Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volumes 1 and 2 (single user digital version)

Feb 2015
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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.

Book written in February, 2008

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Table of Contents

Table of Contents:

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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

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Chapter 15 - Safety Ventilation in Cleanrooms by Bengt Ljungqvist and Berit Reinmüller
Chapter 16 - Environmental Monitoring by Jeanne Moldenhauer
Chapter 17 - Disinfectants Program by Paul K. Priscott and Yung Dai
Chapter 18 - Training of Aseptic Processing Personnel by James L.Vesper
Chapter 19 - The Global State of Microbiological Compendial Methods by Scott Sutton
Chapter 20 - Rapid Microbiological Methods by Michael J. Miller
Chapter 21 - New Technologies for Microbiological Testing by Anthony M. Cundell
Chapter 22 - Bacterial Endotoxin Test by James F. Cooper
Chapter 23 - Microbial Limits Test Program by Michael C. Carroll
Chapter 24 - Stability Program with Microbiological Points to Consider Throughout Drug Development by Hannah Monds and Robert Guardino
Chapter 25 - Management of Deviations by Marianne Scheffler
Chapter 26 - Modern Quality Systems by Richard L. Friedman
Chapter 27 - Regulatory Stewardship: The Global Regulatory Dossier for Parenteral Drugs by Kip Vought
Chapter 28 - Electrons and Microbes: Using the Internet to Advance the Field of Microbiology by Scott Sutton
Chapter 29 - History of Microbial Identification by Ziva Abraham
Chapter 30 - Aseptic Processing in the US and EU: Another Brick in the Wall by Martyn Becker

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.