Michael J Akers

Sterile Drug Products

Formulation, Packaging, Manufacturing and Quality

• Gebundenes Buch

Produktbeschreibung

Supplying the latest research on the formulation, manufacture, quality control, and regulation of pharmaceuticals, biopharmaceuticals, and related products, this reference contains up-to-the-minute chapters on contamination control, facilities management, inspection, distribution, GMP, sterility and stability testing, and aseptic environments.

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Produktdetails

• Verlag: Taylor & Francis Ltd (Sales)
• Seitenzahl: 516
• Erscheinungstermin: 20. August 2010
• Englisch
• Abmessung: 263mm x 181mm x 33mm
• Gewicht: 1047g
• ISBN-13: 9780849339936
• ISBN-10: 0849339936
• Artikelnr.: 22047337

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