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Chapter 1 - Introduction to Biocontamination and Biocontamination Control
Pages 1-9 - Book chapterAbstract only
Chapter 2 - Sources of Microbial Contamination and Risk Profiling
Pages 11-26 - Book chapterAbstract only
Chapter 3 - GMP, Regulations and Standards
Pages 27-46 - Book chapterAbstract only
Chapter 4 - Biocontamination Control Strategy
Pages 47-64 - Book chapterAbstract only
Chapter 5 - Cleanrooms and Environmental Monitoring
Pages 65-82 - Book chapterAbstract only
Chapter 6 - Viable Environmental Monitoring Methods
Pages 83-101 - Book chapterAbstract only
Chapter 7 - Selection and Application of Culture Media
Pages 103-123 - Book chapterAbstract only
Chapter 8 - Particle Counting
Pages 125-139 - Book chapterAbstract only
Chapter 9 - Rapid and Alterative Microbiological Methods
Pages 141-157 - Book chapterAbstract only
Chapter 10 - Designing and Implementing an Environmental Monitoring Program
Pages 159-178 - Book chapterAbstract only
Chapter 11 - Special Types of Environmental Monitoring
Pages 179-197 - Book chapterAbstract only
Chapter 12 - Cleanroom Microbiota
Pages 199-212 - Book chapterAbstract only
Chapter 13 - Assessment of Pharmaceutical Water Systems
Pages 213-224 - Book chapterAbstract only
Chapter 14 - Data Handling and Trend Analysis
Pages 225-247 - Book chapterAbstract only
Chapter 15 - Bioburden and Endotoxin Control in Pharmaceutical Processing
Pages 249-260 - Book chapterAbstract only
Chapter 16 - Risk Assessment and Investigation for Environmental Monitoring
Pages 261-285 - Book chapterAbstract only
Chapter 17 - Assessing, Controlling, and Removing Contamination Risks From the Process
Pages 287-314 - Book chapterAbstract only
Chapter 18 - The Human Factor and Biocontamination Control
Pages 315-338 - Book chapterAbstract only
Chapter 19 - Biocontamination Deviation Management
Pages 339-354 - Book chapterNo access
Index
Pages 355-360
About the book
Description
Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy.
Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy.
Key Features
- Provides the information necessary for a facility to build a complete biocontamination strategy
- Helps facilities understand the main biocontamination risks to medicinal products
- Assists the reader in navigating regulatory requirements
- Provides insight into developing an environmental monitoring program
- Covers the types of rapid microbiological monitoring methods now available, as well as current legislation
- Provides the information necessary for a facility to build a complete biocontamination strategy
- Helps facilities understand the main biocontamination risks to medicinal products
- Assists the reader in navigating regulatory requirements
- Provides insight into developing an environmental monitoring program
- Covers the types of rapid microbiological monitoring methods now available, as well as current legislation
Details
ISBN
978-0-12-814911-9
Language
English
Published
2019
Copyright
Copyright © 2019 Elsevier Inc. All rights reserved.
Imprint
Academic Press