Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 1 (single user digital version)

Apr 2018
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PDF Single user
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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.

Author comment:

"I put where I can access it easily. I expect it to be a useful resource ...it goes well beyond the first edition."

James Agalloco
President of Agalloco & Associates

"It looks great. You are to be congratulated on a job well done"

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 them."

William E. Hall, PhD
Hall and Associates

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Format: PDF (1 file 8.08 MB)

Book written in February, 2008

Table of Contents

Table of Contents:

Click here to download >>> Detailed Table of Contents

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 K.L.Williams
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 Trevor Deeks
Chapter 11 - Sterilization Process Validation by James Agalloco
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. Soli

About the Authors

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 confronting variability.