1st Edition

Rapid Microbiological Methods in the Pharmaceutical Industry

Edited By Martin C. Easter Copyright 2003
    288 Pages 23 B/W Illustrations
    by CRC Press

    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

    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

    Biography

    Martin C Easter