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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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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Pharmaceutical Microbiology

The textbook on `Pharmaceutical Microbiology` has been adequately developed and expanded according to the AICTE- Approved Syllabus-2000 meant for the Pharmacy Degree Programme across all the Indian Universities, and others abroad offering similar curricula.

Specific attention has been duly paid to the presentation of each chapter that essentially includes: brief introduction, theoretical aspects, classification, neat and vivid diagrammatic illustrations of figures-graphics-equipments, lucid explanations, supportive classical examples, and profusely supplemented with explanatory`foot notes`-references in addition to further reading bibliography.

The text content runs over ten chapters that may prove to be of paramount interest and enormous readability not only confined to the B.Pharm., students but also to various M.Sc., academic curricula in such disciplines as: Food Microbiology, Environmental Science, Microbiology etc.

Key Features IncludeConcise and exhaustive presentation of scientific informations from several sources.A wealth of theoretical information that opens newer possibilities.Detailed classification of various microbial aspects.Pharmaceutical assays and methodologies.Comprehensive index includes significant terminologies.Well documented statement of facts.

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