Biocontamination Control for Pharmaceuticals and Healthcare
- 2nd Edition - January 28, 2024
- Author: Tim Sandle
- Language: English
- Paperback ISBN:9 7 8 - 0 - 4 4 3 - 2 1 6 0 0 - 8
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 2 1 6 0 1 - 5
Biocontamination Control for Pharmaceuticals and Healthcare, Second Edition outlines a biocontamination strategy that tracks bio-burden control and reduction at each transitio… Read more
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Request a sales quoteBiocontamination Control for Pharmaceuticals and Healthcare, Second Edition outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covers many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141), this new edition expands coverage of quality risk management and contains completely new examples to help professionals bridge the gap between regulation and implementation.
This book offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy.
- Includes the most current regulations
- Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy
- Offers practical guidance on building a complete biocontamination strategy
Pharmaceutical microbiologists (Quality Control labs), Pharmaceutical QC lab managers and lab directors. Graduate and postgraduate students in pharmaceuticals and healthcare; Engineers, pharmacologists, Quality Assurance personnel; Medical professionals, medical device specialists
- Cover image
- Title page
- Table of Contents
- Copyright
- Dedication
- Preface
- Chapter 1. Biocontamination control: Scope
- Introduction
- Conclusion
- Chapter 2. Sources of biocontamination and risk profiling
- Introduction
- Types of microorganisms
- Assessing product risks
- Sources of microbial contamination
- Weaknesses with environmental controls
- Facility repairs and maintenance
- Remediation actives
- Effective cleaning and disinfection
- Environmental monitoring
- Virological control
- Contamination concerns and regulatory requirements
- Summary
- Chapter 3. GMP for contamination control: regulations and standards
- Introduction
- Cleanrooms and classification
- European regulations
- North American
- Synergy of US and European regulations
- International
- Current good manufacturing practice
- The issue of limits: Competing standards
- Common GMP deficiencies
- Documentation and record keeping
- Summary
- Chapter 4. Identifying the factors for biocontamination control
- Introduction
- Regulatory expectations
- Biocontamination control strategy
- Summary
- Chapter 5. Application of quality risk management and its application in biocontamination control
- Introduction
- Hazards and risks
- Risk assessment
- Quality risk management and risk assessment
- Failure modes and effects analysis
- Case study: Applying risk assessment to aseptic processing
- Summary
- Chapter 6. Cleanrooms, controls and environmental monitoring
- Introduction
- Cleanrooms and clean air devices
- Isolators, gloveboxes, and hatches
- Contamination control
- Particles
- Cleanroom design
- Cleanroom classification
- Ongoing environmental monitoring
- Summary
- Chapter 7. Viable monitoring methods
- Introduction
- Application of environmental monitoring methods
- Settle plates
- Active (volumetric) air samplers
- Surface sampling
- Personnel monitoring
- Data and data integrity
- Summary
- Chapter 8. Selection of culture media
- Introduction
- Defining culture media
- Supply of culture media
- Types of culture media used for biocontamination control
- Quality control testing
- Incubation strategies for environmental monitoring
- Temperatures of incubation and microbial recovery
- General-purpose culture media
- Incubation strategies
- Incubation time
- Summary
- Chapter 9. Airborne particle monitoring
- Introduction
- Particle counts and contamination risk
- Distribution of particles in cleanrooms
- Particle counters: Operation basics
- Limitations of particle counters
- Operational issues with particle counters
- Limits setting
- Frequency of particle counting
- Cleanroom classification
- Particle counting: Data control and data integrity
- Summary
- Chapter 10. Rapid and alternative microbiological methods
- Introduction
- Developments with pharmaceutical microbiology
- Benefits of rapid and alternative microbiological methods
- Regulatory acceptance of rapid methods
- Classes of rapid microbiological methods
- Guidance for selecting rapid microbiological methods
- Summary
- Chapter 11. Designing an environmental monitoring program
- Introduction
- Frequency of monitoring
- Time of monitoring
- Duration of monitoring
- Locations for monitoring
- Cleanrooms in different operating states
- Assessing cleaning and disinfection effectiveness
- Data review
- Monitoring for particulates
- Personnel training
- Written program
- Summary
- Chapter 12. Special types of environmental monitoring
- Introduction
- Monitoring to support parametric release
- The need for anaerobic monitoring?
- The need for psychrophilic monitoring?
- The need for thermophilic monitoring?
- Compressed gas monitoring
- Monitoring sterility test environments
- Monitoring microbiology laboratories
- Test controls
- Summary
- Chapter 13. Cleanrooms and microbiota
- Introduction
- Types of contamination
- Growth requirements of microorganisms
- Strategies for microbial survival in the cleanroom environment
- Effect of survival strategy on microbial identification
- Types of microorganisms found in cleanrooms and their origins
- Details of cleanroom microbiota
- Common bacteria found in cleanroom environments
- Fungal contaminants
- Viruses
- Conclusion
- Chapter 14. Assessment of pharmaceutical water systems
- Introduction
- Use of water in pharmaceutical manufacturing
- Endotoxin risks and water for injection
- Best design practices for water systems
- Controlling other microbial risks to water systems
- Addressing water system contamination
- Case studies
- Water system monitoring: Sampling, testing, and reporting
- Summary
- Chapter 15. Data handling and trend analysis
- Introduction
- Microbial data variations and data variability
- Trending microbial data
- Frequency of trending
- Investigating out of trend
- Tracking microorganisms
- Alert and action levels
- Data integrity
- Summary
- Chapter 16. Bioburden, endotoxin and virus hazards in pharmaceutical processing
- Introduction
- Gathering information about microbial control
- Microbial risks during manufacturing
- Virological control
- Process factors affecting contamination
- Process hold times and process validation
- Sterile products manufacturing
- Testing regimes
- Investigating microbial data deviations
- Summary
- Chapter 17. Risk assessment and investigation for environmental monitoring: Examples of microbial data deviations
- Introduction
- Introducing quality risk management
- Applying risk assessment to environmental monitoring
- Using risk to construct the environmental monitoring program
- Risk assessment tools
- Hazard analysis critical control points
- Failure modes and effects analysis
- Numerical approaches to risk assessment
- Risks associated with conducting environmental monitoring
- Out-of-limits investigations
- Root causes
- Case studies
- Summary
- Chapter 18. Assessing, minimizing and removing contamination risks from the process
- Introduction
- Quality by design
- Cleanroom design
- Equipment design and use
- Cleaning and disinfection
- Control of personnel and contamination transfer risks
- Cleaning validation
- Process hold times
- Sterilization and biodecontamination
- Biodecontamination
- Sterile products: Aseptic processing and terminal sterilization
- Nonsterile products: Preservative efficacy
- Primary and secondary packaging
- Risk assessment
- Conclusion
- Chapter 19. The human factor: Training and controlling people in cleanrooms
- Introduction
- The human risk factor
- The human microbiome
- Implications for biocontamination control
- Importance of clothing
- Cleanroom personnel behavior
- Training
- Changing into cleanroom garments
- Materials access
- Personal hygiene
- Summary
- Chapter 20. Biocontamination deviation management and setting effective CAPA
- Introduction
- Assessing data deviations: Terminology and categories
- Structuring the investigation
- Investigation of laboratory error
- Laboratory controls
- Assessing the investigation
- Further case studies
- Concluding investigations
- Summary
- Chapter 21. Synthesis: An anatomy of a contamination control strategy
- Introduction
- Confirmation of compliance and gap analysis
- Putting the analysis together
- Conclusion
- Index
- No. of pages: 508
- Language: English
- Edition: 2
- Published: January 28, 2024
- Imprint: Academic Press
- Paperback ISBN: 9780443216008
- eBook ISBN: 9780443216015
TS
Tim Sandle
Dr. Sandle is a chartered biologist and holds a first class honours degree in Applied Biology; a Masters degree in education; and has a doctorate from Keele University.
He has over twenty-five years experience of microbiological research, quality assurance, and biopharmaceutical processing. This includes experience of designing, validating and operating a range of microbiological tests including sterility testing, bacterial endotoxin testing, bioburden and microbial enumeration, environmental monitoring, particle counting and water testing. In addition, Dr. Sandle is experienced in quality risk assessment, root cause analysis, and investigation.
Dr. Sandle is a tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester for the university’s pharmaceutical microbiology MSc course, and at University College, London. In addition, Dr. Sandle has served on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards and the National Blood Service advisory cleaning and disinfection committee).
Affiliations and expertise
Head of Microbiology, Bio Products Laboratory, Elstree, UKVisiting Tutor, School of Pharmacy and Pharmaceutical Sciences, Manchester University, UKCommittee Member of the Pharmaceutical Microbiology Interest Group (Pharmig), UKRead Biocontamination Control for Pharmaceuticals and Healthcare on ScienceDirect