Rapid Microbiological Methods in the Pharmaceutical Industry Book

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