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9780824757533

Microbial Contamination Control in the Pharmaceutical Industry

by Jimenez; Luis
  • ISBN13:

    9780824757533

  • ISBN10:

    082475753X

  • eBook ISBN(s):

    9781135523541

  • Edition: 1st
  • Format: Hardcover
  • Copyright: 2004-08-30
  • Publisher: CRC Press

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Summary

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

Preface iii
Contributors vii
Microorganisms in the Environment and Their Relevance to Pharmaceutical Processes
1(14)
Luis Jimenez
Microbial Limits
15(30)
Luis Jimenez
Microbial Monitoring of Potable Water and Water for Pharmaceutical Purposes
45(32)
Anthony M. Cundell
Sterility Test and Procedures
77(26)
Luis Jimenez
Environmental Monitoring
103(30)
Luis Jimenez
Biological Indicator Performance Standards and Control
133(14)
Jeanne Moldenhauer
Rapid Methods for Pharmaceutical Analysis
147(36)
Luis Jimenez
Endotoxin: Relevance and Control in Parenteral Manufacturing
183(68)
Kevin L. Williams
Proper Use and Validation of Disinfectants
251(32)
Laura Valdes-Mora
Antimicrobial Effectiveness Test and Preservatives in Pharmaceutical Products
283(18)
Luis Jimenez
Index 301

Supplemental Materials

What is included with this book?

The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.

The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.

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