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Title Sterile product development : formulation, process, quality and regulatory considerations / Parag Kolhe, Mrinal Shah, Nitin Rathore, editors
Published New York : Springer, 2013
Online access available from:
Springer eBooks    View Resource Record  


Description 1 online resource (xvi, 585 pages) : illustrations (some color)
Series AAPS Advances in the Pharmaceutical Sciences Series, 2210-7371
AAPS advances in the pharmaceutical sciences series. 2210-7371
Contents Formulation approaches for sterile products -- Process, container closure and delivery considerations -- Regulatory and quality aspects
Summary This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines, Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures, Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development
Notes Includes index
Bibliography Includes bibliographical references and index
Notes Online resource; title from PDF title page (SpringerLink, viewed October 14, 2013)
Subject Drugs -- Sterilization.
Pharmaceutical industry -- Quality control.
Chemistry, Pharmaceutical -- standards.
Sterilization -- methods.
Drug Compounding -- standards.
Drug Contamination -- prevention & control.
Form Electronic book
Author Kolhe, Parag, editor
Shah, Mrinal, editor
Rathore, Nitin, editor
LC no. 2013948456
ISBN 9781461479789 (electronic bk.)
1461479789 (electronic bk.)