Title:
Sterile drug products : formulation, packaging, manufacturing, and quality / Michael J. Akers.
Drugs and the pharmaceutical sciences
Drugs and the pharmaceutical sciences.
Main Entry:
Akers, Michael J.
Publisher:
Informa Healthcare,
Publication Date:
2010.
Publication Place:
New York :
ISBN:
9780849339936 (hbk.)
0849339936 (hbk.)
Subject:
Drugs -- Sterilization.
Dosage Forms -- standards.
Quality Control.
Sterilization -- standards.
Technology, Pharmaceutical -- standards.
Series:
Drugs and the pharmaceutical sciences
Drugs and the pharmaceutical sciences.
Contents:
Introduction, scope, and history of sterile products -- Characteristics of sterile dosage forms -- Types of sterile dosage forms -- Sterile product packaging systems -- Overview of product development -- Formulation components (solvents and solutes) -- Sterile products packaging chemistry -- Formulation and stability of solutions -- Dispersed systems -- Formulation of freeze-dried powders -- Overcoming formulation problems and some case studies -- Overview of sterile product manufacturing -- Contaminatin control -- Sterile manufacturing facilities -- Water and air quality in sterile manufacturing facilities -- Personnel requirements for sterile manufacturing -- Sterile methods in sterile product manufacturing -- Sterile filtration -- Sterile product filling, stoppering, and sealing -- Freeze-dry (lyophilization) processing -- Aseptic processing -- Inspection, labeling, and secondary packaging -- Barrier and other advanced technologies in aseptic processing -- Stability, storage, and distribution of sterile drug products -- Good manufacturing practice -- Quality assurance and control -- Microorganisms and sterility testing -- Pyrogens and pyrogen/endotoxin testing -- Particles and particulate matter testing -- Sterile product-package integrity testing -- Administration of injectable drug products -- Clinical hazards of injectable drug administration -- Biopharmaceutical considerations with injectable drug delivery.
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