Download Rapid Microbiological Methods in the Pharmaceutical Industry PDF

TitleRapid Microbiological Methods in the Pharmaceutical Industry
File Size2.8 MB
Total Pages197
Table of Contents
                            Book Cover
Title
Copyright
Contents
Preface
1 Introduction
	MARKET SIZE
	ISSUES AND CHALLENGES
		Microbes and the Analytical Challenge
		What Are We Really Trying to Detect?
		Hazard Analysis and Risk Assessment
	HOPES FOR THE FUTURE
	REFERENCES
2  Historical Perspective on Methods Development
	FOUNDATION OF THE FIELD OF MICROBIOLOGY
	DEVELOPMENT OF THE CLASSICAL MICROBIOLOGICAL METHODS
	DEVELOPMENT OF ADVANCED MICROBIOLOGICAL METHODS
	THE SEARCH FOR RAPID MICROBIOLOGICAL METHODS
	BIBLIOGRAPHY
3  Microbiological Methods of the Pharmacopoeia
	MICROBIAL GROWTH IN PHARMACEUTICAL ENVIRONMENTS: STARVATION-SURVIVAL
	BIOFILM FORMATION
	INFLUENCE OF ENVIRONMENTAL CONDITIONS ON MICROBIAL SURVIVAL
	CULTIVATION OF MICROORGANISMS ON SOLID AND LIQUID SUBSTRATES
		Growth Curves
		Lag Phase
		Exponential Growth Phase
		Stationary Phase
		Reduction Phase
		Influence of Media Composition, Temperature, and Incubation Time
		Selective Media
		Indicator Reactions
		Influence of Antagonistic Agents on Recovery
		Objectionable Microorganisms
		Noncultivable Microorganisms
	MICROBIOLOGICAL STANDARD METHODS OF THE PHARMACOPOEIA
		Neutralization of Antimicrobial Activity and Validation of Recovery
		Total Viable Count
		Yeast and Mold Count
		Specific Microorganisms
		Test for Sterility
		Antimicrobial Effectiveness Tests
		Summary and Outlook
	REFERENCES
4  Overview of Alternative Rapid Microbiological Technologies
	INDUSTRIAL NEEDS AND REQUIREMENTS
		Why Test?
	RAPID METHODS AND THE DRUG DEVELOPMENT PROCESS
		Cost
		New Method Requirements
	AVAILABLE TECHNOLOGIES
		Sample Preparation
		Media Preparation
		Membrane Filtration
		Specific Organism Isolation
		Anaerobes
		Immunological Methods
		Electrical Methods
			Impedance
		Bioluminescence
		Cytometry
	MOLECULAR-BASED TECHNOLOGIES
	IDENTIFICATION SYSTEMS
	CONCLUSIONS
	REFERENCES
5  Labor-Saving Devices and Automation of Traditional Methods
	BLENDERS, STOMACHERS, AND PULSIFIERS
	GRAVIMETRIC DILUTERS
	COUNTING PROCEDURES
		Hydrophobic Grid Membrane Filter
		Petrifilm
			Standard Plate Count
			Coliform and Escherichia coli
			Petrifilm E. coli O157:H7
			Yeast and Mold
		Redigel
		Spiral Platers
			Counting
		Electronic Colony Counters
	SOME VENERABLE, INEXPENSIVE, AND LABOR-SAVING METHODS
		Loop-Tile Method
		Agar Droplet Technique
		Plate Loop
	METHODS FOR SURFACE CONTAMINATION: AGAR CONTACT METHODS
		RODAC Contact Plates
		Agar Syringes and Agar Sausages
		Dip Slides and Samplers
	SPIRAL PLATING APPLICATIONS
		MIC Testing
		Mutagenicity Screening
	REFERENCES
6  ATP Bioluminescence and Its Use in Pharmaceutical Microbiology
	THE SCIENCE
	THE PRODUCTS AVAILABLE
		Pallchek
		RapiScreen
		MicroStar
	THE FUTURE
	SUMMARY
	REFERENCES
7  Impedance
	HISTORY OF DEVELOPMENT
	IMPEDANCE THEORY
		Direct Impedance
		Indirect Impedance
		Principle of Detection by Indirect Impedance
	INFLUENCE OF ELECTRODES
	PRINCIPLE FACTORS AFFECTING DETECTION TIME
	INSTRUMENTS
		Bactometer
		BacTrac
		Separate Registration of M-Value and E-value
		Malthus
	RABIT
	PHARMACEUTICAL APPLICATIONS OF IMPEDANCE
		Enumeration of Bacteria and Fungi
		Testing for Biocidal Activity
		Sterility Testing
		Predictive Modeling of Growth
		Detection of Pathogenic Organisms
			Salmonella
			Escherichia coli
			Pseudomonas spp.
			Staphylococcus aureus
			Clostridia
	MISCELLANEOUS APPLICATIONS IN DRUG DEVELOPMENT
	CONCLUSION
	REFERENCES
8  Traditional and Automated Rapid Methods for Species Identification and Typing
	GENOTYPING
		Restriction Endonuclease Analysis
		Plasmid Typing
		Ribotyping
		PFGE Typing
		PCR-Based Typing Systems
		Identification with Primers and Probes
	CHEMOTAXONOMY
		Mass Spectrometry and Pyrolysis
			Pyrolysis MS
			Reproducibility
		Fourier Transform Infrared Spectroscopy
		Gas Chromatography and the Microbial Identification System
			Microbial Identification System
	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
		Immunological Detection Systems
		Alternative Approaches and Combined Technologies
	DNA-BASED TECHNOLOGIES
		Why Use Nucleic Acids to Detect Microorganisms?
		How Are Nucleic Acids Used in Assays and What Are the New Technologies?
			Recognition of the target by the probe
			Amplification of the target sequence
			Detection of the assay signal
			Amplification of the assay signal
	WHY AREN’T MORE NUCLEIC ACID ASSAYS BEING USED?
	CONCLUSION
	REFERENCES
10  Alternative Technologies for Sterility Testing
	ALTERNATE TECHNOLOGIES: CLINICAL ORIGINS
		BACTEC® System
		ESP® Detection System
		BacT/Alert®
	ALTERNATE TECHNOLOGIES: NONCLINICAL ORIGINS
		Bactometer®
		ScanRDI®
		The Electronic Nose
	REGULATORY ACCEPTANCE AND THE FUTURE FOR STERILITY TESTING
	REFERENCES
11  Limulus Endotoxin Test
	DISCOVERY
		Comparison of Blood Coagulation in Limulus and Mammals
		Preparation of Limulus Amebocyte Lysate
	EARLY REGULATORY INTEREST IN AN ALTERNATIVE TO THE RABBIT PYROGEN TEST
		FDA’s Experience with Bacterial Endotoxin
		Licensing the LAL Test
		LAL Licensed Manufacturers
	COMMERCIALIZATION
		Evolution of the Test Methodology
		Current Technology and Automation
	INDUSTRY ACCEPTANCE
		Replacement of the Pyrogen (Rabbit) Test
		Sensitivity, Reproducibility, Sample Interference
		Non-Endotoxin Pyrogens
		False Positives
	FDA GUIDELINES
		The Guideline
		Legal Effect
	USP BACTERIAL ENDOTOXIN TEST AND RELATED MONOGRAPHS
		Reference Standard and Control Standard Endotoxin
		Preparatory Testing
			Test for Confirmation of Labeled LAL Reagent Sensitivity
			Inhibition or Enhancement Test
			Maximum Valid Dilution
		Test Procedure
			Preparations
			Procedure
		Calculation and Interpretation
			Geometric Mean Calculation
			Endotoxin Content Calculation
			Interpretation
	EUROPEAN AND JAPANESE PHARMACOPOEIA ACCEPTANCE OF THE LAL TEST
		International Standard
	METHODOLOGY
		Gel-Clot Assay
		Turbidimetric Assay
		Chromogenic Assay
	AUTOMATION
	RESEARCH AND CLINICAL APPLICATIONS
		LAL as a Research Tool
	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)
	INSTALLATION QUALIFICATION (IQ)
	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
		Signal Amplification
			Bioluminescent and chemiluminescent labels and detection schemes
			Immuno-PCR and DNA labels
		Background
		Formats
			Capture and enrichment
			Biosensors
			Homogeneous assays
	CELL COMPONENTS
	MICROCHIPS
		Cell Analysis Chips
		Microarrays
	INSTRUMENTAL TECHNIQUES
		Gas Chromatography-Mass Spectrometry
		Atomic Force Microscopy and Optical Tweezers
		Single Molecule Assays
	CONCLUSIONS
	REFERENCES
Afterword
	ADVANCES IN TECHNOLOGY
	ACCEPTABILITY
	ATTITUDE
	REFERENCES
Contributors
Index
                        

Similer Documents