump is used in “Normal Mode” and a manual purge
valve is installed).

8. Replace the outlet ball valve sieve, gold seal, and plastic cap as described in the 1200 Capillary or
Nano Pump Service Manual.

9. Change the frit located in the filter in front of the EMPV.

10. Perform the EMPV cleaning procedure following the instructions in Service Notes G1376-04A and
G1376-05.

11. Prepare a bottle of isopropanol and perform the seal wear-in procedure as defined in the
1200 Capillary or Nano Pump Service Manual. The use of a restriction capillary (5022-2159) is
required.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 9 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

NOTE: This procedure is required for standard seals only (5063-6589). Performing this
procedure on the normal phase application seals (0905-1420) will damage them.

12. Using the same bottle of isopropanol, immerse solvent filter into the solvent and prime Channel A2
at 2500μL/min for 10 minutes. This will require >25mL of isopropanol.

13. Cap the outlet of the pump with a blanking nut (01080-83202).

14. Perform the built-in pressure test following the procedure in the 1200 Capillary or Nano Pump
Service Manual.

− If you use the system in micro mode, perform the “Micro mode pressure test.”

− If you use the system in normal mode, perform the “Normal mode pressure test.”

15. If the test fails, reprime the system for an additional 5 minutes and rerun the test. Continued failure
may indicate an improperly assembled pump or a loose fitting.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 10 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

4.1.7 G1329A Autosamplers, G2260A Preparative Autosamplers

1. This maintenance procedure requires the consumables found in the parts list at the end of this
document.

2. Change the needle and needle seat using the change needle function of the Control Module or
ChemStation maintenance functions. Follow the procedure in the 1200 Autosampler Service
Manual.

3. Switch off power to the ALS.

4. Replace the rotor seal following the procedure in the 1200 Autosampler Service Manual.

5. Check that the chiller unit drain is positioned correctly (if applicable).

6. Purge ALS flow path with isopropanol for 5 minutes using the same channel as the previous
applicable pump maintenance section (4.1.4, 4.1.5, or 4.1.6).

7. If the column compartment contains a column switching valve, cap the outlet of the ALS with a
blanking nut. Otherwise, cap the outlet of the column compartment with the blanking nut (01080-
83202).

8. Run the built-in pressure test following the procedure in the 1200 Pump Service Manual.

9. If the test fails, reprime the system for an additional 5 minutes and rerun the test. Continued failure
may indicate an improperly assembled rotor seal or a loose fitting.

4.1.8 G1367B/G1377A/G2258A High Performance, Micro Well Plate, and Dual Loop
Autosamplers

1. This maintenance procedure requires the consumables found in the parts list at the end of this
document.

2. Switch off power to the ALS.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 11 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

3. Change the needle and needle seat using the change needle function of the Control Module or
ChemStation maintenance functions. Follow the procedure in the 1200 High Performance/Well
Plate Autosampler Service Manual. For the Dual Loop ALS G2258A, this procedure is performed
only if the needle is deformed or needle/seat is leaking (must be billed separately as a repair).

NOTE: The G2258A DLAs buffer loop capillary becomes shorter every time a needle is replaced.
After two to three replacements of the needle the buffer loop capillary must also be
exchanged (must be billed separately as a repair) when it has become too short to connect
the needle to it.

4. Inspect all G2258A DLA tubings and capillaries for visual signs of damage (kinks) and replace if
necessary (must be billed separately as a repair).

5. Replace the rotor seal following the procedure in the 1200 Series High Performance Autosampler &
Micro Well Plate Autoampler Service Manual.

6. Replace the peristaltic pump cartridge following the procedure in the 1200 Series Dual Loop
Autosampler Service Manual.

7. Check that the chiller unit drain is positioned correctly (if applicable).

8. Purge ALS flow path with isopropanol for 5 minutes using the same channel used in section 4.1.4.

9. If the column compartment contains a column switching valve, cap the outlet of the ALS with a
blanking nut. Otherwise, cap the outlet of the column compartment with the blanking nut (01080-
83202).

10. Run the built-in pressure test following the procedure in the 1200 Pump Service Manual.

11. If the test fails, reprime the system for an additional 5 minutes and rerun the test. Continued failure
may indicate an improperly assembled rotor seal or a loose fitting.

4.1.9 G1328B Manual Injection Valve / 5065-9922 Preparative Manual Injection Valve

1. This maintenance procedure requires the consumables found in the parts list at the end of this
document.

2. Replace the rotor seal following the procedure in the 1200 Series Manual Injector Service Manual.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 12 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

3. Purge injector flow path with isopropanol for 5 minutes using the same channel as the previous
applicable pump maintenance section (4.1.4, 4.1.5, or 4.1.6).

4. If the column compartment contains a column switching valve, cap the outlet of the injector
(port 3) with a blanking nut. Otherwise, cap the outlet of the column compartment with the
blanking nut (01080-83202).

5. Run the built-in pressure test following the procedure in the 1200 Pump Service Manual.

6. If the test fails, reprime the system for an additional 5 minutes and rerun the test. Continued failure
may indicate an improperly assembled rotor seal or a loose fitting.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 13 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

4.1.10 G1316A Column Compartments

1. This maintenance procedure requires the consumables found in the parts list at the end of this
document.

2. If a column switching valve is installed, replace the rotor seal as specified in the 1200 Column
Compartment Service Manual.

3. Purge column compartment with isopropanol for 5 minutes using the same channel used in
section 4.1.4.

4. Cap the outlet of the column compartment with a blanking nut (01080-83202).

5. Run the built-in pressure test following the procedure in the Pump Service Manual.

6. If the test fails, reprime the system for an additional 5 minutes and rerun the test. Continued failure
may indicate an improperly assembled rotor seal or a loose fitting.

7. Perform the thermostat test following the procedure in the ChemStation’s Diagnosis View and
attach results to the PM Checklist. If there is no ChemStation installed, create your own method on
the Control Module:

− Both Peltier elements must initially be equilibrated to 25 °C. This temperature is held for
12 seconds, and then the set point is changed to 20 °C. The time required to reach 20 °C is a
measure of the cooling efficiency of the Peltier elements.

− At 3.5 minutes, the set point is changed to 30 °C, and both elements begin heating. The time
required to reach 30 °C is a measure of heating efficiency.

− Upon completion of the test, the cooling and heating efficiencies of both Peltier elements must
be calculated and compared to the acceptance criteria: the cooling rate for each Peltier must be
greater than 2 oC/min, the heating rate for each Peltier must be greater than 3 oC/min.

• Initial set point: 25 oC, stop time 8.0 min

o
Timetable: Min C
0.20 25
0.21 20
3.50 20
3.51 30

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 14 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

• Record the time t1, when the set point for cooling (20 oC) is reached, subtract
t0= 0.21 min. The cooling efficiency is = 5 oC / (t1 –t0)

• Record the time t3, when the set point for heating (30 oC) is reached, subtract
t2= 3.51 min. The heating efficiency is = 10 oC / (t3 –t2)

8. Purge system with HPLC grade water for 10 minutes.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 15 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

4.1.11 G1157A/G1158A/G1159A/G1160A/G1162A/G1163A 1200 Series Valves

1. This maintenance procedure requires the consumables found in the parts list at the end of this
document.

2. Replace the rotor seal (and stator face) as specified in the 1200 Series Valves Operator’s Manual.

3. Purge valve(s) with isopropanol for 5 minutes using the same channel used in section 4.1.4.

4. Cap the outlet of the valve(s) with a blanking nut (01080-83202).

5. Run the built-in pressure test following the procedure in the pump Service manual.

6. If the test fails, reprime the system for an additional 5 minutes and rerun the test. Continued failure
may indicate an improperly assembled rotor seal or a loose fitting.

7. Purge system with HPLC grade water for 10 minutes.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 16 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

4.1.12 G1314B/C Variable Wavelength Detectors

1. Verify that the outlet of the flow cell is unrestricted and flows directly to the waste reservoir.

2. Remove the flow cell from the detector and establish 2mL/min flow rate using HPLC grade water.

3. Observe flow cell for any sign of a leak.

4. Reinstall the flow cell.

5. Perform the holmium oxide test as detailed in the 1200 VWD Service Guide. Record the value in
the Test Result box if this test passes.

− If this test fails, perform the wavelength calibration test also found in the 1200 VWD Service
Guide.

− If the wavelength calibration test is successful rerun the holmium oxide test. Record result in
the Test Result box.

6. Perform the intensity test as specified in the 1200 VWD Service Manual and attach results to the
PM Checklist.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 17 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

4.1.13 G1315B/C Diode Array Detectors and G1365B/C Multiple Wavelength Detectors

1. Verify that the outlet of the flow cell is unrestricted and flows directly to the waste reservoir.

2. Remove the flow cell from the detector and establish 2mL/min flow rate using HPLC grade water.

3. Observe flow cell for any sign of a leak.

4. Reinstall the flow cell.

5. Perform the filter test as specified in the 1200 DAD/MWD Service Manual and attach results to the
PM Checklist.

6. Perform the dark current test as specified in the 1200 DAD/MWD Service Manual and attach results
to the PM Checklist.

7. Perform the holmium oxide test as detailed in the 1200 DAD/MWD Service Guide. Record if this
test passes.

− If this test fails, perform the wavelength calibration test also found in the 1200 DAD/MWD
Service Guide.

− If the wavelength calibration test is successful rerun the holmium oxide test. Record result in
the Test Result box.

8. Perform the intensity test as specified in the 1200 DAD/MWD Service Manual and attach results to
the PM Checklist.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 18 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

4.1.14 G1321A Fluorescence Detectors

1. Verify that the outlet of the flow cell is unrestricted and flows directly to the waste reservoir.

2. Remove the flow cell from the detector and establish 2mL/min flow rate using HPLC grade water.

3. Observe flow cell for any sign of a leak.

4. Reinstall the flow cell.

5. Perform the lamp intensity test as specified in the 1200 FLD Service Manual and attach results to
PM Checklist.

6. Perform the wavelength verification test using the Raman band as specified in the 1200 FLD
Service Manual and attach results to PM Checklist. If this test fails, perform the wavelength
calibration test as specified in the 1200 FLD Service Manual.

4.1.15 G1362A Refractive Index Detectors

1. If not already performed, flush flow cell with water for 10 minutes.

NOTE: The instrument has to be switched to "Purge" for the flushing of both the Service and the
sample side of the flow cell.

2. Check the diode balance as specified in the 1200 RID Service Manual. Verify that the value does
not fall outside the range of –0.2 to +0.2. If value is outside the specified range, perform the optical
balance procedure as specified in the 1200 RID Service Manual. Verify that the diode balance is –
0.2 to +0.2 and record this value in the Test Result box of the PM Checklist.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 19 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

4.1.16 G1364B/C/D Fraction Collectors

1. This maintenance procedure requires the consumables found in Section 6 in the parts list at the end
of this document.

2. Replace the inlet/waste tubing assembly (G1364A/B/C) or the capillary assembly (G1364D) as
specified in the 1200 series Fraction Collectors Service Manual.

3. Replace the valve to the needle tubing assembly (not for G1364D) as specified in the 1200 Series
Fraction Collectors Service Manual.

4. Check that the chiller unit drain is positioned correctly (if applicable).

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 20 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

4.1.17 Service review

1. If ChemStation is the instrument controller, attach all printouts from tests performed to the
PM Checklist.

2. If the instrument firmware was updated at the request of the Customer, complete the IQ Attachment
Protocol and append it to the instrument IQ.

3. Make a test injection of a dilute mixture of acetone in water with no column. One drop in a
2mL vial of water should be sufficient. Use λ 265nm, 4nm BW, >0.01 min PW. Run time should
be 2 minutes or less. The presence of a peak will indicate that the system is plumbed correctly. IF
THE PM IS BEING PERFORMED IN ADVANCE OF AN OQ/PV, USE THE PROTOCOL AS A
GUIDE FOR THE CHECKOUT.

4. Prime system with Customer’s mobile phase. IF THE PM IS BEING PERFORMED IN

ADVANCE OF AN OQ/PV, USE THE PROTOCOL AS A GUIDE FOR THE CHECKOUT.

NOTE: Many Customers prefer that water be left on the system. Confer with the Customer prior
to loading Customer’s mobile phase.

5. Complete instrument logbook if available, stating that a PM was completed.

6. Affix a PM sticker to the 1200 system or the instrument logbook.

NOTE: Some Customers do not approve of the placement of a PM sticker on the instrument.
This is optional and only performed if the Customer approves.

7. Customer and Support Provider sign the PM Checklist indicating service was performed.

5. ACKNOWLEDGEMENTS
Tefzel® is a registered trademark of E.I. DuPont de Nemours Co., Inc.

Vespel® is a registered trademark of E.I. DuPont de Nemours Co., Inc.

PEEK™ is a trademark of Victrex PLC.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 21 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

6. PARTS REQUIREMENTS

Please Note: Any parts, that are not included in the parts lists given below are not part of the
recommended Preventive Maintenance Procedure, and therefore not included in the price of this service.

If a system has a special setup/configuration that requires the use of additional or special parts for the
instrument service, then these parts must be ordered separately and billed as a repair.

If a customer demands additional service that is not listed in the procedures described above to be
performed at his/her instrumentation, then the additional service must be ordered separately and billed
as a repair as well as any additional parts that may be required.

G1310A/11A/12A – Pumps
This maintenance procedure requires the following consumables:

G1310A/11A Isocratic / Quarternary Pumps kit G1310-68730, consists of:

2x Seals 5063-6589 Standard (Pack of 2)

Purge-Valve Assembly

1x PFTE Frit 01018-22707 (pack of 5)

1x Outlet Gold seal 5001-3707

1x Outlet Cap 5042-1346

Outlet Ball Valve Assembly

1x Outlet Gold seal 5001-3707

1x Outlet Cap 5042-1346

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 22 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

G1312A Binary Pump kit G1312-68730, consists of:

4x Seals 2x 5063-6589 Standard (Pack of 2)

Purge-Valve Assembly

1x PFTE Frit 01018-22707 (pack of 5)

1x Outlet Gold seal 5001-3707

1x Outlet Cap 5042-1346

Outlet Ball Valve Assembly

2x Outlet Gold seal 5001-3707

2x Outlet Cap 5042-1346

2x Sieve 5063-6505 (pack of 10, needed for binary pump, only)

G1310A/11A/12A Isocratic / Quarternary / Binary Pumps kit for SEALWASH G1310-68731,

consists of:

2x Wash Seal 0905-1175 and

2x Wash Seal Gasket 5062-2484 (pack of 6),

Seal wash items are needed only, if the seal wash option is installed.

The kit above is needed twice for a G1312A binary pump.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 23 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

G1361A – Preparative Pumps

This maintenance procedure requires the following consumables for each pump (the parts are all
included in the G1361-68710 Prep. Pump PM kit):

Pump Head Assembly

4x Prep Flange Seals 5022-2188

Multi-Assy

1x Filter cup 3150-0942

1x SST Filter Assy 5022-2192

Seal wash pump

1x Cartridge 5042-8507

1x Tubing 0890-1764

2x Fittings 5042-6422

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 24 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

G1376A – Capillary Pumps or G2226A – Nano Pumps

This maintenance procedure requires the following consumables:

Pump Head Assembly

2x Seals 5063-6589 Standard (Pack of 2) or

Purge-Valve Assembly (if pump is to be used in Normal mode)

1x PFTE Frit 01018-22707 (pack of 5)

1x Outlet Gold seal 5001-3707

1x Outlet Cap 5062-2485 (pack of 4)

Outlet Ball Valve Assembly

2x Sieve 5063-6506 (pack of 10)

2x Outlet Gold seal 5001-3707

2x Outlet Cap 5062-2485 (pack of 4)

Filter Assembly

1x Frit 5022-2185

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 25 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

G1329A – Autosamplers and G2260A Preparative Autosamplers

This maintenance procedure requires the following consumables:

For G1329A (these parts are all included in the G1313-68730 Autosampler PM kit):

1x Rotor seal 0100-1853 (Vespel®)

1x Needle Seat G1313-87101 with 0.17mm ID capillary (std.)

1x Needle G1313-87201 (for 100µl head)

For G2260A

1x Rotor Seal and Stator Face kit 0101-1268 (PEEK®)

1x Needle Seat G2260-87101 with 0.50mm ID capillary

1x Needle G2260-87201

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 26 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

G1367B High Performance Autosamplers, G1377A Micro Well Plate Samplers

and G2258A Dual Loop Autosamplers

This maintenance procedure requires the following consumables:

For G1367B (these parts are all included in the G1367-68730 Wellplate Autosampler PM kit):

1x Rotor seal 0100-1853 (Vespel®)

1x Needle seat G1367-87101

1x Needle G1367-87201

1x Peristaltic pump cartridge 5065-4445

1x nut for sample loop fitting 0100-2086

For G1377A

1x Rotor seal 0100-2088 (Vespel®)

1x Needle seat G1377-87101

1x Needle G1377-87201

1x Peristaltic pump cartridge 5065-4445

For G2258A

1x Rotor seal 0100-2415 (Vespel®)

1x Peristaltic pump cartridge 5065-4445 (with Pharmed tubing)

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 27 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

Note: If the following parts replacements are necessary because the needle is deformed or if
needle/seat are leaking these are not covered by the PM and they MUST be BILLED
SEPARATELY as a REPAIR:

1x Needle seat G2258-87102

1x Needle G2258-87306

1x Fitting kit 2mm 5065-9950

Note: After a needle has been replaced several times, the buffer loop capillary will become too
short and will also have to be replaced:

1x buffer loop capillary G2258-87300

G1328B – Manual Injection Valves and 5065-9922 Prep. Manual Injection Valves

This maintenance procedure requires the following consumables:

1x Rotor seal 0101-0623 (Vespel®) for analytical scale manual injection valve (G1328A/B) or

1x Rotor seal 0101-1233 (PEEK®)

for preparative scale manual injection valve 5065-9922.

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 28 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

G1316A – Column Compartments

This maintenance procedure requires the following consumables only if a column-switching valve is
installed (G1316A #055 1200 Series 2PS/6PT or G1316A #057 1200 Series 2PS/10PT Valve options):

1x Rotor seal 0100-1854 (Tefzel®) for valve opt. #055 or

1x Rebuild Kit 0101-1359 (Rotor Seal and Stator Face) for valve option #057.

G1157A, G1158A, G1159A, G1160A, G1162A, G1163A - 1200 Series Valves

This maintenance procedure requires the following consumables:

1x Rebuild kit 0101-1359 (Rotor seal and Stator Face) for G1157A

1x Rebuild kit 0101-1358 (Rotor seal and Stator Face) for G1158A

1x Rebuild kit 0101-1290 (Rotor seal and Stator Face) for G1159A

1x Rebuild kit 0101-1288 (Rotor seal and Stator Face) for G1160A

1x Rotor seal 0100-2087 for G1162A

1x Rotor seal 0101-1361 for G1163A

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 29 of 30
Agilent 1200 Series
Liquid Chromatograph

Scope of Work – Preventive Maintenance

Detectors: G1314B,C VWD, G1315B/C DAD and G1365B/C MWD, G1321A FLD
and G1362A RID

The maintenance procedure requires NO consumables.

G1364B/C/D – Fraction Collectors

This maintenance procedure requires the following consumables.

Inlet/waste tubing and valve to needle tubing kit

G1364-68712 for AS fraction collectors G1364A #050 and G1364C or G1364-68711

for PS fraction collectors G1364A or G1364B).

Capillary assembly for G1364D Micro Fraction collector

G1364-87304 (25 micro-m ID) or

G1364-87305 (50 micro-m ID) or

G1364-87306 (100 micro-m ID).

Issued Feb, 2006-Revision B.01.00 Agilent Restricted WAD Product Support Page 30 of 30
 Performance Qualification (PQ) Phase 5
Preventive Maintenance Checklist

Agilent 1100/1200 Series LC/MSD Quad Major Preventive

Maintenance Checklist

Agilent 1200 Series Qualification Workbook

Agilent 1100/1200 Series LC/MSD Quad

Major Preventive Maintenance Checklist

Purpose of Procedure ‰ Tighten the four bolts on the rough

Preventive maintenance is a factory Preventive Maintenance Checklist pump that hold the oil box to the
recommended procedure designed to pump body. This will help eliminate
‰ Discuss any problems the customer is
reduce the likelihood of electro-mechanical rough pump oil leaks.
failures. Failure to perform preventive having with the instrument
maintenance may reduce the long term ‰ Review customer maintenance records ‰ Replace mist filter element (1535-
reliability of certain instruments and and exclude maintenance on recently 4970).
systems. Two PM’s per year are serviced items.
recommended: the Major PM service ‰ Replace gas filters for nitrogen,
will be performed annually with a ‰ Review the recent Autotune report.
This will give a starting point for (BHT-4).
Interim PM performed 6 months after
the Major PM. evaluating spectral peaks, baseline
noise, peak shape, mass assignments ‰ Replace inlet filter assembly 5μm frit,
and resolution. (0100-2051).
This checklist documents the Major PM
service for the Agilent 1100/1200 Series G1956A/B and G1946A/B/C/D
LC/MSD Quad instruments. ‰ Replace the rotor seal on the MS
‰ Record instrument model no. selection valve (0100-1855).
Customer Responsibilities _____________________________
Customers should ensure that all necessary ‰ Remove the desolvation assembly and
operating supplies, consumables and usage then remove the glass capillary from
‰ Record instrument serial no.
dependent items such as gases, vials, the desolvation assembly. Clean the
syringes, calibrant solution and solvents _____________________________ glass capillary. Follow the
required for the successful preventive documented capillary cleaning
maintenance are available. ‰ Record current vacuum readings: procedure.
A customer representative should be { Rough Vacuum: __________
available while the preventive maintenance { High Vacuum: ___________ ‰ Inspect the platinum plated ends of
procedure is being performed. the glass capillary. Note any physical
‰ Check manually that you have tune damage or wear.
Important notice for customers peaks in positive and negative mode.
The customer should complete the ________________________
following before the Support Provider ‰ Vent the instrument.
‰ Remove the ion optics assembly from
arrives on site:
the vacuum manifold. Disassemble
‰ Perform general system inspection:
‰ Perform a dual polarity Autotune and and clean the ion optics assembly.
retain the printed tune report { Inspect vacuum hoses, pump Follow the documented ion optics
exhaust tubing and power cords cleaning procedure.
Parts required: for excessive wear
{ Look for any obvious external ‰ Remove spray shield, end plate, and
6040-0834 Rough pump fluid, 1L
damage or problems. capillary cap. Clean the parts.
1535-4970 Mist filter element
BHT-4 Nitrogen gas filter { Note any obvious external damage
or problems. ‰ Replace the canted coil spring (1460-
0100-2051 Inlet filter, 5μm frit
1460-2571 Canted coil spring, qty 1 2571) in the capillary cap.
0100-1855 Rotor seal, Vespel ‰ Clean air intake on LC/MSD cabinet
G1946-60136 Nebulizer needle kit, ES (inside access door & above the power ‰ Reinstall the spray shield, end plate,
(or G2427A) module). capillary and capillary cap. Reinstall
G1946-60190 Nebulizer needle kit, APCI the ion optics assembly and
(or G2428A) ‰ Verify system line voltage meets desolvation assembly.
G1947-20029 Corona needle, qty 1 instrument specifications:
‰ Pump the system down.
{ Measured voltage:
The following required parts are supplied
with the instrument in the shipping kit: _________________ ‰ Record current vacuum readings:
8660-0827 Abrasive cloth, 4000 grit { Rough Vacuum: __________
05980-60051 Lint-free cloth, 1 pk { High Vacuum: __________
‰ Drain and replace rough pump fluid
5080-5400 Cotton swabs, 1 pk
(6040-0834).
G1946-80054 Cleaning wire, NiCr, 500 ft

Issued: Nov 2005 – Rev. 3.0 Copyright © 2005 Agilent Technologies LC/MS Technical Marketing Page 1 of 3
Agilent 1100/1200 Series LC/MSD Quad

Major Preventive Maintenance Checklist

‰ Verify that all temperatures, physical damage (i.e. damaged tip

pressures, and gas flows reach tune ‰ Perform general inspection of APCI or corrosion).
file set points. source: { Note any obvious external damage
{ Inspect corona needle holder for or problems.
oxidation or physical damage (i.e.
G1948A API-Electrospray Source
springs on needle holder).
Perform source maintenance on currently { Inspect needle receptacle for ‰ Allow the source to cool completely.
installed source only. oxidation or physical damage (i.e.
cracks inside source) ‰ Clean the lamp window with a lint-
‰ Record serial number { Inspect nebulizer and needle for free cloth and methanol.
_____________________________ physical damage (i.e. damaged tip
or corrosion). ‰ Check that lamp lights. Note:
‰ Perform general inspection of API- { Note any obvious external damage Replacement of the APPI lamp is not
Electrospray source: or problems. covered during the PM procedure.
{ Inspect Vented Standoffs for
chemical deposits or physical
‰ Replace and properly adjust nebulizer
damage.
‰ Replace the APCI corona needle needle (G1946-60190).
{ Inspect nebulizer and needle for (G1947-20029).
physical damage (i.e. dents or
‰ Using the grey abrasive cloth,
corrosion).
‰ Replace and properly adjust nebulizer abrasively clean the bottom of the
{ Note any obvious external damage needle (G1946-60190). vaporizer can, and then wipe with a
or problems. lint-free cloth with methanol.
‰ Using the grey abrasive cloth,
abrasively clean the bottom of the ‰ Clean all other interior surfaces of the
‰ Remove mesh assembly and clean with vaporizer can, and then wipe with a spray chamber, including the window,
abrasive cloth, followed by wiping with lint-free cloth with methanol. with a lint-free cloth with methanol.
a lint-free cloth with methanol. Clean
standoffs with lint-free cloth with ‰ Clean all other interior surfaces of the ‰ Verify that all temperatures,
methanol. Reinstall mesh assembly spray chamber, including the window, pressures, and gas flows reach tune
‰ Clean all other interior surfaces of the with a lint-free cloth with methanol. file set points.
spray chamber, including the window,
with a lint-free cloth with methanol. ‰ Verify that all temperatures, ‰ Check manually that you have tune
pressures, and gas flows reach tune peaks in positive and negative mode.
file set points. Generate tune reports in positive and
‰ Replace and properly adjust nebulizer negative mode.
needle (G1946-60136).
‰ Check manually that you have tune
‰ Verify that all temperatures, peaks in positive and negative mode. ‰ Add results to PM documentation.
pressures, and gas flows reach tune Generate tune reports in positive and
file set points. negative mode.
G1978A Multimode Source
‰ Check manually that you have tune
‰ Add results to PM documentation. Perform source maintenance on currently
peaks in positive and negative mode.
Generate tune reports in positive and installed source only.
negative mode. ‰ Record serial number
G1971A APPI Source
_____________________________
‰ Add results to PM documentation. Perform source maintenance on currently
installed source only. ‰ Perform general inspection:
G1947A APCI Source
‰ Record serial number { Inspect corona needle holder for
oxidation or physical damage (i.e.
Perform source maintenance on currently _____________________________
springs on needle holder).
installed source only.
‰ Perform general inspection of APPI { Inspect needle receptacle for
‰ Record serial number source: oxidation or physical damage (i.e.
_____________________________ { Inspect nebulizer and needle for cracks inside source)

Issued: Nov 2005 – Rev. 3.0 Copyright © 2005 Agilent Technologies LC/MS Technical Marketing Page 2 of 3
Agilent 1100/1200 Series LC/MSD Quad

Major Preventive Maintenance Checklist

{ Inspect nebulizer and needle for ‰ Service Order (SO) Number

physical damage (i.e. damaged tip
or corrosion). ____________________________
{ Note any obvious external damage ‰ Date completed
or problems.

‰ Replace the APCI corona needle ‰ Customer Signature

(G1947-20029).

‰ Replace and properly adjust the

nebulizer needle (G1946-60136). ‰ Support Provider Signature

‰ Clean all other interior surfaces of the

spray chamber, including the window,
with a lint-free cloth with methanol.

‰ Verify that all temperatures,

pressures, and gas flows reach tune
file set points.

‰ Check manually that you have tune

peaks in positive and negative mode.
Generate tune reports in positive and
negative mode

‰ Add results to PM documentation.

Service Review
‰ Record in Instrument Logbook that a
Major PM was performed.

‰ Affix the PM Sticker to the

1100/1200 LC/MSD Quad system or
in the customer logbook as specified
by the Customer.
Note: The purpose of generating tune reports
after planned maintenance is to verify that the
system is functional in positive and negative
modes. Autotune should NOT be performed
at this time.

‰ An Autotune should be run after the

system has been allowed to thermally
equilibrate for at least 11 hours
following a system vent. During this
time, it is not unusual for the
instrument to exhibit mass assignment
shifts, poor peak shapes and/or poor
resolution.

Issued: Nov 2005 – Rev. 3.0 Copyright © 2005 Agilent Technologies LC/MS Technical Marketing Page 3 of 3
5 Performance Qualification (PQ) Phase
Preventive Maintenance Checklist

Agilent 1100/1200 Series LC/MSD Quad Major Interim Preventive

Maintenance Checklist

Agilent 1200 Series Qualification Workbook

Agilent 1100/1200 Series LC/MSD Quad

Interim Preventive Maintenance Checklist

Purpose of Procedure G1956A/B and G1946A/B/C/D ‰ Check manually that you have tune
Preventive maintenance is a factory peaks in positive and negative mode.
‰ Record instrument model no.
recommended procedure designed to Generate tune reports in positive and
reduce the likelihood of electro-mechanical _____________________________ negative mode.
failures. Failure to perform preventive
maintenance may reduce the long term ‰ Record instrument serial no. ‰ Add results to PM documentation.
reliability of certain instruments and _____________________________
systems. Two PM’s per year are
recommended, the Major PM service Service Review
‰ Record current vacuum readings:
will be performed annually with a
{ Rough Vacuum: __________ ‰ Record in the Instrument Logbook
Interim PM performed 6 months after
{ High Vacuum: ___________ that an Interim PM was performed.
the Major PM.
‰ Check manually that you have tune ‰ Affix the PM Sticker to the
This checklist documents the Interim PM
peaks in positive and negative mode. 1100/1200 LC/MSD Quad system or
service for the Agilent 1100/1200 Series
LC/MSD Quad instruments. in the customer logbook as specified
‰ Vent the instrument. by the Customer.
Customer Responsibilities Note: The purpose of generating tune reports
Customers should ensure that all necessary ‰ Perform general system inspection:
after preventive maintenance is to verify that
operating supplies, consumables and usage the system is functional in positive and
{ Inspect vacuum hoses, pump
dependent items such as gases, vials, negative modes. Autotune should NOT be
exhaust tubing and power cords
syringes, calibrant solution and solvents performed at this time.
for excessive wear
required for the successful preventive
maintenance are available. { Look for any obvious external
damage or problems. ‰ An Autotune should be run after the
A customer representative should be system has been allowed to thermally
available while the preventive maintenance { Note any obvious external damage equilibrate for at least 11 hours
procedure is being performed. or problems. following a system vent. During this
time, it is not unusual for the
Important notice for customers ‰ Clean air intake on LC/MSD cabinet instrument to exhibit mass assignment
The customer should complete the (inside access door & above the power shifts, poor peak shapes and/or poor
following before the Support Provider module). resolution.
arrives on site:
‰ Verify system line voltage meets
‰ Perform a dual polarity Autotune and ‰ Service Order (SO) Number
instrument specifications:
retain the printed tune report
{ Measured voltage: ____________________________
_________________ ‰ Date completed
Parts required:
6040-0834 Rough pump fluid, 1L ‰ Drain and replace rough pump fluid
(6040-0834).

Preventive Maintenance Checklist ‰ Customer Signature

‰ Tighten the four bolts on the rough
‰ Discuss any problems the customer is pump that hold the oil box to the
having with the instrument pump body. This will help eliminate
rough pump oil leaks.
‰ Review customer maintenance records ‰ Support Provider Signature
and exclude maintenance on recently ‰ Pump the system down.
serviced items.
‰ Review the recent Autotune report. ‰ Record current vacuum readings:
This will give a starting point for { Rough Vacuum: __________
evaluating spectral peaks, baseline { High Vacuum: __________
noise, peak shape, mass assignments
and resolution. ‰ Verify that all temperatures,
pressures, and gas flows reach tune
file set points.

Issued: Nov 2005 – Rev. 3.0 Copyright © 2005 Agilent Technologies LC/MS Technical Marketing Page 1 of 1
 Performance Qualification (PQ) Phase 5
System performance and noise

System performance and noise

Agilent 1200 Series Qualification Workbook

Data File C:\CHEM32\1\DATA\DEMO\ISOCRA.D
Sample Name: Isocratic standard sample

---------------------------------------------------------------------
---------------------------------------------------------------------
Acq. Operator: marketing
Acq. Instrument: Instrument 1 Location: Viall
Injection Date: 24-Feb-06 5:02:20 PM
Inj Volume: 1 ~l
Method : C:\CHEM32\1\METHODS\ISOCRA.M
Last changed : 24-Feb-06 4:58:15 PM by marketing
Method Info : This method is used to analyse the isocratic standard sample with
standard contitions.

Sample Info : sample: Isocratic standard sample

DAD : slit 2nm/all in peak spectra - DAD-UV - 40 C
method: isocra.m 30% Water 70% ACN

---------------------------------------------------------------------

~
Column Description: Eclipse XDB-C18 Column, 4.6 x 150mm, 5um
Product# 993967-906 Batch#:
Serial#
Diameter 4.6 mm Length: 150.0 mm
particle size 5.0 ~m Void volume: 68.0 %
Maximum Pressure 400 bar Maximum pH : 9
Maximum Temperature: 60°C
Comment
DAD1 A, Slg-254,4 Ref-off (DEMO\ISOCRA.D)
PMP1 , Solvent A
PMP1 , Solvent B
PMP1 , Solvent C
PMP1 , Solvent D
PMP1 , Flow
THM1 , Temperature (Left)
THM1 , Temperature (Right)
PMP1 , Pressure
mAU '<t
0)
C"!

140

N
120 C")
"":

100

L!)
'<t
'<t
80 M

0>-
60 r------ -- f----------- -------------------------- L!)

<ci
A

40

20-

- -< <---'V --<<<<<<<_.

... -.. ..- -.<.. _.m.- < -....-.-
/ \ <.<. ..
0

0 1 2 3 4 5 6 7 mir

---------------------------------------------------------------------
Area Percent Report with Performance and Noise
---------------------------------------------------------------------
---------------------------------------------------------------------

Calib. Data Modified Friday, February 24, 2006 4:58:12 PM

Instrument 1 24-Feb-06 5:39:25 PM Page 1 of 2

Data File C:\CHEM32\1\DATA\DEMO\ISOCRA.D
Sample Name: Isocratic standard sample

Multiplier : 1.0000
Dilution : 1.0000
Use Multiplier & Dilution Factor with ISTDs

Signal 1: DAD1 A, Sig=254,4 Ref=off

Noise determination:

Time range Noise Noise Noise

from to
1 1 (6*SD) 1 (ptoP) 1 (ASTM) I Wander 1 Drift
[min] [min]
1 1 [mAU] 1 [mAU] 1 [mAU] 1 [mAU] 1 [mAUjh]
1 1 1 1 1 1---------

0.000 0.500 6.525e-2 4.73ge-2 - - 2.975

2.000 3.000 8.137e-2 6.124e-2 - - -1.377
4.000 6.000 7.300e-2 7.030e-2 2.405e-2 3.86ge-2 -1.738

RetTime k' Area Height Symm. Width Plates Resol Signal

[min] [mAU*s] [mAU] [min] ution jNoise
1 1 1 1 1 1 1 1------

1.294 0.15 309.39569 151.12311 0.84 0.0308 9761 - 1857.2

1.732 0.53 279.87131 109.87560 0.85 0.0390 10905 7.37 1350.3
3.445 2.05 332.17877 76.41245 0.89 0.0658 15173 19.19 939.0
6.659 4.89 459.16510 53.34309 0.91 Q.1~17 14170 19.12 730.7

---------------------------------------------------------------------
---------------------------------------------------------------------
*** End of Report ***

Instrument 1 24-Feb-06 5:39:25 PM Page 2 of 2

5 Performance Qualification (PQ) Phase
Customer contributed material

Customer contributed material

Agilent 1200 Series Qualification Workbook

5 Performance Qualification (PQ) Phase
Customer contributed material

Agilent 1200 Series Qualification Workbook

www.agilent.com

In This Book
This Qualification Workbook
for the AGILENT
TECHNOLOGIES 1200 Series
systems and modules for LC
contains documents of the 4
phases of the entire
instrument life in a user's
laboratory:
• Design Qualification (DQ),
• Installation Qualification
(IQ),
• Operational Qualification
(OQ),
• Performance Qualification
(PQ).

© Agilent Technologies 2006

Printed in Germany
02/06

*G1310-90300*
*G1310-90300*
G1310-90300

Agilent Technologies