This authoritative reference presents an up-to-date review of the testing methods, emerging technologies, and analytical systems and procedures used to prevent the microbial contamination of pharmaceutical processes, products, and environments. It identifies new tools for sample analysis and evaluation and the impact of these advancements on the continuous supply and manufacturing of pharmaceutical products. With more than 100 tables and 430 current references, the book contains a detailed analysis of microbial contamination recalls for nonsterile and sterile pharmaceutical products, demonstrating the distribution of microorganisms worldwide and the identification by geographical regions.
Table of Contents
Microorganisms in the Environment and Their Relevance to Pharmaceutical Processes; Microbial Limits; Microbial Monitoring of Potable Water and Water for Pharmaceutical Purposes; Sterility Test and Procedures; Environmental Monitoring; Biological Indicator Performance Standards and Control; Rapid Methods for Pharmaceutical Analysis; Endotoxin: Relevance and Control in Parenteral Manufacturing; Proper Use and Validation of Disinfectants; Antimicrobial Effectiveness Test and Preservatives in Pharmaceutical Products