Microbial Limit and Bioburden Tests

In recent years, the field of pharmaceutical microbiology has experienced numerous technological advances, accompanied by the publication of new and harmonized compendial methods.

Microbial Limit and Bioburden Tests

Microbial Limit and Bioburden Tests

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.

More Books:

Microbial Limit and Bioburden Tests
Language: en
Pages: 280
Authors: Lucia Clontz
Categories: Science
Type: BOOK - Published: 2008-10-14 - Publisher: CRC Press

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
Encyclopedia of Pharmaceutical Technology
Language: en
Pages: 500
Authors: James Swarbrick, James C. Boylan
Categories: Medical
Type: BOOK - Published: 2000-12-05 - Publisher: CRC Press

The Encyclopedia of Pharmaceutical Technology presents authoritative and contemporary articles on all aspects of drug development, dosage forms, manufacturing, and regulation-enabling the specialist and novice alike to keep abreast of developments in this rapidly evolving and highly competitive field. A dependable reference tool and a solid investment for years to
Pharmaceutical Microbiological Quality Assurance and Control
Language: en
Pages: 592
Authors: David Roesti, Marcel Goverde
Categories: Technology & Engineering
Type: BOOK - Published: 2020-01-02 - Publisher: John Wiley & Sons

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
Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition
Language: en
Pages: 504
Authors: Stephen P. Denyer, Rosamund M. Baird
Categories: Science
Type: BOOK - Published: 2006-12-26 - Publisher: CRC Press

Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Updated to reflect technological and regulatory changes, the Guide to Microbiological Control in Pharmaceuticals
Handbook of Modern Pharmaceutical Analysis
Language: en
Pages: 566
Authors: Satinder Ahuja, Stephen Scypinski
Categories: Medical
Type: BOOK - Published: 2001-08-02 - Publisher: Elsevier

This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry

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