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Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
This book provides a broad account of various applied aspects of microbiology for quality and safety evaluations in food, water, soil, environment and pharmaceutical sciences. The work is timely, as the safety and quality of various commodities such as water and wastewater, food, pharmaceutical medications and medical devices are of paramount concern in developing countries globally for improved public health quality in areas ranging from food security to disease exposure. The book offers an introduction to basic concepts of biosafety and related microbiological practices and applies these methodologies to a multitude of disciplines in subject-focused chapters. Each chapter offers experiments and exercises pertaining to the specific area of interest in microbiological research, which will allow readers to apply the knowledge gained in a laboratory or classroom setting to see the microbiological methods discussed in practice. The book will be useful for industrialists, researchers, academics and undergraduate/graduate students of microbiology, biotechnology, botany and pharmaceutical sciences. The text aims to be a significant contribution in effectively guiding scientists, analysts, lab technicians and quality managers working with microbiology in industrial and commercial fields.
The Fifth edition of the Compendium of Methods for the Microbiological Examination of Foods has now been fully updated. All chapters have been revised and new chapters have been added. This Compendium is the primary authority for food safety testing and presents a comprehensive selection of proven testing methods with an emphasis on accuracy, relevance, and reliability. The Compendium is a must-have for all food laboratories, food manufacturers, public health laboratories, and anyone performing food safety testing. - Publisher.
Aquatic Ecotoxicology: Advancing Tools for Dealing with Emerging Risks presents a thorough look at recent advances in aquatic ecotoxicology and their application in assessing the risk of well-known and emerging environmental contaminants. This essential reference, brought together by leading experts in the field, guides users through existing and novel approaches to environmental risk assessment, then presenting recent advances in the field of ecotoxicology, including omics-based technologies, biomarkers, and reference species. The book then demonstrates how these advances can be used to design and perform assays to discover the toxicological endpoints of emerging risks within the aquatic environment, such as nanomaterials, personal care products, PFOS and chemical mixtures. The text is an invaluable reference for any scientist who studies the effects of contaminants on organisms that live within aquatic environments. - Provides the latest perspectives on emerging toxic risks to aquatic environments, such as nanomaterials, pharmaceuticals, chemical mixtures, and perfluorooctane sulfonate (PFOS) - Offers practical guidance on recent advances to help in choosing the most appropriate toxicological assay - Presents case studies and information on a variety of reference species to help put the ecotoxicological theory into practical risk assess
Recent and forecasted advances in microbiology, molecular biology, and analytical chemistry have made it timely to reassess the current paradigm of relying predominantly or exclusively on traditional bacterial indicators for all types of waterborne pathogens. Nonetheless, indicator approaches will still be required for the foreseeable future because it is not practical or feasible to monitor for the complete spectrum of microorganisms that may occur in water, and many known pathogens are difficult to detect directly and reliably in water samples. This comprehensive report recommends the development and use of a "tool box" approach by the U.S Environmental Protection Agency and others for assessing microbial water quality in which available indicator organisms (and/or pathogens in some cases) and detection method(s) are matched to the requirements of a particular application. The report further recommends the use of a phased, three-level monitoring framework to support the selection of indicators and indicator approaches.Â
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. The first edition of the book covered 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) the new edition expands the coverage of quality risk management and new complete examples to help professionals bridge the gap between regulation and implementation. Biocontamination Control for Pharmaceuticals and Healthcare offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy. - Includes the most current regulations - Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy - Offers practical guidance on building a complete biocontamination strategy