Developments in surface contamination and cleaning. Volume 10 : types of contamination and contamination resources

Developments in surface contamination and cleaning Volume 10 : types of contamination and contamination resources Volume 10 :

Developments in Surface Contamination and Cleaning, Volume Ten, provides a state-of-the-art guide to the current knowledge on the behavior of film-type and particulate surface contaminants and their cleaning methods. This newest volume in the series discusses mechanisms of particle adhesion, particl...

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Detalles Bibliográficos
Otros Autores: Kohli, Rajiv, 1947- author (author), Mittal, K. L., 1945- editor (editor)
Formato: Libro electrónico
Idioma:Inglés
Publicado: Amsterdam, [Netherlands] : William Andrew 2017.
Edición:1st edition
Colección:Developments in Surface Contamination and Cleaning Series
Materias:
Surfaces (Technology)
Surface contamination > Prevention.
Particles > Measurement.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009630291806719
Tabla de Contenidos:
  • Front Cover
  • Developments in Surface Contamination and Cleaning
  • Copyright Page
  • Contents
  • List of Contributors
  • About the Editors
  • Preface
  • 1 Metallic Contaminants on Surfaces and Their Impact
  • 1 Introduction
  • 2 Cleanliness Levels
  • 3 Metallic Contaminant Behavior
  • 3.1 Diffusion
  • 3.2 Solubility
  • 4 Contamination Sources
  • 4.1 Metal Impurities and Particles
  • 4.2 Ionic Contamination
  • 5 Characterization Techniques
  • 6 Impact of Metallic Contaminants
  • 6.1 Metal Particles and Trace Metal Impurities
  • 6.2 Ionic Contamination
  • 7 Summary
  • Acknowledgments
  • Disclaimer
  • References
  • 2 Particle Resuspension From Surfaces: Overview of Theoretical Models and Experimental Data
  • 1 Introduction
  • 2 Particle Detachment: Theoretical Models
  • 2.1 Adhesion Forces
  • 2.1.1 Adhesion Force
  • 2.1.2 Maximum Adhesion Resistance Moment
  • 2.1.3 Particle Adhesion Models on Rough Surfaces
  • 2.2 External Forces
  • 2.2.1 Hydrodynamic Forces
  • 2.3 Removal Mechanisms
  • 3 Resuspension Experiments
  • 3.1 Wind Tunnel and Duct Flow Characteristics
  • 3.2 Experimental Resuspension Data
  • 3.2.1 Particle Size
  • 3.2.2 Relative Humidity
  • 3.2.3 Time Dependency
  • 4 Comparison of Theory Against Experimental Data for Particle Resuspension
  • 4.1 Roughness Effect
  • 5 Summary and Conclusions
  • References
  • 3 GMP in Pharma Manufacturing-Description of GMP as Related to Air-Handling Units and Prevention of Contamination and Impl ...
  • 1 Introduction
  • 1.1 How Were GMPs Developed?
  • 2 GMP Guidelines
  • 2.1 Need for GMP Monitoring System
  • 2.1.1 Monitoring Key Parameters in GMP
  • 2.1.2 Locations to be Monitored
  • 2.1.3 Ways to Monitor
  • 2.2 Components of GMP
  • 2.3 Quality Management Systems in GMP
  • 2.3.1 Pharmaceutical Quality System
  • 2.3.2 Quality Assurance
  • 2.3.3 Good Manufacturing Practices
  • 2.3.4 Quality Control.
  • 2.3.5 Product Quality Review
  • 3 Organization and Personnel
  • 3.1 Responsibilities of Various Departments
  • 3.1.1 Production Department
  • 3.1.2 QC Department
  • 3.1.3 Shared Responsibilities Between the QC Head and Production Department Head
  • 3.1.4 Personal Responsibilities of Employees in Manufacturing Premises
  • 4 Building and Facilities
  • 4.1 Storage Area
  • 4.2 QC Area
  • 4.3 Production Area
  • 4.4 Ancillary Area
  • 4.5 Lighting
  • 5 Heating, Ventilation, and Air Conditioning (HVAC) System
  • 5.1 Importance of HVAC
  • 5.2 HVAC System
  • 5.3 Cleanroom Classification
  • 5.4 Cleanroom Separation/Segregation
  • 5.5 Personnel Training
  • 5.6 Sanitation and Personal Hygiene
  • 5.7 Gowning/Change Room Control and Configuration
  • 6 Validation of HVAC System
  • 6.1 Airflow Pattern
  • 6.2 Airflow Velocity and Changes per Hour
  • 6.3 Filter Leak Test
  • 6.4 Particle Count Test
  • 6.5 Viable Monitoring
  • 6.5.1 Active Air Sampling
  • 6.5.2 Passive Air Sampling
  • 6.5.3 Surface Monitoring
  • Contact plate method
  • Swabbing method
  • 6.6 Filter Integrity Test (DOP/PAO Test)
  • 6.7 Pressure Difference
  • 6.8 Recovery Test
  • 6.9 Temperature and Humidity Uniformity Test
  • 6.10 Fresh Air Determination
  • 6.11 Acceptance Criteria for HVAC System
  • 7 Summary
  • References
  • 4 The Role of Standards in Cleaning and Contamination Control
  • 1 Scope
  • 2 Why There Are Standards?
  • 2.1 Ideal Standards-and Real Standards
  • 2.2 Chronic Emergency Standards
  • 2.3 Perfection Versus Reality
  • 2.4 Language
  • 2.5 Agendas
  • 2.6 Political Influences
  • 2.6.1 Regulatory Organizations
  • 2.6.2 Intentionally Ambiguous Wording
  • 2.7 Process
  • 2.8 Emergencies
  • 3 Examples of Groups, Industry Standards, and Specifications
  • 3.1 American Society for Testing and Materials
  • 3.1.1 ASTM Standards
  • 3.1.2 Specific Standards
  • 3.1.3 How Does ASTM Develop Standards?.
  • 3.2 ISO and ANSI
  • 3.2.1 ISO Standards
  • 3.2.2 ISO Standards for Cleaning and Contamination Control
  • 3.3 China Food and Drug Administration
  • 3.3.1 CFDA Pharmaceutical Standard
  • 4 Standards Evolution
  • 5 Interpreting Standards
  • 5.1 Interpretation of Cleanroom Standards
  • 5.1.1 Other Standards
  • 5.1.2 What Is the Product Surface?
  • 5.1.3 Communicate and Clarify
  • 6 Points to Consider
  • 6.1 Scope
  • 6.2 Correct People
  • 6.3 Conveying the Information
  • 6.3.1 Sentences Versus Figures/Flowcharts
  • 6.3.2 Figures and Flowcharts
  • 7 Questions to Ask About Standards
  • 7.1 Relevance
  • 7.2 Sufficiency
  • 7.3 Achievability
  • 7.4 Coping With Standards
  • 8 Summary
  • References
  • 5 Droplet-Assisted Laser Cleaning of Contaminated Surfaces
  • 1 Introduction
  • 2 Laser-Based Cleaning Techniques
  • 2.1 Ablative Laser Cleaning
  • 2.2 Laser Shock Cleaning
  • 2.3 Wet Laser Cleaning
  • 2.4 Laser-Assisted Optohydrodynamic Cleaning Process
  • 3 Droplet Assisted Laser Cleaning
  • 3.1 DALC Experimental Setup
  • 3.2 DALC Results
  • 3.3 Discussions of DALC Process
  • 4 Conclusions
  • Acknowledgments
  • References
  • Index
  • Back Cover.

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