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: x Describe the range of rapid microbiological methods and their applications, including practical tips, and their status regarding validation, established use, and regulatory acceptance x Explore the origins of current methods and the current issues facing the requirements of microbiology and its associated test methods x 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