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Full Description
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.
Contents
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 manufacturingSterile filtrationSterile product filling, stoppering, and sealingFreeze-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 controlMicroorganisms and sterility testingPyrogens and pyrogen/endotoxin testingParticles and particulate matter testingSterile product-package integrity testingAdministration of injectable drug productsClinical hazards of injectable drug administrationBiopharmaceutical considerations with injectable drug delivery
