Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 2 (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 17.8 MB)

Book written in February, 2008

Table of Contents

Table of Contents:

Click here to download >>> Detailed Table of Contents

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.