Michael J. Akers

Sterile Drug Products (eBook, PDF)

Formulation, Packaging, Manufacturing and Quality

• Format: PDF

Produktbeschreibung

Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common.

This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology:

• Product development, including formulation, packaging, and process development.
• Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control.
• Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form
• Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 516
• Erscheinungstermin: 19. April 2016
• Englisch
• ISBN-13: 9781420020564
• Artikelnr.: 42765681

Autorenporträt

Michael J. Akers Ph.D. is Senior Director of Pharmaceutical Research and Development at Baxter and leads the Baxter Lyophilization Center of Excellence in Bloomington, Indiana. Dr. Akers received his B.A. degree from Wabash College and Ph.D. degree in Pharmaceutics from the University of Iowa College of Pharmacy, and has previously been employed at Searle Laboratories, Alcon Laboratories, University of Tennessee, and Eli Lilly and Company. Dr. Akers is active in the Parenteral Drug Association and is a Fellow of the American Association of Pharmaceutical Scientists. He is editor-in-chief of Pharmaceutical Development and Technology, and author or editor of six books, including Parenteral Quality Control: Sterility, Pyrogen, Particulate, and Packaging Integrity Testing, Third Edition, 2002.

Inhaltsangabe

Introduction, scope, and history of sterile productsCharacteristics of
sterile dosage formsTypes of sterile dosage formsSterile product packaging
systemsOverview of product developmentFormulation components (solvents and
solutes)Sterile products packaging chemistryFormulation and stability of
solutionsDispersed systemsFormulation of freeze-dried powdersOvercoming
formulation problems and some case studiesOverview of sterile product
manufacturingContamination controlSterile manufacturing facilitiesWater and
air quality in sterile manufacturing facilitiesPersonnel requirements for
sterile manufacturingSterilization methods in sterile product manufacturing
Sterile filtrationSterile product filling, stoppering, and sealing
Freeze-dry (lyophilization) processingAseptic processingInspection,
labeling, and secondary packagingBarrier and other advanced technologies in
aseptic processingStability, storage, and distribution of sterile drug
productsGood manufacturing practiceQuality assurance and control
Microorganisms and sterility testingPyrogens and pyrogen/endotoxin testing
Particles and particulate matter testingSterile product-package integrity
testingAdministration of injectable drug productsClinical hazards of
injectable drug administrationBiopharmaceutical considerations with
injectable drug delivery