A
new book has been published – “Biocontamination Control for Pharmaceuticals and
Healthcare” by written Tim Sandle.
The
book 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 of the book are:
Providing
the information necessary for a facility to build a complete biocontamination
strategy.
Helping
facilities understand the main biocontamination risks to medicinal products.
Assisting
the reader in navigating regulatory requirements.
Providing
insight into developing an environmental monitoring program.
Covering
the types of rapid microbiological monitoring methods now available, as well as
current legislation.
Table of Contents
1
Introduction
2.
Sources of microbial contamination and risk profiling
3.
GMP, regulations and standards
4.
Biocontamination control
5.
Introduction to cleanrooms and environmental monitoring
6.
Viable monitoring methods
7.
Selection of culture media
8.
Non-viable monitoring
9.
Rapid microbiological methods
10.
Designing an environmental monitoring programme
11.
Special Types of Environmental Monitoring
12.
Cleanrooms and microflora
13.
Assessment of pharmaceutical water systems
14.
Data handling and trend analysis
15.
Bioburden and endotoxin assessment of pharmaceutical processing
16.
Risk assessment and investigation for environmental monitoring
17.
Assessing and removing contamination risks from the process
18.
The human factor
19.
Biocontamination deviation management
374
pages
From
Academic Press at: https://www.elsevier.com/books/biocontamination-control-for-pharmaceuticals-and-healthcare/sandle/978-0-12-814911-9
From
Amazon at: https://www.amazon.com/Biocontamination-Control-Pharmaceuticals-Healthcare-Sandle/dp/0128149116
Reference:
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
