Includes bibliographical references and index.

Introuction to biocontamination and biocontamination control -- Sources of microbial contamination and risk profiling -- GMP regulations and standards -- Biocontamination control strategy -- Cleanrooms and environmental monitoring -- Viable environmental monitoring methods -- Selection and application of culture media -- Particle counting -- Rapid and alterative microbiological methods -- Designing and implementing an environmental monitoring program -- Special types of environmental monitoring -- Cleanroom microbiota -- Assessment of pharmaceutical water systems -- Data handling and trend analysis -- Bioburden and endotoxin control in pharmaceutical processing -- Risk assessment and investigation for environmental monitoring -- Assessing, co ntrolling and removing contamination risks from the process -- The human factor and biocontamination control -- Biocontamination deviation management.

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.

Electronic reproduction.: ProQuest LibCentral. Mode of access: World Wide Web.