Rapid Microbiological Methods in the Pharmaceutical Industry PDF Download
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Author: Martin C. Easter
Publisher: CRC Press
ISBN: 0203010876
Category : Medical
Languages : en
Pages : 288
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Book Description
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?
Author: Martin C. Easter
Publisher: CRC Press
ISBN: 0203010876
Category : Medical
Languages : en
Pages : 288
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Book Description
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?
Author: David Roesti
Publisher: John Wiley & Sons
ISBN: 1119356075
Category : Technology & Engineering
Languages : en
Pages : 594
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Book Description
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
Author: C. J. Stannard
Publisher: John Wiley & Sons
ISBN: 1444314157
Category : Technology & Engineering
Languages : en
Pages : 320
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Book Description
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.
Author: Mohammed Zourob
Publisher: Springer Science & Business Media
ISBN: 0387751130
Category : Technology & Engineering
Languages : en
Pages : 980
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Book Description
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.
Author: Rosamund M. Baird
Publisher: CRC Press
ISBN: 0203305191
Category : Medical
Languages : en
Pages : 274
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Book Description
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
Author: Tim Sandle
Publisher: Elsevier
ISBN: 0443216010
Category : Medical
Languages : en
Pages : 510
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Book Description
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
Author: United States. Food and Drug Administration. Division of Microbiology
Publisher:
ISBN:
Category : Microbiology
Languages : en
Pages : 180
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Book Description
Author: Nigel Halls
Publisher: CRC Press
ISBN: 1420025805
Category : Medical
Languages : en
Pages : 200
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Book Description
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
Author: Scott Sutton
Publisher:
ISBN: 9781933722085
Category : Pharmaceutical industry
Languages : en
Pages : 0
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Book Description
Author: Tim Sandle
Publisher: Woodhead Publishing
ISBN: 0081000448
Category : Science
Languages : en
Pages : 316
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Book Description
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
