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Easy and Rapid System Qualification using

the iCAP Series Qualification Kit
Daniel Kutscher, Applications Specialist ICP-MS, Matthew Cassap, Product Manager ICP-OES,
Thermo Fisher Scientific

Key Words
iCAP 7000 Series ICP-OES, iCAP Q Series ICP-MS, System Qualification,
Qtegra ISDS, Pharmaceutical Industry

Goal
To demonstrate how the iCAP Series Qualification Kit can ensure a smooth
and rapid qualification of the system to get production labs up and running
in the shortest possible time frame.

Introduction
System qualification ensures that the instrument and the
procedures used with it are fit for purpose. The qualification
process instils confidence in instrument performance and
subsequent analytical results, with regular tests performed IQ checks the equipment and control systems against the
by service personnel and the instrument operator verifying vendor defined standards of operating environment,
continuing system performance. physical connection, safety and functional parameters
prior to initial utilization of the system. It thus confirms
The system qualification process commences long before
that the system is installed correctly.
an instrument is built; starting with the initial Specification
Qualification (SQ) and Design Qualification (DQ) that OQ defines functional tests and compares them against
provide evidence that quality is specified and designed vendor specification. This is ideally performed following
into the final product by the manufacturer. Thermo Fisher successful completion of the IQ. OQ is the process of
Scientific is responsible for the research, development and ensuring that the instrument meets specifications over all
manufacturing of the Thermo Scientific™ iCAP™ Q Series intended operating ranges.
ICP-MS and Thermo Scientific™ iCAP™ 7000 Series
Performance Qualification (PQ) is an additional
ICP-OES, respectively. The production facilities for these
component of the qualification step for analytical
instruments have been awarded accreditation to the
instruments. PQ requires test criteria specific to a given
ISO 9001:2008 Quality Standards. All Thermo Scientific
application or method. The analytical tests and testing
instruments are designed and manufactured in accordance
interval must be defined and undertaken by the customer
with the requirements of this standard.
in accordance with any applicable protocol of the
The process for instrument qualification after manufacture laboratory. Typically, this is specified in Standard
and delivery of a new system is defined by Installation Operation Procedures (SOPs).
Qualification (IQ) and Operation Qualification (OQ).
Both IQ and OQ processes are performed following
instrument installation, by specially trained and certified
personnel alongside a customer representative.
Figure 1 depicts all the processes involved in the system Furthermore, the kit contains detailed information on the
qualification of an analytical instrument. qualification process for a new instrument and describes

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the compliance of the Thermo Scientific™ Qtegra™
Intelligent Scientific Data Solution™ software to the
guidelines set out in Part 11 in Title 21 of the US Code of
Federal Regulations (FDA 21 CFR Part 11), defining the
storage and protection of electronic records and use of
electronic signatures.

As outlined previously, Performance Qualification is the

sole responsibility of the user. Therefore, applicable test
criteria for PQ are not included in the iCAP Series
Qualification Kit. However, drawing upon the extensive
experience of the Thermo Scientific Application team, the
Qualification Kit contains a summary of best practices for
new users of plasma based instrumentation.

As a reference for the development of methods suitable

for elemental impurities analysis, the iCAP Series
Qualification Kit also contains a number of application
notes describing field-proven methodologies for a variety
of samples.
Figure 1: The entire qualification process from initial design to Compatibility
analytical operation. The iCAP Series Qualification Kit is available for the
iCAP 7000 Series ICP-OES or the iCAP Q Series ICP-MS
Figure 2 gives an overview of the different qualification systems, both operating on the Qtegra ISDS software
tests, explaining the responsibilities of both manufacturer platform. This new modular software easily integrates
and user. different instrument types, leveraging the potential in a
laboratory as operators can seamlessly switch between
different instrument types.

Conclusions
The iCAP Series Qualification kit ideally complements an
iCAP 7000 Series ICP-OES or iCAP Q Series ICP-MS, as
it provides a complete set of materials for a successful new
instrument implementation. By combining Installation
and Operational Qualification (IQ/OQ) with practical
guidelines for effective day-to-day operation of the system
and helpful information for the development of analytical
methods, newly installed instruments will be up and
Figure 2: The system qualification process. running quickly and smoothly ensuring faster validation
and expedited time to production.
The iCAP Series Qualification Kit
The new Thermo Scientific™ iCAP™ Series Qualification
Kit contains the required material for the successful
qualification of an iCAP 7000 Series ICP-OES or an
iCAP Q Series ICP-MS system in a laboratory. The
respective kits contain all the necessary documentation
and solutions for completion of IQ/OQ for either instrument.
The tests themselves are completed upon installation of a
system by a specially trained and certified field service
engineer and in parallel are verified and approved by the
customer representative.

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©2013 Thermo Fisher Scientific Inc. All rights reserved. ISO is a trademark of the International Standards Organization.
All other trademarks are the property of Thermo Fisher Scientific Inc. and its subsidiaries. This information is presented as an
Thermo Fisher Scientific, (Bremen) GmbH
example of the capabilities of Thermo Fisher Scientific Inc. products. It is not intended to encourage use of these products in any Management System Registered is
manners that might infringe the intellectual property rights of others. Specifications, terms and pricing are subject to change. ISO 9001:2008 Certified.
Not all products are available in all countries. Please consult your local sales representative for details.

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