Microbial Contamination Control in the Pharmaceutical Industry 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.

Features:

• Offers comprehensive examination of the literature on the application and implementation of rapid technologies for quality control analysis
• Includes chapters by world-renowned authorities on topics including water testing, endotoxins, environmental monitoring, and more
• Discusses the limitations of standard analytical methods and the use of alternative technologies to enumerate, detect, and identify microorganisms
• Describes and compares the microbiological method and sterility test requirements, pass and fail criteria, and validation procedures of three major pharmacies
• Includes examples of suitable quality control programs for water testing
• Assesses testing protocols and microorganisms utilized in the validation of disinfectant efficacy
• Covers critical factors affecting the preservation of pharmaceutical products

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

Index

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