chapter 1 Microbial Life and Ecology -- chapter 2 Microbial Contamination and Control -- chapter 3 The USP Microbial Limit Tests -- chapter 4 Pharmaceutical Waters -- chapter 5 Environmental Monitoring -- chapter 6 Bioburden Considerations in Equipment-Cleaning Validation -- chapter 7 Method Validation and Media Suitability Testing -- chapter 8 Microbiological Quality of Pharmaceutical and Biopharmaceutical Products and Raw Materials -- chapter 9 Rapid Testing and Alternative Methods in Microbiology -- chapter 10 Biolms -- chapter 11 Handling Aberrant and Out-of-Specication Microbial Data.