Features:

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

Rapid Microbiological Methods in the Pharmaceutical Industry 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 authoritative information in this book will help you find better solutions to ensuring the microbiological safety of pharmaceutical products.

The microbiological 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!

Contents

1. Introduction
   • Market Size
   • Issues and Challenges
   • Hopes for the Future

2. Historical Perspective on Methods Development
   • Foundation of the Field of Microbiology
   • Development of the Classical Microbiological Methods
   • The Search for Rapid Biological Methods
   • Bibliography

3. Microbiological Methods of the Pharmacopoiea: Growth and Recovery of Microorganisms from Pharmaceutical Manufacturing Environments
   • 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

4. Overview of Alternative Rapid Microbiological Technologies
   • Industrial Needs and Requirements
   • Rapid Methods and the Drug Development Process
   • Available Technologies
   • Molecular-Based Technologies
   • Identification Systems
   • Conclusions
   • References

5. Labor-Saving Devices and Automation of Traditional Methods
   • 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
   • References

6. ATP Bioluminescence and Its Use in Pharmaceutical Microbiology
   • The Science
   • The Products Available
   • References

7. Impedance
   • 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

8. Traditional and Automated Rapid Methods for Species Identification and Typing
   • Genotyping
   • Chemotaxonomy
   • Electrophoretic Protein Typing
   • Conclusion
   • References

9. Techniques for Detection of Specific Organisms and Potential for DNA-Based Technologies
   • Current Established Methods for Specific Organism Detection
   • DNA-Based Technologies
   • Why Aren't More Nucleic Acid Assays Being Used?
   • Conclusion
   • References

10. Alternative Technologies for Sterility Testing
    • Alternate Technologies: Clinical Origins
    • Alternate Technologies: Nonclinical Origins
    • Regulatory Acceptance and the Future for Sterility Testing
    • References

11. Limulus Endotoxin Test
    • 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

12. A Practical Guide to Validation
    • 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

13. Regulatory Recognition and Acceptance
    • Objectives
    • Brief History of Regulation Development
    • Regulatory Concerns
    • Regulatory Acceptance
    • Summary and Conclusions
    • References

14. New Technologies for Microbiological Assays
    • Immunological Tests
    • Cell Components
    • Microchips
    • Instrumental Techniques
    • Conclusions
    • References

15. Afterword
    • Advances in Technology
    • Acceptability
    • Attitude
    • References

Index

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