Pharmaceutical dosage forms : Parenteral medications : Volume 2 : Facility design, sterilization and processing /
edited by Sandeep Nema, John D. Ludwig.
- 3rd ed.
- London : Informa healthcare, 2010
- xiv, 396 p. : tables, ill. figs, picture. ; 26 cm.
- V-2 .
Includes bibliographical references and index.
Chapter 1 Aseptic manufacturing facility design Chapter 2 Personnel and their impact on clean room operations; Chapter 3 The fundamentals of an environmental control program; Chapter 4 Water systems for parenteral facilities; Chapter 5 Particulate matter: subvisible Chapter 6 Endotoxin testing; Chapter 7 The compendial sterility tests Chapter 8 Industrial sterilization technologies: principles and overview Chapter 9 Steam sterilization; Chapter 10 Gas, vapor, and liquid chemical sterilization. Chapter 11 Dry heat depyrogenation and sterilization Chapter 12 Radiation sterilization; Chapter 13 Filters and filtration; Chapter 14 Processing of small volume parenterals and large volume parenterals; Chapter 15 Freeze-drying: principles and practice;
Summary:"A historical perspective of injectable drug therapy, common routes of administration, and biopharmaceutics of NCEs and NBEs. - An in-depth discussion on the preformulation and formulation of small and large molecules, including ophthalmic dosage forms. - A presentation of parenteral primary packaging options - glass and plastic containers, as well as elastomeric closures. - A definitive chapter on container-closure integrity. - New chapters on solubility and solubilization, formulation of depot delivery systems and biophysical/biochemical characterization of proteins"--Provided by publishe
9781420086454
Parenteral solutions Pharmaceutical technology Drug Delivery Systems methods Infusions, Parenteral standards Drugs Dosage