Biocontamination Control for Pharmaceuticals and Healthcare

Name: Biocontamination Control for Pharmaceuticals and Healthcare
Price: 180 USD
Availability: InStock
ISBN: 9780443216008

by Tim Sandle

2nd Edition

Publisher: Academic Press

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Pharmaceutical Sciences

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Book Details

Print ISBN	9780443216008
eText ISBN	9780443216015
Publisher	Academic Press
Publishing Year	2024
Edition	2nd Edition
Language	English
Pages	508

Biocontamination Control for Pharmaceuticals and Healthcare, 2nd Edition, authored by Tim Sandle, delivers a structured guide to managing microbiological risks within regulated production environments. The text supports pharmaceutical microbiologists, quality control laboratory directors, and graduate or postgraduate students in pharmaceuticals and healthcare seeking clear methodologies for risk mitigation.

The content synthesizes core monitoring protocols, including viable monitoring methods, the selection of appropriate culture media, and routine airborne particle monitoring. Beyond cleanroom monitoring, the text detail extends to bioburden and endotoxin assessment during processing alongside systematic water systems assessment to identify potential sources of contamination.

A defining element of this update is its integration of the newest version of EU-GMP (EN17141) standards. This structural alignment provides practical guidance for quality assurance personnel, medical device specialists, pharmacologists, and engineers responsible for maintaining regulatory compliance across healthcare facilities.

Chapter 1: Introduction
Chapter 2: Sources of biocontamination, other forms of contamination, and risk profiling
Chapter 3: GMP, regulations and standards
Chapter 4: Biocontamination control
Chapter 5: Application of Quality Risk Management and its application in biocontamination control
Chapter 6: Introduction to cleanrooms and environmental monitoring
Chapter 7: Viable monitoring methods
Chapter 8: Selection of culture media
Chapter 9: Airborne particle monitoring
Chapter 10: Rapid microbiological methods
Chapter 11: Designing an environmental monitoring programme
Chapter 12: Putting an environmental monitoring plan together: A risk-based case study
Chapter 13: Special Types of Environmental Monitoring
Chapter 14: Cleanrooms and microbiota
Chapter 15: Assessment of pharmaceutical water systems
Chapter 16: Data handling and trend analysi
Chapter 17: Bioburden and endotoxin assessment of pharmaceutical processing
Chapter 18: Risk assessment and investigation for environmental monitoring: Examples of microbial data deviations
Chapter 19: Assessing and removing contamination risks from the process
Chapter 20: The human factor: Training and controlling people in cleanrooms
Chapter 21: Biocontamination deviation management
Chapter 22: Synthesis: An anatomy of a contamination control strategy