Pharmaceutical Quality Control Microbiology: A Guidebook to the Basics (single user digital version)

Jan 2017
PDA Item Number
PDF Single user
Member Price
Nonmember Price
Government Price

This book is intended to provide a background to the quality control (QC) microbiology function from the perspective of the laboratory, and particularly from that of the laboratory manager. Sutton focuses on the role of the QC microbiology laboratory in the pharmaceutical manufacturing environment, and provides "heads-up" information to the new microbiologist that is going into the pharmaceutical, medical device or cosmetics industries.

This book will also be useful to the newly-promoted manager of a microbiology laboratory who might not be comfortable with all aspects of the QC microbiology lab. Finally, this book will also be useful to upper management in understanding the microbiology function and assays, and the frequent trade-off between well-controlled and well-executed tests on the one hand, and uncertain microbiology data (with the opportunity to conduct many investigations into unforeseen results) on the other.

The writing style is easy to read, with a minimum of jargon. This book is not a treatise on the science of microbiology, but a practical (if sometimes light-hearted) treatment of how a QC microbiology lab functions in the pharmaceutical and related industries. Pharmaceutical Quality Control Microbiology: A Guidebook to the Basics will not overpower the newcomer, but provides a wealth of readable and useful information to all levels of workers.

Book written in June, 2007

Original Price US$235 PDA Member, US$289 Nonmember, US$155 Government
Sale prices are already displayed and will be reflected during checkout

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 6.46 MB)

Table of Contents

Table of Contents:
Click here to download >>>Detailed Table of Contents

Introduction (Click here to download >>>Introduction )

1. What is Microbiology and Why Do I Care?
2. Microbial Growth and Enumeration
3. Laboratory Design Concerns
4. Microbiology Laboratory Quality Control Practices
5. Microbial Identification Methods
6. Sterilization
7. Microbiology in the Clean Rooms and Aseptic Area Aseptic Processing
8. Process Control Tests: Raw Materials, Media Fills and Environmental Monitoring
9. Finished Product Tests
10. Investigations
11. Rapid Microbiological Methods in the QC Laboratory
12. Training

About the Authors

About the Author

Scott Sutton, PhD earned his B.S. in Genetics from the University of California at Davis, and his Masters and Ph.D. in Microbiology from the University of Rochester (Rochester, NY). After an NIH postdoctoral fellowship at the Medical College of Virginia (Richmond, VA), he joined Bausch and Lomb (Rochester, NY), and in 1994 he accepted a position at Alcon Laboratories (Fort Worth, TX) where he became a Director in the R&D Division. In 2004, he joined Vectech Pharmaceutical Consultants, Inc. as Pharma Consultant (Microbiology) and is now Senior Director, Microbiology Services for Vectech. Dr. Sutton is an active author and speaker for the industry. In addition, he is active in a volunteer capacity, being involved with the USP Analytical Microbiology Committee of Experts since 1993.