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The first edition of Microbiology in Pharmaceutical Manufacturing, published
in 2001, is THE best selling PDA/DHI book of all time. Modeled on the first edition, the 2008 completely revised and
extended edition raises the bar by offering practical and current industrial and regulatory perspectives. While in revision,
20 new chapters were added and sixteen new authors contributed their work to this book making it the most comprehensive
collection of best thinking from subject matter experts in their respective fields.
The goal of this book is to provide updated and expanded microbiological information for the benefit of a global audience of stakeholders.
"I put where I can access it easily. I expect it to be a useful resource
...it goes well beyond the first edition."
President of Agalloco & Associates
"It looks great. You are to be congratulated on a job well
Scott Sutton, PhD
Vectech Pharmaceutical Consultants, Inc.
"I am starting to read it cover to cover since there are so many interesting
chapters and they are so well-written that even a chemist like myself can understand
William E. Hall, PhD
Hall and Associates
Available to download. Prior to purchase please view the download instructions and Terms of Usage
Format: PDF (1 file 8.08 MB)
Book written in February, 2008
Table of Contents:
Click here to
download >>> Detailed Table
Chapter 1 - Origins of Microbial Life by David
R. Singleton, Kamlesh Jangid and William B. Whitman
Chapter 2 -
Epidemiological Principles and the Microbiology Laboratory by Lennox K.
Archibald and William R. Jarvis
Chapter 3 - Taxonomy of
Microorganisms by Shung-Chang Jong
Chapter 4 - A Basic Primer on
Pharmaceutical Microbiology by Hans van Doorne
Chapter 5 - Design,
Commissioning and Validation of a Parenteral Manufacturing Facility by
Robert Del Ciello
Chapter 6 - Process Capability and Product
Specifications by Steven S. Kuwahara
Chapter 7 - Microbiological
Control Strategies During the Development of Pharmaceutical Products and
Processes by M.J. Miller, M.E. Claerbout, R.A. DeMaio, J.K. Farrington, W.H.
Johnston, D.K. Knoy, T.I. Nicas, M.J. Rubino, M.P. Stickelmeyer, and
Chapter 8 - Microbiological Risk Assessment in
Pharmaceutical Production Operations by James Akers
Chapter 9 -
Designing and Validating a Contamination Control Program by Sandra A.
Lowery and Maureen Mueller
Chapter 10 - Microbiological Control
in Fermentation, Cell Culture and Downstream Purification Processes by
Chapter 11 - Sterilization Process Validation by
Chapter 12 - Sterilizing Filtration of Liquids by
Richard V. Levy
Chapter 13 - Cleaning Validation Program by
William E. Hall
Chapter 14 - Pharmaceutical Water by T.C.
About the Editor
Dr. Richard Prince, is Senior Director, Regulatory Affairs,
Quality & Clinical Operations, Immunomedics, Inc., a biotechnology firm
located in New Jersey, USA. He has twenty-two years experience in the industry
with previous positions in general scientific management, business development,
microbiological and toxicological laboratory operations, corporate quality
assurance, GXP regulatory compliance and, most recently, in regulatory affairs
and clinical operations. Dr. Prince, with this work, has now published four
textbooks for the PDA/DHI Books in the areas of microbiology, quality and