Table of Contents

Cover image

Title page

Copyright

List of Contributors

About the Editors

Preface

Chapter 1. Metallic Contaminants on Surfaces and Their Impact

Abstract

1 Introduction

2 Cleanliness Levels

3 Metallic Contaminant Behavior

4 Contamination Sources

5 Characterization Techniques

6 Impact of Metallic Contaminants

7 Summary

Acknowledgments

Disclaimer

References

Chapter 2. Particle Resuspension From Surfaces: Overview of Theoretical Models and Experimental Data

Abstract

1 Introduction

2 Particle Detachment: Theoretical Models

3 Resuspension Experiments

4 Comparison of Theory Against Experimental Data for Particle Resuspension

5 Summary and Conclusions

References

Chapter 3. GMP in Pharma Manufacturing—Description of GMP as Related to Air-Handling Units and Prevention of Contamination and Implementation of GMP Regulatory Requirements

Abstract

1 Introduction

2 GMP Guidelines

3 Organization and Personnel

4 Building and Facilities

5 Heating, Ventilation, and Air Conditioning (HVAC) System

6 Validation of HVAC System

7 Summary

References

Chapter 4. The Role of Standards in Cleaning and Contamination Control

Abstract

1 Scope

2 Why There Are Standards?

3 Examples of Groups, Industry Standards, and Specifications

4 Standards Evolution

5 Interpreting Standards

6 Points to Consider

7 Questions to Ask About Standards

8 Summary

References

Chapter 5. Droplet-Assisted Laser Cleaning of Contaminated Surfaces

Abstract

1 Introduction

2 Laser-Based Cleaning Techniques

3 Droplet Assisted Laser Cleaning

4 Conclusions

Acknowledgments

References

Index

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