Table of Contents

Chapter 1 Introduction Chapter 2 Disinfectants and Biocides Chapter 3 Disinfecting Agents: The Art of Disinfection Chapter 4 The Microbiome and Its Usefulness to Decontamination/ Disinfection Practices Chapter 5 Disinfectant Qualification Testing Considerations for Critical Manufacturing Environments Chapter 6 Methods for Contamination Detection Chapter 7 Residue Removal in Cleanroom Environments Chapter 8 Microbiological Concerns in Non-Sterile Manufacturing Chapter 9 Preservatives and Why They Are Useful Chapter 10 The Problem of Burkholderia cepacia Complex (BCC) in Your Facility Chapter 11 What Is Mold and Why Is It Important? Chapter 12 Sterilization Methods

About the Author

Jeanne Moldenhauer, Vice-President of Excellent Pharma Consulting, has more than 30 years’ experience in the pharmaceutical industry. She chaired the Environmental Monitoring/Microbiology Interest Group of PDA for more than 15 years, served on the Scientific Advisory Board of PDA for 20 years, founded the Rapid Microbiology User’s Group™, and is a member of ASQ and RAPS. She is the author/editor of many books, including Steam Sterilization: A Practitioner’s Guide, Laboratory Validation: A Practitioner’s Guide, Environmental Monitoring: A Comprehensive Handbook (Volumes 1-8), Contamination Control Volumes 1-4 (with Russ Madsen), System’s Based Inspections for Pharmaceutical Manufacturers, Preparing for an FDA Inspection: Review of Warning Letters (Sterile and Non-Sterile), and Biological Indicators, and numerous publications (book chapters and magazine articles).