Bøger af Tim (Head of Microbiology Sandle

Biocontamination Control for Pharmaceuticals and Healthcare, Second Edition outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covers many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141), this new edition expands coverage of quality risk management and contains completely new examples to help professionals bridge the gap between regulation and implementation. This book offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy.

Pharmaceutical microbiology is concerned with protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products the effects can range from discoloration to a potential fatality. Pharmaceutical microbiology is also concerned with the harnessing of microorganisms for the manufacture of biotechnological products. Pharmaceutical microbiologists need to be well versed in laboratory methods (including the advent of rapid methods); they also need sound knowledge of risk assessment and how these principles apply to manufacturing environments (including cleanrooms, sterilization methods, disinfection, and water systems). Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control provides an overview of the function of the pharmaceutical microbiologist and what the pharmaceutical microbiologist needs to know, from regulatory filing and GMP, to laboratory design and management, compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters. Other topics covered include auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media and contamination control.