Standard-Eqp Oq Uv Vis.01.05

© 2015 by Agilent Technologies Enterprise Edition Compliance Services
EQP Name: UVVIS.01.06_OQ_Standard-EQP
Company Name: _______________
Customer Name/Title: _______________
EQP Filename: AgilentRecommendedA.01.15.eqp
Print Date: June 23, 2015 8:35:06 AM
UVVIS.01.06_OQ_Standard-EQP Page 1 / 22 June 23, 2015 8:35:06 AM

Table of Contents
Section Page
Scope and Purpose 3
What is EE 5
RevHistoryUVVisOQ 8
UV-VIS OQ 10
Customer Approval 20
Legal Notice 21
Protocol Details 22

Scope and Purpose

Overview
The Equipment Qualification Plan (EQP) documents the activity program that is performed during the qualification services for the
applicable systems. A complete description of the test specifications is provided for the supported services, including setpoints and
acceptance criteria (or limits) for each test. The test specification section of this document is created directly from the EQP file name
listed on the cover.
This document is an abstraction of the EQP file used to perform the service and is generated directly from the electronic Agilent
Equipment Qualification Plan (eEQP) Editor. The purpose of this document is to allow the user to review and record approval of the
EQP that guides the delivery of compliance services provided by the Agilent Automated Compliance Engine.
Statement of Intent
Unless otherwise requested, the qualification is delivered according to the standard test program described in the
Agilent_Recommended EQP. Agilent defines variances as changes to the default recommended values (as stated in the Agilent
Recommended EQP) that fall within a well-defined range. These changes are considered to be within the intended use range of the
system under test.
Customizations are values that (a) subject the system to limits that exceed the typical operational range or (b) additional tests that are
not considered part of the core program required for completion of the selected service. Because custom setpoints and limits may
exceed the operational envelope of the equipment, Agilent reserves the right to warrant conformance only to the closest variance
value. The user is notified of this stipulation at EQP setup time and the qualification report (EQR) will reflect this situation.
A set of ink signature fields, as determined by the creator of this document, can be included at the end of this document. All fields
should be completed or a single set of fields, initialed by an appropriate approver, run through any signature fields that are not to be
used. This is an optional process that allows a paper record of signoff by the appropriate reviewers where a hybrid (electronic/ink)
signature SOP is followed. If this document will be saved electronically and digitally signed in a document management system, it
should be generated without ink signature fields. Signing this document is for the customer's internal documentation purposes, to
assist with the applicable regulatory requirements. It is available for customer review, but it is not a pre-requisite for the delivery. The
delivery of the services is done according to the terms and conditions stated in the corresponding service exhibit. It is recommended
that after approval, this EQP be archived with the electronic EQP file.
Understanding the Test Specification Section in Tabular Review Documents
(Applies to hardware qualifications only)
For Agilent-recommended setpoints and limits, the range of allowable values (L for low, H for high) are included. As applicable,
variances, customizations, and additional setpoints are listed beneath the Agilent recommended values and marked W (within range)
or O (outside of range) in the left margin; values for added setpoint are also marked W or O and displayed after all configurations
values. Dual limits are marked DW or DO.
Optional tests that are enabled are included and marked as such; required tests that are disabled by the customer are included and
marked as such.

Customer Responsibilities
o Safely store and archive this EQP

o Maintain change control and revision history
o Review and optionally sign the EQP, making sure the service delivery is what was approved
o Review and approve any of the following variances from the Agilent recommended:
-Within Variance Range: changes to the Agilent recommended that are identified by Agilent as within the operation ranges
determined in our test development
-Outside of Variance Range: changes to the Agilent recommended that Agilent identifies as outside of the operational ranges
determined in our test development. Agilent is not under any obligation to make the instrument pass the more stringent limits that fall
in this range and this detail is called out in the EQP Test Specification
-Optional Tests: additional tests that are available but not part of the core testing suite and cost extra
-Disabled Tests: test for which all possible configurations have been disabled (tests are flagged in the test specification)
Agilent Responsibilities
o Deliver the services following the test programs described in the customer EQP
o Provide a locked and e-signed Qualification Report (EQR) upon completion of the service
o If requested, provide an optional ink-signed EQR CD to the customer
General Statements on the Testing Program
The recommended set of hardware OQ tests described in this EQP derives from Agilent's interpretation of authoritative expert
literature issued by the FDA, USP, GAMP5, ASTM 2500, and others. The OQ test design incorporates both modular and holistic
testing, which is a proven approach, acceptable to regulators. As prescribed by the 4Q qualification methodology for Analytical
Instrumentation Qualification (AIQ), the OQ step is separated from the PQ as recommended by the regulatory guidelines.
Enterprise Edition uses a balanced selection of metrology and chemical tests to directly determine the performance of the systems
without unnecessary reliance on inferred or derived results. For example, direct metrology is used to test pump flow rates and
thermal-controlled column compartment and autosampler modules. Holistic chemical testing is used for the evaluation of the following
critical instrument characteristics: linearity, precision, signal to noise, and carry over.

HOW AGILENT ENTERPRISE EDITION

COMPLIANCE SERVICES WORK
Enterprise Edition is designed to fit the traditional quality systems used by firms and recognized by regulatory agencies
worldwide.
How Enterprise Edition aligns with a traditional, paper-based methodology:

• Policy documents dictate the need for validation and qualification of GMP/GLP systems and usually mention the
DQ/IQ/OQ/ PQ model. The precise procedures for IQ and OQ for each type of equipment are prescribed in an approved
SOP, perhaps called SOP #123: Qualification of HPLC Systems. In Enterprise Edition, the equipment qualification plan
(EQP) has the same role as the traditional qualification SOP.
• The traditional SOP provides lists of tests and limits for the range of system configurations found in the laboratory. The
EQP follows this concept. The inventory of systems covered by an SOP or EQP changes over time, so this is kept as a
separate record.
• The traditional qualification SOP typically has blank results forms as attachments to be photocopied for each IQ or OQ
event–the results recorded in ink with manual calculations. In Enterprise Edition, this execution process is streamlined
and automated by use of Adobe forms and the Agilent Compliance Engine (ACE) delivery tool. It provides reports with no
hand-writing errors; validated calculations; automated pass/fail report; traceability to raw data and the number of times a
test was run. This automation provides efficiency and enforces compliance to procedure.
• The traditional qualification SOP is approved and released only once–replacing the need to author individual protocols for
each chromatography system. This is the same concept for the EQP. The appropriate tests for each individual
configuration are automatically selected by ACE from the list in the approved EQP–at time of delivery. The final reports are
unique for each system and each qualification event–but the single approved EQP can cover a lab, department, or as wide
a scope as desired.
• In the traditional qualification methodology, there is no convenient provision to record the actual workflow of the tests
execution and results. In the event that a test is repeated during the Enterprise Edition delivery, ACE maintains a counter
per test which is automatically incremented for GxP compliant work, and the engineer generates a deviation note within
the ACE report.

Design Qualification (DQ)

DQ for commercial lab instruments is recommended by some, but not all, guidances and procedures. Definitions of DQ found in
guidances and firm-specific validation procedures vary widely around the world. Some firms require nothing more than a record
(such as certificate) from the instrument manufacturer demonstrating that the lab system has been designed for purpose and
manufactured to a quality standard. Others treat DQ as the development of a user requirement specification document (URS)
which can be matched to the IQ and OQ specifications for a manufacturer. Other firms consider DQ as including the vendor
selection activities.
USP Chapters literature definition of DQ:
Design qualification (DQ) is the documented collection of activities that define the functional and operational specifications of
the instrument and criteria for selection of the vendor, based on the intended purpose of the instrument. Design qualification
(DQ) may be performed not only by the instrument developer or manufacturer but also may be performed by the user. The
manufacturer is generally responsible for robust design and maintaining information describing how the analytical instrument
is manufactured (design specifications, functional requirements, etc.) and tested before shipment to users. Nonetheless, the
user should ensure that commercial off-the-shelf (COTS) instruments are suitable for their intended application and that the
manufacturer has adopted a quality system that provides for reliable equipment. Users should also determine capability of the
manufacturer for support installation, services, and training.
For your reference, Agilent provides the following statements for DQ purposes:
1. All Agilent hardware and software laboratory products including the ACE software used to deliver qualification services,
are designed, manufactured, and tested according to Agilent internal Quality Life-Cycle Development Procedures.
2. Certificates of Agilent testing, validation, and conformance to standards are provided with new Agilent instruments and
similar certification is provided for ACE software. These documents are checked and recorded in Enterprise Edition
Compliance Services IQ.
3. Agilent maintains information describing how products are manufactured and maintains a problem and bug reporting
program as required by international software quality guidelines.
4. The OQ specifications in this EQP can be used, as appropriate, by the user to prepare URS. The OQ specifications in this
EQP represent the levels of performance acceptable to regulatory agencies for the technique; conform to typical
specifications found in validation literature; are equally suitable for OQ at installation and on-going OQ throughout
operational lifetime; are equivalent to the OQ specifications published in the legacy Agilent Classic OQPV protocols; and
are suitable for most user requirements.
5. Agilent Technologies is capable of installation, support, preventive maintenance, on-going qualification, and re-
qualification after repair and user training worldwide.
Installation Qualification (IQ)

IQ checks and tests for Agilent hardware and software products include the following:
1. Purchase Order Details: Allows the customer to verify that the instrument being qualified matches their design
requirements (if available) and purchase order.
2. Preparation and Installation Details: Gathers and records information about preparation and installation documents.
3. Documentation: Gathers and records information about reference and user manuals for initial installations.
4. Product Quality Assurance Details: Collects and records certificates and other forms that verify that the vendor has
developed and built the product according to internal standards.
5. Startup: Verifies that all modules start up properly.
6. Instrument Check (hardware only): Demonstrates that all modules of the instrument are correctly installed and connected.
It does not test instrument performance as fully as OQ. This test is not necessary and therefore skipped if an OQ is to be
performed by Agilent operator at installation after IQ.
7. Installation Verification (software only): Verifies the correctness of all installation-related files.
Operational Qualification
Refer to the appropriate Test Definitions document for a detailed description of the testing program, setpoints, and acceptance
limits for each system technique, category, and instrument configuration.

Dual-Acceptance Limits
Within the EQP of the Agilent Enterprise Edition, each of the tests final result can be compared against two different limits if
required. This allows customer-configured OQ to report against a User Limit (Limit 1) and the Agilent Recommended Limit
(Limit 2) simultaneously.
In the standard EQP documents, Limit 1 and 2 values are the same – effectively de-activating this feature. Custom EQPs can
also be prepared on request, making effective use of the two-limit feature of the Agilent Compliance Engine (ACE). In those
cases, Limit 2 will always be the Agilent Recommended limit, and Limit 1 will be the limit requested by the user.
Agilent will not be under any obligation regarding the OQ testing results against user-requested limits that are more stringent
than the Agilent Recommended ones.
Re-Qualification after Repair (RQ) Hardware

In the event of a hardware breakdown followed by an engineering repair of a qualified instrument, it is necessary to re-qualify
the system to an appropriate level before release back into operational use.
For some of the instrument techniques, Agilent offers a service contract to repair and re-qualify an instrument during the
period between scheduled annual OQs.
The level of re-testing is prescribed in the RQ section of ACE: a form is displayed for the operator showing all types of repair
possible and the re-testing required. Part of an example form is shown below.
Re-Qualification After Repair
Pump Strategies
Repair/Replace Strategy Modules OQ/PV Testing
Internal pump head parts, active inlet valve (or AIV cartridge), (parts Any pump Flow Accuracy & Precision
of) check valves, reference valves, inlet manifold or pump drive, or
taking pump head apart to clean (versus repair)
Pulse damper, pressure transducer Any pump Flow Accuracy & Precision
Multi-channel gradient valve Quaternary Flow Accuracy & Precision
Gradient Composition
The full list of repair and re-test guidance is available for review by customers of the RQ service.
The RQ form in ACE prescribes which tests the operator must perform for each repair circumstance. The test procedure,
setpoints, and limits will be an exact repeat of the previous OQ test (a regression-testing strategy).
Updated: April 2015
www.agilent.com/chem/enterprise
Information, descriptions and specifications in this
publication are subject to change without notice.
© Agilent Technologies, Inc. 2015

Published in USA

Revision History: UV-Vis Spectrophotometer OQ

This file includes changes for all available revisions. Ignore any that do not apply to your installation.
UVVis.01.06, February 2015

1. Wavelength Accuracy – Didymium; added new test.
2. Stray Light – Acetone: added new test.
3. Wavelength Reproducibility: changed to now be included in the Standard test suite for Cary and Other unspecified models.
4. Photometric Reproducibility – Potassium Dichromate: changed to now be included in the Standard test suite for all models.
5. Wavelength Accuracy – Holmium Oxide in Perchloric Acid: for Cary models, increased theoretical wavelength setpoints from 4 to 14;
for all models, updated the upper variance range limit of the all wavelength accuracy tests from 3 nm to 2 nm (both in accordance
with official USP General Chapter <857>).
6. Wavelength Accuracy – Mercury Line: increased number of setpoints from 10 to 12; updated the upper variance range limit from 3
nm to 2 nm (both in accordance with official USP General Chapter <857>).
7. Wavelength Accuracy – Source Line: updated the upper variance range limit from 3 nm to 2 nm (in accordance with official USP
General Chapter <857>).
8. Resolution – Toluene in Hexane: updated the limit to be >= to 1.6 for all models in accordance with limit in the official USP General
Chapter <857>.
9. Stray Light (Sodium Iodide and Sodium Nitrite): updated the upper variance range limit to < 1.0 %T (in accordance with official USP
General Chapter <857>).
10. Photometric Accuracy – NIST Glass Filters: updated the upper variance range limit to <= 0.008 Abs in accordance with the limit in
the official USP General Chapter <857>.
11. Photometric Reproducibility - NIST Glass Filters: changed upper limits for all models to 0.005 Abs in accordance with the limit in the
official USP General Chapter <857>.
12. Photometric Reproducibility – Potassium Dichromate, NIST Glass Filters: added calculation for the average result and also removed
allowable variances in accordance with the limit in the official USP General Chapter <857>.
13. Calculation Formulas: added Average.
Changed forms: Wavelength Accuracy – Mercury Line, Photometric Reproducibility - Potassium Dichromate, Photometric Reproducibility
- NIST Glass Filters, Wavelength Reproducibility
NOTE: in UVVis.01.04 section, changed item 5 to include 845X limit update.
UVVis.01.05, September 2014

Wavelength Accuracy - Holmium Oxide in Perchloric Acid Solution: for other/unspecified models, increased theoretical wavelength
setpoints from 4 to 14.
NOTE: in UVVis.01.04 section, added item 10 for 8454.
UVVis.01.04, April 2014

1. Added support for dual limits.
2. Added variance ranges for limits for all tests except Photometric Accuracy and Stray Light - Potassium Chloride.
3. Photometric Reproducibility - Potassium Dichromate, NIST Glass Filters: added new tests.
4. Photometric Accuracy: changed limits for setpoints 235, 257, 313, and 350 nm from <=0.01 Abs to <= 0.010 Abs.
5. Wavelength Accuracy– Holmium Oxide in Perchloric Acid: updated holmium oxide's theoretical setpoints to meet published intrinsic
wavelength bands; for 8453 and 8454 models, changed the limit from <= 0.7 nm to <= 0.6 nm.
6. Agilent 8453: added/changed required test suite to include:
• Wavelength Accuracy – Source Line
• Wavelength Accuracy – Holmium Oxide in Perchloric Acid
• Wavelength Reproducibility (added holmium oxide in perchloric acid bands to deuterium bands)
Page 1 / 2

• Toluene/Hexane Resolution
• Stray Light - Sodium Iodide
• Stray Light – Sodium Nitrite
• Photometric Accuracy – Potassium Dichromate
• Baseline Flatness
• Photometric Noise
• Photometric Stability
7. Agilent 8453: added/changed optional test suite to include:
• Photometric Accuracy – NIST Glass Filters
• Photometric Reproducibility – Potassium Dichromate
8. Other unspecified models: changed optional test suite to include:
• Wavelength Accuracy – Mercury Line (as applicable)
• Wavelength Reproducibility (deuterium bands)
• Stray Light - Sodium Iodide
• Stray Light – Sodium Nitrite
• Photometric Accuracy – NIST Glass Filters
• Baseline Flatness
• Photometric Noise
• Photometric Stability
• Photometric Reproducibility – Potassium Dichromate
9. Cary models: changed optional test suite to include same as other unspecified plus:
• Maximum Resolution (as applicable)
• Photometric Reproducibility – NIST Glass Filters
10. Added support for Agilent 8454.
New forms: Photometric Reproducibility - Potassium Dichromate, Photometric Reproducibility - NIST Glass Filters
Changed forms: none
UVVis.01.03, April 2013

PM changes only.
UVVis.01.02, December 2012

1. Added support for Agilent G model spectrophotometers.
2. Added support for other unspecified models.
3. Wavelength Accuracy - Source Line, Wavelength Accuracy - Mercury Line: now scheduled based on lamp type (vs.
spectrophotometer model number).
Changed forms: none
UVVis.01.01, June 2012

Initial release.
Page 2 / 2

UV-VISIBLE SYSTEMS
OPERATIONAL QUALIFICATION
OQ Test Suite
This document describes the test program for qualifying UV-Visible systems, and the following table lists all OQ tests.
In this document, generic models refer to unspecified UV Systems other than the Agilent Cary and 8453/8454. Consult your Agilent
representative for compatibility questions.
Note: Optional tests are NOT INCLUDED in the standard OQ but can be ordered as EXTRA COST TESTS. Select the check boxes
on the right and attach this document to your OQ EQP documentation for a record of qualification conditions.
Key: Standard core tests Optional tests
Test 8453 / 8454 Cary 50/60 Cary 100/300 Cary 4000/ Generic
5000/6000i
Wavelength Accuracy – Source Line     
Wavelength Accuracy – Holmium Oxide in Perchloric Acid     
Wavelength Accuracy – Didymium
Wavelength Accuracy – Mercury Line N/A N/A N/A
Wavelength Reproducibility     
Maximum Resolution N/A N/A N/A N/A
Toluene/Hexane Resolution     
Stray Light – Potassium Chloride     
Stray Light – Acetone
Stray Light – Sodium Iodide 
Stray Light – Sodium Nitrite 
Photometric Accuracy – Potassium Dichromate     
Photometric Accuracy – NIST Glass Filters
Photometric Reproducibility – Potassium Dichromate     
Photometric Reproducibility – NIST Glass Filters N/A N/A
Photometric Noise 
Baseline Flatness 
Photometric Stability 

Test Details, Design, and Rationale
Wavelength Accuracy—Source Line

Standard for all models
Description: Wavelength Accuracy is performed as a verification of the installed source lamp (either Xenon or Deuterium)
performance. The source lamp produces peak maxima at various wavelengths. In this test, Wavelength Accuracy is verified by
scanning a spectrum number of nanometers above and below the theoretical maxima for the installed source lamp. The test passes
if the reported wavelength maxima do not differ from the expected values by more than the accuracy limit. This test meets all major
pharmacopoeia and ASTM requirements.
Procedure: Power on and warm up the spectrophotometer for the appropriate time prior to testing. If a cell changer is present,
disable the cell changer for testing. Verify there are no samples in the reference and sample cell holders. Using the
spectrophotometer’s controlling data software (CDS), setup the Wavelength Accuracy test for the Source Lamp Emission Line.
Perform the test by following the software prompts. Upon completion, record the values to the test record.
Models/Lamp Setpoints Limits
Default Allowable Range Default Allowable Range
8453, 8454/Deuterium 486.0 nm N/A ≤ 0.20 nm 0.20 – 2.0 nm
656.1 nm
Cary 50, 60/Xenon 541.92 nm ≤ 0.50 nm 0.50 – 2.0 nm
Cary 100, 300/Deuterium Zero order ≤ 0.70 nm 0.70 – 1.0 nm
486.0 nm ≤ 0.20 nm 0.20 – 2.0 nm
656.1 nm ≤ 0.20 nm 0.20 – 2.0 nm
Cary 4000/Deuterium Zero order ≤ 0.08 nm 0.08 – 1.0 nm
486.0 nm 0.08 – 2.0 nm
656.1 nm 0.08 – 2.0 nm
Cary 5000, 6000i/Deuterium Zero order ≤ 0.08 nm 0.08 – 1.0 nm
486.0 nm 0.08 – 2.0 nm
656.1 nm 0.08 – 2.0 nm
1312.2 nm ≤ 0.40 nm 0.40 – 2.0 nm
1968.3 nm 0.40 – 2.0 nm
Generic/Deuterium 486.0 nm ≤ 2 nm 0.1 – 2.0 nm
656.1 nm
Generic/Xenon 541.92 nm ≤ 2 nm 0.1 – 2.0 nm

Wavelength Accuracy—Holmium Oxide in Perchloric Acid

Description: Wavelength Accuracy is calculated by comparing the reported wavelength values against the expected wavelength
values of a Holmium Oxide in Perchloric Acid test solution (Holmium Perchlorate). The test passes if the reported wavelength
values do not differ from the expected values by more than the accuracy limit. This test meets all major pharmacopoeia and ASTM
requirements.
Procedure: Power on and warm up the spectrophotometer for the appropriate time prior to testing. If a cell changer is present
disable the cell changer for testing. Using the spectrophotometer’s controlling data software (CDS), setup the Wavelength
Accuracy test for the Holmium Oxide in Perchloric Acid (Holmium Perchlorate). Perform the test by following the software prompts.
Upon completion, record the values to the test record.
Models Setpoints Limits
8453, 8454 241.13 nm 333.49 nm N/A ≤ 0.6 nm 0.6 – 1.0 nm
249.98 nm 345.38 nm
278.11 nm 361.18 nm
287.40 nm 385.70 nm
416.42 nm 485.26 nm ≤ 0.6 nm 0.6 – 2.0 nm
451.33 nm 536.71 nm
467.86 nm 640.62 nm
Cary 50, 60, 100, 300, 4000, 241.13 nm 333.49 nm N/A ≤ 1 nm 0.1 – 1.0 nm
5000, 6000i; generic 249.98 nm 345.38 nm
278.11 nm 361.18 nm
287.40 nm 385.70 nm
416.42 nm 485.26 nm ≤ 2 nm 0.1 – 2.0 nm
451.33 nm 536.71 nm
467.86 nm 640.62 nm
Wavelength Accuracy—Didymium
Optional for all models
Description: Wavelength Accuracy is calculated by comparing the reported wavelength values against the expected wavelength
values of a Didymium standard test solution. The test passes if the reported wavelength values do not differ from the expected
values by more than the accuracy limit. This test meets the United States Pharmacopoeia requirements.
disable the cell changer for testing. Using the spectrophotometer’s controlling data software (CDS), setup a Wavelength Accuracy
test for the Didymium test solution. Perform the test by following the software prompts. Upon completion, record the values to the
test record.
All 731.6 nm 799.0 nm N/A ≤ 2 nm 0.1 – 2.0 nm
740.0 nm 864.4 nm
794.1 nm

Wavelength Accuracy—Mercury Line

Optional for Cary and generic models; mercury lamp required
Description: Wavelength Accuracy is performed as a verification of the mercury lamp performance. The mercury lamp produces
photometric peak maxima at various wavelengths. In this test, Wavelength Accuracy is verified by scanning a wavelength range for
the mercury lamp. The test passes if the reported wavelength maxima do not differ from the expected values by more than the
accuracy limit. This test meets all major pharmacopeia requirements.
disable the cell changer for testing. Verify there are no samples in the reference and sample cell holders. Using the
spectrophotometer’s controlling data software (CDS), setup the Wavelength Accuracy test for the Mercury Lamp. Perform the test
by following the software prompts. Upon completion, record the values to the test record.
Cary 4000, 5000 , 6000i 253.65 nm 334.15 nm N/A ≤ 0.10 nm 0.10 – 1.0 nm
296.73 nm 365.02 nm
302.25 nm 365.48 nm
313.16 nm
404.66 nm 576.96 nm 0.10 –2.0 nm
435.83 nm 579.07 nm
546.08 nm
Generic 253.65 nm 334.15 nm ≤ 1 nm 0.1 – 1.0 nm
296.73 nm 365.02 nm
302.25 nm 365.48 nm
313.16 nm
404.66 nm 576.96 nm ≤ 2 nm 0.1 – 2.0 nm
435.83 nm 579.07 nm
546.08 nm
Wavelength Reproducibility
Description: The Wavelength Reproducibility test measures the instrument’s reproducibility when making repeated readings of the
same wavelength. The reproducibility is defined as the deviation of 10 consecutive wavelength maximum readings taken using the
peak(s) of the reference–either the deuterium lamp or the Holmium Oxide in Perchloric Acid standard. The test passes if the
maximum deviation of the 10 wavelength maxima values is less than the test limit. This test meets the requirements of the United
States Pharmacopeia, NIST and ASTM. For the 8453 and 8454 models, this test is completed with the Wavelength Accuracy tests.
disable the cell changer for testing. Using the spectrophotometer’s controlling data software (CDS), setup the Wavelength
Reproducibility test using either the Holmium Oxide in Perchloric Acid (Holmium Perchlorate) or the deuterium lamp as the
reference. Perform the test by following the software prompts. Upon completion, record the values to the test record.
Models Setpoints (D for Deuterium; H for Holmium Oxide) Limits
Default Allowable Default Allowable Range
Range
8453, 8454 D 486.00 nm H 333.49 nm H 467.86 nm N/A -0.02 – 0.02 nm -0.04 – 0.04 nm
D 656.10 nm H 345.38 nm H 485.26 nm
H 241.13 nm H 361.18 nm H 536.71 nm
H 249.98 nm H 385.70 nm H 640.62 nm
H 278.11 nm H 416.42 nm H 640.62 nm
H 287.40 nm H 451.33 nm
Cary 50, 60 H 536.50 nm -0.1 – 0.1 nm -0.2 – 0.2 nm
Cary 100, 300; generic D 656.10 nm -0.08 – 0.08 nm -0.16 – 0.16 nm
Cary 4000, 5000, 6000i D 656.10 nm -0.025 – 0.025 nm -0.050 – 0.050 nm

Maximum Resolution
Optional for Cary 4000, 5000, 6000i models
Description: Maximum Resolution (often called the ‘limiting’ resolution) of the instrument is determined by calculating the width of
the 656.1 nm peak at half height that the instrument can achieve. The test passes if the calculated maximum resolution is less than
or equal to the test limit.
disable the cell changer for testing. Verify there are no samples in the cell holders. Using the spectrophotometer’s controlling data
software (CDS), setup the Maximum Resolution. Perform the test by following the software prompts. Upon completion, record the
values to the test record.
Cary 4000, 5000 , 6000i N/A N/A 0.000 – 0.048 0.000 – 0.096
Toluene/Hexane Resolution
Description: Decreased spectral resolution can impact the photo metric sensitivity and selectivity. Toluene/Hexane Resolution is
determined by calculating the peak-to-trough ratio between the reported absorbance maximum and minimum from a scan of 0.02%
v/v Toluene in Hexane. The absorbance maximum should occur at approximately 269 and the minimum at approximately 266 nm.
The test passes if the calculated spectral resolution ratio is greater than or equal to the test limit. This test meets all major
pharmacopeia requirements.
disable the cell changer for testing. Using the spectrophotometer’s controlling data software (CDS), set up the Toluene/Hexane
Resolution test. Perform the test by following the software prompts. Upon completion, record the values to the test record.
All N/A N/A ≥ 1.6 1.6 – 2.5
Stray Light—Potassium Chloride

Description: The Stray Light Test measures the presence of light outside the bandwidth of a selected wavelength that reaches the
detector. The presence of stray light can decrease the photometric selectivity, increase the photometric response and create non-
linear response of the instrument causing problems with quantitative analysis. Potassium Chloride will completely absorb light
below 200 nm, however is transparent above 200 nm. The test will pass if the Percent Transmittance is less than 1.0% at 198 nm.
This test meets all major pharmacopoeia and ASTM requirements.
disable the cell changer for testing. Using the spectrophotometer’s controlling data software (CDS), setup the Stray Light–
Potassium Chloride test. Perform the test by following the software prompts. When the test is complete record the values to the
test record.
All 198 nm 190 – 200 nm ≥ 0.0 and < 1.0%T N/A

Stray Light—Acetone
Description: The Stray Light Test measures the presence of light outside the bandwidth of a selected wavelength that reaches the
detector. The presence of stray light can decrease the photometric selectivity, increase the photometric response, and create non-
linear response of the instrument causing problems with quantitative analysis. Acetone absorbs light below 320 nm and is
transparent above 326 nm. The test will pass if the Percent Transmittance is less than 1.0% at 300 nm. This test meets United
States Pharmacopoeia requirements.
disable the cell changer for testing. Using the spectrophotometer’s controlling data software (CDS), setup the Stray Light test using
the Acetone standard solution. Perform the test by following the software prompts. When the test is complete record the values to
the test record.
All 300 nm 250 – 320 nm ≥ 0.0 and < 1.0%T N/A
Stray Light—Sodium Iodide

Standard for 8453/8454; optional for Cary and generic models
Description: The Stray Light test measures the presence of light outside the bandwidth of a selected wavelength that reaches the
linear response of the instrument causing problems with quantitative analysis.
This Stray Light test uses Sodium Iodide as the filter to measure the stray light. Sodium Iodide will begin to absorb light below 260
nm, however is transparent above 260 nm. The test will pass if the Percent Transmittance is less than the test limit. This test
meets ASTM requirements.
disable the cell changer for testing. Using the spectrophotometer’s controlling data software (CDS), setup the Stray Light–NaI
(Sodium Iodide) at 220 nm test. Perform the test by following the software prompts. Upon completion, record the values to the test
record.
8453, 8454; Cary 50, 60; generic 220 nm 200 – 230 nm ≥ 0.00 and < 0.05 %T 0.05 – 1.0 %T
Cary 100 ≥ 0.00 and < 0.02 %T 0.02 – 1.0 %T
Cary 300 ≥ 0.00 and < 0.0005 %T 0.0005 – 1.0 %T
Cary 4000, 5000, 6000i ≥ 0.00 and < 0.00007 %T 0.00007 1.0 %T

Stray Light – Sodium Nitrite

Description: The Stray Light test measures the presence of light outside the bandwidth of a selected wavelength that reaches the
linear response of the instrument causing problems with quantitative analysis.
This Stray Light test uses Sodium Nitrite as the filter to measure the stray light. Sodium Nitrite will begin to absorb light below 385
nm, however is transparent above 385 nm. The test will pass if the Percent Transmittance is less than the test limit. This test
meets ASTM requirements.
disable the cell changer for testing. Using the spectrophotometer’s controlling data software (CDS), setup the Stray Light – NaNO2
(Sodium Nitrite) at 340 nm test. Perform the test by following the software prompts. Upon completion, record the values to the test
record.
8453, 8454 340 nm 340 – 390 nm ≥ 0.0 and < 0.03 %T 0.03 – 1.0 %T
Cary 50, 60; generic ≥ 0.0 and < 0.05 %T 0.05 – 1.0 %T
Cary 100 ≥ 0.0 and < 0.005 %T 0.005 – 1.0 %T
Cary 300 ≥ 0.0 and < 0.0002 %T 0.0002 – 1.0 %T
Cary 4000, 5000, 6000i ≥ 0.0 and < 0.00007 %T 0.00007 – 1.0 %T
Photometric Accuracy—Potassium Dichromate

Description: The Photometric Accuracy - Potassium Dichromate Test uses two strengths of the Potassium Dichromate standard.
First, the 60mg/L Potassium Dichromate standard is used to measure the difference between the expected absorbance values
(listed on the Certificate of Analysis) and the actual absorbance values reported by the instrument at four wavelengths: 235 nm,
257 nm, 313 nm, and 350 nm. The test passes if the expected absorbance values are within +/- 0.010 AU of the actual absorbance
values at the four wavelengths.
Then the 600 mg/L Potassium Dichromate standard is used to measure the difference between the expected absorbance value
(listed on the Certificate of Analysis) and the actual absorbance value reported by the instrument at 430 nm. The test passes if the
expected absorbance value is within+/- 0.012 AU of the actual absorbance value at 430 nm. This test meets all major
pharmacopoeia, ASTM, and NIST requirements.
disable the cell changer for testing. Using the spectrophotometer’s controlling data software (CDS), setup the Photometric
Accuracy – Potassium Dichromate test for both the 60 mg/L and 600 mg/L standard concentrations. Perform the test by following
the software prompts. Upon completion, record the values to the test record.
All 0.747 Abs at 235 nm N/A ≤ 0.010 Abs N/A
0.867 Abs at 257 nm
0.292 Abs at 313 nm
0.644 Abs at 350 nm
0.954 Abs at 430 nm ≤ 0.012 Abs

Photometric Accuracy—NIST Glass Filters

Description: The Photometric Accuracy – NIST Glass Filters test uses certified glass filter standard reference materials to measure
the difference between the expected absorbance value (listed on the Certificate of Analysis) and the actual absorbance value
reported by the instrument at various wavelengths. The Test passes if the expected absorbance value is within the test limit of the
expected absorbance value. This test meets all major pharmacopoeia, ASTM, and NIST requirements.
Accuracy – NIST test using the glass filter standard reference material. Perform the test by following the software prompts. Upon
completion, record the values to the test record.
8453, 8454; generic 1 Abs at 440.0 nm 1 Abs at 590.0 nm N/A ≤ 0.0050 Abs 0.0050 – 0.0080
1 Abs at 465.0 nm 1 Abs at 635.0 nm
1 Abs at 546.1 nm
Cary 50, 60, 100, 300, 1 Abs at 440.0 nm 1 Abs at 590.0 nm ≤ 0.0050 Abs 0.0050 – 0.0080
4000, 5000, 6000i 1 Abs at 465.0 nm 1 Abs at 635.0 nm
1 Abs at 546.1 nm
0.7 Abs at 440.0 nm 0.7 Abs at 590.0 nm ≤ 0.0040 Abs 0.0040 – 0.0080
0.7 Abs at 465.0 nm 0.7 Abs at 635.0 nm
0.7 Abs at 546.1 nm
0.5 Abs at 440.0 nm 0.5 Abs at 590.0 nm ≤ 0.0030 Abs 0.0030 – 0.0080
0.5 Abs at 465.0 nm 0.5 Abs at 635.0 nm
0.5 Abs at 546.1 nm
Photometric Reproducibility—Potassium Dichromate

Description: The Photometric Reproducibility - Potassium Dichromate test uses two strengths of the Potassium Dichromate
standard to find the reproducibility of the photometric measurement.
The 60 mg/L Potassium Dichromate standard is used to measure the absorbance at four wavelengths: 235nm, 257nm, 313nm, and
350nm. Ten measurements are taken at each respective wavelength. The standard deviation is then calculated for each respective
wavelength. The test passes if the calculated results of each measurement set are within the test limits.
The 600 mg/L Potassium Dichromate standard is used to measure the absorbance at 430 nm. Ten measurements are taken at each
respective wavelength. The standard deviation is then calculated for each respective wavelength. The test passes if the calculated
results of each measurement set are within the test limits.
Accuracy – Potassium Dichromate test for both the 60 mg/L and 600 mg/L standard concentrations. Follow the software prompts
to complete the test. Perform the test 10 times to obtain values for reproducibility at each wavelength. Upon completion, record the
All 235 nm 350 nm N/A Standard deviation: 0.000 – 0.005 Abs N/A
257 nm 430 nm
313 nm

Photometric Reproducibility—NIST Glass Filters

Optional for Cary models
Description: The Photometric Reproducibility—NIST Glass Filters test uses certified glass filter standard reference materials to find
the reproducibility of the photometric measurement.
The 30%T glass filter NIST standard is used to take ten measurements at the absorbance at the 546.1 nm wavelength. The
standard deviation is then calculated. The test passes if the calculated standard deviation is within the test limits.
Accuracy – NIST test for the 30%T standard. Follow the software prompts to complete the test. Perform the test 10 times to obtain
values for reproducibility at the 546.1 nm wavelength. Upon completion, record the values to the test record.
Cary 50, 60 0.5 Abs at 546.1 nm N/A Standard deviation: 0.000 – 0.005 Abs N/A
Cary 100, 300, 4000, Standard deviation: 0.000 – 0.005 Abs N/A
5000, 6000i
Photometric Noise
Standard for 8453/8454; optional for Cary and generic systems
Description: Photometric noise measures short-term fluctuations in the detector signal caused by inherent optical and electronic
noise. The amount of photometric noise will define the precision and minimum detection limit of the spectrophotometer. The test
passes if the measured photometric noise is within the test limits. This test’s limits conform to manufacturer requirements.
software (CDS), setup the Photometric Noise test. Perform the test by following the software prompts. Upon completion, record the
8453, 8454 0 Abs at 500 nm N/A < 0.00020 Abs, rms 0.000020 – 0.00200 Abs, rms
Cary 50, 60; generic < 0.00010 Abs, rms 0.00010 – 0.00100 Abs, rms
Cary 100 < 0.000085 Abs, rms 0.000085–0.000850 Abs,rms
Cary 300 < 0.00006 Abs, rms 0.00006 – 0.00060 Abs, rms
Cary 4000 < 0.00003 Abs, rms 0.00003 – 0.00030 Abs, rms
Cary 5000 0 Abs at 500 nm < 0.00003 Abs, rms 0.00003 – 0.00030 Abs, rms
0 Abs at 1500 nm
Cary 6000i 0 Abs at 500 nm < 0.00003 Abs, rms 0.00003 – 0.00030 Abs, rms
0 Abs at 1500 nm < 0.00002 Abs, rms 0.00002 – 0.00020 Abs, rms

Baseline Flatness
Description: Baseline Flatness measures the instrument’s ability to compensate for inherent optical and electronic noise across the
entire wavelength range. A baseline correction and test scan are performed across the entire wavelength range of the instrument.
The corrected signal is evaluated for peak-to-peak fluctuations. The test passes if the measured baseline stability is within test
limits. This test’s limits conform to manufacturer requirements.
software (CDS), setup the Baseline Flatness test. Perform the test by following the software prompts. Upon completion, record the
8453, 8454 0 Abs at 190 – 1100nm N/A -0.00100 – 0.00100 Abs -0.01000 – 0.01000 Abs
Cary 50, 60, 100, 300, g eneric 0 Abs at 200 – 850 nm -0.001 – 0.001 Abs -0.010 – 0.010 Abs
Cary 4000 0 Abs at 200 – 850 nm -0.0012 – 0.0012 Abs -0.0120 – 0.0120 Abs
N/A
Cary 5000 0 Abs at 200 – 3000 nm
Cary 6000i 0 Abs at 200 – 1700 nm
Photometric Stability
Description: Photometric Stability measures the photometric drift of the spectrophotometer when monitoring the Zero Absorbance
signal at a single wavelength for an hour. Photometric Stability is an indicator of how stable photometric results will be over an
extended period of time. The test passes if the measured drift of the photometric stability is within test limits. This test’s limits
conform to manufacturer requirements.
software (CDS), setup the Photometric Stability test. Perform the test by following the software prompts. Upon completion, record
the values to the test record.
8453, 8454 0 Abs at 340 nm N/A -0.00100 – 0.00100 Abs/hr -0.01000 – 0.01000 Abs/hr
Cary 50, 60 0 Abs at 500 nm -0.0004 – 0.0004 Abs/hr -0.0040 – 0.0040 Abs/hr
Cary 100, 300 0 Abs at 500 nm -0.0003 – 0.0003 Abs/hr -0.0030 – 0.0030 Abs/hr
Cary 4000, 5000, 6000i 0 Abs at 500 nm -0.00018 – 0.00018 Abs/hr -0.00180 – 0.00180 Abs/hr
0 Abs at 200 – 3000 nm
0 Abs at 200 – 1700 nm
Generic 0 Abs at 340 nm -0.00100 – 0.00100 Abs/hr -0.01000 – 0.01000 Abs/hr
Updated: February 2015 www.agilent.com/chem/enterprise

Information, descriptions and specifications in this
publication are subject to change without notice.
© Agilent Technologies, Inc. 2015

Published in USA

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Enterprise Edition and its primary components (ACE software tool, procedures, test design, metrology tools, chemical reference
standards, and operator training materials) have been designed, tested, validated, and released for commercial use following Agilent's
Life-Cycle Development Quality Assurance methodology.
Date: April 2015
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Protocol Details
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© 2015 by Agilent Technologies Enterprise Edition Compliance Services

EQP Name: UVVIS.01.06_OQ_Standard-EQP

Company Name: _______________

Customer Name/Title: _______________

EQP Filename: AgilentRecommendedA.01.15.eqp

Print Date: June 23, 2015 8:35:06 AM

UVVIS.01.06_OQ_Standard-EQP Page 1 / 22 June 23, 2015 8:35:06 AM

Scope and Purpose 3

UVVIS.01.06_OQ_Standard-EQP Page 2 / 22 June 23, 2015 8:35:06 AM

Scope and Purpose

Understanding the Test Specification Section in Tabular Review Documents

(Applies to hardware qualifications only)

UVVIS.01.06_OQ_Standard-EQP Page 3 / 22 June 23, 2015 8:35:06 AM

o Safely store and archive this EQP

General Statements on the Testing Program

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HOW AGILENT ENTERPRISE EDITION

How Enterprise Edition aligns with a traditional, paper-based methodology:

UVVIS.01.06_OQ_Standard-EQP Page 5 / 22 June 23, 2015 8:35:06 AM

Design Qualification (DQ)

Installation Qualification (IQ)

UVVIS.01.06_OQ_Standard-EQP Page 6 / 22 June 23, 2015 8:35:06 AM

Re-Qualification after Repair (RQ) Hardware

Updated: April 2015

© Agilent Technologies, Inc. 2015

UVVIS.01.06_OQ_Standard-EQP Page 7 / 22 June 23, 2015 8:35:06 AM

© 2015 by Agilent Technologies Enterprise Edition Compliance Services

Revision History: UV-Vis Spectrophotometer OQ

UVVis.01.06, February 2015

UVVis.01.05, September 2014

UVVis.01.04, April 2014

UVVIS.01.06_OQ_Standard-EQP Page 8 / 22 June 23, 2015 8:35:06 AM

© 2015 by Agilent Technologies Enterprise Edition Compliance Services

UVVis.01.03, April 2013

UVVis.01.02, December 2012

UVVis.01.01, June 2012

UVVIS.01.06_OQ_Standard-EQP Page 9 / 22 June 23, 2015 8:35:06 AM

Key: Standard core tests Optional tests

UVVIS.01.06_OQ_Standard-EQP Page 10 / 22 June 23, 2015 8:35:06 AM

Test Details, Design, and Rationale

Wavelength Accuracy—Source Line

UVVIS.01.06_OQ_Standard-EQP Page 11 / 22 June 23, 2015 8:35:06 AM

Wavelength Accuracy—Holmium Oxide in Perchloric Acid

UVVIS.01.06_OQ_Standard-EQP Page 12 / 22 June 23, 2015 8:35:06 AM

Wavelength Accuracy—Mercury Line

UVVIS.01.06_OQ_Standard-EQP Page 13 / 22 June 23, 2015 8:35:06 AM

Stray Light—Potassium Chloride

UVVIS.01.06_OQ_Standard-EQP Page 14 / 22 June 23, 2015 8:35:06 AM

Stray Light—Sodium Iodide

UVVIS.01.06_OQ_Standard-EQP Page 15 / 22 June 23, 2015 8:35:06 AM

Stray Light – Sodium Nitrite

Photometric Accuracy—Potassium Dichromate

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Photometric Accuracy—NIST Glass Filters

Photometric Reproducibility—Potassium Dichromate

UVVIS.01.06_OQ_Standard-EQP Page 17 / 22 June 23, 2015 8:35:06 AM

Photometric Reproducibility—NIST Glass Filters

UVVIS.01.06_OQ_Standard-EQP Page 18 / 22 June 23, 2015 8:35:06 AM

Updated: February 2015 www.agilent.com/chem/enterprise