Cover for Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare

Book2019

Authors:

Tim Sandle

Biocontamination Control for Pharmaceuticals and Healthcare

Book2019

 

Cover for Biocontamination Control for Pharmaceuticals and Healthcare

Authors:

Tim Sandle

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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 ... read full description

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Table of contents

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  2. Book chapterAbstract only

    Chapter 1 - Introduction to Biocontamination and Biocontamination Control

    Pages 1-9

  3. Book chapterAbstract only

    Chapter 2 - Sources of Microbial Contamination and Risk Profiling

    Pages 11-26

  4. Book chapterAbstract only

    Chapter 3 - GMP, Regulations and Standards

    Pages 27-46

  5. Book chapterAbstract only

    Chapter 4 - Biocontamination Control Strategy

    Pages 47-64

  6. Book chapterAbstract only

    Chapter 5 - Cleanrooms and Environmental Monitoring

    Pages 65-82

  7. Book chapterAbstract only

    Chapter 6 - Viable Environmental Monitoring Methods

    Pages 83-101

  8. Book chapterAbstract only

    Chapter 7 - Selection and Application of Culture Media

    Pages 103-123

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    Chapter 8 - Particle Counting

    Pages 125-139

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    Chapter 9 - Rapid and Alterative Microbiological Methods

    Pages 141-157

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    Chapter 10 - Designing and Implementing an Environmental Monitoring Program

    Pages 159-178

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    Chapter 11 - Special Types of Environmental Monitoring

    Pages 179-197

  13. Book chapterAbstract only

    Chapter 12 - Cleanroom Microbiota

    Pages 199-212

  14. Book chapterAbstract only

    Chapter 13 - Assessment of Pharmaceutical Water Systems

    Pages 213-224

  15. Book chapterAbstract only

    Chapter 14 - Data Handling and Trend Analysis

    Pages 225-247

  16. Book chapterAbstract only

    Chapter 15 - Bioburden and Endotoxin Control in Pharmaceutical Processing

    Pages 249-260

  17. Book chapterAbstract only

    Chapter 16 - Risk Assessment and Investigation for Environmental Monitoring

    Pages 261-285

  18. Book chapterAbstract only

    Chapter 17 - Assessing, Controlling, and Removing Contamination Risks From the Process

    Pages 287-314

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    Chapter 18 - The Human Factor and Biocontamination Control

    Pages 315-338

  20. Book chapterAbstract only

    Chapter 19 - Biocontamination Deviation Management

    Pages 339-354

  21. 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

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Authors

Tim Sandle

Head of Microbiology, Bio Products Laboratory, Elstree, UK

Visiting Tutor, School of Pharmacy and Pharmaceutical Sciences, Manchester University, UK