Rapid Microbiological Methods in the Pharmaceutical Industry

Front Cover
Martin C. Easter
CRC Press, Mar 19, 2003 - Medical - 288 pages
2 Reviews
In recent years there has been increased interest in the possibility of rapid microbiological methods offering enhanced potential error detection capabilities. However, these methods raise a number of questions, such as how to validate new methods, will they be accepted by the pharmacopoeias, and, most importantly, how will the regulators respond? Rapid Microbiological Methods in the Pharmaceutical Industry answers these questions and more.

Martin Easter and his panel of experts:

§ Describe the range of rapid microbiological methods and their applications, including practical tips, and their status regarding validation, established use, and regulatory acceptance
§ Explore the origins of current methods and the current issues facing the requirements of microbiology and its associated test methods
§ Delineate the challenges involved in seeking better and more pragmatic methods for the assessment of microbial hazards and risks to ensure product and consumer safety

The book assists you in applying an effective system to assess the real microbiological hazards and, hence, quantify realistic risks. Additionally, it provides monitoring methods that will deliver meaningful, useful data for effective decision making in manufacturing, quality assurance, and product safety. The expert and authoritative information in Rapid Microbiological Methods in the Pharmaceutical Industry will help you find better solutions to ensuring the microbiological safety of pharmaceutical products.

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Contents

1 Introduction
1
2 Historical Perspective on Methods Development
6
3 Microbiological Methods of the Pharmacopoeia
13
4 Overview of Alternative Rapid Microbiological Technologies
28
5 LaborSaving Devices and Automation of Traditional Methods
41
6 ATP Bioluminescence and Its Use in Pharmaceutical Microbiology
57
7 Impedance
67
8 Traditional and Automated Rapid Methods for Species Identification and Typing
84
10 Alternative Technologies for Sterility Testing
121
11 Limulus Endotoxin Test
126
12 A Practical Guide to Validation
142
13 Regulatory Recognition and Acceptance
149
14 New Technologies for Microbiological Assays
157
Afterword
167
Contributors
170
Index
174

9 Techniques for Detection of Specific Organisms and Potential for DNABased Technologies
109

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