Microbial Contamination Control in the Pharmaceutical Industry edited by Luis Jimenez

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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

Index

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