Rapid Microbiological Methods in the Pharmaceutical Industry: 1st Edition (Hardback) book cover

Rapid Microbiological Methods in the Pharmaceutical Industry

1st Edition

Edited by Martin C. Easter

CRC Press

288 pages | 23 B/W Illus.

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Hardback: 9781574911411
pub: 2003-03-19
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Description

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.

Features

Table of Contents

FITNESS FOR A PURPOSE? TIME FOR A REVOLUTION, M.C. Easter

INTRODUCTION, M.C. Easter

Market Size

Issues and Challenges

Hopes for the Future

HISTORICAL PERSPECTIVE ON METHODS DEVELOPMENT, A.M. Cundell

Foundation of the Field of Microbiology

Development of the Classical Microbiological Methods

The Search for Rapid Biological Methods

Bibliography

MICROBIOLOGICAL METHODS OF THE PHARMACOPOEIA: GROWTH AND RECOVERY OF MICROORGANISMS FROM PHARMACEUTICAL MANUFACTURING ENVIRONMENTS, K. Haberer and M.W. Mittelman

Microbial Growth in Pharmaceutical Environments: Starvation-Survival Biofilm Formation

Influence of Environmental Conditions on Microbial Survival

Cultivation of Microorganisms on Solid and Liquid Substates

Microbiological Standard Methods of the Pharmacopoeia

References

OVERVIEW OF ALTERNATIVE RAPID MICROBIOLOGICAL TECHNOLOGIES, P.J. Newby and B. Johnson

Industrial Needs and Requirements

Rapid Methods and the Drug Development Process

Available Technologies

Molecular-Based Technologies

Identification Systems

Conclusions

References

LABOR-SAVING DEVICES AND AUTOMATION OF TRADITIONAL METHODS, P. Silley and A.N. Sharpe

Blenders, Stomachers, and Pulsifiers

Gravimetric Diluters

Counting Procedures

Some Venerable, Inexpensive, and Labor-Saving Methods

Methods for Surface Contamination: Agar Contact Methods

Spiral Plating Applications

ATP BIOLUMINESCENCE AND ITS USE IN PHARMACEUTICAL MICROBIOLOGY, K. Wills

The Science

The Products Available

References

IMPEDANCE, P. Silley and F. Mortimer

History of Development

Impedance Theory

Influence of Electrodes

Principle Factors Affecting Detection Time

Instruments

Pharmaceutical Applications of Impedance

Miscellaneous Applications in Drug Development

Conclusion

References

TRADITIONAL AND AUTOMATED RAPID METHODS FOR SPECIES IDENTIFICATION AND TYPING, K. Tyler and J.M. Farber

Genotyping

Chemotaxonomy

Electrophoretic Protein Typing

Conclusion

References

TECHNIQUES FOR DETECTION OF SPECIFIC ORGANISMS AND POTENTIAL FOR DNA-BASED TECHNOLOGIES, R. Owen

Current Established Methods for Specific Organism Detection

DNA-Based Technologies

Why Aren't More Nucleic Acid Assays Being Used?

Conclusion

References

ALTERNATIVE TECHNOLOGIES FOR STERILITY TESTING, A. Meszaros

Alternate Technologies: Clinical Origins

Alternate Technologies: Nonclinical Origins

Regulatory Acceptance and the Future for Sterility Testing

References

LIMULUS ENDOTOXIN TEST, T.J. Novitsky and H.D. Hochstein

Discovery

Early Regulatory Interest in an Alternative to the Rabbit Pyrogen Test

Commercialization

Industry Acceptance

FDA Guidelines

USP Bacterial Endotoxin Test and Related Monographs

European and Japanese Pharmacopoeia Acceptance of the LAL Test

Methodology

Automation

Research and Clinical Applications

Future of the Assay

References

A PRACTICAL GUIDE TO VALIDATION, K. Wills

What is Validation?

Background

Start at the Beginning

Specification Qualification (SQ)

Validation Plan

Design Qualification (DQ)

Operation Qualification (OQ)

Performance Qualification (PQ)

Standard Operating Procedures (SOPs)

Validation Summary

Implementation

Periodic Review

Multiple Site Validation

Amendments to Product Marketing Authorizations

Conclusion

References

REGULATORY RECOGNITION AND ACCEPTANCE, E.A. Fitzgerald

Objectives

Brief History of Regulation Development

Regulatory Concerns

Regulatory Acceptance

Summary and Conclusions

References

NEW TECHNOLOGIES FOR MICROBIOLOGICAL ASSAYS, L.J. Kricka

Immunological Tests

Cell Components

Microchips

Instrumental Techniques

Conclusions

References

AFTERWORD, M.C. Easter and A.M. Cundell

Advances in Technology

Acceptability

Attitude

References

Contributors

Index

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
SCI045000
SCIENCE / Life Sciences / Biology / Microbiology