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Microbial Contamination Control in the Pharmaceutical Industry
Edited by Luis Jimenez
Marcel Dekker
August 2004
Hard Cover 370 pp, Illus ISBN 082475753X
£115.00
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- 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
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 - identifying new tools
for sample analysis and evaluation and the impact of these advancements on the continuous
supply and manufacturing of pharmaceutical products.
Contents
Microorganisms in the Environment and Their Relevance to Pharmaceutical Processes
Luis Jimenez
Microbial Limits
Luis Jimenez
Microbial Monitoring of Potable Water and Water for Pharmaceutical Purposes
Anthony M. Cundell
Sterility Test and Procedures
Luis Jimenez
Environmental Monitoring
Luis Jimenez
Biological Indicator Performance Standards and Control
Jeanne Moldenhauer
Rapid Methods for Pharmaceutical Analysis
Luis Jimenez
Endotoxin: Relevance and Control in Parenteral Manufacturing
Kevin L. Williams
Proper Use and Validation of Disinfectants
Laura Valdez-Mora
Antimicrobial Effectiveness Test and Preservatives in Pharmaceutical Products
Luis Jimenez
Index
To find similar publications, click on a keyword below:
Marcel Dekker
: Summer 2004
: disease control
: microbiology
: pharmaceuticals
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