Pharmaceutical Microbiology

Essentials for Quality Assurance and Quality Control
 
 
Woodhead Publishing
  • 1. Auflage
  • |
  • erschienen am 9. Oktober 2015
  • |
  • 316 Seiten
 
E-Book | ePUB mit Adobe DRM | Systemvoraussetzungen
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978-0-08-100044-1 (ISBN)
 

Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality.

The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control.


  • Contains the applications of pharmaceutical microbiology in sterile and non-sterile products
  • Presents the practical aspects of pharmaceutical microbiology testing
  • Provides contamination control risks and remediation strategies, along with rapid microbiological methods
  • Includes bioburden, endotoxin, and specific microbial risks
  • Highlights relevant case studies and risk assessment scenarios


Tim Sandle is Head of Microbiology at the Bio Products Laboratory, Elstree, UK and a visiting tutor with the School of Pharmacy and Pharmaceutical Sciences, Manchester University, UK.
  • Englisch
Elsevier Science
  • 8,03 MB
978-0-08-100044-1 (9780081000441)
0081000448 (0081000448)
weitere Ausgaben werden ermittelt
  • Front Cover
  • Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control
  • Copyright
  • Dedication
  • Contents
  • Introduction
  • References
  • Chapter 1: Introduction to pharmaceutical microbiology
  • 1.1 Introduction
  • 1.2 Overview of pharmaceutical microbiology
  • 1.3 Microbiological test methods
  • 1.3.1 Product-related testing regimes
  • 1.3.2 Starting materials
  • 1.3.3 In-process samples/intermediate product
  • 1.3.4 Final product formulations
  • 1.3.5 Finished product
  • 1.3.6 Testing of utilities
  • 1.3.7 Environmental monitoring
  • 1.3.8 Other microbiology laboratory tests
  • 1.4 The application of pharmaceutical microbiology
  • 1.4.1 Counting
  • 1.4.2 Sampling
  • 1.4.3 Microorganisms detected from pharmaceutical manufacturing environments
  • 1.4.4 Contamination control strategy
  • 1.4.5 Advances in pharmaceutical microbiology
  • 1.5 Conclusion
  • References
  • Chapter 2: Microbiology and pharmaceuticals
  • 2.1 Introduction
  • 2.2 The basics of the pharmaceutical sector
  • 2.2.1 Pharmaceuticals
  • 2.2.2 Product evolution
  • 2.2.3 Importance of R&D
  • 2.2.4 Development
  • 2.2.5 Cost
  • 2.2.6 Generic drug products
  • 2.2.7 Other sectors
  • 2.3 Role of the microbiologist
  • 2.4 Conclusion
  • References
  • Chapter 3: GMP and regulations
  • 3.1 Introduction
  • 3.2 Good manufacturing practice
  • 3.2.1 EU good manufacturing practice
  • 3.2.2 FDA and CFRs
  • 3.2.3 Key aspects of GMP compliance
  • 3.2.4 Ten rules of GMP
  • 3.2.5 Risk management
  • 3.3 Importance of medicines in public health
  • 3.4 The role and development of pharmacopoeias
  • 3.5 Importance of inspections in the lifecycle of medicines
  • 3.5.1 Inspection process
  • 3.6 Role of the company regulatory affairs department
  • 3.6.1 Pharmacovigilance
  • 3.7 Documentation
  • 3.7.1 Types of documents
  • 3.7.1.1 Specifications
  • 3.7.1.2 Instructions
  • 3.8 Conclusion
  • References
  • Chapter 4: Laboratory management and design
  • 4.1 Introduction
  • 4.2 Pharmaceutical microbiology laboratories
  • 4.3 Laboratory management
  • 4.3.1 Training
  • 4.3.2 Quality
  • 4.3.3 Test methods
  • 4.3.3.1 Safety
  • 4.3.3.2 Laboratory information management system
  • 4.3.4 Lean labs
  • 4.4 Laboratory design
  • 4.4.1 General design
  • 4.4.2 Sample collection and testing areas
  • 4.4.3 Equipment
  • 4.4.4 Utilities and services
  • 4.4.5 Air supply
  • 4.4.6 Clean air devices and containment
  • 4.5 Conclusion
  • References
  • Chapter 5: Microbiological culture media
  • 5.1 Introduction
  • 5.2 Cultivation
  • 5.3 A short history of culture media
  • 5.4 Types of culture media
  • 5.5 Quality control of culture media
  • 5.5.1 Physical characteristics
  • 5.5.2 Microbiological characteristics
  • 5.5.3 Test methods and acceptance criteria
  • 5.5.4 Solid media
  • 5.5.5 Broth media
  • 5.5.6 Test regime
  • 5.5.7 Testing of selective media
  • 5.5.8 Expiry time assessment of culture media
  • 5.6 Manufacture of culture media
  • 5.6.1 Initial preparation
  • 5.6.2 Rehydration
  • 5.6.3 Sterilization
  • 5.6.4 Addition of supplements
  • 5.6.5 Filling
  • 5.6.6 Labeling
  • 5.6.7 Secondary sterilization
  • 5.7 Media release and quarantine
  • 5.8 Summary
  • References
  • Chapter 6: Microbiology laboratory techniques
  • 6.1 Introduction
  • 6.2 Good laboratory practice and laboratory safety
  • 6.3 Aseptic technique
  • 6.4 Cultures and identifications
  • 6.5 Microscopy
  • 6.6 Pharmacopeia and microbiological tests
  • 6.7 Microbiological examination of nonsterile products
  • 6.7.1 Total viable aerobic count (Ph. Eur. 2.6.12, USP )
  • 6.7.1.1 Bioburden determination
  • 6.7.1.2 Method validation
  • 6.7.1.3 Media growth promotion
  • 6.7.1.4 Sample preparation
  • Water-soluble products
  • Nonfatty products insoluble in water
  • Fatty products
  • 6.7.1.5 Test method
  • 6.7.2 Tests for specified organisms (Ph. Eur. 2.6.13, USP )
  • 6.7.3 Specification limits (harmonized method)
  • 6.8 Measurement of cell concentration in suspension by optical density
  • 6.9 Sterility testing
  • 6.9.1 Validating the sterility test
  • 6.10 In vitro and in vivo testing for pyrogens and endotoxins
  • 6.10.1 Rabbit ( in vivo) pyrogen test
  • 6.10.2 LAL testing for bacterial endotoxin
  • 6.11 Microbiological assay of antibiotics
  • 6.12 Environmental monitoring
  • 6.13 Water analysis
  • 6.14 Conclusion
  • References
  • Chapter 7: Bioburden determination
  • 7.1 Introduction
  • 7.2 Total microbial count
  • 7.3 Units of measurement
  • 7.4 Nonsterile products and microbial limits testing
  • 7.4.1 Membrane filtration
  • 7.4.2 Direct plating methods
  • 7.4.2.1 Pour plate method
  • 7.4.2.2 Spread plate method
  • 7.4.3 Most probable number method
  • 7.4.4 Method verification
  • 7.5 In-process material bioburden assessment
  • 7.6 Presterilization bioburden assessment
  • 7.6.1 Terminally sterilized products
  • 7.6.2 Aseptically filled products
  • 7.6.3 Medical devices
  • 7.7 Alternative methods of bioburden assessment
  • 7.8 Conclusion
  • References
  • Chapter 8: Specified and objectionable microorganisms
  • 8.1 Introduction
  • 8.2 Indicator microorganisms
  • 8.2.1 Pharmacopeia methods
  • 8.2.2 Method qualification
  • 8.3 Determining which microorganisms are objectionable and assessing risk
  • 8.4 Human microbiome project
  • 8.5 Conclusion
  • References
  • Chapter 9: Microbial identification
  • 9.1 Introduction
  • 9.2 Microbial taxonomy
  • 9.3 Identification methods
  • 9.4 Phenotypic methods
  • 9.4.1 Colony and cell morphology
  • 9.4.2 Staining techniques
  • 9.4.2.1 Gram-stain
  • 9.4.2.2 Bacterial spore stain
  • 9.4.2.3 Fungal staining
  • 9.4.2.4 Ziehl-Neelsen stain
  • 9.4.3 Growth based and metabolic tests
  • 9.5 Genotypic methods
  • 9.6 Method validation
  • 9.7 Conclusion
  • References
  • Chapter 10: Assessment of pharmaceutical water systems
  • 10.1 Introduction
  • 10.2 Pharmaceutical facility water
  • 10.3 The microbial ecology of water
  • 10.4 Design and control of water systems
  • 10.5 Qualifying water systems
  • 10.6 Microbial contamination
  • 10.6.1 Biofilms
  • 10.7 Microbiological sampling and testing
  • 10.8 Action and alert limits
  • 10.9 Undesirable (objectionable) microorganisms
  • 10.10 Rapid microbiological methods
  • 10.11 Microbiological assessment
  • 10.12 Summary
  • References
  • Chapter 11: Endotoxin and pyrogen testing
  • 11.1 Introduction
  • 11.2 Pyrogenicity
  • 11.3 Bacterial endotoxin
  • 11.4 Quantifying endotoxin
  • 11.5 The limulus amebocyte lysate test
  • 11.6 Limulus amebocyte lysate test methods
  • 11.6.1 Gel-clot
  • 11.6.2 Turbidimetric
  • 11.6.3 Chromogenic
  • 11.7 Limulus amebocyte lysate test applications
  • 11.8 Limulus amebocyte lysate test interference
  • 11.9 Alternative test methods
  • 11.10 Conclusion
  • References
  • Chapter 12: Sterilization and sterility assurance
  • 12.1 Introduction
  • 12.2 Sterility
  • 12.3 Sterility assurance and the sterility assurance level
  • 12.4 Sterility testing
  • 12.5 Parametric release
  • 12.6 Sterile products
  • 12.6.1 Terminal sterilization
  • 12.6.2 Aseptic filling
  • 12.6.3 Blow-fill-seal technology
  • 12.7 Sterilization
  • 12.8 Factors affecting sterilization effectiveness
  • 12.8.1 Number and location of microorganisms
  • 12.8.2 Innate resistance of microorganisms
  • 12.8.3 Physical and chemical factors
  • 12.8.4 Organic and inorganic matter
  • 12.8.5 Duration of exposure
  • 12.8.6 Storage
  • 12.9 Good manufacturing practice
  • 12.10 Risk assessment
  • 12.11 Conclusion
  • References
  • Chapter 13: Biological indicators: Measuring sterilization
  • 13.1 Introduction
  • 13.2 Origins
  • 13.3 Types of biological indicators
  • 13.4 Characteristics of biological indicators
  • 13.4.1 Purity
  • 13.4.2 Population
  • 13.4.3 D value
  • 13.4.4 Z value
  • 13.4.5 Assessing results
  • 13.5 Testing issues
  • 13.6 Areas of concern and testing errors
  • 13.7 Summary
  • References
  • Chapter 14: Antibiotics and preservatives
  • 14.1 Introduction
  • 14.2 Antibiotic susceptibility testing
  • 14.2.1 Antimicrobials
  • 14.2.2 Antimicrobial susceptibility test concepts
  • 14.2.3 Broth dilution method
  • 14.2.4 Disc diffusion method
  • 14.2.5 Test variability
  • 14.2.5.1 pH
  • 14.2.5.2 Moisture
  • 14.2.5.3 Effects of medium components
  • 14.2.5.4 Microbial inoculum
  • 14.2.6 Automated methods
  • 14.2.7 Results interpretation
  • 14.3 Antimicrobial efficacy testing (preservative efficacy testing)
  • 14.3.1 Antimicrobial efficacy test
  • 14.3.2 Antimicrobial effectiveness test validation
  • 14.4 Conclusion
  • References
  • Chapter 15: Cleaning and disinfection
  • 15.1 Introduction
  • 15.2 Cleaning
  • 15.3 Disinfection
  • 15.3.1 Disinfectant efficacy
  • 15.3.2 Types of disinfectants
  • 15.3.3 Selecting disinfectants
  • 15.4 Good manufacturing practice requirements
  • 15.5 Measuring disinfection effectiveness: Environmental monitoring
  • 15.6 Disinfectant efficacy
  • 15.7 Conclusion
  • References
  • Chapter 16: Cleanrooms and environmental monitoring
  • 16.1 Introduction
  • 16.2 Cleanroom contamination
  • 16.3 Cleanroom classification
  • 16.4 Isolators
  • 16.5 Cleanroom certification
  • 16.6 Cleanroom testing
  • 16.6.1 Physical parameters
  • 16.6.1.1 Air patterns and air movement
  • 16.6.1.2 Airflows
  • 16.6.1.3 Air changes
  • 16.6.1.4 Clean up times
  • 16.6.1.5 Positive pressure
  • 16.6.1.6 HEPA filters
  • 16.6.1.7 Temperature, humidity, lighting, and room design
  • 16.7 Microbiological environmental monitoring
  • 16.7.1 Air sampling methods
  • 16.7.1.1 Settle plates
  • 16.7.1.2 Active air samples
  • 16.7.2 Surface sampling methods
  • 16.7.2.1 Contact plates
  • 16.7.2.2 Swabs
  • 16.7.3 Key aspects of the monitoring program
  • 16.7.4 Personnel
  • 16.8 Aseptic technique
  • 16.9 Other cleanroom disciplines
  • 16.9.1 Clothing
  • 16.9.2 Grade A areas
  • 16.9.3 Grade C areas
  • 16.10 Cleaning
  • 16.11 Conclusion
  • References
  • Chapter 17: Rapid microbiological methods
  • 17.1 Introduction
  • 17.2 Changing world of microbiology
  • 17.3 Advantages of rapid methods
  • 17.4 Regulatory acceptance
  • 17.5 Types of rapid microbiological methods
  • 17.5.1 Growth-based methods
  • 17.5.2 Direct measurement
  • 17.5.3 Cell component analysis
  • 17.5.4 Optical spectroscopy
  • 17.5.5 Nucleic acid amplification
  • 17.5.6 Microelectrical-mechanical systems
  • 17.6 Selection of rapid microbiological methods
  • 17.6.1 Key considerations
  • 17.6.2 Internal company obstacles
  • 17.6.3 Validation
  • 17.6.4 Method transfer
  • 17.6.5 Training
  • 17.6.6 Expectations from the vendor
  • 17.7 Summary
  • References
  • Chapter 18: Risk assessment and microbiology
  • 18.1 Introduction
  • 18.2 The nature of risk
  • 18.3 The need for microbiological risk assessment
  • 18.4 Microbial contamination transfer
  • 18.4.1 Airborne deposition
  • 18.4.2 Surface contact
  • 18.5 Identification of sources and routes of contamination
  • 18.5.1 Sources of contamination
  • 18.6 Routes of transfer
  • 18.7 Risk assessments for general cleanroom areas
  • 18.8 Risk scoring systems
  • 18.9 Conclusion
  • References
  • Chapter 19: Manufacturing and validation
  • 19.1 Introduction
  • 19.2 Manufacturing procedures
  • 19.2.1 Specifications
  • 19.2.2 Batch manufacturing records
  • 19.2.3 Manufacturing standard operating procedures ( SOPs)
  • 19.3 Validation
  • 19.3.1 Qualifications
  • 19.3.2 Cleaning validation
  • 19.3.3 Other validation exercises requiring the involvement of pharmaceutical microbiology
  • 19.4 Conclusion
  • References
  • Chapter 20: Microbiological data
  • 20.1 Introduction
  • 20.2 Counting microorganisms
  • 20.3 Sampling
  • 20.4 Microbial distribution
  • 20.5 Data trending
  • 20.5.1 Control charts
  • 20.5.2 Data transformation
  • 20.6 The use of alert and action levels and the setting monitoring limits
  • 20.6.1 Percentile cut-off
  • 20.6.2 Standard deviations/negative exponential distribution
  • 20.6.3 Frequency approach
  • 20.6.4 Problems with limits setting
  • 20.6.5 The need to set monitoring limits
  • 20.7 Data reporting
  • 20.8 Conclusion
  • References
  • Chapter 21: Auditing the microbiology laboratory
  • 21.1 Introduction
  • 21.2 Quality audits
  • 21.3 Auditors and the audit process
  • 21.4 Auditing the microbiology laboratory
  • 21.4.1 Microbiology personnel
  • 21.4.2 Laboratory design and sample flow
  • 21.4.3 Sample handling
  • 21.4.4 Culture media
  • 21.4.5 Reference standards
  • 21.4.6 Control of microbial cultures
  • 21.4.7 Documentation and electronic systems
  • 21.4.8 Laboratory equipment
  • 21.4.9 Cleaning and decontamination
  • 21.4.10 Specific tests
  • 21.4.11 Microbial limits testing
  • 21.4.12 Preservative efficacy test and antibiotic assays
  • 21.4.13 Sterility testing
  • 21.4.14 Microbial identification
  • 21.5 Conclusion
  • References
  • Chapter 22: Microbiological challenges to the pharmaceuticals and healthcare
  • 22.1 Introduction
  • 22.2 Microbial risks to pharmaceuticals
  • 22.3 Microbial challenges to process environments
  • 22.4 Sources of microbial contamination
  • 22.4.1 Raw materials
  • 22.4.2 Water
  • 22.4.3 Manufacturing environment
  • 22.4.3.1 Air
  • 22.4.3.2 Equipment and facilities
  • 22.4.3.3 Personnel
  • 22.4.3.4 Users and healthcare professionals
  • 22.5 Fate of microbial contamination in pharmaceutical products
  • 22.5.1 Death of contaminants
  • 22.5.2 Pyrogens and other products of bacterial growth
  • 22.5.3 Static contamination
  • 22.5.4 Dynamic contamination
  • 22.5.5 Physicochemical environment
  • 22.5.6 Product pH
  • 22.5.7 Water activity
  • 22.5.8 Nutrients
  • 22.6 Consequences for microbial growth
  • 22.6.1 Product stability
  • 22.6.2 Infection risk
  • 22.6.3 Therapeutic effect
  • 22.6.4 Sterile products
  • 22.7 Microbiological testing
  • 22.7.1 Nonsterile products
  • 22.7.2 Sterile products
  • 22.8 Conclusion
  • References
  • Index
  • Back Cover

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