Microbial Contamination Control in the Pharmaceutical Industry edited by Luis Jimenez

Special Indian Reprint !

Microbial Contamination Control in the Pharmaceutical Industry
edited by Luis Jimenez

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