Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements,Second Edition

A Practical Guide to Microbial Limit Methodologies

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.

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Microbial Contamination Control in Parenteral Manufacturing

This reference surveys emerging trends, concepts, and procedures used in the characterization and control of contaminants; the sterile production of traditional drugs and biologics; the design, construction, and validation of new parenteral facilities; and the monitoring of clean environments-vividly illustrating the routes by which products, processes, and manufacturing settings become contaminated through contact with the air, water, raw materials, and the actions of personnel, as well as the current methods necessary to successfully preclude contamination.

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Modern Industrial Microbiology and Biotechnology

Nduka Okafor, “Modern Industrial Microbiology and

Science Publishers | 2007-03-30 | ISBN: 1578084342 | 539 pages | PDF | 4 MB

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This book is directed towards undergraduates and beginning graduate students in microbiology, food science and chemical engineering. Those studying pharmacy, biochemistry and general biology will find it of interest. The section on waste disposal will be of interest to civil engineering and public health students and practitioners. For the benefit of those students who may be unfamiliar with the basic biological assumptions underlying industrial microbiology, such as students of chemical and civil engineering, elements of biology and microbiology are introduced. The new elements which have necessitated the shift in paradigm in industrial microbiology such as bioinformatics, genomics, proteomics, site-directed mutation, metabolic engineering, the human genome project and others are also introduced and their relevance to industrial microbiology and biotechnology indicated. As many references as space will permit are included. The various applications of industrial microbiology are covered broadly, and the chapters are grouped to reflect these applications. The emphasis throughout, however, is on the physiological, biochemical principles, and where possible, the genomic principles behind these applications.

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