1st Edition

by Tim Sandle (Author)

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.

• 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