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Rapid Microbiological Methods in the Pharmaceutical Industry

Author: Martin C. Easter

Publisher: CRC Press

Published: 2003-03-19

Total Pages: 288

ISBN-13: 0203010876

In recent years there has been increased interest in the possibility of rapid microbiological methods offering enhanced potential error detection capabilities. However, these methods raise a number of questions, such as how to validate new methods, will they be accepted by the pharmacopoeias, and, most importantly, how will the regulators respond?

Rapid Microbiological Methods for Foods, Beverages and Pharmaceuticals

Author: C. J. Stannard

Publisher: John Wiley & Sons

Published: 2009-07-08

Total Pages: 320

ISBN-13: 1444314157

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This book considers the rapid microbiological techniques that are now increasingly used in industry as alternatives to more conventional methods. Although many of the pioneering studies in this field have taken place in clinical laboratories, the materials listed and organisms sought for foods, beverages and pharmaceuticals are much more varied. In this volume, leading experts from research and industry review the wide variety of approaches that are needed in an industrial setting. The methods described include electrometric techniques, ATP assay, and immunological methods for a wide range of organisms from salmonellas to viruses, each chapter drawing on the authors direct experience in industry to give a highly practical guide. The book should prove invaluable to those in the food, beverage and pharmaceutical industries, or in research and training, who require an up-to-date survey of the use of rapid microbiological methods.

Pharmaceutical Microbiological Quality Assurance and Control

Author: David Roesti

Publisher: John Wiley & Sons

Published: 2020-01-02

Total Pages: 594

ISBN-13: 1119356075

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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

Principles of Bacterial Detection: Biosensors, Recognition Receptors and Microsystems

Author: Mohammed Zourob

Publisher: Springer Science & Business Media

Published: 2008-09-03

Total Pages: 980

ISBN-13: 0387751130

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Principles of Bacterial Detection: Biosensors, Recognition Receptors and Microsystems will cover the up-to-date biosensor technologies used for the detection of bacteria. Written by the world's most renowned and learned scientists each in their own area of expertise, Principles of Bacterial Detection: Biosensors, Recognition Receptors and Microsystems is the first title to cover this expanding research field.

Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices

Author: Rosamund M. Baird

Publisher: CRC Press

Published: 2000-08-17

Total Pages: 274

ISBN-13: 0203305191

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Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by provi

Bacteriological Analytical Manual

Author: United States. Food and Drug Administration. Division of Microbiology

Publisher:

Published: 1969

Total Pages: 180

ISBN-13:

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Biocontamination Control for Pharmaceuticals and Healthcare

Author: Tim Sandle

Publisher: Elsevier

Published: 2024-02-09

Total Pages: 510

ISBN-13: 0443216010

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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

Pharmaceutical Microbiology

Author: Tim Sandle

Publisher: Woodhead Publishing

Published: 2015-10-09

Total Pages: 318

ISBN-13: 0081000448

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Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on 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 the potential for fatality. The book provides an overview of the function of the pharmaceutical microbiologist and what they need to know, from regulatory filing and GMP, to laboratory design and management, and compendia tests and risk assessment tools and techniques. These key aspects are discussed through a series of dedicated chapters, with topics covering auditing, validation, data analysis, bioburden, toxins, microbial identification, culture media, and contamination control. Contains the applications of pharmaceutical microbiology in sterile and non-sterile products Presents the practical aspects of pharmaceutical microbiology testing Provides contamination control risks and remediation strategies, along with rapid microbiological methods Includes bioburden, endotoxin, and specific microbial risks Highlights relevant case studies and risk assessment scenarios

Microbiological Contamination Control in Pharmaceutical Clean Rooms

Author: Nigel Halls

Publisher: CRC Press

Published: 2016-04-19

Total Pages: 198

ISBN-13: 1420025805

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Contamination control in pharmaceutical clean rooms has developed from a jumble of science and engineering, knowledge of what has worked well or badly in the past, dependent upon the technology available at the time the clean room was built and subsequent technological developments. Surrounding it all is a blanket of regulations. Taking a multidisc

Microbial Limit and Bioburden Tests

Author: Lucia Clontz

Publisher: CRC Press

Published: 2008-10-14

Total Pages: 0

ISBN-13: 9781420053487

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In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods. It is therefore imperative for those who are responsible for monitoring the microbial quality of pharmaceutical/biopharmaceutical products to keep abreast of the latest changes. Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements guides readers through the various microbiological methods listed in the compendia with easy-to-follow diagrams and approaches to validations of such test methodologies. Includes New and Updated Material Now in its second edition, this work is the culmination of research and discussions with technical experts, as well as USP and FDA representatives on various topics of interest to the pharmaceutical microbiologist and those responsible for the microbial quality of products, materials, equipment, and manufacturing facilities. New in this edition is an entire chapter dedicated to the topic of biofilms and their impact on pharmaceutical and biopharmaceutical operations. The subject of rapid methods in microbiology has been expanded and includes a discussion on the validation of alternative microbiological methods and a case study on microbial identification in support of a product contamination investigation. Substantially updated and revised, this book assists readers in understanding the fundamental issues associated with pharmaceutical microbiology and provides them with tools to create effective microbial contamination control and microbial testing programs for the areas under their responsibility.