Anal Bioanal Chem (2006) 386:1585–1586
DOI 10.1007/s00216-006-0811-9
BOOKS AND SOFTWARE IN REVIEW
Katherine A. Bakeev (Ed.): Process Analytical Technology
Stephan Küppers
Published online: 7 October 2006
# Springer-Verlag 2006
Bibliography
Process Analytical
Technology
Katherine A. Bakeev (Ed.)
Blackwell Publishing,
Oxford
ISBN 1405121033,
Hardcover, 472 pp.,
August 2005, £110
Book’s topic Process analytical technology (PAT) is an
initiative of the Food and Drug Administration (FDA). The
FDA defines PAT [1] as a system for designing, analyzing,
and controlling manufacturing through timely measurements
(i.e. during processing) of critical quality and performance
attributes of raw and in-process materials and processes with
the goal of ensuring final product quality. It is important to
note that the term analytical in PAT is viewed broadly, to
include physical, microbiological, mathematical, and risk
analysis conducted in an integrated manner. The FDA also
defines process analytical technology tools as the many
current and new tools available that enable scientific, risk-
managed pharmaceutical development, manufacture, and
quality assurance. These tools, when used within a system,
can provide effective and efficient means for acquiring
S. Küppers (*)
Forschungszentrum Jülich GmbH, ZCH,
52425 Jülich, Germany
e-mail: s.kueppers@fz-juelich.de
information to facilitate process understanding, develop
risk-mitigation strategies, achieve continuous improvement,
and share information and knowledge. In the PAT frame-
work, these tools can be categorized as:
– multivariate data acquisition and analysis tools;
– modern process analyzers or process analytical chem-
istry tools;
– process and endpoint monitoring and control tools; and
– continuous improvement and knowledge-management
tools.
The book “Process Analytical Technology” edited by K.A.
Bakeev states its topic in the preface as follows: “Not all
spectroscopic tools are covered. Included in this book are
UV–VIS, IR, Raman and NIR-Imaging”. The title of the
book is misleading at the very least because it is a book
dealing with only a few of the tools that are useful in PAT,
with a very strong focus on IR.
Contents The book has 12 chapters and 451 pages. In
Chapter 1 a general introduction to process analytical
chemistry (PAC) is given, some historical sections describe
the development of optical spectroscopy as part of PAC.
Unfortunately, neither PAC nor any of the other terms used
in the book is defined; not even the definition of PAT is
found in the book. For readers the difference between PAT,
PAC, process analysis, etc., never becomes clear. This is
surprising because Ref. [1] is cited more than once. In
Chapter 2 two colleagues from Merck & Co. give a very
readable introduction to the PAT-implementation approach
at Merck. Here many of the aspects are presented in
accordance with the FDA definition of PAT and this chapter
alone is a good overall introduction to the topic of PAT. In
Chapter 9 two colleagues from Eli Lilly describe some
typical applications of optical spectroscopy in the pharma-
1586
ceutical industry. Here the aspects of PAT found in Chapter
2 appear again. Both chapters fit the title of the book very
well. Chapter 10 is written by colleagues from the
University of Barcelona from the perspective of pharma-
ceutical companies and show how and where NIR and mid-
IR can be applied. This is a good introduction for people in
the pharmaceutical industry who must familiarize them-
selves with IR and its possibilities. In Chapters 3–6, the
tools mentioned in the preface are described in technical
detail. These chapters are well written and might be
understood as a part of a textbook, e.g. for students.
Chapter 7 is also a more or less technical article, in which a
new field “NIR-Imaging” is described. This contribution
would again be well suited as a review contribution to a
special issue of a scientific journal on tools for imaging or
also on PAT. Chapter 8 is a hundred-page introduction to
chemometrics. The chapter is excellent because it starts
very understandably then proceeds to the mathematical
background and finally to the different chemometric
techniques used. Personally, I would never have expected
25% of a book on PAT tools to be a basic introduction to
chemometrics and I wonder if a potential reader would
expect such a contribution in this book. Chapter 11 extends
the use of NIR to other fields of application in the chemical
industry. Finally, the editor gives an outlook of the future of
process analytical chemistry. Some of the general trends
mentioned are miniaturization, the development of different
types of sensor, and data transfer, handling, and manage-
ment. Here wireless communication and chemometrics are
seen as important future trends.
Critical assessment Some of the contributions to the
“Process Analytical Technology” are very much worth
reading. Unfortunately, the book has no clear focus and
some of the articles overlap. Overall, a definition of the
topics of the book is missing and even in optical
spectroscopy the book does not give a complete overview.
For example, there is a contribution on imaging with NIR
but there is no contribution on the equally important
development of imaging with Raman spectroscopy. Many
Anal Bioanal Chem (2006) 386:1585–1586
of the applications mentioned in the book could be solved
by use of NIR, mid-IR, or Raman, some even by all three
techniques. If a book is intended to describe tools for PAT, a
comparison of these tools should at least have been given
for a few of the examples. Overall, the book is a collection
of current contributions to the field of optical spectroscopy
in the pharmaceutical and chemical industries without a
proper focus.
Readership recommendation The book is not an intro-
duction to PAT. Potential readers should be interested in
optical spectroscopy and should either be new to the field
or should skip the more basic Chapters 3–6 and read only
the rest of the book. Potential readers should have some
knowledge of process analytical technology before reading
the book, so they will not be confused by the mixing of
terminology. For the purpose the FDA website might be a
very helpful first introduction. Experienced users of PAT
could read chapters selectively to refresh their view of
current trends in some aspects of optical spectroscopy and
PAT.
Summary Although some of the articles are very well
written and some are excellent in their content, the book
might be confusing for newcomers to the field of process
analytical technology. Some of the articles are current
reviews that can also be found in the literature of scientific
journals and an introduction to chemometrics is also
available elsewhere. Unfortunately, my impression is that
the editor has simply collected contributions and copied the
individual chapters together. I believe the book could find a
place in the libraries of industries involved in the field of
PAT and maybe some scientists or engineers will look at
one contribution or another.
Reference
1. http://www.fda.gov/cder/OPS/PAT.htm